Unassociated Document
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, 2010
|
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
|
|
02452
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
Registrant’s
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 issuer’s classes of common
stock, as of the latest practicable date.
Class
|
|
Outstanding
at October 31, 2010
|
Common
Stock, par value $0.001 per share
|
|
36,584,799
|
INTERLEUKIN
GENETICS, INC.
FORM
10-Q
FOR
THE QUARTER ENDED September 30, 2010
Table
of Contents
|
|
Page
|
|
PART I—FINANCIAL
INFORMATION
|
|
|
|
Item
1. Financial Statements
|
|
|
|
Condensed
Balance Sheets as of September 30, 2010 (Unaudited) and December 31,
2009
|
|
|
3 |
|
Condensed
Statements of Operations (Unaudited)
|
|
|
4 |
|
Condensed
Statements of Stockholders’ Deficit (Unaudited)
|
|
|
5 |
|
Condensed
Statements of Cash Flows (Unaudited)
|
|
|
6 |
|
Notes
to Condensed Financial Statements (Unaudited)
|
|
|
7 |
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
|
|
15 |
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
|
|
23 |
|
Item
4. Controls and Procedures
|
|
|
23 |
|
PART II—OTHER INFORMATION
|
|
|
|
|
Item
1. Legal Proceedings
|
|
|
23 |
|
Item
1A. Risk Factors
|
|
|
23 |
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
|
|
24 |
|
Item
3. Defaults Upon Senior Securities
|
|
|
24 |
|
Item
4. [Removed and Reserved]
|
|
|
24 |
|
Item
5. Other Information
|
|
|
25 |
|
Item
6. Exhibits
|
|
|
25 |
|
Signatures
|
|
|
26 |
|
PART
I —FINANCIAL INFORMATION
Item
1. Financial Statements
INTERLEUKIN
GENETICS, INC.
CONDENSED
BALANCE SHEETS
|
|
|
|
|
|
|
ASSETS
|
|
(Unaudited)
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
5,202,022 |
|
|
$ |
906,248 |
|
Accounts
receivable from related party
|
|
|
3,432 |
|
|
|
24,594 |
|
Trade
accounts receivable
|
|
|
24,525 |
|
|
|
9,285 |
|
Inventory
|
|
|
94,140 |
|
|
|
118,430 |
|
Prepaid
expenses and other current assets
|
|
|
466,472 |
|
|
|
225,493 |
|
Current
assets of discontinued operations
|
|
|
32,666
|
|
|
|
31,941
|
|
Total
current
assets
|
|
|
5,823,257 |
|
|
|
1,315,991 |
|
Fixed
assets, net
|
|
|
618,709 |
|
|
|
769,981 |
|
Intangible
assets, net
|
|
|
658,901 |
|
|
|
745,490 |
|
Other
assets
|
|
|
38,001
|
|
|
|
238,001 |
|
Total
assets
|
|
$ |
7,138,868
|
|
|
$ |
3,069,463
|
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
389,011 |
|
|
$ |
321,444 |
|
Accrued
expenses
|
|
|
647,393 |
|
|
|
281,806 |
|
Deferred
revenue
|
|
|
464,049 |
|
|
|
107,792 |
|
Liabilities
of discontinued
operations
|
|
|
164,700
|
|
|
|
1,123,049 |
|
Total
current
liabilities
|
|
|
1,665,153 |
|
|
|
1,834,091 |
|
Convertible
long-term debt
|
|
|
11,000,000
|
|
|
|
7,000,000 |
|
Total
liabilities
|
|
|
12,665,153 |
|
|
|
8,834,091 |
|
Commitments
and contingencies (Note 7)
|
|
|
|
|
|
|
|
|
Stockholders’
deficit:
|
|
|
|
|
|
|
|
|
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,
2010 and December 31, 2009; aggregate liquidation preference of
$18,000,000 at September 30, 2010
|
|
|
5,000 |
|
|
|
5,000 |
|
Common
stock, $0.001 par value — 100,000,000 shares authorized; 36,551,015
and 32,102,435 shares issued and outstanding at September 30, 2010 and
December 31, 2009, respectively
|
|
|
36,551 |
|
|
|
32,102 |
|
Additional
paid-in capital
|
|
|
90,815,660 |
|
|
|
85,763,379 |
|
Accumulated
deficit
|
|
|
(96,383,496 |
) |
|
|
(91,565,109 |
) |
Total
stockholders’ deficit
|
|
|
(5,526,285 |
) |
|
|
(5,764,628 |
) |
Total
liabilities and stockholders’ deficit
|
|
$ |
7,138,868
|
|
|
$ |
3,069,463
|
|
The
accompanying notes are an integral part of these financial
statements.
INTERLEUKIN
GENETICS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended Sept. 30,
|
|
|
Nine
Months Ended Sept. 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Genetic
testing
|
|
$ |
531,151 |
|
|
$ |
119,309 |
|
|
$ |
1,460,601 |
|
|
$ |
352,130 |
|
Contract
research and development
|
|
|
— |
|
|
|
198,203 |
|
|
|
— |
|
|
|
520,935 |
|
Other
|
|
|
13,593 |
|
|
|
5,370 |
|
|
|
25,805 |
|
|
|
20,274 |
|
Total
revenue
|
|
|
544,744 |
|
|
|
322,882 |
|
|
|
1,486,406 |
|
|
|
893,339 |
|
Cost
of revenue
|
|
|
409,010 |
|
|
|
305,303 |
|
|
|
1,254,033 |
|
|
|
912,150 |
|
Gross
profit (loss)
|
|
|
135,734 |
|
|
|
17,579 |
|
|
|
232,373 |
|
|
|
(18,811 |
) |
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
427,407 |
|
|
|
873,195 |
|
|
|
1,428,523 |
|
|
|
2,628,943 |
|
Selling,
general and administrative
|
|
|
1,058,062 |
|
|
|
1,660,235 |
|
|
|
3,840,806 |
|
|
|
4,473,860 |
|
Amortization
of
intangibles
|
|
|
28,863 |
|
|
|
28,863 |
|
|
|
86,590 |
|
|
|
86,590 |
|
Total
operating
expenses
|
|
|
1,514,332 |
|
|
|
2,562,293 |
|
|
|
5,355,919 |
|
|
|
7,189,393 |
|
Loss
from
operations
|
|
|
(1,378,598 |
) |
|
|
(2,544,714 |
) |
|
|
(5,123,546 |
) |
|
|
(7,208,204 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,522 |
|
|
|
740 |
|
|
|
2,724 |
|
|
|
9,905 |
|
Interest
expense
|
|
|
(73,726 |
) |
|
|
(40,959 |
) |
|
|
(213,254 |
) |
|
|
(108,363 |
) |
Gain
on disposal of
assets
|
|
|
8,659 |
|
|
|
— |
|
|
|
33,159 |
|
|
|
— |
|
Total
other income (expense)
|
|
|
(63,545 |
) |
|
|
(40,219 |
) |
|
|
(177,371 |
) |
|
|
(98,458 |
) |
Loss
from continuing operations before income taxes
|
|
|
(1,442,143 |
) |
|
|
(2,584,933 |
) |
|
|
(5,300,917 |
) |
|
|
(7,306,662 |
) |
Benefit
for income
taxes
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Loss
from continuing operations
|
|
|
(1,442,143 |
) |
|
|
(2,584,933 |
) |
|
|
(5,300,917 |
) |
|
|
(7,306,662 |
) |
Income
(loss) from discontinued operations, net of income taxes
|
|
|
— |
|
|
|
40,661 |
|
|
|
482,530 |
|
|
|
(1,405,214 |
) |
Net
loss
|
|
$ |
(1,442,143 |
) |
|
$ |
(2,544,272 |
) |
|
$ |
(4,818,387 |
) |
|
$ |
(8,711,876 |
) |
Basic and diluted net loss per
common share from:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.23 |
) |
Discontinued
operations
|
|
|
— |
|
|
|
— |
|
|
|
0.01 |
|
|
|
(0.04 |
) |
Net
Loss
|
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.27 |
) |
Weighted
average common shares outstanding, basic and diluted
|
|
|
36,545,747 |
|
|
|
32,059,258 |
|
|
|
35,410,705 |
|
|
|
31,975,953 |
|
The
accompanying notes are an integral part of these financial
statements.
INTERLEUKIN
GENETICS, INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ DEFICIT
For
the Nine Months Ended September 30, 2010 and 2009
(Unaudited)
|
|
Convertible
Preferred Stock
|
|
|
|
|
|
Additional
Paid-in
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2008
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
stock purchase
|
|
|
— |
|
|
|
— |
|
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2009
|
|
|
5,000,000 |
|
|
$ |
5,000 |
|
|
|
32,102,435 |
|
|
$ |
32,102 |
|
|
$ |
85,763,379 |
|
|
$ |
(91,565,109 |
) |
|
$ |
(5,764,628 |
) |
Net
loss
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,818,387 |
) |
|
|
(4,818,387 |
) |
Common
stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private
placement, net of offering costs of $365,329
|
|
|
— |
|
|
|
— |
|
|
|
4,375,002 |
|
|
|
4,375 |
|
|
|
4,880,299 |
|
|
|
— |
|
|
|
4,884,674 |
|
Exercise
of stock option
|
|
|
— |
|
|
|
— |
|
|
|
1,300 |
|
|
|
2 |
|
|
|
336 |
|
|
|
— |
|
|
|
338 |
|
Employee
stock purchase plan
|
|
|
— |
|
|
|
— |
|
|
|
72,278 |
|
|
|
72 |
|
|
|
33,908 |
|
|
|
— |
|
|
|
33,980 |
|
Stock-based
compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
137,738
|
|
|
|
—
|
|
|
|
137,738 |
|
Balance
as of September 30, 2010
|
|
|
5,000,000
|
|
|
$ |
5,000
|
|
|
|
36,551,015
|
|
|
$ |
36,551
|
|
|
$ |
90,815,660
|
|
|
$ |
(96,383,496 |
) |
|
$ |
(5,526,285 |
) |
The
accompanying notes are an integral part of these financial
statements.
INTERLEUKIN
GENETICS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For
the Nine Months
Ended
Sept. 30,
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(4,818,387 |
) |
|
$ |
(8,711,876 |
) |
Income
(loss) from discontinued operations
|
|
|
482,530
|
|
|
|
(1,405,214 |
) |
Loss
from continuing operations
|
|
|
(5,300,917 |
) |
|
|
(7,306,662 |
) |
Adjustments
to reconcile loss from continuing operations to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
320,179 |
|
|
|
380,208 |
|
Stock-based
compensation expense
|
|
|
137,738 |
|
|
|
170,109 |
|
Changes
in operating assets and liabilities, net of business sold:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
5,922 |
|
|
|
(4,002 |
) |
Inventory
|
|
|
24,290 |
|
|
|
(95,913 |
) |
Prepaid
expenses and other current assets
|
|
|
(241,705 |
) |
|
|
(80,050 |
) |
Accounts
payable
|
|
|
67,570 |
|
|
|
(159,159 |
) |
Accrued
expenses
|
|
|
365,587 |
|
|
|
228,440 |
|
Deferred
revenue
|
|
|
356,256 |
|
|
|
(325,654 |
) |
Cash provided on sale of
Alan James Group business
|
|
|
— |
|
|
|
4,372,292 |
|
Net
cash used in operating activities of discontinued
operations
|
|
|
(475,819 |
) |
|
|
(1,093,403 |
) |
Net
cash used in operating activities
|
|
|
(4,740,899 |
) |
|
|
(3,913,794 |
) |
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Capital
additions
|
|
|
(82,318 |
) |
|
|
(709,005 |
) |
Other
assets
|
|
|
200,000
|
|
|
|
28,997 |
|
Net
cash provided by (used in) investing activities
|
|
|
117,682 |
|
|
|
(680,008 |
) |
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of notes payable
|
|
|
4,000,000 |
|
|
|
1,000,000 |
|
Proceeds from registered direct
offering of common stock
|
|
|
5,250,002 |
|
|
|
— |
|
Registered direct offering
costs
|
|
|
(365,329 |
) |
|
|
— |
|
Proceeds
from issuance of common stock
|
|
|
— |
|
|
|
34,156 |
|
Proceeds
from employee stock purchase plan
|
|
|
33,980 |
|
|
|
24,886 |
|
Proceeds
from exercise of employee stock options
|
|
|
338 |
|
|
|
3,900 |
|
Net
cash provided by financing activities
|
|
|
8,918,991
|
|
|
|
1,062,942
|
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
4,295,774 |
|
|
|
(3,530,860 |
) |
Cash
and cash equivalents, beginning of period
|
|
|
906,248
|
|
|
|
4,952,481 |
|
Cash
and cash equivalents, end of period
|
|
$ |
5,202,022 |
|
|
$ |
1,421,621 |
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
Cash
paid for income taxes
|
|
$ |
— |
|
|
$ |
61,300 |
|
Cash
paid for interest
|
|
$ |
189,925 |
|
|
$ |
108,363 |
|
The
accompanying notes are an integral part of these financial
statements.
INTERLEUKIN
GENETICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1—Basis
of Presentation
The condensed financial statements
include the accounts of Interleukin Genetics, Inc. (the Company) as of
September 30, 2010 and December 31, 2009 and for the three and nine months ended
September 30, 2010. The condensed financial statements for the three and nine
months ended September 30, 2009 include the accounts of the Company and its then
wholly-owned subsidiaries. Prior to the opening of business on July 1, 2009 the
Company and its then 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 herein in discontinued
operations.
The financial statements 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. As
of September 30, 2009 all intercompany accounts and transactions have been
eliminated in consolidation. These unaudited condensed 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
Company’s Annual Report on Form 10-K for the year ended December 31,
2009. Operating results are not necessarily indicative of the results that may
be expected for any future interim period or for the entire fiscal
year.
For information regarding our critical
accounting policies and estimates, please refer to “Management’s Discussion and
Analysis of Financial Condition and Results of Operations – Critical Accounting
Policies and Estimates” contained in our Annual Report on Form 10-K for the year
ended December 31, 2009 and Note 4 to our condensed financial statements
contained herein.
The
Company applies the provisions of FASB Accounting Standards Codification (“ASC”)
280, Segment Reporting,
which established 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
management’s approach. The standard also established related disclosures about
products and services, geographic areas and major customers. As a result of the
Company’s 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.
As of
September 30, 2010, the Company has one segment remaining, the genetic test
business, which was formerly defined as the Personalized Health segment and is
reflected herein 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 Company’s principal operations and markets are located
in the United States.
The Company has evaluated all events or
transactions that occurred after September 30, 2010 through the date of issuance
of these financial statements. The Company did not have any material
recognizable or non-recognizable subsequent events.
Note 2—Operating
Matters and Liquidity
The
Company has experienced net operating losses since its inception through
September 30, 2010, including a net loss of $4.8 million for the nine months
then ended, contributing to an accumulated deficit of $96.4 million as of
September 30, 2010. The Company has increased its borrowings at September 30,
2010 to $11.0 million under its line of credit with Pyxis Innovations Inc., an
affiliate of Alticor (“Pyxis”).
The
Company continues to take steps to control expenses and enhance its liquidity
and cash flow. Prior to the opening of business on July 1, 2009, the Company
sold substantially all of the Alan James Group business of its subsidiary AJG
Brands, Inc. for $4.6 million consisting of $4.4 million in cash and a $0.2
million holdback. The Company decided to sell these non-core assets as a way to
concentrate on its genetic test business. The Company no longer has the positive
cash flow of this business but now has lower administrative and operating costs
as a result of the focus on the genetic test business. The Company continues to
further reduce operating costs such as consulting and research expenses to focus
on our product development efforts. On May 24, 2010, the Company completed a
sublease of approximately 6,000 square feet of underutilized office and
laboratory space. The sublease represents approximately one-third of the total
space leased by the Company and will not adversely affect current operations.
The Company’s current laboratory space is deemed to be adequate and able to
process high volumes of genetic tests. The Company is able to add additional
employees before any additional office space would be needed.
On March
5, 2010, the Company entered into a definitive agreement with certain
institutional investors to sell $5.3 million of securities in a registered
direct offering. Net proceeds of approximately $4.9 million were received on
March 10, 2010. In addition, the Company has access to $3.3 million of available
credit under the credit facility with Pyxis which permits borrowings any time
prior to June 30, 2012.
We expect
that our current financial resources, including the amount available under our
credit facility with Pyxis, are adequate to fund our current and planned
operations for the next 18 months.
Note 3—Discontinued
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 price of $4,572,292. The proceeds consisted of a $200,000
holdback reflected in other current assets at September 30, 2010 and $4,372,292
of cash received on July 1, 2009. The holdback is available to satisfy potential
amounts owed to the buyer pursuant to the agreement and may be payable to the
Company on July 1, 2011. 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”). On December 29, 2009
IBI was merged with Interleukin Genetics, Inc. At September 30, 2010 remaining
assets of the former subsidiary consisted primarily of prepaid expenses and
liabilities consisted of accruals for inventory remaining in the retail channel
with the right of return.
The Company recognized a loss on the
sale of discontinued operations of $1,346,202 in the quarter ended June 30, 2009
including direct costs of the disposition of $674,243.
AJG Brands, Inc.’s sales reported in
discontinued operations for the three and nine months ended September 30, 2009
were $0 and $3,580,169, respectively.
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 |
|
|
|
$ |
1,992,413
|
|
We have
continued to reserve for estimated sales returns, discontinued items and trade
promotions applicable to the non-acquired accounts resulting from our sale of
substantially all of the assets of the Alan James Group business. During the
quarter ended June 30, 2010 we completed an analysis of all payments made for
these items since the sale occurred on July 1, 2009, including the final
settlement with a large customer and determined that the reserve should be
reduced by approximately $0.5 million. The remaining balance of $0.2 million at
June 30, 2010 represented management’s best estimate of the cost of future
returns. The adjustment is reflected in income from discontinued operations in
the June 30, 2010 statement of operations. During the quarter ended
September 30, 2010, $35,000 was paid to former customers leaving approximately
$165,000 for future returns.
Note 4—Significant
Accounting Policies
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, 2010 and December 31,
2009, the Company has deferred genetic test revenue of $454,030 and $107,792,
respectively.
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).
Accounts
Receivable
Accounts
receivable is stated at estimated net realizable value, which is generally the
invoiced amount less any estimated discount related to payment terms. The
Company offers its commercial genetic test customers a 2% cash discount if
payment is made by bank wire transfer within 10 days of the invoice
date.
Inventory
Inventory
on hand at September 30, 2010 consists of genetic test kits related to our
Inherent Health® brand of
genetic tests. Inventory is stated at the lower of cost or market. No inventory
reserve is required at September 30, 2010 as all test kits are available for
sale and management has determined will be sold at an amount in excess of cost.
When a kit is sold the corresponding cost of the kit is recorded as cost of
goods sold and removed from inventory.
As part
of the Company’s sale of substantially all of the Alan James Group business and
assets, all non-acquired inventory amounting to approximately $129,000 was
scrapped and written off in the fourth quarter of 2009.
Inventory
consisted of the following at September 30, 2010 and December 31,
2009:
|
|
|
|
|
|
|
Continuing
Operations
|
|
|
|
|
|
|
Raw materials
|
|
$ |
87,428 |
|
|
$ |
103,479 |
|
Finished goods
|
|
|
6,712 |
|
|
|
14,951 |
|
Total inventory,
net
|
|
$ |
94,140
|
|
|
$ |
118,430
|
|
Income
Taxes
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 Company’s 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 approximately
$28.0 million as of September 30, 2010, due to uncertainties related to its
ability to utilize these assets. The valuation allowance is based on
management’s 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.
Prior to
the 2009 tax year, the Company had generated a net operating loss carryforward
in Massachusetts. As a single filer for Massachusetts income tax
purposes it was not expected that the Company would generate taxable income in a
tax year before such carryforward would expire so a full valuation allowance was
applied to the carryforwards. Pursuant to a Massachusetts income tax law
change which become effective for the 2009 tax year, the Company and various
Alticor entities were required to file a unitary combined Massachusettst income
tax return which resulted in net taxable income for the combined group. A
portion was attributable to the Company as a group member having nexus with
Massachusetts. The Company’s Massachusetts net operating loss carryforward
was then used to fully offset the income allocated to it on the Massachusetts
return as filed.
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 as of and during the nine months ended September 30,
2010.
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 set forth in the table below:
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding
|
|
|
1,658,467 |
|
|
|
2,106,917 |
|
Warrants
outstanding
|
|
|
2,150,000 |
|
|
|
400,000 |
|
Convertible
preferred stock
|
|
|
28,160,200 |
|
|
|
28,160,200 |
|
Convertible
debt
|
|
|
1,937,200
|
|
|
|
880,545
|
|
Total
|
|
|
33,905,867
|
|
|
|
31,547,662
|
|
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
nature of these instruments. The carrying amount of long-term convertible debt
approximates its fair value as the rate applicable to such debt is consistent
with periodic changes in overall market interest rates.
Cash
and Cash Equivalents
Cash and cash equivalents include
interest-bearing accounts we have on deposit with a commercial bank. These funds
are available on demand and are at times in excess of FDIC insurance
limits.
Recent Accounting
Pronouncements
Please
see the discussion of “Recent Accounting Pronouncements” in Note 4, Significant
Accounting Policies contained in the Notes to Financial Statements included in
the Company’s Annual Report on Form 10-K for the year ended
December 31, 2009. No pronouncements issued to date by the FASB in 2010 are
expected to have a material impact on the Company’s financial
statements.
Reclassifications
Certain
reclassifications have been made to the 2009 financial statements to conform
them with the presentation used in 2010. Such reclassifications had no impact on
the Company’s reported results of operations.
Note 5—Strategic
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.
On
January 31, 2009, the Company entered into an amendment to its research
agreement (RA8) with Alticor. The amendment extended 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 revenue as of
December 31, 2009 when all research agreements with Alticor were
complete.
On
October 20, 2009, the Company entered into a Merchant Network and Channel
Partner Agreement with Amway Corp., d/b/a/ Amway Global (“Amway Global”) a
subsidiary of Alticor Inc. Pursuant to this Agreement, Amway Global sells the
Company’s Inherent Health® brand of genetic tests through its e-commerce website
via a hyperlink to our e-commerce site. We paid Amway Global $95,000 and
$263,000 in commissions for the three months and nine months ended September 30,
2010, respectively, representing a percentage of net sales to their
customers.
Note
6—Convertible Debt
On
August 17, 2006, our existing credit facility with Pyxis was amended to
provide the Company with access to approximately $14.4 million of additional
working capital borrowings at any time prior to August 17, 2008. Any
amounts borrowed thereunder bear interest at the prime rate, require quarterly
interest payments and become due on demand beginning 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 September 30,
2010, the Company entered into an amendment to extend the availability of
borrowings under the existing credit facility with Pyxis until June 30,
2012. In addition, the due date was extended from August 16, 2011 to
June 30, 2012. As of September 30, 2010, there was $11,000,000 in principal
outstanding under the credit facility which includes $2,000,000 borrowed on
February 1, 2010 and $2,000,000 borrowed on September 30, 2010 leaving
$3,316,255 of available credit.
Note 7—Commitments
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.
Legal
Proceedings
On
February 11, 2010, Genetic Technologies Limited, or GTL, filed a complaint in
the United States District Court for the Western District of Wisconsin. The
complaint named the Company and eight other corporations as defendants in an
alleged patent infringement lawsuit (Genetics Technologies Limited vs. Beckman
Coulter, Inc., et. al., Civil Action No. 10-CV-00069, W.D. Wis., filed February
11, 2010). The Company was served with the complaint on March 24, 2010. The
complaint alleged that the defendants make, use or sell products or services
that infringe one or more claims of the patent owned by GTL, U.S. Patent No.
5,612,179, or the ’179 Patent, which expired on March 10, 2010. In the
Company’s case, the complaint alleged that it offers and provides genetic risk
assessment testing services that utilize methods set forth in one or more claims
of the ‘179 Patent. The complaint did not seek specified damages. While,
the Company believes it is not in violation of the named patent, based on a
review of the options to efficiently resolve the matter, on September 25, 2010,
the Company and GTL entered into an agreement, pursuant to which GTL dismissed
its claims against the Company. The terms of the agreement did not have a
material adverse effect on the Company’s financial condition, results of
operations and cash flows.
Employment
Agreements
On
January 21, 2010, the Company entered into an employment agreement with Lewis H.
Bender, its Chief Executive Officer. The agreement replaced and superseded the
employment agreement between the Company and Mr. Bender that was to expire by
its terms on January 22, 2010. The agreement has an initial term of one year and
is automatically renewable for successive one year periods unless at least 90
days prior notice is given by either the Company or Mr. Bender. The agreement
also provides that Mr. Bender will serve as a member of the Company’s Board of
Directors for as long as he serves as the Company’s Chief Executive Officer,
subject to any required approval of the Company’s shareholders.
The
agreement is terminable by the Company for cause or upon thirty days prior
written notice without cause and by Mr. Bender upon thirty days prior written
notice for “good reason” (as defined in the agreement) or upon ninety days prior
written notice without good reason. If the Company terminates Mr. Bender without
cause or Mr. Bender terminates his employment for good reason, then the Company
will pay Mr. Bender, in addition to any accrued, but unpaid compensation prior
to the termination, an amount equal to eighteen months of his base salary. If
the Company terminates Mr. Bender without cause or Mr. Bender terminates his
employment with good reason after a “change of control” (as defined in the
agreement), then the Company will pay Mr. Bender, in addition to any accrued,
but unpaid compensation prior to the termination, an amount equal to twenty-four
months of his base salary, and all unvested stock options will automatically
vest.
The
agreement also includes non-compete and non-solicitation provisions for a period
of twelve months following the termination of Mr. Bender’s employment with the
Company.
Note 8—Capital
Stock
Authorized
Preferred and Common Stock
At
September 30, 2010, 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, 2010, the Company had authorized 100,000,000
shares of $0.001 par value common stock of which 72,212,203 shares were
outstanding or reserved for issuance. Of those, 36,551,015 shares were
outstanding; 28,160,200 shares were reserved for the conversion of Series A
Preferred to common stock; 1,937,200 shares were reserved for the conversion of
the $11,000,000 of debt outstanding under the credit facility with Pyxis;
2,628,913 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; 1,750,000 shares were reserved for the exercise of outstanding warrants to
purchase common stock at an exercise price of $1.30 per share which are
exercisable currently until the expiration date of March 5, 2015; 200,852 shares
were reserved for the potential exercise of rights held under the Employee Stock
Purchase Plan; and 584,023 shares were reserved for the issuance upon the
conversion of convertible notes that may be issued to Pyxis under the existing
credit facility.
On March
5, 2010, the Company entered into a definitive agreement with certain
institutional investors to sell $5.3 million of securities in a registered
direct offering. The investors purchased an aggregate of 4,375,002 units for
$1.20 per unit, with each unit consisting of a share of common stock and a
warrant to purchase 0.40 of a share of common stock. The warrants are
exercisable at $1.30 per share and expire in five years. Net proceeds to the
Company after fees and expenses were approximately $4.9 million.
Series A
Preferred Stock
On
March 5, 2003, the Company entered into a Stock Purchase Agreement with
Pyxis, pursuant to which Pyxis 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 Company’s 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, 2010 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 Company’s 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, 2010, 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 9—Stock-Based
Compensation Arrangements
Total
compensation cost that has been charged against income for stock-based
compensation arrangements is as follows:
|
|
Three
Months Ended
September
30,
|
|
|
Nine
Months Ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
option grants beginning of period
|
|
$ |
19,490 |
|
|
$ |
53,543 |
|
|
$ |
40,630 |
|
|
$ |
197,206 |
|
Stock-based
arrangements during the period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option
grants
|
|
|
6,936 |
|
|
|
3,837 |
|
|
|
91,258 |
|
|
|
5,721 |
|
Restricted stock
issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee stock purchase
plan
|
|
|
2,019 |
|
|
|
2,160 |
|
|
|
5,850 |
|
|
|
4,334 |
|
Employment
agreements
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,625
|
|
|
|
$ |
28,445
|
|
|
$ |
59,540
|
|
|
$ |
137,738
|
|
|
$ |
208,886
|
|
Stock
option grants
The
following table details stock option activity for the nine months ended
September 30, 2010 and 2009:
|
|
Nine
Months Ended
September
30, 2010
|
|
|
Nine
Months Ended
September
30, 2009
|
|
|
|
|
|
|
Weighted
Avg
Exercise
Price
|
|
|
|
|
|
Weighted
Avg
Exercise
Price
|
|
Outstanding,
beginning of period
|
|
|
1,591,417 |
|
|
$ |
2.06 |
|
|
|
2,100,917 |
|
|
$ |
2.33 |
|
Granted
|
|
|
323,500 |
|
|
|
0.77 |
|
|
|
138,500 |
|
|
|
0.26 |
|
Exercised
|
|
|
(13,800 |
) |
|
|
0.02 |
|
|
|
(15,000 |
) |
|
|
0.26 |
|
Canceled/Expired
|
|
|
(242,650 |
) |
|
|
4.11 |
|
|
|
(117,500 |
) |
|
|
1.22 |
|
Outstanding,
end of period
|
|
|
1,658,467 |
|
|
$ |
1.52 |
|
|
|
2,106,917 |
|
|
$ |
2.27 |
|
Exercisable,
end of period
|
|
|
921,067 |
|
|
$ |
2.04 |
|
|
|
1,487,117 |
|
|
$ |
2.83 |
|
During
the nine-month period ended September 30, 2010, the Company granted stock
options under the 2000 Employee Stock Compensation Plan and the 2004 Employee,
Director & Consultant Stock Plan. The 2000 Employee Stock Compensation Plan
expired in June 2010 and the 2004 Employee, Director & Consultant Stock
Plan is the only remaining plan under which share-based payments may be granted.
At September 30, 2010, the Company had an aggregate of 970,446 shares of Common
Stock available for grant under this plan.
It is the
Company’s policy to grant stock options with an exercise price equal to the fair
market value of the Company’s 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 Company’s stock options have been granted in
connection with the employee’s 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 in 2010, the Black-Scholes option-pricing model was used with the
following weighted-average assumptions:
Risk-free
interest rate
|
2.36%
|
Expected
life
|
5.73 years
|
Expected
volatility
|
126.39%
|
Dividend
Yield
|
0%
|
Using
these assumptions, the weighted average grant date fair value of options granted
in 2010 was $0.70.
Employee
Stock Purchase Plan
Purchases
made under the Company’s 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 Company’s 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, 2010 and 2009, employees purchased 72,278 and 126,452 shares,
respectively, of common stock at a weighted-average purchase price of $0.47 and
$0.20, respectively, while the weighted-average fair value was $0.55 and $0.23
per share, respectively, resulting in compensation expense of $5,850 and $4,334,
respectively.
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 Company’s 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,
2010 and 2009 the Company granted restricted stock awards of 22,500 and 12,500
shares, respectively.
At September 30, 2010, there was
approximately $371,406 of total unrecognized cost related to non-vested
share-based compensation arrangements granted under the Company’s stock
plans.
Note 10—Industry
Risk and Concentration
The
Company develops genetic risk assessment tests under contract, performs research
for its own benefit and, to a lesser extent, provides research services to a
collaborative partner. As of September 30, 2010, the Company has introduced four
genetic risk assessment tests commercially. Two of the tests are branded and
sold through the Company’s strategic partner — Alticor. Commercial success
of the Company’s 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.
During the nine months ended September
30, 2009, we had one significant customer, Alticor, our principal shareholder
that accounted for approximately 92.5% of our revenues from continuing
operations. During the nine months ended September 30, 2010, approximately 36.3%
of our revenue came from sales through our Merchant Network and Channel Partner
Agreement with Amway Global, a subsidiary of Alticor.
On
November 1, 2010 we were awarded two grants totaling $473,000 by the United
States Government under the Qualifying Therapeutic Discovery Project (QTDP)
Program to advance the development of our osteoarthritis and obesity genetic
test programs. The QTDP grant program provides support for innovative projects
that are determined by the U.S. Department of Health and Human Services to have
reasonable potential to result in a new therapy, reduce health care costs, or
significantly advance the goal of curing cancer. The grant will reimburse us for
expenditures made in 2009 and 2010 for these programs according to the QTDP
guidelines. We expect to receive grant funding for 2009 expenditures in the
fourth quarter of 2010 and for expenditures made in 2010 the first quarter of
2011. Grant revenue is expected to be recognized in the
fourth quarter for the full amount of the grants.
Item 2. Management’s
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 the unaudited condensed financial statements and the
notes thereto included elsewhere in this document.
General
Overview and Trends
Interleukin
Genetics, Inc. is a personalized health company that develops specific, health
area focused, unique genetic tests. Our overall mission is to provide test
products that can help individuals improve or maintain their health through
preventive measures. Our vision is to use the science of applied genetics to
empower individuals and physicians to better understand the set of actions and
steps necessary to guide the best lifestyle and treatment options. We believe
that the science of applied genetics can help companies provide improved
services to their consumers, and assist in improving outcomes in drug
development and use.
During the nine months ended September
30, 2010, we continued to focus our resources on sales of our Inherent Health®
brand of genetic tests and related programs, which began in the second quarter
of 2009, including the first-of-its-kind test for weight management that
identifies an individual’s genetic tendencies for weight gain related to either
fat or carbohydrates in the diet. The brand offers customers a full suite of
affordable, easy-to-use and meaningful genetic tests in weight management, heart
health, bone health and nutritional needs. On June 30, 2010, we launched an
additional product under the name Wellness Select that allows our e-commerce
customers to purchase any combination of our Inherent Health® genetic tests at a
discounted price. During the quarter ended September 30, 2010 customer orders
indicated that selling multiple tests in one package has the potential to be a
valuable addition to our Inherent Health® brand. In addition to our Inherent
Health® test products we offer PST®, the periodontal disease risk assessment
test sold through a Licensing Agreement with OralDNA Labs, Inc. a Quest
Diagnostics Inc. company.
We experienced extensive scientific and
media attention relating to our weight management genetic test. On March 3,
2010, we and researchers from Stanford University announced findings from a
retrospective clinical study collaboration involving our weight management
genetic test during a presentation at the American Heart Association’s annual
epidemiology and prevention conference. According to Stanford University
researchers, the differences in weight loss that were observed in individuals
who followed a diet matched to their genotype, based on our test, versus one
that was not matched to their genotype “is highly significant in numerous
categories and represents an approach to weight loss that has not been
previously reported in the literature.” This announcement followed our release
of top line positive results from the study on September 29, 2009.
On September 21, 2010, we and
researchers from The Thurston Arthritis Research Center at the University of
North Carolina at Chapel Hill announced findings from a large clinical study to
evaluate the role of genetic factors in osteoarthritis progression which showed
patients with radiographic evidence of knee osteoarthritis who inherited a
specific pattern of genetic variations in the interleukin-1 receptor antagonist
(IL-1Ra) gene were almost twice as likely to progress to severe disease as other
patients. Results from the study, which followed 1,154 patients for up to 11
years, were presented at the World Congress on Osteoarthritis in Brussels,
Belgium. We expect this important work will allow us to develop tests to
identify high-risk patients for participation in clinical trials for the
development of drugs.
Sales of our genetic tests increased
significantly in the nine months ended September 30, 2010, as compared to the
same period in the prior year driven primarily by media attention after the
findings announced at the American Heart Association’s conference. The findings
were reported in multiple national print publications as well as television.
What we have experienced is a better understanding of the importance of our
genetic test in the field of personalized health when public awareness is
gained. We plan to explore further media opportunities in the future. We did not
incur any significant expenses relating to this media.
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. We continue to pay ongoing amounts owed
on the accrued liabilities primarily related to retail inventory returns. During
the first quarter of 2010, we reached a final settlement with a retailer for
approximately $0.3 million. During the quarter ended June 30, 2010, we reversed
$0.5 million of the accrual for returns after considering the settlement with
one retailer and the pattern of returns with others over the past year. We
expect to continue to settle these accounts within the amounts accrued for at
the date of the transaction. During the quarter ended September 30, 2010 we paid
$35,000 to former customers.
We are
now focusing on genetic test development and commercialization which was
formerly defined as our Personalized Health segment and is reflected as
continuing operations.
Up to and
including September 30, 2009, we had two primary business segments that
included:
·
|
Personalized Health
Segment – this segment conducts, researches, develops, markets and
sells genetic tests panels primarily in inflammatory and metabolic areas
to provide better insight into health, wellness and disease. Following the
sale of substantially all of the Alan James Group business and assets
prior to the opening of business on July 1, 2009, the Personalized Health
segment became our only business
segment.
|
·
|
Consumer Products
Segment – this segment was comprised of the Alan James Group
business assets, which we sold prior to the opening of business on July 1,
2009, and was focused on developing, selling and marketing nutritional
supplements and products into retail consumer channels. Following the sale
of substantially all of the Alan James Group business and assets, the
Consumer Products segment ceased to
exist.
|
We have
traditionally spent approximately $3-4 million annually on research and
development. We completed our research agreements with Alticor in 2009 and are
now dedicating our resources to our own product development efforts. Our
research and development expenses have decreased as we focus more on our own
development and commercialization efforts. Our focus is now on working with
potential commercial partners to validate our technology within their specific
business model often as a collaboration with little or no cost to us. This is
different than in prior years when our development focus was concentrated in
research and development to bring new test configurations to market. 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
2010 and beyond.
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 2010 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 September 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 experience in our test
revenues or whether revenues derived from the Merchant Network and Channel
Partner Agreement with Amway Global will ever be material or if material, will
be sustained in future periods.
Three
Months Ended September 30, 2010 and September 30, 2009
Continuing
Operations
Total
revenue for the three months ended September 30, 2010 was $0.5 million,
compared to $0.3 million for the three months ended September 30, 2009. The
increase of $0.2 million, or 68.7%, is primarily attributable to increases in
genetic testing and royalty revenue offset by a decrease in contract research
revenue. Genetic testing revenue increased to $0.5 million, or 345.2%, in the
three months ended September 30, 2010, compared to $0.1 million in the three
months ended September 30, 2009. The increase is primarily attributable to sales
of our Inherent Health® Brand of genetic tests, which benefited from media
attention surrounding the March 2010 announcement of successful study results
with Stanford University on our weight management genetic test. In addition, we
have experienced an increase in sales of our Inherent Health® weight management
genetic test to commercial customers who have incorporated the test into their
business as well as increased sales of our new Wellness Select multi test
genetic test kit. Genetic testing revenue is derived from tests sold and
processed, which is driven by consumer demand. We had no contract research
revenue in the three months ended September 30, 2010, compared to $0.2 million
in the three months ended September 30, 2009. The decrease of $0.2 million is
primarily attributable to the completion in 2009 of our reimbursable research
projects with Alticor.
During the three months ended September
30, 2009, we had one significant customer, Alticor, our principal shareholder,
that accounted for approximately 89% of our revenues from continuing operations.
During the three months ended September 30, 2010, approximately 32% of our
revenue came from sales through our Merchant Network and Channel Partner
Agreement with Amway Global, a subsidiary of Alticor. Pursuant to this
agreement, Amway Global sells our genetic tests through its e-commerce web site
via a hyperlink to our e-commerce site.
Cost of revenue from continuing
operations for the three months ended September 30, 2010 was $0.4 million, or
75.1% of revenue, compared to $0.3 million, or 94.6% of revenue, for the three
months ended September 30, 2009. The significant decrease in the cost of revenue
as a percentage of revenue is primarily attributable to a significant increase
in genetic test revenue which absorbed fixed costs associated with our genetic
testing laboratory, as compared to the same period in 2009 where $0.2 million of
contract research revenue contributed to increase both the dollar amount and
cost of revenue percentage. Fixed costs of our laboratory primarily relate to
high volume genetic testing equipment installed during the first nine months of
2009. In addition, variable costs, such as laboratory supplies, increased due to
the higher volume of genetic tests processed. We can provide no assurance that
we will be able to maintain or increase the volume of tests performed in
subsequent periods.
Gross margin for the three months ended
September 30, 2010, was $0.1 million, or 24.9%, compared
to $18,000, or 5.4%, for the three months ended September 30, 2009.
The improvement in gross margin is primarily attributable to the increase in
genetic test revenue offset by a decrease in contract research
revenue.
Research
and development expenses were $0.4 million for the three months ended September
30, 2010, compared to $0.9 million for the three months ended September 30,
2009. The decrease of $0.5 million, or 51.1% is primarily attributable to
decreased clinical trial expenses related to our research agreements with
Alticor and decreased compensation and patent related expenses as compared to
the three months ended September 30, 2009.
Selling,
general and administrative expenses were $1.1 million for the three months ended
September 30, 2010, compared to $1.7 million for the three months ended
September 30, 2009. The decrease of $0.6 million, or 36.3% is primarily
attributable to decreases in promotion and product development
expenses and lower professional and consulting expenses offset by increases in
general operating expenses. In addition sales commissions paid to Amway as part
of our Merchant Channel and Partner Store Agreement increased as no commissions
were paid in the three months ended September 30, 2009.
Interest
expense was $74,000 for the three months ended September 30, 2010, as compared
to $41,000 for the three months ended September 30, 2009. The increase in
interest expense of $33,000 is primarily attributable to increased borrowings on
our credit facility with Pyxis.
Nine
Months Ended September 30, 2010 and September 30, 2009
Continuing
Operations
Total
revenue for the nine months ended September 30, 2010 was $1.5 million,
compared to $0.9 million for the nine months ended September 30, 2009. The
increase of $0.6 million, or 66.4%, is primarily attributable to increases in
genetic testing revenue and royalty revenue offset by a decrease in contract
research revenue. Genetic testing revenue increased to $1.5 million, or 314.8%,
in the nine months ended September 30, 2010, compared to $0.4 million in the
nine months ended September 30, 2009. The increase is primarily attributable to
sales of our Inherent Health® Brand of genetic tests, which benefitted from
media attention surrounding the March 2010 announcement of successful study
results with Stanford University on our weight management genetic test. In
addition, we have experienced an increase in sales of our Inherent Health®
weight management genetic test to commercial customers who have incorporated the
test into their business as well as increased sales of our new Wellness Select
multi test genetic test kit. Genetic testing revenue is derived from tests sold
and processed, which is driven by consumer demand. We had no contract research
revenue in the nine months ended September 30, 2010, compared to $0.5 million in
the nine months ended September 30, 2009. The decrease of $0.5 million is
primarily attributable to the completion in 2009 of our reimbursable research
projects with Alticor.
During the nine months ended September
30, 2009, we had one significant customer, Alticor, our principal shareholder,
that accounted for approximately 93% of our revenues from continuing operations.
During the nine months ended September 30, 2010, approximately 36% of our
revenue came from sales through our Merchant Network and Channel Partner
Agreement with Amway Global.
Cost of revenue for the nine months
ended September 30, 2010 was $1.3 million, or 84.4% of revenue, compared to $0.9
million, or 102.1% of revenue, for the nine months ended September 30, 2009. The
significant decrease in the cost of revenue as a percentage of revenue is
primarily attributable to increased genetic test revenue which absorbed fixed
costs associated with our genetic testing laboratory. Fixed costs of the
laboratory primarily relate to high volume genetic testing equipment installed
during the first nine months of 2009. In addition, variable costs, such as
laboratory supplies, increased due to the higher volume of genetic tests
processed. We can provide no assurance that we will be able to maintain or
increase the volume of tests performed in subsequent periods.
Gross margin for the nine months ended
September 30, 2010, was a profit of $0.2 million, or 15.6%, compared to a loss
of $19,000, or 2.1%, for the nine months ended September 30, 2009. The increase
in gross margin is primarily attributable to genetic test revenue offset by a
decrease in contract research revenue.
Research
and development expenses were $1.4 million for the nine months ended September
30, 2010, compared to $2.6 million for the nine months ended September 30, 2009.
The decrease of $1.2 million, or 45.7% is primarily attributable to decreased
clinical trial expenses related to our research agreements with Alticor and
decreased compensation, consulting and patent related expenses as compared to
the nine months ended September 30, 2009.
Selling,
general and administrative expenses were $3.8 million for the nine months ended
September 30, 2010, compared to $4.4 million for the nine months ended September
30, 2009. The decrease of $0.6 million, or 14.1% is primarily attributable to
decreases in promotion and product development expenses, as well as lower
consulting fees offset by increased legal fees. Sales commissions paid to Amway
Global as part of our Merchant Channel and Partner Store Agreement increased as
no commissions were paid in the nine months ended September 30,
2009.
Interest
expense was $213,000 for the nine months ended September 30, 2010, as compared
to $108,000 for the nine months ended September 30, 2009. The increase in
interest expense of $105,000 is primarily attributable to increased borrowings
on our credit facility with Pyxis.
Liquidity
and Capital Resources
Continuing
Operations
As of
September 30, 2010, we had cash and cash equivalents of $5.2 million and
borrowings available under our credit facility of approximately
$3.3 million, which permits borrowing at any time prior to June 30,
2012.
Cash used
in continuing operations was $4.3 million for the nine months ended September
30, 2010, as compared to $7.2 million for the nine months ended September
30, 2009. 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, 2010 were total
payments of $0.4 million, relating to the settlement of our obligations with
former customers of the Alan James Group in connection with their rights of
return of purchased product which included a final settlement reached with a
major customer for inventory yet to be returned in accordance with the
contractual terms of the retail relationship. The total settlement amounted to
$0.3 million which was fully paid by June 30, 2010. The amounts paid were
previously accrued in our financial statements. This use of cash was offset by a
significant increase in genetic test sales resulting from the media surrounding
the weight loss study results. Cash received from genetic test sales which is
reflected in deferred revenue until the test report is issued increased by $0.3
million to $0.4 million during the nine months ended September 30,
2010.
Prior to
the sale of substantially all of the Alan James Group business and assets, we
received positive operating cash flow from the retail sale of supplements. The
combination of positive operating cash flow from the operations of The Alan
James Group reduced our need for borrowings from our credit line with Pyxis. As
we build our genetic test business the need for capital may
increase.
Cash
provided by investing activities was $0.1 million for the nine months ended
September 30, 2010, compared to cash used of $0.7 million for the nine months
ended September 30, 2009. Capital additions were $82,000 for the nine months
ended September 30, 2010 compared to $0.7 million for the nine months ended
September 30, 2009. In addition, the $0.2 million holdback from the sale of the
business of our former AJG Brands, Inc. subsidiary is due to be paid to us on
July 1, 2011 and has been reclassified from other assets to other current
assets. The reclassification is reflected in other current assets on the
September 30, 2010 balance sheet as well as in cash used in operations in the
September 30, 2010 condensed statement of cash flows. During the nine months
ended September 30, 2009, capital additions primarily consisted of new
commercial laboratory equipment that was purchased and installed which allows
for high volume processing of genetic test samples. We believe that based on
current and projected volumes, our laboratory equipment is sufficient to process
genetic tests and no additional material capital purchases will be needed in the
foreseeable future.
Cash
provided by financing activities was $8.9 million for the nine months ended
September 30, 2010 compared to $1.1 million for the nine months ended September
30, 2009. On February 1, 2010, we received $2.0 million and on September 30,
2010 we received an additional $2.0 million in proceeds from the issuance
of notes payable for a total of $4.0 million under our existing
credit facility with Pyxis. We have no financial covenants as part of our credit
facility with Pyxis. As of September 30, 2010, we had $11.0 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. On March 5, 2010, we entered into a definitive
agreement with certain institutional investors to sell $5.3 million of
securities in a registered direct offering. The investors purchased an aggregate
of 4,375,002 units for $1.20 per unit, with each unit consisting of a share of
common stock and a warrant to purchase 0.40 of a share of common stock. The
warrants are exercisable at $1.30 per share and expire in five years. Net
proceeds to us after fees and expenses were approximately $4.9 million. We
received approximately $34,000 and $63,000, respectively, from the exercise of
stock options and stock purchases through the employee stock purchase plan for
the nine months ended September 30, 2010 and 2009.
The
amount of cash we generate from operations is not currently sufficient to
continue to fund and grow our business. We believe our success depends on our
ability to have sufficient capital and liquidity to achieve our objectives of
closing negotiations with partners and creating additional distribution channels
for our genetic testing products and technology. In addition to our current
operating line of credit we currently believe we will be required to raise
additional capital. Even though we are experiencing sales increases in our
genetic testing business we continue to explore additional steps to reduce our
operating costs. In 2009 and 2010, we reduced our headcount in non-essential
areas. We were successful in the second quarter of 2010 in completing a sublease
of approximately 6,000 square feet, or one-third of our total office space. The
space includes offices and a laboratory that was being underutilized. Our
remaining office and laboratory space is adequate for our current business
needs. We are able to process high volumes of genetic tests in our current
laboratory. We have significantly reduced our research and development programs
to only those that focus on technology related to deals with potential
commercial partners. We have taken steps to reduce our corporate administrative
expenses by working with or seeking new vendors who offer the same service for a
lower cost. While we expect that our current and anticipated financial
resources, including the amount available under our credit facility with Pyxis,
are adequate to maintain our current and planned operations for at least the
next 18 months from September 30, 2010, we anticipate we will need substantial
additional funds in the future. We intend to obtain such funds from operations,
through strategic alliances or through the sale of equity or debt securities,
but such funding may not be available on terms acceptable to us, or at
all.
On
December 23, 2009, we filed a shelf registration statement with the SEC for the
issuance of common stock, preferred stock, various series of debt securities
and/or warrants to purchase any of the securities, either individually or in
units, with a total value of up to $75 million, from time to time at prices and
on terms to be determined at the time of such offerings. This filing was
declared effective on January 5, 2010. After taking into account the securities
we issued in the March 2010 registered direct offering, we have approximately
$67.5 million of securities available for sale under our effective shelf
registration statement, although we may be limited by the rules and regulations
of the SEC and the listing exchange in the amount of securities we may offer
under this registration statement. Even if we are successful in raising
additional capital, we may not be able to raise enough capital to cover our
ongoing operating expenses and may be forced to seek other strategic
alternatives.
On
December 23, 2008, we were notified of our failure to comply with the NYSE Amex,
hereinafter referred to as the Exchange, continued listing standards under
section 1003 of the Exchange’s 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. On
January 27, 2009, we submitted a plan to the Exchange to meet the continued
listing requirements and 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 they
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. In December 2009, we provided more information to the
Exchange and requested an extension. The Exchange continued to review our
progress toward regaining compliance and on March 17, 2010 granted us an
extension until June 23, 2010 to regain compliance. On June 24, 2010, we
received notification from the Corporate Compliance Staff of the Exchange that
the Exchange intended to initiate proceedings to delist our common stock because
we did not regain compliance with Section 1003(a)(iii) of the Exchange’s Company
Guide. We requested a hearing before a Listing Qualifications Panel (the
“Panel”) to appeal the Exchange Staffs delisting determination. Despite our
continued attempts to regain compliance and after exhausting the grace period
allowances extended by the Exchange, we did not regain compliance and
withdrew our appeal. As a result, our common stock was suspended from
the Exchange effective with the open of business on August 16, 2010 and began
trading on the OTCQB™ under the symbol ILIU.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are
based upon our 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 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
set forth in Note 4 to our financial statements included in our Annual Report on
Form 10-K for the year ended December 31, 2009. There have been no significant
changes in our accounting policies or changes from the methodology applied by
management for critical accounting estimates previously disclosed in our most
recent Annual Report on Form 10-K.
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, 2010 and December 31,
2009, we had deferred revenue of $454,000 and $108,000, respectively, for tests
that have been prepaid but results have not yet been reported.
Allowance
for Sales Returns and Trade Promotions:
We have
continued to reserve for estimated sales returns, discontinued items and trade
promotions applicable to the non-acquired accounts resulting from our sale of
substantially all of the assets of the Alan James Group business. The remaining
balance of $0.2 million at September 30, 2010 represents management’s best
estimate of the cost of future returns. Payments of approximately $0.4 million
were made that directly related to product returns from non acquired accounts
during the nine months ended September 30, 2010.
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. We provide an allowance against that portion of inventory that we
believe is unlikely to be sold or used. An adverse change in any of these
factors may result in the need for additional inventory allowance.
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. Common stock
purchased pursuant to our employee stock purchase plan is expensed based upon
the fair market value in excess of purchase price.
Intangible
Assets:
Acquisition
accounting requires extensive use of accounting estimates and judgments to
allocate the purchase price to the fair market value of the assets acquired and
liabilities assumed. Values were assigned to intangible assets based on
third-party independent valuations, as well as management’s 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 prior to the
opening of business on July 1, 2009, $3,251,838 of intangible assets became
permanently impaired and were expensed.
At least
annually, we evaluate our intangible assets for possible impairment. We first
must investigate if there was a triggering event that would cause us to evaluate
the value of the intangible assets as outlined in the accounting standard for
intangible assets. There was no triggering event identified in the quarter ended
September 30, 2010.
Income Taxes:
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 approximately $28.0 million as of September 30,
2010, due to uncertainties related to our ability to utilize these assets. The
valuation allowance is based on management’s 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.
Prior to
the 2009 tax year, the Company had generated a net operating loss carryforward
in Massachusetts. As a single filer for Massachusetts income tax
purposes it was not expected that the Company would generate taxable income in a
tax year before such carryforward would expire so a full valuation allowance was
applied to the carryforwards. Pursuant to a Massachusetts income tax law
change which become effective for the 2009 tax year, the Company and various
Alticor entities were required to file a unitary combined Massachusetts income
tax return which resulted in net taxable income for the combined group. A
portion was attributable to the Company as a group member having nexus with
Massachusetts. The Company’s Massachusetts net operating loss carryforward
was then used to fully offset the income allocated to it on the Massachusetts
return as filed.
In
addition, ASC 740 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, 2010, 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. The Company had no uncertain tax positions at September 30,
2010.
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 the discussion of “Recent Accounting Pronouncements” in Note 4, Significant
Accounting Policies contained in the Notes to Financial Statements included in
our Annual Report on Form 10-K for the year ended December 31, 2009.
No pronouncements issued to date by the FASB in 2010 are expected to have a
material impact on the Company’s financial statements.
Item 3. Quantitative and Qualitative
Disclosures about Market Risk
As of
September 30, 2010, 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 may occur outside the United States and might be
transacted in foreign currencies. Accordingly, we may be 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
SEC’s 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, 2010 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial
reporting.
PART
II—OTHER INFORMATION
Item
1.
|
Legal
Proceedings
|
On
February 11, 2010, Genetic Technologies Limited, or GTL, filed a complaint in
the United States District Court for the Western District of Wisconsin. The
complaint named Interleukin and eight other corporations as defendants in an
alleged patent infringement lawsuit (Genetics Technologies Limited vs. Beckman
Coulter, Inc., et. al., Civil Action No. 10-CV-00069, W.D. Wis., filed February
11, 2010). We were served with the complaint on March 24, 2010. The
complaint alleged that the defendants make, use or sell products or services
that infringe one or more claims of the patent owned by GTL, U.S. Patent No.
5,612,179, or the ’179 Patent, which expired on March 10, 2010. In our
case, the complaint alleged we offer and provide genetic risk assessment testing
services that utilize methods set forth in one or more claims of the ‘179
Patent. The complaint did not seek specified damages. While we believe we are
not in violation of the named patent, based on a review of our options to
efficiently resolve the matter, on September 25, 2010, we entered into an
agreement with GTL pursuant to which GTL dismissed its claims against us. The
terms of the agreement did not have a material adverse effect on our financial
conditions, results of operations and cash flows.
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, 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. 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, 2009, except that the Risk Factor
entitled “Any tests that may be developed by us may be subject to regulatory
approval, which can be lengthy, costly and burdensome.” is replaced by the
following Risk Factor:
Any
tests that may be developed by us may be subject to regulatory clearance or
approval, which can be lengthy, costly and burdensome.
Clinical
laboratory tests that are developed and validated by a CLIA–certified laboratory
for its own use are known as laboratory developed tests, or LDTs. Our
currently marketed tests were launched as LDTs performed in our CLIA–certified
clinical laboratory operating in Waltham, Massachusetts. We expect that our
future LDTs will be launched as well at our CLIA-certified laboratory. While
some in vitro diagnostic tests and all in vitro diagnostic test kits that
are sold and distributed through interstate commerce are subject to clearance or
approval by the U.S. Food and Drug Administration, or FDA, most LDTs have
historically been subject to FDA’s enforcement discretion and the FDA has not
required pre-market review.
Recently,
however, the FDA publicized its intention to more actively regulate LDTs,
including tests such as ours that are sold directly to consumers. In July 2010,
the FDA held a two-day workshop related to its future regulation of LDTs.
Nevertheless, it is not clear when its regulatory policy will change and what
changes will be instituted.
In July
2010, we received a letter from the FDA inquiring about our Inherent Health
brand of genetic tests and stating that these tests appear to meet the
definition of a “device” as such term is defined by the FDA. On November 1,
2010, we met with staff from the FDA’s Office of In vitro Diagnostic Device
Evaluation and Safety to present information on our products and discuss
the letter. Based on that meeting, we believe that the FDA will require us
to submit additional information about our tests, perhaps in the form of a
510(k) application or a premarket approval application, or PMA. Our business
could be negatively impacted based on the outcome of the process because we may
be required to revise our tests significantly, potentially delay introduction of
new tests or stop offering certain or all of our current tests in the
future.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q and, in particular, our Management’s 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 Annual Report on Form 10-K for the year ended December 31,
2009 and under “Item 1A. Risk Factors” above in this Quarterly Report on Form
10-Q. 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 |
[Removed
and Reserved.]
|
Item
5.
|
Other
Information.
|
Exhibit
Number
|
|
Exhibit
|
10.1
|
|
Form
of Amended and Restated Promissory Note under credit facility with Pyxis
Innovations Inc. (incorporated by reference to Exhibit 4.1 of the
Company’s current Report on Form 8-K filed on October 4, 2010 (File No.
001-32715))
|
|
|
|
10.2
|
|
Form
of (new) Promissory Note under credit facility with Pyxis Innovations Inc.
(incorporated by reference to Exhibit 4.2 of the Company’s current Report
on Form 8-K filed on October 4, 2010 (File No.
001-32715))
|
|
|
|
10.3
|
|
Third
Amendment, dated September 30, 2010 to Amended and Restated Note Purchase
Agreement by and between the Company and Pyxis Innovations Inc.
(incorporated by reference to Exhibit 10.1 of the Company’s current Report
on Form 8-K filed on October 4, 2010 (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
|
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 11, 2010
|
By:
|
/s/
Lewis H. Bender
|
|
|
Lewis
H. Bender
Chief
Executive Officer
(Principal
Executive Officer)
|
|
|
|
|
|
|
Date:
November 11, 2010
|
By:
|
/s/
Eliot M. Lurier
|
|
|
Eliot
M. Lurier
Chief
Financial Officer
(Principal
Financial Officer)
|