QLT Inc. (Nasdaq:QLTI) (TSX:QLT) ("QLT" or the "Company") is a
biotechnology company dedicated to the development and
commercialization of innovative ocular products that address the
unmet medical needs of patients and clinicians worldwide. The
Company reported financial results today for the fourth quarter and
year ended December 31, 2014. Unless otherwise specified, all
amounts are reported in U.S. dollars and in accordance with U.S.
GAAP.
2014 FOURTH QUARTER AND YEAR END FINANCIAL
RESULTS
Operating Expenses/Income
Research and Development ("R&D") Expenses
R&D expenses relate to QLT's synthetic retinoid program.
During the fourth quarter of 2014, R&D expenses were $2.1
million, compared to $4.8 million for the same period in 2013. The
$2.7 million decrease was primarily due to higher costs incurred in
the fourth quarter of 2013 in connection with QLT's Leber
Congenital Amaurosis ("LCA") and Retinitis Pigmentosa ("RP") Phase
Ib retreatment study, toxicity studies and the commencement of the
impaired dark adaptation ("IDA") study. The quarter-over-quarter
decline in R&D expense was also favorably impacted by a
decrease in overall spending and a lower R&D headcount in 2014
relative to 2013.
For the year ended December 31, 2014, R&D expenses were
$13.8 million compared to $18.5 million for the same period in
2013. The $4.7 million decrease was primarily due to higher costs
incurred in 2013 related to the LCA and RP Phase Ib retreatment
study, which was substantially completed in 2013, and further
savings realized in 2014 from QLT's 2012 restructuring activities.
These R&D expense decreases were partially offset by higher
costs incurred in 2014 related to the preparatory activities for
the QLT091001 proposed pivotal trial, the IDA study, and higher
stock based compensation expense associated with certain stock
options granted for incentive and retention purposes.
Selling, General and Administrative ("SG&A") Expenses
During the fourth quarter of 2014, SG&A expenses were $8.1
million compared to $1.4 million for the same period in 2013. The
$6.7 million increase was primarily due to the $5.7 million breakup
fee ("Breakup Fee") paid to QLT's financial advisor, Credit Suisse
Securities (USA) LLC, in connection with the October 9, 2014
termination of the proposed merger with Auxilium, described below,
as well as other consulting and advisory fees related to the
Company's reevaluation and exploration of strategic
alternatives.
During the year ended December 31, 2014, SG&A expenses were
$16.8 million compared to $7.0 million for the same period in 2013.
The $9.8 million increase was primarily due to $10.2 million of
consulting and transaction fees related to the proposed merger with
Auxilium, which includes the Breakup Fee, and consulting and
advisory costs as described above. These cost increases were
partially offset by net overall savings realized in 2014 related to
the further impact of QLT's 2012 restructuring activities.
Restructuring Charges
During the fourth quarter of 2014, restructuring charges were
nil compared to $0.2 million for the same period in 2013. During
the year ended December 31, 2014, restructuring charges were $0.7
million compared to $2.0 million for the same period in 2013. These
restructuring charges primarily consisted of continuing severance
and termination costs related to QLT's 2012 restructuring
activities.
Termination Fee
In accordance with the termination provisions of the Auxilium
Merger Agreement, as described below, on October 9, 2014, Auxilium
paid QLT a $28.4 million termination fee ("Termination Fee"). The
Termination Fee significantly offset QLT's operating expense for
the year ended December 31, 2014.
Operating Income (Loss) and Net Income (Loss) per
Share
During the fourth quarter of 2014, operating income was $17.9
million compared to an operating loss of $6.6 million for the same
period in 2013. The full year operating loss for 2014 was $3.8
million compared to $28.5 million in 2013. The improvement in
operating results in 2014 is primarily due to the receipt of the
$28.4 million Termination Fee.
Net income per share from continuing operations was $0.31 in the
fourth quarter of 2014, compared to a loss per share of $0.11 for
the same period in 2013. Loss per share for the full year in 2014
was $0.08, compared to a loss per share of $0.51 in 2013. The
improvement in earnings per share in 2014 is primarily due to the
receipt of the $28.4 million Termination Fee.
Cash and Cash Equivalents
As at December 31, 2014, the Company's consolidated cash and
cash equivalents were $155.9 million compared to $118.5 million of
cash and cash equivalents at the end of 2013. The increase was
primarily due to $38.1 million of proceeds received from Tolmar in
connection with the Eligard related contingent consideration and
the $28.4 million Termination Fee received from Auxilium. These
cash increases were partially offset by the $10.2 million of merger
related consulting and transaction fees described under the
SG&A Expenses section above as well as cash used in operating
activities.
Termination of Merger Agreement with
Auxilium
On October 8, 2014, Auxilium terminated the Agreement and Plan
of Merger dated June 25, 2014 (the "Merger Agreement") among
QLT, Auxilium, QLT Holding Corp. and QLT Acquisition Corp. The
Merger Agreement contemplated a business combination whereby
Auxilium would have become an indirect wholly-owned subsidiary of
QLT (the "Combined Company") and Auxilium's stockholders would have
received common shares representing approximately 76% of the
Combined Company. Auxilium terminated the Merger Agreement
after receiving from Endo International plc what Auxilium's board
of directors determined to be a "superior proposal" to acquire all
of the issued and outstanding shares of Auxilium.
Strategic Review and Synthetic Retinoid Program
Update
Following the termination of the Merger Agreement
in October 2014, QLT has continued to review its strategic and
business options, having engaged Greenhill & Co. to
act as its advisor in connection with developing, and providing
advice with respect to, various strategic and business alternatives
for the Company. Strategic and business alternatives that QLT may
consider include, but are not limited to, asset divestiture,
partnering or other collaboration agreements, merger, reverse
merger, reorganization or similar transactions, potential
acquisitions, or recapitalizations.
During 2014, the Company continued to advance development of
QLT091001, its synthetic retinoid product candidate, for the
treatment of certain inherited retinal diseases toward pivotal
trials. Following meetings with the U.S. Food and Drug
Administration ("FDA") and the European Medicines Agency ("EMA"),
in 2014 the Company amended and finalized its proposed pivotal
trial protocol to test the safety and efficacy of QLT091001 in
subjects with Inherited Retinal Disease phenotypically diagnosed as
Leber Congenital Amaurosis ("LCA") or Retinitis Pigmentosa ("RP")
caused by RPE65 or LRAT gene mutations ("IRD"). At present, there
is no approved therapeutic treatment option for these patients.
In an effort to accelerate the commercial availability of
QLT091001 as a treatment option, the Company is currently exploring
with the EMA a submission of a Marketing Authorization Application
("MAA") in 2016 for conditional approval of QLT091001 for the
treatment of IRD based on the existing clinical data.
Advisory meetings with certain European regulatory
authorities are scheduled for early 2015. The outcome of these
meetings will determine whether the Company proceeds to submit a
Marketing Authorization Application for conditional approval with
the EMA and decisions concerning the timing of commencement of a
pivotal trial. Conditional approval, if granted, would
be made subject to specified conditions, including among other
things, that the Company complete and have favorable safety and
efficacy data from additional studies, including one or more
pivotal trials of QLT091001 for IRD.
Passive Foreign Investment Company
The Company believes that it was classified as a Passive Foreign
Investment Company ("PFIC") for 2008 through 2014, and that it may
be classified as a PFIC in 2015, which could have adverse tax
consequences for U.S. shareholders. Please refer to our 2014 Annual
Report on Form 10-K for additional information.
QLT Inc. - Financial
Highlights |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS)
INCOME |
(In thousands of U.S. dollars
except share and per share information) |
|
|
Three months ended
December 31, |
Year ended December
31, |
|
2014 |
2013 |
2014 |
2013 |
|
|
|
|
|
Expenses |
|
|
|
|
Research and development |
$ 2,119 |
$ 4,794 |
$ 13,803 |
$ 18,509 |
Selling, general and administrative |
8,149 |
1,418 |
16,791 |
6,986 |
Depreciation |
211 |
247 |
891 |
964 |
Restructuring charges |
-- |
184 |
744 |
2,031 |
Termination
Fee |
(28,400) |
-- |
(28,400) |
-- |
|
(17,921) |
6,643 |
3,829 |
28,490 |
|
|
|
|
|
Operating income (loss) |
17,921 |
(6,643) |
(3,829) |
(28,490) |
|
|
|
|
|
Other (expense)
income |
|
|
|
|
Net foreign exchange gains
(losses) |
12 |
4 |
(62) |
(32) |
Interest income |
33 |
36 |
113 |
211 |
Fair value change in contingent
consideration |
(2,000) |
961 |
(534) |
2,865 |
Other gains |
-- |
107 |
115 |
207 |
|
(1,955) |
1,108 |
(368) |
3,251 |
|
|
|
|
|
Income (Loss) from continuing
operations before income taxes |
15,966 |
(5,535) |
(4,197) |
(25,239) |
|
|
|
|
|
(Provision for) recovery of
income taxes |
(2) |
(165) |
192 |
(599) |
Income (Loss) from continuing
operations |
15,964 |
(5,700) |
(4,005) |
(25,838) |
|
|
|
|
|
(Loss) income from discontinued operations,
net of income taxes |
(3) |
851 |
(66) |
967 |
|
|
|
|
|
Net income (loss) and
comprehensive income (loss) |
$ 15,961 |
$ (4,849) |
$ (4,071) |
$ (24,871) |
|
|
|
|
|
Basic and diluted net income (loss)
per common share (1) |
|
|
|
|
Continuing
operations |
$ 0.31 |
$ (0.11) |
$ (0.08) |
$ (0.51) |
Discontinued
operations |
(0.00) |
0.02 |
(0.00) |
0.02 |
Net
income (loss) per common share |
$ 0.31 |
$ (0.10) |
$ (0.08) |
$ (0.49) |
|
|
|
|
|
Weighted average number of common
shares outstanding (thousands) (1) |
|
|
|
|
Basic |
51,191 |
51,082 |
51,126 |
50,909 |
Diluted |
51,220 |
51,082 |
51,126 |
50,909 |
|
|
|
|
|
(1) During the
three months ended December 31, 2014, the Company's RSUs had a
dilutive impact. However, the dilutive impact did not change the
income per common share value, as basic and diluted net income per
common share were calculated as $0.31. |
|
|
|
|
|
|
|
CONSOLIDATED BALANCE
SHEETS |
|
|
(In thousands of U.S. dollars) |
|
|
As at December 31, |
2014 |
2013 |
ASSETS |
|
|
Current assets |
|
|
Cash and cash equivalents |
$ 155,908 |
$ 118,521 |
Accounts receivable, net of allowances
for doubtful accounts - current |
363 |
4,590 |
Contingent consideration - current |
-- |
36,582 |
Income taxes receivable |
47 |
77 |
Deferred income tax assets -
current |
-- |
191 |
Prepaid and other
assets |
1,053 |
1,863 |
Total current
assets |
157,371 |
161,824 |
|
|
|
Accounts receivable - non-current |
2,000 |
-- |
Property, plant and equipment |
1,000 |
1,866 |
Deferred income tax assets -
non-current |
-- |
177 |
Total assets |
$ 160,371 |
$ 163,867 |
|
|
|
LIABILITIES |
|
|
Current liabilities |
|
|
Accounts payable |
$ 1,943 |
$ 2,609 |
Accrued liabilities |
1,528 |
1,498 |
Accrued restructuring
charge |
-- |
130 |
Total current
liabilities |
3,471 |
4,237 |
|
|
|
Uncertain tax position
liabilities |
388 |
1,846 |
Total
liabilities |
3,859 |
6,083 |
|
|
|
SHAREHOLDERS' EQUITY |
|
|
Share capital |
|
|
Authorized |
|
|
500,000,000 common shares
without par value |
|
|
5,000,000 first preference
shares without par value, issuable in series |
|
|
Issued and outstanding common
shares |
$ 467,034 |
$ 466,229 |
December 31, 2014 – 51,199,922
shares |
|
|
December 31, 2013 – 51,081,878
shares |
|
|
Additional paid-in capital |
97,838 |
95,844 |
Accumulated deficit |
(511,329) |
(507,258) |
Accumulated other
comprehensive income |
102,969 |
102,969 |
Total shareholders'
equity |
156,512 |
157,784 |
Total shareholders' equity and
liabilities |
$ 160,371 |
$ 163,867 |
About QLT
QLT is a biotechnology company dedicated to the development and
commercialization of innovative ocular products that address the
unmet medical needs of patients and clinicians worldwide. We are
focused on developing our synthetic retinoid program for the
treatment of certain inherited retinal diseases.
QLT's head office is based in Vancouver, Canada and the Company
is publicly traded on NASDAQ Stock Market (symbol: QLTI) and the
Toronto Stock Exchange (symbol: QLT). For more information about
the Company's products and developments, please visit our web site
at www.qltinc.com.
Visudyne® is a registered trademark of Novartis AG
Eligard® is a registered trademark of Tolmar Therapeutics,
Inc.
Certain statements in this press release constitute
"forward-looking statements" of QLT within the meaning of the
Private Securities Litigation Reform Act of 1995 and constitute
"forward-looking information" within the meaning of applicable
Canadian securities laws. Forward-looking statements include, but
are not limited to: statements concerning our PFIC status;
statements concerning the timing and outcome of our evaluation of a
potential EMA conditional approval pathway for QLT091001;
statements concerning our potential submission of Marketing
Authorization Application with the EMA for conditional approval and
the potential commencement of one or more pivotal trials for
QLT091001; statements concerning our review of strategic
alternatives; and statements which contain language such as:
"assuming," "prospects," "goal," "future," "projects," "potential,"
"believes," "expects," "hopes," and "outlook." Forward-looking
statements are predictions only which involve known and unknown
risks, uncertainties and other factors that may cause actual
results to be materially different from those expressed in such
statements. Many such risks, uncertainties and other factors are
taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the
following: the Company's future operating results are uncertain and
likely to fluctuate; currency fluctuations; the risk that we may
not receive any or as much additional contingent consideration as
we might expect under our agreements with respect to the sale of
Visudyne® and the PPDS Technology; the risk that we will be treated
as a Passive Foreign Investment Company (PFIC) in 2014 and future
years; the risk that the Company will determine it is not feasible
to submit a Marketing Authorization Application for conditional
approval with the EMA based upon existing clinical data or other
reasons and the impact of this outcome on the Company's potential
plans to commence a pivotal trial for QLT091001; the risk that the
EMA denies any conditional approval and Marketing Authorization
Application we may submit; risks and uncertainties concerning the
impact that QLT's success or failure in pursuing various future
strategic initiatives will have on the market price of our
securities; the risk that QLT does not pursue any strategic
transaction or business alternative, or that any such transaction
or business alterative that is pursued is unsuccessful; risks
resulting from the potential loss of key personnel; uncertainties
relating to our development plans, timing and results of the
clinical development and commercialization of our products and
technologies, including pivotal clinical trials; assumptions
related to continued enrollment trends, efforts and success, and
the associated costs of these programs; outcomes for our clinical
trials may not be favorable or may be less favorable than
interim/preliminary results and/or previous trials; there may be
varying interpretations of data produced by one or more of our
clinical trials; risks and uncertainties associated with the safety
and effectiveness of our technology; the timing, expense and
uncertainty associated with the regulatory approval process for
products to advance through development stages; risks and
uncertainties related to the scope, validity, and enforceability of
our intellectual property rights and the impact of patents and
other intellectual property of third parties; and general economic
conditions and other factors described in detail in QLT's Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and other
filings with the U.S. Securities and Exchange Commission and
Canadian securities regulatory authorities. Forward-looking
statements are based on the current expectations of QLT and QLT
does not assume any obligation to update such information to
reflect later events or developments except as required by law.
This press release also contains "forward looking information"
that constitutes "financial outlooks" within the meaning of
applicable Canadian securities laws. This information is provided
to give investors general guidance on management's current
expectations of certain factors affecting our business, including
our financial results. Given the uncertainties, assumptions and
risk factors associated with this type of information, including
those described above, investors are cautioned that the information
may not be appropriate for other purposes.
CONTACT: QLT Inc. Contacts:
Investor & Media Relations
Andrea Rabney or David Pitts
Argot Partners
212-600-1902
andrea@argotpartners.com
david@argotpartners.com
Quantshares U.S. Market Neutral Quality Fund Etf (AMEX:QLT)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Quantshares U.S. Market Neutral Quality Fund Etf (AMEX:QLT)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024