Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
x
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE
ACT OF 1934
For the
quarterly period ended March 31, 2009
o
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE
ACT OF 1934
For
the transition period from
to
Commission
File Number: 001-32715
INTERLEUKIN GENETICS, INC.
(Exact name of registrant in its charter)
Delaware
|
|
94-3123681
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(State or other
jurisdiction of
incorporation or organization)
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|
(I.R.S. Employer
Identification No.)
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|
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135 Beaver Street, Waltham, MA
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02452
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(Address of principal
executive offices)
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|
(Zip Code)
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Registrants Telephone Number:
(781) 398-0700
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. YES
x
NO
o
Indicate
by check mark whether each registrant has submitted electronically and posted
on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit and post such files). YES
o
NO
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of large accelerated filer, accelerated filer and smaller
reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer
o
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|
Accelerated
filer
o
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|
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|
Non-Accelerated
filer
o
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|
Smaller
reporting company
x
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(Do
not check if a smaller reporting company)
|
|
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act). YES
o
NO
x
Indicate
the number of shares outstanding of each of the issuers classes of common
stock, as of the latest practicable date.
Class
|
|
Outstanding at April 30, 2009
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Common Stock, par value $0.001 per share
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32,010,837
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Table of Contents
PART I FINANCIAL INFORMATION
Item 1. Financial
Statements
INTERLEUKIN
GENETICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
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March 31,
2009
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December 31,
2008
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(Unaudited)
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(Audited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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1,746,523
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$
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4,952,481
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Accounts receivable from related party
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36,388
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35,167
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Trade accounts receivable, net of allowances for doubtful accounts of
$6,696 at March 31, 2009 and December 31, 2008
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945,165
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720,914
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Inventory
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1,037,288
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828,120
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Deferred tax asset
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57,800
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58,000
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Prepaid expenses and other current assets
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374,812
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271,602
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Total current assets
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4,197,976
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6,866,284
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Fixed assets, net
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929,702
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474,035
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Intangible assets, net
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4,392,604
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4,759,153
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Other assets
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54,916
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54,916
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Total assets
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$
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9,575,198
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$
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12,154,388
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LIABILITIES AND STOCKHOLDERS
EQUITY
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Current liabilities:
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Accounts payable
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$
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855,169
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$
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1,332,258
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Accrued expenses
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2,150,327
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1,820,544
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Deferred receipts
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429,814
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482,103
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State taxes payable
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10,000
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Accrued expenses related to funded research and development projects
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22,055
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22,056
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Total current liabilities
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3,457,365
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3,666,961
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Long Term Debt
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4,000,000
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4,000,000
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Deferred tax liability
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10,000
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5,000
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Total liabilities
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7,467,365
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7,671,961
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|
Stockholders equity:
|
|
|
|
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Convertible preferred stock, $0.001 par value 6,000,000 shares
authorized; 5,000,000 shares of Series A issued and outstanding at
March 31, 2009 and December 31, 2008; aggregate liquidation
preference of $18,000,000 at March 31, 2009
|
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5,000
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5,000
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Common stock, $0.001 par value 100,000,000 shares authorized;
31,969,887 and 31,799,381 shares issued and outstanding at March 31, 2009
and December 31, 2008, respectively
|
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31,970
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31,799
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Additional paid-in capital
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85,539,656
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85,458,334
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Accumulated deficit
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(83,468,793
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)
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(81,012,706
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)
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Total stockholders equity
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2,107,833
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4,482,427
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Total liabilities and stockholders equity
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$
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9,575,198
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$
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12,154,388
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|
The accompanying notes are an integral part of these consolidated
financial statements.
3
Table of Contents
INTERLEUKIN
GENETICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended March 31,
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2009
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2008
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Revenue:
|
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Revenue from related party
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$
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334,538
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$
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640,616
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Revenue from others
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1,560,457
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2,013,907
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Total revenue
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1,894,995
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2,654,523
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Cost of revenue
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1,042,699
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1,335,972
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Gross profit
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852,296
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1,318,551
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Operating Expenses:
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Research and development
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881,556
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813,371
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Selling, general and administrative
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2,034,938
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2,083,235
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Amortization of intangible assets
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337,551
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330,184
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Total operating expenses
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3,254,045
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3,226,790
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Loss from operations
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(2,401,749
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)
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(1,908,239
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)
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Other income (expense):
|
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|
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Interest income
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8,216
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63,552
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|
Interest expense
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(32,055
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)
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(11,865
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)
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Loss on sale of fixed asset
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(12,499
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)
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|
Total other income (expense)
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(36,338
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)
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51,687
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Net loss before income taxes
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|
(2,438,087
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)
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(1,856,552
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)
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Provision for income taxes
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(18,000
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)
|
(18,550
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)
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Net loss
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|
$
|
(2,456,087
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)
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$
|
(1,875,102
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)
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Basic and diluted net loss per common share
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$
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(0.08
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)
|
$
|
(0.06
|
)
|
Weighted average common shares outstanding
|
|
31,855,981
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|
30,832,121
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|
The accompanying notes are an integral part of these consolidated
financial statements.
4
Table of Contents
INTERLEUKIN
GENETICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
For the Three Months Ended March 31, 2009
(Unaudited)
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Convertible
Preferred
Stock
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Common
Stock
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Additional
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|
|
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Shares
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$0.001
par value
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|
Shares
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$0.001
par value
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|
Paid-in
Capital
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|
Accumulated
Deficit
|
|
Total
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|
Balance
as of December 31, 2008 (Audited)
|
|
5,000,000
|
|
$
|
5,000
|
|
31,799,381
|
|
$
|
31,799
|
|
$
|
85,458,334
|
|
$
|
(81,012,706
|
)
|
$
|
4,482,427
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|
Net loss
|
|
|
|
|
|
|
|
|
|
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|
(2,456,087
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)
|
(2,456,087
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)
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Common stock
issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Purchase stock
|
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|
|
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126,500
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|
126
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34,028
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34,154
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Employee stock
purchase plan
|
|
|
|
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31,506
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32
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|
5,325
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|
|
|
5,357
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Restricted stock
awards
|
|
|
|
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|
12,500
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|
13
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|
(13
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)
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Stock-based
compensation expense
|
|
|
|
|
|
|
|
|
|
41,982
|
|
|
|
41,982
|
|
Balance
as of March 31, 2009
|
|
5,000,000
|
|
$
|
5,000
|
|
31,969,887
|
|
$
|
31,970
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|
$
|
85,539,656
|
|
$
|
(83,468,793
|
)
|
$
|
2,107,833
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
5
Table of Contents
INTERLEUKIN
GENETICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
Net loss
|
|
$
|
(2,456,087
|
)
|
$
|
(1,875,102
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
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|
|
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Depreciation and amortization
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428,565
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402,238
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|
Stock-based compensation expense
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41,982
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38,437
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|
Loss on sale of fixed asset
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12,499
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|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
Accounts receivable, net
|
|
(225,472
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)
|
(256,111
|
)
|
Inventory
|
|
(209,169
|
)
|
(1,822
|
)
|
Prepaid expenses and other current assets
|
|
(103,210
|
)
|
(53,069
|
)
|
Accounts payable
|
|
(477,089
|
)
|
349,700
|
|
Accrued expenses
|
|
329,782
|
|
(828,679
|
)
|
State Taxes Payable
|
|
(10,000
|
)
|
(19,705
|
)
|
Deferred revenue
|
|
(52,289
|
)
|
(237,013
|
)
|
Accrued expenses related to funded R&D
|
|
|
|
(23,000
|
)
|
Deferred tax provision
|
|
5,200
|
|
(3,000
|
)
|
Net cash used in operating activities
|
|
(2,715,288
|
)
|
(2,507,126
|
)
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
Capital additions
|
|
(559,179
|
)
|
(9,199
|
)
|
Increase in other assets
|
|
28,998
|
|
(59,268
|
)
|
Settlement of claims relating to the acquisition of the assets and
business of the Alan James Group, LLC
|
|
|
|
(600,000
|
)
|
Net cash used in investing activities
|
|
(530,181
|
)
|
(668,467
|
)
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
34,154
|
|
|
|
Proceeds from exercises of rights offering, stock warrants, options
and employee stock purchase plan
|
|
5,357
|
|
1,590
|
|
Net cash provided by financing activities
|
|
39,511
|
|
1,590
|
|
Net decrease in cash and cash equivalents
|
|
(3,205,958
|
)
|
(3,174,003
|
)
|
Cash and cash equivalents, beginning of period
|
|
4,952,481
|
|
7,646,468
|
|
Cash and cash equivalents, end of period
|
|
$
|
1,746,523
|
|
$
|
4,472,465
|
|
Supplemental disclosures of cash flow
information:
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes
|
|
$
|
|
|
$
|
67,500
|
|
Cash paid for interest
|
|
$
|
50,411
|
|
$
|
11,865
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
6
Table of Contents
INTERLEUKIN
GENETICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1Basis of
Presentation
The condensed consolidated financial statements include the accounts of
Interleukin Genetics, Inc. (the Company), and its wholly-owned
subsidiaries, as of March 31, 2009 and have been prepared by the Company
in accordance with accounting principles generally accepted in the United
States of America for interim financial reporting and with the instructions to Form 10-Q
and Rule 10-01 of Regulation S-X. Accordingly, they do not include
all of the information and notes required by generally accepted accounting
principles for complete financial statements. All intercompany accounts and
transactions have been eliminated. These unaudited condensed consolidated
financial statements, which, in the opinion of management, reflect all
adjustments (including normal recurring adjustments) necessary for a fair
presentation, should be read in conjunction with the financial statements and
notes thereto included in the Companys Annual Report on Form 10-K for the
year ended December 31, 2008. Operating results for the three months ended
March 31, 2009 are not necessarily indicative of the results that may be
expected for any future interim period or for the entire fiscal year.
Note 2Settlement of
acquisition contingency
On March 25, 2008, The Company entered into an agreement with the
former owners of the Alan James Group regarding the acquisition of the assets
and business of the Alan James Group. Under the agreement, the former owners
agreed to release the Company from any further obligations under the Asset
Purchase Agreement, relating to the acquisition of the assets and business of
the Alan James Group on August 17, 2006. The former owners agreed that no
further amounts are or will become due under the Purchase Agreement (including
its earn-out provisions).
In addition, on March 25, 2008, the Company agreed to pay a total
of $1,200,000. This agreement resolved all remaining issues associated with the
Companys August 2006 acquisition of that business including contingent
consideration and compensation arrangements with the sellers/former management.
The $1,200,000 due to sellers was recorded as a current liability at December 31,
2007. The Company applied $600,000 of the settlement cost against the
previously accrued separation expense that was recorded on September 30,
2007 and the remaining $600,000 was applied against the $2,130,374 aggregate
total of contingent liabilities and amounts due under escrow recorded as part
of the original acquisition. The remaining contingent liabilities and amounts
due under escrow balance of $1,530,374 was eliminated as no longer due and
applied as a reduction in the balances on a pro rata basis of the intangible
assets recorded as part of the original acquisition, including the effect of
term reduction on the non-compete agreements.
If the amount initially recognized as if it was a liability exceeds the
fair value of the consideration issued or issuable, that excess shall be
allocated as a pro rata reduction of the amounts assigned to assets acquired in
accordance with SFAS No. 141. The intangible balances as of December 31,
2007 reflect the resolution of the contingency resulting from the acquisition
of the assets and business of the Alan James Group.
Note 3Significant
Accounting Policies
Principles of Consolidation
The condensed consolidated financial statements include the accounts of
Interleukin Genetics, Inc., and its wholly owned subsidiaries, Interleukin
Genetics Laboratory Services, Inc. and AJG Brands, Inc. doing
business as the Alan James Group. All intercompany accounts and transactions
have been eliminated.
Management Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosures of contingent assets and liabilities at the date of the
financial statements, as well as the reported amounts of revenue and expenses
during the reported periods. Actual results could differ from those estimates.
The Companys most critical accounting policies are in areas of its strategic
alliance with Alticor, revenue recognition, allowance for sales returns, trade
promotions, accounts receivable, inventory, stock-based compensation, income
taxes, long-lived assets. These critical accounting policies are more fully
discussed in these notes to the consolidated financial statements.
7
Table of Contents
Revenue Recognition
Revenue
from genetic testing services is recognized when there is persuasive evidence
of an arrangement, service has been rendered, the sales price is determinable
and collectability is reasonably assured. Service is deemed to be rendered when
the results have been reported to the individual who ordered the test. To the
extent that tests have been prepaid but results have not yet been reported,
recognition of all related revenue is deferred. As of March 31, 2009 and December 31,
2008, the Company has deferred receipts of $32,400 and $80,000, respectively,
for tests that have been prepaid but results have not yet been reported.
Revenue
from product sales is recognized when there is persuasive evidence of an
arrangement, delivery has occurred and title and risk of loss have transferred
to the customer, the sales price is determinable and collectability is
reasonably assured. The Company has no consignment sales. Product revenue is
reduced for allowances and adjustments, including returns, discontinued items,
discounts, trade promotions and slotting fees.
Revenue
from contract research and development is recognized over the term of the
contract as the Company performs its obligations under that contract (including
revenue from Alticor, a related party).
Allowance for Sales Returns
The
Companys revenue is affected by retailers right to return products. For
product sales for which the Company believes it can reasonably and reliably
estimate future returns, it recognizes revenue at the time of sale. For product
sales for which the Company cannot reasonably and reliably estimate future
returns, such as new products, the Company defers revenue recognition until the
return privilege has substantially expired or the amount of future returns can be
reasonably and reliably estimated. As of March 31, 2009 and December 31,
2008, the Company has deferred $77,308 and $78,627, respectively, of revenue
for sales for which it cannot reasonably and reliably estimate future returns.
The
Company analyzes sales returns in accordance with SFAS No. 48,
Revenue Recognition When Right of Return Exists.
The Company is able to make reasonable and reliable estimates based on its
history. The Company also monitors the buying patterns of the end-users of its
products based on sales data received. The Company reviews its estimated
product returns based on expected sales data communicated by its customers. The
Company also monitors the levels of inventory at its largest customers to avoid
excessive customer stocking of merchandise. The Company believes it has
sufficient interaction with and knowledge of its customers, industry trends and
industry conditions to adjust the accrual for returns when necessary. If the
Company loses a major account, it may agree to accept a substantial amount of
returns.
Trade Promotions
The
Company uses objective procedures for estimating its allowance for trade
promotions. The allowance for trade promotions offered to customers is based on
contracted terms or other arrangements agreed in advance, as well as historical
experience. The Company may adjust its estimate based on these factors to more
accurately reflect trade promotion costs.
Accounts Receivable
Trade
accounts receivable are stated at their estimated net realizable value, which
is generally the invoiced amount less any estimated discount related to payment
terms. The Company offers its Consumer Product Segment customers a 2% cash
discount if payment is made within 30 days of the invoice date, however,
most customers take the discount regardless of when payment occurs. As of March 31,
2009 and December 31, 2008, the Company has reduced trade accounts
receivable by $16,524 and $13,364, respectively, for discounts anticipated to
be taken. The Company provides for an allowance for estimated bad debts based
on managements estimate of the amount of probable credit losses in the Companys
existing accounts receivable. As of March 31, 2009 and December 31,
2008, the Company has provided an allowance for uncollectible accounts of
$6,696.
Inventory
Inventory
is stated at the lower of cost or market. Cost is determined using the invoice
price from our vendors. Management periodically evaluates inventory to identify
items that are slow moving or have excess quantities. Management also considers
whether certain items are carried at values that exceed the ultimate sales
price less selling costs. Where such items are identified, management adjusts
the carrying value to the lower of cost or market.
8
Table of Contents
Inventory
on hand primarily consisted of the following at March 31, 2009 and December 31,
2008:
|
|
2009
|
|
2008
|
|
Raw materials
|
|
$
|
96,447
|
|
$
|
93,544
|
|
Finished goods
|
|
940,841
|
|
734,576
|
|
Total
|
|
$
|
1,037,288
|
|
$
|
828,120
|
|
Stock-Based Compensation
The
Company accounts for its stock-based compensation expense in accordance with
SFAS No. 123 (Revised 2004),
Share-Based
Payment
(SFAS No. 123R) which requires companies to recognize
compensation expenses for all share-based payments to employees at fair value.
SFAS No. 123R 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. SFAS No. 123R requires the
Company to expense SBP awards with compensation cost for SBP transactions
measured at fair value. SFAS No. 123R applies to new equity awards and to
equity awards modified, repurchased or canceled after the effective date, January 1,
2006. Additionally, compensation cost for the portion of awards for which the
requisite service has not been rendered that are outstanding as of the
effective date shall be recognized as the requisite service is rendered on or
after the effective date. The compensation cost for that portion of awards
shall be based on the grant-date fair value of those awards as calculated from
the pro forma disclosures under SFAS No. 123. Additionally, the Company
records an expense for the amount that the fair market value exceeds the
purchase cost for common stock purchased pursuant to its employee stock
purchase plan.
Income Taxes
The
preparation of its consolidated financial statements requires the Company to
estimate its income taxes in each of the jurisdictions in which it operates,
including those outside the United States, which may be subject to certain
risks that ordinarily would not be expected in the United States. The Company
accounts for income taxes in accordance with SFAS No. 109,
Accounting for Income Taxes
, which
requires the recognition of taxes payable or refundable for the current year
and deferred tax liabilities and assets for the future tax consequences of
events that have been recognized in the financial statements or tax returns.
The measurement of current and deferred tax liabilities and assets is based on
provisions of the enacted tax law; the effects of future changes in tax laws or
rates are not anticipated. The Company records a valuation allowance to reduce
its deferred tax assets to the amount that is more likely than not to be
realized.
Significant
management judgment is required in determining the Companys provision for
income taxes, its deferred tax assets and liabilities and any valuation
allowance recorded against deferred tax assets. The Company has recorded a full
valuation allowance against its deferred tax assets of $25.3 million as of
March 31, 2009, due to uncertainties related to its ability to utilize
these assets. The valuation allowance is based on managements estimates of
taxable income by jurisdiction in which the Company operates and the period
over which the deferred tax assets will be recoverable. In the event that
actual results differ from these estimates or management adjusts these estimates
in future periods, the Company may need to adjust its valuation allowance,
which could materially impact its financial position and results of operations.
The
Company complies with the provisions of the Financial Accounting Standards
Interpretation No. 48,
Accounting for Uncertainty
in Income Taxes
(FIN 48). FIN 48 prescribes a recognition
threshold and measurement process for recording in the financial statements
uncertain tax positions taken or expected to be taken in a tax return. FIN 48
also provides guidance on de-recognition, classification, interest and
penalties, accounting in interim periods, disclosure and transitions. The
Company reviews all material tax positions for all years open to statute to
determine whether it is more likely than not that the positions taken would be
sustained based on the technical merits of those positions. The Company did not
recognize any adjustments for uncertain tax positions during the three months
ended March 31, 2009.
Research and Development
Research
and development costs are expensed as incurred.
Advertising Expense
Advertising
costs are expensed as incurred. During the three months ended March 31,
2009 and 2008 advertising expense was $153,341 and $274,713, respectively.
9
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Basic and Diluted Net Loss per Common Share
The
Company applies SFAS No. 128,
Earnings
per Share
, which establishes standards for computing and presenting
earnings per share. Basic and diluted net loss per share was determined by
dividing net loss applicable to common stockholders by the weighted average
number of shares of common stock outstanding during the period. Diluted net
loss per share is the same as basic net loss per share for all the periods
presented, as the effect of the potential common stock equivalents is
anti-dilutive due to the loss in each period. Potential common stock
equivalents excluded from the calculation of diluted net loss per share
consists of stock options, warrants, convertible preferred stock and
convertible debt as described in the table below:
|
|
As of March 31,
|
|
|
|
2009
|
|
2008
|
|
Options outstanding
|
|
2,225,667
|
|
1,866,073
|
|
Warrants outstanding
|
|
400,000
|
|
400,000
|
|
Convertible preferred stock
|
|
28,160,200
|
|
28,160,200
|
|
Convertible debt
|
|
704,436
|
|
931,377
|
|
Total
|
|
31,490,303
|
|
31,357,650
|
|
Comprehensive Income (Loss)
Comprehensive
income (loss) is defined as the change in equity of a business enterprise
during a period from transactions and other events and circumstances from
non-owner sources. During the three months ended March 31, 2009, and 2008,
there were no items other than net loss included in the comprehensive loss.
Fair Value of Financial Instruments
The
Company, using available market information, has determined the estimated fair
values of financial instruments. The stated values of cash and cash
equivalents, accounts receivable and accounts payable approximate fair value
due to the short-term nature of these instruments. The carrying amounts of
borrowings under short-term agreements approximate their fair value as the
rates applicable to the financial instruments reflect changes in overall market
interest rates.
Cash Equivalents
Cash
and cash equivalents consist of amounts on deposit in checking and savings
accounts with banks and other financial institutions. Short-term investments
primarily consist of bank money market funds which have short-term maturities
of less than ninety days and are carried at cost which approximates fair value.
Fixed Assets
Fixed
assets are stated at cost, less accumulated depreciation and amortization.
Depreciation and amortization are provided using the straight-line method over
estimated useful lives of three to five years. Leasehold improvements are
amortized over the estimated useful life of the asset, or the remaining term of
the lease, whichever is shorter.
Long-Lived Assets
The
Company applies the provisions of SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets
(SFAS No. 144). SFAS No. 144 requires that the Company evaluate its
long-lived assets for impairment whenever events or changes in circumstances
indicate that carrying amounts of such assets may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of the
carrying amount of an asset to the future undiscounted net cash flows expected
to be generated by the asset. Any write-downs, based on fair value, are to be
treated as permanent reductions in the carrying amount of the assets. The
Company believes that no impairment exists related to the Companys long-lived
assets at March 31, 2009.
Intangible Assets
Purchase
accounting requires extensive use of accounting estimates and judgments to
allocate the purchase price to the fair market value of the assets purchased
and liabilities assumed. Prior to 2009, the Company accounted for its
acquisitions using the purchase method of accounting. Values were assigned to
goodwill and intangible assets based on
10
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third-party independent
valuations, as well as managements forecasts and projections that include
assumptions related to future revenue and cash flows generated from the
acquired assets.
The
Company applies the provisions of SFAS No. 142,
Goodwill and Other Intangible Assets
. SFAS No. 142
requires impairment tests be periodically repeated and on an interim basis, if
certain conditions exist, with impaired assets written down to fair value. An
analysis performed by management on December 31, 2007, determined that the
indefinite lived trademarks had a current fair market value of $764,000.
Management adjusted the book value of the indefinite lived trademarks to
reflect this $236,000 impairment in value. See Note 2 for adjustments of
intangible assets related to the settlement effective March 25, 2008.
Recent Accounting Pronouncements
In September 2006, the FASB
issued SFAS No. 157,
Fair Value
Measurements
. SFAS 157 defines fair value, establishes a U.S. GAAP
framework for measuring fair value, and expands financial statement disclosures
about fair value measurements. We adopted SFAS No. 157 on January 1,
2008 for financial assets and liabilities. The adoption of this standard had no
material impact on our results of operations or financial condition. In February 2008,
the FASB issued FASB Staff Position (FSP) 157-2, Effective Date of FASB
Statement No. 157, which permits a one-year deferral in applying the
measurement provisions of SFAS 157 to non-financial assets and non-financial
liabilities (non-financial terms) that are not recognized or disclosed at fair
value in an entitys financial statements on a recurring basis (at least
annually). Therefore, if the change in fair value of a non-financial item is
not required to be recognized or disclosed in the financial statements on an
annual basis or more frequently, the effective date of application of SFAS 157
was deferred until fiscal years beginning after November 15, 2008. The
adoption of this standard as of January 1, 2009 had no material effect on
our results of operations or financial condition.
In
February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities-Including an amendment of FASB Statement No. 115
,
which is effective for fiscal years beginning after November 15, 2007. The
statement permits entities to choose to measure many financial instruments and
certain other items at fair value. The Company adopted SFAS 159 on January 1,
2008. The Company has not elected to account for any of its assets or
liabilities using the fair value option under SFAS 159 and accordingly, the
adoption of SFAS 159 did not have a material effect on the Companys financial
position or results of operations.
In
July 2007, the Emerging Issues Task Force (EITF) issued EITF 07-3, Accounting
for Nonrefundable Advance Payments for Goods or Services to be Used in Future
Research and Development Activities (EITF 07-3). EITF 07-3 clarifies
the accounting for nonrefundable advance payments for goods or services that
will be used or rendered for research and development activities.
EITF 07-3 states that such payments should be capitalized and recognized
as an expense as the goods are delivered or the related services are performed.
If an entity does not expect the goods to be delivered or the services
rendered, the capitalized advance payment should be charged to expense.
EITF 07-3 is effective for fiscal years beginning after December 15,
2007. The Company adopted EITF 07-3 on January 1, 2008. The adoption of
EITF 07-3 did not have a material effect on the Companys financial
position or results of operations.
In December 2007, the FASB
issued SFAS No. 141R, Business Combinations Statement 141R, a
replacement of SFAS No. 141. SFAS 141R is effective for fiscal years
beginning on or after December 15, 2008 and applies to all business
combinations. SFAS 141R provides that, upon initially obtaining control, an
acquirer shall recognize 100% of the fair values of acquired assets, including
goodwill, and assumed liabilities, with only limited exceptions, even if the
acquirer has not acquired 100% of its target. Additionally, SFAS 141R changes
current practice, in part, as follows: (1) contingent consideration
arrangements will be fairly valued at the acquisition date and included on that
basis in the purchase price consideration; (2) transaction costs will be
expensed as incurred, rather than capitalized as part of the purchase price; (3) pre-acquisition
contingencies, such as legal issues, will generally have to be accounted for in
purchase accounting at fair value; and (4) in order to accrue for a
restructuring plan in purchase accounting, the requirements in SFAS No. 146,
Accounting for Costs Associated with Exit or Disposal Activities, would have
to be met at the acquisition date. The adoption of this standard as of January 1,
2009 had no material effect on our results of operations or financial condition
although the new standard could materially change the accounting for business
combinations consummated subsequent to that date.
In
December 2007, the FASB issued Statement of Financial Accounting Standards
SFAS 160,
Noncontrolling Interests in Consolidated Financial
Statements
, an Amendment of ARB 51. SFAS 160 establishes new
accounting and reporting standards for noncontrolling interests in a subsidiary
and for the deconsolidation of a subsidiary. SFAS 160 will require entities to
classify noncontrolling interests as a component of stockholders equity and
will require subsequent changes in ownership interest in a subsidiary to be
accounted for as an equity transaction. Additionally, SFAS 160 will
11
Table of Contents
require entities to
recognize a gain or loss upon the loss of control of a subsidiary and to
remeasure any ownership interest retained at fair value on that date. This
statement also requires expanded disclosures that clearly identify and
distinguish between the interests of the parent and the interests of the
noncontrolling owners. SFAS 160 is effective on a prospective basis for fiscal
years, and interim periods within those fiscal years, beginning on or after December 15,
2008, except for the presentation and disclosure requirements, which are
required to be applied retrospectively. Early adoption is not permitted. The
adoption of SFAS 160 as of January 1, 2009 did not have a material effect
on the Companys financial position or results of operations.
In
December 2007, the FASB ratified a consensus opinion reached by the EITF
on EITF Issue 07-1, Accounting for Collaborative Arrangements (EITF 07-1).
The guidance in EITF 07-1 defines collaborative arrangements and establishes
presentation and disclosure requirements for transactions within a
collaborative arrangement (both with third parties and between participants in
the arrangement). The consensus in EITF 07-1 is effective for fiscal years, and
interim periods within those fiscal years, beginning after December 15,
2008. The consensus requires retrospective application to all collaborative
arrangements existing as of the effective date, unless retrospective
application is impracticable. The impracticability evaluation and exception
should be performed on an arrangement-by-arrangement basis. The adoption of
EITF 07-1 did not have a significant effect on our financial statements.
In
April 2008, the FASB issued FASB Staff Position No. 142-3,
Determination of the Useful Life of Intangible Assets (FSP 142-3). FSP 142-3
amends the factors that should be considered in developing renewal or extension
assumptions used to determine the useful life of a recognized intangible asset
under Statement of Financial Accounting Standards No. 142, Goodwill and
Other Intangible Assets (SFAS 142). The objective of this FSP is to improve
the consistency between the useful life of a recognized intangible asset under
SFAS 142 and the period of expected cash flows used to measure the fair value
of the asset under SFAS 141R. This FSP is effective for financial statements
issued for fiscal years beginning after December 15, 2008, and interim
periods within those fiscal years. The adoption of FSP 142-3 on January 1,
2009 did not have a material effect on the Companys financial position or
results of operations.
In November 2008,
the FASB issued EITF Issue No. 08-7,
Accounting
for Defensive Intangible Assets,
or EITF 08-7. EITF 08-7
seeks to clarify how to account for defensive intangible assets, or those
intangible assets acquired in a business combination that an entity does not
intend to actively use but does intend to prevent others from using, subsequent
to initial measurement. EITF 08-7 is effective for all intangible assets
acquired during the first fiscal year beginning on or after December 15,
2008. Early adoption is not permitted. The impact of the adoption of
EITF 08-7 will be dependent upon the type and structure of future
transactions that the Company consummates.
Note 4Strategic
Alliance with Alticor Inc.
Since
March 2003, the Company has maintained a broad strategic alliance with
several affiliates of the Alticor family of companies to develop and market
novel nutritional and skin care products. The alliance initially included an
equity investment, a multi-year research and development agreement, a licensing
agreement with royalties on marketed products, the deferment of outstanding
loan repayment and the refinancing of bridge financing obligations. The
alliance continues to evolve and recent events under the alliance are described
in this Note 4.
On
February 25, 2008, the Company entered into research agreement (RA8) with
an affiliate of Alticor, effective January 1, 2008, to expand the research
being performed under its current agreements with Alticor through 2008. The
Company received $1,200,000 during 2008 under the research agreement, on a time
and materials basis. Additionally, in 2008 the Company recognized as revenue
approximately $800,000 of previously deferred revenue. The Company recognized
$203,686 in the three months ended March 31, 2009 and $537,013 in the
three months ended March 31, 2008 from this agreement. In addition to the
$800,000 of deferred revenue recognized under RA8, $168,254 of funds previously
paid to the Company by Alticor under research agreement 3 (RA3) and research
agreement 4 (RA4), for which no work has been performed, will not need to be
repaid to Alticor by the Company. Since the Company performed no prior services
relating to the $168,254 received from Alticor, and the Company is not required
to perform any future services relating to these funds, the Company has
determined that the funds should be classified as additional paid-in capital
and are recorded as such on the Companys balance sheet as such as of March 31,
2009.
On
January 31, 2009, the Company entered into an amendment to the RA8. The
amendment extends the term from a maximum of six months to eight months
terminating on September 30, 2009. The Company received an additional
$200,316 on March 31, 2009 under the terms of the amendment to complete
ongoing research. The $200,316 is recognized as deferred revenue on the Companys
Balance Sheet of March 31, 2009.
12
Table
of Contents
Note 5Debt
On August 17, 2006, a new credit
facility with Alticor was extended to provide the Company with access to an
additional $14,400,000 of working capital borrowings at any time prior to August 17,
2008. Any amounts borrowed will bear interest at prime, require quarterly
interest payments and will mature on August 16, 2011. The principal amount
of any borrowing under this credit facility is convertible at Alticors
election into a maximum of 2,533,234 shares of common stock, reflecting a
conversion price of $5.6783 per share. As a condition of this financing, the
Company initiated a rights offering of 2,533,234 shares of its common stock to
existing stockholders (other than Alticor) at a per share price of $5.6783. The
proceeds received from the rights offering reduced the availability under the
credit facility. As a result of the rights offering, the availability under the
credit facility has been reduced by $68,208, leaving approximately $14,316,255
available.
On June 10, 2008, the Company borrowed
$4,000,000 under the credit facility which is the amount outstanding at March 31,
2009 leaving $10,316,255 of available credit. On August 12, 2008, this
credit facility was extended to permit borrowing at any time prior to March 31,
2009.
On June 11, 2008, pursuant to the terms
of the notes, Pyxis Innovations Inc., an affiliate of Alticor (Pyxis),
converted the indebtedness due on June 30, 2008, representing an aggregate
principal amount of $595,336 and accrued interest of $7,450, into 943,032
shares of the Companys common stock.
On March 11,
2009, the Company entered into an amended and restated note purchase agreement,
dated as of March 10, 2009, with Pyxis, to extend the availability of the
existing credit facility from March 31, 2009 until March 31, 2010.
All such borrowing under this credit facility becomes due on August 16,
2011 and is convertible into shares of common stock at a conversion price equal
to $5.68 per share.
Note 6Commitments and Contingencies
Acquisition of Databases
In connection
with the research agreement with Alticor dated March 5, 2003, the Company
is obligated to purchase two clinical databases. As of June 30, 2004, the
Company determined that this obligation met the criteria for accrual of SFAS No. 5,
Accounting for Contingencies,
and
estimated the cost of these two databases at $450,000. Accordingly, the Company
recorded a liability and charged research and development expenses of $450,000
at that time. As of March 31, 2009 and 2008, the Company had cumulative
expenditures of $427,944 and $380,944, respectively, associated with the
acquisition of these databases. The Company believes that the acquisition of
the databases will not exceed the amount that the Company has estimated,
however actual amounts could differ.
Sponsored Research Agreements
In connection
with the research agreement with Alticor dated March 5, 2005, the Company
entered into a sponsored research agreement with Yonsei University to conduct a
clinical study. The sponsored research agreement was originally for an amount
of $499,882. This amount has been renegotiated to $412,288 and is payable upon
achievement of certain milestones. As of March 31, 2009 and 2008, Yonsei
University had achieved milestones valued at $412,288 and $316,000
respectively. The milestones are fully paid by the Company as of March 31,
2009.
Off-Balance Sheet Arrangements
The Company
has no off-balance sheet arrangements that have, or are reasonably likely to
have, a current or future material effect on its financial condition, results
of operations or cash flows.
Note 7Capital Stock
Authorized Preferred and Common Stock
At March 31,
2009, the Company had authorized 6,000,000 shares of $0.001 par value Series A
Preferred Stock, of which 5,000,000 were issued and outstanding. At March 31,
2009, the Company had authorized 100,000,000 shares of $0.001 par value common
stock of which 66,931,082 shares were outstanding or reserved for issuance. Of
those, 31,969,887 shares were outstanding; 28,160,200 shares were reserved for
the conversion of Series A Preferred to common stock; 704,436 shares were
reserved for the conversion of the $4,000,000 of debt outstanding under the
credit facility with Pyxis; 3,489,095 shares were reserved for the 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
13
Table of Contents
currently until the expiration
date of August 9, 2012; 390,678 shares were reserved for the exercise of
rights held under the Employee Stock Purchase Plan; 1,816,786 shares were
reserved for the issuance upon the conversion of convertible notes that may be
issued to Pyxis under the existing credit facility.
Series A Preferred Stock
On March 5,
2003, the Company entered into a Stock Purchase Agreement with Alticor,
pursuant to which Alticor purchased from the Company 5,000,000 shares of Series A
Preferred Stock for $7,000,000 in cash on that date, and an additional
$2,000,000 in cash that was paid, as a result of the Company achieving a
certain milestone, on March 11, 2004.
The Series A
Preferred Stock accrues dividends at the rate of 8% of the original purchase
price per year, payable only when, as and if declared by the Board of Directors
and are non-cumulative. To date, no dividends have been declared on these
shares. If the Company declares a distribution, with certain exceptions,
payable in securities of other persons, evidences of indebtedness issued by the
Company or other persons, assets (excluding cash dividends) or options or
rights to purchase any such securities or evidences of indebtedness, then, in
each such case the holders of the Series A Preferred Stock shall be
entitled to a proportionate share of any such distribution as though the
holders of the Series A Preferred Stock were the holders of the number of
shares of Common Stock into which their respective shares of Series A
Preferred Stock are convertible as of the record date fixed for the
determination of the holders of Common Stock entitled to receive such
distribution.
In the event
of any liquidation, dissolution or winding up of the Company, whether voluntary
or involuntary, the holders of the Series A Preferred Stock shall be
entitled to receive, prior and in preference to any distribution of any of the
Companys assets or surplus funds to the holders of its Common Stock by reason
of their ownership thereof, the amount of two times the then-effective purchase
price per share, as adjusted for any stock dividends, combinations or splits
with respect to such shares, plus all declared but unpaid dividends on such
share for each share of Series A Preferred Stock then held by them. The
liquidation preference at March 31, 2009 was $18,000,000. After receiving
this amount, the holders of the Series A Preferred Stock are entitled to
participate on an as-converted basis with the holders of Common Stock in any of
the remaining assets.
Each share of Series A
Preferred Stock is convertible at any time at the option of the holder into a
number of shares of the Companys Common Stock determined by dividing the
then-effective purchase price ($1.80, and subject to further adjustment) by the
conversion price in effect on the date the certificate is surrendered for
conversion. As of March 31, 2009, the Series A Preferred Stock was
convertible into 28,160,200 shares of Common Stock reflecting a current
conversion price of $0.3196 per share.
Each holder of
Series A Preferred Stock is entitled to vote its shares of Series A
Preferred Stock on an as-converted basis with the holders of Common Stock as a
single class on all matters submitted to a vote of the stockholders, except as
otherwise required by applicable law. This means that each share of Series A
Preferred Stock will be entitled to a number of votes equal to the number of
shares of Common Stock into which it is convertible on the applicable record
date.
Note 8Stock-Based Compensation Arrangements
Stock-based
compensation arrangements consisted of the following as of March 31, 2009:
three share-based compensation plans, restricted stock awards; an employee
stock purchase plan; and employee compensation agreements. Total compensation
cost that has been charged against income for stock-based compensation
arrangements is as follows:
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
Stock option grants beginning of period
|
|
$
|
38,984
|
|
$
|
21,743
|
|
Stock-based arrangements during the period:
|
|
|
|
|
|
Stock option grants
|
|
428
|
|
16,421
|
|
Unrestricted stock issued:
|
|
|
|
|
|
Employee stock purchase plan
|
|
945
|
|
273
|
|
Employment Agreements
|
|
1,625
|
|
|
|
|
|
$
|
41,982
|
|
$
|
38,437
|
|
14
Table of Contents
Stock option grants
The following table details all stock option activity
for the three months ended March 31, 2009 and 2008:
|
|
Three Months Ended March 31,
2009
|
|
Three Months Ended March 31,
2008
|
|
|
|
Shares
|
|
Weighted Avg
Exercise
Price
|
|
Shares
|
|
Weighted Avg
Exercise
Price
|
|
Outstanding, beginning of period
|
|
2,100,917
|
|
$
|
2.33
|
|
1,366,406
|
|
$
|
3.11
|
|
Granted
|
|
138,500
|
|
0.26
|
|
508,000
|
|
1.07
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
Canceled
|
|
|
|
|
|
(8,333
|
)
|
3.41
|
|
Expired
|
|
(13,750
|
)
|
0.75
|
|
|
|
|
|
Outstanding, end of period
|
|
2,225,667
|
|
$
|
2.21
|
|
1,866,073
|
|
$
|
2.55
|
|
Exercisable, end of period
|
|
1,470,667
|
|
$
|
2.85
|
|
1,430,073
|
|
$
|
2.98
|
|
The Companys share-based payments that result in compensation expense
consist solely of stock option grants.
During the three-month period ended March 31, 2009, the Company
granted stock options under the 2000 Employee Stock Compensation Plan and the
2004 Employee, Director & Consultant Stock Plan. At March 31,
2009, the Company had an aggregate of 1,263,428 shares of Common Stock
available for grant; including 482 shares under the 2000 Employee Stock
Compensation Plan and 1,262,946 under the 2004 Employee, Director &
Consultant Stock Plan. Each of these plans expires ten years from the date the
plan was approved.
It is the Companys policy to grant stock options with an exercise
price equal to the fair market value of the Companys Common Stock at the grant
date, and stock options to employees generally vest over five years based upon
continuous service. Historically, the majority of the Companys stock options
have been granted in connection with the employees start date with the
Company. In addition, the Company may grant stock options in recognition of
promotion and/or performance.
For purposes of determining the stock-based compensation expense for
stock option awards, the Black-Scholes option-pricing model was used with the
following weighted-average assumptions:
|
|
2009
|
|
Risk-free interest rate
|
|
2.56
|
%
|
Expected life
|
|
6.50 years
|
|
Expected volatility
|
|
87.1
|
%
|
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 recognition
of compensation expense for these awards did not change as a result of adopting
SFAS No. 123R on January 1, 2006. The Company measures the fair value
of the shares based on the last reported price at which the Companys common
stock traded on the date of the grant and compensation cost is recognized over
the remaining service period. During the three months ended March 31, 2009
and 2008 the Company granted restricted stock awards of 12,500 shares,
respectively, under an employment agreement dated March 31, 2006.
Employee Stock Purchase Plan
Purchases made under the Companys Employee
Stock Purchase Plan are now deemed to be compensatory under SFAS No. 123R
because employees may purchase stock at a price equal to 85% of the fair market
value of the Companys common stock on either the first day or the last day of
a calendar quarter, whichever is lower. During the three months ended March 31,
2009 and 2008, employees purchased 31,506 and 1,709 shares, respectively, of
common stock at a
15
Table of Contents
weighted-average purchase price
of $0.17 and $0.93, respectively, while the weighted-average fair value was
$0.20 and $1.09 per share, respectively, resulting in compensation expense of
$945 and $273, respectively.
Employment Agreements
On March 13, 2009 Lewis Bender received
a cash bonus of $102,850 pursuant to his employment agreement and elected to
receive $29,700 in 110,000 shares of our common stock. On March 13, 2009
Eliot Lurier received a cash bonus of $43,695 pursuant to his employment
agreement and elected to receive $4,455 in 16,500 shares of our common stock.
During the three months ended March 31, 2009 12,500 shares of restricted
stock vested pursuant to an employment agreement with Dr. Kornman. The
recognition of compensation expense for this type of award did not change as a
result of adopting SFAS No. 123R on January 1, 2006. The Company
measures the fair value of the shares, prior to issuance, based on the last
reported price at which the Companys common stock traded for the reporting
period and compensation cost is recognized ratably over the employment period
required to earn the stock award. At time of issuance, the Company will measure
the fair value of the shares based on the last reported price at which the
Companys common stock traded on the date of the issuance and will record a
cumulative adjustment, if any.
A summary of
stock compensation cost included in the statement of operations for the three
months ended March 31, 2009 and 2008 is as follows:
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
Cost of revenue
|
|
3,275
|
|
6,504
|
|
Research and development expenses
|
|
8,360
|
|
9,821
|
|
Selling, general and administrative
expenses
|
|
30,347
|
|
22,112
|
|
Total
|
|
41,982
|
|
38,437
|
|
Note 9Segment Information
The Company
follows SFAS No. 131,
Disclosures about
Segments of an Enterprise and Related Information
(SFAS No. 131),
which establishes standards for reporting information about operating segments
in annual and interim financial statements, and requires that companies report
financial and descriptive information about their reportable segments based on
managements approach. SFAS No. 131 also establishes standards for related
disclosures about products and services, geographic areas and major customers.
As a result of the acquisition of the assets and business of the Alan James
Group in August 2006, the Company has two reportable segments:
Personalized Health and Consumer Products.
Through its Personalized Health business
segment, 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.
Through its Consumer Products business segment, the Company develops, markets
and sells nutritional products and engages in related activities. The Companys
principal operations and markets are located in the United States. The Company
has no operations outside of the United States. For the three months ended March 31,
2009 and 2008, the Company had minimal royalty income derived from distributors
outside the United States, minimal expenses derived from research partners
outside the United States and minimal assets outside the United States. The
Company does not believe that foreign currency exchange rate risk is material
and does not use derivative financial instruments to manage foreign currency
fluctuation risk.
The accounting
policies of each of the segments are the same as those described in the summary
of significant accounting policies. The Company evaluates performance based on
revenue and earnings before interest, taxes, depreciation and amortization
(EBITDA). Common costs not directly attributable to a segment are included in
our Personalized Health Segment. These costs include corporate costs such as
legal, audit, tax and other professional fees.
16
Table of Contents
The following
is a summary of the Companys operations by operating segment:
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
Personalized Health:
|
|
|
|
|
|
Revenue
|
|
$
|
347,464
|
|
$
|
641,872
|
|
EBITDA
|
|
$
|
(2,230,791
|
)
|
$
|
(1,798,900
|
)
|
Interest, net
|
|
(23,839
|
)
|
52,531
|
|
Provision for income taxes
|
|
(10,000
|
)
|
(6,050
|
)
|
Depreciation
|
|
(87,426
|
)
|
(66,696
|
)
|
Amortization
|
|
(28,863
|
)
|
(21,499
|
)
|
Net loss
|
|
$
|
(2,380,919
|
)
|
$
|
(1,840,614
|
)
|
Capital expenditures
|
|
$
|
557,736
|
|
$
|
9,200
|
|
Total Assets
|
|
$
|
8,874,212
|
|
$
|
12,846,798
|
|
Consumer Products:
|
|
|
|
|
|
Revenue
|
|
$
|
1,547,531
|
|
$
|
2,012,651
|
|
EBITDA
|
|
$
|
245,108
|
|
$
|
292,899
|
|
Interest, net
|
|
|
|
(844
|
)
|
Provision for income taxes
|
|
(8,000
|
)
|
(12,500
|
)
|
Depreciation
|
|
(3,588
|
)
|
(5,358
|
)
|
Amortization
|
|
(308,688
|
)
|
(308,686
|
)
|
Net income/(loss)
|
|
$
|
(75,168
|
)
|
$
|
(34,488
|
)
|
Capital expenditures
|
|
$
|
1,443
|
|
$
|
|
|
Total Assets
|
|
$
|
700,986
|
|
$
|
351,379
|
|
Consolidated:
|
|
|
|
|
|
Total revenue
|
|
$
|
1,894,995
|
|
$
|
2,654,523
|
|
EBITDA
|
|
$
|
(1,985,683
|
)
|
$
|
(1,506,001
|
)
|
Interest, net
|
|
(23,839
|
)
|
51,687
|
|
Provision for income taxes
|
|
(18,000
|
)
|
(18,550
|
)
|
Depreciation
|
|
(91,014
|
)
|
(72,053
|
)
|
Amortization
|
|
(337,551
|
)
|
(330,185
|
)
|
Net loss
|
|
$
|
(2,456,087
|
)
|
$
|
(1,875,102
|
)
|
Capital expenditures
|
|
$
|
559,179
|
|
$
|
9,200
|
|
Total Assets
|
|
$
|
9,575,198
|
|
$
|
13,198,177
|
|
Note 10Industry Risk and Concentration
The Company develops genetic risk assessment
tests under contract, performs research for its own benefit and provides
research services to a collaborative partner. As of March 31, 2009, the
Company has introduced three genetic risk assessment tests commercially, two of
which are currently sold exclusively through its strategic partner
Alticor, and is in various stages of development for several other genetic risk
assessment tests. Commercial success of the Companys genetic risk assessment tests
will depend on their success as scientifically credible and cost-effective by
consumers and the marketing success of 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.
The market for
health supplement products is competitive and other companies sell products
similar to those sold by the Company. The Companys sales and margins may be
influenced by competitor actions or other factors, such as the cost of product,
contract terms and general market conditions.
17
Table of Contents
For the three
months ended March 31, 2009 and 2008, approximately 59.2% and 48%,
respectively, of the consumer products revenue was from a single customer. As
of March 31, 2009 and December 31, 2008, approximately 52.3% and
47.6% respectively, of the trade accounts receivable was from that same
customer.
During the
three months ended March 31, 2009, the majority of the Companys consumer
products were sourced from three suppliers. The Company pays a contracted rate
per completed unit for each product. The suppliers are responsible for
procuring raw materials and packaging finished products. If the Company is
unable to maintain the relationship with these suppliers, it will need to find
an alternative.
Item 2.
Managements Discussion and Analysis of Financial Condition and Results
of Operations
The following discussion of our financial condition and results of
operations should be read in conjunction with our Selected Consolidated
Financial Data and the audited Consolidated Financial Statements and the notes
thereto included elsewhere in this document.
General Overview and Trends
We are a
genetics-focused personalized health company that develops preventive consumer
products and genetic tests for sale to the emerging personalized health market.
Our vision is to build a leading personalized health and wellness company using
the science of applied genetics to empower people to understand the genetic
components of their health, to provide physicians guidance on patient care and
to provide drug developers the tools necessary to create new, innovative
therapeutic products.
We currently
have two primary business segments that include:
·
Personalized Health Segment this
segment conducts, researches, develops, market and sells genetic test panels
primarily in inflammatory and metabolic areas to provide better insight into
health, wellness and disease.
·
Consumer Products Segment
comprising the Alan James Group (AJG) business, is focused on developing,
selling and marketing nutritional supplements and products into retail consumer
channels.
These two
segments contribute toward our overall mission of developing tests and products
that can help individuals improve and maintain their health through preventive
measures. We plan to pursue this by:
·
developing genetic risk assessment
tests for use in multiple indications, countries and various demographics in
our Personalized Health Segment;
·
processing genetic risk assessment
tests in our Clinical Laboratory Improvement Act of 1988 (CLIA) certified lab
or in those of sublicensees in our Personalized Health Segment; and
·
developing and acquiring nutritional
products to be distributed in multiple consumer channels in our Consumer
Products Segment.
In 2006, sales
of our personalized health products began under marketing and other business
arrangements with Alticor. Alticor represents a significant customer
representing virtually all of our Personalized Health Segment revenues and over
18% of consolidated revenues in the first quarter of 2009.
Our Consumer
Products Segment sells branded nutritional products, including Ginsana
®
, Ginkoba
, and Venastat
®
through the nations largest food, drug and
mass retailers and contributed over 82% of the consolidated revenues to our
business in the three months ended March 31, 2009. Customer concentration
in our Consumer Products Segment is high and our largest customer accounted for
approximately 59% of revenues in that segment.
We have
traditionally spent approximately $3-4 million annually on research and
development. We expect to continue spending at this level in 2009. We expect to
complete our research agreements with Alticor in 2009 and dedicate more of our
resources to our own product development efforts. Our current development
programs focus on obesity, heart disease, osteoporosis, osteoarthritis, skin
aging, sports nutrition and weight management genetic risk assessment tests, as
well as new proprietary supplements for distribution through our Consumer
Products Segment. We expect that these programs will also lead to the
personalized selection of nutritional and therapeutic products and provide
consumers and healthcare professionals with better preventive product
alternatives. We are in the process of developing our own brand of genetic test
18
Table of Contents
products for launch with
partners and on our own. As a result, corporate selling, general, marketing and
administrative expenses associated with the launch of this new brand of genetic
test products is likely to increase in 2009. We currently have borrowings
available under our credit line of $10.3 million, which permits borrowing any
time prior to March 31, 2010. We expect to be able to fund our operations
through at least the next twelve months with revenue from product sales and
borrowings from our credit facility. Current unfavorable economic conditions
have had a negative effect on our consumer product sales, which may impact the
funding of projects in development. We continue to monitor our spending accordingly.
In March 2003,
we entered into a research agreement with Alticor to develop genetic tests and
software to assess personalized risk and develop and use screening technologies
to validate the effectiveness of the nutrigenomic consumables Alticor is
developing. In March 2005 and in March 2007, we entered into new
agreements with Alticor to continue the research. In June 2004, we entered
into another research agreement with Alticor to conduct research into the
development of a test to identify individuals with specific genetic variations
that affect how people gain and maintain weight. This project was completed
during 2006. In June 2006, we entered into another research agreement with
Alticor to perform association studies on composite genotypes to skin
inflammatory response. As of December 31, 2008, the research agreements
described above have been completed. See financial statement footnote 4 for a
discussion of our strategic alliance with Alticor.
On February 25,
2008, we entered into a new research agreement with Access Business Group
International LLC (ABG), a subsidiary of Alticor. The research agreement
encompasses four primary areas: osteoporosis, cardiovascular disease,
nutrigenomics, and dermagenomics. We will be conducting various clinical studies,
which shall be fully funded by Alticor. On January 31, 2009, the
Company entered into an amendment to research agreement (RA8) with ABG. The
amendment extends the term from a maximum of six months to eight months
terminating on September 30, 2009. The Company received an additional
$200,316 on March 31, 2009 per the amendment to complete ongoing research.
Some of the
clinical studies aim to correlate SNP gene variations to the risk of
osteoporosis or cardiovascular disease in Asian populations. Other studies
conducted in North American populations will seek to identify genetic factors
that influence athletic performance (nutrigenomics) and skin health, such as
wrinkles, elasticity, aging (dermagenomics), for the purpose of developing
products to enhance healthy aging. Under the terms of the research agreement
(RA8), ABG paid us $1.2 million during 2008 for the research. In addition,
we recognized approximately $800,000 of deferred receipts which were unused
from prior research agreements with Alticor.
In our
Personalized Health Segment, the 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 placed a significant focus of this effort in our
relationship with our primary customer, Alticor, a significant direct marketing
company. Our challenge in 2009 and beyond will be to work to develop this
market. We have begun to allocate considerable resources to our own brand of
consumer products. We cannot predict any fluctuations we may experience in our
test revenues or whether revenues derived from Alticor related to the heart
health and general nutrition genetic tests will be sustained in future periods.
As part of our strategy to partner with the companies in the pharmaceutical and
biotechnology industries, we have recently entered into a research
collaboration with a biotechnology company for biomarker research for an
inflammatory disease.
In our Consumer
Product Segment, the nutritional products and supplement industry is
characterized by rapid and frequent changes in demand for products and new
product introductions. The success of new product offerings depends upon a
number of factors, including: the state of the economy; accurately anticipating
customer needs; innovating and developing new products; successfully
commercializing new products in a timely manner; pricing our products
competitively; manufacturing and delivering our products in sufficient volumes
and in a timely manner; and differentiating our product offerings from those of
our competitors.
In the first
quarter of 2009, the aggregate sales of our brand name nutritional products,
including Ginkoba
,
Ginsana
®
, and
Venastat
®
in our Consumer Products Segment demonstrated
a decrease from the same period in the prior year which we believe is due to
current economic conditions. We believe that retailers are carrying lower
inventory levels which have had a negative impact on our quarter sales figures.
In addition, we believe that consumers are spending less. We face competition
with private label offerings as well as other branded product introductions.
Further, our opportunities for new distribution on the existing product lines
are limited. Increased growth, we believe will be more dependent on our ability
to adapt to changing consumer trends with the introduction of new products,
making customers more aware of our products or improvements to existing
products.
Liquidity and Capital Resources
As of March 31, 2009, we had cash and
cash equivalents of $1.7 million and borrowings available under our credit
19
Table of Contents
facilities of
$10.3 million which permits borrowing at any time prior to March 31,
2010.
Cash used in operations was $2.7 million
for the three months ended March 31, 2009 as compared to $2.5 million
for the three months ended March 31, 2008. Cash used in operations is
primarily impacted by operating results and changes in working capital,
particularly the timing of the collection of receivables, inventory levels and
the timing of payments to suppliers. A significant use of cash in the three
months ended March 31, 2008 was a payment of $1.2 million, relating to the
settlement of purchase obligations with the Alan James Group, $0.6 million of
which had been accrued prior to 2008 and is reflected as being paid in net cash
used in operating activities in the three months ended March 31, 2009. The
remaining $0.6 million is reflected in net cash used in investing activities as
described below. Net cash used in operations for the three months ended March 31,
2008 without the settlement payment of $0.6 million was $1.9 million. The
increase of $0.8 million is primarily attributable to increased inventory
resulting from a decrease in sales of our consumer products combined with
increased costs relating to increased advertising and promotion in both of our
segments as well as expenses relating to increased headcount. During the three
months ended March 31, 2009 $0.2 million was added to inventory levels as
compared to the three months ended March 31, 2008. The increase is
primarily attributable to higher inventory levels resulting from a slow down in
consumer product sales during the first quarter of 2009. We continue to monitor
inventory levels and will adjust spending accordingly.
Cash used in investing activities was $0.5
million for the three months ended March 31, 2009 compared to $0.7 million
for the three months ended March 31, 2008. The most significant use of
cash in investing activities during the three months ended March 31, 2008
was the settlement of claims related to the acquisition of the assets and business
of the Alan James Group as described above. As a result of the settlement, we
paid additional consideration of $0.6 million. Capital additions were $0.5
million for the three months ended March 31, 2009 compared to $9 thousand
for the three months ended March 31, 2008. The increase in capital
additions primarily consists of new commercial laboratory equipment installed
and validated in the first three months of 2009 allowing high volume processing
of genetic test samples.
Cash provided by financing activities was $40
thousand for the three months ended March 31, 2009 compared to $2 thousand
for the three months ended March 31, 2008. We received $40 thousand from
the exercise of stock options and stock purchases through the employee stock
purchase plan.
On December 23, 2008, we were notified
of our failure to comply with the NYSE Amex, LLCs (the Exchange) continued
listing standards under section 1003 of the Company Guide. Specifically, the
Exchange noted our failure to comply with section 1003(a)(iii) of the
Company Guide because our stockholders equity was less than $6,000,000 and we
had losses from continuing operations and net losses in our five most recent
fiscal years. The notice was based on a review by the Exchange of publicly
available information, including the Companys quarterly report on From 10-Q
for the quarter ended September 30, 2008. As of December 31, 2008 the
Companys stockholders equity was $4.5 million. On January 27, 2009 we
submitted a plan to the exchange to meet the continued listing requirements.
The plan consists of several elements, but is primarily focused on increasing
the sales of our products and services and raising additional equity capital. On March 27, 2009, we were notified that
the Exchange found our plan to regain compliance with the continued listing
standards to be unacceptable. We filed an appeal for an oral hearing and
submitted a revised plan to the Exchange. On May 11, 2009 the Exchange
notified us that the Exchange accepted our redrafted plan of compliance,
without a hearing, and granted us an extension until December 31, 2009 to
regain compliance with the continued listing standards. The Exchange will
periodically review our progress. Failure to make progress consistent with the
plan or to regain compliance with the continued listing standards by the end of
the extension could result in delisting from the Exchange.
We currently do not have any commitments for
any additional material capital purchases.
We currently generate operating cash by sales
of consumer products, genetic tests, royalties, and reimbursements for funded
research. The amount of operating cash we generate is not currently sufficient
to continue to fund and grow our operations. In addition to funds generated by
our income, we have available a $10.3 million credit line with Alticor, our
major investor. Cash we receive from customers and pay to vendors is relatively
stable from period to period due to the nature of our consumer products
business. Clinical studies and other research and development activities may
require cash outflows that depend on the timing of activities.
We believe that our cash on hand and line of
credit availability from Alticor will be sufficient to fund our operations and
meet our overall strategic plan for at least the next twelve months. We will
need to raise additional capital, if market conditions permit, to continue
investment in new product development, to improve our distribution channels, to
maintain our listing on the NYSE Alternext US, and other aspects of our overall
strategic plan. The current status of the financial markets may adversely
affect our ability to raise additional capital in the markets.
20
Table of Contents
We have no financial covenants as part of our
credit facility with Alticor. We currently have $4.0 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. We
anticipate drawing down additional funds available under our credit facility in
the foreseeable future.
Results of
Operations (000s)
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
Personalized Health:
|
|
|
|
|
|
Genetic Testing
|
|
$
|
137,511
|
|
$
|
101,752
|
|
Contract research & development
|
|
203,687
|
|
537,013
|
|
Other
|
|
6,266
|
|
3,107
|
|
Segment Total
|
|
347,464
|
|
641,872
|
|
Consumer Products
|
|
1,547,531
|
|
2,012,651
|
|
Total Revenue
|
|
$
|
1,894,995
|
|
$
|
2,654,523
|
|
Cost of revenue
|
|
$
|
1,042,699
|
|
$
|
1,335,972
|
|
Gross margin
|
|
$
|
852,296
|
|
$
|
1,318,551
|
|
Gross margin percent
|
|
45.0
|
%
|
49.7
|
%
|
Three Months Ended March 31,
2009 and March 31, 2008
Total revenue
for the three months ended March 31, 2009 was $1.9 million compared
to $2.7 million for the three months ended March 31, 2008. The
decrease of $0.8 million, or 28.6%, is primarily attributable to a decrease in
consumer product revenue and a decrease in contract research revenue, offset by
an increase in genetic test revenue and royalty revenue. During the three
months ended March 31, 2009, sales of consumer products were impacted
negatively by current unfavorable economic conditions. We believe retailers are
stocking less inventory and consumers continue to monitor their spending
patterns more aggressively than in recent years. Contract research revenue
decreased to $0.2 million in the three months ended March 31, 2009
compared to $0.5 million in the three months ended March 31, 2008. The
decrease is primarily attributable to timing of our reimbursable research
projects. Genetic testing revenue increased to $0.14 million, or 35.1%, in the
three months ended March 31, 2009, compared to $0.10 million in the three
months ended March 31, 2008. The increase is primarily attributable to a
health and wellness pilot program that incorporates genetic testing into a
customers benefit plan for their employees completed in the first quarter of
2009. Genetic testing revenue is a result of tests sold and processed which is
driven by consumer demand. Contract research revenue is recognized when Alticor
sponsored research expenses are incurred.
We have two
significant customers. In our Personalized Health Segment, our significant
customer, Alticor, which is our principal shareholder, represented approximately
96% and 99%, respectively, of revenues in the three months ended March 31,
2009 and 2008. In our Consumer Products Segment, our other significant customer
represented approximately 59% and 48%, respectively of revenues at March 31,
2009 and 2008.
Cost of
revenue for the three months ended March 31, 2009 was $1.0 million or
55.0% of revenue compared to $1.3 million or 50.3% for the three months ended March 31,
2008. In our Personalized Health Segment, cost of revenue for the three months
ended March 31, 2009 was $0.3 million, or 87.8% of its revenue, compared
to $0.2 million, or 36.6% of its revenue, for the three months ended March 31,
2008. The significant increase in the cost of revenue as a percentage of
revenue in our Personalized Health Segment is primarily attributable to fixed
costs associated with our genetic testing laboratory not withstanding changes
in our revenue. Fixed costs were impacted during the three months ended March 31,
2009 by the purchase and installation of new high volume genetic testing
equipment. Increased costs associated with this equipment are recognized in the
first quarter of 2009 where no such costs were recognized in the first quarter
of 2008. The equipment will allow for higher volume processing, which will be absorbed
with changes in volume of tests performed. In our Consumer Products Segment,
cost of revenue for the three months ended March 31, 2009 was $0.7 million
or 47.7% of its revenue, compared to $1.1 million, or 54.7% of its revenue, for
the three months ended March 31, 2008. The decrease of $0.4 million is
primarily attributable to decreased consumer product sales which we believe is
attributable to current unfavorable economic conditions. The corresponding
decrease in cost of revenue as a percentage of revenue in our Consumer Products
Segment is attributable to the mix of products sold having a lower cost in the
three months ended March 31, 2009 compared with the same period in 2008.
21
Table of Contents
Gross margin
for the three months ended March 31, 2009, was $0.9 million, or 45.0%,
compared to $1.3 million, or 49.7%, for the three months ended March 31,
2008. In our Personalized Health Segment gross margin for the three months
ended March 31, 2009, was $0.04 million, or 12.2%, compared to $0.4
million, or 63.4%, for the three months ended March 31, 2008. The decrease
in gross margin of $0.3 million is primarily attributable to the fixed costs
associated with our genetic testing laboratory which remain constant with
changes in revenue. In addition gross margin in our Personalized Health Segment
was affected by lower research reimbursement revenue. In our Consumer Products
Segment gross margin was $0.8 million, or 52.3%, for the three months ended March 31,
2009, compared to $0.9 million, or 45.3%, for the three months ended March 31,
2008. The decrease of $0.1 million is primarily attributable to decreased sales
of our consumer products. Gross margin as a percentage of revenue increased as
a result of the mix of products sold having a lower cost in the three months
ended March 31, 2009 compared with the same period in 2008.
Research and
development expenses were $0.9 million for the three months ended march 31,
2009 compared to $0.8 million for the three months ended March 31, 2008.
The increase of $0.1 million is primarily attributable to expenses relating to
our patent portfolio.
Selling,
general and administrative expenses were $2.0 million for the three months
ended March 31, 2009, compared to $2.1 million for the three months
ended March 31, 2008. The decrease of $0.1 million is primarily
attributable to reduced expenses relating to administrative support consultants
offset by increased promotional and advertising expenses in both our
Personalized Health Segment and Consumer Products Segment, plus additional
compensation expenses due to our increased headcount.
Amortization of intangible assets remained
unchanged at $0.3 million for the three months ended March 31, 2009 and
2008. Amortization expense is associated with the basis of intangible assets we
acquired from the Alan James Group combined with patents relating to our
technology in development.
Total other expense was $36,000 for the three
months ended March 31, 2009 as compared to other income of $52,000 for the
three months ended March 31, 2008. The increase in expense of $88,000 is
primarily attributable to interest expense associated with borrowings on our
credit line with Alticor and lower interest being earned on available cash
balances. Financial market conditions have significantly reduced the interest
rate we earn on our cash and cash equivalent balances.
Critical Accounting Policies and Estimates
Our discussion
and analysis of our financial condition and results of operations are based
upon our consolidated financial statements. The preparation of these financial
statements and related disclosures in conformity with accounting principles
generally accepted in the United States of America requires us to (i) make
judgments, assumptions and estimates that affect the reported amounts of
assets, liabilities, revenue and expenses; and (ii) disclose contingent
assets and liabilities. A critical accounting estimate is an assumption that
could have a material effect on our consolidated financial statements if
another, also reasonable, amount were used or a change in the estimates is
reasonably likely from period to period. We base our accounting estimates on
historical experience and other factors that we consider reasonable under the
circumstances. However, actual results may differ from these estimates. To the
extent there are material differences between our estimates and the actual
results, our future financial condition and results of operations will be
affected. Our most critical accounting policies and estimates upon which our
financial condition depends, and which involve the most complex or subjective
decisions or assessments are the following:
Strategic alliance with Alticor:
We account for
our strategic alliance with Alticor in accordance with Emerging Issues Task
Force (EITF) No. 01-1, Accounting for Convertible Instruments Granted or
Issued to a Nonemployee for Goods or Services or a Combination of Goods or Services
and Cash (EITF No. 01-1). Under EITF No. 01-1, the proceeds received
from Alticor in connection with the March 5, 2003 transaction must first
be allocated to the fair value of the convertible instruments issued. As of March 5,
2003, the fair value of the convertible instruments issued was
$23.7 million; therefore proceeds received from Alticor in connection with
the March 5, 2003 transaction, up to $23.7 million, have been
recorded as equity.
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.
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Revenue from
product sales is recognized when there is persuasive evidence of an arrangement,
delivery has occurred and title and risk of loss have transferred to the
customer, the sales price is determinable and collectability is reasonably
assured. We have no consignment sales. Product revenue is reduced for
allowances and adjustments, including returns, discontinued items, discounts,
trade promotions and slotting fees.
Revenue from
contract research and development is recognized over the term of the contract
as we perform our obligations under the contract.
Allowance for Sales Returns:
Our
recognition of revenue from sales to retailers is impacted by giving them
rights to return damaged and outdated products as well as the fact that as a
practical business matter, our sales force, along with our customers, is
constantly working to ensure profitability of our products within retailers by
rotating slow moving items out of stores and replacing those products with what
we and the retailer expect will be more profitable, faster selling items. For
product sales, we believe we can reasonably and reliably estimate future
returns, therefore we recognize revenue at the time of sale. For product sales
which we cannot estimate future returns, particularly new products, we defer
revenue recognition until the return privilege has substantially expired or the
amount of future returns can be reasonably estimated. An adverse change in any
of these factors may result in the need for additional sales returns.
We analyze
sales returns in accordance with Statement of Financial Accounting Standards
(SFAS) No. 48,
Revenue Recognition When
Right of Return Exists.
We are able to make reasonable and reliable
estimates based on history. We also monitor the buying patterns of the
end-users of our products based on sales data received. We review our estimated
product returns based on expected data communicated by our customers. We also
monitor the levels of inventory at our largest customers to avoid excessive
customer stocking of merchandise. We believe we have sufficient interaction and
knowledge of our customers and of the industry trends and conditions to adjust
the accrual for returns when necessary. We believe that this analysis creates
appropriate estimates of expected future returns. There is no guarantee that
future returns will not increase to, or exceed, the levels experienced in the
past. Furthermore, the possibility exists that should we lose a major account,
we may agree to accept a substantial amount of returns.
Trade Promotions:
We use
objective procedures for estimating our allowance for trade promotions. The
allowance for trade promotions offered to customers is based on contracted
terms or other arrangements agreed in advance, as well as historical
experience. The Company may adjust its estimate based on these factors to more
accurately reflect trade promotion costs.
Inventory:
We value our
inventory at the lower of cost or market. We monitor our inventory and analyze
it on a regular basis. Cycle counts are taken periodically to verify inventory
levels. In addition, we analyze the movement of items within our inventory in
an effort to determine the likelihood that inventory will be sold or used
before expiration dates are reached. We provide an allowance against that
portion of inventory that we believe is unlikely to be sold or used before
expiration dates are reached. An adverse change in any of these factors may
result in the need for additional inventory allowance.
Stock-based compensation:
We account for
our stock-based compensation expense in accordance with SFAS No. 123
(Revised 2004),
Share-Based Payment
(SFAS No. 123R) using the modified prospective basis. SFAS No. 123R
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. SFAS No. 123R requires us to expense SBP awards
with compensation cost for SBP transactions measured at fair value. SFAS No. 123R
applies to new equity awards and to equity awards modified, repurchased or
canceled after the effective date. Additionally, compensation cost for the
portion of awards for which the requisite service has not been rendered that
are outstanding as of the effective date shall be recognized as the requisite
service is rendered on or after the effective date. The compensation cost for
that portion of awards shall be based on the grant-date fair value of those
awards as calculated from the pro forma disclosures under SFAS No. 123.
Additionally, common stock purchased pursuant to our employee stock purchase
plan will be expensed based upon the fair market value in excess of purchase
price.
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Intangible Assets:
Purchase accounting requires
extensive use of accounting estimates and judgments to allocate the purchase
price to the fair market value of the assets purchased and liabilities assumed.
We have accounted for our acquisitions using the purchase method of accounting.
Values were assigned to intangible assets based on third-party independent
valuations, as well as managements forecasts and projections that include
assumptions related to future revenue and cash flows generated from the
acquired assets.
Income taxes:
The preparation of our
consolidated financial statements requires us to estimate our income taxes in
each of the jurisdictions in which it operates, including those outside the
United States, which may be subject to certain risks that ordinarily would not
be expected in the United States. We account for income taxes in accordance
with SFAS No. 109,
Accounting for
Income Taxes
, which requires the recognition of taxes payable or
refundable for the current year and deferred tax liabilities and assets for the
future tax consequences of events that have been recognized in the financial
statements or tax returns. The measurement of current and deferred tax
liabilities and assets is based on provisions of the enacted tax law; the
effects of future changes in tax laws or rates are not anticipated. We record a
valuation allowance to reduce our deferred tax assets to the amount that is
more likely than not to be realized.
Significant management
judgment is required in determining our provision for income taxes, our
deferred tax assets and liabilities and any valuation allowance recorded
against deferred tax assets. We have recorded a full valuation allowance
against our deferred tax assets of $25.3 million as of March 31,
2009, due to uncertainties related to its ability to utilize these assets. The
valuation allowance is based on managements estimates of taxable income by
jurisdiction in which 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 its valuation allowance, which could materially impact its financial
position and results of operations.
In January 2007, we
adopted FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes (an interpretation of FASB Statement No. 109) (FIN 48).
FIN 48 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 March 31, 2009, we reviewed
all material tax positions for all years open to statute and for all tax
jurisdictions open to statute to determine whether it was more likely than not
that the positions taken would be sustained based upon the technical merits of
those positions. The implementation of FIN 48 had no impact on our
financial statements.
Contingencies:
Estimated losses from
contingencies are accrued by management based upon the likelihood of a loss and
the ability to reasonably estimate the amount of the loss. Estimating potential
losses, or even a range of losses, is difficult and involves a great deal of
judgment. Management relies primarily on assessments made by its external legal
counsel to make our determination as to whether a loss contingency arising from
litigation should be recorded or disclosed. Should the resolution of a contingency
result in a loss that we did not accrue because management did not believe a
loss was probable or capable of being reasonably estimated, then this loss
would result in a charge to income in the period the contingency was resolved.
Recent Accounting Pronouncements:
Please see our discussion of
Recent Accounting Pronouncements in Note 3. Significant Accounting Policies
contained in the Notes to Condensed Consolidated Financial Statements elsewhere
in this Form 10-Q.
Item 3.
Quantitative and Qualitative Disclosures about Market
Risk
As of March 31, 2009, the only financial instruments we carried
were cash and cash equivalents denominated in U.S. Dollars. We believe the
market risk arising from holding these financial instruments is not material. While
we recognize that the interest rates these instruments bear are currently at
historically low levels, we believe it is most prudent to maintain these
relatively low risk positions during this time of unprecedented volatility and
uncertainty across the global financial markets.
Some of our sales and some of our costs occur outside the United States
and are transacted in foreign currencies. Accordingly, we are subject to
exposure from adverse movements in foreign currency exchange rates. At this
time we do not believe this risk is material and we do not currently use
derivative financial instruments to manage foreign currency
24
Table of
Contents
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 material information relating to us, including our
consolidated subsidiaries, was made known to them by others within those
entities, particularly during the period in which this Quarterly Report on Form 10-Q
was being prepared.
In designing and evaluating our
disclosure controls and procedures, our management recognizes that any controls
and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and our
management necessarily is required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
There are inherent limitations in
any system of internal control. A control system, no matter how well designed
and operated, can provide only reasonable, not absolute, assurance that its
objectives are met. Further, the design of a control system must consider that
resources are not unlimited and the benefits of controls must be considered
relative to their costs. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within the company have been
detected. These inherent limitations include the realities that judgment in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the controls.
(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 March 31, 2009 that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
25
Table of
Contents
PART IIOTHER INFORMATION
Item
1.
Legal
Proceedings.
Not applicable.
Item
1A.
Risk
Factors
In addition to the other
information set forth in this report, you should carefully consider the factors
discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K
for the year ended December 31, 2008, 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.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on Form 10-Q and,
in particular, our Managements Discussion and Analysis of Financial Condition
and Results of Operations set forth in Part I Item 2 contain or
incorporate a number of forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Exchange
Act. Any or all of our forward-looking statements in this Quarterly Report on Form 10-Q
may turn out to be wrong. They can be affected by inaccurate assumptions we
might make or by known or unknown risks and uncertainties. Many factors
mentioned in our discussion in this Quarterly Report on Form 10-Q will be
important in determining future results. Consequently, no forward-looking
statement can be guaranteed. Actual future results may vary materially.
Without limiting the foregoing, the words believes,
anticipates, plans, expects and similar expressions are intended to
identify forward-looking statements. There are a number of factors that could
cause actual events or results to differ materially from those indicated by
such forward-looking statements, many of which are beyond our control,
including the factors set forth under Item 1A. Risk Factors of our 2008
Annual Report on Form 10-K. In addition, the forward-looking statements
contained herein represent our estimate only as of the date of this filing and
should not be relied upon as representing our estimate as of any subsequent
date. While we may elect to update these forward-looking statements at some
point in the future, we specifically disclaim any obligation to do so to
reflect actual results, changes in assumptions or changes in other factors
affecting such forward-looking statements.
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds.
Not applicable.
Item
3.
Defaults
Upon Senior Securities.
Not applicable.
Item
4.
Submission
of Matters to a Vote of Security Holders.
Not applicable.
Item
5.
Other
Information.
Item
6.
Exhibits.
Exhibit
Number
|
|
Exhibit
|
10.1
|
|
Amended and Restated
Note Purchase Agreement between the Company and Pyxis Innovations Inc. dated
March 10, 2009 (incorporated by reference to Exhibit 99.1 of the
Companys Current Report on Form 8-K filed on March 13, 2009.
|
26
Table of Contents
31.1*
|
|
Certification by
Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
31.2*
|
|
Certification by
Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
32.1*
|
|
Certification Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002
|
*
Filed
herewith.
27
Table of Contents
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
INTERLEUKIN GENETICS, INC.
|
|
|
Date: May 14,
2009
|
By:
|
/s/
Lewis H. Bender
|
|
|
Lewis
H. Bender
|
|
|
Chief
Executive Officer
|
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
Date: May 14,
2009
|
By:
|
/s/
ELIOT M. LURIER
|
|
|
Eliot
M. Lurier
|
|
|
Chief
Financial Officer
|
|
|
(Principal
Financial Officer)
|
28
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