Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES AND EXCHANGE ACT OF 1934
|
|
|
For the quarterly period ended
September 30, 2009
|
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND
EXCHANGE ACT OF 1934
|
For
the transition period from
to
Commission
File Number: 001-32715
INTERLEUKIN GENETICS, INC.
(Exact name of
registrant in its charter)
Delaware
|
|
94-3123681
|
(State
or other jurisdiction of
incorporation or organization)
|
|
(I.R.S.
Employer
Identification No.)
|
|
|
|
135 Beaver Street, Waltham, MA
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|
02452
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
Registrants Telephone
Number:
(781) 398-0700
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. YES
x
NO
o
Indicate
by check mark whether each registrant has submitted electronically and posted
on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit and post such files). YES
o
NO
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of large accelerated filer, accelerated filer and smaller
reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
o
|
|
Accelerated filer
o
|
|
|
|
Non-Accelerated
filer
o
(Do
not check if a smaller reporting company)
|
|
Smaller
reporting company
x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act). YES
o
NO
x
Indicate
the number of shares outstanding of each of the issuers classes of common
stock, as of the latest practicable date.
Class
|
|
Outstanding
at October 29, 2009
|
Common Stock, par value $0.001 per share
|
|
32,102,435
|
Table of Contents
PART I FINANCIAL INFORMATION
Item 1. Financial
Statements
INTERLEUKIN
GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
September 30,
2009
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|
December 31,
2008
|
|
|
|
(Unaudited)
|
|
(Audited)
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|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,421,621
|
|
$
|
4,952,481
|
|
Accounts receivable from related party
|
|
36,410
|
|
35,167
|
|
Trade accounts receivable
|
|
10,978
|
|
8,219
|
|
Inventory
|
|
95,913
|
|
|
|
Prepaid
expenses and other current assets
|
|
242,884
|
|
162,834
|
|
Current
assets of discontinued operations
|
|
53,247
|
|
1,707,583
|
|
Total current assets
|
|
1,861,053
|
|
6,866,284
|
|
Fixed assets, net
|
|
850,865
|
|
435,480
|
|
Intangible assets, net
|
|
774,354
|
|
889,941
|
|
Other assets
|
|
238,001
|
|
38,001
|
|
Other assets of discontinued
operations
|
|
|
|
3,924,682
|
|
Total assets
|
|
$
|
3,724,273
|
|
$
|
12,154,388
|
|
LIABILITIES
AND STOCKHOLDERS EQUITY
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
725,262
|
|
$
|
884,421
|
|
Accrued expenses
|
|
425,463
|
|
197,023
|
|
Deferred revenue
|
|
77,820
|
|
403,475
|
|
Accrued
expenses related to funded research and development projects
|
|
22,056
|
|
22,056
|
|
Liabilities of discontinued operations
|
|
1,431,293
|
|
2,159,986
|
|
Total current liabilities
|
|
2,681,894
|
|
3,666,961
|
|
Convertible long term debt
|
|
5,000,000
|
|
4,000,000
|
|
Deferred tax liability
|
|
|
|
5,000
|
|
Total liabilities
|
|
7,681,894
|
|
7,671,961
|
|
Stockholders (deficit) equity:
|
|
|
|
|
|
Convertible preferred stock, $0.001 par value
6,000,000 shares authorized; 5,000,000 shares of Series A issued and
outstanding at September 30, 2009 and December 31, 2008; aggregate
liquidation preference of $18,000,000 at September 30, 2009
|
|
5,000
|
|
5,000
|
|
Common stock, $0.001 par value 100,000,000
shares authorized; 32,079,833 and 31,799,381 shares issued and outstanding at
September 30, 2009 and December 31, 2008, respectively
|
|
32,080
|
|
31,799
|
|
Additional paid-in capital
|
|
85,729,881
|
|
85,458,334
|
|
Accumulated deficit
|
|
(89,724,582
|
)
|
(81,012,706
|
)
|
Total stockholders (deficit) equity
|
|
(3,957,621
|
)
|
4,482,427
|
|
Total liabilities and stockholders
(deficit) equity
|
|
$
|
3,724,273
|
|
$
|
12,154,388
|
|
The accompanying notes are
an integral part of these consolidated financial statements.
3
Table
of Contents
INTERLEUKIN GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended September 30,
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|
Nine
Months Ended September 30,
|
|
|
|
2009
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|
2008
|
|
2009
|
|
2008
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Revenue from related party
|
|
$
|
286,146
|
|
$
|
533,310
|
|
$
|
826,423
|
|
$
|
1,666,949
|
|
Revenue from others
|
|
36,736
|
|
12,284
|
|
66,916
|
|
42,136
|
|
Total revenue
|
|
322,882
|
|
545,594
|
|
893,339
|
|
1,709,085
|
|
Cost of revenue
|
|
305,303
|
|
235,795
|
|
912,150
|
|
679,037
|
|
Gross profit (loss)
|
|
17,579
|
|
309,799
|
|
(18,811
|
)
|
1,030,048
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
873,195
|
|
933,003
|
|
2,628,943
|
|
2,455,230
|
|
Selling, general and administrative
|
|
1,660,235
|
|
1,196,580
|
|
4,473,860
|
|
3,864,216
|
|
Amortization of intangibles
|
|
28,863
|
|
26,271
|
|
86,590
|
|
70,611
|
|
Total operating expenses
|
|
2,562,293
|
|
2,155,854
|
|
7,189,393
|
|
6,390,057
|
|
Loss from operations
|
|
(2,544,714
|
)
|
(1,846,055
|
)
|
(7,208,204
|
)
|
(5,360,009
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
740
|
|
38,591
|
|
9,905
|
|
130,498
|
|
Interest expense
|
|
(40,959
|
)
|
(50,411
|
)
|
(108,363
|
)
|
(79,842
|
)
|
Total other income (expense)
|
|
(40,219
|
)
|
(11,820
|
)
|
(98,458
|
)
|
50,656
|
|
Net loss from continuing
operations before income taxes
|
|
(2,584,933
|
)
|
(1,857,875
|
)
|
(7,306,662
|
)
|
(5,309,353
|
)
|
Benefit for income taxes
|
|
|
|
37,000
|
|
|
|
31,000
|
|
Net loss from continuing
operations
|
|
$
|
(2,584,933
|
)
|
$
|
(1,820,875
|
)
|
$
|
(7,306,662
|
)
|
$
|
(5,278,353
|
)
|
Discontinued operations:
|
|
|
|
|
|
|
|
|
|
Profit(loss) from discontinued operations, net of
income taxes
|
|
40,661
|
|
179,026
|
|
(59,012
|
)
|
95,057
|
|
Loss on sale of discontinued operations including
impairment charge of $3,251,838 in 2009
|
|
|
|
|
|
(1,346,202
|
)
|
|
|
Profit(loss) on discontinued
operations
|
|
$
|
40,661
|
|
$
|
179,026
|
|
$
|
(1,405,214
|
)
|
$
|
95,057
|
|
Net loss
|
|
$
|
(2,544,272
|
)
|
$
|
(1,641,849
|
)
|
$
|
(8,711,876
|
)
|
$
|
(5,183,296
|
)
|
Basic and diluted net (loss)
income per common share from
:
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
$
|
(0.08
|
)
|
$
|
(0.06
|
)
|
$
|
(0.23
|
)
|
$
|
(0.17
|
)
|
Discontinued operations
|
|
|
|
0.01
|
|
$
|
(0.04
|
)
|
|
|
Net loss
|
|
$
|
(0.08
|
)
|
$
|
(0.05
|
)
|
$
|
(0.27
|
)
|
$
|
(0.17
|
)
|
Weighted average common shares
outstanding, basic and diluted
|
|
32,059,258
|
|
31,792,999
|
|
31,975,953
|
|
31,204,196
|
|
The accompanying notes are
an integral part of these consolidated financial statements.
4
Table of Contents
INTERLEUKIN GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS
(DEFICIT) EQUITY
For the Nine Months Ended September 30, 2009
(Unaudited)
|
|
Convertible Preferred
Stock
|
|
Common Stock
|
|
Additional
|
|
|
|
|
|
|
|
Shares
|
|
$0.001
par value
|
|
Shares
|
|
$0.001
par value
|
|
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Total
|
|
Balance as of December 31, 2008
(Audited)
|
|
5,000,000
|
|
$
|
5,000
|
|
31,799,381
|
|
$
|
31,799
|
|
$
|
85,458,334
|
|
$
|
(81,012,706
|
)
|
$
|
4,482,427
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
(8,711,876
|
)
|
(8,711,876
|
)
|
Common stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock grants
|
|
|
|
|
|
126,500
|
|
126
|
|
34,030
|
|
|
|
34,156
|
|
Exercise of stock option
|
|
|
|
|
|
15,000
|
|
15
|
|
3,885
|
|
|
|
3,900
|
|
Employee stock purchase plan
|
|
|
|
|
|
126,452
|
|
127
|
|
24,759
|
|
|
|
24,886
|
|
Restricted stock awards
|
|
|
|
|
|
12,500
|
|
13
|
|
(13
|
)
|
|
|
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
208,886
|
|
|
|
208,886
|
|
Balance as of September 30,
2009
|
|
5,000,000
|
|
$
|
5,000
|
|
32,079,833
|
|
$
|
32,080
|
|
$
|
85,729,881
|
|
$
|
(89,724,582
|
)
|
$
|
(3,957,621
|
)
|
The accompanying notes are
an integral part of these consolidated financial statements.
5
Table of Contents
INTERLEUKIN GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the
Nine Months Ended Sept. 30,
|
|
|
|
2009
|
|
2008
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES:
|
|
|
|
|
|
Net loss
|
|
$
|
(8,711,876
|
)
|
$
|
(5,183,296
|
)
|
Loss on disposal of
discontinued operations
|
|
1,346,202
|
|
|
|
Net loss from discontinued operations
|
|
59,012
|
|
(95,057
|
)
|
Net loss from continuing
operations
|
|
(7,306,662
|
)
|
(5,278,353
|
)
|
Adjustments to reconcile
net loss from continued operations to net cash used in operating activities:
|
|
|
|
|
|
Depreciation and
amortization
|
|
380,208
|
|
275,389
|
|
Stock-based compensation
expense
|
|
170,109
|
|
119,595
|
|
Changes in operating
assets and liabilities, net of business sold:
|
|
|
|
|
|
Accounts receivable, net
|
|
(4,002
|
)
|
16,974
|
|
Inventory
|
|
(95,913
|
)
|
|
|
Prepaid expenses and other
current assets
|
|
(80,050
|
)
|
52,097
|
|
Accounts payable
|
|
(159,159
|
)
|
(84,355
|
)
|
Accrued expenses
|
|
228,440
|
|
(382,674
|
)
|
Deferred revenue
|
|
(325,654
|
)
|
(493,009
|
)
|
Accrued expenses related
to funded research and development
|
|
|
|
(70,000
|
)
|
Deferred tax provision
|
|
|
|
(31,000
|
)
|
Cash provided on sale of
Alan James Group business
|
|
4,372,292
|
|
|
|
Net cash used in operating
activities of discontinuing operations
|
|
(1,093,403
|
)
|
1,060,127
|
|
Net cash used in operating
activities
|
|
(3,913,794
|
)
|
(4,815,209
|
)
|
CASH FLOWS FROM INVESTING
ACTIVITIES:
|
|
|
|
|
|
Capital additions
|
|
(709,005
|
)
|
(107,143
|
)
|
Other assets
|
|
28,997
|
|
(222,297
|
)
|
Settlement of claims
relating to the acquisition of the assets and business of the Alan James
Group, LLC
|
|
|
|
(600,000
|
)
|
Net cash used in investing
activities
|
|
(680,008
|
)
|
(929,440
|
)
|
CASH FLOWS FROM FINANCING
ACTIVITIES:
|
|
|
|
|
|
Proceeds from issuance of
notes payable
|
|
1,000,000
|
|
4,000,000
|
|
Proceeds from exercises of rights offering, stock
warrants, options and employee stock purchase plan
|
|
62,942
|
|
13,029
|
|
Net cash provided by
financing activities
|
|
1,062,942
|
|
4,013,029
|
|
Net decrease in cash and
cash equivalents
|
|
(3,530,860
|
)
|
(1,731,620
|
)
|
Cash and cash equivalents,
beginning of period
|
|
4,952,481
|
|
7,646,468
|
|
Cash and
cash equivalents, end of period
|
|
$
|
1,421,621
|
|
$
|
5,914,848
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
|
Cash paid for income taxes
|
|
$
|
61,300
|
|
$
|
|
|
Cash paid for interest
|
|
$
|
108,363
|
|
$
|
30,488
|
|
Supplemental disclosures of
non-cash investing activities:
|
|
|
|
|
|
Receivable for
discontinued operations
|
|
$
|
200,000
|
|
$
|
|
|
The accompanying notes are
an integral part of these consolidated financial statements.
6
Table of
Contents
INTERLEUKIN GENETICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1Basis
of Presentation
The condensed consolidated financial statements include the accounts of
Interleukin Genetics, Inc. (the Company), and its wholly-owned
subsidiaries, as of September 30, 2009 and have been prepared by the
Company in accordance with accounting principles generally accepted in the
United States of America for interim financial reporting. Accordingly, they do
not include all of the information and notes required by generally accepted
accounting principles for complete financial statements. All intercompany
accounts and transactions have been eliminated. These unaudited condensed
consolidated financial statements, which, in the opinion of management, reflect
all adjustments (including normal recurring adjustments) necessary for a fair
presentation, should be read in conjunction with the financial statements and
notes thereto included in the Companys Annual Report on Form 10-K for the
year ended December 31, 2008. Operating results for the nine months ended September 30,
2009 include results from continuing operations. Prior to the opening of business
on July 1, 2009 the Company and its wholly-owned subsidiary AJG Brands, Inc.
sold substantially all of the Alan James Group Business and assets of AJG
Brands, Inc. Operating results for AJG Brands, Inc. are reflected in
discontinued operations. Operating results are not necessarily indicative of
the results that may be expected for any future interim period or for the
entire fiscal year.
Note 2Settlement of
acquisition contingency
On March 25, 2008, the Company entered into an agreement with the
former owners of the Alan James Group regarding the acquisition of the assets
and business of the Alan James Group. Under the agreement, the former owners
agreed to release the Company from any further obligations under the Asset
Purchase Agreement, relating to the acquisition of the assets and business of
the Alan James Group on August 17, 2006. The former owners agreed that no
further amounts are or will become due under the Purchase Agreement (including
its earn-out provisions).
In addition, on March 25, 2008, the Company agreed to pay a total
of $1,200,000. This agreement resolved all remaining issues associated with the
Companys August 2006 acquisition of that business including contingent
consideration and compensation arrangements with the sellers/former management.
The Company applied $600,000 of the settlement cost against the previously
accrued separation expense that was recorded on September 30, 2007 and the
remaining $600,000 was applied against the $2,130,374 aggregate total of
contingent liabilities and amounts due under escrow recorded as part of the
original acquisition. The remaining contingent liabilities and amounts due
under escrow balance of $1,530,374 was eliminated as no longer due and applied
as a reduction in the balances on a pro rata basis of the intangible assets
recorded as part of the original acquisition, including the effect of term
reduction on the non-compete agreements.
Note 3Discontinued Operations
Prior to the opening of business on July 1, 2009, the Company and
its wholly-owned subsidiary, AJG Brands, Inc. entered into an asset
purchase agreement with Nutraceutical Corporation and Pep Products, Inc.,
a wholly-owned subsidiary of Nutraceutical Corporation, pursuant to which
substantially all of the Alan James Group business and assets of AJG Brands, Inc.
were sold to Pep Products, Inc. for an aggregate sale price of $4,572,292.
The proceeds consist of a $200,000 holdback reflected in other assets and
$4,372,292 received on July 1, 2009. The assets sold consisted primarily of
accounts receivable, inventories, property and equipment and other assets
related to the
business,
which primarily develops, markets and sells nutritional supplements and related
products into retail consumer channels
. The buyer did not assume
accounts payable and accrued liabilities. Subsequent to the closing, AJG Brands, Inc.s
name was changed to Interleukin Brands, Inc. (IBI). The assets remaining
in IBI consist primarily of certain remaining accounts receivable and
inventory. All remaining accounts receivable and inventory has been fully
reserved for. Liabilities of discontinued operations primarily consist of
accruals for inventory in the retail channel with the right of return.
At June 30, 2009 the Company recognized a loss on the sale of
discontinued operations of $1,346,202. This includes a gain on the sale of net
tangible assets of $2,579,879, direct costs of the disposition of $674,243 and
a loss from the permanent impairment of all remaining AJG Brands, Inc.s
intangible assets in the amount of $3,251,838.
AJG Brands, Inc.s sales reported in discontinued operations for
the three months and nine months ended September 30, 2009 were $0 and
$3,580,169, respectively, and for the three months and nine months ended September 30,
2008 were $1,626,001 and $5,593,267, respectively.
7
Table
of Contents
The following is a summary of the net assets sold at the close of
business on June 30, 2009.
Accounts receivable
|
|
$
|
1,114,835
|
|
Inventories
|
|
783,512
|
|
Property and equipment,
net
|
|
21,073
|
|
Other assets
|
|
72,993
|
|
Net tangible assets sold from discontinued
operations
|
|
$
|
1,992,413
|
|
Note 4Significant Accounting Policies
Principles of Consolidation
The condensed consolidated financial statements include the accounts of
Interleukin Genetics, Inc., and its wholly-owned subsidiaries, Interleukin
Genetics Laboratory Services, Inc. and Interleukin Brands, Inc.,
formerly AJG Brands, Inc. doing business as the Alan James Group. All
intercompany accounts and transactions have been eliminated. In 2008 the
Company has separately disclosed the operating portion of cash flows
attributable to discontinued operations, which in prior periods were reported
in a combined basis as a single amount.
Management Estimates
The preparation of financial
statements in conformity with accounting principles generally accepted in the
United States of America requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosures of
contingent assets and liabilities at the date of the financial statements, as
well as the reported amounts of revenue and expenses during the reported
periods. Actual results could differ from those estimates. The Companys most
critical accounting policies are in areas of its strategic alliance with
Alticor (see Note 5), revenue recognition, allowance for sales returns, trade
promotions, accounts receivable, inventory, stock-based compensation, income
taxes, and long-lived assets. These critical accounting policies are more fully
discussed in these notes to the consolidated financial statements.
Revenue Recognition
Revenue from genetic testing
services is recognized when there is persuasive evidence of an arrangement,
service has been rendered, the sales price is determinable and collectability
is reasonably assured. Service is deemed to be rendered when the results have
been reported to the individual who ordered the test. To the extent that tests
have been prepaid but results have not yet been reported, recognition of all
related revenue is deferred. As of September 30, 2009 and December 31,
2008, the Company has deferred revenue of $23,200 and $80,000, respectively,
for tests that have been prepaid but results have not yet been reported.
Revenue from product sales
is recognized when there is persuasive evidence of an arrangement, delivery has
occurred and title and risk of loss have transferred to the customer, the sales
price is determinable and collectability is reasonably assured. The Company has
no consignment sales. Product revenue is reduced for allowances and
adjustments, including returns, discontinued items, discounts, trade promotions
and slotting fees.
Revenue from contract
research and development is recognized over the term of the contract as the
Company performs its obligations under that contract (including revenue from
Alticor, a related party).
Allowance for Sales Returns
We analyze sales returns in
accordance with the provisions of Financial Accounting Standards Board (FASB)
Accounting Standards Codification (ASC) 605,
Revenue
Recognition.
We are able to make reasonable and reliable estimates
based on the buying patterns of the end-users of its products based on sales
data received. We believe we have sufficient interaction with and knowledge of
our customers, industry trends and industry conditions to adjust the accrual
for returns when necessary.
At September 30, 2009,
we have fully reserved for any potential sales returns and discontinued items
applicable to the non-acquired accounts resulting from our sale of
substantially all of the assets of the Alan James Group business. The
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reserve of approximately $1.3 million is
deemed to be adequate and no additional amounts were added at September 30,
2009.
Trade Promotions
Pursuant to the asset
purchase agreement in connection with the Companys sale of substantially all
of the Alan James Group business and assets, the Company fully accrued for the
approximately $150,000 of agreed upon trade promotions implemented prior to June 30,
2009. At September 30, 2009 the balance of trade promotions estimated to
be due in the future was $128,000.
Accounts Receivable
Pursuant to the asset
purchase agreement in connection with the Companys sale of substantially all
of the Alan James Group business and assets the Company retained non acquired
accounts receivable in the amount of $180,605 which was fully reserved for as
uncollectible at June 30, 2009. At September 30, 2009 the balance in
non acquired accounts receivable was $64,179 and is fully reserved for in the
Companys financial statements. Prior to the acquisition trade accounts
receivable were stated at their estimated net realizable value, which is
generally the invoiced amount less any estimated discount related to payment
terms. The Company offered its Consumer Product customers a 2% cash discount if
payment was made within 30 days of the invoice date, however, most
customers took the discount regardless of when payment occurred. At December 31,
2008, the Company has reduced trade accounts receivable by $13,364 for discounts
anticipated to be taken and had provided an allowance for uncollectible
accounts of $6,696.
Inventory
Inventory is stated at the
lower of cost or market. Cost is determined using the invoice price from our
vendors. Management periodically evaluates inventory to identify items that are
slow moving or have excess quantities. Management also considers whether
certain items are carried at values that exceed the ultimate sales price less
selling costs. Where such items are identified, management adjusts the carrying
value to the lower of cost or market.
Inventory on hand includes
items not acquired as part of the sale of substantially all of the assets and
business of AJG Brands, Inc. and product inventory related to our Inherent
Health brand of genetic tests.
The inventory reserve at September 30,
2009 consists entirely of the non acquired inventory in connection with the
Companys sale of substantially all of the Alan James Group business and assets
Inventory primarily
consisted of the following at September 30, 2009 and December 31,
2008:
|
|
2009
|
|
2008
|
|
Raw materials
|
|
$
|
31,791
|
|
$
|
130,108
|
|
Finished goods
|
|
166,798
|
|
701,081
|
|
Inventory reserve
|
|
(102,676
|
)
|
|
|
Total inventory, net
|
|
$
|
95,913
|
|
$
|
831,189
|
|
Stock-Based Compensation
We account for our stock-based
compensation expense in accordance with FASB ASC 718,
Compensation
Stock Compensation
. The standard addresses all forms of
share-based payment (SBP) awards, including shares issued under employee stock
purchase plans, stock options, restricted stock and stock appreciation rights.
We expense SBP awards with compensation cost for SBP transactions measured at
fair value. Compensation cost for the portion of awards for which the requisite
service has not been rendered that are outstanding as of the effective date
shall be recognized as the requisite service is rendered on or after the
effective date. The compensation cost for that portion of awards shall be based
on the grant-date fair value of those awards as calculated from the pro forma
disclosures. Common stock purchased pursuant to our employee stock purchase
plan will be expensed based upon the fair market value in excess of purchase
price.
Income Taxes
The preparation of its
consolidated financial statements requires the Company to estimate its income
taxes in each of the jurisdictions in which it operates, including those
outside the United States, which may be subject to certain risks that
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ordinarily would not be expected in the
United States. The Company accounts for income taxes in accordance with FASB
ASC 740,
Income Taxes
, which
requires the recognition of taxes payable or refundable for the current year
and deferred tax liabilities and assets for the future tax consequences of
events that have been recognized in the financial statements or tax returns.
The measurement of current and deferred tax liabilities and assets is based on
provisions of the enacted tax law; the effects of future changes in tax laws or
rates are not anticipated. The Company records a valuation allowance to reduce
its deferred tax assets to the amount that is more likely than not to be
realized.
Significant management judgment
is required in determining the Companys provision for income taxes, its
deferred tax assets and liabilities and any valuation allowance recorded
against deferred tax assets. The Company has recorded a full valuation
allowance against its deferred tax assets of $25.4 million as of September 30,
2009, due to uncertainties related to its ability to utilize these assets. The
valuation allowance is based on managements estimates of taxable income by
jurisdiction in which the Company operates and the period over which the
deferred tax assets will be recoverable. In the event that actual results
differ from these estimates or management adjusts these estimates in future
periods, the Company may need to adjust its valuation allowance, which could
materially impact its financial position and results of operations.
Due to recent changes in
Massachusetts corporate income tax regulations, the Company will be filing on a
combined basis with Alticor affiliated entities on a go-forward basis and, as a
result, net operating losses will be fully utilized at September 30, 2009.
The combined filing will have no impact on the Companys financial statements
due to the full valuation allowance that offsets any deferred tax assets.
The Company reviews its
recognition threshold and measurement process for recording in the financial
statements uncertain tax positions taken or expected to be taken in a tax
return. The Company reviews all material tax positions for all years open to
statute to determine whether it is more likely than not that the positions
taken would be sustained based on the technical merits of those positions. The
Company did not recognize any adjustments for uncertain tax positions during
the nine months ended September 30, 2009.
Research and Development
Research and development
costs are expensed as incurred.
Advertising Expense
Advertising costs are
expensed as incurred. During the nine months ended September 30, 2009 and
2008 advertising expense was $887,400 and $471,752, respectively.
Basic and Diluted Net Loss per Common Share
The Company applies the
provisions of FASB ASC 260,
Earnings per
Share
, which establishes standards for computing and presenting
earnings per share. Basic and diluted net loss per share was determined by
dividing net loss applicable to common stockholders by the weighted average
number of shares of common stock outstanding during the period. Diluted net
loss per share is the same as basic net loss per share for all the periods
presented, as the effect of the potential common stock equivalents is
anti-dilutive due to the loss in each period. Potential common stock
equivalents excluded from the calculation of diluted net loss per share
consists of stock options, warrants, convertible preferred stock and
convertible debt as described in the table below:
|
|
As of September 30,
|
|
|
|
2009
|
|
2008
|
|
Options outstanding
|
|
2,106,917
|
|
2,014,073
|
|
Warrants outstanding
|
|
400,000
|
|
400,000
|
|
Convertible preferred
stock
|
|
28,160,200
|
|
28,160,200
|
|
Convertible debt
|
|
880,545
|
|
704,436
|
|
Total
|
|
31,547,662
|
|
31,278,709
|
|
Comprehensive Income (Loss)
Comprehensive income (loss)
is defined as the change in equity of a business enterprise during a period
from transactions and other events and circumstances from non-owner sources.
During the nine months ended September 30, 2009, and 2008, there were no
items other than net loss included in the comprehensive loss.
10
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Fair Value of Financial Instruments
The Company, using available
market information, has determined the estimated fair values of financial
instruments. The stated values of cash and cash equivalents, accounts
receivable and accounts payable approximate fair value due to the short-term
nature of these instruments. The carrying amounts of borrowings under short and
long term agreements approximate their fair value as the rates applicable to
the financial instruments reflect changes in overall market interest rates.
Cash and Cash Equivalents
Cash and cash equivalents
consist of amounts on deposit in checking and savings accounts with banks and
other financial institutions. Short-term investments primarily consist of bank
money market funds which have short-term maturities of less than ninety days
and are carried at cost which approximates fair value.
Fixed Assets
Fixed assets are stated at
cost, less accumulated depreciation and amortization. Depreciation and
amortization are provided using the straight-line method over estimated useful
lives of three to five years. Leasehold improvements are amortized over the
estimated useful life of the asset, or the remaining term of the lease,
whichever is shorter.
Long-Lived Assets
The Company evaluates its
long-lived assets for impairment whenever events or changes in circumstances
indicate that carrying amounts of such assets may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of the
carrying amount of an asset to the future undiscounted net cash flows expected
to be generated by the asset. Any write-downs, based on fair value, are to be
treated as permanent reductions in the carrying amount of the assets. The
Company believes that no impairment exists related to the Companys long-lived
assets at September 30, 2009.
Intangible Assets
The
Company performs
impairment tests on an interim basis, if certain
conditions exist, with impaired assets written down to fair value. See
Note 2 for adjustments of intangible assets related to the settlement
effective March 25, 2008. The Company determined that due to the sale of
substantially all of the Alan James Group business and assets of its
wholly-owned subsidiary, AJG Brands, Inc., prior to the opening of
business on July 1, 2009, the remaining $3,251,838 of intangible assets
became permanently impaired and was expensed.
Recent Accounting Pronouncements
Since January 1, 2008, the Company has applied the provisions of
FASB ASC 820,
Fair Value Measurements and Disclosures
for
financial assets and liabilities. The standard had no material impact on our
results of operations or financial condition. There is a one-year deferral in
applying the measurement provisions to non-financial assets and non-financial
liabilities (non-financial terms) that are not recognized or disclosed at fair
value in an entitys financial statements on a recurring basis (at least
annually). Therefore, if the change in fair value of a non-financial item is
not required to be recognized or disclosed in the financial statements on an
annual basis or more frequently, the effective date of application was deferred
until fiscal years beginning after November 15, 2008. The adoption of this
standard as of January 1, 2009 had no material effect on our results of
operations or financial condition.
Since January 1, 2008
the Company has applied the provisions of FASB ASC 825,
Financial
Instruments
. The statement permits entities to choose to measure
many financial instruments and certain other items at fair value. The Company
has not elected to account for any of its assets or liabilities using the fair
value option and accordingly, the adoption did not have a material effect on
the Companys financial position or results of operations.
Since January 1, 2009 the Company has applied the provisions of
FASB ASC 805,
Business Combinations.
The
Company, upon initially obtaining control in a transaction,
shall recognize 100% of the fair values of acquired assets, including goodwill,
and assumed liabilities, with only limited exceptions, even if the Company has
not acquired 100% of the acquiree. The adoption of this standard had no
material effect on the Companys results of operations or financial condition,
although it could have a material impact on future acquisitions.
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Since January 1, 2009,
The Company has applied the provisions of FASB ASC 810,
Consolidation.
The standard establishes new accounting and reporting standards for
noncontrolling interests in a subsidiary and for the deconsolidation of a
subsidiary and will require entities to classify noncontrolling interests as a
component of stockholders equity as well as require subsequent changes in
ownership interest in a subsidiary to be accounted for as an equity
transaction. Additionally, the standard will require entities to recognize a
gain or loss upon the loss of control of a subsidiary and to remeasure any
ownership interest retained at fair value on that date. This statement also
requires expanded disclosures that clearly identify and distinguish between the
interests of the parent and the interests of the noncontrolling owners. The
standard did not have a material effect on the Companys financial position or
results of operations.
Since January 1, 2009
the Company has applied the provisions of FASB ASC 808,
Collaborative
Arrangements.
The guidance defines collaborative arrangements and
establishes presentation and disclosure requirements for transactions within a
collaborative arrangement (both with third parties and between participants in
the arrangement) and requires retrospective application to all collaborative
arrangements existing as of the effective date, unless retrospective
application is impracticable. The impracticability evaluation and exception
should be performed on an arrangement-by-arrangement basis. The adoption did
not have a significant effect on the Companys financial statements.
Since June 30, 2009 the
Company has applied the provisions of FASB ASC 855,
Subsequent Events
, which established general standards of
accounting for and disclosures of events that occur after the balance sheet
date but before the financial statements are issued or available to be used. The
Company evaluated its September 30, 2009 financial statements for
subsequent events through November 12, 2009, the date the financial
statements were available to be issued. The Company is not aware of any
subsequent events which would require recognition or disclosure in the
financial statements beyond the $2.0 million borrowing on November 9, 2009
disclosed in note 12.
In June 2009, the FASB
issued SFAS No. 166,
Accounting for Transfers
of Financial Assets an amendment of FASB Statement No. 140
(SFAS No. 166). In SFAS No. 166, the FASB improves the relevance,
representational faithfulness, and comparability of the information that a
reporting entity provides in its financial statements about a transfer of
financial assets; the effects of a transfer on its financial position,
financial performance, and cash flows; and a transferors continuing
involvement, if any, in transferred financial assets. SFAS No. 166 shall
be effective as of the first annual reporting period that begins after November 15,
2009, for interim periods within that first annual reporting period, and for
interim and annual reporting periods thereafter. Earlier application is
prohibited. Adoption of the Standard will not have a material effect on the
Companys consolidated financial statements.
In June 2009, the FASB
issued SFAS No. 167,
Amendments to FASB
Interpretation No. 46(R)
. In SFAS No. 167, the FASB
replaces the quantitative-based risks and rewards calculation for determining
whether an enterprise is the primary beneficiary in a variable interest entity
with an approach that is primarily qualitative, requires ongoing assessments of
whether an enterprise is the primary beneficiary of a variable interest entity,
and requires additional disclosures about an enterprises involvement in
variable interest entities. SFAS No. 167 shall be effective as of the
first annual reporting period that begins after November 15, 2009, for
interim periods within that first annual reporting period, and for interim and
annual reporting periods thereafter. Earlier application is prohibited. The
Companys adoption of SFAS No. 167 will not have a material effect on its
consolidated financial statements.
Since September 30, 2009 the Company has applied
the provisions of FASB ASC 105,
The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principles.
The Standard is now the single source of authoritative nongovernmental U.S.
generally accepted accounting principles or GAAP, superseding existing FASB,
American Institute of Certified Public Accountants (AICPA), EITF, and related
accounting literature. The Standard reorganizes the thousands of GAAP
pronouncements into roughly 90 accounting topics and displays them using a
consistent structure. Also included is relevant Securities and Exchange
Commission guidance organized using the same topical structure in separate
sections. The Standard did not have a material impact on the Companys
financial statements. However, the Standard changed the Companys references to
GAAP in its consolidated financial statements.
Note 5Strategic
Alliance with Alticor Inc.
Since March 2003, the
Company has maintained a broad strategic alliance with several affiliates of
the Alticor family of companies to develop and market novel nutritional and
skin care products. The alliance initially included an equity investment, a
multi-year research and development agreement, a licensing agreement with
royalties on marketed products, the deferment of outstanding loan repayment and
the refinancing of bridge financing obligations. The alliance continues to
evolve and recent events under the alliance are described in this Note 5.
12
Table
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On February 25, 2008,
the Company entered into a research agreement (RA8) with an affiliate of
Alticor, effective January 1, 2008, to expand the research being performed
under its current agreements with Alticor through 2008. The Company received
$1,200,000 during 2008 under the research agreement, on a time and materials
basis. Additionally, in 2008 the Company recognized as revenue approximately
$800,000 of previously deferred revenue. The Company recognized $198,203 in the
three months ended September 30, 2009 and $441,467 in the three months
ended September 30, 2008 from this agreement. In addition to the $800,000
of deferred revenue recognized under RA8, $168,254 of funds previously paid to
the Company by Alticor under research agreement 3 (RA3) and research agreement
4 (RA4), for which no work has been performed, will not need to be repaid to
Alticor by the Company. Since the Company performed no prior services relating
to the $168,254 received from Alticor, and the Company is not required to
perform any future services relating to these funds, the Company has determined
that the funds should be classified as additional paid-in capital and are
recorded as such on the Companys balance sheet as such as of September 30,
2009.
On January 31, 2009,
the Company entered into an amendment to the RA8. The amendment extends the
term from a maximum of six months to eight months, terminating on September 30,
2009. The Company received an additional $200,316 on March 31, 2009 under
the terms of the amendment to complete ongoing research, which was recognized
as deferred revenue on the Companys balance sheet as of March 31, 2009.
At September 30, 2009, there was a balance of $2,857 in deferred revenue
under RA8.
Note
6Convertible Debt
On August 17,
2006, our existing credit facility with
Pyxis Innovations Inc., an
affiliate of Alticor (Pyxis),
was amended to provide the Company with access to an
additional $14,400,000 of working capital borrowings at any time prior to August 17,
2008. Any amounts borrowed bear interest at prime, require quarterly interest
payments and will mature on August 16, 2011. The principal amount of any
borrowing under this credit facility is convertible at Pyxis election into a
maximum of 2,533,234 shares of common stock, reflecting a conversion price of
$5.6783 per share.
This credit facility has
been extended several times, most recently on August 10, 2009 to permit
borrowings at anytime prior to January 1, 2011. As of September 30,
2009, there was $5,000,000 in principal outstanding under the credit facility.
On November 9, 2009 the Company borrowed $2,000,000 leaving $7,316,255 of
available credit and $7,000,000 in principal outstanding under the credit
facility (see note 12).
Note 7Commitments and Contingencies
Off-Balance Sheet Arrangements
The Company has no
off-balance sheet arrangements that have, or are reasonably likely to have, a
current or future material effect on its financial condition, results of
operations or cash flows.
Note 8Capital
Stock
Authorized Preferred and Common Stock
At September 30, 2009,
the Company had authorized 6,000,000 shares of $0.001 par value Series A
Preferred Stock, of which 5,000,000 were issued and outstanding. At September 30,
2009, the Company had authorized 100,000,000 shares of $0.001 par value common
stock of which 66,931,082 shares were outstanding or reserved for issuance. Of
those, 32,079,833 shares were outstanding; 28,160,200 shares were reserved for
the conversion of Series A Preferred to common stock; 880,545 shares were
reserved for the conversion of the $5,000,000 of debt outstanding under the
credit facility with Pyxis; 3,474,095 shares were reserved for the potential
exercise of authorized and outstanding stock options; 400,000 shares were
reserved for the exercise of outstanding warrants to purchase common stock at
an exercise price of $2.50 per share which are exercisable currently until the
expiration date of August 9, 2012; 295,732 shares were reserved for the
potential exercise of rights held under the Employee Stock Purchase Plan; and
1,640,677 shares were reserved for the issuance upon the conversion of
convertible notes that may be issued to Pyxis under the existing credit
facility.
13
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Series A Preferred Stock
On March 5, 2003, the
Company entered into a Stock Purchase Agreement with Alticor, pursuant to which
Alticor purchased from the Company 5,000,000 shares of Series A Preferred
Stock for $7,000,000 in cash on that date, and an additional $2,000,000 in cash
that was paid, as a result of the Company achieving a certain milestone, on March 11,
2004.
The Series A Preferred
Stock accrues dividends at the rate of 8% of the original purchase price per
year, payable only when, as and if declared by the Board of Directors and are
non-cumulative. To date, no dividends have been declared on these shares. If
the Company declares a distribution, with certain exceptions, payable in
securities of other persons, evidences of indebtedness issued by the Company or
other persons, assets (excluding cash dividends) or options or rights to
purchase any such securities or evidences of indebtedness, then, in each such
case the holders of the Series A Preferred Stock shall be entitled to a
proportionate share of any such distribution as though the holders of the Series A
Preferred Stock were the holders of the number of shares of Common Stock into
which their respective shares of Series A Preferred Stock are convertible
as of the record date fixed for the determination of the holders of Common
Stock entitled to receive such distribution.
In the event of any
liquidation, dissolution or winding up of the Company, whether voluntary or
involuntary, the holders of the Series A Preferred Stock shall be entitled
to receive, prior and in preference to any distribution of any of the Companys
assets or surplus funds to the holders of its Common Stock by reason of their
ownership thereof, the amount of two times the then-effective purchase price
per share, as adjusted for any stock dividends, combinations or splits with
respect to such shares, plus all declared but unpaid dividends on such share
for each share of Series A Preferred Stock then held by them. The
liquidation preference at September 30, 2009 was $18,000,000. After
receiving this amount, the holders of the Series A Preferred Stock are
entitled to participate on an as-converted basis with the holders of Common
Stock in any of the remaining assets.
Each share of Series A
Preferred Stock is convertible at any time at the option of the holder into a
number of shares of the Companys Common Stock determined by dividing the
then-effective purchase price ($1.80, and subject to further adjustment) by the
conversion price in effect on the date the certificate is surrendered for
conversion. As of September 30, 2009, the Series A Preferred Stock
was convertible into 28,160,200 shares of Common Stock reflecting a current
conversion price of $0.3196 per share.
Each holder of Series A
Preferred Stock is entitled to vote its shares of Series A Preferred Stock
on an as-converted basis with the holders of Common Stock as a single class on
all matters submitted to a vote of the stockholders, except as otherwise
required by applicable law. This means that each share of Series A
Preferred Stock will be entitled to a number of votes equal to the number of
shares of Common Stock into which it is convertible on the applicable record
date.
Note 9Stock-Based
Compensation Arrangements
Stock-based compensation
arrangements consisted of the following as of September 30, 2009: three
share-based compensation plans, restricted stock awards; an employee stock
purchase plan; and employee compensation agreements. Total compensation cost
that has been charged against income for stock-based compensation arrangements
is as follows:
|
|
Three Months Ended Sept. 30,
|
|
Nine Months Ended Sept. 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Stock option grants
beginning of period
|
|
$
|
53,543
|
|
$
|
7,250
|
|
$
|
197,206
|
|
$
|
31,342
|
|
Stock-based arrangements
during the period:
|
|
|
|
|
|
|
|
|
|
Stock option grants
|
|
3,837
|
|
32,381
|
|
5,721
|
|
78,364
|
|
Restricted stock issued:
|
|
|
|
|
|
|
|
|
|
Employee stock purchase plan
|
|
2,160
|
|
704
|
|
4,334
|
|
977
|
|
Employment agreements
|
|
|
|
1,813
|
|
1,625
|
|
13,469
|
|
|
|
$
|
59,540
|
|
$
|
42,148
|
|
$
|
208,886
|
|
$
|
124,152
|
|
Stock option grants
The following table details stock option activity for the nine months
ended September 30, 2009 and 2008:
14
Table of Contents
|
|
Nine
Months Ended September 30
,
2009
|
|
Nine
Months Ended
September 30,
2008
|
|
|
|
Shares
|
|
Weighted Avg
Exercise
Price
|
|
Shares
|
|
Weighted Avg
Exercise
Price
|
|
Outstanding, beginning of period
|
|
2,100,917
|
|
$
|
2.33
|
|
1,366,406
|
|
$
|
3.11
|
|
Granted
|
|
138,500
|
|
0.26
|
|
752,500
|
|
1.17
|
|
Exercised
|
|
(15,000
|
)
|
0.26
|
|
|
|
|
|
Canceled
|
|
(47,900
|
)
|
1.04
|
|
(29,833
|
)
|
1.93
|
|
Expired
|
|
(69,600
|
)
|
1.35
|
|
(75,000
|
)
|
2.48
|
|
Outstanding, end of period
|
|
2,106,917
|
|
$
|
2.27
|
|
2,014,073
|
|
$
|
2.43
|
|
Exercisable, end of period
|
|
1,487,117
|
|
$
|
2.83
|
|
1,350,073
|
|
$
|
3.01
|
|
The
Companys share-based payments that result in compensation expense consist of
stock option grants and shares issued under the Employee Stock Purchase Plan.
During the nine-month period ended September 30, 2009, the Company granted
stock options under the 2000 Employee Stock Compensation Plan and the 2004
Employee, Director & Consultant Stock Plan. At September 30,
2009, the Company had an aggregate of 1,367,178 shares of Common Stock
available for grant; including 88,232 shares under the 2000 Employee Stock
Compensation Plan and 1,278,946 under the 2004 Employee, Director &
Consultant Stock Plan. Each of these plans expires ten years from the date the
plan was approved.
It
is the Companys policy to grant stock options with an exercise price equal to
the fair market value of the Companys common stock at the grant date, and
stock options to employees generally vest over five years based upon continuous
service. Historically, the majority of the Companys stock options have been
granted in connection with the employees start date with the Company. In
addition, the Company may grant stock options in recognition of promotion
and/or performance.
For
purposes of determining the stock-based compensation expense for stock option
awards, the Black-Scholes option-pricing model was used with the following
weighted-average assumptions:
|
|
2009
|
|
Risk-free interest rate
|
|
2.56
|
%
|
Expected life
|
|
6.50 years
|
|
Expected volatility
|
|
87.1
|
%
|
Employee Stock Purchase Plan
Purchases made under the Companys Employee Stock Purchase Plan are
deemed to be compensatory because employees may purchase stock at a price equal
to 85% of the fair market value of the Companys common stock on either the
first day or the last day of a calendar quarter, whichever is lower. During the
nine months ended September 30, 2009 and 2008, employees purchased 126,452
and 5,620 shares, respectively, of common stock at a weighted-average purchase
price of $0.20 and $0.99, respectively, while the weighted-average fair value
was $0.23 and $1.17 per share, respectively, resulting in compensation expense
of $4,334 and $977, respectively.
Employment Agreements
On March 13, 2009 Lewis Bender received a cash bonus of $102,850
pursuant to his employment agreement and elected to receive $29,700 in 110,000
shares of our common stock. On March 13, 2009 Eliot Lurier received a cash
bonus of $43,695 pursuant to his employment agreement and elected to receive
$4,455 in 16,500 shares of our common stock. During the nine months ended September 30,
2009, 12,500 shares of restricted stock vested pursuant to an employment
agreement with Dr. Kornman. The Company measures the fair value of the
shares, prior to issuance, based on the last reported price at which the
Companys common stock traded for the reporting period and compensation cost is
recognized ratably over the employment period required to earn the stock award.
At time of issuance, the Company will measure the fair value of the shares
based on the last reported price at which the Companys common stock traded on
the date of the issuance and will record a cumulative adjustment, if any.
15
Table of Contents
A summary of stock
compensation cost included in the statement of operations for the three and
nine months ended September 30, 2009 and 2008 is as follows:
|
|
Three Months Ended September
30,
|
|
Nine Months Ended September
30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Continuing operations:
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
1,972
|
|
4,755
|
|
6,204
|
|
17,566
|
|
Research and development
expenses
|
|
3,964
|
|
6,342
|
|
27,773
|
|
25,118
|
|
Selling, general and administrative expenses
|
|
19,605
|
|
28,772
|
|
136,132
|
|
76,911
|
|
Total continuing operations
|
|
25,541
|
|
39,869
|
|
170,109
|
|
119,595
|
|
Discontinued operations
|
|
33,999
|
|
2,279
|
|
38,777
|
|
4,557
|
|
Total
|
|
59,540
|
|
42,148
|
|
208,886
|
|
124,152
|
|
Restricted Stock Awards
Holders
of restricted stock awards participate fully in the rewards of stock ownership
of the Company, including voting and dividend rights. Recipients of restricted
stock awards are generally not required to pay any consideration to the Company
for these restricted stock awards. The Company measures the fair value of the
shares based on the last reported price at which the Companys common stock
traded on the date of the grant and compensation cost is recognized over the
remaining service period. During each of the nine months ended September 30,
2009 and 2008 the Company granted restricted stock awards of 12,500 shares
under an employment agreement dated March 31, 2006.
Note 10Segment Information
The Company applies the provisions of FASB ASC 280,
Segment Reporting
, which establishes
standards for reporting information about operating segments in annual and
interim financial statements, and requires that companies report financial and
descriptive information about their reportable segments based on managements
approach. The standard also establishes related disclosures about products and
services, geographic areas and major customers. As a result of the acquisition
of the assets and business of the Alan James Group in August 2006 and
until prior to the opening of business on July 1, 2009 when substantially
all of the assets and business were sold, the Company had two reportable
segments: Personalized Health and Consumer Products.
Beginning in the third quarter the Company has one segment remaining,
the genetic test business, which was formerly defined as the Personalized
Health segment and is reflected as continuing operations. The Company develops
genetic tests for sale into the emerging personalized health market and
performs testing services that can help individuals improve and maintain their
health through preventive measures. The Companys principal operations and
markets are located in the United States. The Company has no operations outside
of the United States. For the nine months ended September 30, 2009 and
2008, the Company had minimal royalty income derived from distributors outside
the United States, minimal expenses derived from research partners outside the
United States and minimal assets outside the United States. The Company does
not believe that foreign currency exchange rate risk is material and does not
use derivative financial instruments to manage foreign currency fluctuation
risk.
Note 11Industry Risk and Concentration
The Company develops genetic risk assessment tests under contract,
performs research for its own benefit and provides research services to a
collaborative partner. As of September 30, 2009, the Company has
introduced four genetic risk assessment tests commercially. Two of the tests
are branded and sold through the Companys strategic partner Alticor.
Commercial success of the Companys genetic risk assessment tests will depend
on their success as scientifically credible and cost-effective by consumers and
the marketing success of the Company and its collaborative partner.
Research in the field of disease predisposing genes and genetic markers
is intense and highly competitive. The Company has many competitors in the
United States and abroad that have considerably greater financial, technical,
marketing, and other resources available. If the Company does not discover
disease predisposing genes or genetic markers and develop risk assessment tests
and launch such services or products before its competitors, then the potential
for significant revenues may be reduced or eliminated.
16
Table of Contents
Prior to the sale of
substantially all of the Alan James Group business and assets of the Companys
wholly-owned subsidiary, AJG Brands, Inc., for the nine months ended September 30,
2009 and 2008, approximately 52.1% and 50.9%, respectively, of the Companys
consumer products revenue was from a single customer. As of September 30,
2009 and December 31, 2008, approximately 0% and 60.6% respectively, of
the trade accounts receivables were from that same customer.
Prior to the sale of
substantially all of the Alan James Group business and assets of the Companys
wholly-owned subsidiary, AJG Brands, Inc., the majority of the Companys
consumer products were sourced from three suppliers. The Company paid a
contracted rate per completed unit for each product. The suppliers were
responsible for procuring raw materials and packaging finished products.
Our significant customer, Alticor,
which is our principal shareholder, represented approximately 88.6% of our
revenues from continuing operations in the three months ended September 30,
2009.
The Company fully reserved
in its financial statements for all non-acquired inventory and accounts
receivable as a result of the Alan James Group transaction.
Note 12Subsequent Event
On November 9, 2009, we drew down $2.0 million under our existing
convertible credit facility with Pyxis, an affiliate of Alticor Inc., and
issued a convertible promissory note to Pyxis in that amount. A description of
the credit facility is set forth in Note 6 of the Notes to our Condensed
Consolidated Financial Statements. The principal amount of the note is due and
payable on August 16, 2011. The note bears interest at a variable rate
equal to the prime rate and the interest is payable quarterly. Prior to the
maturity date, any portion or the entire outstanding principal and any accrued
but unpaid interest under the note is convertible at Pyxiss election into
shares of our common stock at a price of $5.6783 per share. Immediately following the issuance of the
note on November 9, 2009, the note was convertible into an aggregate of
352,218 shares of our common stock, we had $7.0 million outstanding under the
credit facility and we had $7.3 million available to us to borrow under the
credit facility.
17
Table
of Contents
Item 2.
Managements Discussion and Analysis of Financial Condition and Results
of Operations
The
following discussion of our financial condition and results of operations
should be read in conjunction with our unaudited condensed consolidated
financial statements and the notes thereto included elsewhere in this document.
General Overview and Trends
We are a genetics-focused
personalized health company that develops preventive consumer products and
genetic tests for sale to the emerging personalized health market. Our vision
is to build a leading personalized health and wellness company using the
science of applied genetics to empower people to understand the genetic
components of their health, to provide physicians guidance on patient care and
to provide drug developers and other companies the tools necessary to create
new, innovative therapeutic and other products.
During the three months
ended September 30, 2009 we continued with the launch of our new Inherent
Health brand of genetic tests and related programs, which began at the end of
the second quarter of 2009, including the first-of-its-kind test for weight
management that identifies an individuals genetic tendencies for weight gain
and metabolism. In addition, the brand launch offers customers a full suite of
affordable, easy-to-use and meaningful genetic tests in heart health, bone
health which we expect to launch in the fourth quarter, nutritional needs, as
well as PST®, the periodontal disease risk assessment test. To support the
launch, we implemented a fully functional web presence with e-commerce
capabilities. Genetic tests may be purchased through the website. A nationwide
advertising campaign consisting of television, print and internet media was
started in the third quarter of 2009, which we anticipated would allow us to
better understand the proper media mix for this brand. A third party support
and call center was put in place in advance of the advertising campaign. We
anticipated the initial phase of advertising to cost approximately $1.0
million. The nationwide advertising campaign ran for two weeks and cost
approximately $0.8 million. The media campaign provided strategic direction to
our product marketing efforts. Distribution of our tests and related technology
in the short term will focus on:
·
partnering with
large national and international companies for the sale and distribution of our
genetic test products
·
partnering with
biotechnology companies in the area of drug discovery
·
health care
professional partnerships
In addition, we will continue
to offer our products through our e-commerce web site.
On September 23, 2009
we announced top line positive results from a retrospective clinical study on
weight management using patients who participated in a diet study previously
reported in the Journal of The American Medical Association. Our study
demonstrated that individuals following diets matched to their genotype, as
determined by our weight management genetic test, showed statistically
significant greater weight loss and other benefits at all time points (2, 6 and
12 months) when compared to individuals on diets not matched to their genotype
(6.2% versus 2.4% p<0.013 at 12 months).
Prior to the opening of
business on July 1, 2009 we sold substantially all of the Alan James Group
business and assets of our wholly-owned subsidiary AJG Brands, Inc. to Pep
Products, Inc., a subsidiary of Nutraceutical Corporation, for
approximately $4.6 million in cash. The proceeds consist of a $0.2 million
holdback reflected in other assets and $4.4 million cash due which was received
on July 1, 2009. The assets sold consisted primarily of accounts
receivable, inventories, property and equipment and other assets related to the
business.
The buyer did
not assume accounts payable and accrued liabilities. Subsequent to the closing,
AJG Brands, Inc.s name was changed to Interleukin Brands, Inc. (IBI).
The assets remaining in IBI consist primarily of certain remaining accounts
receivable and inventory. IBI will remain as a wholly-owned subsidiary of
Interleukin until all remaining accounts receivable and inventory is settled or
liquidated at which time we will determine whether to keep the subsidiary
active. We expect this to occur in the next twelve months. We have fully
reserved for all non-acquired inventory and accounts receivable assets in our
financial statements. As a requirement of the transaction, we are prohibited
from continuing to operate in a business competitive to the one previously
conducted by AJG Brands, Inc., which
primarily developed, marketed and sold nutritional
supplements and related products into retail consumer channels
. The sale of
substantially all of the Alan James Group business and assets, which previously
comprised the Consumer Products segment of our business, will allow us to focus
our resources and attention exclusively on our genetic test business by
developing new and selling our existing genetics tests to the growing
personalized health market. During the three months ended September 30,
2009 we did not receive any revenue from the Alan James Group reflected in
discontinued operations. We expect to continue to incur expenses as the
remaining assets and liabilities are disposed of. We are now focusing on
18
Table of Contents
genetic test development and
commercialization which was formerly defined as our Personalized Health segment
and is reflected as continuing operations.
On April 6, 2009, we
entered into a licensing agreement with LABEC Pharma, S.L. to market and sell
our Heart Health genetic test throughout Spain and Portugal. As part of the
agreement, the test will be marketed by LABEC Pharma and the tests will be
processed at our Clinical Laboratory Improvement Act of 1988 (CLIA) certified
laboratory at our Corporate Headquarters in Waltham, Massachusetts. We will
receive royalties and commercial milestone payments. We have submitted the
necessary documents to LABEC who will be filing the CE mark application with
the European regulatory authorities.
Our genetic test business
contributes toward our overall mission of developing tests and products that
can help individuals improve and maintain their health through preventive
measures. We plan to pursue this by:
·
developing
genetic risk assessment tests for use in multiple indications, countries and
various demographics; and
·
processing
genetic risk assessment tests in our CLIA-certified lab or in those of
sublicensees.
In 2006, sales of our
genetic test products began under marketing and other business arrangements
with Alticor. Alticor is a significant customer, representing virtually all of
our genetic test revenues and contract research revenue and over 89% of
consolidated revenues in the three month ended September 30, 2009. With
the launch of our Inherent Health brand of genetic tests and related programs
in June 2009, we would expect that revenues from Alticor may represent a
smaller percentage of our revenues in the future, although we can provide no
assurance that the launch of our own brand of genetic tests will be
commercially successful.
We have traditionally spent
approximately $3-4 million annually on research and development. We expect
to complete our research agreements with Alticor in 2009 and dedicate more of
our resources to our own product development efforts. We expect our research &
development expenses to decrease as we focus on our own development efforts.
Our current development programs focus on obesity, heart disease, osteoporosis,
osteoarthritis, skin aging, sports nutrition and weight management genetic risk
assessment tests. We expect that these programs will also lead to the
personalized selection of nutritional and therapeutic products and provide
consumers and healthcare professionals with better preventive product
alternatives. As a result of the launch of our Inherent Health Brand of
genetic tests, we expect corporate selling, general, marketing and
administrative expenses associated with our genetic test products to increase
in the remainder of 2009 and beyond. We currently have $9.3 million of
borrowings available under our credit line with Pyxis Innovations, Inc.,
an affiliate of Alticor (Pyxis), which permits borrowing any time prior to January 1,
2011. We expect to be able to fund our operations through at least the next
twelve months with revenue from product sales, borrowings from our credit
facility and the cash proceeds from the sale of substantially all of the Alan
James Group business and assets.
On February 25, 2008,
we entered into our most recent research agreement, known as RA8, with Access
Business Group International LLC (ABG), a subsidiary of Alticor. RA8
encompasses four primary areas: osteoporosis, cardiovascular disease,
nutrigenomics, and dermagenomics.
On January 31, 2009, the Company entered into an
amendment to RA8, which extends the term from a maximum of six months to eight
months terminating on September 30, 2009. We received an additional
$200,316 on March 31, 2009 per the amendment to complete ongoing research.
See financial
statement footnote 5 for a discussion of our strategic alliance with Alticor.
As of September 30, 2009, we have completed the clinical studies under RA8
which aim to correlate SNP gene variations to the risk of osteoporosis or
cardiovascular disease in Asian populations. Other studies conducted in North
American populations identified genetic factors that influence athletic
performance (nutrigenomics) and skin health, such as wrinkles, elasticity,
aging (dermagenomics), for the purpose of developing products to enhance
healthy aging. Under the terms of RA8, ABG paid us $1.2 million during
2008 for the research. In addition, we recognized approximately $800,000 of
revenue which was unused from prior research agreements with Alticor and its
subsidiaries.
In the genetic test business,
competition is in flux and the markets and customer base are not well
established. Adoption of new technologies by consumers requires substantial
market development and customer education. Historically, we have focused on our
relationship with our primary customer, Alticor, a significant direct marketing
company, in order to assist us in developing the market for our products and
educating our potential customers. Our challenge in 2009 and beyond will be to
develop the market for our own personalized health products. We have begun to
allocate considerable resources to our own brand of consumer products,
including the June 2009 launch of our new Inherent Health Brand of
genetic tests and related programs. Due to the early stage of these
initiatives, we cannot predict with certainty fluctuations we may
19
Table of Contents
experience in our test revenues or whether
revenues derived from Alticor related to the heart health and general nutrition
genetic tests will be sustained in future periods.
Liquidity and Capital Resources
As of September 30, 2009, we had cash and cash equivalents of
$1.4 million and borrowings available under our credit facility of
$9.3 million, which permits borrowing at any time prior to January 1,
2011. On November 9, 2009 we borrowed an additional $2.0 million leaving
$7.3 million of available credit. In connection with the closing of the sale of
substantially all of the Alan James Group business and assets of AJG Brands, Inc.,
prior to the opening of business on July 1, 2009, we received $4.4 million
of cash proceeds on July 1, 2009.
Cash used in continuing operations was $7.2 million for the nine months
ended September 30, 2009, as compared to $5.9 million for the nine
months ended September 30, 2008. Cash used in operations is primarily
impacted by operating results and changes in working capital, particularly the
timing of the collection of receivables, inventory levels and the timing of
payments to suppliers. A significant use of cash in the nine months ended September 30,
2008 was a payment of $1.2 million, relating to the settlement of purchase
obligations with the Alan James Group, $0.6 million of which had been accrued
prior to 2008 and is reflected as being paid in net cash used in continuing
operation activities in the nine months ended September 30, 2008. The
remaining $0.6 million is reflected in net cash used in investing activities of
our continuing operations as described below. The increase of $1.3 million of
cash used in continuing operations is primarily attributable to closing costs
related to the sale of substantially all of the Alan James Group business and
assets of AJG Brands, Inc., as well as costs of advertising, media and
product development costs related to the launch of our Inherent Health brand
of genetic tests.
Cash used in investing activities of our continuing operations was $0.7
million for the nine months ended September 30, 2009, compared to $0.9
million for the nine months ended September 30, 2008. The most significant
use of cash in investing activities during the nine months ended September 30,
2008 was the settlement of claims related to the acquisition of the assets and
business of the Alan James Group as described above. As a result of the
settlement, we paid additional consideration of $0.6 million. Capital additions
were $0.7 million for the nine months ended September 30, 2009, compared
to $0.1 million for the nine months ended September 30, 2008. The increase
in capital additions primarily consists of new commercial laboratory equipment
installed and validated in the first nine months of 2009, which allows for high
volume processing of genetic test samples.
Cash provided by financing activities of our continuing operations was
$1.1 million for the nine months ended September 30, 2009, compared to
$4.0 million for the nine months ended September 30, 2008. On May 29,
2009, we received proceeds from the issuance of a note payable in the amount of
$1.0 million under our existing credit facility with Pyxis. On June 10,
2008 we received $4.0 million under the same credit facility. We received
approximately $63,000 and $13,000, respectively from the exercise of stock
options and stock purchases through the employee stock purchase plan for the
nine months ended September 30, 2009 and September 30, 2008.
On December 23, 2008, we were notified of our failure to comply
with the NYSE Amex, LLCs, hereinafter referred to as the Exchange, continued
listing standards under section 1003 of the Exchanges Company Guide.
Specifically, the Exchange noted our failure to comply with section 1003(a)(iii) of
the Company Guide because our stockholders equity was less than $6,000,000 and
we had losses from continuing operations and net losses in our five most recent
fiscal years. The notice was based on a review by the Exchange of publicly
available information, including our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008. As of December 31, 2008, our
stockholders equity was $4.5 million. On January 27, 2009, we submitted a
plan to the exchange to meet the continued listing requirements. The plan
consists of several elements, but is primarily focused on increasing the sales
of our products and services and raising additional equity capital. On March 27,
2009, we were notified that the Exchange found our plan to regain compliance
with the continued listing standards to be unacceptable. We filed an appeal for
an oral hearing and submitted a revised plan to the Exchange. On May 11,
2009, the Exchange notified us that the Exchange accepted our redrafted plan of
compliance, without a hearing, and granted us an extension until December 31,
2009 to regain compliance with the continued listing standards. The Exchange
will periodically review our progress toward regaining compliance. Failure to
make progress consistent with the plan or to regain compliance with the
continued listing standards by December 31, 2009 could result in delisting
from the Exchange, which could significantly impact our ability to raise
additional capital.
We currently do not have any commitments for any additional material
capital purchases.
Prior to June 30, 2009, we generated operating cash by sales of
consumer products and subsequent to that date we continue to generate cash from
the sale of genetic tests, royalties, and reimbursements for funded research.
Subsequent to
20
Table of
Contents
June 30, 2009, pursuant to the asset
purchase agreement with the Alan James Group, we are prohibited from continuing
to operate in a business competitive to the one previously conducted by AJG
Brands, Inc., which
primarily developed, marketed and sold nutritional supplements and
related products into retail consumer channel
. The amount of operating
cash we generate is not currently sufficient to continue to fund and grow our
operations. In addition to funds generated by our operations, we have a $14.3 million
credit facility with Pyxis, under which we had $9.3 million in borrowings
available as of September 30, 2009. On November 9, 2009 we borrowed
an additional $2.0 million leaving borrowings available of $7.3 million under
the credit facility. Clinical studies and other research and development
activities may require cash outflows that depend on the timing of activities.
We believe that our cash on hand and availability under our line of
credit with Pyxis will be sufficient to fund our operations and meet our
overall strategic plan for at least the next twelve months. We will need to
raise additional capital, if market conditions permit, to continue investment
in new product development, to improve our distribution channels, to maintain
our listing on the NYSE Amex, LLC, and other aspects of our overall strategic
plan. The current status of the financial markets may adversely affect our
ability to raise additional capital.
We have no financial covenants as part of our credit facility with
Pyxis. We currently have $5.0 million outstanding under the credit facility,
which is reflected as long term debt on our balance sheet and is convertible,
at the option of Pyxis into shares of our common stock
at a price of $5.6783 per share
. We anticipate
drawing down additional funds available under our credit facility in the
foreseeable future.
21
Table of Contents
Results of Operations (000s)
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Continuing operations
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Genetic testing
|
|
$
|
119,309
|
|
$
|
102,782
|
|
$
|
352,130
|
|
$
|
295,527
|
|
Contract research and
development
|
|
198,203
|
|
441,467
|
|
520,935
|
|
1,380,759
|
|
Other
|
|
5,370
|
|
1,345
|
|
20,274
|
|
32,799
|
|
Total revenue from continuing operations
|
|
322,882
|
|
545,594
|
|
893,339
|
|
1,709,085
|
|
Cost of revenue
|
|
$
|
305,303
|
|
$
|
235,795
|
|
$
|
912,150
|
|
$
|
679,037
|
|
Gross profit (loss)
|
|
$
|
17,579
|
|
$
|
309,799
|
|
$
|
(18,811
|
)
|
$
|
1,030,048
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
873,195
|
|
933,003
|
|
2,628,943
|
|
2,455,230
|
|
Selling, general and
administrative
|
|
1,660,235
|
|
1,196,580
|
|
4,473,860
|
|
3,864,216
|
|
Amortization of
intangibles
|
|
28,863
|
|
26,271
|
|
86,590
|
|
70,611
|
|
Other expense (income)
|
|
40,219
|
|
11,820
|
|
98,458
|
|
(50,656
|
)
|
Total expenses
|
|
$
|
2,602,512
|
|
$
|
2,167,674
|
|
$
|
7,287,851
|
|
$
|
6,339,401
|
|
Net loss from continuing operations before income
taxes
|
|
$
|
(2,584,933
|
)
|
$
|
(1,857,875
|
)
|
$
|
(7,306,662
|
)
|
$
|
(5,309,353
|
)
|
Benefit for income taxes
|
|
|
|
37,000
|
|
|
|
31,000
|
|
Net loss from continuing operations
|
|
$
|
(2,584,933
|
)
|
$
|
(1,820,875
|
)
|
$
|
(7,306,662
|
)
|
$
|
(5,278,353
|
)
|
Discontinued operations
|
|
|
|
|
|
|
|
|
|
Consumer product revenue
|
|
$
|
|
|
$
|
1,626,000
|
|
$
|
3,580,169
|
|
$
|
5,593,267
|
|
Cost of revenue
|
|
|
|
764,469
|
|
1,892,815
|
|
2,963,675
|
|
Gross profit
|
|
$
|
|
|
$
|
861,531
|
|
$
|
1,687,354
|
|
$
|
2,629,592
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
83,215
|
|
365,821
|
|
1,187,368
|
|
1,586,920
|
|
Amortization of intangibles
|
|
|
|
308,684
|
|
617,375
|
|
926,058
|
|
Other expenses
|
|
(123,876
|
)
|
|
|
1,234,825
|
|
1,057
|
|
Total expenses
|
|
$
|
(40,661
|
)
|
$
|
674,505
|
|
$
|
3,039,568
|
|
$
|
2,514,035
|
|
Net profit (loss) from discontinued operations
before income taxes
|
|
$
|
40,661
|
|
$
|
187,026
|
|
$
|
(1,352,214
|
)
|
$
|
115,557
|
|
Provision for income taxes
|
|
|
|
(8,000
|
)
|
(53,000
|
)
|
(20,500
|
)
|
Net profit (loss) from discontinued operations
|
|
$
|
40,661
|
|
$
|
179,026
|
|
$
|
(1,405,214
|
)
|
$
|
95,057
|
|
Combined continuing and discontinued operations
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
322,882
|
|
$
|
2,171,594
|
|
$
|
4,473,508
|
|
$
|
7,302,352
|
|
Cost of revenue
|
|
305,303
|
|
1,000,264
|
|
2,804,965
|
|
3,642,712
|
|
Gross profit
|
|
$
|
17,579
|
|
$
|
1,171,330
|
|
$
|
1,668,543
|
|
$
|
3,659,640
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
873,195
|
|
933,003
|
|
2,628,943
|
|
2,455,230
|
|
Selling, general and administrative
|
|
1,743,450
|
|
1,562,401
|
|
5,661,228
|
|
5,451,136
|
|
Amortization of intangibles
|
|
28,863
|
|
334,955
|
|
703,965
|
|
996,669
|
|
Other (income) expense
|
|
(83,657
|
)
|
11,820
|
|
1,333,283
|
|
(49,599
|
)
|
Total expenses
|
|
$
|
2,561,851
|
|
$
|
2,842,179
|
|
$
|
10,327,419
|
|
$
|
8,853,436
|
|
Net loss before income taxes
|
|
$
|
(2,544,272
|
)
|
$
|
(1,670,849
|
)
|
$
|
(8,658,876
|
)
|
$
|
(5,193,796
|
)
|
Benefit (provision) for income taxes
|
|
|
|
29,000
|
|
(53,000
|
)
|
10,500
|
|
Net loss
|
|
$
|
(2,544,272
|
)
|
$
|
(1,641,849
|
)
|
$
|
(8,711,876
|
)
|
$
|
(5,183,296
|
)
|
22
Table of
Contents
Three Months Ended September 30,
2009 and September 30, 2008
Continuing operations
Total
revenue from continuing operations for the three months ended September 30,
2009 was $0.3 million, compared to $0.5 million for the three months
ended September 30, 2008. The decrease of $0.2 million, or 40.8%, is
primarily attributable to a decrease in contract research revenue, offset by
increases in genetic test and royalty revenue. Contract research revenue was
$0.2 million in the three months ended September 30, 2009, compared to
$0.4 million in the three months ended September 30, 2008. The decrease of
$0.2 million, or 55.1%, is primarily attributable to the completion and timing
of our reimbursable research projects. Genetic testing revenue increased to
$0.12 million, or 16.1%, in the three months ended September 30, 2009,
compared to $0.10 million in the three months ended September 30, 2008.
The increase is primarily attributable to the launch of our Inherent Health
Brand of genetic tests, which commenced in June 2009. Genetic testing
revenue is derived from tests sold and processed, which is driven by consumer
demand. Contract research revenue is recognized when Alticor sponsored research
expenses are incurred.
We
have one significant customer, Alticor, which is our principal shareholder,
represented approximately 88.6% and 97.7%, respectively, of our revenues from
continuing operations in the three months ended September 30, 2009 and
2008.
Cost
of revenue from continuing operations for the three months ended September 30,
2009 was $0.3 million or 94.6% of its revenue, compared to $0.2 million, or
43.2% of its revenue, for the three months ended September 30, 2008. The
significant increase in the cost of revenue as a percentage of revenue is
primarily attributable to increased fixed costs associated with our genetic
testing laboratory notwithstanding changes in our revenue. Fixed costs were
impacted during the three months ended September 30, 2009 by costs
associated with the installation of new high volume genetic testing equipment,
which we expect to be absorbed with changes in volume of tests performed.
Increased costs associated with this equipment are recognized in the third
quarter of 2009, where no such costs were recognized in the third quarter of
2008. The equipment will allow for higher volume processing.
Gross
margin from continuing operations for the three months ended September 30,
2009, was $18,000, or 5.4%, compared to $0.3 million, or 56.8%, for the three
months ended September 30, 2008. The significant decrease in gross margin
is primarily attributable to increased fixed costs associated with our genetic
testing laboratory and a decrease in contract research revenue.
Research and development
expenses from continuing operations were $0.87 million for the three months
ended September 30, 2009, compared to $0.93 million for the three months
ended September 30, 2008. The slight decrease from 2008 to 2009 is primarily
attributable to increased expenses for patent and separation costs which were
offset by lower consulting and clinical trial expenses as compared to the three
months ended September 30, 2008.
Selling, general and
administrative expenses from our continuing operations were $1.7 million for
the three months ended September 30, 2009, compared to $1.2 million for
the three months ended September 30, 2008. The increase of $0.5 million is
primarily attributable to the product development and advertising costs
associated with our new Inherent Health Brand of genetic tests offset by
decreased expenses relating to administrative support consultants.
Interest expense from continuing operations was $41,000 for the three
months ended September 30, 2009, as compared to $50,000 for the three
months ended September 30, 2008. The decrease in interest expense of
$9,000 is primarily attributable to lower interest rate associated with
borrowings on our credit facility with Pyxis.
Interest income from continuing operations was $700 for the three
months ended September 30, 2009 as compared to $39,000 for the three
months ended September 30, 2008. The decrease in interest income of
$38,000 is primarily attributable to the decrease in our cash balances as well
as lower interest being earned on available cash balances. The current
financial market conditions have significantly reduced the interest rate we are
able to earn on our cash and cash equivalent balances.
Nine Months Ended September 30,
2009 and September 30, 2008
Continuing operations
Total revenue from our continuing operations for the nine months ended September 30,
2009 was $0.9 million, compared to $1.7 million for the nine months ended September 30,
2008. The decrease of $0.8 million or 47.7% is
23
Table of Contents
attributable
to a decrease in contract research revenue and royalty revenue offset by an
increase in genetic test revenue. Contract research revenue decreased $0.9
million primarily due to the completion of sponsored projects with reimbursable
research expenses. Genetic testing revenue increased to $0.4 million, or 19.2%
in the nine months ended September 30, 2009, compared to $0.3 million in
the nine months ended September 30, 2008 primarily attributable to the
launch of our Inherent Health Brand of genetic tests, which commenced in June 2009.
Alticor represented approximately 92.5% and 97.5%, respectively of our
revenues from continuing operations in the nine months ended September 30,
2009 and 2008.
Cost of revenue from continuing operations for the nine months ended September 30,
2009 was $0.9 million, or 102.1% of its revenue, compared to $0.7 million, or
39.7% of its revenue, for the nine months ended September 30, 2008. The
significant increase in the cost of revenue as a percentage of revenue is
primarily attributable to increased fixed costs associated with our genetic
testing laboratory notwithstanding decreases in our revenue.
Gross margin from continuing operations for the nine months ended September 30,
2009 was a loss of $19,000, or 2.1% of its revenue, compared to a profit of
$1.0 million, or 60.3% of its revenue, in the nine months ended September 30,
2008. The decrease in gross margin of $1.0 million, or 101.8%, is primarily
attributable to a reduction in contract research revenue and royalty revenue
offset by an increase in genetic testing revenue for the nine months ended September 30,
2009, compared to the nine months ended September 30, 2008. Fixed costs
increased during the nine months ended September 30, 2009 due to the
purchase and installation of new high volume genetic testing equipment, which
we expect to be absorbed with changes in volume of tests performed. The
equipment will allow for higher volume processing. No such costs were
recognized in the nine months ended September 30, 2008.
Research and development expenses from continuing operations were $2.6
million for the nine months ended September 30, 2009, compared to $2.5
million for the nine months ended September 30, 2008. The increase of $0.1
million is primarily attributable to increased separation costs, clinical trial
expenses related to our research agreements with Alticor and increased expenses
related to our patent portfolio, which was offset by a decrease in consulting
expenses.
Selling, general and
administrative expenses from continuing operations were $4.5 million for the
nine months ended September 30, 2009 compared to $3.9 million for the nine
months ended September 30, 2008. The increase of $0.6 million is primarily
attributable to increased product development and advertising expenses for our
Inherent Health Brand of genetic test and increased headcount, offset by
decreased expenses relating to administrative support consultants.
Interest expense from continuing operations was $108,000 for the nine
months ended September 30, 2009, as compared to $80,000 for the nine
months ended September 30, 2008. The increase in interest expense of
$28,000 is primarily attributable to interest expense associated with
borrowings on our credit facility with Pyxis.
Interest income from continuing operations was $10,000 for the nine
months ended September 30, 2009, as compared to $130,000 for the nine
months ended September 30, 2008. The decrease in interest income of
$120,000 is primarily attributable to the decrease in cash balance with lower
interest being earned on available cash balances. The current financial market
conditions have significantly reduced the interest rate we are able to earn on
our cash and cash equivalent balances.
Critical Accounting Policies and Estimates
Our discussion and analysis
of our financial condition and results of operations are based upon our
consolidated financial statements. The preparation of these financial
statements and related disclosures in conformity with accounting principles
generally accepted in the United States of America requires us to (i) make
judgments, assumptions and estimates that affect the reported amounts of
assets, liabilities, revenue and expenses; and (ii) disclose contingent
assets and liabilities. A critical accounting estimate is an assumption that
could have a material effect on our consolidated financial statements if
another, also reasonable, amount were used or a change in the estimates is
reasonably likely from period to period. We base our accounting estimates on
historical experience and other factors that we consider reasonable under the
circumstances. However, actual results may differ from these estimates. To the
extent there are material differences between our estimates and the actual
results, our future financial condition and results of operations will be
affected. Our most critical accounting policies and estimates upon which our
financial condition depends, and which involve the most complex or subjective
decisions or assessments are the following:
24
Table of Contents
Revenue Recognition:
Revenue from genetic testing
services is recognized when there is persuasive evidence of an arrangement,
service has been rendered, the sales price is determinable and collectability
is reasonably assured. Service is deemed to be rendered when the results have
been reported to the individual who ordered the test. To the extent that tests
have been prepaid but results have not yet been reported, recognition of all
related revenue is deferred. As of September 30, 2009 and December 31,
2008, the Company has deferred revenue of $23,200 and $80,000, respectively,
for tests that have been prepaid but results have not yet been reported.
Revenue from product sales
is recognized when there is persuasive evidence of an arrangement, delivery has
occurred and title and risk of loss have transferred to the customer, the sales
price is determinable and collectability is reasonably assured. The Company has
no consignment sales. Product revenue is reduced for allowances and
adjustments, including returns, discontinued items, discounts, trade promotions
and slotting fees.
Revenue from contract
research and development is recognized over the term of the contract as the
Company performs its obligations under that contract (including revenue from
Alticor, a related party).
Allowance for Sales Returns:
We analyze sales returns in
accordance with the provisions of FASB ASC 605,
Revenue Recognition.
We are able to make reasonable and
reliable estimates based on the buying patterns of the end-users of its
products based on sales data received. We believe we have sufficient
interaction with and knowledge of our customers, industry trends and industry
conditions to adjust the accrual for returns when necessary.
At September 30, 2009,
we have fully reserved for any potential sales returns and discontinued items
applicable to the non-acquired accounts resulting from our sale of
substantially all of the assets of the Alan James Group business. The reserve
of approximately $1.3 million is deemed to be adequate and no additional amounts
were added at September 30, 2009.
Trade Promotions:
Pursuant to the asset
purchase agreement in connection with the Companys sale of substantially all
of the Alan James Group business and assets, the Company fully accrued for the
approximately $150,000 of agreed upon trade promotions implemented prior to June 30,
2009. At September 30, 2009 the balance of trade promotions estimated to
be due in the future was $128,000.
Accounts Receivable
Pursuant to the asset purchase agreement in connection with the Companys
sale of substantially all of the Alan James Group business and assets the
Company retained non acquired accounts receivable in the amount of $180,605
which was fully reserved for as uncollectible at June 30, 2009. At September 30,
2009 the balance in non acquired accounts receivable was $64,179 and is fully
reserved for in the Companys financial statements. Prior to the acquisition
trade accounts receivable were stated at their estimated net realizable value,
which is generally the invoiced amount less any estimated discount related to
payment terms. The Company offered its Consumer Product customers a 2% cash
discount if payment is made within 30 days of the invoice date, however,
most customers take the discount regardless of when payment occurs. At December 31,
2008, the Company has reduced trade accounts receivable by $13,364 for
discounts anticipated to be taken and had provided an allowance for
uncollectible accounts of $6,696.
Inventory:
We value our inventory at
the lower of cost or market. We monitor our inventory and analyze it on a
regular basis. Cycle counts are taken periodically to verify inventory levels.
In addition, we analyze the movement of items within our inventory in an effort
to determine the likelihood that inventory will be sold or used before
expiration dates are reached. We provide an allowance against that portion of
inventory that we believe is unlikely to be sold or used before expiration
dates are reached. An adverse change in any of these factors may result in the need
for additional inventory allowance.
25
Table of Contents
Stock-based compensation:
We account for our
stock-based compensation expense in accordance with FASB ASC 718,
Compensation Stock Compensation
. The standard addresses
all forms of share-based payment (SBP) awards, including shares issued under
employee stock purchase plans, stock options, restricted stock and stock
appreciation rights. We expense SBP awards with compensation cost for SBP
transactions measured at fair value. Compensation cost for the portion of
awards for which the requisite service has not been rendered that are
outstanding as of the effective date shall be recognized as the requisite
service is rendered on or after the effective date. The compensation cost for
that portion of awards shall be based on the grant-date fair value of those
awards as calculated from the pro forma disclosures. Common stock purchased
pursuant to our employee stock purchase plan will be expensed based upon the
fair market value in excess of purchase price.
Cash Equivalents
Cash and cash equivalents
consist of amounts on deposit in checking and savings accounts with banks and
other financial institutions. Short-term investments primarily consist of bank
money market funds which have short-term maturities of less than ninety days
and are carried at cost which approximates fair value.
Fixed Assets
Fixed assets are stated at cost, less accumulated depreciation and
amortization. Depreciation and amortization are provided using the
straight-line method over estimated useful lives of three to five years.
Leasehold improvements are amortized over the estimated useful life of the
asset, or the remaining term of the lease, whichever is shorter.
Intangible assets:
Purchase accounting requires
extensive use of accounting estimates and judgments to allocate the purchase
price to the fair market value of the assets purchased and liabilities assumed.
We have accounted for our acquisitions using the purchase method of accounting.
Values were assigned to intangible assets based on third-party independent
valuations, as well as managements forecasts and projections that include
assumptions related to future revenue and cash flows generated from the
acquired assets. We determined that due to the sale of substantially all of the
Alan James Group business and assets of its wholly-owned subsidiary, AJG Brands, Inc.,
prior to the opening of business on July 1, 2009, $3,251,838 of intangible
assets became permanently impaired and were expensed.
Income taxes:
The preparation of our
consolidated financial statements requires us to estimate our income taxes in
each of the jurisdictions in which we operate, including those outside the
United States, which may be subject to certain risks that ordinarily would not
be expected in the United States. We account for income taxes in accordance
with FASB ASC 740,
Income Taxes
,
which requires the recognition of taxes payable or refundable for the current
year and deferred tax liabilities and assets for the future tax consequences of
events that have been recognized in the financial statements or tax returns.
The measurement of current and deferred tax liabilities and assets is based on
provisions of the enacted tax law; the effects of future changes in tax laws or
rates are not anticipated. We record a valuation allowance to reduce our
deferred tax assets to the amount that is more likely than not to be realized.
Significant management
judgment is required in determining our provision for income taxes, our
deferred tax assets and liabilities and any valuation allowance recorded
against deferred tax assets. We have recorded a full valuation allowance
against our deferred tax assets of $25.4 million as of September 30,
2009, due to uncertainties related to our ability to utilize these assets. The
valuation allowance is based on managements estimates of taxable income by
jurisdiction in which we operate and the period over which the deferred tax
assets will be recoverable. In the event that actual results differ from these
estimates or management adjusts these estimates in future periods, we may need
to adjust our valuation allowance, which could materially impact our financial
position and results of operations.
Due to recent changes in the
Massachusetts corporate income tax regulations, we will be filing on a combined
basis with our other affiliated entities on a go-forward basis and as a result,
net operating losses will be fully utilized at September 30, 2009. The
combined filing will have no impact on our financial statements due to the full
valuation allowance that offsets any deferred tax assets.
26
Table
of Contents
In addition, the standard
prescribes how a company should recognize, measure, present and disclose in its
financial statements uncertain tax positions that a company has taken or expects
to take on a tax return. At September 30, 2009, we reviewed all material
tax positions for all years open to statute and for all tax jurisdictions open
to statute to determine whether it was more likely than not that the positions
taken would be sustained based upon the technical merits of those positions.
These provisions had no impact on our financial statements.
Contingencies:
Estimated losses from
contingencies are accrued by management based upon the likelihood of a loss and
the ability to reasonably estimate the amount of the loss. Estimating potential
losses, or even a range of losses, is difficult and involves a great deal of
judgment. Management relies primarily on assessments made by its external legal
counsel to make our determination as to whether a loss contingency arising from
litigation should be recorded or disclosed. Should the resolution of a
contingency result in a loss that we did not accrue because management did not
believe a loss was probable or capable of being reasonably estimated, then this
loss would result in a charge to income in the period the contingency was
resolved.
Recent Accounting Pronouncements
Please see our discussion of
Recent Accounting Pronouncements in Note 4. Significant Accounting Policies
contained in the Notes to Condensed Consolidated Financial Statements elsewhere
in this Form 10-Q.
Item 3.
Quantitative and Qualitative Disclosures about Market
Risk
As of September 30, 2009, the only financial instruments we
carried were cash and cash equivalents denominated in U.S. Dollars. We believe
the market risk arising from holding these financial instruments is not
material. While we recognize that the interest rates these instruments bear are
currently at historically low levels, we believe it is most prudent to maintain
these relatively low risk positions during this time of unprecedented
volatility and uncertainty across the global financial markets.
Some of our sales and some of our costs occur outside the United States
and are transacted in foreign currencies. Accordingly, we are subject to
exposure from adverse movements in foreign currency exchange rates. At this
time we do not believe this risk is material and we do not currently use
derivative financial instruments to manage foreign currency fluctuation risk.
However, if foreign sales increase and the risk of foreign currency exchange
rate fluctuation increases, we may in the future consider utilizing derivative
instruments to mitigate these risks.
Item 4.
Controls and Procedures
(a)
Evaluation of Disclosure Controls and Procedures.
Our
principal executive officer and principal financial officer, after evaluating
the effectiveness of our disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15(d)-15(e)) as of the end of the
period covered by this Quarterly Report on Form 10-Q, have concluded that,
based on such evaluation, our disclosure controls and procedures were adequate
and effective to ensure that information
required to be disclosed by us in the reports that we
file or submit under the Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the SECs rules and forms,
and is accumulated and communicated to our management, including our principal
executive and principal financial officers, or persons performing similar
functions, as appropriate to allow timely decisions regarding required
disclosure
.
(b)
Changes in Internal Control Over Financial Reporting.
No change in our internal control over financial reporting (as
defined in Rules 13a-15(f) and 15(d)-15(f)) occurred during the
quarter ended September 30, 2009 that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
27
Table of
Contents
PART IIOTHER INFORMATION
Item
1.
Legal
Proceedings.
Not applicable.
Item
1A.
Risk
Factors
In addition to the other
information set forth in this report, you should carefully consider the factors
discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K
for the year ended December 31, 2008 and Part II, Item 1A. Risk
Factors in our Quarterly Report on Form 10-Q for the quarter ended June 30,
2009, which could materially affect our business, financial condition or future
results. The risks described in our Annual Report on Form 10-K are not the
only risks that we face. In addition, risks and uncertainties not currently
known to us or that we currently deem to be immaterial also may materially
adversely affect our business, financial condition and/or operating results.
Except for the addition of the following risk factor, there have been no
material changes in or additions to the risk factors included in our Annual
Report on Form 10-K for the year ended December 31, 2008 and our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on Form 10-Q and, in
particular, our Managements Discussion and Analysis of Financial Condition and
Results of Operations set forth in Part I Item 2 contain or incorporate
a number of forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Exchange
Act. Any or all of our forward-looking statements in this Quarterly Report on Form 10-Q
may turn out to be wrong. They can be affected by inaccurate assumptions we
might make or by known or unknown risks and uncertainties. Many factors
mentioned in our discussion in this Quarterly Report on Form 10-Q will be
important in determining future results. Consequently, no forward-looking
statement can be guaranteed. Actual future results may vary materially.
Without limiting the foregoing, the words believes,
anticipates, plans, expects and similar expressions are intended to
identify forward-looking statements. There are a number of factors that could
cause actual events or results to differ materially from those indicated by
such forward-looking statements, many of which are beyond our control,
including the factors set forth under Item 1A. Risk Factors of our 2008
Annual Report on Form 10-K. In addition, the forward-looking statements
contained herein represent our estimate only as of the date of this filing and
should not be relied upon as representing our estimate as of any subsequent
date. While we may elect to update these forward-looking statements at some
point in the future, we specifically disclaim any obligation to do so to
reflect actual results, changes in assumptions or changes in other factors
affecting such forward-looking statements.
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds.
Not applicable.
Item
3.
Defaults
Upon Senior Securities.
Not applicable.
Item 4 Submission of Matters
to a Vote of Security Holders
Not
applicable
Item
5.
Other
Information.
On
November 9, 2009, we
dr
ew down $2.0 million under our existing
convertible credit facility
wi
th Pyxis, an affiliate of Alticor Inc.,
and issued a convertible promissory note to Pyxis in that amount.
A
description of the
credit
facility is
set forth
in Note 6 of the Notes to our Condensed
Consolidated Financial Statements (Unaudited), contained in this Quarterly Report
on Form 10-Q
, which description is
incorporated into this Item 5 by reference. T
he promissory note issued to Pyxis was in the
form of promissory note filed
with the Securities and
Exchange Commission
as
Exhibit 10.4
to
our Current Report on Form 8-K/A (File
No. 001-32715) on October 31, 2006. The principal amount of the note
is due and payable on August 16, 2011. The note bears interest at a
variable rate equal to the prime rate and the interest is payable quarterly.
Prior to the maturity date, any portion or the entire outstanding principal and
any accrued but unpaid interest under the note is convertible at Pyxiss
election into shares of our common stock at a price of $5.6783 per share.
Immediately
following the issuance of the note on November 9, 2009, the note
was convertible into an aggregate of
352,218 shares of our
28
Table of
Contents
common
stock
, we had $7.0 million outstanding under
the credit facility and we had $7.3 million available to us to borrow under the
credit facility.
Item
6.
Exhibits.
Exhibit
Number
|
|
Exhibit
|
|
|
|
10.1
|
|
First Amendment dated
August 10, 2009 to Amended and Restated Note Purchase Agreement, dated
March 10, 2009 by and between the Company and Pyxis
Innovations, Inc. (incorporated by reference to Exhibit 10.1 of the
Companys Quarterly Report on Form 10-Q for the Quarter ended
June 30, 2009 (File No. 001-32715))
|
31.1*
|
|
Certification by Principal
Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
31.2*
|
|
Certification by Principal
Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
32.1*
|
|
Certification Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
|
*
Filed
herewith.
29
Table of Contents
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
INTERLEUKIN
GENETICS, INC.
|
|
|
|
Date: November 12,
2009
|
By:
|
/s/
Lewis H. Bender
|
|
|
Lewis
H. Bender
|
|
|
Chief
Executive Officer
|
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
Date: November 12,
2009
|
By:
|
/s/
ELIOT M. LURIER
|
|
|
Eliot
M. Lurier
|
|
|
Chief
Financial Officer
|
|
|
(Principal
Financial Officer)
|
30
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