PART I
ITEM
1. IDENTITY
OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS
Not applicable.
ITEM
2. OFFER
STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM
3. KEY
INFORMATION
A
. Selected consolidated financial data
The following table presents
selected financial data of the Company as of the dates and for each of the
periods indicated. You should read the selected financial data set forth below
together with Item 5. Operating and Financial Review and Prospects as well as
the Companys audited consolidated financial statements and notes thereto
appearing elsewhere in this Annual Report.
The selected consolidated
financial data as of June 30, 2007, 2006 and 2005 and for each of the three
years in the period ended June 30, 2007 have been derived from, and
are
qualified in its entirety by reference to,
the Companys audited consolidated financial statements and notes
thereto included elsewhere in this Annual Report.
The
selected consolidated financial data as of and for the years ended June 30, 2005,
2004 and 2003 have been derived from the Companys audited consolidated
financial statements not included in this Annual Report.
The Company prepares its consolidated financial statements in
accordance with current Australian Accounting Standards, which differ in
certain significant respects from U.S. GAAP. A description of the significant
differences and reconciliations of net loss and shareholders equity for
the periods and as of the dates therein indicated
are set forth in Note
26 to the Companys consolidated financial statements included elsewhere
herein.
Selected consolidated financial data as of and for the years ended June
30, 2007, 2006, 2005, 2004 and 2003 is set out below.
Consolidated Income Statement Data
in
Accordance with AIFRS
:
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
A$000, except per share data
|
|
|
|
|
|
|
|
Revenues from ordinary activities
|
|
2,288
|
|
2,297
|
|
4,095
|
|
|
|
|
|
|
|
|
|
Research expenditure
|
|
(7,732
|
)
|
(7,186
|
)
|
(4,621
|
)
|
Employee costs
|
|
(2,518
|
)
|
(2,710
|
)
|
(2,631
|
)
|
Patent costs
|
|
(565
|
)
|
(576
|
)
|
(447
|
)
|
Legal costs
|
|
(66
|
)
|
(114
|
)
|
(106
|
)
|
Depreciation
|
|
(271
|
)
|
(272
|
)
|
(270
|
)
|
Other expenses from ordinary activities(a)
|
|
(2,837
|
)
|
(1,809
|
)
|
(2,255
|
)
|
Operating loss
|
|
(11,701
|
)
|
(10,370
|
)
|
(6,235
|
)
|
Profit on sale of subsidiary
|
|
|
|
|
|
|
|
Net loss
|
|
(11,701
|
)
|
(10,370
|
)
|
(6,235
|
)
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (A$)
|
|
(0.07
|
)
|
(0.09
|
)
|
(0.06
|
)
|
Basic and diluted weighted average number
of shares(b)
|
|
162,281,115
|
|
117,647,158
|
|
105,707,630
|
|
7
Consolidated Income Statement Data in Accordance with U.S. GAAP
|
|
2007
|
|
2006
|
|
2005
|
|
2004
|
|
2003
|
|
Revenues from ordinary activities
|
|
1,266
|
|
2,055
|
|
3,828
|
|
3,490
|
|
4,997
|
|
Net loss
|
|
(11,701
|
)
|
(10,444
|
)
|
(6,189
|
)
|
(20,060
|
)
|
(1,943
|
)
|
Basic and diluted loss per share (A$)
|
|
(0.07
|
)
|
(0.09
|
)
|
(0.06
|
)
|
(0.35
|
)
|
(0.04
|
)
|
Consolidated Balance Sheet Data in Accordance with AIFRS:
|
|
2007
|
|
2006
|
|
2005
|
|
A$000
|
|
|
|
|
|
|
|
Cash assets
|
|
25,367
|
|
15,554
|
|
8,512
|
|
Plant and equipment, net
|
|
82
|
|
329
|
|
587
|
|
Total assets
|
|
42,761
|
|
32,965
|
|
26,575
|
|
Long-term debt
|
|
|
|
|
|
|
|
Total liabilities
|
|
2,891
|
|
1,960
|
|
1,340
|
|
Net assets
|
|
39,870
|
|
31,005
|
|
25,235
|
|
Accumulated deficit
|
|
(92,723
|
)
|
(81,023
|
)
|
(70,633
|
)
|
Contributed equity
|
|
120,773
|
|
99,893
|
|
84,592
|
|
Reserves
|
|
11,820
|
|
12,135
|
|
11,296
|
|
Consolidated Balance Sheet Data in Accordance with U.S. GAAP
|
|
2007
|
|
2006
|
|
2005
|
|
2004
|
|
2003
|
|
A$000
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
25,829
|
|
16,034
|
|
9,718
|
|
2,252
|
|
4,495
|
|
Net assets
|
|
22,938
|
|
14,073
|
|
8,378
|
|
131
|
|
4,048
|
|
Contributed equity
|
|
120,381
|
|
99,501
|
|
84,201
|
|
69,865
|
|
54,236
|
|
(a)
Other expenses from ordinary activities comprise
consulting and advisory costs, scientific advisory board costs, accounting and
auditing costs, travel expenses and outsourced employee costs.
(b)
Basic loss per share is determined by dividing the
loss after income tax by the weighted average number of ordinary shares,
outstanding during the period. The computation of diluted loss per share is
similar to basic loss per share, except that it assumes the potentially
dilutive securities, such as options, were converted to shares at the beginning
of the period. For all periods presented, diluted loss per share is equivalent
to basic loss per share as the potentially dilutive securities are excluded from
the computation of diluted loss per share because the effect is anti-dilutive.
Dividends
No dividend has been paid by the Company in the five fiscal years up to
and including fiscal 2007.
Exchange rates
The consolidated financial statements of the Company which form part of
this Annual Report are presented in Australian dollars (A$).
8
The following table sets forth, for the periods and dates indicated,
certain information concerning the noon buying rate in New York City for
Australian dollars expressed in U.S. dollars per A$1.00 as certified for
customs purposes by the Federal Reserve Bank of New York.
Month
|
|
Months highest exchange rate
|
|
Months lowest exchange rate
|
|
October 2007
|
|
0.8847
|
|
0.9223
|
|
September 2007
|
|
0.8884
|
|
0.8190
|
|
August 2007
|
|
0.8589
|
|
0.7873
|
|
July 2007
|
|
0.8845
|
|
0.8498
|
|
June 2007
|
|
0.8485
|
|
0.8252
|
|
May 2007
|
|
0.8332
|
|
0.8184
|
|
April 2007
|
|
0.8381
|
|
0.8091
|
|
Years ended June 30,
|
|
Average
|
|
|
|
|
|
2007
|
|
0.7865
|
|
2006
|
|
0.7475
|
|
2005
|
|
0.7535
|
|
2004
|
|
0.7134
|
|
2003
|
|
0.5847
|
|
As at November 2, 2007 the Australian dollar closed at US$0.9180
B
. Capitalization and indebtedness
Not applicable.
C. Reasons
for the offer and use of proceeds
Not applicable.
D. Risk
factors
Prospective investors and shareholders should be aware that any
investment in the Company involves a degree of risk and should be made only by
those with the necessary expertise to appraise the investment. In addition to
the other information in this document, the following risk factors should be
considered in evaluating whether to make or hold an investment in the Company.
Any or all of these factors could have a material and adverse effect on the
Companys operational results, financial condition and prospects. Furthermore,
the trading price of ChemGenex shares could decline resulting in the loss of
all or part of any investment therein.
The Company has a history of operating losses and negative cash flow
and may never become profitable
ChemGenex is a company that has a history of operating losses. These
losses have arisen mainly from the costs incurred in research and development
of its products and general administrative costs. For the year ended June 30,
2007, the Companys net loss was A$11,700,919 and its accumulated deficit as of
June 30, 2007 was A$92,723,921.
9
The Company expects to continue to incur operating losses over the next
two years and may never be profitable. To date, the Company has generated
revenues through research and development funding from its partners, milestone
payments and contract research. In order to support the research and
development of the Companys business, the Company plans to incur expenses in
excess of revenue. The Companys strategy is to utilize its understanding of
the genetics of complex diseases and its expertise in medicinal chemistry to
identify novel targets for therapeutic intervention and to develop personalized
medicines particularly in the field of cancer. The discovery of novel gene and
protein targets and the subsequent development of therapeutic products based on
these targets is an expensive process and the Company has in the past partnered
its discovery programs in diabetes and obesity and in depression with
international pharmaceutical companies. The Companys cancer program has led to
the development of two therapeutic agents that are currently in clinical trial
in the U.S. The Company may not develop any products and any other products it
may develop may not generate revenues.
Additional funding is likely to be required to give the Company time to
reach profitability. Raising such additional funding could entail restrictions
on the rights of holders of ordinary shares. If the Company is unable to raise
additional funds it may have to curtail its operations.
The Companys need for capital at any given time depends on a number of
factors, including:
the ability to
enter collaborations to support its research and development programs;
the rate of progress
and cost of the Companys research activities;
the costs of
preparing, filing, prosecuting, maintaining and enforcing patent claims and
other intellectual property rights;
the
costs and timing of obtaining regulatory approvals for the Companys products;
the emergence of
competing products and other adverse market development; and
changes in, or
termination of, the Companys existing collaboration and licensing
arrangements.
The Company may not receive further revenues from collaboration and
licensing agreements or changes in the development of the Companys drug
candidates may cause available capital resources to be used more quickly than
expected.
The Company is likely in the future to require additional funds, in
addition to funds received from licensing and collaboration agreements, to
continue research and development. It is likely that the Company will seek
funds through further licensing and collaboration agreements and through
additional sale of the Companys securities. The Company may not be able to
secure licensing and collaboration agreements on satisfactory terms, if at all.
Also, the public markets for issues of biotechnology company securities are
volatile and competitive. The Company may not be able to attract additional funds
on acceptable terms, if at all. The Company also may decide to access the
public equity markets whenever conditions are favorable, even if the Company
does not have an immediate need for additional capital at that time. If the
Company raises additional funds by issuing equity securities, dilution to
shareholders may result. This might be the case, for example, because U.S.
investors may not be able to participate in certain fund raising, such as
rights offerings, under applicable securities laws and may therefore be
diluted. Other shareholders may not have the means to exercise their rights in
such an offering, and will see their interests diluted, and the price at which
any further capital raising is made also may be below the price at which other
investors acquired their shares.
If
adequate funds are not available, the Company may have to significantly reduce
its research and development programs or obtain funds through licensing and
collaboration agreements at an earlier stage in the drugs development than the
Company envisaged. If adequate funds are not available on acceptable terms, its
ability to invest in the progress of its development programs and product
portfolio will be materially and adversely affected, with the result that its
prospects are less favorable. Following the issue of 33,948,293 shares at
A$0.62 cents each on Feb/April of 2007 ChemGenex had working capital of
approximately A$23 million as at June 30, 2007. Based on the anticipated cash
flow requirements of the Companys existing research and development
activities, the Board has concluded that these funds should be sufficient to
support operations into the second half of calendar 2008. The Board remains
confident that adequate funds to continue the Companys operations will be
raised from partnership agreements and/or equity placements as required in the
future.
The Company anticipates a net loss in fiscal 2008.
10
If the Company is unable to retain and attract key employees, its scientific
and management capabilities could be reduced.
The loss of key employees could weaken the Companys scientific and
management capabilities, resulting in delays in the development of its cancer
clinical trials and broader research programs thus impacting negatively on the
Companys business. ChemGenex is significantly dependent on certain scientific
and management personnel, including Dr. Gregory R. Collier, Dr. Dennis M.
Brown, Dr. James A. Campbell, Eric P. Merrigan, Tina Herbert, and Eric
Humphriss. Although the Company has entered into employment or consultancy
arrangements with each of the Companys key personnel with the aim of securing
their services, the retention of such services cannot be guaranteed. Companies
such as ChemGenex are highly dependent on employees who have an in-depth and
long-term understanding of their companies technologies, products, programs,
collaborative relationships and strategic goals. The loss of these key
employees and the Companys inability to recruit new employees to replace them
could have a negative impact on the business and prospects of the Company
because the Companys scientific and management capabilities would be reduced.
The Company is dependent on its academic collaborators, consultants and
scientific advisors and their confidentiality.
The Company has relationships with
collaborators and consultants at academic and other scientific institutions who
conduct trials under contractually defined terms at the Companys request. It
is the Companys policy that all of its employees, academic collaborators,
consultants and scientific advisors enter into confidentiality agreements that
control the dissemination of all intellectual property produced that results
from their work for the Company. It is possible; however, that unauthorized
dissemination of such confidential information could materially adversely
affect the Companys business, financial condition and results of operations. Such
collaborators also could enter into employment agreements or consulting arrangements
with competitors.
The Company may not be successful in its clinical trials programs. These
programs are costly, time consuming and of uncertain outcome. If such programs
are not successful, the Company may invest substantial amounts of time and money
without developing revenue-producing products.
Clinical trials of promising products can take years, the duration
depending among other factors on type, complexity, novelty and intended use of
the product candidate. The Company may fail to successfully complete clinical
trials and bring products to market for a number of reasons, including:
as the Company
enters a more extensive clinical program in several different diseases, the
data generated in these studies may not be as compelling as the earlier
results;
unforeseen
safety issues or side effects;
variability in
the number and types of patients available for each study, and difficulty in
maintaining contact with patients after treatment, resulting in incomplete
data;
delays
resulting from review board action at institutions assisting the Company with
its clinical trials; and
the failure to
obtain required regulatory approvals.
If the products that the Company brings to market are not commercially
successful, the Companys liquidity may be adversely affected.
The Companys success depends on acceptance of the Companys products
by the market, including physicians and third-party payers, and consequently
the Companys liquidity and viability as a going concern may be adversely
affected if it is unable to achieve market acceptance of its products. Factors
that may affect the rate and level of market acceptance of any of the Companys
products include:
the existence or
entry onto the market of superior competing products or therapies;
the price of the
Companys products compared to competing products;
11
public
perception regarding the safety, efficacy and benefits of the Companys
products compared to competing products or therapies;
the
effectiveness of the Companys sales and marketing efforts and those of the
Companys marketing partners;
regulatory
developments related to manufacturing or use of the Companys products;
the willingness
of physicians to adopt a new treatment regimen; and
publicity
concerning the product type in general.
Even if the Companys products are approved, they may still face later
regulatory difficulties, which could impair its ability to market its products
or force it to incur substantial additional expenses.
Even if the Company receives regulatory approval to sell any of its
products, the U.S. Food and Drug Administration (FDA), the Australian
Therapeutics Goods Administration or comparable foreign regulatory agencies
could require the Company to conduct post-marketing trials to further evaluate
safety and efficacy or could prevent the Company from using the labeling claims
which the Company would like to use to promote its products. Regulators will
undertake periodic reviews and inspections. If they discover previously unknown
problems with a product or its manufacturing facility or if the Company fails
to comply with regulatory requirements, regulators could:
impose fines
against the Company;
impose
restrictions on the product, its manufacturer, or the Company;
require the
Company to recall or remove a product from the market;
suspend or
withdraw its regulatory approvals;
require the
Company to conduct additional clinical trials;
require the
Company to change its product labeling; or
require the
Company to submit additional marketing applications.
If any of these events occur, the Companys ability to sell its
products will be impaired and the Company may incur substantial additional
expense to comply with the regulatory requirements. In addition, in certain
countries, even after regulatory approval, the Company is still required to
obtain price reimbursement approval. This may delay the marketing of the
Companys products or, when approval cannot be obtained, mean that the product
cannot be sold at all.
If the Company is unable to keep pace with technological change or with
the advances of its competitors, its technology and products may become
obsolete or non-competitive.
The biotechnology and pharmaceutical industries are subject to rapid
technological change which could affect the success of the Companys drugs or
make them obsolete. The field of biotechnology is characterized by significant
and rapid technological change. Research and discoveries by others may result
in medical insights or breakthroughs which render the Companys drug candidates
less competitive or even obsolete before they generate revenue.
12
The Companys business faces intense competition from major
pharmaceutical companies and specialized biotechnology companies engaged in the
development of drugs directed at the conditions and disorders that are the
focus of the Companys therapeutics programs. As a result its competitors may
be able to establish superior proprietary positions.
The Companys competitors in the biotechnology and pharmaceutical
industries may have superior research and development capabilities, drugs,
manufacturing capability or marketing expertise. Many of the Companys
competitors have significantly greater financial and human resources and may
have more experience in research and development. As a result, the Companys
competitors may develop safer or more effective drugs, or implement more
effective sales and marketing programs or be able to establish superior
proprietary positions. In addition, the Company anticipates that it will face
increased competition in the future as new companies enter the Companys
markets and alternative drugs become available.
The Companys products under development are expected to address a
broad range of markets including, but not limited to anti-cancer drugs for the
treatment of chronic myelogenous leukemia (CML) and other forms of leukemia,
prostate cancer and other solid tumors. The Companys competitive position will
be determined in part by the potential indications for which the Companys
products are developed and ultimately approved by regulatory authorities. The
relative speed with which the Company or its collaborative partners can develop
products, complete the clinical trials and approval processes and supply
commercial quantities of the products to the market, are expected to be
important competitive factors.
The Companys competitors may be developing products that could compete
with the products the Company is developing. The Company and its collaborators
will need to persuade patients and physicians to adopt its products over its
competitors products.
In the field of cancer therapeutics the Company faces intense
competition from major pharmaceutical companies and specialized biotechnology
companies engaged in the development of product candidates and other
therapeutic products. Several of these companies have products in the same
indications or utilize similar technologies and/or personalized medicine
techniques. The FDA has approved two drugs for Gleevec
®
-resistant
CML; Sprycel
®
(dasatinib), a drug developed and commercialized by
Bristol-Myers Squibb was approved in June 2006, and Nilotinib
®
(nilotinib)
a drug developed and commercialized by Novartis was approved in October 2007.
Significantly, neither Sprycel
®
nor Nilotinib
®
have
demonstrated efficacy against the T315I bcr-abl mutation, and it is this
sub-set of resistant CML patients that are being targeted by the Company for
initial approval. Several biotechnology and pharmaceutical companies are
seeking to develop effective therapeutics specifically for CML patients with
the T315I mutation. Vertex Pharmaceuticals and its partner Merck are developing
an aurora kinase inhibitor referred to as MK-0457 or VX-680. This agent is
currently in phase 2 clinical trials. Astex Therapeutics is developing
AT9283,
an inhibitor of several targets including bcr-abl. This agent is currently in
phase 1/2 clinical trials. Several companies have agents in phase 1 clinical
trials, including Exelixis (XL228), Kyowa Hakko (KW2449) and Medimmune/Infinity
Pharmaceuticals (IPI504).
Xanthus
Pharmaceuticals is currently
conducting a phase 3 study with amonafide malate (listed as an example product
candidate Refer Item 4B. Business Overview ChemGenexs development
pipeline) in acute myeloid leukemia. The previous list is indicative only, and
there may be other competitive trials or technologies elsewhere in the world.
Additionally, many of the Companys competitors, including large pharmaceutical
companies, have greater financial and human resources and more experience than
the Company does.
If the healthcare industry limits coverage or
reimbursement levels, the acceptance of the Companys products could suffer. It
may not be able to sell its drug profitably.
The healthcare industry is subject to changing political, economic and
regulatory influences that may affect the procurement practices and operations
of healthcare facilities. During the past several years, the healthcare
industry has been subject to increased government regulation of reimbursement
rates and capital expenditures. Among other things, third party payers are
increasingly attempting to contain or reduce healthcare costs by limiting both
coverage and levels of reimbursement for healthcare products and procedures.
Cost control policies of third party payers, including government agencies, may
adversely affect acceptance and use of the Companys product line.
13
If the Company is unable to successfully establish and protect its
intellectual property, which is significant to the Companys competitive
position, its competitors may be able to take advantage of its research and
development efforts.
The Companys success depends in part on its ability to obtain and
maintain protection for its inventions and proprietary information, so that it
can stop others from making, using or selling its inventions or proprietary
rights. The Company owns a portfolio of patents and patent applications. There
is a significant delay between the time of filing of a patent application and
the time its contents are made public, and others may have filed patent
applications for subject matter covered by the Companys pending patent
applications without the Company being aware of those applications. The Companys
patent applications may not have priority over patent applications of others
and its pending patent applications may not result in issued patents. Even if
the Company obtains patents, they may not be valid or enforceable against
others. Moreover, even if the Company receives patent protection for some or
all of its products, those patents may not give the Company an advantage over
competitors with similar products.
To develop and maintain its competitive position, the Company also
relies on unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation, which it protects with security measures
it considers to be reasonable, including confidentiality agreements with its
collaborators, consultants and employees. The Company may not have adequate
remedies if these agreements are breached and the Companys competitors may
independently develop any of this proprietary information.
If the Company fails to obtain adequate protection for its intellectual
property, the Companys competitors may be able to take advantage of the
Companys research and development efforts. The Companys success will depend,
in large part, on its ability to obtain and maintain patent or other
proprietary protection for its technologies in general and, in particular,
drugs and processes. The Company may not be able to obtain patent protection
for the use of certain drug compounds, processes developed by its employees or
medical uses of compounds discovered through its technology. Legal standards
relating to patents covering pharmaceutical or biotechnological inventions and
the scope of claims made under these patents are still developing. There is no
consistent policy regarding the breadth of claims allowed in biotechnology
patents. The Companys patent position is therefore uncertain and involves
complex legal and factual issues. This risk factor is one that faces many
companies in the biotechnology industry and the Company is not aware of any
Company-specific risks.
The Company may incur substantial costs as a result of disputes
relating to intellectual property.
The Company may have to initiate litigation to enforce its patent and
license rights. If the Companys competitors file patent applications that
claim technology also claimed by the Company, the Company may have to
participate in interference or opposition proceedings to determine the priority
of invention. An adverse outcome could subject the Company to significant
liabilities and require the Company either to cease using a technology or to
pay license fees.
The Company could incur substantial costs in any litigation or other
proceeding relating to patent rights, even if it is resolved in the Companys
favor. Some of the Companys competitors may be able to sustain the costs of
complex litigation more effectively or for a longer time than the Company can
because of their substantially greater resources. In addition, uncertainties
relating to any patent, pending patent or intellectual property litigation
could have a material adverse effect on the Companys ability to bring a
technology to market, enter into collaborations in respect of the disputed or
other technologies, or raise additional funds.
The Company may not be able to bring any of the drug candidates it is
developing to market.
Development of drug candidates involves a lengthy and complex process.
Any drug candidate that the Company seeks to offer commercially to the public
must be put through extensive research, development and pre-clinical and
clinical testing which will be costly to the Company. This development process
takes several years. In addition, the Company or its partners will need to
obtain regulatory approvals to conduct clinical trials and manufacture drugs
before they can be marketed. Results of pre-clinical studies are not
necessarily indicative of results that may be obtained in clinical trials and
results in early clinical trials may be different from those obtained in long-term
testing or in general use. Adverse or inconclusive results from pre-clinical
testing or clinical trials may substantially delay, or halt entirely, the
development of products.
The Company may fail to successfully develop a drug candidate for many
reasons, including:
the failure to
establish any collaborative third party agreements to support drug development;
14
the failure to
produce a promising compound in sufficient quantities to conduct clinical
trials or to manufacture the compound at commercially acceptable quantities and
prices;
the failure of
the drug in pre-clinical studies;
the inability of
clinical trials to demonstrate that the drug is safe and effective in humans;
or
the failure to
obtain required regulatory approvals.
ChemGenex Pharmaceuticals Limited shares may fluctuate in value.
The market price for ChemGenex Pharmaceuticals Limited shares and the
securities of other similar companies have been volatile. Factors that could
significantly impact the market price of ChemGenex Pharmaceuticals Limited
shares in the future other than those described elsewhere in this Annual Report
include:
announcements
concerning research activities, technological innovations, clinical trials or
financial results by the Company or its competitors;
termination of
collaborations by the Company or its partners;
governmental
regulatory initiatives;
the FDA, the
Australian Therapeutic Goods Administration or European Medicines Evaluation
Agency approving or denying new applications;
patent or
proprietary rights developments;
public concern
as to the safety or ethical implications of biotechnology products;
sales of
substantial amounts of the Companys shares by existing shareholders;
price and volume
fluctuations in the stock market at large that do not relate to the Companys
operating performance;
changes in
financial estimates by securities analysts, comments by securities analysts, or
the Companys failure to meet analysts expectation;
actual or
anticipated variations in periodic operating results;
new products or
services introduced or announced by the Company or its competitors;
changes in the
market valuations of other similar companies;
announcements by
the Company of significant acquisitions, strategic partnerships, joint ventures
or capital commitments; and
additions or
departures of key personnel.
The Companys products may not receive and maintain regulatory
approval. The complexity and multi-jurisdictional nature of the applicable
regulatory processes could result in delays in achieving such regulatory
approval, which would have an adverse effect on the Companys financial
conditions, its programs and projected revenues.
The international pharmaceutical industry is highly regulated by
numerous governmental authorities in the U.S., Australia and Europe and by
regulatory agencies in other countries where the Company intends to market
products it may develop. National regulatory authorities administer a wide
range of laws and regulations governing the testing, approval, manufacturing,
labeling and marketing of drugs and also review the quality, safety and
effectiveness of such products. These regulatory requirements are a major
factor in determining whether a technology can be developed into a marketable
clinical application or a specific product and the amount of time and expense
associated with such development.
Government regulation imposes significant costs and restrictions on the
development of pharmaceutical products for human use, including those the
Company is developing. The development, clinical evaluation, manufacture and
15
marketing of the Companys products and ongoing research and development
activities are subject to regulation by governments and regulatory agencies in
all territories within which the Company intends to manufacture and market its
products (whether themselves or through a partner). The Companys products may
not successfully complete the clinical trial process. Similarly, regulatory
approvals to manufacture and market the Companys products may not ultimately
be obtained.
The time taken to obtain regulatory approval varies between countries.
The Companys products may not be approved in any country within the timescale
envisaged, or at all. This may result in a delay, or make impossible, the
commercialization of its products. Furthermore, each regulatory authority may
impose its own requirements (for instance, by restricting the products
indicated uses) and may refuse to grant, or may require additional data before
granting, an approval, even though the relevant product candidate may have been
approved by another countrys authority.
If regulatory
approval is obtained, the product and its manufacture will be subject to
continual review and this approval may be withdrawn or restricted. Changes in
applicable legislation or regulatory policies, or discovery of problems with
the product, or its production process, site or manufacturer, may result in the
imposition of restrictions on the product, its sale, manufacture or use,
including withdrawal of the product from the market, or may otherwise have an
adverse effect on the Companys liquidity and financial condition.
The Company has not had any of its product candidates receive approval
for commercialization in Australia, the U.S. or elsewhere.
The Company may be unable to secure adequate insurance at an acceptable
cost. Failure to secure such insurance may expose the Company to liability in
the event of a claim.
The Companys business exposes it to potential product liability,
professional indemnity and other risks which are inherent in the research and
development, pre-clinical studies, clinical trials, manufacturing, marketing
and use of pharmaceutical products. The Company in carrying out its activities
will potentially face contractual and statutory claims, or other types of
claims. Consumers, healthcare producers or persons selling products based on
the Companys technology may be able to bring claims against the Company based
on the use of such products in clinical trials and the sale of products based
on the Companys technology. The Company is insured for product liability with
a policy covering US$5,000,000 that covers bodily injury or property damage
arising out of the Companys products used in the regular course of the
clinical trials. The policy was recently renewed for the period from May 1,
2007 to April 30, 2008. The Company also carries directors and officers liability
policies in the U.S. and Australia, with coverage of US$10,000,000, and
customary employers liability, fiduciary liability and property insurance
coverages in amounts that are considered usual for similarly situated
companies. Product liability or any future necessary insurance cover may not be
available to the Company at an acceptable cost, if at all, and if there is any
claim, the level of the insurance the Company carries now or in the future may
not be adequate. Similarly, a product liability, professional indemnity or
other claim may materially and adversely affect the Companys liquidity or its
ability to continue to progress its product development. In addition, it may be
necessary for the Company to secure certain levels of insurance as a condition
to the conduct of clinical trials. In the event of any claim, the Companys
insurance coverage may not be adequate.
The Company may face product liability claims.
The testing, marketing and sale of human health care products entails
an inherent risk of product liability. The Company in carrying out its
activities will potentially face contractual and statutory claims, or other
types of claim. In addition, the Company is exposed to potential product
liability risks that are inherent in the research and development, pre-clinical
study, clinical trials, manufacturing, marketing and use of medical devices and
drug products. Consumers, healthcare producers or persons selling products
based on the Companys technology may be able to bring claims against the
Company based on the use of such products in clinical trials and the sale of
products based on the Companys technology.
The Company may be subject to special interest groups and adverse
public opinion.
Government bodies and regulatory agencies require that potential
pharmaceutical products are subject to pre-clinical studies, including animal
testing, prior to conducting human trials. ChemGenex arranges for such work
either directly or through its collaborators. While the Company has not been
subject to the attention of special interest
16
groups, or any adverse public opinion of which it is aware, such work
entails the risk of adverse public opinion and the attention of special
interest groups, including those of animal rights activists. These groups may
in the future focus on the Companys activities or those of its licensees or
collaborators, and this might adversely affect the Companys operations, by
requiring it to curtail its activities or to change its testing procedures.
The pharmaceutical and biotechnology industries are frequently subject
to adverse publicity on many topics, including corporate governance or
accounting issues, product recalls and research and discovery methods, as well
as political controversy over the impact of novel techniques and therapies on
humans, animals and the environment. While there has to date been no adverse
publicity about the Company, its collaborators, or its products, such adverse
publicity in the future, should it arise, may hurt the Companys public image,
which could harm its operations, cause its share price to decrease or impair
its ability to gain market acceptance for its products. The Company has adopted
an ethics policy for genetic research.
ITEM
4. INFORMATION
ON THE COMPANY
A
. History and development of the
Company
The Company was founded in September 1958 as N & B Finance and
Development Corporation. It was renamed the Kingsway Finance Group in August
1964 and then became Australia Wide Industries Limited in May 1986. Australia
Wide Industries Limited listed on the Australian Stock Exchange (ASX) in July
1986 and operated for ten years as a listed mining and exploration company
(ASX: AWI). The Company commenced biotechnology activities in July 1996 and
changed its name to Autogen Limited (ASX: AGT) in May 1999. Autogen Limited, in
turn, changed its name to AGT Biosciences Limited in March 2003 and then to
ChemGenex Pharmaceuticals Limited (ASX: CXS) in June 2004. Biotechnology
remains the focus of the Companys activities. The Companys Australian
Business Number (ABN) is 79 000 248 304. It operates pursuant to its
constitution, the Australian Corporations Act 2001, other legislation in
Australia and the U.S., and the rules of the ASX. The Companys representative
in the U.S. is Dr. Dennis M Brown, President U.S. Operations, 3715 Haven
Avenue, Suite 100, Menlo Park, CA 94025 U.S.A. The Companys registered office
is Edmondson Turner & Co., 439 Bay Street, Brighton, Melbourne, Victoria
3186 Australia. Its principal administration office is Pigdons Road, Waurn
Ponds, Victoria 3217 Australia. Its telephone number is +613-5227-2752. The
Companys website address is www.chemgenex.com. Information on the Companys
website and websites linked to it does not constitute part of this Annual
Report.
The Company in its present form is the result of the merger of AGT
Biosciences Limited and ChemGenex Therapeutics, Inc. which was approved by
shareholders in the General Meeting on June 21, 2004 and concluded on the same
date. ChemGenex is a genomics-driven pharmaceutical development company
dedicated to improving the lives of patients by developing novel personalized
therapeutics in the areas of cancer, obesity, diabetes and depression. The
Company has two molecules in Phase 2 clinical trials in the U.S. and has a
pipeline of pre-clinical anti-cancer compounds in development. The Company has
assembled a comprehensive technology platform that enables the identification
of novel targets for complex diseases. These discoveries are then validated
with a range of systems biology approaches and evaluated in terms of drugability.
The target discovery and validation approach is based on:
A collection of tissue and DNA samples from worldwide
population groups (>44,000 samples);
Validated animal
model systems for diabetes/obesity and depression/anxiety;
A 1400 Central
Processing Unit parallel Linux cluster supercomputer for statistical analysis
of genetic data;
The eXpress
Technology Platform, a proprietary research engine for rapid target discovery
and validation for any disease.
The Companys development platform is more fully discussed at Items 4B.
Business Overview and 4C Research and Product Development Programs.
The Companys research commitments (not including fees payable to
scientific consultants and advisors to the Company) as of June 30, 2007 are as
follows:
17
A twelve month, A$2,400,000 extension to a research agreement first
signed on 2 June, 2005 with Deakin University (Geelong, Australia) to conduct
gene discovery, small molecule screening and validation research according to
instruction from the Company in the fields of obesity, diabetes and depression.
This agreement is called Research, License and Commercialisation Agreement (Research
Services Provision). The extension covers the period from January 1, 2007 to
December 31, 2007.
A twelve month, A$150,000 extension to a research agreement first
signed on January 14, 1998 with the International Diabetes Institute
(Melbourne, Australia) to conduct gene discovery and validation research
according to instruction from the Company in the fields of obesity and
diabetes. This agreement is called Research Agreement for Human Diabetes /
Obesity Discovery. The extension covers the period from January 1, 2007 to
December 31, 2007.
An agreement signed in June 16, 2006 with Premier Research Group plc to
provide clinical study services which ChemGenex may submit to the FDA in
support of clinical studies being conducted with Ceflatonin®. The agreement is
called the Master Clinical Service Agreement. The services to be provided by
this agreement cover a period of approximately 24 months but may be terminated,
by either party, during that time within the terms provided in the agreement.
The Company has no fixed asset commitments as at June 30, 2007, and has
incurred no significant fixed asset expenditure since that date. Expenditure on
plant and equipment is usually minimal due to the Companys outsourcing
arrangements. Recent capital expenditure on plant and equipment is as follows:
|
|
Plant and equipment expenditure (A$000)
|
|
Year ended June 30, 2007
|
|
24
|
|
Year ended June 30, 2006
|
|
14
|
|
Year ended June 30,2005
|
|
15
|
|
Important events since June 30, 2007
On October 26, 2007ChemGenex Pharmaceuticals Limited announced a
strategic restructuring based upon the spinoff of its metabolic diseases assets
by early December, pending shareholder approval. ChemGenexs metabolic diseases
assets currently reside within the companys wholly-owned subsidiary Autogen
Research, which is to be renamed Verva Pharmaceuticals. Pending shareholder
approval at the Annual General Meeting, scheduled to take place in Melbourne on
November 28, Verva Pharmaceuticals will be demerged from ChemGenex. Verva
Pharmaceuticals then intends to merge with Adipogen Pharmaceuticals, pursuant
to a merger implementation agreement signed on October 29, 2007. Upon
shareholder approval, ChemGenex shareholders will receive one share in Verva
Pharmaceuticals for every five ChemGenex Pharmaceuticals shares held at the
record date. In accordance with ASX listing rules and the option agreements,
existing ChemGenex option holders will not be allocated shares in Verva
Pharmaceuticals unless options are exercised prior to the record date. The
Verva Pharmaceuticals shares will not be registered under the U.S. Securities
Act for distribution to holders of the Companys ADRs. After the record date
the exercise price for each remaining ChemGenex option will be reduced by
approximately 7 cents.
B. Business
overview
The Company focuses on the development of novel therapeutic agents in
two diseases: cancer and metabolic syndrome (which includes diabetes and
obesity). Product development in the two disease areas is supported by four
product development platforms: Gene-Based Target Discovery, Target Validation,
Drug Discovery and Drug Development. The combination of these platforms is
collectively known as the eXpress Technology Platform. In the field of cancer,
ChemGenex currently has two small molecule drug candidates in Phase 2 human
trials (Ceflatonin® and Quinamed®) and a broad pipeline of compounds and
validated targets, including four pre-clinical cancer compounds (CXS299,
CXS2101, CXS6001 and CXS273) and two early-stage discoveries identified in the
Target Discovery program. In the field of metabolic syndrome, the Company has
previously partnered its Target Discovery and Target Validation capabilities
with Merck Santé, has discovered and protected by patent more than 50 other
gene and protein targets and has established two new unencumbered programs; (i)
a small molecule discovery program, and (ii) a predictive biomarker program.
18
ChemGenexs competitive advantage
The Companys competitive advantage can be considered in terms of
protected intellectual property (IP), the research and development platforms
that support the development of existing IP and the creation of new IP and the
organizational ability to realize the commercial value of the Companys IP and
other assets.
The Company has approximately 50 patent families in various states of
protection ranging from provisional applications through to granted patents in
a number of jurisdictions. In addition to IP that is protected by patents there
is significant know how and expertise within the senior research staff of the
Company.
The research and development infrastructure of the Company is described
below and consists of skills in medicinal chemistry and product development for
cancer therapeutics, gene discovery using animal models and human samples from
known populations, high-powered statistical analysis capabilities to determine
linkages between gene variations and disease states and a suite of validation
technologies to characterize the biological roles of given genes (and their
protein products) by altering their expression levels in cell culture and in
animals. Specific competitive advantage is realized through (a) ChemGenexs
product development pipeline (b) exclusive commercial access to Deakin
Universitys out-bred colony of
Psammomys obesus
,
a species of gerbil also known as the sand rat, a well-defined model for
dietary induced Type 2 diabetes, (c) exclusive access to the International
Diabetes Institutes substantial collection of phenotyped human tissue and DNA
samples for the purpose of discovery of novel metabolic syndrome targets and
(d) access to the experience of Dr. J. Blangero and supercomputing
infrastructure at the Southwest Foundation for Biomedical Research.
Business strategy
The Companys business strategy for growth and profitability is to
discover, develop and commercialize novel therapeutics that address significant
unmet needs in the pharmaceutical industry, based on the Companys
understanding of the genetic basis of disease. The Company keeps its core
competencies in-house (such as laboratory research management, pre-clinical
work, clinical strategy and management), outsourcing the majority of laboratory
research and all clinical testing to specialists, to minimize its
infrastructure and fixed overhead costs. In the fields of diabetes and obesity
the Company seeks early partnering of discovery programs in order to share
development costs and risks with partners and to ensure that programs are
commercially and scientifically focused. In the field of cancer, the Company
intends to seek out joint venture or licensing partners for further development
and commercialization of its products following Phase 2 clinical evaluation. This
will allow ChemGenex to license its products before full regulatory approval is
required to place the product in the market. The goal in each case is to seek
multinational partners with drug development milestones payable to the Company
on completion of agreed targets and submission of regulatory documents and,
eventually, payment or royalties on sales of commercialized products. The
expectation is that the size of the payments to the Company will vary depending
on the size of the eventual market, the stage of development of the product
concerned and the strength of the data that is generated prior to partnering.
Components of ChemGenexs discovery, validation and drug development
platforms
Target discovery and Biomarkers
The target discovery, validation and drug
development platforms utilize infrastructure located at Deakin University
(Geelong, Australia), the International Diabetes Institute (Melbourne,
Australia) and the Southwest Foundation for Biomedical Research (San Antonio,
Texas). Key features of the Target Discovery platform include:
Deakin Universitys out-bred colony of
Psammomys obesus
, a well-characterized animal model of
diabetes and obesity. The Company has exclusive access to this colony for both
discovery and validation activities;
a library of extensive family pedigrees of
more than 44,000 human tissue and DNA samples and a dedicated human genotyping
facility that is used for sequencing target genes to identify variations
associated with disease states; and
access to the computing facilities at the
Southwest Foundation for Biomedical Research for statistical analysis of gene
variations as relating to disease state.
The Companys research scientists have found
the animal model to be useful in studying metabolic disorders, such as diabetes
and obesity.
Psammomys obesus
populations
develop a range of body weight, blood glucose, and insulin
19
levels with distributions similar to those
found in human populations. This animal model is used to discover candidate
genes (and the proteins they encode) with altered levels of expression that are
associated with each disease. For example, specific genes are up- or
down-regulated in diabetic animals compared to normal healthy animals. The
candidate genes identified in this way are then analyzed and compared with
human population data using the Companys Human Gene Discovery facility at the
International Diabetes Institute (Melbourne) and in the U.S., at the Center for
Human Statistical Genetics at the Southwest Foundation for Biomedical Research.
The Company has contractual agreements with both institutions. Candidate genes
that are found to exist in the human genome and be associated with the diseases
in question are then subject to further rigorous analysis. As an example the
PSARL (Presenilin-Associated Rhomboid-like protein) gene was discovered by the
Company in
Psammomys obesus
and subsequently
identified in humans. This gene identified originally in the animal model was
found to have a human analogue and detailed genetic analysis of samples from
more than 1,000 humans confirmed that variation in the gene in humans was
significantly associated with increased risk of diabetes.
Some of the
genes that were discovered using the Target Discovery platform have potential
utility as biomarkers. That is, gene variants or differences in levels of gene
expression, and thus protein levels, may predict disease state or propensity to
develop certain diseases. The Company has recently expanded its efforts in
biomarker discovery and is screening for novel genes and proteins that might
have commercial utility.
Target validation
The Target validation platform utilizes
infrastructure located at Deakin University in Geelong, Australia. It
encompasses a comprehensive set of proprietary and non-proprietary technologies
from gene discovery, gene structure and function analysis to the validation of
gene and protein products that may be potential therapeutic or diagnostic
targets. The validation platform is used to characterize the biological role of
targets that have been discovered and found to be related to disease state
using the combined resources of the discovery platform.
Examples of the technologies employed in
Target Validation include in vitro (cell culture) experiments to determine the
effect of up- or down-regulation of genes on quantifiable end-points, in vivo
experiments to manipulate the levels of target genes or expressed proteins in
animals and tracking of physiological and behavioral responses, and
clarification of the nature of any protein-protein interactions, which can
reveal potential drug targets.
An example of the role of validation is the
blocking of expression of the gene target SGIP1 (SH3-Domain GRB2-Like Interacting
Protein 1) in
Psammomys obesus
and
Rattus norvegicus
. In the Companys laboratory experiments
SGIP1 was identified as having
increased expression in the
hypothalamus of obese compared to lean
Psammomys obesus
.
The candidate gene was confirmed as being associated with disease using the
Companys human genetics group in the
Southwest Foundation for Biomedical Research. To examine the role of
SGIP1 in the development of obesity, antisense oligonucleotides of the genes
were infused into a specific region of the brain (the lateral cerebral
ventricle) in both
Psammomys obesus
and
Rattus norvegicus
.
The procedure has the effect of blocking the expression of the SGIP1 genes in
the brain and the Company believes this is a proxy of what could occur if
therapeutic agents could be used to affect the level of the protein. When
treated with antisense SGIP1, both species showed approximately 40% reduction
in food intake and 5-8% loss of body weight compared with control animals.
Drug discovery
The Companys
diabetes and obesity program based at Deakin University has expanded its scope
to include chemical screening and the discovery of small molecules that are
potential insulin sensitizers. This new chemogenomics-based program integrates
systems biology with drug discovery and development, and has already identified
a range of lead compounds that are progressing into preclinical studies.
The Companys
diabetes screen is based on Gene Expression Signatures, which are accurate
measurements of gene expression in model systems of diabetes reflecting changes
in the complex control mechanisms and pathways that are involved in the
treatment of the disease. By understanding the signature of cells recovering
from diabetes it is possible to quickly and accurately determine the effects of
any given compounds actions across multiple pathways within a cell, and
ascertain if it has potential as a treatment. As lead molecules progress
through preclinical development the signatures are used to accelerate medicinal
chemistry programs, allowing rapid assessment of compounds based on the
signatures of different molecular iterations.
The Companys anti-cancer therapeutic development platform focuses on
developing novel small molecule therapeutics for the treatment of cancer and
related conditions. The major strategy has been to screen agents studied by the
U.S. National Cancer Institute that have
confirmed human clinical
activity but were not fully developed. Among these agents the Company
identifies compounds suitable for development based on its assessment of
20
mechanism of action, molecular targets affected, potential formulation
improvements and genetic differences between patients that can be exploited in
clinical development. It utilizes chemical genomics and drug screening systems
to identify agents affecting novel targets and evaluates a compounds
suitability as a drug and formulation technology to maximize delivery and
bioavailability, meaning the extent to which a chemical is absorbed and
distributed in the blood in an unchanged form following administration to a
living organism.
Drug development
The
Companys pre-clinical and clinical development efforts are based in Menlo
Park, California. In vitro and in vivo screening models are used to evaluate
lead compounds. Data from these models is fed back into extensive in-house
databases for iterative analysis. A parallel series of profiling assays is
performed to determine the potential pharmaceutical attributes and
vulnerabilities of a compound.
Compounds
that merit further development proceed through pre-formulation and advanced
pre-clinical in support of regulatory filings for human clinical evaluation.
These include non- Good Laboratory Practice (GLP) and GLP pharmacology, efficacy
and toxicology studies in laboratory animal models. Additionally, compound
manufacturing, scale-up considerations and dosage form stability studies are
also performed.
Those
agents with acceptable pharmacological and toxicological profiles may become the
subject of evaluation in humans. This requires submission to the U.S. FDA of an
Investigational New Drug (IND) application for permission to begin Phase I dose
escalation studies. After the Maximum Tolerated Dose is identified at the
schedule contemplated for therapeutic use, Phase 2 studies evaluating potential
disease indications are performed. If significant activity is identified, then
larger Phase 3 studies are conducted in support of a New Drug Application
(NDA). If approved the product can then be commercialized.
ChemGenexs development pipeline
In the field of cancer the Company has two clinical stage product
candidates, four pre-clinical stage product candidates and two discovery stage
targets that have recently been identified.
Clinical stage product candidates
The Company has applied its genomic and clinical development expertise
with its knowledge of cancer to identify small molecule therapeutic targets in
oncology. By focusing on compounds with confirmed clinical activity and using
genomic tools to optimize their development, the Company has been able to
create a pipeline of product candidates described below:
Ceflatonin® (homoharringtonine)
Homoharringtonine (HHT) is a small molecule with established clinical
activity as a single agent in hematological malignancies. The Companys
scientists have discovered that it affects a number of critical cellular
pathways, including the regulation of genes associated with programmed cell
death (apoptosis) and the inhibition of formation of new blood vessels in solid
tumors (angiogenesis). The Company has received Orphan Drug Status protection
for HHT in CML in both the U.S.A. and Europe, as well as Fast Track Status from
the U.S. F.D.A. In previous published Phase 2 clinical trials, 70% of patients
showed complete hematological remission (CHR) in chronic myeloid leukemia (CML)
after interferon-α failure. In more recent pilot studies in CML patients
who had failed Gleevec
®
, 100% of chronic-phase
patients and 70% of accelerated-phase patients achieved a CHR. The Company is
currently conducting Phase 2/3 trials in the U.S.A. and Europe for CML patients
who have the T315I bcr-abl mutation that confers resistance to Gleevec
®
and other TKIs. Data published
in 2007 indicated that Ceflatonin had positive clinical activity against
Gleevec
®
-resistant, chronic myeloid leukemia (CML) associated with
the T315I Bcr-Abl mutation. The Company is conducting a complementary phase 2
clinical trial in the U.S.A. for CML patients who have failed multiple TKIs
regardless of mutation status. At the M.D. Anderson Cancer Center the Company
is conducting a combination (with Gleevec
®
) therapy Phase 2 trial in CML patients who had failed
Gleevec
®
. Preliminary
data presented at the American Society of Hematology (ASH) Annual Meeting in
December 2006 reported that 42% of patients on the combination therapy regime
achieved a hematologic response (reduction of leukemic cells in the blood).The
Company is also conducting Phase 2 trials in patients with the bone marrow
disease called myelodysplastic syndrome (MDS) in collaboration at the M.D.
Anderson Cancer Center. The Company has one issued patent and has four active
patent applications covering Ceflatonin
®
formulations,
21
purification, synthesis and uses. The Company has licensed from Stragen
Pharma S.A. three issued patents and has four active patent applications
covering the preparation of homoharringtonine derivates, purification, and the
use of homoharringtonine resistant to Gleevec
®
.
Quinamed® (amonafide dihydrochloride)
Amonafide dihydrochloride
(amonafide) is a synthetic organic compound with established anti-cancer
clinical activity. The Company has recently discovered that amonafide effects a
number of targets in the epidermal growth factor receptor pathway, which
controls the growth of a number of tumor types, in addition to affects on an
enzyme that is critical for normal cell replication, topoisomerase II. In
National Cancer Institute (NCI)-sponsored clinical studies with amonafide
monohydrochloride, 25% of breast cancer patients and 15% of prostate cancer
patients showed either partial (>50% reduction in tumor volume) or complete
(no measurable disease) responses. However, researchers also noted some
unpredictable side effects. It was later discovered that differences in how
patients metabolize the drug has a significant impact on toxicities. These
metabolic differences can now be determined by testing a patients NAT-2
genotype. The Companys development strategy is to determine a patients NAT-2
genotype and then treat them with a more precise and personal dose needed to
produce the optimal result. At the American Association of Clinical Oncologists
(ASCO Annual Meeting in June 2007, data was presented from the phase 1/2a
dose-escalation study of Quinamed. The key outcomes from this study were (i)
demonstration that dose level could be optimised according to patient genotype,
(ii) the drug was well tolerated, with predictable and manageable side effects,
and (iii) there was evidence of anticancer activity in several solid tumor
types. The Company has two issued patents and has three active patent
applications covering amonafide salts, formulations, synthesis and uses.
Pre-clinical
stage product candidates
In addition to Ceflatonin
®
and Quinamed
®
the Company is developing
several other pre-clinical oncology compounds, including the following:
CXS299: This is a new platinum (IV) compound recently licensed from the
M.D. Anderson Cancer Center in Houston, Texas. CXS299 is a first in class
platinum IV agent that is active against cancer cells resistant to the effects
of commercially available platinum-based therapies. Currently approved platinum
II agents have generated sales of greater than US$1 billion. However, some
patients develop resistance to platinum II therapy resulting in a need for
additional therapies. CXS299 is currently in pre-clinical development and could
enter Phase I in 2009.
CXS2101: This compound inhibits
NF-Kappa B and has been shown to increase the anti-cancer activity of other
agents in animal models.
CXS6001: This compound affects
levels of the structural protein tubulin in cancer cells and has shown
anti-tumor efficacy in mouse models.
CXS273: This compound affects
the integrity of DNA and has been shown to increase the anti-cancer activity of
cisplatin in a mouse model.
Validated
targets
The SEPS 1 gene (formerly called Tanis) was
identified by the Company following the observation of increased hepatic gene
expression in diabetes in
Psammomys obesus
.
The Company has since determined the genes sequence and location on the human
chromosome and the characteristics of the genes protein product. Evidence
indicates that the SEPS 1 gene represents an important target not only in
diabetes but potentially in other diseases, such as cancer and inflammatory
diseases and the Companys patent protection has been broadened accordingly.
It has been determined that the PSARL gene is
linked to signaling pathways within a cell that are thought to be associated
with insulin resistance, which is the cause of Type 2 diabetes. Evidence
indicates that the PSARL gene represents an important target not only in
diabetes but potentially in other diseases, such as cancer and age-related
degenerative diseases and the Companys patent protection has been broadened accordingly.
Beacon was isolated in
Psammomys
obesus
as a gene expressed in direct proportion to body fat content.
The protein product of the Beacon gene is expressed as a small peptide in the
hypothalamus, a part of the brain that regulates energy intake and expenditure,
and is understood to play a role in energy balance. The Companys research has
22
demonstrated that the expression of the
Beacon gene is proportional to the amount of body fat, and that giving the
Beacon peptide to lean animals significantly increased their feeding rate and
body weight in direct proportion to the quantity of Beacon peptide. This
suggests that blocking the action of the Beacon peptide by biological or
chemical means could provide a means of treating obesity.
SGIP1 is a protein involved in the regulation
of satiation at the neurological level. The Company has determined that
suppression of SGIP1 expression reduced the feeding rate of
Psammomys obesus
significantly over a period of four days. While
the SGIP1 gene has been identified in humans, additional work on the expression
and function of the gene in humans is still needed.
Discovery
stage targets
The Company has more than 50 discovery stage candidates, in different
stages of patent protection.
Additional opportunities
The Company has generated revenue through the use of the capacity in
its technology platform for fee-for-service contract research. Many drug
development companies do not have proprietary technology to validate genetic
targets with demonstrable links to a disease state. These companies are the
prospective clients for use of the Companys technology. In 2002 the Company
had a significant contract with Sequenom for this purpose and from 2003 to 2007
the service has been utilized by several Australian biotechnology companies. The
Company continues to seek fee-for-service revenue although no further contracts
have yet been arranged.
Research and product development programs
The Company currently contracts its target
discovery research programs to three organizations; Deakin University in
Geelong, Victoria, Australia, the International Diabetes Institute in
Melbourne, Victoria, Australia and the Southwest Foundation for Biomedical
Research in San Antonio, Texas. The discovery and validation programs are
involved in the previously described collaborative programs with Merck Santé
(diabetes and obesity targets) and Vernalis (depression targets). Cancer
research is carried out at the Companys laboratory in Menlo Park, California,
and clinical trials conducted at leading US and European hospitals.
The Company has been accepted into the inaugural Pharmaceutical
Partnership Program (P3) of the Australian Federal government, through which
the Company has the ability to earn grant revenue based on the growth of the
Companys research in Australia over the next three years. Admission into the
Australian governments P3 scheme involved a peer review process and the
Company was one of only seven Australian-owned biotechnology companies admitted
into the first round of the scheme. The scheme will subsidize incremental
increases in research and development activities by means of a 30% cash grant
for every dollar spent on eligible research by the Company at the end of each
fiscal year.
Commercial and research and development collaborations
The following
section describes the Companys existing commercial collaborators and the
commercial agreements with respect to the Companys principal research and
development programs and commercialization agreement:
General Research Agreement:
Chemgenex Pharmaceuticals entered into a General Research Agreement on
December 20, 2005 with Merck Santé (a subsidiary of Merck KGaA) pursuant to
which Merck Santé agrees to fund a minimum of 210,000 per annum for the
Company to undertake preclinical research on its behalf. The term of the
agreement is to December 31, 2008. Additional fees are payable if additional
staff resources are required to complete specific research programs.
Patent and
Technology License Agreement: On February 7, 2005 ChemGenex Pharmaceuticals
Limited entered into a technology licensing agreement with The University of
Texas M. D. Anderson Cancer Center to develop information or discoveries
relating to the anti-cancer activities of DACH-Ac-Pt
[(1R,2R-diaminocyclohexane)-(trans-diacetato)-(dichloro)-platinum(IV)] a novel
cisplatin analog now referred to by the Company as CXS299. The royalty-bearing,
exclusive license is for certain IP rights defined in United States Patent No.
5,434,256, and foresees the pre-clinical and clinical development of CXS299.
ChemGenex Pharmaceuticals Limited has incurred expenses of US$50,000 (paid by
cash and issue of shares) in March 2005. Further fees payable under this
agreement will be dependent upon the commencement of various stages of clinical
trials required, the results of those trials and the
23
licensing of
product associated with the trials. Unless terminated by either party the
agreement will remain in effect until patent rights or technology rights
associated with the agreement expire.
Research,
License and Commercialization Agreement (Research Services Provision): A contract dated April 21, 2005 between
ChemGenex Pharmaceuticals Limited and Deakin University consolidated the
provision of research services by Deakin University previously defined in the
agreements of June 26, 2000 (Research Services (Subcontracting), August 16,
2000 (Research, License and Commercialization Agreement (Gene Discovery in
Depression) and February 28, 1997 (Research Agreement). Under the consolidated
agreement ChemGenex undertakes to fund research and development programs with
Deakin University in the fields of diabetes, obesity, cancer, respiratory
diseases, inflammatory diseases, osteoporosis, allergy, asthma, depression and
autoimmunity. All intellectual property developed under the terms of the
agreement belongs to the Company. If ChemGenex commercializes or licenses
products resulting from the research program conducted under the contract, it
is obligated to pay Deakin University a royalty on net sales. The contract may
be terminated if the University does not timely commence its work, if it fails
to achieve milestones or use appropriate professional standards or if the
program is not producing results in the opinion of the Company, among other
conditions. It may also be terminated by Deakin University if ChemGenex fails
to provide the agreed funding. Under certain circumstances the Company is
obligated to pay the royalties to Deakin University even in the event of early
termination. The original term of this agreement from January 1, 2005 to
December 31, 2005 was twice extended by 12 months to December 31, 2006 and
December 30, 2007 (on December 18, 2006). ChemGenex incurred expenses of
A$2,420,000 in fiscal 2006, and A$2,410,000 in fiscal 2007 for services
provided under the agreement. Further expenses of $1,200,000 will be incurred
until expiry date.
Research, License and Commercialization Agreement: Autogen Research Pty Ltd. entered into this
agreement with the SFBR, based in San Antonio, Texas, on December 31, 2002. Under
the terms of this agreement Autogen Research Pty Ltd undertakes to collaborate
with SFBR and to provide funding for a project in return for the joint
ownership and an exclusive license to use and commercialize the intellectual
property resulting from the funded project on the terms set forth in the
agreement. Among the conditions for termination are failure to timely commence
and progress the agreed work plan, insolvency, change in control and other
similar conditions. The agreement also is terminable if Autogen Research Pty
Ltd does not provide the agreed funding. The term of this agreement was
extended to December 31, 2007 on January 11, 2007. Autogen Research Pty
Ltd incurred expenses of A$490,929 in fiscal 2005, A$895,138 in fiscal 2006 and
A$711,824 in fiscal 2007 under this agreement. No further expenses will be
incurred until expiry date.
Research Agreement: On January
14, 1998 Autogen Pty Ltd. entered into a research agreement with the
International Diabetes Institute (IDI) to conduct gene discovery and validation
research according to instruction from the Company in the fields of obesity and
diabetes pursuant to which Autogen Research Pty Ltd undertakes to collaborate
with the IDI and to provide the funding for a project in return for joint
ownership and a license to the intellectual property resulting from the
project. If Autogen Research Pty Ltd commercializes or licenses products
resulting from the research program conducted under the contract, it is
obligated to pay the IDI a royalty on net sales. The contract may be terminated
if the IDI does not timely commence its work, if it fails to achieve milestones
or use appropriate professional standards or if the program is not producing
results in the opinion of Autogen Research Pty Ltd, among other conditions. It
may also be terminated by the IDI if Autogen Research Pty Ltd fails to provide
the agreed funding. Under certain circumstances Autogen Research Pty Ltd is
obligated to pay the royalties to the IDI even in the event of early
termination. The term of this agreement was extended to December 31, 2007 on
December 22, 2006. Autogen Research Pty Ltd incurred expenses of
A$1,104,190 in fiscal 2005, A$501,838 in fiscal 2006 and A$221,662 in fiscal
2007 under this agreement. Further expenses of A$75,000 will be incurred until
expiry date.
Sole License Agreement: On March
1, 1999: Autogen Pty Ltd and Kyokuto Pharmaceutical Industrial Co. Ltd.,
licensed certain intellectual property for use in Kyokutos diagnostic products
in Japan. The contract relates to the use of an engineered hybrid of certain
forms of glutamic acid decarboxylase in the diagnostic and presymptomatic detection
of insulin dependent (type 1) diabetes. Under the agreement Kyokuto is
obligated to pay a net royalty on sales, at certain minimum levels. If less
than the minimum net royalty is paid, the Company can terminate the license on
three months notice or convert it to a non-exclusive license. The license
agreement, which is for a term of 15 years or so long as there is patent
coverage over the licensed property, whichever is longer, can be terminated by
either party for an uncured breach upon 60 days notice; for a payment default;
upon certain insolvency events and in the event of a change of control of
either party, by the non-defaulting party.
24
Patents, licenses and proprietary rights
The Company pursues a policy of seeking to obtain patent protection for
its inventions in Australia, the U.S., Europe, Japan and in selected other
countries. The Company also relies upon trade secrets, know-how, continuing
technological innovations and licensing opportunities to develop and maintain
its competitive position. To date, the Company has not threatened or instituted
proceedings against any third party on patent or other proprietary rights nor
has any third party threatened or instituted proceedings against the Company.
Certain products and processes currently being developed or considered
for development by the Company are in the area of biotechnology. The number of
patent filings by biotechnology firms in major jurisdictions is particularly
high and the outcome of such applications is generally uncertain and involves
complex legal and factual questions. To date, no consistent international
policy has emerged regarding the breadth of claims allowed in biotechnology
patents. Accordingly, there can be no assurance that the Company will develop
products or processes that are patentable, that patent applications made by the
Company, or made by parties who have agreed to license their inventions to the
Company, will result in patents being issued or that, if issued, the claims
allowed will be sufficiently broad to protect what the Company believes to be
its proprietary rights or that such patents will prevent others from developing
similar or functionally equivalent products or processes. In addition, products
or processes covered by such patents, or any other products or processes
developed by the Company or licensed to the Company, may infringe patents owned
by third parties or be subject to claims of patent infringement by these
parties. In such a situation, the Company may have to obtain a license, defend
an infringement action in court or challenge the scope or validity of any
infringed or allegedly infringed patents. Such required licenses may not be
available to the Company at all, or if available, such licenses may not be on
terms acceptable to the Company or that the Company will prevail in any patent
litigation. Failure to obtain a license or prevail in any patent litigation
relating to any technology that the Company may require to commercialize its
products or processes may have a material adverse impact on the Company.
Litigation may also be necessary to enforce any patents granted to the
Company or to determine the scope and validity of third party patents. Patent
litigation is time consuming and expensive. The Company may not have, or be
able to devote the necessary resources to conduct patent litigation. Patent
applications made by or licensed to the Company may not result in patents being
issued or, if issued, the patents may not provide the right to exclude
competitors with similar technology.
The Company maintains an active policy of filing patent applications. It
is possible that patents may not be granted on pending applications made by the
Company or parties that have licensed their inventions to the Company.
Similarly, issued patents may not provide significant proprietary protection or
commercial advantage or may be infringed or designed around by others. Since
publication of inventions or discoveries in scientific or patent literature
often lags behind actual invention or discovery, it is possible that the
inventions covered by each of the Companys pending patent applications may not
have dominant status in terms of date of invention. The Companys patents or
patent applications may become involved in opposition proceedings instituted by
third parties. If such proceedings were initiated against the Companys rights,
the defense of such rights could involve substantial costs and the outcome
cannot be anticipated. If patents are issued to other parties that contain
valid claims that are interpreted to cover any of the Companys products, it is
possible that the Company may not be able to obtain licenses to such patents at
a reasonable cost, if at all, or may not be able to develop or obtain alternative
technology. Competitors or potential competitors may have filed applications
for, may have received patents covering, or may obtain additional patents and
proprietary rights that may relate to, compounds or processes competitive with
those of the Company.
The Company also relies upon unpatented proprietary technology, and no
assurance can be given that others will not independently develop substantially
equivalent proprietary technology and techniques, or otherwise gain access to
the Companys proprietary technology or disclose such technology, or that the
Company can meaningfully protect its rights to its unpatented proprietary
technology, secrets and know-how.
It is the Companys policy generally to require its consultants,
outside scientific collaborators, sponsored researchers and other advisors to
execute confidentiality agreements prior to the commencement of consulting or
other relationships with the Company. Employees have a similar confidentiality
provision in their employment contracts. These agreements provide that all
confidential information developed or made known to the individual during the
course of the individuals relationship with the Company is to be kept
confidential and not disclosed to third parties except in specific, limited
circumstances. The Company also requires signed confidentiality or material
transfer agreements from any person who is to receive confidential data or
proprietary material from the Company. In the case of consultants, the
agreements generally provide that all inventions conceived by the individual
while rendering services to the Company shall be assigned to the Company as the
exclusive property of the Company. Similar provisions are contained in the
Companys employment contracts, and provisions of many national laws, including
25
Australia, provide that intellectual property rights created during the
course of employment belong to the employer. There can be no assurance,
however, that these agreements and provisions will provide meaningful
protection or adequate remedies for the Companys intellectual property rights,
trade secrets or other confidential information in the event of unauthorized
use or disclosure.
Patent
protection is being sought in major markets through the filing of U.S. and
International Patent Cooperation Treaty (PCT) applications. The portfolio
includes 22 PCT applications and currently derived from these applications are
over 96 national and regional patent applications in 12 different jurisdictions,
including the U.S., Europe
and Japan. The portfolio also includes 20
provisional patent applications not listed above that have been submitted in
the past year.
Under
the PCT, a single patent application is filed which designates various countries
or regions. The application is r
eferred to as an International
application. All major countries and regions (e.g. Europe) can be designated
and this effectively reserves the right to lodge patent applications in those
countries and regions up to 18 months following the filing of the PCT
application. During that period, an International Search Report and an
International Preliminary Examination Report are issued by the relevant
national patent office (e.g. the United States Patent and Trademark Office (USPTO),
or Australian Patent Office) and there are opportunities to amend the claims
and specification although new matters cannot be added. At the end of the 18
month period (i.e. generally 30 months after filing of the initial provisional
application), the applicant decides in which countries to pursue national or
regional applications.
Competition
The
Company faces, and will continue to face, intense competition from one or more
of the following entities:
biotechnology companies;
pharmaceutical companies;
academic and research institutions; and
government agencies.
The
Company is also subject to significant competition from organizations that are
pursuing approaches, technologies and products that are the same as, or similar
to, its technology and products. Any products that are developed through the
Companys technologies will compete in highly competitive markets. Further, the
Companys competitors may be more effective at using their technologies to
develop commercial products. Many of the organizations competing with the
Company have greater capital resources, larger research and development staffs
and facilities, more experience in obtaining regulatory approvals and more
extensive product manufacturing and marketing capabilities. As a result, the
Companys competitors may be able to more easily develop technologies and
products that would render the Companys technologies and products, and those
of its collaborators, obsolete and noncompetitive. In addition, there may be
product candidates of which the Company is not aware at an earlier stage of
development that may compete with the Companys product candidates.
Specific
competition risk according to disease class is summarized below.
Cancer
In the field of cancer therapeutics the Company faces intense
competition from major pharmaceutical companies and specialized biotechnology
companies engaged in the development of product candidates and other
therapeutic products. Several of these companies have products in the same
indications or utilize similar technologies and/or personalized medicine
techniques. The FDA has approved two drugs for Gleevec
®
-resistant
CML; Sprycel
®
(dasatinib), a drug developed and commercialized by
Bristol-Myers Squibb was approved in June 2006, and Nilotinib
®
(nilotinib)
a drug developed and commercialized by Novartis was approved in October 2007.
Significantly, neither Sprycel
®
nor Nilotinib
®
have
demonstrated efficacy against the T315I bcr-abl mutation, and it is this
sub-set of resistant CML patients that are being targeted by the Company for
initial approval. Several biotechnology and pharmaceutical companies are
seeking to develop effective therapeutics specifically for CML patients with
the T315I mutation. Vertex Pharmaceuticals and its partner Merck are developing
an aurora kinase inhibitor referred to as MK-0457 or VX-680. This agent is
currently in phase 2 clinical trials. Astex Therapeutics is developing
AT9283,
an inhibitor of several targets including bcr-abl. This agent is currently in
phase 1/2 clinical trials. Several companies have agents in phase 1 clinical
trials, including Exelixis (XL228), Kyowa Hakko (KW2449) and Medimmune/Infinity
Pharmaceuticals (IPI504).
Xanthus
Pharmaceuticals is currently
conducting a
26
phase
3 study with amonafide malate in acute myeloid leukemia.
There are also
a number of other competitive trials or technologies elsewhere in the world.
Metabolic
Syndrome and Depression
There
are numerous internationally-regarded genomics and target discovery companies
that are active in the search for new potent therapeutics against these
diseases. Some of the Companys competitors have entered into collaborations
with leading companies within the Companys target markets. Companies that are
applying different proprietary technologies to the search for novel targets
include:
Amgen, Inc.
Curagen Corporation, Inc.
DeCode Genetics.
Excelixis, Inc.
Genentech, Inc.
Human Genome Sciences, Inc.
Incyte Pharmaceuticals, Inc.
ZymoGenetics, Inc.
A
number of organizations are attempting to rapidly identify and patent genes and
gene fragments sequenced at random, typically without specific knowledge of the
function of such genes or gene fragments. If the Companys competitors discover
or characterize important genes or gene fragments before it does, it could
adversely affect the Companys ability to commercialize its products. The
Company expects that competition in genomics research will intensify as
technical advances are made and become more widely known. In addition, a number
of competitors are claiming patent protection without having cellular, animal,
or human data to support their claims. In many cases generic claims are being
issued by the USPTO, and these claims may make it difficult to commercialize
products, or, if licenses are made available, may make the royalty burden on
these products so high as to prevent commercial success.
Material
effects of government regulation
The
international pharmaceutical industry is highly regulated by numerous
governmental authorities in Australia, the U.S., the U.K., Europe and by
regulatory agencies in other countries where the Company intends to test or
market products it may develop. National regulatory authorities administer a wide
range of laws and regulations governing the testing, approval, manufacturing,
labeling and marketing of drugs and devices and also review the quality, safety
and effectiveness of pharmaceutical products and devices. These regulatory
requirements are a major factor in determining whether a substance can be
developed into a marketable product and the amount of time and expense
associated with such development.
The
national regulatory authorities have high standards of technical appraisal.
Consequently, the introduction of new pharmaceutical products generally entails
a lengthy development and approval process. Of particular importance is the
requirement that products be authorized or registered prior to marketing and
such authorization or registration be maintained. Of particular significance in
the U.S. are the U.S. FDA requirements covering research and development,
testing, manufacturing, quality control, labeling and marketing of drugs for
human use. A pharmaceutical product cannot be marketed in the U.S. until it has
been approved by the FDA, and then can only be marketed for the indications and
claims approved by the FDA. As a result of these requirements, the length of
time, the level of expenditure and the laboratory and clinical information
required for approval of a New Drug Application (NDA) or a product license
application are substantial and can require a number of years, although
recently revised regulations are designed to reduce the time for approval of
new products. In Europe, two systems for the registration of pharmaceutical
products are in operation, the centralized procedure and the mutual recognition
procedure. In the centralized system, review of the proposed new product is
co-coordinated by the European Medicines Evaluation Agency (EMEA) located in
London and, if the product is found to meet the criteria for marketing
authorization, a European Marketing Authorization is granted which is valid
throughout the EU. In the mutual recognition procedure, the initial review is
undertaken by the national health authority of one of the EU member states and,
if this country considers the product acceptable for marketing authorization,
the other EU member states are asked to recognize this approval and issue their
own authorization. The mutual recognition procedure thus results in a national
authorization in each member state. However, irrespective of the procedure
followed, the technical requirements for marketing authorization are the same.
For European countries that are outside the EU, national marketing
authorization procedures with similar technical standards exist. The Company
27
anticipates
that the introduction of new products will continue to require substantial
effort, time and expense in order to comply with regulatory requirements.
No
new drug is permitted to be sold in developed countries without extensive data
on its quality, safety and efficacy first being obtained, organized and
submitted to governmental regulatory authorities. The development stage of this
process may be divided into two parts: (i) pre-clinical; and (ii) clinical
development. Included in pre-clinical development are the development of
processes for manufacturing the product candidate, toxicology studies and other
activities such as pharmacology and drug metabolism studies. Clinical trials
run until, and in some cases after, the product is marketed and covers several,
sometimes overlapping, phases.
In
Phase I trials, a small number of healthy human volunteers are exposed to a
product candidate. Typically, the volunteers are administered single or
multiple doses, following which the effects of the candidate drug are closely
monitored. The way the body deals with the product candidate from
administration to elimination (pharmacokinetics) is also studied. Phase 2
trials involve the first studies on patients and explore the doses required to
produce the desired benefits. Safety and pharmacokinetic information is also
collected. Phase 3 trials typically involve larger numbers of patients and
geographically dispersed test sites. The trials in this Phase may compare the
new agent with other available treatments. In Phase 3 trials, costs are
significantly higher than in earlier Phases due to the larger number of
patients and longer duration of trial.
In
addition to the forms of regulation referred to above, the prices of
pharmaceutical products in many countries are controlled by law. In some
countries, such as France and Japan, the prices of individual products are
regulated. By contrast, in the U.K., prices are controlled by reference to
limits upon the overall profitability, measured by the rate of return on
capital employed, of sales of products supplied under the U.K. National Health
Service. The permitted rate of return on capital employed for each
pharmaceutical company is determined through negotiations with the U.K.
Department of Health under the 1999 Pharmaceutical Price Regulation Scheme. If
a companys actual rate of return exceeds the agreed rate, it is required to negotiate
either a repayment of past profits which the Department of Health considers to
be excessive or future price reductions. There is no assurance that the current
arrangements will continue in the future.
Governments
may also influence the price of pharmaceutical products through their control
of national healthcare organizations which may bear a large part of the cost of
supply of such products to consumers. In the U.S. and Germany, indirect
pressure can be exerted on prices by government funded or private medical care
plans. The Company is unable to predict whether, or to what extent, its
business may be affected by legislative and regulatory developments relating to
specific pharmaceutical products or the pricing of such products, or to its
overall business. The uncertainties involved, or any adverse regulatory
developments, could significantly affect the Companys operational results and
its ability to achieve profitability.
C. Organizational structure
ChemGenex Pharmaceuticals Limited is a limited liability corporation
listed on the ASX. Its subsidiaries are set forth below:
Name of entity
|
|
Country of incorporation
|
|
Ownership interest (%)
|
|
Business
|
|
|
|
|
|
|
|
Autogen Research Pty Ltd
|
|
Australia
|
|
100
|
|
Research and development
|
|
|
|
|
|
|
|
ChemGenex Pharmaceuticals, Inc. (formerly ChemGenex
Therapeutics, Inc.)
|
|
U.S. (Delaware)
|
|
100
|
|
Research and development
|
D. Property, plant and equipment
The Companys headquarters are in Geelong, Victoria, Australia. Its
headquarters, comprising leased premises of approximately 80 square meters,
contains office space and storage space. The property plant and equipment
recorded includes leasehold improvements, furniture and fittings, computer
equipment, and equipment used in research and development by external providers.
These properties are in good condition.
28
The headquarters premises are leased from Deakin University under an
annual lease agreement which expires on December 31, 2007. Designated research
projects are subcontracted to third party laboratories including Deakin
University.
ChemGenex Pharmaceuticals, Inc. leases approximately 2,400 square feet
of corporate office space in Menlo Park, California, under a lease agreement
that terminates on December 31, 2007. The U.S. subsidiary also subleases
approximately 500 square feet of laboratory space to conduct
in vitro
experiments to support oncology discovery and
development programs in Menlo Park, California under a sublease that terminates
on December 31, 2007. On August 1, 2007 the Company moved into new premises of
approximately 5,000 square feet in Menlo Park under a 38 month lease agreement
which expires on October 31, 2010. This lease allows for an option for a
further 2 years to October 31, 2012.
Environmental
The Companys operations are not subject to any significant
environmental regulations under either Australian Commonwealth or State
legislation. The Company uses hazardous materials that could be dangerous to
human health, safety or the environment. As appropriate, the Company stores
these materials and various wastes resulting from their use at its facilities
pending ultimate use and disposal. The Company is subject to a variety of
federal, state and local laws in both Australia and the U.S. and regulations
governing the use, generation, manufacture, storage, handling and disposal of
these materials and wastes resulting from the use of such materials. While the
costs for compliance, including costs related to the disposal of hazardous
materials, to date have been nominal, the Company may incur significant costs
complying with both existing and future environmental laws and regulations.
ChemGenex Pharmaceuticals, Inc. is subject to regulation by the Occupational
Safety and Health Administration, or OSHA, the California and federal
environmental protection agencies and to regulation under the Toxic Substances
Control Act. OSHA or the California or federal EPA may adopt regulations that
may affect the U.S. subsidiarys research and development programs. The Company
is unable to predict whether any agency will adopt any regulations that could
have a material adverse effect on its operations.
ITEM
5. OPERATING AND FINANCIAL REVIEW AND
PROSPECTS
The following discussion and analysis should be read in conjunction
with Item 3A. Selected consolidated financial data and the Companys audited
consolidated financial statements, the notes thereto and other financial
information appearing elsewhere in this Annual Report. In addition to
historical information, the following discussion and other parts of this Annual
Report contain forward-looking statements that reflect the Companys plans,
estimates, intentions, expectations and beliefs. Actual results could differ
materially from those discussed in the forward-looking statements. See the Risk
Factors section of Item 3D and other forward-looking statements in this Annual
Report for a discussion of some, but not all factors that could cause or
contribute to such differences.
The following review is based on the Companys audited consolidated
financial statements prepared in accordance with Australian Accounting
Standards, which include Australian equivalents to International Financial
Reporting Standards (AIFRS). A summary of the significant differences
between these standards and U.S. GAAP is given below and more detailed
information is provided in the Companys audited consolidated financial
statements included elsewhere in this Annual Report.
For all periods up to and including the year ended June 30, 2005, the
Company prepared its financial statements in accordance with Australian
generally accepted accounting practice (AGAAP). The financial
statements for the years ended June 30, 2007 and 2006 are prepared in
accordance with AIFRS. In preparing these consolidated financial
statements, the Company has started from an opening balance sheet date as at
July 1, 2004, the Companys date of transition to AIFRS.
Recently issued but not yet adopted accounting pronouncements
applicable to ChemGenex
Australian pronouncements
Certain Australian
Accounting Standards and Urgent Issues Group (UIG) interpretations have
recently been issued or amended but are not yet effective and have not been
adopted by the Group for the annual reporting period ended 30 June 2007. The
directors have assessed the impact of these new or amended standards (to the
extent relevant to the group) and interpretations as follows:
29
Reference
|
|
Title
|
|
Summary
|
|
Application
date of
standard*
|
|
Impact on Group financial report
|
AASB
2005-10
|
|
Amendments to Australian
Accounting Standards [AASB 132, AASB 101, AASB 114, AASB 117, AASB 133, AASB
139, AASB 1, AASB 4, AASB 1023 & AASB 1038]
|
|
Amendments arise from the
release in August 2005 of AASB 7 Financial Instruments: Disclosures.
|
|
1 January 2007
|
|
AASB 7 is a disclosure
standard so will have no direct impact on the amounts included in the Groups
financial statements. However, the amendments will result in changes to the
financial instrument disclosures included in the Groups financial report.
|
AASB
2007-1
|
|
Amendments to Australian
Accounting Standards arising from AASB Interpretation 11 [AASB 2]
|
|
Amending standard issued
as a consequence of AASB Interpretation 11 Interim Financial Reporting and Impairment.
|
|
1 March 2007
|
|
This is consistent with
the Groups existing accounting policies for share-based payments so will
have no impact.
|
AASB
2007-3
|
|
Amendments to Australian
Accounting Standards arising from AASB 8 [AASB 5, AASB, AASB 6, AASB 102, AASB
107, AASB 119, AASB 127, AASB 134, AASB 136, AASB 1023 & AASB 1038]
|
|
Amending standard issued
as a consequence of AASB 8 Operating Segments.
|
|
1 January 2009
|
|
AASB 8 is a disclosure
standard so will have no direct impact on the amounts included in the Groups
financial statements. The impact of the new standard is yet to be determined.
|
AASB 7
|
|
Financial Instruments:
Disclosures
|
|
New standard replacing
disclosure requirements of AASB 132.
|
|
1 January 2007
|
|
Refer to AASB 2005-10
above.
|
AASB 8
|
|
Operating Segments
|
|
This new standard will
replace AASB 114 Segment Reporting and adopts a management approach to
segment reporting.
|
|
1 January 2009
|
|
Refer to AASB 2007-3
above.
|
U.S. pronouncements
Uncertainty in Income Taxes
In July 2006, the FASB issued FASB Interpretation (FIN) No. 48,
Accounting for Uncertainty in Income Taxes,
an
interpretation of FASB No. 109,
Accounting for Income
Taxes
(FIN 48). FIN 48 creates a single model to address
uncertainty in tax positions and clarifies the accounting for income taxes by
prescribing the minimum recognition threshold a tax position is required to meet before
being recognized in the financial statements. FIN 48 also provides guidance on
derecognition, measurement, classification, interest and penalties, accounting
in interim periods, disclosure, and transition. In addition, FIN 48 clearly
scopes out income taxes from SFAS No. 5,
Accounting for
Contingencies
. FIN 48 applies to all tax positions related to income taxes
subject to SFAS No. 109. This includes tax positions considered to be routine
as well as those with a high degree
of uncertainty. The guidance contained in FIN 48 is also applicable to
pass-through entities, non-taxable
entities, and entities whose tax liability is subject to 100% credit for
dividends paid. FIN 48 utilizes the following two-step approach for evaluating
tax positions: recognition (step one) and measurement (step two). Step one
occurs when an enterprise concludes that a tax position, based solely on its
technical merits, is more-likely-than-not to be sustained on examination. Step
two is only addressed if step one has been satisfied. Under step two, the tax
benefit is measured as the largest amount of benefit, determined on a
cumulative probability basis, which is more-likely-than-not to be realized on
ultimate settlement. Derecognition of a tax position that was previously
recognized would occur when a company subsequently determines that a tax
position no longer meets the more-likely-than-not threshold of being
30
sustained. FIN 48 specifically prohibits the use of a valuation
allowance as a substitute for derecognition of tax positions. FIN 48 requires
expanded disclosures, including a tabular roll forward of the beginning and
ending aggregate unrecognized tax benefits as well as specific detail related
to tax uncertainties for which it is reasonably possible the amount of
unrecognized tax benefit will significantly increase or decrease within twelve
months. These disclosures are required at each annual reporting period, unless
a significant change occurs in an interim period. FIN 48 is effective for
fiscal years beginning after December 15, 2006. The Company plans to adopt this
pronouncement in fiscal year beginning July 1, 2007 and does not believe the
adoption of FIN 48 will have a material effect on the consolidated financial
statements.
Fair Value Measurements
In September 2006, the FASB issued SFAS No. 157,
Fair Value
Measurements
(SFAS 157). SFAS 157 provides enhanced guidance for
using fair value to measure assets and liabilities and also responds to
investors requests for expanded information about the extent to which
companies measure assets and liabilities at fair value, the information used to
measure fair value, and the effect of fair value measurements on earnings. SFAS
157 applies whenever other standards require (or permit) assets or liabilities
to be measured at fair value and does not expand the use of fair value in any
new circumstances. Under SFAS 157, fair value refers to the price that would be
received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants in the market in which the reporting
entity transacts. SFAS 157 clarifies the principle that fair value should be
based on the assumptions market participants would use when pricing the asset
or liability. In support of this principle, SFAS 157 establishes a fair value
hierarchy that prioritizes the information used to develop those assumptions. The
fair value hierarchy gives the highest priority to quoted prices in active
markets and the lowest priority to unobservable data. Under SFAS 157, fair
value measurements would be separately disclosed by level within the fair value
hierarchy. SFAS 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. The Company plans to adopt this
pronouncement in fiscal years beginning July 1, 2008 and does not believe the
adoption of SFAS 157 will have a material effect on the consolidated financial
statements.
Accounting for Research and Development Costs
In June 2007, the Financial Accounting Standards Board (FASB)
considered the Emerging Issues Task Force (EITF) review of FASB Statement No.
2 Accounting for Research and development Costs. The Task Force reached a
consensus that nonrefundable advance payments for future research and
development activities should be deferred and capitalized. Such amounts
should be recognized as an expense as the related goods are delivered or the
related services are performed. Entities should continue to evaluate
whether they expect the goods to be delivered or services to be rendered.
If an entity does not expect the goods to be delivered or services to be
rendered, the capitalized advance payment should be charged to expense. The
consensus in this Issue should be effective for fiscal years beginning after
December 15, 2007, including interim periods within those fiscal years.
Entities should report the effects of applying the [consensus] in this Issue as
a change in accounting principle through a cumulative-effect adjustment to
retained earnings or to other components of equity or net assets in the
statement of financial position as of the beginning of the year of
adoption. An entity should disclose the cumulative effect of the change
on retained earnings or on other components of equity or net assets in the
statement of financial position. Earlier application is not permitted.
The Company plans to adopt this pronouncement in fiscal years beginning July 1,
2008 and does not believe the adoption of EITF 07-3 will have a material effect
on the consolidated financial statements.
Fair Value Measurements
In February 2007, the FASB issued FAS 159, The Fair Value Option for
Financial Assets and Financial Liabilities (FAS 159). FAS 159 permits
entities to choose to measure many financial instruments and certain other
items at fair value. The objective is to improve financial reporting by
providing entities with the opportunity to mitigate volatility in reported
earnings caused by measuring related assets and liabilities differently without
having to apply complex hedge accounting provisions. FAS 159 is expected to
expand the use of fair value measurement, which is consistent with the FASBs
long-term measurement objectives for accounting for financial instruments. FAS
159 also establishes presentation and disclosure requirements designed to
facilitate comparisons between entities that choose different measurement
attributes for similar types of assets and liabilities. FAS 159 does not affect
any existing accounting literature that requires certain assets and liabilities
to be carried at fair value. This Statement does not establish requirements for
recognizing and measuring dividend income, interest income, or interest
expense. This Statement does not eliminate disclosure
31
requirements included in other accounting standards, including
requirements for disclosures about fair value measurements included in FASB
Statements No. 157, Fair Value Measurements, and No. 107, Disclosures
about Fair Value of Financial Instruments. FAS 159 is effective for financial
statements issued for fiscal years beginning after November 15, 2007. The
Company plans to adopt this pronouncement in fiscal years beginning July 1,
2008 and does not believe the adoption of FAS 159 will have a material effect
on the consolidated financial statements.
Differences
between Australian accounting standards and U.S. accounting standards
The Company prepares its
audited consolidated financial statements in accordance with AIFRS, which
differ in certain significant respects from U.S. GAAP. The following table sets
forth a comparison of the Companys net loss and total equity in accordance
with AIFRS and U.S. GAAP as of the dates and for the periods indicated:
Period
|
|
Year to June 30, 2007
A$000
|
|
Year to June 30, 2006
A$000
|
|
Year to June 30, 2005
A$000
|
|
|
|
|
|
|
|
|
|
Net loss in accordance with A IFRS
|
|
(11,701
|
)
|
(10,370
|
)
|
(6,235
|
)
|
Net loss in accordance with U.S. GAAP
|
|
(11,701
|
)
|
(10,444
|
)
|
(6,189
|
)
|
As at
|
|
June 30, 2007
|
|
June 30, 2006
|
|
June 30, 2005
|
|
|
|
|
|
|
|
|
|
Total equity in accordance with AIFRS
|
|
39,870
|
|
31,005
|
|
25,235
|
|
Total equity in accordance with U.S. GAAP
|
|
22,938
|
|
14,073
|
|
8,378
|
|
See Note 26 to the audited
consolidated financial statements included elsewhere herein for a description
of the differences between AIFRS and U. S. GAAP as they relate to the Company,
and a reconciliation to U.S. GAAP of net loss and total equity for the dates
and periods indicated therein. Differences between AIFRS and U.S. GAAP that
have a material effect on net loss and total equity relate to share-based
compensation, purchase accounting and marketable securities.
Application of critical accounting policies
The Company prepares its financial statements
in accordance with generally accepted accounting principles. As such, it is
required to make estimates, judgments, and assumptions that management believes
are reasonable based upon the information available. The estimates, judgments
and assumptions affect the reported amounts of assets and liabilities at the
date of the financial statements and the reported amounts of revenues and
expenses during the periods presented. The significant accounting policies
listed in Note 2 of the Companys audited consolidated financial statements
that management believes are the most critical to aid in fully understanding
and evaluating its financial condition and results of operations are discussed
below.
AIFRS and
U.S. GAAP
Revenue Recognition
Research revenue comprises amounts received for certain research and
development activities under the Companys collaborations with Merck Santé and
Vernalis
For these contracts revenues are recognized as earned on a straight
line basis over the lives of the respective agreements as this reflects the
level of effort required over the performance period. Such agreements are
performed on a best efforts basis with no guarantee of either technological
or commercial success. Project funding received in advance of the period in
which the associated research efforts are performed is included in deferred
revenue.
Revenue from government grants is recognised when received and all
attaching conditions have been complied with.
When the grant relates to an expense item, it is recognised as income
over the periods necessary to match the grant on a systematic basis to the
costs that it is intended to compensate.
32
U.S. GAAP
In-Process Research and Development
In connection with the June 21, 2004 merger with ChemGenex
Therapeutics, Inc. (accounted for under the purchase method of accounting), for
U.S. GAAP purposes the Company allocated A$16.6 million of the purchase price
to in-process research and development projects that had not yet reached
technological feasibility and
are reasonably
believed to have no alternative future use. Under US GAAP this inprocess
research and development expenditure was written off in the financial
statements for that year. The value assigned to in-process research and
development was determined by estimating the cost to develop the purchased
in-process research and development into commercially feasible products, the
percentage of completion at the acquisition date and the resulting net
risk-adjusted cash flows from the projects, and discounting the net cash flows
to their present value. The discount rate of 43.5% used in determining the
in-process research and development expenditures reflects a higher risk of
investment because of the higher level of
uncertainty due in part to the nature of the Company and the industry to
constantly develop new technology for future product releases. The forecasts
used by the Company in valuing in-process research and development were based
on assumptions the Company believed at the time to be reasonable, but which are
inherently uncertain and unpredictable. Given the uncertainties of the
development process, no assurance can be given that deviations from the Companys
estimates will occur and no assurance can be given that the in-process research
and development projects identified will ever reach either technological or
commercial success.
Share-based Compensation
Under U.S. GAAP, the Company had elected, to June 30, 2005, to account
for share-based compensation attributable to the issuance of share options to
directors and employees using the intrinsic value method as prescribed by APB
No. 25. Accordingly, share-based compensation expense is only recorded if the
quoted market price of the Companys stock, as at the measurement date, exceeds
the amount that the director or employee must pay. The intrinsic value
attributable to unvested options is amortized over the remaining vesting period
of the options. For options that vest upon the achievement of a target stock
price, compensation expense is recognized when the target is achieved.
Since July 1, 2005 the Company has accounted for share-based
compensation attributable to share options granted to employees in accordance
with FAS No. 123R (as for share-based compensation attributable to share
options granted to non-employees as detailed below).
Under U.S.
GAAP, the Company accounts for share-based compensation attributable to share
options granted to non-employees in accordance with FAS No. 123,
Accounting for Stock-Based Compensation
, as amended by FAS
No. 148,
Accounting for Stock-Based Compensation-Transition
and Disclosure
(collectively,
FAS No. 123),
and Emerging Issues Task Force Issue No. 96-18
, Accounting for Equity Instruments That Are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services
(EITF
No. 96-18). Share-based compensation for stock options granted to employees
and non-employees is equal to the fair value of the share options as of the
measurement date. The Company determines the fair value of options
granted to employees and non-employees
using the Black-Scholes option valuation model, which requires the input of
highly subjective assumptions, including the estimated fair value of the
Companys common stock and expected stock price volatility.
A
. Operating results
The Companys principal activity since July 1996 has been research and
development of novel targets and therapeutics for human diseases including
obesity, diabetes, depression and cancer. The Company has made losses since
commencing its current principal activities. As at June 30, 2007, the Companys
accumulated deficit was A$92,723,921 compared to A$81,023,002 as at June 30,
2006.
The Companys losses fluctuate from year to year principally due to the
commencement or termination of collaborative research and development
agreements, the timing of milestone payments, government grants, the level of
interest income and variations in the level of expenditures relating to
research and clinical development programs. The Company expects to incur
continued losses in coming years. The Company continues to incur the greater
part of its costs on personnel and external contract costs needed to support
the research and development of its platforms, including expenses related to
the protection of patent and other intellectual property rights.
33
Overview
The Company is a
biopharmaceutical company committed to advancing patient care by discovering,
developing and commercializing novel medicines for cancer, diabetes, obesity,
depression and anxiety. ChemGenex Pharmaceuticals Limited was formed through
the merger of AGT Biosciences Limited and ChemGenex Therapeutics, Inc. on June
21, 2004. AGT Biosciences Limited was a publicly-listed company that
specialized in the use of genomics tools to identify and validate novel targets
for therapeutic intervention in diabetes, obesity, depression and anxiety. AGT
Biosciences Limited, which had previously been called Autogen Limited (from May
1999 to March 2003) and Australia Wide Industries Limited (from July 1986 to
May 1999), commenced biotechnology activities on July 10, 1996. On June 28,
2002, a 20% shareholding in Autogen Limited held by the then Executive Chairman
was sold to the publicly-listed Australian investment company, Charter Pacific
Corporation Limited. This led to a significant restructure of the management
team and significantly improved financial performance of the Company. ChemGenex
Therapeutics, Inc. was a private company incorporated in the state of Delaware
on September 14, 1999 to use genomic tools and medicinal chemistry to
accelerate the development of anti-cancer therapeutics. The merged entity
commenced trading on the ASX as ChemGenex Pharmaceuticals Limited on June 29,
2004. At June 30, 2007 the merged entity has an aggregate of
185,847,331
shares of ordinary stock outstanding.
To date, the
Company has devoted substantially all of its resources to the development of
its target discovery and validation technologies, research and development and
preclinical and early stage clinical testing of Ceflatonin® (homoharringtonine)
and Quinamed® (amonafide dichloride) and other product candidates. It has
incurred net losses since the commencement of biotechnology operations and
expects to incur substantial and increasing losses for the next several years
as it expands its research and development activities and moves its product
candidates into later stages of development. To date, the Company has no
product revenue and has funded its operations primarily through the payments
from pharmaceutical industry partners, issue of equity securities and interest
income. It has established an ongoing partnership agreement in diabetes and
obesity with Merck Santé. Planned core activities over the next several years
are to:
continue the development of
Ceflatonin®, currently in Phase 2/3 clinical trial for the treatment of CML;
continue the development of
Quinamed®, currently in Phase 2 clinical trial for the treatment of solid
tumors
including prostate, breast
and ovarian cancer;
continue the development of
its other cancer-treating product candidates;
expand the Companys research,
discovery and development programs in the fields of diabetes and obesity;
advance the Companys
preclinical cancer-treating candidates into clinical development;
establish and maintain sales
and marketing operations;
commercialize any product
candidates that receive regulatory approval; and
in-license technology and
acquire or invest in businesses, products or technologies that are synergistic
with the Companys own.
ChemGenex has
a limited history of operations with its current management team and business
focus.
The Companys
business is subject to significant risks, including but not limited to the
risks inherent in its ongoing clinical trials and the regulatory approval
process, the results of its research and development efforts, competition from
other products and technologies and uncertainties associated with obtaining and
enforcing patent rights.
Results of operations fiscal years
The following tables are intended to illustrate a tabular analysis of
the consolidated statements of income for the 2007, 2006 and 2005 fiscal years.
34
The table below shows contribution of different revenue and other
income types to total revenue and other income for fiscal 2007, 2006 and 2005.
All revenue was earned in Australia and is expressed in A$.
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
A$
|
|
A$
|
|
Research revenue
|
|
536,111
|
|
1,676,297
|
|
3,527,312
|
|
Interest revenue
|
|
862,096
|
|
241,634
|
|
266,987
|
|
Other revenue
|
|
|
|
|
|
|
|
-Patent reimbursement
|
|
|
|
230,223
|
|
104,085
|
|
-Exchange rate benefit
|
|
157,917
|
|
|
|
|
|
-Government grants
|
|
730,099
|
|
148,868
|
|
196,902
|
|
-Other revenue
|
|
1,911
|
|
|
|
|
|
Total revenue and other income
|
|
2,288,134
|
|
2,297,022
|
|
4,095,286
|
|
The table below shows percentage revenue and other income changes for
fiscal 2007, 2006 and 2005:
|
|
2007
|
|
2006
|
|
2005
|
|
Revenues and other income from ordinary
activities
|
|
-0.3
|
%
|
-43.9
|
%
|
13.9
|
%
|
The table below shows the proportion of individual expenses items to
total operating costs for fiscal 2007, 2006 and 2005.
|
|
2007
|
|
2006
|
|
2005
|
|
Research expenditure
|
|
55.3
|
%
|
56.7
|
%
|
44.7
|
%
|
Employee costs
|
|
18.0
|
%
|
21.5
|
%
|
25.5
|
%
|
Patent costs
|
|
4.0
|
%
|
4.5
|
%
|
4.3
|
%
|
Legal costs
|
|
0.5
|
%
|
0.9
|
%
|
1.0
|
%
|
Depreciation
|
|
1.9
|
%
|
2.1
|
%
|
2.7
|
%
|
Other expenses from ordinary activities
|
|
20.3
|
%
|
14.3
|
%
|
21.8
|
%
|
|
|
|
|
|
|
|
|
TOTAL EXPENSES
|
|
100.0
|
%
|
100.0
|
%
|
100.0
|
%
|
While the level of research and development expenditure has remained
relatively constant for the past two fiscal years, the relativity to other
expenses altered significantly in 2005 reflecting the increase in the Companys
operating base following the merger with ChemGenex Therapeutics Inc. in June
2004.
Comparison of fiscal year 2007 with fiscal year 2006
Revenue
The Companys total revenue decreased by A$9
thousand or 0.3% from A$2.3 million in fiscal 2006 to A$2.3 million in fiscal
2007. The decrease reflects a reduction in research revenue following the
completion a Research Agreement with Merck Sante and an increase in interest
and government grants during the year.
Costs and expenses
The Companys
costs and expenses are detailed in the consolidated statements of income.
Research
expenditure
Research
expenditure increased by 8% from A$7.2 million in fiscal 2006 to A$7.7 million
in fiscal 2007. This reflects continued
increased expenses associated with clinical trials for Ceflatonin
incurred during the year.
35
Employee
costs
Employee
expenses decreased by A$0.2 million or 7% to A$2.5 million in fiscal 2007,
Patent
costs
Patent costs
include regulatory charges involved in applying for, and maintaining, patent
protection together with charges from patent attorneys for specialist advice on
these matters. Patent costs are expensed as incurred. Patent costs decreased by
2% to A$0.5million in fiscal 2007.
Legal
costs
Legal costs
reduced by 42% to A$66 thousand in fiscal 2007.
Depreciation
No substantive
change from previous year.
Other
expenses from ordinary activities
Other expenses
from ordinary activities increased by 57% from A$1.8 million in fiscal 2006 to
A$2.8 million in fiscal 2007. The major increases incurred in travel and
consulting costs associated with increased clinical trials and capital raising
activities.
Net loss
The Companys
net loss increased by A$1.3 million or 13% from A$10.4 million in fiscal
2005 to A$11.7 million in fiscal 2007 for the reasons described above.
Comparison of fiscal year 2006 with fiscal year 2005
Revenue
The Companys total revenue decreased by A$1.8
million or 43.9% from A$4.1 million in fiscal 2005 to A$2.3 million in fiscal
2006. The decrease primarily reflects the completion Research Agreements with
Merck Sante Vernalis (R&D) Limited during the year which have not been
replaced at the same agreements with similar revenue values.
Costs and expenses
The Companys
costs and expenses are detailed in the consolidated statements of income.
Research
expenditure
Research
expenditure increased by 55% from A$4.6 million in fiscal 2005 to A$7.2 million
in fiscal 2006. This reflects increased expenses associated with clinical
trials for Ceflatonin incurred during the year.
Employee
costs
Employee
expenses increased by A$0.07 million or 3% to A$2.7 million in fiscal 2006,
36
Patent
costs
Patent costs
include regulatory charges involved in applying for, and maintaining, patent
protection together with charges from patent attorneys for specialist advice on
these matters. Patent costs are expensed as incurred. Patent costs increased by
29% in fiscal 2006 due to different timing of various patent activities.
Legal
costs
Legal costs
did not alter significantly from fiscal year 2005 to 2006.
Depreciation
No substantive
change from previous year.
Amortization
With the
introduction of AIFRS Accounting Standards from July 1, 2004 there were no
Amortization costs recognised in fiscal 2006 or 2005.
Other
expenses from ordinary activities
Other expenses
from ordinary activities decreased by 20% from A$2.3 million in fiscal 2005 to
A$1.8 million in fiscal 2006. This decrease primarily reflects the one off
costs associated with the initial SEC registration and NASDAQ listing incurred
fiscal June 2005.
Net loss
The Companys
net loss increased by A$4.1 million or 66% from A$6.2 million in fiscal
2005 to A$10.4 million in fiscal 2006 for the reasons described above.
B
. Liquidity and capital resources
The Companys future revenues, liquidity and capital requirements are
dependent upon several factors, including, but not limited to, its success in
generating significant revenues from partnerships and/or sales; the time and
cost required to manufacture and find partners for its products; the time and
cost required for clinically developed products to obtain regulatory approvals;
competitive technological developments; additional government-imposed
regulation and control; and changes in healthcare systems which affect
reimbursement, pricing or availability of drugs and market acceptance of drugs
and drug technologies.
To
date, the Company has funded its operations primarily through the payments from
pharmaceutical industry partners and the issue of equity securities. From July
1, 1996, when the Companys biotechnology activities commenced, it has received
approximately A$80.9 million (including A$50.5 million since 1 July 2004) from
the issue of equity securities. In addition, during this period, the Company
has received A$26.5 million from its pharmaceutical partners for depression,
diabetes and obesity research.
37
Over
the past five years the Company has been able to obtain approximately 66% of
the funding required for the combined diabetes, obesity, depression and anxiety
contracts research spending via collaborative research agreements -
Period
|
|
Contract Research Spending
|
|
Collaborative Funding
|
|
|
|
A$
|
|
|
|
Fiscal year 2007
|
|
3,411,386
|
|
524,377
|
|
Fiscal year 2006
|
|
3,859,875
|
|
1,641,855
|
|
Fiscal year 2005
|
|
4,065,119
|
|
3,760,142
|
|
Fiscal year 2004
|
|
4,308,627
|
|
2,875,401
|
|
Fiscal year 2003
|
|
4,476,305
|
|
4,501,101
|
|
Total since July 1, 2002
|
|
20,121,312
|
|
13,302,876
|
|
Net
cash used in operating activities of A$11,905,605 in fiscal 2007, A$8,485,618
in fiscal 2006 and $6,944,186 in fiscal 2005 was primarily a result of the cash
shortfall associated with our research activities (detailed in Item 4B
Business Overview - commercial and research and development collaborations) and
expenses incurred for administration infrastructure.
As
of June 30, 2007, the Company had A$25.4 million in available cash and cash
equivalents. The Companys existing cash reserves and revenues received from
existing pharmaceutical partners will be utilized to support company
administration costs, research costs and the ongoing cancer development and
clinical trial programs. Based on existing cash and cash equivalents, the
Company anticipates that it has adequate funds to operate at current levels and
meet its contractual obligations, described further in Item 5F. Tabular
Disclosure of Contractual Obligations, until the second half of calendar 2008
without obtaining further partnership agreements for the cancer clinical trial
programs. The Company continues to monitor this situation and is constantly
reviewing its relationships to ensure adequate funding will be available to
support current projects.
Minimal
cash (apart from interest on cash assets) has been provided by, or used for,
investing activities during each of the three years in the period ended June
30, 2007.
While
the Companys cash resources are currently held in Australian dollars (A$), a
significant part of its cash flow burden over the next year is committed to
funding clinical trial programs in the U.S. The Company monitors the potential
foreign currency exposure from this situation and utilizes forward exchange
contracts when appropriate to manage this risk.
C. Research and product development
programs
Included within research and development expenditure is the following
external expenditure on research and development projects.
Over the last three years total expenditure on research and development
has resulted in the consumption of significant cash resources, totaling
A$19,538,372. The principal expenditures have been as follows:
Program
|
|
Annual Expenditure
Fiscal 2007
|
|
Annual Expenditure
Fiscal 2006
|
|
Annual Expenditure
Fiscal 2005
|
|
Diabetes and obesity
|
|
A$
|
3,221,386
|
|
A$
|
3,479,875
|
|
A$
|
3,685,119
|
|
Depression
|
|
A$
|
190,000
|
|
A$
|
380,000
|
|
A$
|
380,000
|
|
Cancer
|
|
A$
|
4,320,602
|
|
A$
|
3,325,103
|
|
A$
|
556,287
|
|
38
Whilst the Company made no expenditure in cancer research until fiscal
2005, ChemGenex Therapeutics, Inc. had expended US$5,955,000 (A$9,353,000) in
cancer related research. This expenditure is reflected in the purchase price
paid by the Company for ChemGenex Therapeutics, Inc.
The major expenditure during the last three years by specific research
undertaking is as follows:
Collaborator
|
|
Agreement and commencement date
|
|
Commitment at
June 30, 2007
|
|
Expiry
date
|
|
Expenditure
|
|
|
|
|
|
|
|
|
|
Deakin
University
|
|
Research,
License and Commercialization Agreement (April 21, 2005)
|
|
A$1,200,000
|
|
December
31, 2007
|
|
2007:A$2,410,000
2006:A$2,420,000
2005:A$2,470,000
|
|
|
|
|
|
|
|
|
|
International
Diabetes Institute
|
|
Research
Agreement for Human Diabetes / Obesity Discovery
Gene discovery and validation
research according to instruction from the Company in the fields of obesity
and diabetes. (January 14, 1998)
|
|
A$75,000
|
|
December
31, 2007
|
|
2007:A$221,662
2006:A$501,838
2005:A$1,104,190
|
|
|
|
|
|
|
|
|
|
Southwest
Foundation for Biomedical Research
|
|
the
Research Agreement
Human genomics research
according to instruction from the Company. (December 31, 2002)
|
|
US$0
(A$0)
|
|
June
30, 2006
|
|
2007:A$711,824
2006:A$895,138
2005:A$490,929
|
|
|
|
|
|
|
|
|
|
Various
contracts managed by ChemGenex Pharmaceuticals,
Inc.
|
|
Ongoing
preclinical and clinical development of cancer therapeutics (June 30, 2007
commitments based on Premier Research CRO Agreement)
|
|
US$ 4,083,420
(A$4,805,598)
|
|
Trial
dependent
|
|
2007:A$4,320,6027
2006:A$3,325,103
2005:A$556,287
|
These research and development expenses have been financed principally
through working capital raised by equity placements and through ongoing funding
from commercial collaborators. Since its commencement of biotechnology
activities in 1996 the Company has raised A$80.9 million, of which a net total
of A$51.2 million has been invested in direct research expenditure by the
Company through June 30, 2007.
See Item 4B. Business overview - Components of the ChemGenex
Discovery, Development and Validation Platforms for further information on the
current status of the development programs.
See Item 4B. Business overview - Commercial Collaborations for
further information on the status of research and development and commercial
collaborations.
See Item 3D. Risk Factors for the risks associated with developing
and bringing drug candidates to market.
Research
and Development
The
Company has two programs; (i) cancer and (ii) diabetes and obesity. The cancer
program has two molecules in clinical trials and a suite of earlier-stage
molecules in pre-clinical development. The latter two programs are preclinical,
focusing on the discovery and validation of novel gene and protein targets and
screening for small molecules that may have potential as new drugs to treat
these diseases. The status of these two programs is discussed below.
Cancer
The
cancer program has two therapeutic agents in Phase 2 clinical trials for three
indications in the USA and several molecules in pre-clinical development.
39
Ceflatonin
is currently in a
Phase 2/3 trial in the U.S.A. and Europe for CML
patients who have the T315I bcr-abl mutation that confers resistance to Gleevec
®
and other tyrosine kinase
inhibitors (TKIs). The company is also conducting a complementary phase 2
trial in CML patients who have failed Gleevec
®
and one other TKI. At the M.D. Anderson Cancer Center
the Company is conducting a combination (with Gleevec
®
) therapy Phase 2 trial in CML
patients who had failed Gleevec
®
.
The Company is also conducting Phase 2 trials in patients with the bone marrow
disease called myelodysplastic syndrome (MDS) in collaboration at the M.D.
Anderson Cancer Center.
A
Phase I clinical trial of Quinamed was completed successfully in early 2004,
and the Company initiated a Phase 2 trial in prostate cancer patients in late
2004. The trial is being performed at the Sarah Cannon Cancer Center in
Nashville, Tennessee. The most advanced pre-clinical therapeutic is CXS299,
which was recently licensed from the MD Anderson Cancer Center.
Completion
of the project as pertaining to the three clinical trials for the two
therapeutic agents is defined as the completion of the Phase 2 studies. Phase 2
trials are clinical trials conducted on a limited number of patients to,
(i) determine the efficacy of the compound for specific indications,
(ii) determine dosage tolerance and optimal dosage and (iii) identify
possible adverse effects and safety risks. The trials also seek to establish the
most effective route of administration. Trials are conducted on a larger, but
still limited number of carefully monitored patients. Phase 2 trials may last
up to two and one-half years.
The
regulatory authorities in each country may impose their own requirements and may
refuse to grant, or may require additional data before granting approval even
though the relevant product has been approved by another authority. The US,
Australia and European Union countries have very high standards of technical
appraisal and, consequently, in most cases, a lengthy approval process for
pharmaceutical products. The time required to obtain such approval in
particular countries varies, but if obtained generally takes from six months to
several years, if approval is received at all, from the date of application,
depending upon the degree of control exercised by the regulatory authority, the
duration of its review procedures, and the nature of the product. The trend in
recent years has been towards stricter regulation and higher standards.
In
the US, the primary regulatory authority is the FDA. In addition to regulating
clinical procedures and processes, the FDA investigates and approves market
applications for new pharmaceutical products and is responsible for regulating
the labeling, marketing and monitoring of all pharmaceutical products, whether
currently marketed or under investigation. Upon approval in the US, a drug may
be marketed only for the approved indications in the approved dosage forms and
dosages. In addition to obtaining FDA approval for each indication to be
treated with each product, each domestic drug manufacturing firm must register
with the FDA, list its drug products with the FDA, comply with current Good
Manufacturing Practice (cGMP) requirements and be subject to inspection by
the FDA. In Australia, a similar role is played by the Therapeutic Goods
Administration, and in Europe, the European Committee for Proprietary Medicinal
Products provides a mechanism for European Union-member states to exchange
information on all aspects of product licensing and assesses license
applications submitted under two different procedures (the multistate and the
high-tech concentration procedures).
The
Company has launched an international Phase 2/3 study in CML patients with the
T315I bcr-abl point mutation, which confers resistance to TKI therapy. The
first patients were dosed in September 2006, and enrollment under FDA approved
protocols in is ongoing. The Company was
awarded Fast Track status from the FDA for this trial on November 15, 2006. The
Fast Track designation will enable the Company to file a New Drug
Application (NDA) on a rolling basis as data becomes available. This
permits the FDA to review the filing as it is received, rather than waiting for
an entire document prior to commencing the review process.
The
Company has an additional Phase 2 study in CML patients who have failed Gleevec
and an additional TKI. This study is currently enrolling patients in the U.S.A.
Ceflatonin
is currently in a Phase 2 clinical trial to treat MDS patients at the MD
Anderson Cancer Center in Houston, Texas. To date the study has completed
treatments on nine patients, and approximately eleven more patients will be
treated to complete the Phase 2 trial. Expected completion of this trial is during
the first half of 2008.
A
Phase 2a clinical trial of Quinamed in solid cancer patients was completed in
early 2007 and data was presented at the ASCO meeting in June 2007. The trial
was performed at the Sarah Cannon Cancer Center in Nashville, Tennessee.
The
key outcomes from this study were (i) demonstration that dose level could be
optimised according to
40
patient genotype, (ii) the drug was well tolerated, with predictable
and manageable side effects, and (iii) there was evidence of anticancer
activity in several solid tumor types.
Due
to the high level of funds required to support clinical trials the Company has
decided to concentrate its activities on the trial involving Ceflatonin on CML
patients with the T315I mutation, as this has been deemed to provide the best
prospects for an early product approval at this time.
During
these studies, the Company may seek to license the compounds to a
pharmaceutical industry partner who would support appropriate
registration-directed trials.
Actual
and estimated direct expenditures associated with the progression of the cancer
programs since June 21, 2004 (the merger with ChemGenex Therapeutics, Inc) to
the end of fiscal 2008 are shown below.
|
|
Fiscal 2008
(Estimated)
|
|
Fiscal 2007
(Actual)
|
|
Fiscal 2006
(Actual)
|
|
Fiscal 2005
(Actual)
|
|
|
|
A$000s
|
|
Ceflatonin
|
|
9,995
|
|
4,281
|
|
2,002
|
|
349
|
|
Quinamed
|
|
598
|
|
97
|
|
111
|
|
110
|
|
Other pre-clinical projects
|
|
138
|
|
0
|
|
27
|
|
0
|
|
Total
|
|
10,731
|
|
4,378
|
|
2,140
|
|
459
|
|
None of our
product candidates have been approved for commercialization in the U.S. or
elsewhere. We, or any of our collaborators, may not be able to conduct clinical
testing or obtain the necessary approvals from the FDA or other regulatory
authorities for some products. Failure by us, or our collaborators, to obtain
required governmental approvals will delay or preclude our collaborators or us
from marketing therapeutics or diagnostic products developed with us or limit
the commercial use of such products and could have a material adverse effect on
our business, financial condition and results of operations.
Diabetes
and Obesity
The
current status of the diabetes and obesity program is that it is an ongoing
discovery and validation program. That is, proprietary and non-proprietary
technologies are employed to discover novel genes and proteins associated with
the diseases, and small molecules screening is undertaken to identify potential
therapeutic agents. The Company has discovered and protected, by patent
application, more than 50 novel targets in these diseases.
D. Trend information
The Company is a development stage company and it is difficult to
predict with any degree of accuracy the outcome of the Companys research and
development efforts. The following are developments that the Company considers
a possible progression in the near term in its business:
Phase 2 clinical
trials for Quinamed® and Ceflatonin®, Phase 2/3 clinical trials for
Ceflatonin® and possible partnering of
these lead therapeutics with a pharmaceutical or biotechnology partner;
Progression of
targets from the diabetes and obesity target discovery program to preclinical
development; and
Partnering of
the novel satiation target for either therapeutic or over the counter
development and ongoing development of that program.
For additional information on the current status of the Companys
product development and research programs, see above Item 4B, Business
overview - Commercial and Research and Development Collaborations and Item 5C,
Research and Product Development Programs. The Company is not aware of any
changes bearing upon its financial condition since the date of the financial
statements included in this Annual Report.
41
E
. Off-balance Sheet Arrangements
The Company has no off-balance sheet arrangements that have or are
reasonably likely to have current or future effect on the Companys financial
condition, changes in financial condition, revenues or expenses, results of
operations, liquidity, capital expenditures or capital resources that are
material to investors.
F. Tabular
Disclosure of Contractual Obligations
The table below shows the contractual obligations and commercial
commitments as at June 30, 2007:
|
|
Payments due by period
|
|
In A$s
|
|
Total
|
|
Less than 1 year
|
|
1-3 years
|
|
After 3 years
|
|
Operating leases
|
|
29,903
|
|
29,903
|
|
|
|
|
|
Research expenditure commitments(a)
|
|
6,228,172
|
|
5,097,818
|
|
1,130,354
|
|
|
|
Total contractual cash obligations
|
|
6,258,075
|
|
5,127,721
|
|
1,130,354
|
|
|
|
(a)
Research expenditure commitments include fees
payable under the major research and development programs discussed in Item 5C.
Research and Product Development Programs as well as fees payable to
scientific consultants and advisors to the Company.
G. Assets
Acquired in a Business Combination to be used in Research & Development
Activities
In
June 2004 ChemGenex Pharmaceuticals Limited (then AGT Biosciences Limited)
acquired all of the shares in ChemGenex Therapeutics Inc. for a total purchase
price, including direct acquisition costs, of approximately A$17.1 million. The
fair value of net tangible assets amounted to approximately A$0.1 million.
The
remaining value received from the acquisition relates primarily to the relevant
patents for the anti-cancer compounds Ceflatonin and Quinamed held by ChemGenex
Therapeutics Inc. at the time of the acquisition, and the in process research
and development already undertaken on these compounds.
Ceflatonin
is a small molecule with established clinical activity as a single agent in
blood cell cancers. Phase 2 trials of Ceflatonin commenced in patients with CML
in US and European hospitals.
Quinamed
is a synthetic small molecule with established anti-cancer activity in humans.
Quinamed affects the growth of a number of tumor types; however, researchers
have also noted some unpredictable side effects. Researchers have been working
on treating patients with a precise and personal dose that maximizes Quinameds
clinical effect while minimizing its side effects.
The
development history of these compounds prior to the acquisition is as follows-
(a)
NCI
in the USA began funding early research relating to the two projects in the
early 1980s.
(b)
In
early 1999 management of ChemGenex Therapeutics Inc. began work on both
research and development projects, continuing the drug development phase from
the initial NCI development work.
(c)
From
2000 ChemGenex Therapeutics Inc. continued chemical development, and by the
business combination date of June 30, 2004 approximately A$3.9 million (or 20%)
of the total expected research and development program costs of A$19.7 million
had been spent on the Ceflatonin project and approximately A$5.3 million (or
28%) of the total program costs of A$19.1 million had been spent on the
Quinamed project.
42
The
Company has developed discounted cash flow models for the compounds based on
the following assumptions-
Projected market share for the compounds
based on the forecast market share for each type of cancer
Projected cash flows based on patent expiry
dates of 2022 for Ceflatonin and 2024 for Quinamed and allowed for eroded cash
flows to 2026 for Ceflatonin and 2028 for Quinamed as generic drug providers
take advantage of the patents expiries
Research and development expenses projected
over the forecast period by project, including an analysis of expenses incurred
to June 2007 and remaining expenses expected until proposed approval dates
Projected capital expenditure, depreciation,
tax and working capital, and
A risk-adjusted discount rate which the
Company believes is toward the middle of the range adopted by second stage or
expansion companies and slightly above the top end of the range of discount
rates for Bridge/Initial Public Offering assessments usually undertaken by
venture capital investors.
The
model projected that the Ceflatonin compound would commence producing net
positive annual cash flows in 2009 and would continue to generate net positive
annual cash flows for the Company to 2026. The model projected that the
Quinamed compound would commence producing net positive annual cash flows in
2012 and would continue to generate net positive annual cash flows until 2028.
Naturally any delays in taking these compounds to the market would delay the
achievement of positive cash flows; however, given the overall uncertainty
involved with getting such products to the market, it is impossible to
accurately predict the consequences of any unknown delays.
From these models the Company estimated the value of Ceflatonin at
A$12.9 million and Quinamed at A$6.8 million. Based on these valuations, the
Company concluded that the entire excess purchase price of A$17.0 million can
be considered as in-process research and development, which is classified as
goodwill under AIFRS.
Subsequent to the acquisition, there have been no significant
developments related to the current status of the acquired in-process research
and development that would result in material changes to the assumptions.
Failure to achieve the expected levels of revenue and net income from a
product or products based on this acquired research and development will
negatively impact the return on investment expected at the time that the
purchase was completed and may result in impairment charges to the goodwill of
A$17.0 million under AIFRS.
ITEM
6. DIRECTORS,
SENIOR MANAGEMENT AND EMPLOYEES
A
. Directors and senior management.
Certain information concerning the current directors of the Company is
set forth below. Non-executive directors are not full-time employees of the
Company. There exists no arrangement or understanding with major shareholders,
customers, suppliers or others pursuant to which any person referred to below
was selected as a director or member of senior management.
No director is related to any other. Biographical information with
respect to the directors in office at June 30, 2007 is as follows:
Mr Brett Heading B
Com LLB(Hons) ASIA
(Non-executive Chairman)
Mr Heading is an experienced corporate lawyer, a partner of McCullough
Robertson for over 22 years. He specialises in capital raisings, mergers
and acquisitions and board advice. He has a wide ranging client base including
emerging companies in the biotechnology and agribusiness sectors. His
government appointments include membership of the Takeovers Panel, and the
Board of Taxation. During the past 3 years Mr Heading served as a director of
the following ASX listed companies - Australian Cancer Technology Limited (from
November 2004 to April 2005), Village Life Limited (from October 2003 to April
2005) and Ambri Limited (from 10 November 2006 to present day). Age 51.
43
Dr Greg Collier B
Sc(Hons) PhD
(Chief Executive Officer and Managing Director)
Dr. Collier is one of Australias leading biotechnology executives, and
is credited with leading the transformation of the former Australian genomics
company Autogen into the integrated international biopharmaceutical company
ChemGenex Pharmaceuticals. As CEO of the company, Dr. Collier has overseen the
partnering of major research programs, the $14 million acquisition of a private
US biotechnology company and listing of the companys securities on the NASDAQ
exchange. Dr. Collier is recognised internationally as a leader who has guided
his company along a value-creating path towards marketed products, and is a
regular invited speaker at international research and biotechnology
conferences. Age 49.
Mr Elmar Schnee B Com
M Mktg
(Non-executive Director)
Mr Schnee held management positions in marketing and sales in the
consumer goods industry before commencing with the pharmaceuticals industry in
1988. Following senior appointments with Fisons Pharmaceuticals PLC, Migliara/Kaplan
Associates, Sonofi-Synthelabo and UCB Pharma he took a Directorship position at
Merck subsidiary Merck Sante S.A.S in May 2003. In addition to his duties at
the French subsidiary, he took on responsibility for the global operations of
the Ethicals division in January 2004 and was named Head of the Ethicals
division in 2005. In November 2005 Mr Schnee was appointed Deputy Member of the
Executive Board and Head of the Pharmaceuticals business sector. In 2006 he was
appointed Regular Member of the Executive Board and General Partner of Merck
KGaA. Age 48.
Dr Dennis Brown B
Sc M A PhD
(Executive Director)
Dr. Brown has over 25 years experience in the biotechnology
and biopharmaceutical industries with specific experience in cancer research
and product development. Dr. Brown received his PhD. degree from New York
University, and held academic positions at Stanford University and Harvard
University Medical School prior to beginning his industry career. Dr. Brown was
a co-founder of Matrix Pharmaceutical Inc. and was the scientific founder of
ChemGenex Therapeutics Inc. in 1999, shaping and leading the companys clinical
and early stage research programs. Age 58.
Mr Patrick Burns BA
LLB (Hons)
(Non-executive Director)
Mr Burns has extensive experience as an executive and director in
technology and venture capital organisations. He is a director of firmView Inc.
(from December 2003), Euclid Systems Corporation (from March 1998) and the ASX
listed Progen Pharmaceuticals Limited (from March 1999). Prior to this Mr Burns
had over 25 years experience as a senior executive in the venture capital
industry after practising law in New York with Milbank, Tweed, Hadley &
McCloy. Mr Burns is Chairman of the Companys Audit Committee and is also a
member of the Remuneration Committee. Age 69.
Dr Geoff Brooke MBBS
MBA
(Non-executive Director, appointed February 8, 2007)
Dr Brooke is Managing Director of GBS Venture Partners and
has 20 years venture capital experience. He was formerly President of Medvest
Inc, a US-based early stage venture capital group he co-founded with Johnson
& Johnson. Dr Brookes experience includes company formation and
acquisitions, as well as public listings on both NASDAQ and ASX. Dr Brooke is a
director of Sunshine Heart Inc and CogState Limited. Dr Brooke is a member of
the Companys Audit Committee and Remuneration Committee. Age 51.
Mr Dan Janney BA
MBA
(Non-executive Director, appointed February 8, 2007)
Mr Janney joined Alta Partners immediately following the firms
founding in 1996, and was a co-founder of the Alta BioPharma effort. Mr Janney
focuses on investments in biopharmaceutical products and therapeutics and has
been directly involved in the funding and development of over 25 life sciences
companies. Prior to joining Alta Partners he was a senior investment banker at
Montgomery Securities focusing on life sciences companies. Mr Janney was a
director of public companies CoTherix Inc. (April 2001 to January 2007),
Dynavax Technologies Corporation
44
(December 1996 to December 2006) and Anesiva Inc. (November
2000 to December 2005). Mr Janney is Chairman of the Companys Remuneration
committee. Age 41
Dr George Morstyn MBBS
BMedSci MAICD PhD FRACP
(Non-executive Director, appointed May 31, 2007)
Dr Morstyn has substantial clinical, research and commercial
experience in biotechnology and oncology. He is a former Head of the Clinical
Program of the Ludwig Institute of Cancer Research and held a number of
positions including Senior Vice President of Development and Chief Medical
Officer of Amgen Inc from 1991 to 2002.He was a director of Bionomics until
2006. He is currently a director of Proacta Limited, Neuprotect, Cancer Trials
Australia and the Royal Womens Hospital, Melbourne. He is chairman of the SAB
of Symbio (Japan) Dr Morstyn is a member of the companys Audit Committee. Age
56
B
. Compensation
The aggregate amount of compensation paid to all directors of the
Company as a group by the Company and its subsidiaries for services in all
capacities during fiscal 2007 was A$1,229,911 including A$101,016 of options. This
amount includes directors fees, salaries and bonus payments, but excludes
amounts set aside or accrued to provide pension, retirement or similar
benefits. The aggregate amount set aside or accrued to provide pension,
retirement or similar benefits for directors of the Company by the Company and
its subsidiaries during fiscal 2007 was A$37,737. The Companys remuneration
policy for directors and executives is to:
have regard to
the directors experience and the nature and complexity of their work and due
regard to directors remuneration in comparable companies in order to pay a
competitive salary that attracts and retains management of the highest quality;
link individual
remuneration packages to the Companys long-term performance through the award
of share options and incentive schemes; and
provide
post-retirement benefits through the Companys pension schemes.
There are four main elements of the remuneration
package to executive directors:
basic salary;
benefits in
kind;
share options
and incentives; and
pension
arrangements.
The remuneration of each of the directors and senior management who
served during fiscal 2007 is set out below. For details regarding share options
held by directors and senior management, see Item 6E. Share Ownership and
Options.
Remuneration packages, which consist of base salary, fringe benefits,
incentive schemes (including performance-related bonuses), superannuation, and
entitlements upon retirement or termination, are reviewed with due regard to
performance and other relevant factors. The following table discloses the
remuneration of the directors and senior management of the Company:
45
|
|
|
|
|
|
Post employment
|
|
Equity
|
|
Other
|
|
|
|
Name
|
|
Salary/fees
|
|
Bonus
|
|
Superannuation
|
|
Options
|
|
Benefits
|
|
Total
|
|
|
|
A$
|
|
A$
|
|
A$
|
|
A$
|
|
A$
|
|
A$
|
|
Specified Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brett Heading
|
|
70,849
|
|
|
|
|
|
|
|
|
|
70,849
|
|
Dr. Gregory Collier (a)
|
|
383,764
|
|
|
|
28,355
|
|
101,016
|
|
20,203
|
|
533,338
|
|
Kevin Dart
|
|
30,342
|
|
|
|
2,731
|
|
|
|
|
|
33,073
|
|
Roger Byrne
|
|
30,342
|
|
|
|
2,731
|
|
|
|
|
|
33,073
|
|
Elmar Schnee
|
|
54.500
|
|
|
|
|
|
|
|
|
|
54,500
|
|
Dr. Dennis Brown
|
|
317,864
|
|
|
|
|
|
|
|
39,831
|
|
357,695
|
|
Patrick Burns
|
|
54,500
|
|
|
|
|
|
|
|
|
|
54,500
|
|
Peter Bradfield
|
|
30,340
|
|
|
|
2,731
|
|
|
|
|
|
33,071
|
|
Denis Wade
|
|
9,040
|
|
|
|
814
|
|
|
|
|
|
9,854
|
|
Geoff Brooke
|
|
22,708
|
|
|
|
|
|
|
|
|
|
22,708
|
|
Dan Janney
|
|
22,708
|
|
|
|
|
|
|
|
|
|
22,708
|
|
George Morstyn
|
|
4,167
|
|
|
|
375
|
|
|
|
|
|
4,542
|
|
Total Remuneration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specified directors
|
|
1,031,124
|
|
|
|
37,737
|
|
101,016
|
|
60,034
|
|
1,229,911
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specified Executives
(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. James Campbell
|
|
179,663
|
|
|
|
16,170
|
|
|
|
|
|
195,833
|
|
Tina Herbert
|
|
209,790
|
|
|
|
|
|
|
|
16,058
|
|
225,848
|
|
Shawnya Michaels
|
|
127,146
|
|
|
|
|
|
|
|
27,522
|
|
154,668
|
|
Eric Merrigan
|
|
108,750
|
|
|
|
32,700
|
|
|
|
|
|
141,450
|
|
Eric Humphriss
|
|
101,399
|
|
|
|
|
|
|
|
12,202
|
|
113,601
|
|
Total Remuneration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specified executives
|
|
726,748
|
|
|
|
48,870
|
|
|
|
55,782
|
|
831,400
|
|
(a) Equity options included in
Dr Colliers 2007 remuneration relates to 1,000,000 options to ordinary shares
issued to Dr. Collier following approval by shareholders at an Extraordinary
General Meeting on June 21, 2004. These options have an exercise price of
A$0.50 and expire on March 24, 2010. 500,000 of these options vest when the
after the ordinary share price on the ASX reaches $1.00 and trades continuously
for 30 days at $1.00 per share or above. The remaining 500,000 options vest
when the after the ordinary share price on the ASX reaches $1.25 and trades
continuously for 30 days at $1.25 per share or above.
(b) Specified executives are the five highest paid non-consultant
executives of the Company other than the Board of Directors.
C. Board
practices
All executives hold service contracts with the Company or one of its
subsidiaries. Service contracts for Australian-based executives are for fixed
terms, while those of U.S.-based staff are for an indefinite term. All service
contracts are approved by the Board of Directors. The Companys purpose in
entering into service contracts with executives is to enable the recruitment of
high quality executives and to obtain protection from their sudden departure to
competitor companies. Additionally, service contracts optimize protection for
the Companys intellectual property rights and other commercially sensitive
information.
46
The details of the senior management executives contracts are
summarized below:
Executive
|
|
Date of Contract
|
|
Notice period for termination
|
Dr. Gregory R. Collier
|
|
July 1, 2007 June 30, 2012
|
|
Six months
|
Dr. Dennis M. Brown
|
|
July 1, 2006 ongoing
|
|
Four months
|
Dr. James A. Campbell
|
|
September 1, 2006 ongoing
|
|
Three months
|
Eric P.
Merrigan
|
|
October 1,
2006 ongoing
|
|
Three months
|
Shawnya
Michaels
|
|
July 1, 2006
ongoing
|
|
One month
|
Tina Herbert
|
|
July 1, 2006
ongoing
|
|
One month
|
Eric
Humphriss
|
|
January 8,
2007- January 7, 2007
|
|
One month
|
Dr. Kenneth
R. Walder
|
|
December 20,
2002 ongoing
|
|
Thirty days
|
Dr. John
Blangero
|
|
September 4,
2001 ongoing
|
|
Thirty days
|
The terms and conditions of the appointment of non-executive directors
are set out in a formal letter of appointment which deals with the following
matters: duration of appointment
(subject to approval of shareholders), remuneration, expectations concerning
preparation and attendance at Board meetings, conflict resolution and the right
to seek independent legal and professional advice (subject to the prior
approval of the Chairman). The Company is committed to practicing good
corporate governance of its affairs as part of its management of relationships
with its shareholders and other stakeholders. The Company seeks to uphold, and
to report on compliance with, best practice in corporate governance. During the
fiscal year ended June 30, 2006, and at present, the Company paid a premium in
respect of a contract insuring the directors of the Company, the Company
Secretary, and all executive officers of the Company and of any affiliate
against a liability incurred as such by a director, Secretary or executive
officer to the extent permitted by the Australian Corporations Act 2001,
including
(a) a willful breach of
duty; or
(b) a contravention of
sections 182 or 183 of the Corporations Act 2001,
as permitted by section 199B of the Corporations Act 2001.
The contract of insurance prohibits disclosure of the nature of the
liability and the amount of the premium.
The Board
The Board of the Company is responsible for the Companys system of
corporate governance. This includes responsibility for the approval of the
annual and half-year financial report, the establishment of the long-term goals
of the Company and strategic plans to achieve those goals, the review and
adoption of annual budgets for the financial performance of the Company and
monitoring the results on a quarterly basis, and ensuring that the Company has
implemented adequate systems of internal controls together with appropriate
monitoring of compliance activities. The Board currently comprises five
directors: a Chairman with non-executive responsibilities, an executive
director, and three non-executive directors. The role of non-executive
directors is to ensure that independent judgment is brought to Board
deliberations and decisions. The non-executive directors possess a wide range
of skills and experience, relevant to the development of the Company, which
complement those of the Chairman. It is the Companys policy that the Board
should comprise a majority of non-executive directors.
47
The number of meetings of
directors (including meetings of committees of directors) held during the year
and the number of meetings attended by each director was as follows:
|
|
Directors Meetings
|
|
Audit Committee
Meetings
|
|
Remuneration Committee
Meetings
|
|
Number of meetings held:
|
|
13
|
|
6
|
|
7
|
|
Number of meetings attended:
|
|
|
|
|
|
|
|
Brett
Heading
|
|
13
|
|
|
|
|
|
Dr. Gregory
Collier
|
|
12
|
|
|
|
|
|
Kevin Dart*
|
|
7
|
|
|
|
3
|
|
Roger Byrne
|
|
8
|
|
1
|
|
|
|
Elmar Schnee
|
|
4
|
|
|
|
|
|
Dr. Dennis
Brown
|
|
10
|
|
|
|
|
|
Patrick
Burns
|
|
11
|
|
6
|
|
7
|
|
Peter
Bradfield
|
|
7
|
|
3
|
|
7
|
|
Denis Wade
|
|
2
|
|
1
|
|
|
|
Geoff Brooke
|
|
4
|
|
|
|
|
|
Dan Janney
|
|
4
|
|
|
|
|
|
George
Morstyn
|
|
1
|
|
1
|
|
|
|
Stephen
Cole*
|
|
1
|
|
|
|
4
|
|
During the year ended June 30, 2007 1 Circular Resolutions of Directors
was also passed, pursuant to S248A of the Corporations Act 2001
* Mr. S.A. Cole was Alternate Director for Mr. K.J. Dart and
participated in the 1 Directors Meeting and 4 Remuneration Committee Meetings
which Mr. Dart was unable to attend.
The Board of Directors of the Company is responsible for the corporate
governance of the Company. The Board guides and monitors the business and
affairs of the Company on behalf of the shareholders by whom they are elected
and to whom they are accountable. In 2004 the Australian Stock Exchange
Corporate Governance Councils (the Councils) Principles of Good Corporate
Governance and Best Practice Recommendations (the Recommendations) were
introduced. ChemGenex Pharmaceuticals Limiteds Corporate Governance Statement
is now structured with reference to the Councils principles and
recommendations, which are as follows:
Principle 1.
|
Lay solid foundations for management and
oversight
|
|
|
Principle 2.
|
Structure the board to add value
|
|
|
Principle 3.
|
Promote ethical and responsible decision
making
|
|
|
Principle 4.
|
Safeguard integrity in financial reporting
|
|
|
Principle 5.
|
Make timely and balanced disclosure
|
|
|
Principle 6.
|
Respect the rights of shareholders
|
|
|
Principle 7.
|
Recognize and manage risk
|
|
|
Principle 8.
|
Encourage enhanced performance
|
|
|
Principle 9.
|
Remunerate fairly and responsibly
|
|
|
Principle 10.
|
Recognize the legitimate interests of
stakeholders
|
The Companys corporate governance practices were in place throughout
the year ended June 30, 2005 and were fully compliant with the Councils best
practice recommendations. For further information on corporate governance
policies adopted by ChemGenex Pharmaceuticals Limited, refer to the Companys
website: www.chemgenex.com.
48
Board committees
In accordance with best practice, the Company has established an Audit
Committee with written terms of reference that deal with its authorities and
duties. The terms of reference of the Audit Committee have been reviewed during
the year and updated to ensure compliance with current best practice.
Audit committee
The Board has established an audit committee, which operates under a
charter approved by the Board. It is the Boards responsibility to ensure that
an effective internal control framework exists within the entity. This includes
internal controls to deal with both the effectiveness and efficiency of
significant business processes, the safeguarding of assets, the maintenance of
proper accounting records, and the reliability of financial information as well
as non-financial considerations such as the benchmarking of operational key
performance indicators. The Board has delegated the responsibility for the
establishment and maintenance of a framework of internal control and ethical standards
for the management of the Company to the audit committee.
The committee also provides the Board with additional assurance
regarding the reliability of financial information for inclusion in the
financial reports. All members of the audit committee are non-executive
directors.
The members of the audit committee during the year ended June 30, 2007
were: Patrick O Burns (Chairman), Roger V. Byrne, Peter J. Bradfield, Denis
Wade and George Morstyn .
Qualifications of audit committee members
Patrick O. Burns has over 40 years experience as a corporate lawyer,
senior executive and director of public and private companies.
Roger V. Byrne has over 15 years experience as a corporate lawyer who
retired as a partner from Clayton Utz in 2002. Mr. Byrne engaged in mergers and
acquisitions, public capital raisings, private equity raisings and corporate
structuring.
Peter J. Bradfield has over 30 years experience as a senior executive
and director of public and private companies.
Denis Wade has over 30 years experience as a senior executive and
director of public and private companies.
George Morstyn has over 15 years experience as a senior executive and
director of public and private companies.
The Audit Committee held six meetings during fiscal year 2007.
Remuneration committee
The Board has established a Remuneration Committee to review all
compensation arrangements for the directors, the chief executive officer and
the executive team, under the direction of the Board, and to make
recommendation to the Board on these matters.
Members of the remuneration committee during the year ended June 30,
2007 were: Peter J. Bradfield, Kevin .J. Dart, Patrick .O. Burns, Geoff Brooke
and Dan Janney.
Qualifications of remuneration committee members
Peter J. Bradfield has over 30 years experience as a senior executive
and director of public and private companies.
Kevin J. Dart has over 25 years experience as a senior executive and
director of public and private companies.
Patrick O. Burns has over 40 years experience as a corporate lawyer,
senior executive and director of public and private companies.
Geoff E. D. Brooke has over 20 years experience as a senior executive
and director of public and private companies.
Daniel S. Janney has over 15 years experience as a senior executive and
director of public and private companies.
The Remuneration Committee held seven meetings during fiscal year 2007.
It is the Companys objective to provide maximum stakeholder benefit
from the retention of a high quality board and executive team by remunerating
directors and key executives fairly and appropriately with reference to
relevant employment market conditions. To assist in achieving this objective,
the Board links the nature and amount of
49
executive directors and officers emoluments to the Companys
financial and operational performance. The expected outcomes of the
remuneration structure are:
retention and
motivation of key executives;
attraction of
quality management to the company; and
performance
incentives that allow executives to share the rewards of the success of the
Company.
The Board assesses the appropriateness of the nature and amount of
emoluments of such officers on a periodic basis by reference to relevant
employment market conditions with the overall objective of ensuring maximum
stakeholder benefit from the retention of a high quality board and executive
team. Such officers are given the opportunity to receive their base emolument
in a variety of forms including cash and fringe benefits such as motor vehicles
and expense payment plans. It is intended that the manner of payment chosen
will be optimal for the recipient without creating undue cost for the Company.
Further details on the remuneration of directors and executives are also
provided in Note 20 to the Companys audited consolidated financial statements
included elsewhere in this Annual Report.
All senior executives have the opportunity to qualify for participation
in the Senior Executive Share Option Plan which currently provides incentives
where specified criteria are met including criteria relating to profitability,
cash flow, share price growth and environmental performance. Details regarding
the issue of share options under this plan are provided in Note 15 to the
Companys audited consolidated financial statements included elsewhere in this
Annual Report.
In relation to the payment of bonuses, options and other incentive
payments, discretion is exercised by the Board, having regard to the overall
performance of the Company and the performance of the individual during the
period. There is no scheme to provide retirement benefits, other than statutory
superannuation, to non-executive directors.
Scientific Advisory Board
The Companys Scientific Advisory Board identifies new research
opportunities and monitors existing programs. Its members are as follows:
Professor Paul Zimmet, AO, MD, FRACP, FACE, is the Chairman of the
Companys Scientific Advisory Board. Professor Zimmet is a leading scientist in
the fields of diabetes and obesity. He is Professor/Director of the
International Diabetes Institute, Professor of Diabetes at the Monash
University, Honorary Professor at Deakin University and Professor in the
Graduate School of Public Health at the University of Pittsburgh in the U.S. He
is actively involved with the World Health Organizations diabetes and obesity
study groups and is a member of the Australian Federal Government National
Advisory Group on Diabetes and the Victorian Government Advisory Committee for
Diabetes. In 2004, Professor Zimmet was awarded the Hellmut Mehnert Award at
the 40th annual meeting of the European Association for the Study of Diabetes.
Dr. John Blangero, PhD, is a scientist at the Department of Genetics at
the Southwest Foundation for Biochemical Research in San Antonio, U.S. He is
the first researcher from the Southwest Foundation to be selected for a Method
to Extend Research in Time (MERIT) award from the U.S. National Institutes of
Health. He is a leading international statistical geneticist. Dr. Blangero is
also on the management team of the Company where he serves as the Chief
Scientific Director of Human Genomics. He was responsible for developing new
statistical software to increase greatly the amount of data that could be
handled in genetic studies of families. Dr. Blangero leads a number of
government-funded research projects in the U.S. related to the genetics of
common complex diseases.
Professor Ian Gust, AO, MD, FRCPA, FRACP, FTS, was the founding
Director of the MacFarlane Burnet Centre for Medical Research and subsequently
was Research and Development Director for CSL Limited (CSL). During the
ensuing decade, he was responsible for managing a research and development
budget of more than A$20 million per annum. Recently retired from CSL,
Professor Gust serves as a scientific adviser to Bill and Melinda Gates
Childrens Vaccine Program, the International AIDS Vaccine Initiative and the
World Health Organization. He is a non-executive director of Promics Pty Ltd,
Biota Holdings Limited and Biota, Inc..
Professor David James B.Sc (Hons) PhD is the Director of the Diabetes
and Obesity Research Program, Garvan Institute of Medical Research in Sydney.
Professor James was the discoverer of the GLUT4 glucose transporter molecule
and is recognized as an international leader in the field of diabetes molecular
cell biology. Professor James has a distinguished academic research career, was
the recipient of a Wellcome Trust Senior Research Fellowship, and was the
recipient in 1999 of the Glaxo Wellcome Australia Medal.
50
Professor Hagop Kantarjian MD is Professor of Medicine and Chairman of
the Department of Leukemia at M.D. Anderson Cancer Center in Houston, Texas.
Professor Kantarjian specializes in leukemia and holds an interest in creating
new treatment approaches for these diseases. Professor Kantarjian has authored
and contributed to over 560 medical publications, articles and abstracts and,
for his accomplishments, has received awards, including a Leukemia Society of
America Scholarship from 1989-1994 and a Leukemia Society of America Special
Fellow Scholarship from 1982-1983.
Dr. John Hughes B.Sc (Hons) PhD FIPAA is a leading Australian
biotechnology patent attorney and a partner with Davies Collison Cave with more
than 13 years experience in patent law. Dr. Hughes is involved in the drafting
and prosecution of patent applications directed to all facets of biotechnology,
including inventions relating to molecular biotechnology, pharmacology,
transgenic plants and animals as well as general chemistry and microbiology.
Dr. Hughes has a substantial U.S. practice at the drafting and prosecution
levels of patent filing. Dr. Hughes has post-doctoral experience at Yale
University and Genentech, Inc., mainly in microbial genetics and molecular
biology and trained as a patent attorney in New York before returning to
Australia.
Compliance with NASDAQ Rules
NASDAQ listing rules require
that the Company disclose the home country practices that it follows in lieu of
compliance with NASDAQ corporate governance rules. The following describes the
home country practices and the related NASDAQ rule:
Majority of Independent Directors: The Company follows home country practice
rather than NASDAQs requirement in Marketplace Rule 4350(c)(1) that the
majority of the Board of each issuer be comprised of independent directors as
defined in Marketplace Rule 4200. The Companys Board of Directors is not
comprised of a majority of independent directors, a practice which is not
prohibited by the laws of Australia. The ASX does not have a requirement that
each issuers Board be comprised of a majority of independent directors. Furthermore,
no law, rule or regulation of the Australian Securities and Investments
Commission (ASIC), the public authority which exercises securities law
jurisdiction over the Company, has such a requirement nor does the Corporations
Act (the Act), which is the applicable corporate law legislation.
Compensation of Officers: The Company follows home country practice
rather than NASDAQs requirement in Marketplace Rule 4350(c)(3) that chief
executive compensation be determined or recommended to the Board by the
majority of independent directors of a compensation committee of independent
directors. Similarly, compensation of other officers is not determined or
recommended to the Board by a majority of the independent directors or a
compensation committee comprised solely of independent directors. These decisions
are made by the Companys Board as a whole, and it is not comprised of a
majority of independent directors; the Company has no remuneration committee. The
ASX does not have a requirement that each listed issuer have a remuneration
committee or otherwise follow the procedures embodied in NASDAQs Marketplace
Rule. Furthermore, no law, rule or regulation of the ASIC has such a
requirement nor does the applicable corporate law legislation. Such home
country practices are not prohibited by the laws of Australia.
Nomination:
The Company follows home country practice rather than NASDAQs
requirement in Marketplace Rule 4350(c)(4) that director nominees be selected
or recommended by a majority of the independent directors or by a nominations
committee comprised of independent directors. These decisions are made by the
Companys Board as a whole, and it is not comprised of a majority of
independent directors; the Company has no nominations committee. The ASX does
not have a requirement that each listed issuer have a nominations committee or
otherwise follow the procedures embodied in NASDAQs Marketplace Rule. Furthermore,
no law, rule or regulation of the ASIC has such a requirement nor does the
applicable corporate law legislation. Accordingly, selections or
recommendations of director nominees by a board of directors that is not
comprised of a majority of directors that are not independent is not prohibited
by the laws of Australia.
Quorum: The
Company follows home country practice rather than NASDAQs requirement in
Marketplace Rule 4350(f) that each issuer provide for a quorum of at least
331/3 percent of the outstanding shares of the issuers common stock (voting
stock). Pursuant to its Constitution the Company is currently required to have
a quorum for a general meeting of two persons holding ordinary shares. The
practice followed by the Company is not prohibited by Australian law.
Pursuant to the Sarbanes-Oxley Act of 2002, the Securities and Exchange
Commission issued new rules that, among other things, require NASDAQ to impose
independence requirements on each member of the audit committee of a
51
listed company and the NASDAQ also reformulated its corporate
governance requirements. The recently-adopted SEC and NASDAQ rules apply to the
Company as of July 31, 2005. The Company has taken the appropriate steps with
respect to its corporate governance system, including the addition of
independent directors to its audit committee, to assure timely compliance with
the SEC rules and the amended corporate governance standards of NASDAQ
D.
Employees
As at June 30, 2007, the Company employed eight individuals on a
full-time basis.
The Company employs a number of contract employees in research and
development. During the last fiscal year, the average number of contract
employees was 50.
The following table summarizes the number of full-time employees
employed by the Company, including executive directors, as at the year end of
the last three fiscal years:
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
8
|
|
|
7
|
|
8
|
|
|
|
|
|
|
|
|
|
E.
Share ownership and
options
The relevant interest of each director in the share
capital of the Company as notified by the directors to the ASX in accordance
with S205G(1) of the Corporations Act 2001 at September 30, 2007 is as follows:
|
|
Ordinary shares
|
|
% of shares
issued
|
|
Options over
ordinary shares
|
|
% of options
issued
|
|
Brett
Heading
|
|
110,000
|
|
0.05
|
|
3,333
|
|
0.01
|
|
Dr. Gregory
Collier
|
|
|
|
|
|
3,400,000
|
|
8.52
|
|
Elmar Schnee
*
|
|
18,833,750
|
|
10.08
|
|
4,439,308
|
|
11.12
|
|
Dr. Dennis
Brown
|
|
13,876,552
|
|
7.43
|
|
|
|
|
|
Patrick
Burns
|
|
|
|
|
|
|
|
|
|
Dr.Geoff
Brooke *
|
|
16,629,765
|
|
8.90
|
|
2,736,065
|
|
6.86
|
|
Dan Janney *
|
|
37,009,671
|
|
19.82
|
|
6,088,053
|
|
15.25
|
|
Dr. George
Morstyn
|
|
|
|
|
|
|
|
|
|
*Includes shares and options held by entities in which Messrs Schnee
and Janney, and Dr. Brooke hold directorships.
Employee share option plan
An employee
share option plan (ESOP) has been established where the Company may, at the
discretion of the Board, grant options over the ordinary shares of the Company
to directors, executives, advisors and support staff of the Company. These
options, issued for nil consideration, are granted in accordance with
performance guidelines established by the directors of the Company. The options
cannot be transferred and will not be quoted on the ASX. There are currently
one director, three employees and 22 scientific advisors and support staff who
hold options issued under the ESOP.
52
Information with respect to the number of options granted under the
ESOP is as follows:
|
|
Year to June 30, 2007
|
|
Year to June 30, 2006
|
|
|
|
Number of options
|
|
Weighted average
exercise price (A$ )
|
|
Number of options
|
|
Weighted average
exercise price (A$ )
|
|
Balance at beginning of period
|
|
1,979,500
|
|
0.67
|
|
1,475,000
|
|
0.75
|
|
- granted
|
|
1,000,000
|
|
0.64
|
|
544,500
|
|
0.54
|
|
- forfeited
|
|
|
|
|
|
(40,000
|
)
|
0.52
|
|
- exercised
|
|
(120,000
|
)
|
0.50
|
|
|
|
|
|
Balance at end of period
|
|
2,859,500
|
|
0.68
|
|
1,979,500
|
|
0.70
|
|
Exercisable at end of period
|
|
2,244,500
|
|
0.58
|
|
1,364,500
|
|
0.53
|
|
In addition to options granted under the ESOP, 3,600,000 options have
been granted to Dr. Gregory Collier after approval by shareholders at General
Meetings. Details of theses options and ESOP options granted to Dr. Gregory
Collier are included in Note 14 to the Companys audited consolidated financial
statements. 400,000 of these options previously granted to Dr. Collier were
exercised during the year ended June 30, 2007.
The Company uses the fair value
measurement provisions of AASB 2
Share-Based Payments
for all options granted to directors and relevant executives after November 7,
2002. The straight-line amortization of the fair value of such grants over the
vesting period is disclosed as part of director and executive emoluments. Options
granted as part of director and executive emoluments have been valued using the
Black-Scholes option pricing model, which takes account of factors including
the option exercise price, the current level and volatility of the underlying
share price, the risk-free interest rate, expected dividends on the underlying
share, current market price of the underlying share and the expected life of
the option. See below for further details.
Fair values of options: The fair value of each option is estimated on
the date of grant using Black-Scholes option pricing model with the following
assumptions used for grants made during the 2007 financial year:
Option exercise price
|
|
$0.85 and $0.50
|
|
|
|
Share price at date of issue
|
|
$0.85 and $0.78
|
|
|
|
Dividend yield
|
|
0%
|
|
|
|
Expected volatility
|
|
70%
|
|
|
|
Risk-free interest rate at
issue date
|
|
5.25%
|
|
|
|
Life of option
|
|
3 and 5 years
|
The dividend
yield reflects the assumption that the current dividend payout will continue
with no anticipated increases. The expected life of the options is based on
historical data and is not necessarily indicative of exercise patterns that may
occur. The expected volatility reflects the assumption that the historical
volatility is indicative of future trends, which may also not necessarily be
the actual outcome.
53
The resulting
weighted average fair values per option for those options vesting after July 1,
2003 are:
Number
of options
|
|
Grant
date
|
|
Vesting
date
|
|
Weighted
average fair
value (A$)
|
300,000
|
|
November 21, 2003
|
|
November 21, 2003
|
|
0.34
|
|
|
|
|
|
|
|
325,000
|
|
November
21, 2003
|
|
November
21, 2003
|
|
0.36
|
|
|
|
|
|
|
|
1,000,000
|
|
June 21, 2004
|
|
June 21, 2004
|
|
0.35
|
|
|
|
|
|
|
|
1,000,000
|
|
June 21, 2004
|
|
June 21, 2006
|
|
0.35
|
|
|
|
|
|
|
|
500,000
|
|
June 21, 2004
|
|
June 21, 2007
|
|
0.35
|
|
|
|
|
|
|
|
500,000
|
|
June 21, 2004
|
|
June 21, 2008
|
|
0.35
|
|
|
|
|
|
|
|
360,000
|
|
December 21, 2004
|
|
December 21, 2004
|
|
0.40
|
|
|
|
|
|
|
|
275,000
|
|
September 23, 2005
|
|
September 23, 2005
|
|
0.35
|
|
|
|
|
|
|
|
269,500
|
|
February 22, 2006
|
|
February 22, 2006
|
|
0.36
|
|
|
|
|
|
|
|
400,000
|
|
May 7, 2007
|
|
May 7, 2007
|
|
0.42
|
|
|
|
|
|
|
|
600,000
|
|
June 6, 2007
|
|
June 6, 2007
|
|
0.55
|
Under AIFRS these fair values are recognized
as expenses in the financial statements when the options were granted after 7
November 2002 and vested after 1 July 2005.
ITEM 7.
MAJOR
SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A
.
Major shareholders
As at October 30, 2007 the Company had knowledge of the following
ownership interest (direct and beneficial) of 5% or greater in its ordinary
shares:
Shareholder
|
|
Number of shares held
|
|
% of issued shares
|
|
Berne No 132 Nominees Pty Ltd
|
|
37,009,671
|
|
19.8
|
%
|
Merck Santé
|
|
18,793,750
|
|
10.1
|
%
|
GBS Venture Partners Ltd
|
|
16.629,765
|
|
8.9
|
%
|
Queensland Investment Corporation
|
|
15,158,424
|
|
8.1
|
%
|
Dr. Dennis M. Brown
|
|
13,876,552
|
|
7.4
|
%
|
Kinetic Investment Partners Limited
|
|
9,459,209
|
|
5.1
|
%
|
Berne No 132
Nominees Pty Ltd, which became a shareholder during fiscal 2007, hold shares on
behalf of Alta Partners, a US based biotech investment manager.
Merck
Santé
held 18,793,750 shares (12.4%) at August 31, 2006 and 9,793,750
shares (8.5%) at September 23, 2005.
GBS Venture
Partners Ltd is an Australian based biotech venture capital company which
became a shareholder during fiscal 2007.
Queensland
Investment Corporation is wholly owned by the Government of the State of
Queensland in the Commonwealth of Australia. Queensland Investment Corporation
held 15,158,424 shares (10.0%) at August 31, 2006 and 10,574,416 shares (9.2%)
in September 23, 2005.
54
Following the
merger with Chemgenex Therapeutics Inc. in 2004 Dennis Brown held 14,398,297
shares (9.5%) at August 31, 2006 and (12.5%) at September 23, 2005.
Kinetic
Investment Partners Limited is an Australian based biotech investment manager
which became a shareholder in fiscal 2007.
Charter
Pacific Corporation Limited, which held 28,100,087 shares (18.6%) at August 31,
2006 and 23,510,087 shares (20.5%) at September 23, 2005, ceased to be a
shareholder during fiscal 2007.
At October 31,
2007 calculation of major shareholders, the issued share capital of the Company
was 186,754,906 ordinary shares. The major shareholders do not have different
voting rights.
At October 31,
2007, the directors of the Company controlled ordinary shares representing
approximately 46.3% of the Companys outstanding share capital, as follows:
Directors
|
|
Number of shares held
|
|
|
|
|
|
Brett Heading
|
|
110,000
|
|
Dan Janney
|
|
37,009,671
|
|
Elmar Schnee
|
|
18,833,750
|
|
Dr. Geoff Brooke
|
|
16,629,765
|
|
Dr. Dennis Brown
|
|
13,876,552
|
|
Total
|
|
86,459,738
|
|
Specified Executives
|
|
Number of shares held
|
|
|
|
|
|
Dr. James Campbell
|
|
5,500
|
|
Tina Herbert
|
|
760,027
|
|
Shawnya Michaels
|
|
658,027
|
|
Eric Merrigan
|
|
55,000
|
|
Total
|
|
1,478,554
|
|
As far as is known to the Company and subject to the disclosure
provided under Item 8B. Financial information Significant Changes the
Company is not directly or indirectly owned or controlled by another
corporation or by any government, and there are no arrangements the operation
of which may result in a change of its control.
B.
Related party transactions
Legal services
were provided by McCullough Robertson lawyers, a legal firm of which Mr. Brett
Heading is a partner. The value of legal services provided by McCullough
Robertson lawyers was A$93,282 during the year ended June 30, 2007. During the three
months from July to September 2007, the value of legal services provided by
McCullough Robertson was $31,993.
Mr. Brett
Heading is a director of two companies that are the joint holders of 5% of the
shares of Global Markets Capital Group LLC (GMCG) which has provided advisory
and consulting services to the Company. The value of advisory and consulting
services provided by GMCG was A$200,483 (including share-based compensation of
$165,924) during the year ended June 30, 2007. During the three months from
July to September 2007 no services were provided by GMCG. Mr. Brett Heading has
no beneficial interest in the two companies that are 5% shareholders in GMCG.
As an
individual investor, Mr. Brett Heading holds 110,000 shares in the Company.
Mr. Elmar
Schnee is a director of Merck Santé which holds 18,793,750 shares and 4,439,308
options exercisable at A$1.25 expiring March 12, 2010 in the Company. As an
individual investor Mr. Schnee holds 40,000 shares in the
55
Company. Merck
Santé is party to research and development and commercialization agreements
with the Companys 100% owned subsidiary Autogen Research Pty Ltd. Under these
ongoing agreements Merck Santé provided research and development payments to
Autogen Research Pty Ltd totaling A$331,377 for the year ended June 30, 2007. Under
existing agreements Merck Santé was not due to provide, and has not provided
research and development funding between July and September 2007.
Dr. Dennis M. Brown is an executive director of the Company. As an
individual investor Dr. Dennis M. Brown holds 13,876,552 shares
.
C
.
Interests of experts and counsel
Not applicable.
ITEM 8.
FINANCIAL
INFORMATION
A
.
Consolidated statements and other
financial information
Reference is made to page F-1. Financial Statements for a list of all
financial statements, including the notes thereto, and exhibits.
Dividends
The Company does not currently pay dividends. The payment of future
dividends will be dependent upon future earnings, the financial condition of
the Company and other factors. In addition, the Company expects to retain a
substantial portion of future earnings, if only to finance the growth and
development of the business. Accordingly, the Company does not expect to pay
dividends in the near future.
Legal matters
The Company is not engaged in any legal or
arbitration proceedings
.
B
.
Significant changes
On October 26, 2007ChemGenex Pharmaceuticals Limited announced a
strategic restructuring based upon the spinoff of its metabolic diseases assets
by early December, pending shareholder approval.
ChemGenexs metabolic diseases assets currently reside within the
companys wholly-owned subsidiary Autogen Research, which is to be renamed
Verva Pharmaceuticals. Pending shareholder approval at the Annual General
Meeting, scheduled to take place in Melbourne on November 28, Verva
Pharmaceuticals will be demerged from ChemGenex. Verva Pharmaceuticals then
intends to merge with Adipogen Pharmaceuticals, pursuant to a merger
implementation agreement signed on October 29, 2007. Upon shareholder approval,
ChemGenex shareholders will receive one share in Verva Pharmaceuticals for
every five ChemGenex Pharmaceuticals shares held at the record date. In
accordance with ASX listing rules and the option agreements, existing ChemGenex
option holders will not be allocated shares in Verva Pharmaceuticals unless
options are exercised prior to the record date. The Verva Pharmaceuticals
shares will not be registered under the U.S. Securities Act for distribution to
holders of the Companys ADRs. After the record date the exercise price for
each remaining ChemGenex option will be reduced by approximately 7 cents.
56
ITEM
9.
THE OFFER AND LISTING
A
.
Offer and listing details
Trading market for ordinary shares and ADRs
The Companys ordinary shares were listed on the ASX on July 10, 1986.
The ASX is the principal trading market for the ordinary shares. The following
table sets forth, for the periods indicated, the highest and lowest market
quotations for the ordinary shares reported on the Daily Official List of the
ASX.
Annual high and low market price of ordinary shares and average daily
trading volume on ASX for last five full fiscal years
|
|
|
|
High (A$ )
|
|
Low (A$ )
|
|
Ave. daily trading volume
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
July 1, 2006
to June 30,2007
|
|
1.15
|
|
0.36
|
|
308,041
|
|
2006
|
|
July 1, 2005
to June 30, 2006
|
|
0.72
|
|
0.37
|
|
71,880
|
|
2005
|
|
July 1, 2004
to June 30, 2005
|
|
0.80
|
|
0.43
|
|
95,048
|
|
2004
|
|
July 1, 2003
to June 30, 2004
|
|
0.84
|
|
0.25
|
|
247,578
|
|
2003
|
|
July 1, 2002
to June 30, 2003
|
|
0.65
|
|
0.17
|
|
84,713
|
|
Quarterly high and low market price of ordinary shares and average
daily trading volume for last two full fiscal years and beyond
|
|
|
|
High
|
|
Low
|
|
Ave. daily trading volume
|
|
|
|
|
|
(A$)
|
|
(A$)
|
|
|
|
Fiscal 2008
|
|
September quarter
|
|
1.13
|
|
0.72
|
|
109,260
|
|
Fiscal 2007
|
|
June quarter
|
|
1.15
|
|
0.78
|
|
171,743
|
|
|
|
March quarter
|
|
0.85
|
|
0.57
|
|
765,478
|
|
|
|
December quarter
|
|
0.66
|
|
0.45
|
|
183,772
|
|
|
|
September quarter
|
|
0.55
|
|
0.36
|
|
121,669
|
|
Fiscal 2006
|
|
June quarter
|
|
0.62
|
|
0.37
|
|
133,959
|
|
|
|
March quarter
|
|
0.66
|
|
0.58
|
|
50,995
|
|
|
|
December quarter
|
|
0.68
|
|
0.47
|
|
54,481
|
|
|
|
September quarter
|
|
0.72
|
|
0.50
|
|
48,083
|
|
Monthly high and low market price of ordinary shares and average daily
trading volume for last six months
|
|
|
|
High
|
|
Low
|
|
Ave. daily trading volume
|
|
|
|
|
|
(A$)
|
|
(A$)
|
|
|
|
October 2007
|
|
|
|
1.18
|
|
1.01
|
|
155,291
|
|
September
2007
|
|
|
|
1.06
|
|
0.89
|
|
134,636
|
|
August 2007
|
|
|
|
0.90
|
|
0.72
|
|
70,699
|
|
July 2007
|
|
|
|
1.13
|
|
0.91
|
|
126,504
|
|
June 2007
|
|
|
|
1.12
|
|
0.93
|
|
190,614
|
|
May 2007
|
|
|
|
0.90
|
|
0.78
|
|
167,309
|
|
As at November 2, 2007 the ordinary shares closed at AUD1.15.
At November 2, 2007 the Company had 186,754,906 ordinary shares issued
and outstanding. This includes the issue of 907,507 ordinary shares following
the exercise of 900,000 unlisted options previously granted to Global Markets
Capital Corporation and 7,575 listed CXSOA options, since June 30, 2007.The
shares are without par value. See Item 10B Memorandum
and articles of incorporation for a detailed description of the rights
attaching to the shares. Also see Item 12A. American Depositary Shares for a
description of the rights attaching to the ADR.
57
As of October 31, 2007 approximately 12.7 million of the Companys
ordinary shares (CXS), 6.8% of the total ordinary shares issued and
outstanding, were held by 83 U.S. residents (based solely on their addresses).
As of October 31, 2007 approximately 960,000 of the Companys listed
AUD1.25 options (CXSO), 4.3% of the total listed AUD1.25 options issued and
outstanding, were held by 17 U.S. residents (based solely on their addresses).
As of October 31, 2007 none of the Companys listed AUD0.75 options
(CXSOA) were held by U.S. residents (based solely on their addresses).
On December 10, 2002 the Company established a Level I ADR program, in
which the ordinary shares trade in the form of ADSs, which are evidenced by
American Depositary Receipts or ADRs, issued by The Bank of New York, as
Depositary, and registered on Form F-6 pursuant to the U.S. Securities Act of
1933, as amended.
The Companys Level I ADR program was upgraded to a Level II program on
June 28, 2005, in connection with the Companys listing on the NASDAQ Capital
Market. One American Depositary Share (ADS) represents fifteen ordinary
shares.
As of November 2, 2007, there were 46,602 ADRs outstanding.
Annual high and low market price ADRs and average daily trading volume
on NASDAQ for full fiscal years since listing
|
|
|
|
High
(US$)
|
|
Low
(US$)
|
|
Ave.
daily trading volume
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
July 1, 2006 to June 30, 2007
|
|
14.50
|
|
3.85
|
|
527
|
|
2006
|
|
July 1, 2005 to June 30, 2006
|
|
8.55
|
|
4.12
|
|
1,588
|
|
Quarterly high and low market price of ADRs and average daily trading
volume since NASDAQ listing
|
|
|
|
High (US$)
|
|
Low (US$)
|
|
Ave. daily trading volume
|
|
Fiscal 2008
|
|
September
quarter
|
|
15.14
|
|
8.58
|
|
786
|
|
Fiscal 2007
|
|
June quarter
|
|
14.50
|
|
9.20
|
|
913
|
|
|
|
March quarter
|
|
9.80
|
|
7.00
|
|
587
|
|
|
|
December quarter
|
|
7.90
|
|
5.10
|
|
408
|
|
|
|
September quarter
|
|
5.61
|
|
3.85
|
|
202
|
|
Fiscal 2006
|
|
June quarter
|
|
8.25
|
|
4.12
|
|
497
|
|
|
|
March quarter
|
|
7.57
|
|
5.15
|
|
1,243
|
|
|
|
December quarter
|
|
8.48
|
|
5.49
|
|
3,749
|
|
|
|
September quarter
|
|
8.55
|
|
6.00
|
|
863
|
|
Monthly high and low market price ADRs and average daily trading volume
for the last six months
|
|
|
|
High (US$)
|
|
Low (US$)
|
|
Ave. daily trading volume
|
|
October 2007
|
|
|
|
16.80
|
|
14.10
|
|
830
|
|
September
2007
|
|
|
|
13.50
|
|
10.60
|
|
463
|
|
August 2007
|
|
|
|
11.84
|
|
8.58
|
|
391
|
|
July 2007
|
|
|
|
15.14
|
|
10.50
|
|
1,510
|
|
June 2007
|
|
|
|
14.50
|
|
11.10
|
|
1,567
|
|
May 2007
|
|
|
|
11.47
|
|
10.35
|
|
100
|
|
As at November 2, 2007 ADRs on the NASDAQ Capital Market closed at US$16.20
58
B.
Plan of distribution
Not applicable.
C.
Markets
The Companys ordinary shares were listed on the ASX on July 10, 1986.
The ASX is the principal trading market for the ordinary shares.
The Companys ADRs were listed on the NASDAQ Capital Market on June 28,
2005. Each ADR evidences 15 ordinary shares.
D.
Selling shareholders
Not applicable.
E.
Dilution
Not applicable.
F.
Expenses of the issue
Not applicable.
ITEM
10.
ADDITIONAL INFORMATION
A.
Share capital
Not applicable
B.
Memorandum and articles
of incorporation
Incorporated by reference to the Companys Registration Statement on
Form 20-F (file no. 0-51373) filed with the Commission on June 23, 2005.
C.
Material contracts
The following contracts are the only contracts not entered into in the
ordinary course of business which have been entered into by the Company within
two years immediately preceding the date of this document and are or may be
material to the Company:
The Companys principal commercial collaborations are described under
Item 4.B. Business overview commercial and research and development
collaborations.
Under the Agreement and Plan of Merger dated as of April 27, 2004 among
AGT Biosciences Limited (the Company), AGT Biosciences, Inc., ChemGenex
Therapeutics, Inc. (now ChemGenex Pharmaceuticals, Inc.) and Dr. Dennis M.
Brown, the Company acquired 100% of ChemGenex Therapeutics, Inc. through a
merger, using ordinary shares. Pursuant to the terms of the agreement, the
Company has continuing indemnity obligations in favor of the selling
shareholders, represented by Dr. Dennis M. Brown, and Dr. Dennis M. Brown has
certain continuing indemnity obligations in favor of the Company. Each of the
selling shareholders, who are now shareholders of the Company, entered into a
non-sale undertaking restricting their ability to trade the ordinary shares
received in the merger for a period ending on June 21, 2005.
59
D.
Exchange controls and
other limitations affecting security holders
Exchange controls
Under existing Australian legislation, the Reserve Bank of Australia
does not inhibit the import and export of funds, and, generally, no permission
is required to be given to the Company for the movement of funds in and out of
Australia. However, from time to time, Australian foreign exchange controls are
implemented against prescribed countries, entities and persons. Certain
transactions relating to Iraq, the National Union for the Total Independence of
Angola (UNITA), certain persons associated with the former government of the
Federal Republic of Yugoslavia, and ministers and senior officials of the
Government of Zimbabwe are currently prohibited, without the specific prior
approval, of the Reserve Bank of Australia. Restrictions also apply to
transactions, accounts and assets relating to the Taliban, Osama bin Laden, the
Al-Qaida organization and other persons and entities identified as terrorists
or sponsors of terrorism.
Accordingly, at the present time, remittances of any dividends,
interest or other payment by the Company to non-resident holders of the Companys
securities in the U.S. are not, subject to the above, restricted by exchange
controls or other limitations.
Takeovers Act
There are no limitations, either under the laws of Australia or under
the Constitution of ChemGenex Pharmaceuticals Limited, to the right of
non-residents to hold or vote the Companys ordinary shares other than the
Commonwealth Foreign Acquisitions and Takeovers Act 1975 (the Takeovers Act).
The Takeovers Act may affect the right of non-Australian residents, including
U.S. residents, to hold ordinary shares but does not affect the right to vote,
or any other rights associated with any ordinary shares held in compliance with
its provisions. Acquisitions of shares in Australian companies by foreign
interests are subject to review and approval by the Treasurer of the
Commonwealth of Australia under the Takeovers Act. The Takeovers Act applies to
any acquisition of outstanding shares of an Australian company that exceeds, or
results in a foreign person or persons controlling the voting power of more
than a certain percentage of those shares. The thresholds are 15% where the
shares are acquired by a foreign person, or group of associated foreign
persons, or 40% in aggregate in the case of foreign persons who are not
associated. Any proposed acquisition that would result in an individual foreign
person (with associates) holding more than 15% must be notified to the
Treasurer in advance of the acquisition. At January 31, 2005, approximately
39.6% of the Companys fully paid outstanding ordinary shares were held by
shareholders outside Australia. In addition to the Takeovers Act, there are
statutory limitations in Australia on foreign ownership of certain businesses,
such as banks and airlines, not relevant to the Company. However, there are no
other statutory or regulatory provisions of Australian law or ASX requirements
that restrict foreign ownership or control of the Company.
Corporations Act 2001
As applied to the Company, the Corporations Act 2001 (the Corporations
Act 2001) prohibits any legal person (including a corporation) from acquiring
a relevant interest in ordinary shares if after the acquisition that person or
any other persons voting power in the Company increases from 20% or below to
more than 20%, or from a starting point that is above 20% and below 90%.
This prohibition is subject to a number of specific exceptions set out
in section 611 of the Corporations Act 2001 which must be strictly complied
with to be applicable.
In general terms, a person is considered to have a relevant interest
in a share in the Company if that person is the holder of that share, has the
power to exercise, or control the exercise of, a right to vote attached to that
share, or has the power to dispose of, or to control the exercise of a power to
dispose of that share.
It does not matter how remote the relevant interest is or how it arises.
The concepts of power and control are given wide and extended meanings in
this context in order to deem certain persons to hold a relevant interest. For
example each person who has voting power above 20% in a company which in turn
holds shares in the Company is
60
deemed to have a relevant interest in those shares. Certain situations
(set out in section 609 of the Corporations Act 2001) which would otherwise
constitute the holding of a relevant interest are excluded from the definition.
A persons voting power in the Company is that percentage of the total
votes attached to ordinary shares in which that person and its associates (as
defined in the Corporations Act 2001) holds a relevant interest.
E.
Taxation
This summary is based on the tax laws of the United States (including
the Internal Revenue Code of 1986, as amended (the Code), its legislative
history, existing and proposed U.S. Treasury Regulations promulgated
thereunder, published rulings and administrative pronouncements of the Internal
Revenue Service (the IRS) and judicial decisions) and on the Australian tax
law and practice, all as in effect on the date hereof. In addition, this summary
is based on the income tax convention between the U.S. and Australia (the Treaty).
The foregoing laws and legal authorities as well as the Treaty are subject to
change (or changes in interpretation), possibly with retroactive effect and to
differing interpretations. Finally, this summary is based in part upon the
representations of the Companys ADR Depositary and the assumption that each
obligation in the Deposit Agreement and any related agreement will be performed
in accordance with its terms.
The discussion does not address any aspects of U.S. taxation other than
federal income taxation or any aspects of Australian taxation other than
federal income taxation, inheritance taxation, stamp duty and goods and
services tax. This discussion does not address all aspects of U.S. or
Australian federal tax considerations that may be important to particular
investors in light of their individual investment circumstances or investors
subject to special tax regimes, like broker-dealers, banks or other financial institutions,
insurance companies, tax-exempt organizations, regulated investment companies,
real estate investment trusts or real estate mortgage investment conduits,
certain former U.S. citizens or residents, persons who actually or
constructively own ten percent or more of the Companys ADRs or ordinary
shares, persons who hold ADRs or ordinary shares as part of a straddle, hedge,
conversion or constructive sale transaction or other integrated transaction for
tax purposes, persons who have elected mark-to-market accounting, persons that
have a functional currency other than the U.S. dollar, persons liable for
alternative minimum tax, partnerships and other pass-through entities, or
persons who acquired their ADRs or ordinary shares through the exercise of options
or similar derivative securities or otherwise as compensation. This discussion
applies only to shares held as capital assets. Prospective investors are urged
to consult their tax advisers regarding the U.S. and Australian federal, state
and local tax consequences and any other tax consequences of owning and
disposing of ADRs and ordinary shares.
Australian Tax Consequences
In this section the Company discusses Australian tax considerations
that apply to non-Australian tax residents who are residents of the U.S. with
respect to the ownership and disposal by the absolute beneficial owners of ADRs.
This summary does not discuss any foreign or state tax considerations, other
than stamp duty.
Nature of ADRs for Australian Taxation Purposes
ADRs held by a U.S. Holder will be treated for Australian taxation
purposes as held under a bare trust for that holder. Consequently, the
underlying ordinary shares will be regarded as owned by the ADR holder for
Australian income tax and capital gains tax purposes. Dividends paid on the
underlying ordinary shares will also be treated as dividends paid to the ADR
holder, as the person beneficially entitled to those dividends. Therefore, in
the following analysis the Company discusses the tax consequences to non-Australian
resident holders of ordinary shares which, for Australian taxation purposes,
will be the same as to U.S. Holders of ADRs.
Taxation of Dividends
Australia operates a dividend imputation system under which dividends
may be declared to be franked to the extent of tax paid on company profits.
Fully franked dividends are not subject to dividend withholding tax. Dividends
payable by the Company to non-Australian resident stockholders will be subject
to dividend withholding tax, to the extent the dividends are unfranked.
Dividend withholding tax will be imposed at 30%, unless a stockholder is a
resident of a country with which Australia has a double taxation agreement.
Under the provisions of the Treaty, the Australian tax withheld on unfranked
dividends paid by the Company to which a resident of the U.S. is beneficially
entitled is generally limited to 15% if the U.S. resident holds less than 10%
of the voting rights of the
61
Company, unless the shares are effectively connected to a permanent
establishment or fixed base in Australia through which the stockholder carries
on business or provides independent personal services, respectively. Where the
U.S. resident holds 10% or more of the voting rights of the Company, the
withholding tax rate is reduced to 5%.
Tax on Sales or other Dispositions of Shares - Capital Gains Tax
Non-Australian resident stockholders will not be subject to Australian
capital gains tax on the gain made on a sale or other disposal of our shares,
unless they, together with associates, hold 10% or more of our issued capital
at any time during the five years before the disposal of the shares. If a
non-Australian resident stockholder did own a 10% or more interest, that
stockholder would be subject to Australian capital gains tax to the same extent
as Australian resident stockholders. The Australian Taxation Office maintains
the view that the Double Taxation Convention between the U.S. and Australia
does not limit Australian capital gains tax. Australian capital gains tax
applies to net capital gains at a taxpayers marginal tax rate but for certain
stockholders a discount of the capital gain may apply if the shares have been
held for 12 months or more. For individuals, this discount is 50%. Net capital
gains are calculated after reduction for capital losses, which may only be
offset against capital gains.
Tax on Sales or other Dispositions of Shares - Stockholders Holding
Shares on Revenue Account
Some non-Australian resident stockholders may hold shares on revenue
rather than on capital account, for example, share traders. These stockholders
may have the gains made on the sale or other disposal of the shares included in
their assessable income under the ordinary income provisions of the income tax
law, if the gains are sourced in Australia. Non-Australian resident
stockholders assessable under these ordinary income provisions in respect of
gains made on shares held on revenue account would be assessed for those gains
at the Australian tax rates for non-Australian residents, which start at a
marginal rate of 29%. Some relief from the Australian income tax may be
available to non-Australian resident stockholders under the Double Taxation
Convention between the U.S. and Australia, for example, because the stockholder
does not have a permanent establishment in Australia.
To the extent an amount would be included in a non-Australian resident
stockholders assessable income under both the capital gains tax provisions and
the ordinary income provisions, the capital gain amount would generally be
reduced, so that the stockholder would not be subject to double tax on any part
of the income gain or capital gain.
Dual Residency
If a stockholder were a resident of both Australia and the U.S. under those
countries domestic taxation laws, that stockholder may be subject to tax as an
Australian resident. If, however, the stockholder is determined to be a U.S.
resident for the purposes of the Double Taxation Convention between the U.S.
and Australia, the Australian tax would be subject to limitation by the Double
Taxation Convention. Stockholders should obtain specialist taxation advice in
these circumstances.
Stamp Duty
Any transfer of shares through trading on the ASX, whether by
Australian residents or foreign residents, are not subject to stamp duty within
Australia.
Australian Death Duty
Australia does not have estate or death duties. No capital gains tax
liability is realized upon the inheritance of a deceased persons shares. The
disposal of inherited shares by beneficiaries, may, however, give rise to a
capital gains tax liability.
Goods and Services Tax
The issue or transfer of shares will not incur Australian goods and
services tax and does not require a stockholder to register for Australian
goods and services tax purposes.
62
U.S
.
Federal Income Taxation
The following discussion summarizes
the principal U.S. federal income tax considerations relating to the purchase,
ownership and disposition of ADRs and ordinary shares. This summary does not
describe any state, local or non-U.S. tax law considerations, or any aspect of
U.S. federal tax other than income taxation; investors are urged to consult
their own tax advisers regarding such matters.
As used below, a U.S. Holder is a
beneficial owner of an ADR or ordinary share that is, for U.S. federal income
tax purposes, (i) a citizen or resident alien individual of the United States,
(ii) a corporation (or an entity treated as a corporation) organized under the
law of the United States, any State thereof or the District of Columbia, (iii)
an estate, the income of which is subject to U.S. federal income tax without
regard to its source or (iv) a trust if (1) a court within the United States is
able to exercise primary supervision over the administration of the trust, and
one or more U.S. persons have the authority to control all substantial
decisions of the trust, or (2) the trust has a valid election in effect under
applicable U.S. Treasury Regulations to be treated as a U.S. person. For
purposes of this discussion, a non-U.S. Holder is a beneficial owner of an
ADR or ordinary share that is (i) a nonresident alien individual, (ii) a
corporation (or an entity treated as a corporation) created or organized in or
under the law of a country other than the United States or a political
subdivision thereof or (iii) an estate or trust that is not a U.S. Holder. If a
partnership (including for this purpose any entity treated as a partnership for
U.S. federal tax purposes) is a beneficial owner of an ADR or ordinary share,
the U.S. federal tax treatment of the partner in the partnership generally will
depend on the status of the partner and the activities of the partnership. A
holder of an ADR or ordinary share that is a partnership and partners in that
partnership should consult their own tax advisers regarding the U.S. federal
income tax consequences of holding and disposing of ADRs or ordinary shares.
Nature
of ADRs for U.S. Federal Income Tax Purposes
In
general, for U.S. federal income tax purposes, a holder of an ADR will be
treated as the owner of the underlying ordinary shares. Accordingly, except as
specifically noted below, the tax consequences discussed below with respect to
ADRs will be the same for ordinary shares in the Company, and exchanges of
ordinary shares for ADRs, and ADRs for ordinary shares, generally will not be
subject to U.S. federal income tax.
Taxation of
Dividends
U.S. Holders
. In
general, subject to the passive foreign investment company rules discussed
below, a distribution on an ADR will constitute a dividend for U.S. federal
income tax purposes to the extent that it is made from the Companys current or
accumulated earnings and profits as determined under U.S. federal income tax
principles. If a distribution exceeds the Companys current and accumulated
earnings and profits, it will be treated as a non-taxable reduction of basis to
the extent of the U.S. Holders tax basis in the ADR on which it is paid, and
to the extent it exceeds that basis it will be treated as a capital gain. For
purposes of this discussion, the term dividend means a distribution that
constitutes a dividend for U.S. federal income tax purposes.
T
he gross amount of any dividend on
an ADR (which will include the amount of any Australian taxes withheld) will be
subject to U.S. federal income tax as foreign source dividend income. The
amount of a dividend paid in Australian dollars will be its value in U.S.
dollars based on the prevailing spot market exchange rate in effect on the day
that the U.S. Holder receives the dividend or, in the case of a dividend
received in respect of an ADR, on the date the Depositary receives it, whether
or not the dividend is converted into U.S. dollars. A U.S. Holder will have a
tax basis in any distributed Australian dollars equal to its U.S. dollar amount
on the date of receipt, and any gain or loss realized on a conversion or other
disposition of the Australian dollars generally will be treated as U.S. source
ordinary income or loss. If dividends paid in Australian dollars are converted
into U.S. dollars on the date they are received by a U.S. holder or the
Depositary or its agent, as the case may be, the U.S. holder generally should
not be required to recognize foreign currency gain or loss in respect of the
dividend income.
Subject to certain exceptions for
short-term and hedged positions, a dividend a noncorporate U.S. Holder receives
on an ADR before January 1, 2011 will be subject to a maximum tax rate of 15%
if the dividend is a qualified dividend.
A dividend will be a qualified dividend if (a) the dividend is paid on
an ordinary share and the ordinary shares
are readily tradable on an established securities market in
the United States and (b) the dividend is paid on an ADR or an ordinary share
and the Company is eligible for benefits of a comprehensive income tax treaty
with the United
States that the Secretary of the Treasury determines is
satisfactory for purposes of these rules and that includes an exchange of information
program, and (ii) the Company was not, in the year prior to the year the
dividend was paid, and is not, in the year the dividend is paid, a PFIC. The
ADRs will be listed on the NASDAQ
63
Capital Market. It is not clear
whether that listing will qualify them as readily tradable on an established
securities market in the United States. Moreover, because only the ADRs and not
the shares themselves are listed on a U.S. exchange, based on existing guidance
it is not clear whether dividends paid by the Company will be treated as paid
on shares that are readily tradable on an established securities market in the
United States. However, the Treaty satisfies the requirements of clause (i)(b),
and, although the matter is not free from doubt, the Company
should be a
resident of Australia entitled to the benefits of the Treaty. Based on the
Companys audited financial statements and relevant market and shareholder
data, the Company
believes it was not a PFIC for U.S. federal income tax purposes for its , the Company believes it was not a PFIC for
U.S. federal income tax purposes for its 2005 or 2006 taxable years, nor does
it anticipate being classified as a PFIC in 2007 or in future taxable years. However, because the
determination of whether the Company is a PFIC is based upon the composition of
the income and assets from time to time, there can be no assurances that the
Company will not become a PFIC for any future taxable year. However, as
described in the section below entitled Passive Foreign Investment Company
Rules, if the Company were a PFIC in a year while a U.S. Holder held an ADR or
ordinary share, and if the U.S. Holder has not made a qualified electing fund
election effective for the first year the U.S. Holder held the ADR or ordinary
share, the ADR or ordinary share remains an interest in a PFIC for all future
years or until such an election is made. The IRS takes the position that that
rule will apply for purposes of determining whether an ADR is an interest in a
PFIC in the year a dividend is paid or in the prior year, even if the Company
does not satisfy the tests to be a PFIC in either of those years. Even if the
Company has not been a PFIC in any prior year and is not currently a PFIC,
because the composition of the Companys income and assets will vary over time,
there can be no assurance that the Company will not be considered a PFIC for
any taxable year. The U.S. Treasury has announced its intention to
promulgate rules pursuant to which holders of stock of non-U.S. corporations,
and intermediaries though whom the stock is held, will be permitted to rely on
certifications from issuers to establish that dividends are treated as
qualified dividends. Because those procedures have not yet been issued, it is
not clear whether the Company will be able to comply with them. Special
limitations on foreign tax credits apply to dividends subject to the reduced
rate of tax. U.S. Holders of ADRs and ordinary shares should consult their own
tax advisers regarding the availability of the reduced dividend tax rate in the
light of their own particular circumstances.
Any Australian withholding tax will
be treated as a foreign income tax eligible for credit against a U.S. Holders
U.S. federal income tax liability, subject to generally applicable limitations
under U.S. federal income tax law. For purposes of computing those limitations
separately for specific categories of income, a dividend generally will
constitute foreign source passive income or, in the case of certain holders, financial
services income for purposes of taxable years beginning before January 1, 2007.
For taxable years beginning after December 31, 2006, passive income generally
will be treated as passive category income, and financial services income
generally will be treated as general
category income. A U.S. Holder
will be denied a foreign tax credit with respect to Australian income tax
withheld from dividends received on an ADR to the extent the U.S. Holder has
not held the ADR for at least 16 days of the 30-day period beginning on the
date which is 15 days before the ex-dividend date or to the extent the U.S.
Holder is under an obligation to make related payments with respect to
substantially similar or related property. Any days during which a U.S. Holder
has substantially diminished its risk of loss on the ADR are not counted toward
meeting the 16-day holding period required by the statute. The rules relating
to the determination of the foreign tax credit are complex, and U.S. Holders
should consult with their own tax adviser to determine whether and to what
extent they will be entitled to foreign tax credits as well as with respect to
the determination of the foreign tax credit limitation (including changes in
the rules for taxable years beginning after December 31, 2006). Alternatively,
any Australian withholding tax may be taken as a deduction against taxable
income, provided that the U.S. Holder takes a deduction and not a credit for
all foreign income taxes paid or accrued in the same taxable year. A dividend
will not be eligible for the corporate dividends received deduction.
Non-U.S. Holders
. A
dividend paid to a non-U.S. Holder of an ADR will not be subject to U.S. federal income tax
unless the dividend is effectively connected with the conduct of trade or
business by the non-U.S. Holder within the United States (and is attributable to a
permanent establishment or fixed base the non-U.S. Holder maintains in the United States
if an applicable income tax treaty so requires as a condition for the non-U.S.
Holder to be subject to U.S. taxation on a net income basis on income from the
ADR). A non-U.S. Holder generally will be subject to tax on an effectively
connected dividend in the same manner as a U.S. Holder. A corporate non-U.S.
Holder may also be subject under certain circumstances to an additional branch
profits tax, the rate of which may be reduced pursuant to an applicable income
tax treaty.
Taxation of
Capital Gains
U.S. Holders
. Subject
to the passive foreign investment company rules discussed below, on a sale or
other taxable disposition of an ADR, a U.S. Holder will recognize capital gain
or loss in an amount equal to the difference
64
between the U.S. Holders adjusted
basis in the ADR and the amount realized on the sale or other disposition, each
determined in U.S. dollars. Any gain a U.S. Holder recognizes generally will be
U.S. source income for U.S. foreign tax credit purposes, and, subject to
certain exceptions, any loss generally will be a U.S. source loss. If
Australian tax is withheld on a sale or other disposition of an ADR, the amount
realized will include the gross amount of the proceeds of that sale or
disposition before deduction of the Australian tax. The generally applicable
limitations under U.S. federal income tax law on crediting foreign income taxes
may preclude a U.S. Holder from obtaining a foreign tax credit for any
Australian tax withheld on a sale of an ADR.
In general, any adjusted net
capital gain of an individual in a taxable year beginning before January 1,
2011 is subject to a maximum tax rate of 15%. In subsequent years, the maximum
tax rate on the net capital gain of an individual will be 20%. The
deductibility of capital losses is subject to limitations.
Non-U.S. Holders.
A
non-U.S. Holder will not be subject to U.S. federal income tax on gain
recognized on a sale or other disposition of an ADR unless (i) the gain is
effectively connected with the conduct of trade or business by the non-U.S.
Holder within the United States (and is attributable to a
permanent establishment or fixed base that the non-U.S. Holder maintains in the
United States if an applicable income tax treaty so requires as a
condition for the non-U.S. Holder to be subject to U.S. taxation on a net
income basis on income from the ADR), or (ii) in the case of a non-U.S. Holder
who is an individual, the holder is present in the United
States for 183 or more days in the taxable year of the sale or
other disposition and certain other conditions apply. Any effectively connected
gain of a corporate non-U.S. Holder may also be subject under certain
circumstances to an additional branch profits tax, the rate of which may be
reduced pursuant to an applicable income tax treaty.
Passive Foreign
Investment Company Rules
A special set of U.S. federal
income tax rules applies to a foreign corporation that is a PFIC for U.S.
federal income tax purposes. As noted above, based on the Companys audited
financial statements and relevant market and shareholder data, the Company
believes it was not a PFIC for U.S. federal income tax purposes for its
2005 or 2006 taxable years, nor
does it anticipate being classified as a PFIC in 2007 or in future taxable
years.
In general, a foreign corporation
is a PFIC if at least 75% of its gross income for the taxable year is passive
income or if at least 50% of its assets for the taxable year produce passive
income or are held for the production of passive income. In general, passive
income for this purpose means, with certain designated exceptions, dividends,
interest, rents, royalties (other than certain rents and royalties derived in
the active conduct of trade or business), annuities, net gains from
dispositions of certain assets, net foreign currency gains, income equivalent
to interest, income from notional principal contracts and payments in lieu of
dividends. The determination of whether a foreign corporation is a PFIC is a
factual determination made annually and is therefore subject to change. Subject
to exceptions pursuant to certain elections that generally require the payment
of tax, once stock in a foreign corporation is stock in a PFIC in the hands of
a particular shareholder that is a
United States
person, it remains stock in a PFIC in the hands of that shareholder.
If the Company is treated as a
PFIC, contrary to the tax consequences described in U.S. Federal Income Tax
ConsiderationsTaxation of Dividends and U.S. Federal Income Tax
ConsiderationsTaxation of Capital Gains above, a U.S. Holder that does not
make an election described in the succeeding two paragraphs would be subject to
special rules with respect to (i) any gain realized on a sale or other
disposition of an ADR (for purposes of these rules, a disposition of an ADR
includes many transactions on which gain or loss is not realized under general
U.S. federal income tax rules) and (ii)
any excess distribution by the Company to the U.S. Holder (generally, any
distribution during a taxable year in which distributions to the U.S. Holder on
the ADR exceed 125% of the average annual taxable distributions (whether actual
or constructive and whether or not out of earnings and profits) received by the
U.S. Holder on the ADR during the
preceding
three taxable years or, if shorter, the U.S. Holders holding period for the
ADR). Under those rules, (i) the gain or excess distribution would be allocated
ratably over the U.S. Holders holding period for the ADR, (ii) the amount
allocated to the taxable year in which the gain or excess distribution is
realized would be taxable as ordinary income in its entirety and not as capital
gain, would be ineligible for the reduced qualified dividend rates, and could
not be offset by any deductions or losses, and (iii) the amount allocated to
each prior year, with certain exceptions, would be subject to tax at the
highest tax rate in effect for that year, and the interest charge generally
applicable to underpayments of tax would be imposed in respect of the tax
attributable to each of those years. A U.S. Holder who owns an ADR during any
year the Company is
a PFIC may
have to file IRS Form 8621.
65
The special PFIC rules described
above will not apply to a U.S. Holder if the U.S. Holder makes a timely election,
which remains in effect, to treat the Company as a qualified electing fund (QEF)
in the first taxable year in which the U.S. Holder owns an ADR and the Company
is a PFIC and if the Company complies with certain reporting requirements. Instead,
a shareholder of a QEF generally is currently taxable on a pro rata share of
the Companys ordinary earnings and net capital gain as ordinary income and
long-term capital gain, respectively. Neither that ordinary income nor any
actual dividend from the Company would qualify for the 15% maximum tax rate on
dividends described above if the Company is a PFIC in the taxable year the
ordinary income is realized or the dividend is paid or in the preceding taxable
year. The Company has
not yet
determined whether, if it is a PFIC, it would make the computations necessary
to supply U.S. Holders with the information needed to report income and gain
pursuant to a QEF election. It is, therefore, possible that U.S. Holders would
not be able to make or retain that election in any year the Company is a PFIC. Although
a QEF election generally cannot be revoked, if a U.S. Holder made a timely QEF
election for the first taxable year it owned an ADR and the Company is a PFIC
(or is treated as having done so pursuant to any of certain elections), the QEF
election will not apply during any later taxable year in which the Company does
not satisfy the tests to be a PFIC. If a QEF election is not made in that first
taxable year, an election in a later year generally will require the payment of
tax and interest.
In lieu of a QEF election, a U.S.
Holder of stock in a PFIC that is considered marketable stock could elect to
mark the stock to market annually, recognizing as ordinary income or loss each
year an amount equal to the difference as of the close of the taxable year
between the fair market value of the stock and the U.S. Holders adjusted basis
in the stock. Losses would be allowed only to the extent of net mark-to-market
gain previously included in income by the U.S. Holder under the election for
prior taxable years. A U.S. Holders adjusted basis in the ADRs will be
adjusted to reflect the amounts included or deducted with respect to the
mark-to-market election. If the mark-to-market election were made, the rules
set forth in the second preceding paragraph would not apply for periods covered
by the election. A mark-to-market election will not apply during any later
taxable year in which the Company does not satisfy the tests to be a PFIC. In
general, the ADRs will be marketable stock if the ADRs are traded, other than
in
de minimis
quantities, on at least 15
days during each calendar quarter on a national securities exchange that is
registered with the SEC or on a designated national market system or on any
exchange or market that the Treasury Department determines to have rules
sufficient to ensure that the market price accurately represents the fair
market value of the stock. The ADRs will be listed on the NASDAQ Capital
Market. It is not clear whether trading on that market will qualify them as
readily tradable on an established securities market in the United States.
Thus, there is no certainty that the shares will be considered marketable
stock for these purposes unless and until the IRS designates the
ASX
as having rules adequate to carry out the purposes of the PFIC rules. There can
be no assurance that the IRS will make that designation.
Information
Reporting and Backup Withholding
Dividends paid on, and proceeds
from the sale or other disposition of, an ADR to a U.S. Holder generally may be
subject to information reporting requirements and may be subject to backup
withholding (currently at the rate of 28%) unless the U.S. Holder provides an
accurate taxpayer identification number or otherwise demonstrates that they are
exempt. The amount of any backup withholding collected from a payment to a U.S.
Holder will be allowed as a credit against the U.S. Holders U.S. federal
income tax liability and may entitle the U.S. Holder to a refund, provided that
certain required information is submitted to the IRS. A non-U.S. Holder
generally will be exempt from these information reporting requirements and
backup withholding tax but may be required to comply with certain certification
and identification procedures in order to establish its eligibility for
exemption.
The discussion above is not intended to constitute a complete analysis
of all tax considerations applicable to an investment in ADRs or ordinary
shares. Holders and potential holders should consult their tax adviser(s)
concerning the tax consequences relevant to them in their particular situation.
F.
Dividends and paying
agents
Not applicable
G. Statement by experts
Not applicable
66
H.
Documents on display
This Annual Report on Form 20-F and any related documents may be
inspected by investors at the Companys registered office at Edmondson Turner
& Co., 439 Bay Street, Brighton, Victoria, Australia, or at the Companys
headquarters at Pigdons Road, Waurn Ponds, Victoria, Australia or at the public
reference room of the SEC located at Room 1024, Judiciary Plaza, 450 Fifth
Street, N.W., Washington DC 20549, at prescribed rates. The Company is subject
to the information requirements of the U.S. Securities Exchange Act of 1934, as
amended, and, in accordance therewith, is required to file reports, including
annual reports on Form 20-F, and other information with the U.S. Securities and
Exchange Commission in electronic form. More information concerning the public
reference room of the SEC can be obtained by calling the SEC at 1-800-SEC-0330.
The SEC filings of the Company are available to the public from commercial
document retrieval services and at the website maintained by the SEC at www.sec.gov.
The Company also maintains a website at www.chemgenex.com. Information on the
Companys website and websites linked to it do not constitute part of this
Annual Report.
I.
Subsidiary information
Not applicable
ITEM
11.
QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
The
Company has exposure to changes in foreign currency exchange rates and interest
rates. The Company does not utilize derivative financial instruments or other
financial instruments subject to market risk.
Foreign
currency exchange rates
The
principal currency of the Company is the Australian dollar. Under existing
partnership agreements the Company receives funds Euros. Cash to fund working
capital requirements is managed centrally in Australia and held in Australian dollars.
The following table shows the sensitivity of the Companys 2007/2008
earnings as a result of an appreciation or depreciation in the value of the
June 30, 2007 exchange rate of the Australian dollar against the Euro (based on
foreign currency receipts from partnership agreements) and against the US
dollar (for commitments for expenditure existing at June 30, 2007).
|
|
A$ Depreciation
|
|
A$ Appreciation
|
|
|
|
-15%
|
|
-10%
|
|
-5%
|
|
0%
|
|
5%
|
|
10%
|
|
15%
|
|
|
|
50,159
|
|
33,439
|
|
16,720
|
|
|
|
(16,720
|
)
|
(33,439
|
)
|
(50,159
|
)
|
US $
|
|
(737,390
|
)
|
(491,593
|
)
|
(245,797
|
)
|
|
|
245,797
|
|
491,593
|
|
737,390
|
|
Total
|
|
(687,231
|
)
|
(458,154
|
)
|
(229,077
|
)
|
|
|
229,077
|
|
458,154
|
|
687,231
|
|
Interest
rates
Cash, held in call and short-term deposit accounts at the National
Australia Bank Limited and Greater Bay Bank are subject to variable interest
rates. The Company does not consider its exposure to interest rates to be
significant.
ITEM
12.
DESCRIPTION OF SECURITIES OTHER THAN
EQUITY SECURITIES
A
Debt Securities
Not applicable.
B
Warrants and Rights
Not applicable.
67
C
Other Securities
Not applicable.
D
American Depositary
Shares
Not applicable.
PART II
ITEM
13.
DEFAULTS, DIVIDEND ARREARAGES AND
DELINQUENCIES
None.
ITEM
14.
MATERIAL MODIFICATIONS TO THE RIGHT OF
SECURITY HOLDERS AND USE OF PROCEEDS
None.
ITEM
15.
CONTROLS AND PROCEDURES
A.
Controls and Procedures
As of June 30, 2007 the Companys management, including its Chief
Executive Officer and its Chief Financial Officer, reviewed the effectiveness of the design and operation
of the Companys disclosure controls and procedures, as defined in Rule
13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934. Based on that
review, the Companys Chief Executive Officer and Chief Financial Officer
concluded that the design and operation of the Companys existing disclosure
controls and procedures are effective to ensure that information required to be
disclosed in the reports that the Company files and submits under the Exchange
Act is (i) recorded, processed, summarized and reported as and when required
and (ii) accumulated and communicated to management, including the Chief
Executive Officer and Chief Financial Officer, to allow timely decisions
regarding required disclosure as of the end of the Companys most recent fiscal
year.
In preparation for the adoption of Section 404 of the Sarbanes-Oxley
Act of 2002 by all Foreign Private Issuers, management has initiated a detailed
evaluation of existing internal controls against Section 404 requirements.
Management will allocate the necessary resources and initiate required actions
to redress any possible Section 404 weaknesses prior to that date.
In planning and performing the audit of the consolidated financial
statements of ChemGenex Pharmaceuticals Limited for the year ended June 30,
2005, June 30, 2006 and June 2007 Ernst & Young considered the internal
controls over financial reporting to design auditing procedures for the purpose
of expressing an opinion on the consolidated financial statements. The
consideration of internal controls over financial reporting was not to express
an opinion on the effectiveness of the Companys internal controls over
financial reporting. However they noted certain matters involving internal
controls over financial reporting and its operation that they considered to be
material weaknesses under standards established by the Public Company Oversight
Board (United States).
A control deficiency exists when the design or operation of a control
does not allow management or employees, in the normal course of performing
their assigned functions, to prevent or detect misstatements on a timely basis.
A significant deficiency is a deficiency, or a combination of deficiencies, in
internal control over financial reporting that is less severe than a material
weakness, yet important enough to merit attention by those responsible for
oversight of the companys financial reporting. A material weakness is a
deficiency, or combination of deficiencies
68
in internal control over financial reporting, such that there is a
reasonable possibility that a material misstatement of the companys annual or
interim financial statements will not be prevented or detected on a timely
basis.
In connection with the audit of our fiscal year ended June 30, 2006,
Ernst & Young, the Companys independent auditors, informed our Audit
Committee that they consider the following matters represent material
weaknesses in the operation of our internal controls over financial reporting:
Lack
of knowledge to perform tax effective accounting; and
Lack
of US GAAP expertise
We have and will continue to mitigate the above material weaknesses by
conferring and / or hiring outside accounting advisers with respect to the
technical requirements applicable to our financial statements.
No changes in the Companys internal controls over financial reporting
occurred during the period covered by this report that materially affected, or
are reasonably likely to materially affect, the Companys internal controls
over financial reporting.
B.
Managements annual report on internal
control over financial reporting
Not applicable.
C.
Attestation report of the registered
public accounting firm
Not applicable
.
D.
Changes in internal control over
financial reporting
There were no significant changes in our internal controls or in other
factors that could significantly affect these controls and procedures
subsequent to the date our chief executive officer and our chief financial
officer completed their evaluation, nor were there any significant deficiencies
or material weaknesses in our internal controls and procedures requiring
corrective actions, other than those described above.
ITEM
16A.
AUDIT COMMITTEE FINANCIAL EXPERT
The Board of Directors of the Company has determined that Patrick Owen
Burns, an independent member of its Board of Directors and a member of its
Audit Committee, is an audit committee financial expert within the meaning of
the Sarbanes-Oxley and related regulations.
ITEM
16B.
CODE OF ETHICS
We have adopted a Code of Ethics that applies to all of the Companys
employees, including our principal executive officer, principal financial
officer, principal accounting officer or controller. The Code can be downloaded
at our website (www.chemgenex.com). Additionally, any person, upon request, can
ask for a hard copy or electronic file of such Code. If we make any substantive
amendment to the Code of Ethics or grant any waivers, including any implicit
waiver, from a provision of the Code of Ethics, we will disclose the nature of
such amendment or waiver on our website. During the year ended June 30, 2007,
no such amendment was made or waiver granted
ITEM
16C.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
For purposes of this Form 20-F Annual Report and other SEC filings, the
Companys independent registered public accounting firm is Ernst & Young. For
statutory reporting purposes and filings with the ASX and ASIC in Australia,
the Companys auditor is Ernst & Young.
69
The following
table sets forth the fees billed to us by our statutory auditor, Ernst &
Young, for the years ended June 30, 2007, 2006 and 2005, respectively:
Ernst & Young
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Audit fees
|
|
269,435
|
|
212,325
|
|
93,250
|
|
Tax fees
|
|
|
|
|
|
12,000
|
|
All other
fees
|
|
|
|
|
|
17,709
|
|
Total
|
|
269,435
|
|
212,325
|
|
122,959
|
|
For purposes of the initial registration Form 20-F
and the 2005 20-F Annual Report the Companys independent registered
public accounting firm was Deloitte Touche Tohmatsu. The following table sets
forth the fees billed to us by the independent registered public accounting
firm, Deloitte Touche Tohmatsu, since the year ended June 30, 2005:
Deloitte Touche Tohmatsu
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Audit fees (a)
|
|
|
|
|
|
497,804
|
|
Audit-related fees
|
|
|
|
|
|
|
|
Tax fees
|
|
|
|
|
|
|
|
All other fees
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
497,804
|
|
(a) Audit fees billed by
Deloitte Touche Tohmatsu relate to the
audit of financial statements and review of SEC filings for purposes of the
Companys Registration Statement on Form 20-F lodged in June 2005 as well as
the Annual Report on Form 20-F for the year ended June 30, 2005.
Audit Committee Pre-Approval Policies and Procedures
The Companys
Board of Directors has established pre-approval policies and procedures for the
engagement of its independent registered public accounting firms for all audit
and non-audit services.
The Audit
Committee reviews the scope of all the services to be provided, before their
commencement, in order to ensure that there are no independence issues and the
services are not prohibited services as defined by Sarbanes-Oxley Act of 2002.
ITEM
16D.
EXEMPTIONS FROM THE LISTING STANDARDS FOR
AUDIT COMMITTEES
Not applicable.
ITEM
16E.
PURCHASES OF EQUITY SECURITIES BY THE
ISSUER AND AFFILIATED PURCHASERS
Not applicable.
70
PART III
ITEM
17.
FINANCIAL STATEMENTS
Refer to page F-1 for an index of all Financial Statements.
ITEM
18.
FINANCIAL STATEMENTS
The Company has chosen to respond to Item 17 in lieu of responding to
this Item.
ITEM
19.
EXHIBITS
The following documents are filed as exhibits to this Annual Report on
Form 20-F:
1.
Constitution of
the Registrant #.
2.
Deposit
Agreement, dated as of December 6, 2002, by and among Autogen Limited, The Bank
of New York, as Depositary, and the Owners and Holders of American Depositary
Receipts (such agreement is incorporated herein by reference to the Registration
Statement on Form F-6 relating to the ADSs (File No. 333-101016) filed with the
Commission on November 1, 2002)
3.
Material Contracts:
3.1
Service
Contracts of Directors and Consultants
(a)
Secondment Agreement
between Deakin University and the Autogen Limited dated March 19, 2002 in
respect of the secondment to the Company of Dr. Gregory R. Collier #.
(b)
Supplementary
Secondment Deed among the Company, Autogen Research Pty Ltd and Dr. Gregory R.
Collier dated March 26, 2002 #.
71
3.2
Other
Contracts
(a)
Research and License
Agreement dated April 28, 1999 between Autogen Pty Ltd. and Lipha S.A.* #
(b)
Deed dated March 16,
2001 between Autogen Research Pty Limited and Lipha S.A.* #
(c)
Research and License
Agreement dated April 28, 1999 between Autogen Pty Ltd. and Lipha S.A.* #
(d)
Research and License
Agreement dated February 11, 2002 between Autogen Research Pty Ltd. and Lipha
S.A.* #
(e)
Research Services
(Subcontracting) Agreement dated June 26, 2000 between Autogen Research Pty
Limited and Deakin University.* #
(f)
Research and
Development Option Agreement dated August 30, 2004 between Autogen Research Pty
Ltd and Vernalis (R&D) Limited.* #
(g)
Research, License and
Commercialisation Agreement (Gene Discovery in Depression), dated August 16,
2000 between Autogen Research Pty Ltd. and Deakin University.* #
(h)
Commercialisation
License (Field of Diabetes and Obesity) AGT 203 dated March 14, 2003 between
Autogen Limited (now ChemGenex Pharmaceuticals Limited) and Merck Santé s.a.s.*
#
(i)
Commercialisation
License (Field of Diabetes and Obesity) AGT 121 dated March 14, 2003 between the Autogen Limited (now ChemGenex
Pharmaceuticals Limited) and Merck Santé s.a.s.* #
(j)
Commercialisation
License (Field of Diabetes and Obesity) TANIS dated August 26, 2002 between
the Autogen Pty Ltd and Merck Santé s.a.s.* #
(k)
Commercialisation
License (Field of Obesity) BEACON dated April 28, 1999 between Autogen Pty
Ltd and Lipha S.A.* #
(l)
Research, License
and Commercialization Agreement dated December 31, 2002 between Autogen
Research Pty Ltd. and the Southwest Foundation for Biomedical Research.* #
(m)
Variation Agreement
dated June 24, 2003 between Autogen Research Pty Limited and Southwest
Foundation for Biomedical Research.* #
(n)
Extension Agreement
dated July 1, 2004 between Autogen Research Pty Limited and Southwest
Foundation for Biomedical Research.* #
(o)
Research Agreement
dated February 28, 1997 among Autogen Pty Ltd., Deakin University and
International Diabetes Institute.* #
(p)
Research, License and
Commercialisation Agreement dated January 14, 1998 between Autogen Pty Ltd and
International Diabetes Institute.* #
(q)
Agreement dated August
18, 2004 between Autogen Pty Ltd and International Diabetes Institute.* #
(r)
Sponsored Clinical
Study Agreement dated April 14, 2003 between The University of Texas M.D.
Anderson Cancer Center and ChemGenex Therapeutics, Inc., as amended by
Amendment No. 1 dated November 18, 2004.* #
(s)
Patent and Technology
License Agreement dated February 7, 2005 between ChemGenex Pharmaceuticals
Limited and The University of Texas M. D. Anderson Cancer Center.* #
72
(t)
Voting Rights deed
dated June 21, 2004 between Dr. Dennis M. Brown and Charter Pacific Corporation
Ltd. #
(u)
Sole Licence Agreement
dated March 1, 1999 between Autogen Pty Ltd and Kyokuto Pharmaceutical
Industrial Co. Ltd. #
(v)
Agreement and Plan of
Merger dated April 27, 2004 between AGT Biosciences Limited, AGT Biosciences
Inc., ChemGenex Therapeutics Inc. and Dr. Dennis M. Brown. #
(w)
Research, Licence and
Commercialisation Agreement dated April 21, 2005 between ChemGenex
Pharmaceuticals Limited and Deakin University. #
(x)
HHT Development and
Commercialisation Agreement dated June 27, 2005 between ChemGenex
Pharmaceuticals Limited, Stragen Investment B.V. and Stragen Pharma S.A.*+
(y)
HHT Supply and
Distribution Agreement dated June 27, 2005 between ChemGenex Pharmaceuticals
Limited and Stragen Investment B.V.*+
(z)
Extension Agreement
dated July 27, 2005 between Autogen Research Pty Limited and Southwest
Foundation for Biomedical Research. *+
(aa)
Extension Agreement dated
September 20, 2005 between Autogen Pty Ltd and International Diabetes
Institute. *+
(bb)
Clinical Master Service
Agreement dated September 28, 2005 between ChemGenex Pharmaceuticals Limited
and Inveresk Research Limited.+
12.01
Certification
by the Companys Chief Executive Officer required by Item 15.
12.02
Certification
by the Companys Chief Financial Officer required by Item 15.
13.01
Certification
pursuant to 18 U.S.C. Section 1350.
13.02
Certification
pursuant to 18 U.S.C. Section 1350.
# Incorporated by reference to the Companys Registration Statement on
Form 20-F (file no. 0-51373) filed with the Commission on June 23, 2005
+ Incorporated by reference to the Companys Annual Report on Form 20-F
(file no. 0-51373) filed with the Commission on December 19, 2005.
* Certain provisions of this exhibit have been omitted and filed
separately with the Commission pursuant to an application for confidential
treatment under Rule 24b-2 promulgated under the Securities Exchange Act of
1934, as amended.
73
SIGNATURES
The registrant hereby certifies that it meets all of the requirements
for filing on Form 20-F and that it has duly caused and authorized the
undersigned to sign this Annual Report on its behalf.
CHEMGENEX PHARMACEUTICALS LIMITED
By:
|
/s/ Greg Collier
|
|
Name:
|
Greg Collier
|
Title:
|
Chief Executive Officer and Managing Director
|
Date:
|
November 27, 2007
|
74
CHEMGENEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Contents
F-1
CHEMGENEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Report of Independent Registered Public
Accounting Firm
To the Board of Directors and Shareholders of ChemGenex Pharmaceuticals
Ltd:
We have
audited the accompanying consolidated balance sheets of ChemGenex
Pharmaceuticals Ltd and its controlled entities (the Company) as of 30 June
2007 and 2006, and the related consolidated statements of income, shareholders
equity and cash flows for each of the three years in the period ended 30 June
2007. These financial statements are the responsibility of the Companys
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We conducted
our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. We were not engaged to perform an
audit of the Companys internal control over financial reporting. Our audits
included consideration of internal control over financial reporting as a basis
for designing audit procedures that are appropriate in the circumstances, but
not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no
such opinion. An audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing
the accounting principles used and significant estimates made by management,
and evaluating the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of ChemGenex
Pharmaceuticals Ltd and its controlled entities at 30 June 2007 and 2006 and
the consolidated results of their operations and their cash flows for each of
the three years in the period ended 30 June 2007, in conformity with Australian
Accounting Standards.
Australian
Accounting Standards vary in certain significant respects from U.S. generally
accepted accounting principles. Information relating to the nature and effect
of such differences is presented in Note 26 to the consolidated financial
statements.
/s/ Ernst & Young
|
|
|
Melbourne,
Australia
|
23 November
2007
|
F-2
CHEMGENEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Consolidated Statements of Income
FOR THE YEAR ENDED JUNE 30
|
|
Notes
|
|
200
7
|
|
200
6
|
|
2005
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
Research
revenue
|
|
|
|
536,111
|
|
1,676,297
|
|
3,527,312
|
|
Finance
income
|
|
4
|
(b)
|
862,096
|
|
241,634
|
|
266,987
|
|
|
|
|
|
1,398,207
|
|
1,917,931
|
|
3,794,299
|
|
Research
expenditure
|
|
4
|
(d)
|
(7,731,988
|
)
|
(7,184,978
|
)
|
(4,621,406
|
)
|
Gross profit/(loss)
|
|
|
|
(6,333,781
|
)
|
(5,267,047
|
)
|
(827,107
|
)
|
|
|
|
|
|
|
|
|
|
|
Other
income
|
|
4
|
(a)
|
889,927
|
|
379,091
|
|
300,987
|
|
Administration
costs
|
|
|
|
(1,710,706
|
)
|
(967,032
|
)
|
(847,903
|
)
|
NASDAQ
listing expenses
|
|
|
|
|
|
|
|
(911,578
|
)
|
Employee
benefits expense
|
|
4
|
(c)
|
(2,517,915
|
)
|
(2,710,341
|
)
|
(2,631,862
|
)
|
Scientific
advisory board expense
|
|
|
|
(118,643
|
)
|
(120,913
|
)
|
(125,763
|
)
|
Patent
expense
|
|
|
|
(564,543
|
)
|
(575,567
|
)
|
(446,527
|
)
|
Legal
expense
|
|
|
|
(66,434
|
)
|
(114,416
|
)
|
(105,945
|
)
|
Depreciation
|
|
|
|
(271,344
|
)
|
(272,198
|
)
|
(269,937
|
)
|
Travel
expense
|
|
|
|
(387,450
|
)
|
(341,037
|
)
|
(240,340
|
)
|
Accounting
and audit expense
|
|
|
|
(298,526
|
)
|
(380,259
|
)
|
(129,208
|
)
|
Loss from operations before tax and finance
costs
|
|
|
|
(11,379,415
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
|
|
|
|
|
|
|
|
|
|
Finance costs
|
|
|
|
|
|
|
|
|
|
Loss before income tax
|
|
|
|
(11,379,415
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
5
|
|
(321,504
|
)
|
|
|
|
|
Loss after tax
|
|
|
|
(11,700,919
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to members of the parent
|
|
|
|
(11,700,919
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
|
|
|
|
|
|
|
|
|
|
Basic
loss in cents per share
|
|
6
|
|
$
|
(0.07
|
)
|
$
|
(0.09
|
)
|
$
|
(0.06
|
)
|
Diluted
loss in cents per share
|
|
6
|
|
$
|
(0.07
|
)
|
$
|
(0.09
|
)
|
$
|
(0.06
|
)
|
F-3
CHEMGENEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Consolidated Balance Sheets
AS AT JUNE 30
|
|
Notes
|
|
200
7
|
|
200
6
|
|
|
|
|
|
$
|
|
$
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
8
|
|
25,366,562
|
|
15,553,696
|
|
Trade
and other receivables
|
|
9
|
|
18,000
|
|
79,011
|
|
Prepayments
|
|
|
|
363,251
|
|
71,974
|
|
TOTAL CURRENT ASSETS
|
|
|
|
25,747,813
|
|
15,704,681
|
|
NON-CURRENT ASSETS
|
|
|
|
|
|
|
|
Plant
and equipment
|
|
11
|
|
81,546
|
|
328,820
|
|
Goodwill
|
|
12
|
|
16,931,750
|
|
16,931,750
|
|
TOTAL NON-CURRENT ASSETS
|
|
|
|
17,013,296
|
|
17,260,570
|
|
TOTAL ASSETS
|
|
|
|
42,761,109
|
|
32,965,251
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
Trade
and other payables
|
|
16
|
|
2,445,328
|
|
1,621,865
|
|
Deferred
revenue
|
|
|
|
165,688
|
|
185,372
|
|
Employee
entitlements
|
|
|
|
231,284
|
|
153,105
|
|
Provisions
|
|
17
|
|
16,079
|
|
|
|
TOTAL CURRENT LIABILITIES
|
|
|
|
2,858,289
|
|
1,960,342
|
|
NON-CURRENT LIABILITIES
|
|
|
|
|
|
|
|
Employee
entitlements
|
|
|
|
33,222
|
|
|
|
TOTAL NON-CURRENT LIABILITIES
|
|
|
|
33,222
|
|
|
|
TOTAL LIABILITIES
|
|
|
|
2,891,511
|
|
1,960,342
|
|
|
|
|
|
|
|
|
|
NET ASSETS
|
|
|
|
39,869,598
|
|
31,004,909
|
|
EQUITY
|
|
|
|
|
|
|
|
Equity
attributable to equity holders of the parent
|
|
|
|
|
|
|
|
Issued
capital
|
|
18
|
|
120,773,060
|
|
99,892,615
|
|
Retained earnings
|
|
|
|
(92,723,921
|
)
|
(81,023,002
|
)
|
Other
reserves
|
|
18
|
|
11,820,459
|
|
12,135,296
|
|
TOTAL EQUITY
|
|
|
|
39,869,598
|
|
31,004,909
|
|
F-4
CHEMGENEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Consolidated Cash Flow Statements
FOR THE YEAR ENDED JUNE 30
|
|
Notes
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Customer
revenues received
|
|
|
|
516,427
|
|
1,920,107
|
|
3,618,233
|
|
Government
grants received
|
|
4
|
(a)
|
730,099
|
|
148,868
|
|
|
|
VAT
refund
|
|
|
|
1,911
|
|
|
|
|
|
Payments
to suppliers and employees
|
|
|
|
(12,860,804
|
)
|
(10,554,593
|
)
|
(10,562,419
|
)
|
Income
taxes paid
|
|
|
|
(293,238
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
CASH FLOWS USED IN OPERATING ACTIVITIES
|
|
8
|
|
(11,905,605
|
)
|
(8,485,618
|
)
|
(6,944,186
|
)
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Interest
received
|
|
4
|
(b)
|
862,096
|
|
241,634
|
|
266,987
|
|
Purchase
of plant and equipment
|
|
11
|
|
(24,070
|
)
|
(13,996
|
)
|
(15,218
|
)
|
NET
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
(838,026
|
|
227,638
|
|
251,769
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Proceeds
from issues of shares
|
|
18
|
|
21,260,131
|
|
15,723,021
|
|
14,451,937
|
|
Transaction
cost of issue of shares
|
|
18
|
|
(379,686
|
)
|
(423,297
|
)
|
(189,353
|
)
|
NET
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
(20,880,445
|
|
15,299,724
|
|
14,262,584
|
|
|
|
|
|
|
|
|
|
|
|
Net
increase in cash and cash equivalents
|
|
|
|
9,812,866
|
|
7,041,744
|
|
7,570,167
|
|
Cash
and cash equivalents at beginning of period
|
|
|
|
15,553,696
|
|
8,511,952
|
|
941,785
|
|
CLOSING CASH CARRIED FORWARD
|
|
8
|
|
25,366,562
|
|
15,553,696
|
|
8,511,952
|
|
F-5
CHEMGENEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Consolidated Statements of Changes in Equity
|
|
|
|
Equity
|
|
Foreign Currency
|
|
Equity
|
|
|
|
|
|
|
|
Issued
|
|
Premium
|
|
Translation
|
|
Options
|
|
Retained
|
|
Total
|
|
From JULY 1, 2004 to JUNE 30, 2007
|
|
Capital
|
|
Reserve
|
|
Reserve
|
|
Reserve
|
|
Earnings
|
|
Equity
|
|
|
|
$
|
|
$
|
|
|
|
$
|
|
$
|
|
$
|
|
At July 1, 2004
|
|
70,257,383
|
|
10,866,878
|
|
|
|
6,857
|
|
(64,518,100
|
)
|
16,713,018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
for year to June 30, 2005
|
|
|
|
|
|
|
|
|
|
(6,235,183
|
)
|
(6,235,183
|
)
|
Total
recognised income and expense for the period
|
|
|
|
|
|
|
|
|
|
(6,235,183
|
)
|
(6,235,183
|
)
|
Issue
of share capital
|
|
14,439,437
|
|
|
|
|
|
|
|
|
|
14,439,437
|
|
less
cost of issue
|
|
(189,353
|
)
|
|
|
|
|
|
|
|
|
(189,353
|
)
|
Fees
paid in lieu of cash
|
|
72,924
|
|
|
|
|
|
|
|
|
|
72,924
|
|
Cost
of option-based payments
|
|
|
|
|
|
|
|
422,105
|
|
|
|
422,105
|
|
Options
exercised under Employee Share Option Plan
|
|
12,500
|
|
|
|
|
|
|
|
|
|
12,500
|
|
At July 1, 2005
|
|
84,592,891
|
|
10,866,878
|
|
|
|
428,962
|
|
(70,653,283
|
)
|
25,235,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
for year to June 30, 2006
|
|
|
|
|
|
|
|
|
|
(10,369,719
|
)
|
(10,369,719
|
)
|
Total
recognised income and expense for the period
|
|
|
|
|
|
|
|
|
|
(10,369,719
|
)
|
(10,369,719
|
|
Issue
of share capital
|
|
15,723,021
|
|
|
|
|
|
|
|
|
|
15,723,021
|
|
less
cost of issue
|
|
(423,297
|
)
|
|
|
|
|
|
|
|
|
(423,297
|
)
|
Cost
of option-based payments
|
|
|
|
|
|
|
|
839,456
|
|
|
|
839,456
|
|
At June 30, 2006
|
|
99,892,615
|
|
10,866,878
|
|
|
|
1,268,418
|
|
(81,023,002
|
)
|
31,004,909
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
Exchange Translation
|
|
|
|
|
|
(751,314
|
)
|
|
|
|
|
(751,314
|
)
|
Loss
for year ended June 30, 2007
|
|
|
|
|
|
|
|
|
|
(11,700,919
|
)
|
(11,700,919
|
)
|
Total
recognised income and expense for the period
|
|
|
|
|
|
(751,314
|
)
|
|
|
(11,700,919
|
)
|
(12,452,233
|
)
|
Issue
of share capital
|
|
21,260,131
|
|
|
|
|
|
|
|
|
|
21,260,131
|
|
less
cost of issue
|
|
(379,686
|
)
|
|
|
|
|
|
|
|
|
(379,686
|
)
|
Cost
of option-based payments
|
|
|
|
|
|
|
|
436,477
|
|
|
|
436,477
|
|
At June 30, 2007
|
|
120,773,060
|
|
10,866,878
|
|
(751,314
|
)
|
1,704,895
|
|
(92,723,921
|
)
|
39.869,598
|
|
REFER NOTE 17 ISSUED CAPITAL AND RESERVES FOR DETAILS
MOVEMENTS IN CAPITAL AND RESERVES DURING THE PERIOD FROM JULY1, 2004 TO JUNE
30, 2007
F-6
CHEMGENEX
PHARMACEUTICALS LIMITED AND SUBSIDIARIES
Notes to the Consolidated Financial
Statements
1.
CORPORATE INFORMATION
The financial
report of ChemGenex Pharmaceuticals Limited (ChemGenex or Company or Group)
for the year ended June 30, 2007 was authorised for issue in accordance with a
resolution of the directors on August 29, 2007.
ChemGenex is a
company limited by shares incorporated in Australia whose shares are publicly
traded on the Australian Stock Exchange (ASX) and are traded as Level 2
American Depository Receipts (ADRs) on the NASDAQ Stock Market.
The nature of
the operations and principal activities of ChemGenex are described in note 3.
The
consolidated financial statements have been prepared on the basis of going
concern which contemplates continuity of normal business activities and the
realisation of assets and settlement of liabilities in the ordinary course of
business
. Since commencing biotechnology activities in
June 1996 the Company has experienced recurring net losses and negative cash
flows from operations. At June 30, 2007, the Company had accumulated losses of
$92,723,921 and recorded a net loss of $11,700,919 and negative cash flows from
operations of $11,905,605 for the year ended June 30, 2007. Based on anticipated
cash flow requirements of the Companys existing research and development
activities, the directors consider that the Company will have sufficient funds
to support existing operations to the second half of calendar 2008.
The directors
are confident that adequate funds to support the Companys continued operations
into 2009 and beyond will be raised from collaboration and licensing agreements
and/or equity placements as required. From July 1, 1996 it has raised
approximately $80.9 million (including $50.5 million since July 1, 2004) from
the issue of equity securities. In addition, during this time, the Company has
received approximately $26.4 million from its pharmaceutical partners pursuant
to collaboration and licensing agreements.
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(a) Basis of accounting
The financial
report is a general-purpose financial report, which has been prepared in
accordance with the requirements of the Corporations Act 2001 and Australian
Accounting Standards. The financial report has also been prepared on a
historical cost basis.
The financial
report is presented in Australian dollars.
(b) Statement of compliance
The financial
report complies with Australian Accounting Standards, which include Australian
equivalents to International Financial Reporting Standards (AIFRS).
Compliance with AIFRS ensures that the financial report, comprising the
financial statements and notes thereto, complies with International Financial
Reporting Standards (IFRS).
Certain
Australian Accounting Standards and Urgent Issues Group (UIG) interpretations
have recently been issued or amended but are not yet effective and have not
been adopted by the Group for the annual reporting period ended 30 June 2007.
The directors have assessed the impact of these new or amended standards (to
the extent relevant to the group) and interpretations as follows:
F-7
Reference
|
|
Title
|
|
Summary
|
|
Application
date of
standard*
|
|
Impact on Group financial
report
|
|
Application
date for
Group*
|
AASB
2005-10
|
|
Amendments to Australian Accounting Standards [AASB 132, AASB 101,
AASB 114, AASB 117, AASB 133, AASB 139, AASB 1, AASB 4, AASB 1023 & AASB
1038]
|
|
Amendments arise from the release in August 2005 of AASB 7
Financial Instruments: Disclosures.
|
|
1 January 2007
|
|
AASB 7 is a disclosure standard so will have no direct impact on the
amounts included in the Groups financial statements. However, the amendments
will result in changes to the financial instrument disclosures included in
the Groups financial report.
|
|
1 July 2007
|
|
|
|
|
|
|
|
|
|
|
|
AASB
2007-1
|
|
Amendments to Australian Accounting Standards arising from AASB
Interpretation 11 [AASB 2]
|
|
Amending standard issued as a consequence of AASB Interpretation 11
Interim Financial Reporting and Impairment
.
|
|
1 March
2007
|
|
This is consistent with the Groups existing accounting policies for
share-based payments so will have no impact.
|
|
1 July 2007
|
|
|
|
|
|
|
|
|
|
|
|
AASB
2007-3
|
|
Amendments to Australian Accounting Standards arising from AASB 8
[AASB 5, AASB, AASB 6, AASB 102, AASB 107, AASB 119, AASB 127, AASB 134, AASB
136, AASB 1023 & AASB 1038]
|
|
Amending standard issued as a consequence of AASB 8
Operating Segments
.
|
|
1 January 2009
|
|
AASB 8 is a disclosure standard so will have
no direct impact on the amounts included in the Groups financial statements.
The impact of the new
standard is yet to be
determined.
|
|
1 July 2009
|
|
|
|
|
|
|
|
|
|
|
|
AASB 7
|
|
Financial Instruments:
Disclosures
|
|
New standard replacing disclosure requirements of AASB 132.
|
|
1 January 2007
|
|
Refer to AASB 2005-10 above.
|
|
1 July 2007
|
|
|
|
|
|
|
|
|
|
|
|
AASB 8
|
|
Operating Segments
|
|
This new standard will replace AASB 114
Segment
Reporting
and adopts a management approach to segment reporting.
|
|
1 January 2009
|
|
Refer to AASB 2007-3 above.
|
|
1 July 2009
|
(c) Basis of consolidation
The
consolidated financial statements comprise the financial statements of
ChemGenex Pharmaceuticals Limited (the Parent) and its subsidiaries (the
Group).
The financial
statements of subsidiaries are prepared for the same reporting period as the
parent company, using consistent accounting policies. Adjustments are made to
bring into line any dissimilar accounting policies that may exist.
All
intercompany balances and transactions, including unrealised profits arising
from intra-group transactions, have been eliminated in full. Unrealised losses
are eliminated unless costs cannot be recovered.
Subsidiaries
are consolidated from the date on which control is transferred to the Group and
cease to be consolidated from the date on which control is transferred from the
Group.
(d) Significant accounting estimates and
assumptions
The carrying
amount of certain assets and liabilities are often determined based on
estimates and assumptions of future events. The key estimates and assumptions
that have a significant risk of causing a material adjustment to the carrying
amounts of certain assets and liabilities within the next annual reporting
period are:
Impairment
of goodwill and intangibles with indefinite useful lives
The Group
determines whether goodwill and intangibles with indefinite useful lives are
impaired at least on an annual basis. This requires an estimate of the
recoverable amount of the cashgenerating units to which the goodwill and
intangibles with indefinite lives are allocated. The assumptions used in this
estimation of recoverable amount and the carrying amount of goodwill and
intangibles with indefinite useful lives are discussed in note 13.
Share-based
payment transactions
The Group
measures the cost of share-based payments at fair value at the grant date using
the Black-Scholes formula, taking into account, the terms and conditions upon
which the instruments were granted, as discussed in note 14.
F-8
(e) Foreign currencies
Both the
functional and presentation currency of ChemGenex Pharmaceuticals Limited and
its Australian subsidiary Autogen Research Pty Ltd is Australian dollars (A$).
Transactions
in foreign currencies are initially recorded in the functional currency at the
rate of exchange ruling at the date of the transaction. Monetary assets and
liabilities denominated in foreign currencies are retranslated at the rate of
exchange ruling at the balance sheet date.
All
differences in the consolidated financial report are taken to the income
statement.
Non-monetary
items that are measured in terms of historical cost in a foreign currency are
translated using the exchange rate as at the date of the initial transaction.
Non-monetary items that are measured at fair value in a foreign currency are
translated using the exchange rates at the date the fair value was determined.
The functional
currency of the overseas subsidiary ChemGenex Pharmaceuticals Inc. is United
States dollars (US$).
As at the reporting
date the assets and liabilities of the overseas subsidiary are translated into
the presentation currency of the Parent at the rate of exchange ruling at the
balance sheet date and the income statement is translated at the weighted
average exchange rates for the period. The exchange differences arising on
translation are taken directly to a separate component of equity.
On disposal of
a foreign entity, the deferred cumulative amount recognised in equity relating
to that particular foreign operation is recognised in the income statement.
(f) Cash and cash equivalents
Cash and
short-term deposits in the balance sheet comprise cash at bank and in hand and
short-term deposits with an original maturity of three months or less. For the
purposes of the Cash Flow Statement, cash includes cash and cash equivalents as
defined above, net of outstanding bank overdrafts.
(g) Trade and other receivables
Trade
receivables, which generally have 30 day terms, are recognised and carried at
original invoice amount less any allowance for any uncollectible amounts. An
estimate for doubtful debts is made when collection of the full amount is no
longer probable. Bad debts are written-off when incurred.
(h) Plant and equipment
Cost
and valuation
Plant and
equipment are carried at cost less accumulated depreciation and any impairment
in value.
Depreciation
Depreciation
is provided on a straight-line basis on all plant and equipment.
Major
depreciation periods are:
|
|
|
|
|
|
Plant and
equipment:
|
|
|
research equipment
|
|
5-7 years
|
office equipment
|
|
3-13 years
|
Impairment
The carrying
values of plant and equipment are reviewed for impairment when events or
changes in circumstances indicate the carrying value may not be recoverable.
If any such
indication exists and where the carrying value exceeds the estimated
recoverable amount the assets are written down to their recoverable amount. The
recoverable amount of plant and equipment is the greater of the fair value less
costs to sell and value in use.
F-9
(i) Goodwill
Goodwill on
acquisition is initially measured at cost, being the excess of the cost of the
business combination over the acquirers interest in the fair value of
identifiable assets, liabilities and contingent assets acquired. Following
initial recognition, goodwill is measured at cost less any accumulated
impairment losses. The basis for calculating possible impairment of goodwill is
set out in note 13.
Goodwill has
not been amortised since the implementation of AIFRS on July 1, 2004. Goodwill
is reviewed for impairment annually or more frequently if events or changes in
circumstances indicate that the carrying value may be impaired.
At the
acquisition date, any goodwill acquired is allocated to each of the cash-generating
units expected to benefit from the combinations synergies. Impairment is
determined by assessing the recoverable amount of the cash-generating unit to
which the goodwill relates.
Where the
recoverable amount of the cash-generating unit is less than the carrying
amount, an impairment loss is recognised.
Where goodwill
forms part of a cash-generating unit and part of the operation within that unit
is disposed of, the goodwill associated with the operation disposed of is
included in the carrying amount of the operation when determining the gain or
loss on disposal of the operation.
Goodwill
disposed of in this circumstance is measured on the basis of the relative
values of the operation disposed of and the portion of the cash-generating unit
retained.
(j) Research costs
Research costs
are expensed as incurred.
(k) Impairment of assets
At each
reporting date, the Group assesses whether there is any indication that an
asset may be impaired. Where an indicator of impairment exists, the Group makes
a formal estimate of the recoverable amount. Where the carrying amount of an
asset exceeds its recoverable amount the asset is considered impaired and is
written down to its recoverable amount.
An assets
recoverable amount is the higher of its fair value less costs to sell and its
value in use and is determined for an individual asset, unless the asset does
not generate cash inflows that are largely independent of those from other
assets or group of assets and the assets value in use cannot be estimated to
be close to its fair value. In such cases the asset is tested for impairment as
part of the cash generating unit to which it belongs. When the carrying amount
of an asset or cash-generating unit exceeds its recoverable amount, the asset
or cash-generating unit is considered impaired and is written down to its
recoverable amount.
In assessing
value in use, the estimated future cash flows are discounted to their present
value using a pre-tax discount rate that reflects current market assessments of
the time value of money and the risks specific to the asset.
(l) Pension and post-employment benefits
T
he Group makes contributions to external
superannuation funds in accordance with existing employment contracts and to
meet its obligations under Australian taxation law.
The Group has
no liabilities or commitments for post employment benefits for any employee as
at June 30, 2007.
(m) Employee benefits
Provision is
made for employee benefits accumulated as a result of employees rendering
services up to the reporting date. These benefits include wages and salaries,
annual leave and long service leave.
Liabilities
arising in respect of wages and salaries, annual leave and other employee
entitlements expected to be settled within twelve months of the reporting date
are measured based on remuneration rates which are expected to be paid when the
liability is settled. All other employee entitlement liabilities are measured
at the present value of the estimated future cash outflow to be made in respect
of services provided by employees up to the reporting date. In determining the
present value of the future cash outflows, the interest rates attaching to
government guaranteed securities which have terms to maturity approximating the
terms of the related liability are used.
F-10
(n) Share-based payment transactions
The Group may
provide benefits to employees (including directors), consultants and suppliers
of the Group in the form of share-based payment transactions, whereby employees
render services in exchange for shares or rights to purchase shares (equity
settled transactions). These benefits may be provided under the Employee Share
Option Plan (ESOP) or by issues approved at General Meetings of Shareholders.
The cost of
equity-settled transactions is measured by reference to the fair value at the
date at which they are granted. The fair value is determined using the Black
Scholes option pricing model. In valuing equity-settled transactions, no
account is taken of any performance conditions, other than conditions linked to
the price of the shares of ChemGenex Pharmaceuticals Limited (market
conditions).
The cost of
equity-settled transactions is recognised, together with a corresponding
increase in equity, over the period in which the performance conditions are
fulfilled, ending on the date on which the recipients become entitled to the
award (vesting date).
The cumulative
expense recognised for equity-settled transactions at each reporting date until
vesting date reflects:
(i)
the extent to which the vesting
period has expired, and
(ii)
the number of awards that, in the
opinion of the directors of the Group, will ultimately vest.
This opinion
is formed based on the best available information at balance date. No
adjustment is made for the likelihood of market performance conditions being
met as the effect of these conditions is included in the determination of fair
value at grant date.
Where the
terms of an equity-settled award are modified, as a minimum an expense is
recognised as if the terms had not been modified. In addition, an expense is
recognised for any increase in the value of the transaction as a result of the
modification, as measured at the date of modification.
Where an
equity-settled award is cancelled, it is treated as if it had vested on the
date of cancellation, and any expense not yet recognised for the award is
recognised immediately. However, if a new award is substituted for the
cancelled award, and designated as a replacement award on the date that it is
granted, the cancelled and new award are treated as if they were a modification
of the original award, as described in the previous paragraph.
(o) Leases
Leases where
the lessor retains substantially all of the risks and benefits of ownership of
the assets are classified as operating leases. Operating lease payments are
recognised as an expense in the income statement on a straight-line basis over
the lease term.
(p) Trade and payables
Liabilities
for trade creditors and other amounts are carried at cost which is fair value
of the consideration to be paid in the future for goods and services, whether
or not billed to the Group.
(q) Issued Capital
Issued and
paid up capital is recognised at the fair value of the consideration received
by the Group and is classified as equity.
Any
transaction costs arising on the issue of ordinary shares are recognised
directly in equity as a reduction of the share proceeds received.
(r) Revenue recognition
a) Research revenue
Revenue under research collaboration agreements is recognised as earned
on a straight-line basis over the life of the respective agreement as this
reflects the level of effort required over the performance period. These
agreements are performed on a best efforts basis with no guarantees of either
technical or commercial success. Project funding received in advance of the
period in which the associated research efforts are performed is included in
deferred revenue.
b) Interest
Interest income is recognised as interest accrues using the effective
interest method, which is the rate that exactly discounts estimated future cash
receipts through the expected life of the financial asset to the net carrying
amount of the financial asset.
F-11
c) Patent reimbursement
Patent reimbursement comprises amounts received in accordance with
partnership agreements for patent costs incurred by the Group in conjunction
with specified research projects. The revenue is recognised when the
reimbursable expense is incurred and approved in accordance with the agreement.
d) Government grants
Revenue from government grants is recognised when received and all
attaching conditions have been complied with.
When the grant relates to an expense item, it is recognised as income
over the periods necessary to match the grant on a systematic basis to the
costs that it is intended to compensate.
e) Reimbursement of initial NASDAQ expenses
Under an agreement with the Bank of New York ChemGenex was reimbursed for
some costs associated with obtaining the initial NASDAQ listing. The revenue
was recognised when the reimbursable expenses were incurred in accordance with
the agreement.
(s) Loss per share
Basic loss per share is determined by dividing the loss after income tax
by the weighted average number of ordinary shares, outstanding during the
period.
The computation of diluted loss per share is similar to basic loss per
share, except that it assumes the potentially dilutive securities, such as
share options, were converted to shares as of the beginning of the period. For
all periods presented, diluted loss per share is equivalent to basic loss per
share as the potentially dilutive securities are excluded from the computation
of diluted loss per share because the effect is anti-dilutive.
(t) Income taxes
Deferred income tax assets and liabilities are measured at the tax rates
that are expected to apply to the year when the asset is realised or the
liability is settled, based on tax rates that have been enacted or
substantively enacted at the balance sheet date.
Deferred income tax assets have not been recognised as it is not
considered probable that taxable profit will be available against which
deductible temporary differences, and the carry-forward of unused tax assets
and unused tax losses can be utilised.
(u) Other taxes
Revenues, expenses and assets are recognised net of the amount of GST
except:
where the GST incurred on a
purchase of goods and services is not recoverable from the taxation authority,
in which case the GST is recognised as part of the cost of acquisition of the
asset or as part of the expense item as applicable; and
receivables and payables are
stated with the amount of GST included.
The net amount of GST recoverable from, or payable to, the taxation
authority is included as part of receivables or payables in the consolidated
Balance Sheet.
Cash flows are included in the consolidated Cash Flow Statement on a
gross basis and the GST component of cash flows arising from investing and
financing activities, which is recoverable from, or payable to, the taxation
authority are classified as operating cash flows.
Commitments and contingencies are disclosed net of the amount of GST
recoverable from, or payable to, the taxation authority.
(v) Impact of adoption of AIFRS
For
all periods up to and including the year ended June 30, 2005, the Group
prepared its financial statements in accordance with Australian generally
accepted accounting practice (AGAAP). The financial statements for the year
ended June 30, 2006 were the first the Group was required to prepare in
accordance with AIFRS.
Accordingly
the Group prepared financial statements that comply with AIFRS applicable for
periods beginning after January 1, 2005 and the significant accounting policies
meeting those requirements are described in note 2. In preparing the financial
statements, the Group has started from an opening balance sheet as at July 1,
2004 the Groups date of transition to AIFRS, and made those changes in accounting
policies and other restatements required by AASB 1 First-time adoption of
AIFRS.
This
note explains the principal adjustments made by the Group in restating its
AGAAP balance sheet as at July 1, 2004 and its previously published AGAAP
financial statements for the year ended June 30, 2005.
F-12
Exemptions
applied
AASB
1 allows first-time adopters certain exemptions from the general requirement to
apply AIFRS retrospectively.
The
Group has taken the following exemptions:
AASB 2
Share-based Paymen
t has not been applied to any equity
instruments that were granted on or before November 7, 2002, nor has it been
applied to equity instruments granted after November 7, 2002 that vested before
January 1, 2005.
AASB 3
Business Combinations
has not been applied to acquisitions
of subsidiaries that occurred before July 1, 2004.
Explanation
of material adjustments to the cash flow statement
There
are no material differences between the cash flow statement presented under
AIFRS and the cash flow statement presented under previous AGAAP.
The
impacts of adopting AIFRS on the total equity and profit after tax as reported
under AGAAP are illustrated below.
(i)
Reconciliation of total equity as presented under AGAAP to that under AIFRS
|
|
June 30, 2005
|
|
July 1, 2004
|
|
|
|
$
|
|
$
|
|
Total
equity under AGAAP
|
|
24,387,320
|
|
16,713,018
|
|
|
|
|
|
|
|
Adjustments
to equity-
|
|
|
|
|
|
Write-back
of goodwill-amortisation (A)
|
|
848,128
|
|
|
|
|
|
|
|
|
|
Total
equity under AIFRS
|
|
25,235,448
|
|
16,713,018
|
|
(A)
Under AASB 3
Business
Combination
Goodwill is not amortised as impairment is expensed when
it is identified. Under AGAAP Goodwill was expensed over 20 years. The
Amortisation of Goodwill charged after July 1, 2004 has been reversed under
AIFRS.
(ii)
Reconciliation of loss after tax under AGAAP to that under AIFRS
June 30, 2005
|
|
Consolidated
|
|
|
|
$
|
|
Loss
after tax as previously reported
|
|
(6,661,206
|
)
|
|
|
|
|
Write-back
of goodwill-amortisation (A)
|
|
848,128
|
|
Recognition
of share-based payment expense (B)
|
|
(422,105
|
)
|
|
|
|
|
Loss
after tax under AIFRS
|
|
(6,235,183
|
)
|
(A)
Under AASB 3
Business Combination
Goodwill is not amortised as
impairment is expensed when it is identified. Under AGAAP Goodwill was expensed
over 20 years. The Amortisation of Goodwill charged after July1, 2004 has been
reversed under AIFRS.
(B)
Share-based payment costs are charged to the
income statement under AASB 2
Share-Based Payments
,
but not under AGAAP.
F-13
3. SEGMENT INFORMATION
The Group
performs biotechnology research.
Following the
acquisition of ChemGenex Therapeutics Inc. in June 2004 the groups operations
have been conducted in Australia and the United States of America.
Discovery and clinical research activities in oncology are managed at the
Groups American offices in Menlo Park, California.
Discovery into metabolic syndrome and depression are managed at the Groups
Australian offices in Geelong, Victoria.
JUNE 30, 2007
|
|
Australia
|
|
United States of
America
|
|
Total
|
|
|
|
$
|
|
$
|
|
$
|
|
Revenue
|
|
|
|
|
|
|
|
Research
revenue
|
|
536,111
|
|
|
|
536,111
|
|
Finance
revenue
|
|
642,910
|
|
219,186
|
|
862,096
|
|
Other
revenue
|
|
889,927
|
|
|
|
889,927
|
|
Inter-segment sales
|
|
|
|
5,566,298
|
|
5,566,298
|
|
Total
segment revenue
|
|
2,068,948
|
|
5,785,484
|
|
7,854,432
|
|
Inter-segment
elimination
|
|
|
|
(5,566,298
|
)
|
(5,566,298
|
)
|
Total
consolidated revenue
|
|
2,068,948
|
|
219,186
|
|
2,288,134
|
|
Result
|
|
|
|
|
|
|
|
Segment
result
|
|
(11,598,108
|
)
|
5,784,991
|
|
(5,813,117
|
)
|
Income
tax expense
|
|
|
|
(321,504
|
)
|
(321,504
|
|
Inter-segment
elimination
|
|
|
|
(5,566,298
|
)
|
(5,566,298
|
)
|
Net
loss for the year
|
|
(11,598,108
|
)
|
(102,811
|
)
|
(11,700,919
|
)
|
Assets and liabilities
|
|
|
|
|
|
|
|
Segment
assets
|
|
38,354,678
|
|
7,714,880
|
|
46,069,558
|
|
Inter-segment
elimination
|
|
|
|
(3,308,449
|
)
|
(3,308,449
|
)
|
Total
consolidated assets
|
|
38,354,678
|
|
4,406,431
|
|
42,761,109
|
|
|
|
|
|
|
|
|
|
Segment
liabilities
|
|
4,892,081
|
|
1,307,879
|
|
6,199,960
|
|
Inter-segment
elimination
|
|
(3,308,449
|
)
|
|
|
(3,308,449
|
)
|
Total
consolidated liabilities
|
|
1,583,632
|
|
1,307,879
|
|
2,891,511
|
|
|
|
|
|
|
|
|
|
Cash flow information
|
|
|
|
|
|
|
|
Net
operating cash flows
|
|
(7,839,297
|
)
|
(4,066,308
|
)
|
(11,905,605
|
)
|
Net
investing cash flows
|
|
634,611
|
|
203,415
|
|
838,026
|
|
Net
financing cash flows
|
|
13,681,152
|
|
7,199,293
|
|
20,880,445
|
|
Net
increase in cash and cash equivalents
|
|
6,476,466
|
|
3,336,400
|
|
9,812,866
|
|
Other segment information
|
|
|
|
|
|
|
|
Capital
expenditure
|
|
8,299
|
|
15,771
|
|
24,070
|
|
Depreciation
|
|
260,528
|
|
10,816
|
|
271,344
|
|
Inter-segment revenue
in 2007 relates to revenues associated with work undertaken by ChemGenex
Pharmaceuticals Inc. under a Research Services Agreement with ChemGenex
Pharmaceuticals Limited which is invoiced at cost plus a 15% margin for certain
costs.
F-14
JUNE 30, 2006
|
|
Australia
|
|
United States of
America
|
|
Total
|
|
|
|
$
|
|
$
|
|
$
|
|
Revenue
|
|
|
|
|
|
|
|
Research
revenue
|
|
1,676,297
|
|
|
|
1,676,297
|
|
Finance
revenue
|
|
241,591
|
|
43
|
|
241,634
|
|
Other
revenue
|
|
379,091
|
|
|
|
379,091
|
|
Inter-segment sales
|
|
|
|
13,471,642
|
|
13,471,642
|
|
Total
segment revenue
|
|
2,296,979
|
|
13,471,685
|
|
15,768,664
|
|
Inter-segment
elimination
|
|
|
|
(13,471,642
|
)
|
(13,471,642
|
)
|
Total
consolidated revenue
|
|
2,296,979
|
|
43
|
|
2,297,022
|
|
Result
|
|
|
|
|
|
|
|
Segment
result
|
|
(6,085,764
|
)
|
9,187,687
|
|
3,101,923
|
|
Inter-segment
elimination
|
|
|
|
(13,471,642
|
)
|
(13,471,642
|
)
|
Net
loss for the year
|
|
(6,085,764
|
)
|
(4,283,955
|
)
|
(10,369,719
|
)
|
Assets and liabilities
|
|
|
|
|
|
|
|
Segment
assets
|
|
32,159,526
|
|
7,768,644
|
|
39,928,170
|
|
Inter-segment
elimination
|
|
|
|
(6,962,919
|
)
|
(6,962,919
|
)
|
Total
consolidated assets
|
|
32,159,526
|
|
805,725
|
|
32,965,251
|
|
|
|
|
|
|
|
|
|
Segment
liabilities
|
|
8,415,744
|
|
507,517
|
|
8,923,261
|
|
Inter-segment
elimination
|
|
(6,962,919
|
)
|
|
|
(6,962,919
|
)
|
Total
consolidated liabilities
|
|
1,452,825
|
|
507,517
|
|
1,960,342
|
|
|
|
|
|
|
|
|
|
Cash flow information
|
|
|
|
|
|
|
|
Net
operating cash flows
|
|
(4,483,040
|
)
|
(4,002,578
|
)
|
(8,485,618
|
)
|
Net
investing cash flows
|
|
235,625
|
|
(7,987
|
)
|
227,638
|
|
Net
financing cash flows
|
|
10,758,207
|
|
4,541,517
|
|
15,299,724
|
|
Net
increase in cash and cash equivalents
|
|
6,510,792
|
|
530,952
|
|
7,041,744
|
|
Other segment information
|
|
|
|
|
|
|
|
Capital
expenditure
|
|
5,956
|
|
8,040
|
|
13,996
|
|
Depreciation
|
|
259,677
|
|
12,521
|
|
272,198
|
|
Inter-segment revenue in 2006 relates to revenues
associated with the transfer of Intellectual property under a Sale of
Intellectual Property Agreement between ChemGenex Pharmaceuticals Inc. and
ChemGenex Pharmaceuticals Limited.
F-15
4. REVENUES AND EXPENSES
JUNE 30
|
|
Notes
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
(a)
Other Income
|
|
|
|
|
|
|
|
|
|
Export
market development grant
|
|
|
|
74,290
|
|
148,868
|
|
|
|
P3
grant
|
|
|
|
655,809
|
|
|
|
|
|
Patent
reimbursement
|
|
|
|
|
|
230,223
|
|
104,085
|
|
Exchange
rate benefit
|
|
|
|
157,917
|
|
|
|
|
|
Reimbursement
of initial NASDAQ expenses
|
|
|
|
|
|
|
|
196,902
|
|
VAT
refund
|
|
|
|
1,911
|
|
|
|
|
|
|
|
|
|
889,927
|
|
379,091
|
|
300,987
|
|
|
|
|
|
|
|
|
|
|
|
(b)
Finance income
|
|
|
|
|
|
|
|
|
|
Bank
interest received
|
|
|
|
862,096
|
|
241,634
|
|
266,987
|
|
|
|
|
|
|
|
|
|
|
|
(c)
Employee benefits expense
|
|
|
|
|
|
|
|
|
|
Wages
and salaries
|
|
|
|
(1,837,968
|
)
|
(1,927,841
|
)
|
(1,834,591
|
)
|
Workers
compensation costs
|
|
|
|
(13,005
|
)
|
(7,240
|
)
|
(15,630
|
)
|
Expense
of share-based payments
|
|
|
|
(270,553
|
)
|
(467,895
|
)
|
(422,104
|
)
|
Superannuation
costs
|
|
|
|
(93,805
|
)
|
(76,755
|
)
|
(81,708
|
)
|
Wages
on-costs
|
|
|
|
(302,584
|
)
|
(230,610
|
)
|
(277,829
|
)
|
|
|
|
|
(2,517,915
|
)
|
(2,710,341
|
)
|
(2,631,862
|
)
|
|
|
|
|
|
|
|
|
|
|
(d)
Research costs
|
|
|
|
|
|
|
|
|
|
Metabolic
syndrome
|
|
|
|
(3,221,386
|
)
|
(3,479,875
|
)
|
(3,685,119
|
)
|
Depression
|
|
|
|
(190,000
|
)
|
(380,000
|
)
|
(380,000
|
)
|
Oncology
|
|
|
|
(4,320,602
|
)
|
(3,325,103
|
)
|
(556,287
|
)
|
|
|
|
|
(7,731,988
|
)
|
(7,184,978
|
)
|
(4,621,406
|
)
|
|
|
|
|
|
|
|
|
|
|
(e)
Operating lease costs
|
|
|
|
(80,282
|
)
|
(89,698
|
)
|
(75,201
|
)
|
F-16
5. INCOME TAX
JUNE 30
|
|
Notes
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
A reconciliation of income tax expense applicable to accounting
profit before income tax and income tax expense for the years ended June
2007, 2006 and 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
Accounting
loss before income tax
|
|
|
|
(11,379,415
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
|
|
|
|
|
|
|
|
|
|
Tax
at statutory rates (30% Australia, 34% USA)
|
|
|
|
(3,465,018
|
)
|
(3,265,930
|
)
|
(1,946,294
|
)
|
Research
and development allowance
|
|
|
|
(283,829
|
)
|
(321,077
|
)
|
(308,884
|
)
|
Internal
intellectual property transfer eliminated on consolidation but taxable in USA
|
|
|
|
|
|
4,580,358
|
|
|
|
Non-deductible
items-
|
|
|
|
|
|
|
|
|
|
Increase
in employee entitlements
|
|
|
|
34,233
|
|
|
|
|
|
Entertainment
expenses
|
|
|
|
8,979
|
|
|
|
|
|
NASDAQ
registration
|
|
|
|
|
|
|
|
214,400
|
|
Equity
based benefits
|
|
|
|
130,943
|
|
251,837
|
|
126,631
|
|
Other
differences
|
|
|
|
(29,381
|
)
|
|
|
|
|
Adjustment
in respect of current income tax in previous year
|
|
|
|
341,691
|
|
|
|
|
|
|
|
|
|
(3,262,382
|
)
|
1,245,188
|
|
(1,914,147
|
)
|
Future
income tax benefits not recognised
|
|
|
|
3,583,886
|
|
(1,245,188
|
)
|
1,914,147
|
|
Income
tax expense reported in income statement
|
|
|
|
321,504
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Future
income tax benefit arising from tax losses of the parent and a controlled
entity not recognised at reporting date as realisation of the benefit is not
regarded as probable.
|
|
|
|
|
|
|
|
|
|
|
Revenue
losses
|
|
|
|
17,462,021
|
|
13,878,135
|
|
15,123,323
|
|
Capital
gains tax losses
|
|
|
|
436,439
|
|
436,439
|
|
436,439
|
|
|
|
|
|
17,989,460
|
|
14,314,574
|
|
15,559,762
|
|
This future
income tax benefit will only be obtained if:
(a) future assessable income is derived
of a nature and of an amount sufficient to enable the benefit to be realised;
(b) the conditions for deductibility
imposed by tax legislation continue to be complied with; and
(c) no changes in tax legislation
adversely affect the consolidated entity in realising the benefit.
Deferred income tax liabilities
At June 30, 2007 there is no recognised or unrecognised deferred income
tax liabilities included (2006: $nil).
Tax consolidation
Effective July 1, 2003, for the purposes of income taxation, ChemGenex
Pharmaceuticals Limited and its 100% owned Australian subsidiary formed a tax
consolidated group. Members of the group have entered into a tax sharing
arrangement in order to allocate income tax expense to the wholly-owned
Australian subsidiary on a pro-rata basis. In addition, the agreement provides
for the allocation of income tax liabilities between the entities should the
head entity default on its tax payment obligations. At the balance date, the
possibility of default is remote. The head entity of the tax consolidated group
is the Parent Entity.
Tax effect accounting by members
of the tax consolidated group
Members of the
tax consolidated group have entered into a tax funding agreement. The tax
funding agreement provides for the allocation of current taxes to members of
the tax consolidated group in accordance with their accounting profit for the
period, while deferred taxes are allocated to members of the tax consolidated
group in accordance with the principles of AASB 112
Income taxes
.
Refer to note 26(e) for additional income tax disclosures.
F-17
6. LOSS PER SHARE
Basic loss per
share is determined by dividing the loss after income tax by the weighted
average number of ordinary shares, outstanding during the period.
The computation
of diluted loss per share is similar to basic loss per share, except that it
assumes the potentially dilutive securities, such as share options, were
converted to shares as of the beginning of the period. For all periods
presented, diluted loss per share is equivalent to basic loss per share as the
potentially dilutive securities are excluded from the computation of diluted
loss per share because the effect is ant-dilutive.
The following
reflects the income and share data used in the earnings per share computations:
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Net
loss attributable to ordinary shareholders
|
|
(11,700,919
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
|
|
|
|
|
|
|
|
|
|
Number of shares
2007
|
|
Number of shares
2006
|
|
Number of shares
2005
|
|
Weighted
average number of ordinary shares used in calculating earnings per share:
|
|
162,281,115
|
|
117,647,158
|
|
105,707,630
|
|
There have
been no other transactions involving ordinary shares or potential ordinary
shares since the reporting date and before the completion of these financial
statements.
7. DIVIDENDS PAID AND PROPOSED
There were no
dividends paid or proposed during the year ended June 30, 2006 and there have
been no dividends paid or proposed since reporting date and before the
completion of these financial statements.
8.
CASH AND CASH EQUIVALENTS
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Cash
at bank and at hand
|
|
25,366,562
|
|
15,553,696
|
|
8,511,952
|
|
Cash
at bank earns interest at floating rates based on daily bank deposits
|
|
|
|
|
|
|
|
Reconciliation of the net loss after tax to the net cash flows from
operations
|
|
|
|
|
|
|
|
Net
loss
|
|
(11,700,919
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
Adjustments for
|
|
|
|
|
|
|
|
Depreciation
of plant and equipment
|
|
271,344
|
|
272,198
|
|
269,937
|
|
Interest
received
|
|
(862,096
|
)
|
(241,634
|
)
|
(266,987
|
)
|
Share
options expensed
|
|
436,477
|
|
839,456
|
|
495,029
|
|
Net
exchange differences
|
|
(751,314
|
)
|
|
|
|
|
Changes in assets and liabilities
|
|
|
|
|
|
|
|
(Increase)/decrease
in trade and other receivables
|
|
61,011
|
|
302,516
|
|
(351,086
|
)
|
(Increase)/decrease
in prepayments
|
|
(291,277
|
)
|
91,399
|
|
(74,751
|
)
|
Increase/(decrease)
in trade payables
|
|
823,605
|
|
866,873
|
|
(1,238,419
|
)
|
Increase
in provisions and employee entitlements
|
|
127,480
|
|
33,754
|
|
119,351
|
|
Increase/(decrease
in deferred income)
|
|
(19,684
|
)
|
(280,461
|
)
|
337,923
|
|
Net
cash flow used in operating activities
|
|
(11,905,605
|
)
|
(8,485,618
|
)
|
(6,944,186
|
)
|
F-18
9. TRADE AND OTHER RECEIVABLES (CURRENT)
JUNE 30,
|
|
Notes
|
|
2007
|
|
2006
|
|
|
|
|
|
$
|
|
$
|
|
Trade
debtors
|
|
(i)
|
|
18,000
|
|
|
|
Other
debtors
|
|
(ii)
|
|
|
|
79,011
|
|
|
|
|
|
18,000
|
|
79,011
|
|
Terms and conditions
Terms and
conditions relating to the above financial instruments:-
(i) Trade debtors are non-interest
bearing and generally on 30 day terms.
(ii) Other debtors and other receivables
are non-interest bearing and have repayment terms between 30 and 90 days.
10. CONSOLIDATED SUBSIDIARIES
|
|
|
|
Percentage of equity interest held by the consolidated entity
|
|
Name
|
|
Country of
incorporation
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
%
|
|
%
|
|
%
|
|
Autogen
Research Pty Ltd
|
|
Australia
|
|
100
|
|
100
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
ChemGenex
Pharmaceuticals Inc.
|
|
USA
|
|
100
|
|
100
|
|
100
|
|
F-19
11. PLANT AND EQUIPMENT
|
|
2007
|
|
2006
|
|
|
|
|
|
$
|
|
$
|
|
|
|
Carrying amount
|
|
|
|
|
|
|
|
Office
equipment
|
|
|
|
|
|
|
|
At
cost
|
|
116,403
|
|
92,333
|
|
|
|
Accumulated
depreciation
|
|
(75,665
|
)
|
(56,345
|
)
|
|
|
|
|
40,738
|
|
35,988
|
|
|
|
Research
equipment
|
|
|
|
|
|
|
|
At
cost
|
|
1,604,036
|
|
1,604,036
|
|
|
|
Accumulated
depreciation
|
|
(1,563,228
|
)
|
(1,311,204
|
)
|
|
|
|
|
40,808
|
|
292,832
|
|
|
|
Total
plant and equipment
|
|
81,546
|
|
328,820
|
|
|
|
|
|
|
|
|
|
|
|
Total
plant and equipment
|
|
|
|
|
|
|
|
At
cost
|
|
1,720,439
|
|
1,696,369
|
|
|
|
Accumulated
depreciation
|
|
(1,638,893
|
)
|
(1,367,549
|
)
|
|
|
Total net carrying amount
|
|
81,546
|
|
328,820
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliations
|
|
|
|
|
|
|
|
Reconciliations
of the carrying amounts of plant and equipment at the beginning and end of
the financial year
|
|
|
|
|
|
|
|
Office
equipment
|
|
|
|
|
|
|
|
Carrying amount at beginning
|
|
35,988
|
|
42,166
|
|
44,861
|
|
Additions
at cost
|
|
24,070
|
|
13,996
|
|
15,218
|
|
Depreciation
expense
|
|
(19,320
|
|
(20,174
|
)
|
(17,913
|
)
|
Carrying
amount at the end of year
|
|
40,738
|
|
35,988
|
|
42,166
|
|
|
|
|
|
|
|
|
|
Research
equipment
|
|
|
|
|
|
|
|
Carrying amount at beginning
|
|
292,832
|
|
544,856
|
|
796,880
|
|
Additions
at cost
|
|
|
|
|
|
|
|
Depreciation
expense
|
|
(252,024
|
)
|
(252,024
|
)
|
(252,024
|
)
|
Carrying
amount at the end of year
|
|
40,808
|
|
292,832
|
|
544,856
|
|
F-20
12.
GOODWILL
|
|
2007
|
|
2006
|
|
|
|
$
|
|
$
|
|
Carrying amount
|
|
|
|
|
|
At
cost
|
|
16,962,561
|
|
16,962,561
|
|
Accumulated
amortisation
|
|
(30,811
|
)
|
(30,811
|
)
|
|
|
16,931,750
|
|
16,931,750
|
|
Goodwill
represents the intellectual property previously held by ChemGenex Therapeutics
Inc. This intellectual property relates to chemical compounds which have not
yet received regulatory approval, and therefore a finite life for any products
associated with these compounds cannot be determined.
As at June 30,
2007 and 2006, these assets were tested for impairment (see note 13 below).
No impairment
loss was charged for the years ended June 30, 2007 and 2006.
13. IMPAIRMENT TESTING OF GOODWILL
The goodwill
acquired through a business combination of $16.932M relates to one individual
cash generating unit, being anti-cancer compounds.
The
recoverable amount of the anti-cancer compounds have been determined based on a
value in use calculation using cash flow projections based on financial
budgets, information from scientific journals on the existing incidence of the
disease, projections of patients that would be eligible for the proposed
treatment and the expected growth figures.
The valuation
has been based on cash flow projection covering 10 years from the expected
registration date after which a 10% decline in cash flow rate is assumed. A 10
year cash flow projection of revenues has been used to reflect the expected
increasing market share over the period.
The
calculation of value in use for the anti-cancer compounds is most sensitive to
the following assumptions-
Availability of patients
Discount rate
Raw material costs
Indirect costs
The
availability of patients is dependent upon the incidence of the disease
(estimated determined from scientific journals) from projections of the likely
use of the products (based on the current status of alternative treatments).
Due to the
uncertainty associated with cash flow projections for products that have not
yet received regulatory approval a pre-tax discount rate of 40% has been
applied (2006:40%).
Raw materials
costs used in the projection are based on the existing manufacturing agreement
with Stragen.
Indirect costs
have been based on industry standards for companies with pharmaceutical
products in the market as costs structures in the companys current development
stage are not deemed to be appropriate.
14. SHARE BASED PAYMENT PLANS
Employee Share Option Scheme
An Employee
Share Option Plan (ESOP) has been established where ChemGenex Pharmaceuticals
Limited may, at the discretion of management, grant options over the ordinary
shares of ChemGenex Pharmaceuticals Limited to directors, executives and
certain contractors who provide consulting services to the Group.
The options,
issued for nil consideration, are granted in accordance with performance
guidelines established by the directors of ChemGenex Pharmaceuticals Limited,
who retain the final discretion on the issue of the options. The options cannot
be transferred and will not be quoted on the ASX. Currently one director, three
employees and 22 scientific consultants hold options issued under the ESOP.
F-21
On May 7, 2007
400,000 options with a fair value of $0.42 were granted over ordinary shares
with an exercise price of $0.85. These options vested upon issue and are
exercisable until May 7, 2010. (During the year ended June 30, 2006, 275,000
options with a fair value of $0.35 were granted over ordinary shares with an
exercise price of $0.43 and 269,500 options with a fair value of $0.36 were
granted over ordinary shares with an exercise price of $0.65. These options
vested upon issue and are exercisable until March 2010.)
On June 6,
2007, 600,000 options with a fair value of $0.55 were issued over ordinary
shares with an exercise price of $0.50. These options vested upon issue and are
exercisable until June 6, 2012. These options were issued under a contract
entered into by the Company with Global Markets Capital Group LLC (GMCG)
dated April 1, 2002 and amended April 1, 2003.
The fair value
of the options issued under ESOP are estimated at the date of grant using the
Black Scholes Valuation Method. The following table gives the assumptions made
in determining fair value of options granted during the year ending June 30,
2007, 2006 and 2005.
|
|
2007
|
|
2006
|
|
2005
|
|
Dividend
yield (%)
|
|
0.00
|
|
0.00
|
|
0.00
|
|
Expected
volatility (%)
|
|
70.00
|
|
70.00
|
|
65.00
|
|
Risk-free
interest rate (%)
|
|
5.25
|
|
5.40
|
|
5.17
|
|
Expected
life of options (years)
|
|
3-5
|
|
4.1 4.5
|
|
5.3
|
|
Option
exercise price ($)
|
|
0.85
and 0.50
|
|
0.43 and
0.65
|
|
0.56
|
|
Share
price at grant date ($)
|
|
0.85
and 0.78
|
|
0.54 and
0.64
|
|
0.63
|
|
When
calculating the expected life of the options it is assumed the options will not
be exercised until the expiry date.
The expected
volatility rates used reflect the assumption that historical volatility is
indicative of future trends and may not necessarily be the actual outcome.
Other than the
assumptions outlined above no other features of the options granted were
incorporated into the measurement of fair value.
During the
year ended June 30, 2007 120,000 options were exercised over ordinary shares.
(2006: Nil) The market price for the companys ordinary fully share at the date
these options were issued was 80 cents.
The following
table illustrates the number and weighted average exercise prices (WAEP) of
share options issued under the ESOP:
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
Number
|
|
WAEP
|
|
Number
|
|
WAEP
|
|
Number
|
|
WAEP
|
|
Balance
at beginning of year
|
|
1,979,500
|
|
$
|
0.67
|
|
1,475,000
|
|
$
|
0.75
|
|
1,140,000
|
|
$
|
0.74
|
|
-
granted
|
|
1,000,000
|
|
$
|
0.64
|
|
544,500
|
|
$
|
0.54
|
|
360,000
|
|
$
|
0.56
|
|
-
forfeited
|
|
|
|
|
|
(40,000
|
)
|
$
|
0.52
|
|
|
|
|
|
-
exercised
|
|
(120,000
|
)
|
$
|
0.50
|
|
|
|
|
|
(25,000
|
)
|
$
|
0.50
|
|
Balance
at end of year
|
|
2,859,500
|
|
$
|
0.68
|
|
1,979,500
|
|
$
|
0.70
|
|
1,475,000
|
|
$
|
0.75
|
|
Exercisable
at end of year
|
|
2,244,500
|
|
$
|
0.58
|
|
1,364,500
|
|
$
|
0.53
|
|
1,160,000
|
|
$
|
0.52
|
|
The contractual life for the share options outstanding at June 30, 2007
is 5 years for 600,000 options issued to GMCG and 2 years and 9 months for the
remainder (2006: 3 years and 9 months for all options; 2005: 4 years and 9
months for all options).
F-22
Share options issued under ESOP and outstanding at the end of the year
have the following exercise prices:
Expiry date
|
|
Exercise price
|
|
Outstanding 2007
|
|
Outstanding 2006
|
|
|
|
$
|
|
|
|
|
|
March 24, 2010
|
|
1.15
|
|
400,000
|
|
400,000
|
|
March 24, 2010
|
|
0.90
|
|
215,000
|
|
215,000
|
|
March 24, 2010
|
|
0.50
|
|
140,000
|
|
190,000
|
|
March 24, 2010
|
|
0.50
|
|
210,000
|
|
280,000
|
|
March 24, 2010
|
|
0.56
|
|
350,000
|
|
350,000
|
|
March 24, 2010
|
|
0.43
|
|
275,000
|
|
275,000
|
|
March 24, 2010
|
|
0.65
|
|
269,500
|
|
269,500
|
|
May 7, 2010
|
|
0.85
|
|
400,000
|
|
|
|
June 6, 2012
|
|
0.50
|
|
600,000
|
|
|
|
Options approved by resolution of shareholders
The following
table summarises information about options previously issued to Dr Greg Collier
on different terms and conditions to ESOP after approval by resolution at
shareholder meetings-
Number of
options
|
|
Grant date
(date issue approved by
shareholders)
|
|
Vesting date
|
|
Expiry date
|
|
Exercise
price $
|
|
Fair Value$
|
|
300,000
|
|
November 28,
2002
|
|
November 28,
2002
|
|
March 24,
2010
|
|
0.50
|
|
0.36
|
|
300,000
|
|
November 21,
2003
|
|
November 21,
2003
|
|
December 26,
2006
|
|
0.30
|
|
0.34
|
|
1,000,000
|
|
June 21,
2004
|
|
June 21, 2004
|
|
March 24,
2010
|
|
0.50
|
|
0.35
|
|
1,000,000
|
|
June 21,
2004
|
|
June 21,
2006
|
|
March 24,
2010
|
|
0.50
|
|
0.35
|
|
500,000
|
|
June 21,
2004
|
|
June 21,
2007
|
|
March 24,
2010
|
|
0.50
|
|
0.35
|
|
500,000
|
|
June 21,
2004
|
|
June 21,
2008
|
|
March 24,
2010
|
|
0.50
|
|
0.35
|
|
No options
were issued to Greg Collier during the years ended June 30, 2007 or 2006.
400,000
options issued with shareholder approval were exercised during the year ended
June 30, 2007 (2006:Nil) The market price for the companys ordinary fully paid
shares at the date these options were issued was 58 cents for 300,000 and 80
cents for 100,000.
The following share options
issued to Dr Greg
Collier after approval by resolution at shareholder meetings remain outstanding at the end of the year
-
Number of options
|
|
Grant date
(date issue
approved by
shareholders)
|
|
Vesting date
|
|
Expiry date
|
|
Exercise price $
|
|
300,000
|
|
November 28,
2002
|
|
November 28,
2002
|
|
March 24,
2010
|
|
0.50
|
|
900,000
|
|
June 21,
2004
|
|
June 21,
2004
|
|
March 24,
2010
|
|
0.50
|
|
1,000,000
|
|
June 21,
2004
|
|
June 21,
2006
|
|
March 24,
2010
|
|
0.50
|
|
500,000
|
|
June 21,
2004
|
|
June 21,
2007
|
|
March 24,
2010
|
|
0.50
|
|
500,000
|
|
June 21,
2004
|
|
June 21,
2008
|
|
March 24,
2010
|
|
0.50
|
|
F-23
The fair value
of the options issued to Greg Collier with Annual General Meeting (AGM)
approval under are estimated at the date of grant using the Black Scholes
Valuation Method. The following table gives the assumptions made in determining
fair value of these options-
|
|
November 2002
|
|
November 2003
|
|
June 2004
|
|
Dividend
yield (%)
|
|
0.00
|
|
0.00
|
|
0.00
|
|
Expected
volatility (%)
|
|
85.00
|
|
65.00
|
|
65.00
|
|
Risk-free
interest rate (%)
|
|
5.52
|
|
5.77
|
|
5.77
|
|
Expected
life of options (years)
|
|
7.33
|
|
3.0
|
|
5.75
|
|
Option
exercise price ($)
|
|
0.50
|
|
0.30
|
|
0.50
|
|
Share
price at grant date ($)
|
|
0.26
|
|
0.53
|
|
0.54
|
|
When
calculating the expected life of the options it is assumed the options will not
be exercised until the expiry date.
The expected
volatility rates used reflect the assumption that historical volatility is
indicative of future trends and may not necessarily be the actual outcome.
Other than the
assumptions outlined above no other features of the options granted were
incorporated into the measurement of fair value.
On November 16, 2005 shareholders approved the issue of 1,000,000 options
over ordinary shares to Stragen Investments B.V.
The options, with a fair value of $0.37, can be exercised from June 28,
2006 to June 27, 2008 at an exercise price of $0.75.
The fair value of these options has been calculated at grant date using
the Black Scholes Valuation Method with the following assumptions-
Dividend yield- 0%
Expected volatility- 70%
Risk-free interest rate 5.4%
Expected life of options- 3 years
Option exercise price- $0.75
Share price at issue date- $0.65
Options issued
to Global Markets Capital Corporation (June 6, 2007) and Stragen Investments
B.V. (November 16, 2005) have been valued using the Black Scholes method as the
fair value of the actual goods and services to be provided under these
contracts could not be reliably estimated and valued at the time of issue.
During the
year ended June 30, 2007 a total of $436,477 was recognised in the Consolidated
Statement of Income as share based expenditure of this $270,553 appeared as
Employee benefits expense (Note 4(c)) and $165,994 as administration costs. (2006:
$839,456; 2005: $422,105)
F-24
15.
TRADE AND OTHER PAYABLES
JUNE 30
|
|
2007
|
|
2006
|
|
|
|
$
|
|
$
|
|
|
|
|
|
|
|
Trade
creditors and other payables
|
|
2,445,470
|
|
1,621,865
|
|
|
|
2,2445,470
|
|
1,621,865
|
|
Trade payables
are non-interest bearing and are normally settled on 30 day terms.
As at June 30,
2007 the amount owing to related parties and included in Trade and other
payables was $4,494 (2005: $4,168). Refer to Note 25 for Related Party
Disclosures.
16.
EMPLOYEE ENTITLEMENTS
Current
|
|
|
|
|
|
Employee
entitlements
|
|
231,284
|
|
153,105
|
|
Non-current
|
|
|
|
|
|
Provision
for long service leave
|
|
33,222
|
|
|
|
|
|
264,506
|
|
153,105
|
|
17.
ISSUED CAPITAL AND RESERVES
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
Ordinary shares
|
|
Number of
shares
|
|
Number of
shares
|
|
Number of
shares
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued
and fully paid
|
|
185,847,331
|
|
151,362,786
|
|
114,797,616
|
|
120,773,060
|
|
99,892,615
|
|
84,592,891
|
|
|
|
Movements in shares on issue
|
|
|
|
Beginning
of the financial year
|
|
151,362,786
|
|
114,797,616
|
|
86,728,294
|
|
99,892,615
|
|
84,592,891
|
|
70,257,383
|
|
Issued
during the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
Shares issued for cash
|
|
34,484,545
|
|
36,565,170
|
|
27,934,244
|
|
21,260,131
|
|
15,723,021
|
|
14,451,937
|
|
- less
cost of share issues
|
|
|
|
|
|
|
|
(379,686
|
)
|
(423,297
|
)
|
(189,353
|
)
|
Fees
paid in lieu of cash
|
|
|
|
|
|
135,078
|
|
|
|
|
|
72,924
|
|
End
of the financial year
|
|
185,847,331
|
|
151,362,786
|
|
114,797,616
|
|
120,773,060
|
|
99,892,615
|
|
84,592,891
|
|
F-25
On July 14,
2004, the company issued 13,009,244 ordinary shares at an issue price of $0.48
each raising $6,244,437 for working capital and to further develop the companys
two anti-cancer compounds in Phase 2 clinical trials in the United States. This
issue was ratified by the Annual General Meeting of shareholders held on
November 23, 2004.
On January 24,
2005, the company issued 14,900,000 ordinary shares at an issue price of $0.55
each raising $8,195,000 to expedite the continued clinical trials for the
companys two anti-cancer compounds.
On February
14, 2005, the company issued 25,000 ordinary shares at an issue price of $0.50
each raising $12,500 upon the exercise of 25,000 options previously issued
under the ESOP.
In May 2006
Chemgenex Pharmaceuticals Limited announced a programme of share issues to
provide working capital and to continue the companys ongoing research
activities-
On May 18, 2006 16,700,000 ordinary shares were issued at 43 cents
each raising $7,181,000. This issue was ratified by an Extraordinary General
Meeting of shareholders held on June 16, 2006.
On June 1, 2006 1,665,170 ordinary shares were issued at 43 cents
raising $716,021 under a Share Placement Programme offered to all shareholders.
On June 16, 2006 18,200,000 ordinary shares were issued at 43 cents
per share raising $7,826,000 following approval by an Extraordinary General
Meeting of shareholders held on June 16, 2006.
On December
21, 2006 the company issued 300,000 ordinary shares at an issue price of $0.30
each raising $90,000 upon the exercise of 300,000 options previously issued
under the Employee Share Option Plan (ESOP) and approved at the Annual General
Meeting of Shareholders held on November 21, 2003.
In February
2007 Chemgenex Pharmaceuticals Limited announced a programme of share issues to
provide working capital and to continue the companys ongoing research
activities-
On February 8, 2007 17,056,377 ordinary shares were issued to
institutional investors at 62 cents each raising $10,574,954. In accordance
with ASX Listing Rules this issue is to be ratified by at the next Annual
General Meeting of shareholders.
On April 3, 2007 16,891,916 ordinary shares were issued at 62 cents
raising $10,472,988 under a 1:10 Rights Issue offered to all eligible
shareholders by prospectus dated February 26, 2007.
On February 8,
2007 (200,000) and April 24, 2007 (20,000), a total of 220,000 ordinary shares
at an issue price of $0.50 each raising $110,000 upon the exercise of 120,000
options previously issued under the Employee Share Option Plan (ESOP) and
100,000 approved at a previous Annual General Meeting of Shareholders.
A total of
16,252 ordinary shares [April 24, 2007 (1,778), May 17, 2007 (6,290) and June
27, 2007 (6,138)] were issued at a price of 75 cents each raising $12,189 upon
the exercise of CXSOA listed options issued as part of the 1:10 Rights Issue
prospectus.
Ordinary
shares have the right to receive dividends as declared and, in the event of
winding up the company, to participate in the proceeds from the sale of all
surplus assets in proportion to the number of and amounts paid up on shares
held.
Ordinary
shares entitle their holders to one vote per share, either in person or by
proxy, at a meeting of the company.
New ordinary
shares are issued whenever options are exercised.
Share
Options
(i)Listed
options
At June 30,
2007 there were 22,158,526 (2006: 22,158,526) unissued ordinary shares for
which options were outstanding exercisable at $1.25 per share expiring March
12, 2010. These options are listed under code CXSO on the ASX.
On February 8,
2007 ChemGenex Pharmaceuticals Limited issued 5,685,459 options to
institutional investors at an exercise price of $0.75 per share expiring on
February 8, 2012.These options were allocated at no cost, on a one option for
every three new ordinary shares issued basis to shareholders who participated
in the February 8 share issue. In accordance with ASX Listing Rules this issue
is to be ratified by at the next Annual General Meeting of shareholders.
On April 3,
2007 ChemGenex Pharmaceuticals Limited issued 5,631,013 options at an exercise
price of $0.75 per share expiring on February 8, 2012 associated
with 1:10 Rights Issue offered to all eligible shareholders by
prospectus dated February 26, 2007. These options were allocated at no cost, on
a one option for every three new ordinary shares issued basis to all
shareholders who participated in the Rights Issue.
At June 30,
2007 there were 11,300,200 (2006: Nil) unissued ordinary shares for which
options were outstanding exercisable at $0.75 per share expiring February 8,
2012. These options are listed under code CXSOA on the ASX.
F-26
Share
Options
(ii)Unlisted
Options
Employee
Share Plan Options (ESOP)
All employees
of the company and its controlled entities are eligible to receive options
under ESOP.
During the
financial year 1,000,000 options were issued over ordinary shares to employees
and consultants as set out in Note 14 (2006: 544,500). During the financial
year 120,000 options issued under ESOP were exercised (2006: Nil). During the
financial year no options previously under ESOP lapsed or were cancelled (2006:
40,000).
At the end of the year there were 2,859,500 (2006:
1,979,500) unissued ordinary shares in respect of which ESOP options were outstanding.
Options
approved at General Meetings of Shareholders
Separate
issues of other unlisted options have been approved by resolutions passed by
shareholders on November 28, 2002 (300,000 options) November 21, 2003 (300,000
options), June 21, 2004 (3,000,000 options) and November 16, 2005 (1,000,000
options) During the financial year 400,000 options issued following resolutions
of shareholders were exercised (2006: Nil).
At the end of
the year there were 4,200,000 (2006: 4,600,000) unissued ordinary shares in
respect of which these options were outstanding.
JUNE 30
|
|
Notes
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
$
|
|
$
|
|
$
|
|
Other reserves
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity premium reserve
|
|
|
|
10,866,878
|
|
10,866,878
|
|
10,866,878
|
|
|
|
|
|
|
|
|
|
|
|
Equity options reserve
|
|
|
|
1,704,895
|
|
1,268,418
|
|
428,962
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation reserve
|
|
|
|
(751,314
|
)
|
|
|
|
|
|
|
|
|
11,820,459
|
|
12,135,296
|
|
11,295,840
|
|
Equity premium reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nature and purpose of reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts
contributed for the future right to acquire shares at a pre-determined price.
The reserve can be used to pay dividends or issue bonus shares.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity options reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nature and purpose of reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
equity benefits reserve is used to record the value of equity based benefits
provided as remuneration under the ESOP (see note 14) or to pay for services
provided by third parties in lieu of cash.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning
|
|
|
|
1,268,418
|
|
428,962
|
|
6,858
|
|
|
|
|
|
|
|
|
|
|
|
Movements in reserve
|
|
|
|
436,477
|
|
839,456
|
|
422,104
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year
|
|
|
|
1,704,459
|
|
1,268,418
|
|
428,962
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nature and purpose of reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
foreign exchange translation reserve is used to record exchange differences
arising when the assets and liabilities of the overseas subsidiary are
translated into the presentation currency of the Parent at the rate of
exchange ruling at the balance sheet date and the income statement is
translated at the weighted average exchange rates for the period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Movements in reserve
|
|
|
|
(751,314
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year
|
|
|
|
(751,314
|
)
|
|
|
|
|
F-27
18. FINANCIAL RISK
MANAGEMENT OBJECTIVES AND POLICIES
The Groups financial instruments are cash and bank
deposits used to finance the Groups operations. The Group also has receivables
and payables. The main risks arising from the Groups financial instruments are
interest rate risk, foreign currency risk, credit risk and liquidity risk.
(a) Interest rate risk
The Groups
exposure to the risk of changes in market interest rates relates to cash at
bank which attracts a floating interest rate of 6%. (2006:4%).
It is the
Groups policy to monitor interest exposures and make fixed interest
investments, when appropriate, to maximise interest income.
There were no fixed interest investments in place as at
June 30, 2007 and 2006.
(b) Foreign currency
risk
T
he Group has research agreements with European
companies and conducts significant research operations in the USA which provide
transactional currency exposures. Such exposures arise from sales or purchases
in currencies other than the measurement currency.
All research
revenue is denominated in currencies other than the reporting currency and
approximately 50% of all costs are denominated in currencies other than the
reporting currency.
It is the
Groups policy to monitor currency exposures and to take forward cover, when
appropriate, to minimise exposure.
There were no
forward currency contracts in place as at June 30, 2007 and 2006.
(c) Credit risk
The Group
trades only with recognised, creditworthy third parties.
(d) Liquidity risk
The Group
accesses capital raisings to maintain liquidity as required.
19. FINANCIAL
INSTRUMENTS
Net fair values
Recognised
financial Instruments
Cash and cash
equivalents: The carrying amount approximates fair value.
Trade
receivables: The carrying amount approximates fair value.
Trade
payables: The carrying amount approximates fair value.
20. CONTINGENT
LIABILITIES
The Group has
nil contingent liabilities as at June 30, 2007 and 2006, and nil contingent
liabilities have arisen during the period to the date of this report.
The Group has
commercialisation and licensing agreements with research partners that may
create an obligation to pay royalties, upon successful commercialisation of
discovery targets, in the future. The possible value of these contingent
liabilities cannot be quantified until such time as sales are made.
The Group has
a manufacturing agreement with Stragen Investment B V which provides for a
potential bonus payment to Stragen upon Federal Drug Administration (FDA)
approval for Ceflatonin following clinical trials. Due to uncertainty of FDA
approval of Ceflatonin, no amounts have been accrued for in the accompanying
Balance Sheet.
21. MATTERS SUBSEQUENT
TO THE END OF THE FINANCIAL YEAR
On October 26,
2007ChemGenex Pharmaceuticals Limited announced a strategic restructuring based
upon the demerger of its metabolic diseases assets by early December, pending
shareholder approval. ChemGenexs metabolic diseases assets currently reside
within the companys wholly-owned subsidiary Autogen Research, which is to be
renamed Verva Pharmaceuticals. Pending shareholder approval at the Annual
General Meeting, scheduled to take place in Melbourne on November 28, Verva
Pharmaceuticals will be demerged from ChemGenex. Verva Pharmaceuticals then
intends to merge with Adipogen Pharmaceuticals, pursuant to a merger
implementation agreement signed on October 29, 2007. Upon shareholder approval,
ChemGenex shareholders will receive one share in Verva Pharmaceuticals for
every five ChemGenex Pharmaceuticals shares held at the record date. In
accordance with ASX listing rules and the option agreements, existing ChemGenex
option holders will not be allocated shares in Verva Pharmaceuticals unless
options are exercised prior to the record date. After the record date the
exercise price for each remaining ChemGenex option will be reduced by
approximately 7 cents.
F-28
22. COMMITMENTS
(a)
Research
expenditure commitments
Estimated research expenditure contracted for at reporting date, but
not provided for, payable:
not later than
one year- $5,097,818 (2006: $4,064,426)
later than one
year and not later than two years- $1,100,189 (2006: $2,316,982)
later than two
years and not later than three years- $30,166 (2006: $257,442)
A Controlled
Entity, Autogen Research Pty Ltd has agreed to provide certain monies for
research projects covering areas of diabetes, obesity, autoimmune disorders and
depression and anxiety with the object of long term commercialisation. Research
agreements have been undertaken with Deakin University, Southwest Foundation
and The International Diabetes Institute. These agreements expire during 2007
and negotiations to continue the agreements for under similar terms are
continuing.
Autogen
Research Pty Ltd has the option to continue funding these research agreements
subject to annual reviews which are dependent upon research milestones being
met. Autogen Research Pty Ltd has the right to benefit from the
commercialisation of any resulting products.
A Controlled
Entity, Chemgenex Pharmaceuticals Inc. has appointed Premier Research Plc. as
the Clinical Research Organisation for the Ceflatonin Stage 2/3 Clinical Trials
for CML patients. Patients recruited for Clinical Trials are guaranteed a level
of treatment beyond the trial period. Commitments for later than one year and
less than five years are based estimates of patient numbers and future
treatments required.
(b) Operating lease commitments
Estimated operating lease commitments at June 30, 2007:
not later
than one year- $29,903 (2006: $39,606)
ChemGenex Pharmaceuticals, Inc. leases approximately 2,400 square feet
of corporate office space in Menlo Park, California and also subleases
approximately 500 square feet of laboratory space under separate agreements
that expire on December 31, 2007. The Company is negotiating arrangements for
the lease of premises after December 31, 2007.
As at June 30, 2007, the company also leased office premises from
Deakin University under a lease agreement that expires on December 31, 2007.
23.
DIRECTOR AND EXECUTIVE DISCLOSURES
(a) Details of Key Management Personnel
(i) Directors
|
|
|
|
|
|
J.B.L.
Heading
|
|
Chairman
(non-executive)
|
Dr.
G.R. Collier
|
|
Director
and Chief Executive Officer
|
K.J.
Dart
|
|
Director
(non-executive) (Resigned February 8, 2007)
|
R.V.
Byrne
|
|
Director
(non-executive) (Resigned February 8, 2007)
|
E.J.
Schnee
|
|
Director
(non-executive)
|
Dr.
D.M. Brown
|
|
Director
(executive)
|
P.O.
Burns
|
|
Director
(non-executive)
|
P.J.
Bradfield
|
|
Director
(non-executive) (Resigned February 8, 2007)
|
Dr. D
Wade
|
|
Director
(non-executive) (Appointed December 5, 2006 and resigned February 8, 2007)
|
Dr.
G.E.D. Brooke
|
|
Director
(non-executive) (Appointed February 8, 2007)
|
D.S.
Janney
|
|
Director
(non-executive) (Appointed February 8, 2007)
|
Dr. G
Morstyn
|
|
Director
(non-executive) (Appointed May 31, 2007)
|
|
|
|
(ii) Executives
|
|
|
|
|
|
Dr.
J. Campbell
|
|
Vice
President of Operations
|
E.
Merrigan
|
|
Chief
Financial Officer and Company Secretary
|
T.
Herbert
|
|
Senior Director of Finance
|
S.
Michaels
|
|
Senior
Director of Discovery Research
|
E.
Humphriss
|
|
Senior
Director of clinical affairs
|
F-29
(b) Remuneration of Key Management personnel
(i)
Remuneration Policy
The Board of
Directors of ChemGenex Pharmaceuticals Limited, through the Remuneration
Committee, is responsible for determining and reviewing compensation arrangements
for the directors, the chief executive officer and the executive team. In
accordance with best practice corporate governance, the structure of
non-executive director and senior manager remuneration is separate and
distinct.
The Board
seeks to set aggregate remuneration at a level which provides the company with
the ability to attract and retain directors of the highest calibre, whilst
incurring a cost which is acceptable to shareholders.
The
Constitution and the ASX Listing Rules specify that the aggregate remuneration
of non-executive directors shall be determined from time to time by a general
meeting. An amount not exceeding the amount determined is then divided between
the directors as agreed. The amount of aggregate remuneration sought to be
approved by shareholders and the manner in which it is apportioned amongst
directors is reviewed annually. The Board considers the fees paid to
non-executive directors of comparable companies when undertaking the annual
review process. Each non-executive director receives a fee for being a director
of the company.
The company
aims to reward executives with a level and mix of remuneration commensurate
with their position and responsibilities within the company and so as to:-
reward executives for company performance against target;
align the interests of executives with those of shareholders;
link reward with the strategic goals and performance of the company;
and
ensure total remuneration is competitive by market standards.
The Board
assesses the appropriateness of the nature and amount of emoluments of such
officers on a periodic basis by reference to relevant employment market
conditions with the overall objective of ensuring maximum stakeholder benefit
from the retention of a high quality executive team. Such officers are given
the opportunity to receive their base emolument in a variety of forms including
cash and fringe benefits such as motor vehicles and expense payment plans. It
is intended that the manner of payment chosen will be optimal for the recipient
without creating undue cost for the company.
To assist in
achieving these objectives, the Board links the nature and amount of executive
directors and officers emoluments to the companys financial and operational
performance. It is the Boards policy that employment agreements shall be
entered into with the Chief Executive Officer and other specified executives.
F-30
(ii) Compensation for Key
Management Personnel
|
|
Short-term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non
|
|
Post Employment
|
|
Share Based
|
|
|
|
|
|
|
|
Cash
|
|
Monetary
|
|
Super-
|
|
Retirement
|
|
Payments
|
|
|
|
Directors
|
|
Salary & Fees
|
|
Bonus
|
|
Benefits
|
|
annuation
|
|
Benefits
|
|
Options
|
|
Total
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
70,849
|
|
|
|
|
|
|
|
|
|
|
|
70,849
|
|
2006
|
|
70,532
|
|
|
|
|
|
|
|
|
|
|
|
70,532
|
|
2005
|
|
65,000
|
|
|
|
|
|
|
|
|
|
|
|
65,000
|
|
Dr.
G. R. Collier
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
383,764
|
|
|
|
20,203
|
|
28,355
|
|
|
|
101,016
|
|
533,338
|
|
2006
|
|
379,097
|
|
|
|
20,628
|
|
27,973
|
|
|
|
273,774
|
|
701,472
|
|
2005
|
|
414,882
|
|
|
|
3,834
|
|
38,702
|
|
|
|
278,104
|
|
735,522
|
|
K.J.
Dart
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
30,342
|
|
|
|
|
|
2,731
|
|
|
|
|
|
33,073
|
|
2006
|
|
50,000
|
|
|
|
|
|
4,500
|
|
|
|
|
|
54,500
|
|
2005
|
|
50,000
|
|
|
|
|
|
4,500
|
|
|
|
|
|
54,500
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
30,342
|
|
|
|
|
|
2,731
|
|
|
|
|
|
33,073
|
|
2006
|
|
50,000
|
|
|
|
|
|
4,500
|
|
|
|
|
|
54,500
|
|
2005
|
|
50,000
|
|
|
|
|
|
4,500
|
|
|
|
|
|
54,500
|
|
E.J.
Schnee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
54,500
|
|
|
|
|
|
|
|
|
|
|
|
54,500
|
|
2006
|
|
54,500
|
|
|
|
|
|
|
|
|
|
|
|
54,500
|
|
2005
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
|
50,000
|
|
Dr.
D.M. Brown
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
317,864
|
|
|
|
39,831
|
|
|
|
|
|
|
|
357,695
|
|
2006
|
|
272,720
|
|
|
|
36,817
|
|
|
|
|
|
|
|
309,537
|
|
2005
|
|
265,516
|
|
|
|
18,666
|
|
|
|
|
|
|
|
284,182
|
|
P.O.
Burns
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
54,500
|
|
|
|
|
|
|
|
|
|
|
|
54,500
|
|
2006
|
|
50,215
|
|
|
|
|
|
|
|
|
|
|
|
50,215
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P.J.
Bradfield
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
30,340
|
|
|
|
|
|
2,731
|
|
|
|
|
|
33,071
|
|
2006
|
|
45,833
|
|
|
|
|
|
4,125
|
|
|
|
|
|
49,958
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
D Wade
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
9,040
|
|
|
|
|
|
814
|
|
|
|
|
|
9,854
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
G.E.D. Brooke
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
22,708
|
|
|
|
|
|
|
|
|
|
|
|
22,708
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D.S.
Janney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
22,708
|
|
|
|
|
|
|
|
|
|
|
|
22,708
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
G Morstyn
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
4,167
|
|
|
|
|
|
375
|
|
|
|
|
|
4,542
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-31
Executives
Dr.
J. Campbell
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
179,663
|
|
|
|
|
|
16,170
|
|
|
|
|
|
195,833
|
|
2006
|
|
160,550
|
|
|
|
|
|
14,449
|
|
|
|
69,769
|
|
244,768
|
|
2005
|
|
159,223
|
|
|
|
|
|
14,330
|
|
|
|
40,000
|
|
213,553
|
|
T.
Herbert
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
209,790
|
|
|
|
16,058
|
|
|
|
|
|
|
|
225,849
|
|
2006
|
|
202,966
|
|
|
|
13,407
|
|
|
|
|
|
|
|
216,373
|
|
2005
|
|
199,137
|
|
|
|
10,295
|
|
|
|
|
|
|
|
209,432
|
|
E.
Merrigan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
108,750
|
|
|
|
|
|
32,700
|
|
|
|
|
|
141,450
|
|
2006
|
|
120,000
|
|
|
|
|
|
10,800
|
|
|
|
26,163
|
|
156,963
|
|
2005
|
|
94,154
|
|
|
|
|
|
8,425
|
|
|
|
10,000
|
|
112,579
|
|
S.
Michaels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
127,146
|
|
|
|
27,522
|
|
|
|
|
|
|
|
154,668
|
|
2006
|
|
124,078
|
|
|
|
24,442
|
|
|
|
|
|
|
|
148,520
|
|
2005
|
|
119,482
|
|
|
|
9,140
|
|
|
|
|
|
|
|
128,622
|
|
E.
Humphriss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
101,399
|
|
|
|
12,202
|
|
|
|
|
|
|
|
113,601
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
1,757,872
|
|
|
|
115,816
|
|
86,607
|
|
|
|
101,016
|
|
2,006,311
|
|
2006
|
|
1,580,492
|
|
|
|
95,294
|
|
66,348
|
|
|
|
369,706
|
|
2,111,838
|
|
2005
|
|
1,467,394
|
|
|
|
41,935
|
|
70,457
|
|
|
|
328,104
|
|
1,907,890
|
|
(iii) Compensation by
Category: Key Management Personnel
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Short-term
|
|
1,873,688
|
|
1,675,786
|
|
1,509,329
|
|
Post
employment
|
|
86,607
|
|
66,348
|
|
70,457
|
|
Share-based payment
|
|
101,016
|
|
369,706
|
|
328,104
|
|
|
|
2,061,311
|
|
2,111,840
|
|
1,907,890
|
|
(c) Remuneration options: Granted and
vested
ESOP options
granted as equity compensation benefits to directors and executives during the
financial year are disclosed below. The options were issued free of charge. Each
option entitles the holder to subscribe for one fully paid ordinary share in
the Group at exercise prices set out in the table below. The options may only
be exercised after the first exercise date and before the expiry date as set
out in the table below:
|
|
|
|
|
|
|
|
Terms & Conditions for Each Grant
|
|
|
|
Vested
Number
|
|
Granted
Number
|
|
Grant date
|
|
Fair Value per
option at grant
date
|
|
Exercise Price
per share
|
|
First Exercise Date
|
|
Expiry Date
|
|
|
|
|
|
|
|
|
|
($)
|
|
($)
|
|
|
|
|
|
2007 Directors & Executives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nil options issued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nil options issued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-32
|
|
|
|
|
|
|
|
Terms & Conditions for
Each Grant
|
|
|
|
Vested
Number
|
|
Granted
Number
|
|
Grant date
|
|
Fair Value per
option at grant
date
|
|
Exercise Price
per share
|
|
First Exercise Date
|
|
Expiry Date
|
|
|
|
|
|
|
|
|
|
($)
|
|
($)
|
|
|
|
|
|
2006 Executives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. J. Campbell
|
|
200,000
|
|
200,000
|
|
Sept. 23, 2005
|
|
0.35
|
|
0.43
|
|
Sept. 23, 2005
|
|
Mar. 24, 2010
|
|
E. Merrigan
|
|
75,000
|
|
75,000
|
|
Sept. 23, 2005
|
|
0.35
|
|
0.43
|
|
Sept. 23, 2005
|
|
Mar. 24, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
275,000
|
|
275,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nil options issued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. J. Campbell
|
|
100,000
|
|
100,000
|
|
Dec. 21, 2004
|
|
0.40
|
|
0.43
|
|
Dec. 21, 2004
|
|
Mar. 24, 2010
|
|
E. Merrigan
|
|
25,000
|
|
25,000
|
|
Dec. 21, 2004
|
|
0.40
|
|
0.43
|
|
Dec. 21, 2004
|
|
Mar. 24, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
125,000
|
|
125,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(d) Shares issued on
exercise of remuneration options
400,000 shares
were issued to either Greg Collier or related parties of Greg Collier on the
exercise of remuneration options in 2007. No shares were issued to directors or
executives on the exercise of remuneration options in 2006 or 2005.
F-33
(e)
Option holdings of Key Management Personnel
|
|
Balance at
|
|
Granted as
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
|
|
|
|
beginning
|
|
Remuner-
|
|
|
|
|
|
end of
|
|
Vested at June 30, 2007
|
|
|
|
of period
|
|
ation
|
|
Options
|
|
Net Change
|
|
period
|
|
|
|
Not
|
|
|
|
June 30, 2007
|
|
July 1, 2006
|
|
#
|
|
Exercised
|
|
Other
|
|
June 30, 2007
|
|
Total
|
|
exercisable
|
|
Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
|
|
|
|
|
|
3,333
|
|
3,333
|
|
3,333
|
|
|
|
3,333
|
|
Dr.
G.R. Collier
|
|
3,800,000
|
|
|
|
(400,000
|
)
|
|
|
3,400,000
|
|
2,400,000
|
|
200,000
|
|
2,200,000
|
|
K.J.
Dart
|
|
7,399,324
|
|
|
|
|
|
(7,399,324
|
)
|
|
|
|
|
|
|
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.J.
Schnee
|
|
4,439,308
|
|
|
|
|
|
|
|
4,439,308
|
|
4,439,308
|
|
|
|
4,439,308
|
|
Dr.
D.M. Brown
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P.O.
Burns
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P.J.
Bradfield
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr D.
Wade
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr
G.E.D. Brooke
|
|
|
|
|
|
|
|
2,736,065
|
|
2,736,065
|
|
2,736,065
|
|
|
|
2,736,065
|
|
D.S.
Janney
|
|
|
|
|
|
|
|
6,088,053
|
|
6,088,053
|
|
6,088,053
|
|
|
|
6,088,053
|
|
Dr G.
Morstyn
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. J.
Campbell
|
|
385,000
|
|
|
|
|
|
167
|
|
385,167
|
|
385,167
|
|
|
|
385,167
|
|
E.
Humphriss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.
Merrigan
|
|
100,000
|
|
|
|
|
|
1,667-
|
|
101,667
|
|
101,667
|
|
|
|
101,667
|
|
T.
Herbert
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
S.
Michaels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
16,123,632
|
|
|
|
(400,000
|
)
|
1,429,961
|
|
17,153,593
|
|
16,153,593
|
|
200,000
|
|
15,953,593
|
|
#
Includes forfeits and offers to
employees under the ESOP to June 30, 2007
Net
Change Other includes-
Listed
options issued as part of the April 2007 Rights Issue to all eligible shareholders
including B. Heading, Dr. J. Campbell and E. Merrigan.
K.J.
Dart resigned as a director on February 8, 2007 and the options he controlled
have been deducted from the total for the year ended June 30, 2007 D.S. Janney and Dr. G.E.D. Brooke became
directors on February 8, 2007 and the options held by entities in which they
hold directorships are added to the total for the year ended June 30, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
Granted as
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
|
|
|
|
beginning
|
|
Remuner-
|
|
|
|
|
|
end of
|
|
Vested at June 30, 2006
|
|
|
|
of period
|
|
ation
|
|
Options
|
|
Net Change
|
|
period
|
|
|
|
Not
|
|
|
|
June 30, 2006
|
|
July 1, 2005
|
|
#
|
|
Exercised
|
|
Other
|
|
June 30, 2006
|
|
Total
|
|
exercisable
|
|
Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
G.R. Collier
|
|
3,800,000
|
|
|
|
|
|
|
|
3,800,000
|
|
2,800,000
|
|
200,000
|
|
2,600,000
|
|
K.J.
Dart
|
|
7,399,324
|
|
|
|
|
|
|
|
7,399,324
|
|
7,399,324
|
|
|
|
7,399,324
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.J.
Schnee
|
|
4,439,308
|
|
|
|
|
|
|
|
4,439,308
|
|
4,439,308
|
|
|
|
4,439,308
|
|
Dr.
D.M. Brown
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P.O.
Burns
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P.J.
Bradfield
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
Granted as
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
|
|
|
|
beginning
|
|
Remuner-
|
|
|
|
|
|
end of
|
|
Vested at June 30, 2006
|
|
|
|
of period
|
|
ation
|
|
Options
|
|
Net Change
|
|
period
|
|
|
|
Not
|
|
|
|
June 30, 2006
|
|
July 1, 2005
|
|
#
|
|
Exercised
|
|
Other
|
|
June 30, 2006
|
|
Total
|
|
exercisable
|
|
Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. J.
Campbell
|
|
185,000
|
|
200,000
|
|
|
|
|
|
385,000
|
|
385,000
|
|
|
|
385,000
|
|
E.
Humphriss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.
Merrigan
|
|
25,000
|
|
75,000
|
|
|
|
|
|
100,000
|
|
100,000
|
|
|
|
100,000
|
|
T.
Herbert
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
S.
Michaels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
15,848,632
|
|
275,000
|
|
|
|
|
|
16,123,632
|
|
15,123,132
|
|
200,000
|
|
14,923,632
|
|
#
Includes forfeits and offers to
employees under the ESOP to June 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
Granted as
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
|
|
|
|
beginning
|
|
Remuner-
|
|
|
|
|
|
end of
|
|
Vested at June 30, 2005
|
|
|
|
of period
|
|
ation
|
|
Options
|
|
Net Change
|
|
period
|
|
|
|
Not
|
|
|
|
June 30, 2005
|
|
July 1, 2004
|
|
#
|
|
Exercised
|
|
Other
|
|
June 30, 2005
|
|
Total
|
|
exercisable
|
|
Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
G.R. Collier
|
|
3,800,000
|
|
|
|
|
|
|
|
3,800,000
|
|
1,800,000
|
|
200,000
|
|
1,600,000
|
|
K.J.
Dart
|
|
7,399,324
|
|
|
|
|
|
|
|
7,399,324
|
|
7,399,324
|
|
|
|
7,399,324
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.J.
Schnee
|
|
4,439,308
|
|
|
|
|
|
|
|
4,439,308
|
|
4,439,308
|
|
|
|
4,439,308
|
|
Dr.
D.M. Brown
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. J.
Campbell
|
|
85,000
|
|
100,000
|
|
|
|
|
|
185,000
|
|
185,000
|
|
|
|
185,000
|
|
H.
Pedersen
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.
Merrigan
|
|
|
|
25,000
|
|
|
|
|
|
25,000
|
|
25,000
|
|
|
|
25,000
|
|
T.
Herbert
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
S.
Michaels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
15,723,632
|
|
125,000
|
|
|
|
|
|
15,848,632
|
|
13,848,632
|
|
200,000
|
|
13,648,632
|
|
#
Includes forfeits and offers to
employees under the ESOP to June 30, 2005
F-35
(f) Shareholdings of Key Management
Personnel
|
|
Balance
July 1, 2006
|
|
Granted as
Remuneration
|
|
On Exercise
of Options
|
|
Net Change
Other
|
|
Balance
June 30, 2007
|
|
June 30, 2007
|
|
Ord
|
|
Ord.
|
|
Ord
|
|
Ord
|
|
Ord
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
100,000
|
|
|
|
|
|
10,000
|
|
110,000
|
|
Dr.
G.R. Collier
|
|
|
|
|
|
400,000
|
|
(400,000
|
)
|
|
|
K.J.
Dart @
|
|
28,259,247
|
|
|
|
|
|
(28,259,247
|
)
|
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
E.J.
Schnee
|
|
18,833,750
|
|
|
|
|
|
|
|
18,833,750
|
|
Dr.
D.M. Brown
|
|
14,398,297
|
|
|
|
|
|
(521,745
|
)
|
13,876,552
|
|
P.O.
Burns
|
|
|
|
|
|
|
|
|
|
|
|
P.J.
Bradfield
|
|
|
|
|
|
|
|
|
|
|
|
Dr D.
Wade
|
|
|
|
|
|
|
|
|
|
|
|
Dr
G.E.D. Brooke
|
|
|
|
|
|
|
|
16,629,765
|
|
16,629,765
|
|
D.S.
Janney
|
|
|
|
|
|
|
|
37,009,671
|
|
37,009,671
|
|
Dr G
Morstyn
|
|
|
|
|
|
|
|
|
|
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
J. Campbell
|
|
5,000
|
|
|
|
|
|
500
|
|
5,500
|
|
E.
Humphriss
|
|
|
|
|
|
|
|
|
|
|
|
E.
Merrigan
|
|
50,000
|
|
|
|
|
|
5,000
|
|
55,000
|
|
T.
Herbert
|
|
760,027
|
|
|
|
|
|
|
|
760,027
|
|
S.
Michaels
|
|
760,027
|
|
|
|
|
|
|
|
760,027
|
|
Total
|
|
63,166,348
|
|
|
|
|
|
24,873,944
|
|
88,040,292
|
|
Net
Change Other includes-
Shares issued as part of the April 2007 Rights
Issue to all eligible shareholders including B. Heading, Dr. J. Campbell and E.
Merrigan.
During
the year ended June 30, 2007 Dr. D. Brown sold 521,745 ordinary shares in the
market. These sales were disclosed to the ASX in accordance with the Listing
Rules.
K.J.
Dart resigned as a director on February 8, 2007 and the shares he controlled
have been deducted from the total for the year ended June 30, 2007. D.S. Janney
and Dr G.E.D .Brooke became directors on February 8, 2007 and the shares held
by entities in which they hold directorships are added to the total for the
year ended June 30, 2007.
|
|
Balance
July 1, 2005
|
|
Granted as
Remuneration
|
|
On Exercise
of Options
|
|
Net Change
Other
|
|
Balance
June 30, 2006
|
|
June 30, 2006
|
|
Ord
|
|
Ord.
|
|
Ord
|
|
Ord
|
|
Ord
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
100,000
|
|
|
|
|
|
|
|
100,000
|
|
Dr.
G.R. Collier
|
|
|
|
|
|
|
|
|
|
|
|
K.J.
Dart
|
|
23,159,247
|
|
|
|
|
|
5,100,000
|
|
28,259,247
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
E.J.
Schnee
|
|
9,833,750
|
|
|
|
|
|
9,000,000
|
|
18,833,750
|
|
Dr.
D.M. Brown
|
|
14,398,297
|
|
|
|
|
|
|
|
14,398,297
|
|
P.O.
Burns
|
|
|
|
|
|
|
|
|
|
|
|
P.J.
Bradfield
|
|
|
|
|
|
|
|
|
|
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
J. Campbell
|
|
5,000
|
|
|
|
|
|
|
|
5,000
|
|
E.
Humphriss
|
|
|
|
|
|
|
|
|
|
|
|
E.
Merrigan
|
|
25,000
|
|
|
|
|
|
25,000
|
|
50,000
|
|
T.
Herbert
|
|
760,027
|
|
|
|
|
|
|
|
760,027
|
|
S.
Michaels
|
|
760,027
|
|
|
|
|
|
|
|
760,027
|
|
Total
|
|
49,041,348
|
|
|
|
|
|
14,125,000
|
|
63,166,348
|
|
F-36
|
|
Balance
July 1, 2004
|
|
Granted as
Remuneration
|
|
On Exercise
of Options
|
|
Net Change
Other
|
|
Balance
June 30, 2005
|
|
June 30, 2005
|
|
Ord
|
|
Ord.
|
|
Ord
|
|
Ord
|
|
Ord
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
J.B.L.
Heading
|
|
100,000
|
|
|
|
|
|
|
|
100,000
|
|
Dr.
G.R. Collier
|
|
|
|
|
|
|
|
|
|
|
|
K.J.
Dart
|
|
19,864,347
|
|
|
|
|
|
3,294,900
|
|
23,159,247
|
|
R.V.
Byrne
|
|
|
|
|
|
|
|
|
|
|
|
E.J.
Schnee
|
|
5,748,750
|
|
|
|
|
|
4,085,000
|
|
9,833,750
|
|
Dr.
D.M. Brown
|
|
14,398,297
|
|
|
|
|
|
|
|
14,398,297
|
|
Executives
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
J. Campbell
|
|
5,000
|
|
|
|
|
|
|
|
5,000
|
|
E.
Humphriss
|
|
|
|
|
|
|
|
|
|
|
|
E.
Merrigan
|
|
|
|
|
|
|
|
25,000
|
|
25,000
|
|
T.
Herbert
|
|
760,027
|
|
|
|
|
|
|
|
760,027
|
|
S.
Michaels
|
|
760,027
|
|
|
|
|
|
|
|
760,027
|
|
Total
|
|
41,636,448
|
|
|
|
|
|
7,404,900
|
|
49,041,348
|
|
All equity
transactions with directors and executives other than those arising from the
exercise of remuneration options have been entered into under terms and
conditions no more favourable than those the Group would have adopted if
dealing at arms length.
(g) Loans to directors and executives
Options granted under the ESOP in 2000 and 2001
contained an issue price which the company, in accordance with the terms of the
ESOP, funded via an interest free off balance sheet loan to the option
holder. The loan is repayable upon the sale of shares obtained through exercise
of the options.
Dr Greg Collier (who was not a director at the time of
the grants) received 100,000 options under the ESOP in financial years 2000 and
2001 and, as a result, was given a loan to fund the issue price of these
options. Subsequent to the date of these option grants the terms and conditions
of the off balance sheet loans have not been changed, no repayments have been
made and the balance of $96,820 is outstanding at June 30, 2007. Interest not
charged for the year ended June 30, 2007 of $3,834 has been included in Note
23(b)(ii) as a non-monetary benefit. (2006: $3,834)
Neither the loans nor equity items relating to these
options are included in the companys financial statements as share price
hurdle rates associated with these options have not been achieved.
There are no other loans to specified directors and
specified executives and there have been no other loans made to or repaid by
specified directors and specified executives during the years ended June 30,
2007 and 2006.
(h)
Employment contracts
The CEO, Dr
Greg Collier, is employed under contract. The current employment contract
commenced on July 1, 2007 and terminates on June 30, 2012, at which time the
company may choose to commence negotiation to enter into a new employment contract
with Dr Collier. Under the terms of the present contract:-
|
|
Dr
Collier may resign from his position and thus terminate this contract by
giving 6 months written notice.
|
|
|
The
company may terminate this employment agreement by providing 6 months written
notice or provide payment in lieu of the notice period.
|
|
|
The
company may terminate the contract at any time without notice if serious
misconduct has occurred. Where termination with cause occurs the CEO is only
entitled to remuneration up to the date of termination.
|
All other
executives are employed under contracts which have a term of 12 months and
provide for termination, by either party, with notice periods between 2 and 4
months.
F-37
24. AUDITORS REMUNERATION
JUNE 30
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Amounts
paid or payable to Ernst & Young Australia for:
|
|
|
|
|
|
|
|
an
audit or review of the financial report of the entity and any other entity in
the consolidated entity
|
|
269,435
|
|
212,325
|
|
93,250
|
|
other services in relation to the entity and any other entity in the
consolidated entity
|
|
|
|
|
|
17,709
|
|
tax
advice
|
|
|
|
|
|
12,000
|
|
|
|
269,435
|
|
212,325
|
|
122,959
|
|
Amounts
paid or payable to Deloitte Touche Tohmatsu for initial SEC registration form
20F and 2005 SEC Annual Report 20F
|
|
|
|
|
|
|
|
an
audit or review of the financial report of the entity and any other entity in
the consolidated entity
|
|
|
|
|
|
497,804
|
|
other services in relation to the entity and any other entity in the
consolidated entity
|
|
|
|
|
|
|
|
tax
advice
|
|
|
|
|
|
|
|
|
|
|
|
|
|
497,804
|
|
25. RELATED PARTY DISCLOSURES
Revenues
Mr E. J.
Schnee, a director of Chemgenex Pharmaceuticals Limited is also a director of
Merck Santé which holds 18,793,750 shares and 4,439,308 options in the company.
Merck Santé is party to research and commercialisation agreements with the
companys 100% owned subsidiary Autogen Research Pty Limited. Under these
agreements Merck Santé provided research revenue of $331,377 and patent
reimbursement of $Nil to Autogen Research Pty Ltd. during the year ended June
30, 2007. (2006: $1,436,053 and $230,223, and 2005: $2,533,113 and $104,085)
Expenses
During the
year ended June 30, 2007 legal services to the value of $93,282 (2006: $52,337;
2005: $52,934) were provided by McCullough Robertson solicitors, a legal firm
of which Mr J.B.L. Heading, a director of Chemgenex Pharmaceuticals Limited, is
a partner. $62,872 of the 2007 amount was charged to Contributed Equity for
costs associated with the February prospectus and rights issue (2006and 2005:
Nil)
Mr. J.B.L.
Heading is also a director of two companies that are the joint holders of 5% of
the shares of Global Markets Capital Group LLC that has provided advisory and
consulting services to the company to the value of $200,483 (including sharebased
compensation of $165,924) during the year ended June 30, 2007 (2006: $53,751
and $Nil; 2005: $65,214 and $Nil). Mr Heading has no beneficial interest in
these shareholders.
Mr K.J. Dart a
former director of Chemgenex Pharmaceuticals Limited, was also a director and
shareholder of Charter Pacific Corporation Limited. Charter Pacific Corporation
Limited is a significant shareholder of Global Markets Capital Group LLC that
has provided advisory and consulting services to the company to the value of
$200,483 (including share-based compensation of $165,924) during the year ended
June 30, 2007 (2006: $53,751 and $Nil; 2005: $65,214 and $Nil ).
Assets
As at June 30, 2007 and 2006 no related parties had funds
owing to Chemgenex Pharmaceuticals Limited as Trade receivables.
Liabilities
Included in Trade and other payables as at June 30, 2007
was an amount of $ 4,494 owing to McCullough Robertson on normal commercial
terms.
F-38
25. RELATED PARTY DISCLOSURES (cont)
Included in Trade and other payables as at June 30, 2006
was an amount of $4,168 owing to McCullough Robertson on normal commercial
terms.
Deferred revenue
Included in
Deferred revenue as at June 30, 2007 was an amount of $165,688 which had been
received from Merck Santé for which services contracted had not been provided
at that time. (2006: $177,442).
Amounts recognised at the reporting date as related party
transactions
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Assets and Liabilities
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Trade
receivables
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
Trade
creditors
|
|
4,494
|
|
4,168
|
|
|
|
Deferred
revenue
|
|
165,688
|
|
177,422
|
|
|
|
Total Liabilities
|
|
170,162
|
|
181,590
|
|
|
|
|
|
|
|
|
|
|
|
Revenues and Expenses
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
Research
Revenue
|
|
331,377
|
|
1,436,053
|
|
2,533,113
|
|
Patent
reimbursements
|
|
|
|
230,223
|
|
104,085
|
|
Total Revenues
|
|
331,377
|
|
1,666,273
|
|
2,637,198
|
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
Legal
services provided
|
|
93,282
|
|
52,337
|
|
52,934
|
|
Advisory
and consulting services provided
|
|
458,515
|
|
53,751
|
|
65,214
|
|
Total Expenses
|
|
551,797
|
|
106,088
|
|
118,148
|
|
26. RECONCILIATION TO US GAAP
The
consolidated financial statements have been prepared in accordance with AIFRS,
which differ in certain respects from accounting principles generally accepted
in the United States of America (US GAAP). The following is a summary of the
adjustments to net loss and total equity required when reconciling such amounts
recorded in the consolidated financial statements to the corresponding amounts
in accordance with US GAAP, considering the differences between AIFRS and US
GAAP.
Reconciliation
of net loss
The following
is a reconciliation of net loss as reported in the Consolidated Income
Statements under AIFRS to the net loss as adjusted for the effects of the
application of US GAAP for the years ended June 30, 2007, 2006 and 2005.
Years Ended June 30,
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Net
loss in accordance with AIFRS
|
|
(11,700,919
|
)
|
(10,369,719
|
)
|
(6,235,183
|
)
|
US
GAAP adjustments
|
|
|
|
|
|
|
|
Share-based
compensation expenses
|
(a)
|
|
|
|
|
|
|
-
AIFRS expense
|
|
436,477
|
|
839,456
|
|
422,105
|
|
- US
GAAP expenses
|
|
(436,477
|
)
|
(839,456
|
)
|
(101,100
|
)
|
Marketable
securities
|
(d)
|
|
|
(74,631
|
)
|
(275,182
|
)
|
Deferred
tax effect of US GAAP adjustments
|
(e)
|
|
|
|
|
|
|
Net
loss in accordance with US GAAP
|
|
(11,700,919
|
)
|
(10,444,350
|
)
|
(6,189,360
|
)
|
|
|
|
|
|
|
|
|
Loss
per share in accordance with US GAAP:
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$
|
(0.07
|
)
|
$
|
(0.09
|
)
|
$
|
(0.06
|
)
|
Weighted
average shares - basic and diluted
|
|
162,281,115
|
|
117,647,158
|
|
105,707,630
|
|
|
|
|
|
|
|
|
|
|
|
|
F-39
Reconciliation
of total equity
The following
is a reconciliation of the total equity as reported in the Consolidated Balance
Sheets under AIFRS to total equity as adjusted for the effects of the
application of US GAAP as of June 30, 2007, 2006 and 2005.
June 30,
|
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
$
|
|
$
|
|
$
|
|
Total
equity in accordance with AIFRS
|
|
|
39,869,598
|
|
31,004,909
|
|
25,235,448
|
|
US
GAAP adjustments
|
|
|
|
|
|
|
|
|
Fair
value of shares issued as consideration
|
(b)
|
|
(392,000
|
)
|
(392,000
|
)
|
(392,000
|
)
|
In-process
research and development
|
(c)
|
|
(16,570,561
|
)
|
(16,570,561
|
)
|
(16,570,561
|
)
|
Reversal
of amortisation of goodwill
|
(c)
|
|
30,811
|
)
|
30,811
|
|
30,811
|
|
Marketable
securities
|
(d)
|
|
|
|
|
|
74,631
|
|
Deferred
tax effect of US GAAP adjustments
|
(e)
|
|
|
|
|
|
|
|
Total
equity in accordance with US GAAP
|
|
|
22,937,848
|
|
14,073,159
|
|
8,378,329
|
|
Roll forward
analysis of total equity under US GAAP
Years Ended June 30,
|
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
$
|
|
$
|
|
$
|
|
Balance
in accordance with US GAAP, beginning of year
|
|
|
14,073,159
|
|
8,378,329
|
|
131,081
|
|
Issue
of shares, net of issue costs
|
18
|
|
20,880,445
|
|
15,299,724
|
|
14,335,508
|
|
Issue
of options, net of forfeitures
|
(a)
|
|
436,477
|
|
839,456
|
|
101,100
|
|
Recognition
of foreign currency translation reserve
|
18
|
|
(751,314
|
)
|
|
|
|
|
Net
loss in accordance with US GAAP
|
|
|
(11,700,919
|
)
|
(10,444,350
|
)
|
(6,189,360
|
)
|
Balance in accordance with US GAAP, end of year
|
|
|
22,937,848
|
|
14,073,159
|
|
8,378,329
|
|
a)
Share-based compensation
As disclosed
in Notes 14 and 17 to the consolidated financial statements, the Company issued
share options to directors, employees and non-employees as an incentive for
future performance or in consideration for services rendered.
Under AIFRS,
the Company accounts for share-based payments under AASB 2
Share-Based Payments.
Options issued after November 7, 2002 and vested on or after January 1,
2005 are required to have the grant-date fair value be recognized as an expense
over the vesting period.
Under US GAAP,
prior to July 1, 2005, the Company accounted for its stock options in
accordance with Accounting Principles Board Opinion No. 25:
Accounting for Stock
Issued to Employees
and related interpretations (APB 25) and
adopted the disclosure-only provisions of SFAS No. 123 Accounting for
Stock-Based Compensation (SFAS 123). Under APB 25, the Company recognized
compensation expense for stock options only if the current market price of the
underlying stock exceeded the exercise price as at the measurement date. The
resultant compensation cost is charged to earnings rateably over the vesting
period.
Effective July
1, 2005, the Company adopted the requirements of SFAS 123 (revised 2004)
Share-Based Payments
(SFAS 123R) under US GAAP. SFAS
123R eliminates the option to apply the intrinsic value measurement provisions
of APB 25 to stock compensation awards issued to employees. Rather, SFAS No.
123R requires companies to measure the cost of employee services received in
exchange for an award of equity instruments based on the grant-date fair value
of the award. That cost will be recognized over the period during which an
employee is required to provide services in exchange for the award - the
requisite service period (usually the vesting period).
F-40
The Company
has elected to apply SFAS 123R using the modified prospective method thereby
recognising the compensation cost in the
consolidated financial statements based on grant-date fair value for all
share-based payments granted after July 1, 2005, and based on the requirements
of SFAS 123, for all unvested awards granted prior to the effective date of
SFAS 123R.
SFAS 123R is
consistent with share-based payments recognition under AASB 2, however,
differences arise in terms of transition dates. This resulted in difference in
compensation expense between AIFRS and US GAAP for the year ended June 30, 2005
by $321,005. There are no differences in share-based payment expense between US
GAAP and AIFRS during the years ended June 30, 2006 and 2007.
As a result of
adopting SFAS 123R on July 1, 2005, the Companys net loss and net loss per
share for the year ended June 30, 2006 was higher by $406,471 and $.003,
respectively, than if it had continued to account for share-based compensation
under APB 25. The adoption of FAS123R has had no effect on cash flows.
The following
table illustrates the effect on net loss and net loss per share if the Company
had applied the fair value recognition provisions of SFAS 123 to stock based
employee compensation for the year ended June 30, 2005.
Net
Loss, as reported
|
|
(6,189,360
|
)
|
Share-based
employee compensation expense under APB 25
|
|
101,100
|
|
Share-based
employee compensation expense determined under fair value-based method
|
|
(422,105
|
)
|
Net
loss according to US GAAP pro forma
|
|
(6,510,365
|
)
|
|
|
|
|
Net
loss per share
|
|
|
|
Basic-
as reported
|
|
($0.06
|
)
|
Basic-
pro forma
|
|
($0.06
|
)
|
|
|
|
|
Diluted-
as reported
|
|
($0.06
|
)
|
Diluted-
pro forma
|
|
($0.06
|
)
|
-
Options issued to non-employees
Under US GAAP, the Company accounts for share-based
compensation to non-employees in accordance with SFAS 123, as amended by SFAS
No. 148,
Accounting for Stock-Based Compensation-Transition
and Disclosure
, and Emerging Issues Task Force Issue No. 96-18,
Accounting for Equity Instruments That Are Issued to Other Than Employees
for Acquiring, or in Conjunction with Selling, Goods or Services
. Accordingly, the Company has calculated
compensation cost based on the estimated fair value of the options as of the
measurement date, using the Black-Scholes model, and recognised the
compensation cost over the period in which the options vest.
Employee
Share Option Plan (ESOP)
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Total
grant-date intrinsic value of options exercised
|
|
5,600
|
|
|
|
1,050
|
|
Total
grant-date fair value of options issued
|
|
498,000
|
|
193,270
|
|
144,000
|
|
Total
grant-date fair value of options vested
|
|
498,000
|
|
193,270
|
|
144,000
|
|
Aggregate
intrinsic value of options:
|
|
|
|
|
|
|
|
Outstanding
at end of year
|
|
352,800
|
|
254,900
|
|
356,500
|
|
Exercisable
at end of year
|
|
112,800
|
|
114,900
|
|
116,500
|
|
F-41
Options
issued to Global Markets Capital Group LLC.
An amount of
$165,924 was included in general and administrative expense for the year ended
June 30, 2007 for options, which were issued to GMCG and which vested
immediately.
Options
Approved by Resolution of Shareholders
Options
issued to Dr Greg Collier
The options
issued to Dr. Greg Collier are subject to minimum service vesting condition of
between two to four years and a market condition in the form of a target share
price.
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
$
|
|
$
|
|
$
|
|
Number
of options outstanding at end of year
|
|
3,200,000
|
|
3,600,000
|
|
3,600,000
|
|
Weighted-average
exercise price of options outstanding at end of year
|
|
0.50
|
|
0.48
|
|
0.48
|
|
Aggregate
intrinsic value of options:
|
|
|
|
|
|
|
|
Outstanding
at end of year
|
|
116,000
|
|
189,000
|
|
189,000
|
|
Exercisable
at end of year
|
|
76,000
|
|
149,000
|
|
149,000
|
|
Weighed-average
remaining contractual term of options outstanding at end of year
|
|
2.2
|
|
3.2
|
|
4.2
|
|
No options to
Dr. Greg Collier were issued, cancelled or forfeited during the years ended
June 30, 2007, 2006 and 2005.
400,000
options to Dr. Greg Collier were exercised during the year ended June 30, 2007.
(2006 and 2005: Nil).
Following is a
summary of non-vested options to Dr Greg Collier and the weighted-average
grant-date fair value (WAFV):
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
Number
|
|
WAFV
|
|
Number
|
|
WAFV
|
|
Number
|
|
WAFV
|
|
Balance
at beginning of year
|
|
1,000,000
|
|
$
|
0.35
|
|
1,000,000
|
|
$
|
0.35
|
|
2,000,000
|
|
$
|
0.35
|
|
Vested
during the year
|
|
|
|
$
|
0.0
|
|
|
|
$
|
0.0
|
|
(1,000,000
|
)
|
$
|
0.35
|
|
Balance
at end of year
|
|
1,000,000
|
|
$
|
0.35
|
|
1,000,000
|
|
$
|
0.35
|
|
1,000,000
|
|
$
|
0.35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total
grant-date fair value of options vested during the year ended June 30, 2007 and
2006 was nil (2005 $351,289).
As of June 30,
2007, there was approximately $42,825 of unrecognized compensation expense
related to these non-vested share-based payments. This cost is expected to be
recognized in the year ending June 30, 2008.
Options
issued to Stragen Investments B.V.
The total fair
value of options to Stragen, which were granted and vested during the year
ended June 30, 2006, was $371,561 and included in research and development
expense.
Refer to Note
14 to the consolidated financial statements for the assumptions in determining
grant-date fair value of options and other information on share-based payments
to employees and non-employees.
b)
Fair value of shares issued as consideration.
As disclosed
in Note 18 to the consolidated financial statements, the Company issued
28,000,000 ordinary shares as consideration for acquiring 100% of ChemGenex
Therapeutics, Inc. In accordance with the acquisition agreement the value
placed on the issue under the prevailing A-GAAP standards was 54 cents per
share, the closing market price on June 21, 2004. Under US GAAP the fair value
of the shares issued to affect the acquisition is the average quoted market
price for a period of two days before and after the date the terms of the
agreement are agreed and announced (52.6 cents). Accordingly, for US GAAP
purposes, the Company has recorded an adjustment to the purchase price as well
as the value of the shares issued.
F-42
c)
Goodwill on acquisition
At June 30,
2004 the Company calculated goodwill relating to the acquisition of ChemGenex
Therapeutics, Inc. as the excess of the purchase price over the fair value of
identifiable net assets acquired. In accordance with the prevailing A-GAAP
standards, the resultant goodwill was to be amortised over 20 years. With the
implementation of AIFRS Goodwill is no longer amortised and impairment is
evaluated and expensed as per notes 2(i) and 13 of these consolidated financial
statements. For US GAAP purposes, the Company considered the guidance contained
in
FASB Interpretations
(FIN) 4, Applicability of FASB Statement No. 2 to Business Combinations
Accounted for by the Purchase Method and determined
that the excess of the US GAAP purchase price over the fair value of
identifiable net assets acquired represents the estimated value of acquired
in-process research and development projects that had not yet reached
technological feasibility and had no alternative future use. Accordingly, this
amount was immediately expensed at the date of acquisition under US GAAP.
Additionally, the A-GAAP goodwill amortisation from 1 July 2004, has been
reversed for US GAAP purposes.
d)
Marketable securities
The Company
holds an investment in a marketable security that was fully provided for under
A-GAAP during the year ended June 30, 1999 because the security was deemed
worthless by management. Under US GAAP, the investment is classified as
available-for-sale and reported at fair value based on the average of the closing
bid and asked prices as reported by the OTC Bulletin Board. Unrealized gains
and losses are excluded from earnings, and reported, net of tax, in accumulated
other comprehensive income until realized.
During the
year ended June 30, 2005, a decline in market value, judged to be other than
temporary occurred and resulted in a reduction in the carrying value of the
investment. During the year ended June 30, 2006, a further decline in market
value, judged to be other than temporary, occurred such that investment was
deemed by management to have no ongoing carrying value. As a result the value
of the investment was totally written off under US GAAP as at June 30, 2006.
e)
Deferred tax effect of US GAAP adjustments
The deferred
tax effect of US GAAP adjustments is nil because it is more likely than not
that the net deferred tax asset will not be realized and, accordingly, the
Company has recorded a 100% valuation allowance against the net deferred tax
assets.
Income Tax and
Deferred Tax Supplement Disclosures.
Loss before
income taxes for the years ended June 30, 2007, 2006 and 2005 was realized in
the following jurisdictions:
|
|
2007
|
|
2006
|
|
2005
|
|
Australia
Operating Loss
|
|
(11,598,108
|
)
|
(6,031,234
|
)
|
(4,337,743
|
)
|
USA
Operating Profit/(Loss)
|
|
218,693
|
|
(4,283,955
|
)
|
(1,893,484
|
)
|
USA
Profit on transfer of Intellectual Property
|
|
|
|
13,471,642
|
|
|
|
USA
Profit from Research Agreement
|
|
5,556,487
|
|
|
|
|
|
Consolidated
Exchange Loss
|
|
|
|
(54,530
|
)
|
(3,955
|
)
|
Elimination
of Internal USA Profit
|
|
(5,566,487
|
)
|
(13,471,642
|
)
|
|
|
Loss
before income taxes
|
|
(11,379,415
|
)
|
(10,369,719
|
)
|
(6,235,182
|
)
|
At June 30,
2007, deferred income tax relates to the following:
|
|
2007
|
|
2006
|
|
2005
|
|
Deferred tax assets
|
|
|
|
|
|
|
|
Current deferred tax asset
|
|
|
|
|
|
|
|
Sundry
creditors and accruals
|
|
13,500
|
|
39,986
|
|
132,695
|
|
Employee
benefits
|
|
52,513
|
|
25,187
|
|
35,805
|
|
Non-current deferred tax asset
|
|
|
|
|
|
|
|
Sec
40-880 costs
|
|
86,085
|
|
196,022
|
|
|
|
Capital
Losses available for offset against future capital gains
|
|
436,439
|
|
436,439
|
|
436,439
|
|
Losses
available for offset against future taxable income*
|
|
17,462,021
|
|
13,878,135
|
|
15,123,323
|
|
Gross
deferred tax assets
|
|
18,050,558
|
|
14,575,769
|
|
15,123,323
|
|
Valuation
allowance
|
|
(18,050,558
|
)
|
(14,575,769
|
)
|
(15,123,323
|
)
|
Net
deferred tax asset assets
|
|
|
|
|
|
|
|
F-43
Deferred tax
assets relating to tax losses
At June 30,
2007, the Company had net operating tax loss carry-forwards generated in
Australia which are indefinite as to use unless it is unable to comply with the
recognition criteria for carrying forward tax losses under Australian taxation
laws. The net operating tax loss carry-forwards generated in the USA are
available indefinitely subject to existing and future US tax regulations.
At June 30,
2007, the Company also has capital losses that arose in predominately 2002 of
$436,439 and are available indefinitely for offset against future capital gains
of a similar nature subject to continuing to meet relevant statutory tests.
At June 30,
2007, the Company has unrealized capital losses of $1,084,488 in respect of held
for sale marketable securities. The unrealized capital losses incurred in
respect of such securities shall be available to offset against other capital
gains derived by the Australian group once the securities have physically been
disposed of / sold. Further, any future capital losses incurred in respect of
the marketable securities will be available indefinitely for offset against
future capital gains of a similar nature subject to continuing to meet the
relevant statutory tests.
As a result of
the above tax loss carry-forwards, the Company has significant potential
deferred tax assets. However due to the Companys lack of earnings history,
realization of these deferred tax assets is not more likely than not,
therefore, the deferred tax assets have been fully offset by a valuation
allowance.
The change in
the valuation allowance and the corresponding change in the deferred tax asset
amounted to $3,474,789, ($547,554) and $1,498,362 for the years ended June 30,
2007, 2006 and 2005 respectively.
Operating
losses noted above in 2007 and 2006 relate to expenditure on research projects
and general company administration costs. In 2006 the US subsidiary recorded a
profit of AUD13,471,642 on the sale of IP relating to the anti-cancer compound
Ceflatonin to the parent company. As the sale is between consolidated entities,
this transaction is eliminated for financial reporting purposes. However, as
the intellectual property was transferred across tax jurisdictions, a taxable
gain is recognized within the U.S. tax group which was substantially offset
with available tax losses. Due to uncertainties regarding the commercialization
of the Companys intellectual property, the Company has recognized a full
provision related to the realization of the underlying tax asset through income
tax expense. This transaction resulted in the recognition of $321,504 of income
tax expense in 2007 representing the amount of income tax paid in the U.S. to
tax authorities.
Refer to Note
5 for the reconciliation of income tax expense applicable to accounting profit
before income tax and income tax expense for the years ended June 30, 2007,
2006 and 2005.
f)
Consolidated Income Statement classification differences
In
addition to the differences in valuation and income recognition, other
differences, essentially related to presentation, exist between AIFRS and US
GAAP. Although there is no impact on US GAAP reported Equity and Net Loss due
to these differences, it may be useful to understand them to interpret the
Consolidated Financial Statements presented in accordance with US GAAP. The
following is a summary of presentation differences that relate to the basic
AIFRS Consolidated Financial Statements
Under AIFRS,
exchange rate gains are reported as a component of revenue from ordinary
activities. Under US GAAP, exchange rate gains relating to operating activities
are classified within operating income (loss) whereas exchange rate gains
related to non-operating activities are classified as a component of
non-operating income (loss).
Under AIFRS,
interest income is reported as a component of revenue from operations. Under US
GAAP, interest income is reported as a component of non-operating income
(loss).
Under AIFRS,
the Company classifies costs paid to third parties under research and
development contracts as research expenditure. Other costs directly
attributable to research activities, such as depreciation of plant and
equipment, patent costs, legal costs, personnel costs, among others, are
classified in separate line items in the Consolidated Income Statements. Under
US GAAP, all costs of research and development activities are classified as
research and development in the Consolidated Income Statements.
g)
Recently Issued but not yet adopted Accounting Pronouncements
The following
accounting pronouncements have been issued but have not yet been adopted by
ChemGenex Pharmaceuticals Limited as at June 30, 2007-
F-44
Uncertainty
in Income Taxes
In
July 2006, the FASB issued FASB Interpretation (FIN) No. 48,
Accounting for Uncertainty in Income Taxes
,
an interpretation of FASB No. 109,
Accounting
for Income Taxes
(FIN 48). FIN 48 creates a single model to
address uncertainty in tax positions and clarifies the accounting for income
taxes by prescribing the minimum recognition threshold a tax position is required to meet before
being recognized in the financial statements. FIN 48 also provides guidance on
derecognition, measurement, classification, interest and penalties, accounting
in interim periods, disclosure, and transition. In addition, FIN 48 clearly
scopes out income taxes from SFAS No. 5,
Accounting
for Contingencies
. FIN 48 applies to all tax positions related to income taxes
subject to SFAS No. 109. This includes tax positions considered to be routine
as well as those with a high degree
of uncertainty. The guidance contained in FIN 48 is also applicable to
pass-through entities, non-taxable
entities, and entities whose tax liability is subject to 100% credit for
dividends paid. FIN 48 utilizes the following two-step approach for evaluating
tax positions: recognition (step one) and measurement (step two). Step one occurs
when an enterprise concludes that a tax position, based solely on its technical
merits, is more-likely-than-not to be sustained on examination. Step two is
only addressed if step one has been satisfied. Under step two, the tax benefit
is measured as the largest amount of benefit, determined on a cumulative
probability basis, which is more-likely-than-not to be realized on ultimate
settlement. Derecognition of a tax position that was previously recognized
would occur when a company subsequently determines that a tax position no
longer meets the more-likely-than-not threshold of being sustained. FIN 48
specifically prohibits the use of a valuation allowance as a substitute for
derecognition of tax positions. FIN 48 requires expanded disclosures, including
a tabular roll forward of the beginning and ending aggregate unrecognized tax
benefits as well as specific detail related to tax uncertainties for which it
is reasonably possible the amount of unrecognized tax benefit will
significantly increase or decrease within twelve months. These disclosures are
required at each annual reporting period, unless a significant change occurs in
an interim period. FIN 48 is effective for fiscal years beginning after
December 15, 2006. The Company plans to adopt this pronouncement in fiscal year
beginning July 1, 2007 and does not believe the adoption of FIN 48 will have a
material effect on the consolidated financial statements.
Fair Value
Measurements
In
September 2006, the FASB issued SFAS No. 157,
Fair
Value Measurements
(SFAS 157). SFAS 157 provides enhanced guidance
for using fair value to measure assets and liabilities and also responds to
investors requests for expanded information about the extent to which
companies measure assets and liabilities at fair value, the information used to
measure fair value, and the effect of fair value measurements on earnings. SFAS
157 applies whenever other standards require (or permit) assets or liabilities
to be measured at fair value and does not expand the use of fair value in any
new circumstances. Under SFAS 157, fair value refers to the price that would be
received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants in the market in which the reporting
entity transacts. SFAS 157 clarifies the principle that fair value should be
based on the assumptions market participants would use when pricing the asset
or liability. In support of this principle, SFAS 157 establishes a fair value
hierarchy that prioritizes the information used to develop those assumptions. The
fair value hierarchy gives the highest priority to quoted prices in active
markets and the lowest priority to unobservable data. Under SFAS 157, fair
value measurements would be separately disclosed by level within the fair value
hierarchy. SFAS 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. The Company plans to adopt this
pronouncement in fiscal years beginning July 1, 2008 and does not believe the
adoption of SFAS 157 will have a material effect on the consolidated financial
statements.
Accounting
for Research and Development Costs
In
June 2007, the Financial Accounting Standards Board (FASB) considered the
Emerging Issues Task Force (EITF) review of FASB Statement No. 2 Accounting
for Research and development Costs. The Task Force reached a consensus that
nonrefundable advance payments for future research and development activities
should be deferred and capitalized. Such amounts should be recognized as
an expense as the related goods are delivered or the related services are
performed. Entities should continue to evaluate whether they expect the
goods to be delivered or services to be rendered. If an entity does not
expect the goods to be delivered or services to be rendered, the capitalized
advance payment should be charged to expense. The consensus in this Issue
should be effective for fiscal years beginning after December 15, 2007,
including interim periods within those fiscal years. Entities should report
the effects of applying the [consensus] in this Issue as a change in accounting
principle through a cumulative-effect adjustment to retained earnings or to
other components of equity or net assets in the statement of financial position
as of the beginning of the year of adoption. An entity should disclose
the cumulative effect of the change on retained earnings or on other components
of equity or net assets in the statement of financial position. Earlier
application is not permitted. The Company plans to adopt this pronouncement in
fiscal years beginning July 1, 2008 and does not believe the adoption of EITF
07-3 will have a material effect on the consolidated financial statements.
F-45
Fair Value
Measurements
In
February 2007, the FASB issued FAS 159, The Fair Value Option for Financial
Assets and Financial Liabilities (FAS 159). FAS 159 permits entities to
choose to measure many financial instruments and certain other items at fair
value. The objective is to improve financial reporting by providing entities
with the opportunity to mitigate volatility in reported earnings caused by
measuring related assets and liabilities differently without having to apply
complex hedge accounting provisions. FAS 159 is expected to expand the use of
fair value measurement, which is consistent with the FASBs long-term
measurement objectives for accounting for financial instruments. FAS 159 also
establishes presentation and disclosure requirements designed to facilitate comparisons
between entities that choose different measurement attributes for similar types
of assets and liabilities. FAS 159 does not affect any existing accounting
literature that requires certain assets and liabilities to be carried at fair
value. This Statement does not establish requirements for recognizing and
measuring dividend income, interest income, or interest expense. This Statement
does not eliminate disclosure requirements included in other accounting
standards, including requirements for disclosures about fair value measurements
included in FASB Statements No. 157, Fair Value Measurements, and
No. 107, Disclosures about Fair Value of Financial Instruments. FAS 159 is
effective for financial statements issued for fiscal years beginning after November
15, 2007. The Company plans to adopt this pronouncement in fiscal years
beginning July 1, 2008 and does not believe the adoption of FAS 159 will have a
material effect on the consolidated financial statements.
F-46
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