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 EXCHANGE ACT OF 1934

 

 

 

For the quarterly period ended September 30, 2007

 

 

 

or

 

 

 

o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

 

For the transition period from       to     

 

Commission File Number:  000-50791

 

SENOMYX, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

33-0843840

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

 

 

4767 Nexus Centre Drive
San Diego, California

 


92121

(Address of principal executive offices)

 

(Zip code)

 

(858) 646-8300
(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

 

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 twelve 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 ninety days. Yes x No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one): Large Accelerated Filer o Accelerated Filer x Non-Accelerated Filer o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Total shares of common stock outstanding as of the close of business on October 31, 2007: 30,451,072

 

 



 

SENOMYX, INC.

 

FORM 10-Q
 
TABLE OF CONTENTS
 
TABLE OF CONTENTS
 

PART I. FINANCIAL INFORMATION

 

Item 1.

Unaudited Financial Statements

 

 

 

Condensed Balance Sheets as of September 30, 2007 and December 31, 2006

 

 

 

Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2007 and 2006

 

 

 

Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2007 and 2006

 

 

 

Notes to Unaudited Condensed Financial Statements

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

Item 4.

Controls and Procedures

 

 

PART II. OTHER INFORMATION

 

Item 1A.

Risk Factors

 

 

Item 6.

Exhibits

 

 

SIGNATURES

 

 



 

PART I. FINANCIAL INFORMATION

 

ITEM 1.                                                     CONDENSED FINANCIAL STATEMENTS

 

SENOMYX, INC.

BALANCE SHEETS

(In thousands, except for share amounts)

(Unaudited)

 

 

 

September 30, 2007

 

December 31, 2006

 

 

 

 

 

[Note]

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

37,425

 

$

21,225

 

Investments available-for-sale

 

32,350

 

52,879

 

Other current assets

 

2,157

 

1,239

 

Total current assets

 

71,932

 

75,343

 

 

 

 

 

 

 

Property and equipment, net

 

14,611

 

14,839

 

Total assets

 

$

86,543

 

$

90,182

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

 

$

5,498

 

$

5,449

 

Leasehold incentive obligation

 

987

 

966

 

Deferred revenue

 

10,048

 

3,473

 

Total current liabilities

 

16,533

 

9,888

 

 

 

 

 

 

 

Deferred rent

 

1,010

 

213

 

Leasehold incentive obligation

 

8,309

 

8,854

 

Deferred revenue

 

1,000

 

1,750

 

 

 

 

 

 

 

Commitments

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $.001 par value; 7,500,000 shares authorized; no shares issued or outstanding at September 30, 2007 (unaudited) and December 31, 2006, respectively

 

 

 

Common stock, $.001 par value; 120,000,000 shares authorized at September 30, 2007 (unaudited) and December 31, 2006; 30,447,072 and 30,166,399 shares issued and outstanding at September 30, 2007 (unaudited) and December 31, 2006, respectively

 

30

 

30

 

Additional paid-in capital

 

204,153

 

196,748

 

Accumulated other comprehensive loss

 

(16

)

(18

)

Accumulated deficit

 

(144,476

)

(127,283

)

Total stockholders’ equity

 

59,691

 

69,477

 

Total liabilities and stockholders’ equity

 

$

86,543

 

$

90,182

 

 

[NOTE: The balance sheet at December 31, 2006 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements.]

 

See accompanying notes to condensed financial statements.

 

1



 

SENOMYX, INC.

STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

 

 

 

 

 

 

 

 

 

 

Revenue under collaborative agreements

 

$

5,053

 

$

3,204

 

$

11,857

 

$

8,830

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development (including $776, $774, $1,977 and $2,321 of stock-based compensation, respectively)

 

7,668

 

6,143

 

21,480

 

18,978

 

General and administrative (including $1,056, $996, $3,321 and $3,453 of stock-based compensation, respectively)

 

2,999

 

3,103

 

10,177

 

10,502

 

Total operating expenses

 

10,667

 

9,246

 

31,657

 

29,480

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(5,614

)

(6,042

)

(19,800

)

(20,650

)

 

 

 

 

 

 

 

 

 

 

Interest income

 

852

 

1,027

 

2,607

 

2,848

 

Net loss

 

$

(4,762

)

$

(5,015

)

$

(17,193

)

$

(17,802

)

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.16

)

$

(0.17

)

$

(0.57

)

$

(0.60

)

 

 

 

 

 

 

 

 

 

 

Shares used in calculating net loss per share, basic and diluted

 

30,394,177

 

29,857,607

 

30,283,499

 

29,729,816

 

 

See accompanying notes to condensed financial statements.

 

2



 

SENOMYX, INC.

STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Nine months ended September 30,

 

 

 

2007

 

2006

 

Operating activities

 

 

 

 

 

Net loss

 

$

(17,193

)

$

(17,802

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation

 

2,151

 

1,088

 

Accretion of discount on available-for-sale securities

 

(1,589

)

(742

)

Amortization of leasehold incentive obligation

 

(700

)

 

Stock-based compensation for non-employees

 

565

 

936

 

Stock-based compensation for employees and non-employee directors

 

4,733

 

4,838

 

Change in operating assets and liabilities:

 

 

 

 

 

Other assets

 

(918

)

296

 

Accounts payable, accrued expenses and other current liabilities

 

580

 

6

 

Deferred revenue

 

5,825

 

4,150

 

Leasehold incentive obligation

 

176

 

2,092

 

Deferred rent

 

797

 

(151

)

Net cash used in operating activities

 

(5,573

)

(5,289

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of property and equipment

 

(2,454

)

(3,903

)

Purchases of available-for-sale securities

 

(57,658

)

(68,060

)

Maturities of available-for-sale securities

 

79,778

 

33,450

 

Net cash provided by/(used in) investing activities

 

19,666

 

(38,513

)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from issuance of common stock

 

2,107

 

2,269

 

Net cash provided by financing activities

 

2,107

 

2,269

 

 

 

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

16,200

 

(41,533

)

Cash and cash equivalents at beginning of period

 

21,225

 

73,908

 

Cash and cash equivalents at end of period

 

$

37,425

 

$

32,375

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

Purchases of property and equipment included in accounts payable, accrued expenses and other current liabilities at 9/30 compared to 12/31

 

$

9

 

$

404

 

Purchases of property and equipment and leasehold incentive obligation directly reimbursed by lessor of facility

 

 

$

5,257

 

 

See accompanying notes to condensed financial statements.

 

3



 

SENOMYX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

1.                                      Basis of Presentation

 

The financial statements of Senomyx, Inc. (“Senomyx” or the “Company”) at September 30, 2007 and for the three and nine months ended September 30, 2007 and 2006 are unaudited. The unaudited financial statements have been prepared on the same basis as the Company’s audited financial statements and, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary to state fairly the financial information therein. The results of operations for the three and nine months ended September 30, 2007 are not necessarily indicative of the results that may be reported for the year ended December 31, 2007. For more complete financial information, these financial statements, and the notes thereto, should be read in conjunction with the audited financial statements for the year ending December 31, 2006, including the notes thereto, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”).

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Revenue Recognition

 

The Company’s revenue recognition policies are in compliance with the Staff Accounting Bulletin (“SAB”) No. 104, Revenue Recognition, and Emerging Issues Task Force (“EITF”) Issue No. 00-21, Revenue Arrangements with Multiple Deliverables. Some of the Company’s agreements contain multiple elements, including technological and territorial licenses and research and development services. In accordance with these agreements, the Company may be eligible for upfront fees, research funding, cost reimbursements, milestones and royalty payments.

 

Non-refundable license fees, if not associated with future Company performance, are recognized when received. Non-refundable license fees, if associated with future Company performance, are attributed to a specific program or collaboration and recognized over the period of service for that specific program or collaboration.

 

Amounts received for research funding are recognized as revenues as the services are performed. Revenue is deferred for fees received before earned.

 

Revenue from milestones is recognized when earned, as evidenced by written acknowledgment from the collaborator or other persuasive evidence that the milestone has been achieved, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (ii) the Company’s performance obligations after the milestone achievement will continue to be funded by the collaborator at a level comparable to before the milestone achievement. If both of these criteria are not met, the milestone payment is recognized over the remaining minimum period of the Company’s performance obligations under the agreement.

 

Revenue from cost reimbursements is recognized when earned, as evidenced by written acknowledgment from the collaborator or other persuasive evidence.

 

Royalties to be received based on product sales made by the Company’s collaborators incorporating the Company’s products, if any, will be recognized as received. To date, the Company has not earned any royalties.

 

4



 

Recent Accounting Pronouncements

 

In September 2006, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 157, Fair Value Measurement. SFAS No. 157 establishes a framework for measuring fair value in accordance with GAAP, clarifies the definition of fair value within that framework, and expands disclosures about the use of fair value measurements. It also responds to investors’ requests for expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value and the effect of fair value measurements on earnings. SFAS No. 157 applies whenever other standards require (or permit) assets or liabilities to be measured at fair value, and does not expand the use of fair value in any new circumstances. SFAS No. 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007. The FASB has stated that it is considering a potential deferral on the application of Statement No. 157 to the fair value measurement of non-financial assets and liabilities. The Company does not expect the adoption of SFAS No. 157 to have a material impact on its financial statements.

 

In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities.  SFAS No. 159 allows certain financial assets and liabilities to be recognized, at the Company’s election, at fair market value, with any gains or losses for the period recorded in the statement of income.  SFAS No. 159 includes available-for-sales securities in the assets eligible for this treatment.  Currently, the Company records the gains or losses for the period in comprehensive income and in the equity section of the balance sheet.  SFAS No. 159 is effective for fiscal years beginning after November 15, 2007, and interim periods in those fiscal years.  The Company does not expect the adoption of SFAS No. 159 to have a material impact on its financial statements.

 

In June 2007, the EITF issued EITF Issue No. 07-3, Accounting for Advance Payments for Goods or Services to be Received for Use in Future Research and Development Activities. The consensus requires companies to defer and capitalize prepaid, nonrefundable research and development payments to third parties over the period that the research and development activities are performed or the services are provided, subject to an assessment of recoverability. EITF Issue No. 07-3 is effective for new contracts entered into in fiscal years beginning after December 15, 2007, including interim periods within those fiscal years. The Company does not expect the adoption of EITF Issue No. 07-3 to have a material impact on its financial statements.

 

Stock-Based Compensation

 

Total estimated stock-based compensation expense, related to all of the Company’s stock-based awards granted to employees and non-employee directors, recognized for the three and nine months ended September 30, 2007 and 2006 was comprised as follows (in thousands, except per share data):

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

(542

)

$

(427

)

$

(1,422

)

$

(1,458

)

General and administrative

 

(1,056

)

(978

)

(3,311

)

(3,380

)

Employee and non-employee director stock-based compensation expense

 

$

(1,598

)

$

(1,405

)

$

(4,733

)

$

(4,838

)

 

At September 30, 2007, total unrecognized estimated compensation expense related to non-vested stock options granted prior to that date was $13.9 million, which is expected to be recognized over a weighted average period of 2.0 years.

 

Net Loss Per Share

 

The Company calculates net loss per share in accordance with SFAS No. 128, Earnings Per Share, and SAB No. 98. Basic earnings per share (“EPS”) is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted EPS is computed by dividing the net loss by the weighted average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common share equivalents include the dilutive effect of in-the-money shares, which is calculated based on the average share price for each period using the treasury stock method. Under the treasury stock method, the exercise price of a share, the amount of compensation cost, if any, for future service that the Company has not yet recognized, and the amount of estimated tax benefits that would be recorded in paid-in capital, if any, when the share is exercised are assumed to be used to repurchase shares in the current period. For purposes of this calculation, common stock subject to repurchase by the Company, options and warrants are considered to be common stock equivalents and are only included in the calculation of diluted EPS when their effect is dilutive.

 

5



 

The following table sets forth the computation of basic and diluted net loss per share for the respective periods.

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Historical:

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

Net loss (in thousands)

 

$

(4,762

)

$

(5,015

)

$

(17,193

)

$

(17,802

)

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average common shares

 

30,407,313

 

29,946,770

 

30,313,950

 

29,841,023

 

Weighted average unvested common shares subject to repurchase

 

(13,136

)

(89,163

)

(30,451

)

(111,207

)

 

 

 

 

 

 

 

 

 

 

Denominator for basic and diluted earnings per share

 

30,394,177

 

29,857,607

 

30,283,499

 

29,729,816

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.16

)

$

(0.17

)

$

(0.57

)

$

(0.60

)

 

Comprehensive Loss

 

Comprehensive loss represents net loss adjusted for the change during the periods presented in unrealized gains and losses on available-for-sale securities less reclassification adjustments for realized gains or losses included in net loss. The accumulated unrealized gains or losses are reported as accumulated other comprehensive loss as a separate component of stockholders’ equity. Comprehensive loss is as follows (in thousands):

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss

 

$

(4,750

)

$

(5,005

)

$

(17,191

)

$

(17,794

)

 

2.                                      Income Tax

 

On July 13, 2006, the FASB issued Interpretation No. (“FIN”) 48, Accounting for Uncertainty in Income Taxes – An Interpretation of FASB Statement No. 109. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance with SFAS No. 109, Accounting for Income Taxes, and prescribes a recognition threshold and measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return. Under FIN 48, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006.

 

The Company adopted the provisions of FIN 48 on January 1, 2007. The total amount of unrecognized tax benefits as of the date of adoption was $958,000. As a result of the implementation of FIN 48, the Company recognized a $958,000 decrease in deferred tax assets and a corresponding decrease in the valuation allowance, resulting in net deferred tax assets and an offsetting valuation allowance of $44.5 million. There are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the effective tax rate.

 

The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense. During the three and nine month periods ended September 30, 2007 and 2006, the Company did not recognize any interest or penalties. Upon adoption of FIN 48 on January 1, 2007, the Company did not record any interest or penalties.

 

The Company is subject to taxation in the U.S. and various state jurisdictions. The Company’s tax years for 2002 and forward are subject to examination by the U.S. and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits.

 

6



 

The adoption of FIN 48 did not impact the Company’s financial condition, results of operations or cash flows. At January 1, 2007, the Company had net deferred tax assets of $44.5 million. The deferred tax assets are primarily composed of federal and state tax net operating loss (“NOL”) carryfowards and federal and state research and development (“R&D”) credit carryforwards. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these assets, a full valuation has been established to offset the net deferred tax asset. Additionally, the future utilization of the Company’s NOL and R&D credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of ownership changes that may have occurred previously or that could occur in the future. The Company has not yet determined whether such an ownership change has occurred; however, the Company plans to complete a Section 382 analysis regarding the limitation of the NOL and R&D credits. When this project is completed, the Company plans to update their unrecognized tax benefits under FIN 48. The Company intends to perform a comprehensive review of the components of its R&D credit. The timing for such a review has not been established by the Company. Therefore, the Company expects that the unrecognized tax benefits may change within 12 months of this reporting date. At this time, the Company cannot estimate how much the unrecognized tax benefits may change. Any carryforwards that will expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the valuation allowance. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact the Company’s effective tax rate.

 

3.                                      Subsequent Event

 

On October 31, 2007, the Company received notification from Kraft Global Foods, Inc. terminating its collaboration agreement dated December 6, 2000, as amended, effective as of December 9, 2007.  The collaborative agreement with Kraft Foods covers the development of a sweet enhancer for use by Kraft Foods on an exclusive basis in a specified product field in the dessert product category and on a co-exclusive basis in the powdered beverage product field.  The agreement also covers the discovery and development of novel salt enhancers to be used by Kraft Foods on a co-exclusive basis in the chilled and processed meat product category in North America. 

 

Through October 31, 2007, the Company has received $12.7 million in license fees, research and development funding and milestone payments from all sources.  Based on the early conclusion of the Kraft Foods agreement, the Company is no longer entitled to receive research and development funding for the final year of the Kraft Foods agreement or potential milestone payments, representing a combined total of up to $3.3 million if all milestones had been achieved.  The Company does not have to reimburse Kraft Foods any monies paid to the Company.  In addition, the Company is no longer entitled to receive royalties on future net sales of products containing a discovered flavor enhancer if commercialization had occurred.  All rights previously licensed to Kraft Foods will return to the Company. 

 

7



 

ITEM 2.                                                     MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes included in this quarterly report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2006 included with our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC. Operating results are not necessarily indicative of results that may occur in future periods.

 

Certain statements contained in this quarterly report on Form 10-Q, including statements regarding the development, growth and expansion of our business, our intent, belief or current expectations, primarily with respect to our future operating performance, and the products we expect to offer and other statements regarding matters that are not historical facts, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act, and are subject to the “safe harbor” created by these sections. Future filings with the SEC, future press releases and future oral or written statements made by us or with our approval, which are not statements of historical fact, may also contain forward-looking statements. Because such statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed or implied by such forward-looking statements. Some of the factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements can be found under the caption “Risk Factors,” and elsewhere in this quarterly report on Form 10-Q. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.

 

Overview and Recent Developments

 

We are a leading company focused on using proprietary taste receptor-based assays, screening technologies and optimization chemistry to discover and develop novel flavor ingredients for the packaged food and beverage industry. We believe our flavor ingredients will enable packaged food and beverage companies to improve the nutritional profile of their products while maintaining or enhancing taste and may generate cost of goods savings. We license our flavor ingredients to our collaborators on an exclusive or co-exclusive basis, which we believe will provide these companies with the ability to differentiate their products subsequent to the conclusion of the collaboration with Kraft Foods. Subsequent to the conclusion of the collaboration with Kraft Foods, we will have product discovery and development collaborations with six of the world’s leading packaged food and beverage companies: Ajinomoto, Cadbury, Campbell, Coca-Cola, Nestlé and Solae, LLC. We currently anticipate that we will derive all of our revenues from existing and future collaborations. Depending upon the collaboration, our existing collaboration agreements provide for upfront fees, research and development funding, reimbursement of certain regulatory costs, milestone payments based upon our achievement of research or development goals and, in the event of commercialization, royalties on future sales of consumer products incorporating our flavor ingredients. Our current programs focus on the development of savory, sweet and salt flavor enhancers, high potency sweeteners and bitter taste modulators.

 

We have incurred significant losses since our inception in 1998 and as of September 30, 2007 our accumulated deficit was $144.5 million. We expect to incur additional losses over at least the next two years as we continue to develop flavor ingredients. Our results of operations have fluctuated from period to period and likely will continue to fluctuate substantially in the future based upon:

 

                  termination of any of our product discovery and development collaboration agreements;

                  our ability to discover and develop new flavor ingredients or the ability of our product discovery and development collaborators to incorporate them into their products;

                  our ability to enter into new, or extend existing, product discovery and development collaborations and technology collaborations;

                  the demand for our collaborators’ products containing our flavor ingredients; and

                  variability of our stock-based compensation expense in conjunction with fluctuations of our stock price.

 

In July 2007, we amended our Collaborative Research and License Agreement with Cadbury Adams USA, LLC, dated July 15, 2005, to extend the collaborative period for an additional twelve months, through July 15, 2008. During the extension period, we will continue to work with Cadbury on the discovery and commercialization of new flavor ingredients in the gum confectionary area. Under the terms of the extension, Cadbury has agreed to pay us incremental research funding of up to $600,000 based on research progress during the extension period. The other payment terms, including milestones and royalties based on sales of products containing new flavor ingredients developed under the agreement, remain unchanged.

 

8



 

In July 2007, we amended our collaboration agreement, dated December 6, 2000, as amended, with Kraft Foods Global, Inc., a global leader in branded foods and beverages, to extend until December 9, 2008 Kraft Foods’ ability to evaluate novel flavor modifiers under development by us for potential use by Kraft Foods on an exclusive basis in a specified product field in the dessert product category and on a co-exclusive basis in the powdered beverage product field. On October 31, 2007 we received notification from Kraft Foods terminating our collaboration agreement effective as of December 9, 2007. Under the Kraft Foods agreement, through October 31, 2007, we have received $12.7 million in license fees, research and development funding and milestone payments from all sources.  Based on the early conclusion of the Kraft Foods agreement, we are no longer entitled to receive research and development funding for the final year of the Kraft Foods agreement or potential milestone payments, representing a combined total of up to $3.3 million if all milestones had been achieved. We believe the majority of the $3.3 million would have been paid subsequent to the end of 2008.  We do not have to reimburse Kraft Foods any monies paid to us.  In addition, we are no longer entitled to receive royalties on future net sales of products containing a discovered flavor enhancer if commercialization had occurred.  All rights previously licensed to Kraft Foods will return to us. 

 

In March 2006, the Company entered into a Collaborative Research, Development, Commercialization and License Agreement with Ajinomoto Co., Inc. for the discovery and commercialization of novel flavor ingredients in select product categories within Japan and other Asian markets. In August 2007, we amended the agreement to expand Ajinomoto’s rights into additional product categories and geographies not previously licensed by us. The expanded license will provide Ajinomoto with exclusive rights on the development and commercialization of certain existing flavor ingredients in a wide variety of product categories that were not previously licensed within a respective territory including soups, sauces, instant noodles, snack foods, frozen foods and processed meats. The new territories for these product categories include Africa, the Caribbean, Europe, Latin America, the Middle East and Oceania. Under the terms of the new amendment, Ajinomoto has agreed to pay us a license fee of $8.0 million. Upon commercialization, we will receive royalty payments based on sales of products containing flavor ingredients developed under the agreement. In addition, the royalty obligation for both amendments includes predetermined minimum royalties.

 

Results of Operations

 

Three Months Ended September 30, 2007 and 2006

 

Revenue Under Collaboration Agreements

 

We recorded revenue of $5.1 million and $3.2 million during the three months ended September 30, 2007 and 2006, respectively. The increase of $1.8 million was primarily due to the commencement of revenue recognition of new collaborations in the second and third quarters of 2007. Research and development payments under collaborations with Ajinomoto, Cadbury, Campbell, Coca-Cola, Kraft Foods, Nestlé and Solae accounted for 100% of total revenue for the three months ended September 30, 2007. Research and development payments under collaborations with Ajinomoto, Cadbury, Campbell, Coca-Cola, Kraft Foods and Nestlé accounted for 100% of total revenue for the three months ended September 30, 2006.

 

Research and Development Expenses

 

Our research and development expenses were $7.7 million and $6.1 million for the three months ended September 30, 2007 and 2006, respectively. A comparison of research and development expenses by category is as follows (in thousands):

 

 

 

Three months ended
September 30,

 

 

 

2007

 

2006

 

Salaries and personnel

 

$

2,934

 

$

2,197

 

Facilities and depreciation

 

1,391

 

1,177

 

Research and development supplies

 

1,113

 

1,019

 

Patent and licensing

 

1,045

 

20

 

Outside services

 

238

 

847

 

Miscellaneous

 

171

 

109

 

Total research and development expenses (excluding stock-based compensation)

 

6,892

 

5,369

 

 

 

 

 

 

 

Stock-based compensation

 

776

 

774

 

Total research and development expenses

 

$

7,668

 

$

6,143

 

 

Salaries and Personnel. Our expenses for research and development personnel, including consultants, were $2.9 million and $2.2 million for the three months ended September 30, 2007 and 2006, respectively. The increase of $737,000 was primarily due to increases in payroll expense of approximately $587,000. Our research and development staff increased from an average of 83 for the three months ended September 30, 2006 to an average of 89 for the three months ended September 30, 2007. The increase in payroll expense reflects the addition of employees to support discovery and development operations and the impact of annual salary adjustments.

 

9



 

Facilities and Depreciation.    Our facilities and depreciation expenses were $1.4 million and $1.2 million for the three months ended September 30, 2007 and 2006, respectively. The increase of $214,000 was primarily attributable to an increase in depreciation expense of $290,000 primarily due to tenant improvements in our current facility being placed in service during the fourth quarter of 2006. The increase was partially offset by a decrease in rent expense of $76,000 primarily due to the amortization of leasehold incentive obligations and to a decrease in rent expense for our current facility compared to our former facility. For a further discussion of the accounting for our leasehold incentive obligations, see our annual report on Form 10-K for the year ended December 31, 2006.

 

Research and Development Supplies. Our expenses for supplies used in research and development were $1.1 million and $1.0 million for the three months ended September 30, 2007 and 2006, respectively. The increase of $94,000 was primarily attributable to higher discovery and development screening and other lab supplies expenses partially offset lower compound acquisition expenses.

 

Patent and Licensing. Our patent and licensing expenses were $1.0 million and $20,000 for the three months ended September 30, 2007 and 2006, respectively. The increase of $1.0 million was primarily attributable to outsourced patent filing related activities associated with our expanding intellectual property portfolio.

 

Outside Services. Our outside services expenses were $238,000 and $847,000 for the three months ended September 30, 2007 and 2006, respectively. The decrease of $609,000 was primarily attributable to a decrease in costs for chemistry outsourcing as we redeployed these resources to internal activities.

 

Stock-based Compensation. Our stock-based compensation expenses were $776,000 and $774,000 for the three months ended September 30, 2007 and 2006, respectively. The increase of $2,000 was primarily attributable to increases in expense related to stock options granted to employees during 2006 and the first, second and third quarters of 2007, offset by decreases in compensation expense in 2007 compared to 2006 for stock options granted to both employees prior to 2006 and to non-employees, as the expense for these options is accounted for on an accelerated basis, which results in more expense being recognized for the options earlier in the options’ vesting period. Options granted to employees after 2005 are accounted for on a straight-line basis.

 

General and Administrative Expenses

 

Our general and administrative expenses (including stock-based compensation expenses charged to general and administrative) were $3.0 million and $3.1 million for the three months ended September 30, 2007 and 2006, respectively. The $104,000 decrease in expenses from the three months ended September 30, 2006 to 2007 was primarily attributable to decreases in management consulting expense and facilities expense, partially offset by an increase in depreciation expense. The decrease in consulting expenses of approximately $90,000 from 2006 to 2007 was due to the one-time use of strategic planning consultants in the second and third quarters of 2006. The decrease in facilities expense of approximately $74,000 was primarily due to a decrease in rent expense for our current facility compared to our former facility. The increase in depreciation expense of approximately $77,000 was primarily due to tenant improvements in our current facility being placed in service during the fourth quarter of 2006.

 

Interest Income

 

Interest income was $852,000 and $1.0 million for the three months ended September 30, 2007 and 2006, respectively. The decrease of $175,000 was primarily attributable to lower invested balances and to lower rates of return on those balances for the three months ended September 30, 2007 compared to the same period in 2006.

 

Nine Months Ended September 30, 2007 and 2006

 

Revenue Under Collaboration Agreements

 

We recorded revenue of $11.9 million and $8.8 million during the nine months ended September 30, 2007 and 2006, respectively. The increase of $3.0 million was primarily due to the commencement of revenue recognition in the second quarter of 2007 of a new collaboration and the commencement of revenue recognition in the third quarter of 2007 of a new collaboration. In addition, the increase was due to the earnings of a milestone, and to the recognition of three quarters’ of revenue for the Ajinomoto collaboration in 2007, compared to only two quarters for 2006. Research and development

 

10



 

payments under collaborations with Ajinomoto, Cadbury, Campbell, Coca-Cola, Kraft Foods, Nestlé and Solae accounted for 100% of total revenue for the nine months ended September 30, 2007. Research and development payments under collaborations with Ajinomoto, Cadbury, Campbell, Coca-Cola, Kraft Foods and Nestlé accounted for approximately 100% of total revenue for the nine months ended September 30, 2006.

 

Research and Development Expenses

 

Our research and development expenses were $21.5 million and $19.0 million for the nine months ended September 30, 2007 and 2006, respectively. A comparison of research and development expenses by category is as follows (in thousands):

 

 

 

Nine months ended
September 30,

 

 

 

2007

 

2006

 

Salaries and personnel

 

$

8,534

 

$

6,765

 

Facilities and depreciation

 

4,292

 

3,443

 

Research and development supplies

 

2,936

 

2,860

 

Patent and licensing

 

2,090

 

1,366

 

Outside services

 

875

 

1,674

 

Miscellaneous

 

776

 

549

 

Total research and development expenses (excluding stock based compensation)

 

19,503

 

16,657

 

 

 

 

 

 

 

Stock-based compensation

 

1,977

 

2,321

 

Total research and development expenses

 

$

21,480

 

$

18,978

 

 

Salaries and Personnel. Our expenses for research and development personnel, including consultants, were $8.5 million and $6.8 million for the nine months ended September 30, 2007 and 2006, respectively. The increase of $1.8 million was primarily due to increases in payroll expenses of approximately $1.6 million. Our research and development staff increased from an average of 76 for the nine months ended September 30, 2006 to an average of 87 for the nine months ended September 30, 2007. The increase in payroll expense reflects the addition of employees to support discovery and development operations and the impact of annual salary adjustments.

 

Facilities and Depreciation.    Our facilities and depreciation expenses were $4.3 million and $3.4 million for the nine months ended September 30, 2007 and 2006, respectively. The increase of $849,000 was primarily attributable to an increase in depreciation expense of $828,000 primarily due to tenant improvements in our current facility being placed in service during 2006.

 

Research and Development Supplies. Our expenses for supplies used in research and development were $2.9 million for the nine month periods ended September 30, 2007 and 2006. The increase of $76,000 was primarily attributable to higher discovery and development screening and other lab supplies expenses partially offset by lower compound acquisition expenses.

 

Patent and Licensing. Our patent and licensing expenses were $2.1 million and $1.4 million for the nine months ended September 30, 2007 and 2006, respectively. The increase of $724,000 was primarily attributable outsourced patent filing related activities associated with our expanding intellectual property portfolio.

 

Outside Services. Our outside services expenses were $875,000 and $1.7 million for the nine months ended September 30, 2007 and 2006, respectively. The decrease of $799,000 was primarily attributable to a decrease in costs for chemistry outsourcing, as we redeployed these resources to internal activities.

 

Stock-based Compensation. Our stock-based compensation expenses were $2.0 million and $2.3 million for the nine months ended September 30, 2007 and 2006, respectively. The decrease of $344,000 was primarily attributable to decreases in compensation expense in 2007 compared to 2006 for stock options granted to both employees prior to 2006 and to non-employees, as the expense for these options is accounted for on an accelerated basis, which results in more expense being recognized for the options earlier in the options’ vesting period. This decrease was partially offset by increases in expense related to stock options granted to employees during 2006 and the first three quarters of 2007. Options granted to employees after 2005 are accounted for on a straight-line basis.

 

11



 

General and Administrative Expenses

 

Our general and administrative expenses (including stock-based compensation expenses charged to general and administrative) were $10.2 million and $10.5 million for the nine months ended September 30, 2007 and 2006, respectively. The $325,000 decrease in expenses from the nine months ended September 30, 2006 to 2007 was primarily attributable to decreases in consulting expenses and recruiting expenses, partially offset by increases in salaries and personnel costs. The decrease in consulting expenses of approximately $412,000 from 2006 to 2007 was due to the one-time use of strategic planning consultants in the first quarter of 2006. The decrease in recruiting and relocation expenses of approximately $204,000 was due to the addition of key general and administrative personnel in the second quarter of 2006. The increase in expenses for salaries and personnel of approximately $398,000 was primarily due to the impact of salary adjustments.

 

Interest Income

 

Interest income was $2.6 million and $2.8 million for the nine months ended September 30, 2007 and 2006, respectively. The decrease of $241,000 was primarily attributable to lower invested balances for the nine months ended September 30, 2007 compared to the same period in 2006. The effect of these lower balances was partially offset by higher average rates of return on those invested balances for the nine months ended September 30, 2007 compared to the nine months ended September 30, 2006.

 

Liquidity and Capital Resources

 

Since our inception, we have financed our business primarily through private and public placements of stock, research and development payments under our product discovery and development collaborations with Ajinomoto, Cadbury, Campbell, Coca-Cola, Kraft Foods, Nestlé and Solae and interest income. As of September 30, 2007, we had received in excess of $170.1 million in proceeds from the sales of common and preferred stock. In addition, we had received $72.1 million in non-refundable license fees, research and development payments, cost reimbursements and milestone payments from our collaboration agreements and $10.1 million in interest income. Over the remaining life of our current collaboration agreements, we may receive up to an additional $18.1 million in non-refundable research and development payments from our collaborators. We expect to receive royalty payments from Nestlé. We may receive payments in the event we achieve research or development milestones and royalty payments in the event our collaborators commercialize additional products incorporating our flavor ingredients. We may not recognize revenues for research and development funding or milestones if the collaborations are terminated, or if we do not achieve the milestones set forth in the collaboration agreements.

 

At September 30, 2007, we had $69.8 million in cash, cash equivalents and investments available-for-sale as compared to $74.1 million at December 31, 2006, a decrease of $4.3 million. This overall decrease resulted primarily from the use of cash to fund our operations and to purchase capital equipment, partially offset by the receipt of proceeds of $2.1 million from the issuance of common stock through the exercise of employee and non-employee stock options and from purchases of stock from the employee stock purchase plan.

 

Operating Activities

 

Operating activities used cash of $5.6 million for the nine months ended September 30, 2007 compared to $5.3 million for the nine months ended September 30, 2006. Non-cash income from the accretion of discount on available-for-sale securities increased $847,000 to $1.6 million for the nine months ended September 30, 2007 from $742,000 for the nine months ended September 30, 2006. Non-cash expenses for the nine months ended September 30, 2007 decreased $113,000 to $6.7 million for the nine months ended September 30, 2007 from $6.9 million for the nine months ended September 30, 2006. This decrease was primarily due to an increase in the amortization of leasehold obligation of $700,000 (a contra-expense) and relative decreases in both employee and non-employee stock-based compensation expense for $105,000 and $371,000, respectively. These reductions in non-cash expenses were partially offset by a relative increase in depreciation expense of $1.1 million. Net changes in other assets used cash of $918,000 and provided cash of $296,000 during the nine months ended September 30, 2007 and 2006, respectively. Additionally, net increases in operating liabilities over the nine months ended September 30, 2007 and 2006 provided cash of $7.4 million and $6.1 million, respectively.

 

Investing Activities

 

Investing activities provided cash of $19.7 million and used cash of $38.5 million for the nine months ended September 30, 2007 and 2006, respectively. Cash provided in the nine months ended September 30, 2007 reflects the maturities of available-for-sale securities purchased to obtain higher rates of interest income, partially offset by purchases of available-for-sale securities and purchases of fixed assets. Cash used in the nine months ended September 30, 2006 reflects the purchases of available-for-sale securities to obtain higher rates of interest income, partially offset by the maturities of available-for-sale securities.

 

12



 

Financing Activities

 

Financing activities provided cash of $2.1 million and $2.3 million for the nine months ended September 30, 2007 and 2006, respectively. Cash provided by financing activities in the nine months ended September 30, 2007 and 2006 reflects the net proceeds from the issuance or sale of common stock of $2.1 million and $2.3 million, respectively, pursuant to the exercise of employee and non-employee stock options and from purchases of stock from the employee stock purchase program.

 

As of September 30, 2007 future minimum payments due under our contractual obligations are as follows (in thousands):

 

 

 

Payments Due by Period

 

 

 

Total

 

Less than 1 year

 

1-3 years

 

4-5 years

 

After 5 years

 

Operating leases

 

$

26,090

 

$

2,481

 

$

5,136

 

$

5,400

 

$

13,073

 

License payments

 

199

 

94

 

51

 

36

 

18

 

Total

 

$

26,289

 

$

2,575

 

$

5,187

 

$

5,436

 

$

13,091

 

 

As of September 30, 2007, we had no long-term debt obligations.

 

Our future capital uses and requirements depend on numerous forward-looking factors. These factors may include, but are not limited to, the following:

 

                  the rate of progress and cost of research and development activities;

                  the number and scope of our research activities;

                  the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

                  our ability to establish and maintain product discovery and development collaborations;

                  the effect of competing technological and market developments;

                  the terms and timing of any collaborative, licensing and other arrangements that we may establish; and

                  the extent to which we acquire or in-license new products, technologies or businesses.

 

We believe our available cash, cash equivalents, investments and existing sources of funding will be sufficient to satisfy our anticipated operating and capital requirements through at least the next 12 months.

 

Until we can generate significant cash from our operations, we expect to continue to fund our operations with existing cash resources that were primarily generated from the proceeds of offerings of our equity securities and research and development payments and milestone payments under our product discovery and development collaborations. Under our existing collaboration agreements, assuming all remaining milestones are achieved and we receive all remaining research and development funding, we may be entitled to additional payments which total up to $32.7 million. In the next three months (through December 31, 2007), we anticipate receiving $2.3 million in non-refundable research and development payments. We may not receive the payments if the collaborations are terminated or not renewed, or if we do not achieve the milestones set forth in the collaboration agreements. In addition, the timing of the receipt of milestone payments in particular is uncertain, as we may achieve milestones significantly earlier or later than we currently expect. We continue to pursue additional collaborations, which could result in additional revenue. We may not recognize revenues for research and development funding or milestones if the collaborations are terminated, or if we do not achieve the milestones set forth in the collaboration agreements.

 

Off-Balance Sheet Arrangements

 

As of September 30, 2007 and 2006, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as special purpose or structured finance entities, which would have been established for the purposes of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.

 

13



 

Critical Accounting Policies

 

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate these estimates, including those related to revenue recognition, long-lived assets, accrued liabilities and income taxes. These estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.

 

Revenue Recognition

 

Our revenue recognition policies are in compliance with Staff Accounting Bulletin, or SAB, No. 104, Revenue Recognition and Emerging Issues Task Force, or EITF, Issue No. 00-21, Revenue Arrangements with Multiple Deliverables. Some of our agreements contain multiple elements, including technological and territorial licenses and research and development services. In accordance with these agreements, we may be eligible for upfront fees, research funding, cost reimbursements, milestones and royalty payments.

 

Revenue is deferred for fees received before earned. Non-refundable upfront fees associated with our future performance are deferred and recognized over the remaining period of our performance obligations under the agreement. Non-refundable license fees associated with future performance involving a specific program or collaboration are recognized over the period of service for that specific program or collaboration. Non-refundable upfront fees, if not associated with our future performance, are recognized when received. Amounts received for research funding are recognized as revenues as the services are performed. Revenue from milestones is recognized when earned, as evidenced by written acknowledgement from the collaborator or other persuasive evidence that the milestone has been achieved, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (ii) our performance obligations after the milestone achievement will continue to be funded by the collaborator at a level comparable to before the milestone achievement. If both of these criteria are not met, the milestone payment is recognized over the remaining minimum period of our performance obligations under the agreement. Revenue from cost reimbursements is recognized when earned, as evidenced by written acknowledgement from the collaborator or other persuasive evidence. Royalties to be received based on product sales made by our collaborators incorporating our products, if any, will be recognized as received. To date, we have not earned any royalties.

 

Stock-based Compensation Expense

 

We grant options to purchase our common stock to our employees and directors under our equity incentive plan. Eligible employees can also purchase shares of our common stock under our employee stock purchase plan at the lower of: (i) 85% of the fair market value on the first day of a two-year offering period; or (ii) 85% of the fair market value on the last date of each six-month purchase period within the two-year offering period. In addition, we grant options to purchase our common stock to non-employee members of our Scientific Advisory Board and other consultants under our equity incentive plan.

 

Stock-based compensation expense recognized under Statement of Financial Accounting Standards, or SFAS, No. 123R, Share-Based Payment, was $1.6 million and $4.7 million for the three and nine months ended September 30, 2007. Stock-based compensation expense recognized under SFAS No. 123R was $1.4 million and $4.8 million for the three and nine months ended September 30, 2006. At September 30, 2007, total unrecognized estimated compensation expense related to non-vested stock options granted prior to that date was $13.9 million, which is expected to be recognized over a weighted average period of 2.0 years.

 

For purposes of estimating the fair value of stock options granted during the nine months ended September 30, 2007 using the Black-Scholes model, we have made a subjective estimate regarding our stock price volatility (weighted average of 67.4%). We used an average of the historical volatility of our stock for the period our stock has been publicly traded and the historical volatilities of the common stock of several publicly traded companies management feels are comparable to us, consistent with the guidance in SFAS No. 123R and SAB No. 107. If our stock price volatility assumption were increased to 75%, the weighted average estimated fair value of stock options granted during the nine months ended September 30, 2007 would increase by $0.59 per share, or 7.0%.

 

14



 

The expected term of options granted is derived from the average midpoint between vesting and the contractual term, as described in SAB No. 107. For options granted during the nine months ended September 30, 2007, we have calculated a weighted average expected term of 6.0 years. If the expected term of the options granted was increased to 8.0 years, the weighted average estimated fair value of stock options granted during the nine months ended September 30, 2007 would increase by $0.97 per share, or 11.5%.

 

The risk-free interest rate for the expected term of the option is based on the average U.S. Treasury yield curve at the balance sheet date for the expected term (weighted average of 4.6% for the nine months ended September 30, 2007) which, if increased to 6.00%, would increase the weighted average estimated fair value of stock options granted during the three months ended September 30, 2007 by $0.22 per share, or 2.6%.

 

Income Tax

 

In July 2006, the Financial Accounting Standards Board, or FASB, issued Interpretation No., or FIN, 48, Accounting for Uncertainty in Income Taxes – An Interpretation of FASB Statement No. 109. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance with SFAS No. 109, Accounting for Income Taxes, and prescribes a recognition threshold and measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return. Under FIN 48, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006.

 

We adopted the provisions of FIN 48 on January 1, 2007. The total amount of unrecognized tax benefits as of the date of adoption was $958,000. As a result of the implementation of FIN 48, we recognized a $958,000 decrease in deferred tax assets and a corresponding decrease in the valuation allowance. The adoption of FIN 48 did not impact our financial condition, results of operations or cash flows.

 

For additional information regarding the adoption of FIN 48, see Note 2, Income Taxes. For further discussion of our critical accounting estimates related to income taxes, see our annual report on Form 10-K for the year ended December 31, 2006.

 

Recent Accounting Pronouncements

 

In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS No. 157 establishes a framework for measuring fair value in accordance with GAAP, clarifies the definition of fair value within that framework, and expands disclosures about the use of fair value measurements. It also responds to investors’ requests for expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value and the effect of fair value measurements on earnings. SFAS No. 157 applies whenever other standards require (or permit) assets or liabilities to be measured at fair value, and does not expand the use of fair value in any new circumstances. SFAS No. 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007. The FASB has stated that it is considering a potential deferral on the application of Statement No. 157 to the fair value measurement of non-financial assets and liabilities. We do not expect the adoption of SFAS No. 157 to have a material impact on our financial statements.

 

In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities.  SFAS No. 159 allows certain financial assets and liabilities to be recognized, at our election, at fair market value, with any gains or losses for the period recorded in the statement of income.  SFAS No. 159 included available-for-sale securities in the assets eligible for this treatment.  Currently, we record the gains or losses for the period in comprehensive income and in the equity section of the balance sheet.  SFAS No. 159 is effective for fiscal years beginning after November 15, 2007, and interim periods in those fiscal years.  We do not expect the adoption of SFAS No. 159 to have a material impact on our financial statements.

 

In June 2007, the EITF issued EITF Issue No. 07-3, Accounting for Advance Payments for Goods or Services to be Received for Use in Future Research and Development Activities. The consensus requires companies to defer and capitalize prepaid, nonrefundable research and development payments to third parties over the period that the research and development activities are performed or the services are provided, subject to an assessment of recoverability. EITF Issue No. 07-3 is effective for new contracts entered into in fiscal years beginning after December 15, 2007, including interim periods within those fiscal years. We do not expect the adoption of EITF Issue No. 07-3 to have a material impact on our financial statements.

 

15



 

ITEM 3.                                                     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of United States interest rates. Due to the nature of our investments, we believe that we are not subject to any material market risk exposure. We do not have any foreign currency or other derivative financial instruments.

 

ITEM 4.                                                     CONTROLS AND PROCEDURES

 

Prior to the filing of this quarterly report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Senior Vice President and Chief Financial and Business Officer, of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a - 15(e) or 15d -15(e) of the Exchange Act) as of the end of the period covered by this quarterly report on Form 10-Q. Disclosure controls and procedures are designed to ensure that information required to be disclosed in our periodic reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Based upon that evaluation, our President and Chief Executive Officer and our Senior Vice President and Chief Financial and Business Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this quarterly report on Form 10-Q.

 

An evaluation was also performed under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Senior Vice President and Chief Financial and Business Officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Our management, including our President and Chief Executive Officer and our Senior Vice President and Chief Financial and Business Officer, does not expect that our disclosure controls will prevent all errors or potential fraud. A control system, no matter how well conceived and operated, can provide only reasonable and not absolute assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their cost. 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 our company have been detected. These inherent limitations include the realities that judgments 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 or by collusion of two or more people. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

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PART II. OTHER INFORMATION

 

ITEM 1A.               RISK FACTORS

 

The following sets forth risk factors associated with our business. The risk factors set forth below with an asterisk (*) next to the title contain changes to the description of the risk factors associated with our business previously disclosed in Item 1A. of our annual report on Form 10-K for the year ended December 31, 2006 and our subsequent filings with the SEC. Additional risks and uncertainties that we are unaware of may also become important factors that affect us. If any of the following risks occur, our business, financial condition or results of operations could be materially and adversely affected. In these circumstances, the market price of our common stock could decline.

 

Risks Related To Our Business

 

We are dependent on our product discovery and development collaborators for all of our revenue and we are dependent on our current and any future product discovery and development collaborators to develop and commercialize any flavor ingredients we may discover.*

 

A key element of our strategy is to commercialize our flavor ingredients through product discovery and development collaborations. To date, all of our revenue has been derived solely from research and development payments, milestone payments and cost reimbursement payments received under collaboration agreements with Ajinomoto, Cadbury Schweppes, Campbell, Coca-Cola, Kraft Foods, Nestlé and Solae. Substantially all of our revenue in the foreseeable future will result from these types of payments from these collaborations until such time, if ever, that we earn material royalties on future sales of consumer products incorporating our flavor ingredients.

 

Our agreement, as amended, with Campbell provides for research and development funding until March 2009 and gives Campbell the right to terminate the agreement earlier without cause, provided that it pay a specified termination fee if it terminates the agreement prior to March 28, 2009. Our agreement with Coca-Cola provides for research and development funding until April 2008 and gives Coca-Cola the right to conclude the collaborative program earlier for any reason upon payment to us of an early conclusion fee. Our initial agreement with Nestlé (as amended in April 2005) provides for research and development funding through April 2008 and gives Nestlé the right to terminate the agreement earlier without cause, provided that it pay additional specified research funding if it terminates the agreement prior to April 18, 2008. Our most recent agreement with Nestlé regarding the discovery and commercialization of novel flavor ingredients in the coffee and coffee whitener fields provides for research and development funding through April 2011 and gives Nestlé the right to terminate the agreement earlier without cause on or after April 26, 2008, provided that it pay additional specified research funding if it terminates the agreement after April 26, 2008 but prior to April 26, 2011.  Our agreement with Cadbury provides for research and development funding through July 2008 and gives Cadbury the right to terminate the agreement earlier without cause upon 90 days’ written notice. Our initial agreement with Ajinomoto provides for research and development funding through March 2009 and gives Ajinomoto the right to terminate the agreement without cause provided that it pay additional specified research funding if it terminates the agreement prior to March 23, 2009. Our most recent agreement with Ajinomoto provides for research and development funding through October 2009 and gives Ajinomoto the right to terminate the agreement without cause provided that it pay additional specified research funding if it terminates the agreement prior to October 5, 2009. Our agreement with Solae provides for discovery and development funding through April 2010, and gives Solae the right to terminate the agreement without cause on April 23, 2008 upon 60 days’ prior notice, or subsequent to April 23, 2008 upon 90 days’ prior notice provided it pay additional specified research funding if it terminates the agreement prior to April 23, 2010. If any or all of our material agreements with our collaborators expire or are terminated, our revenue could significantly decline and if all of our agreements expire or are terminated, our revenue would be substantially eliminated, which would have a material adverse effect on our business, financial condition and results of operations. Our collaborators may not renew their agreements with us or, if they do, they may not be on terms that are as favorable to us as our current agreements.

 

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Our current collaboration agreements provide that we will receive royalties of up to 4% on our collaborators’ sales of retail and food service products, and up to 5% on our collaborators’ sales of ingredient supplies containing our flavor ingredients. The actual royalties payable vary by agreement and depend on a number of factors including, for example, the product field, cost of goods savings, degree of flavor enhancement and sales volume of collaborator products incorporating our flavor ingredients. It is possible that our collaborators will not incorporate our flavor ingredients into any or all of their products within their exclusive or co-exclusive product fields.

 

We are dependent on our current and any other possible future collaborators to commercialize any flavor ingredients that we successfully develop and to provide the sales, marketing and distribution capabilities required for the success of our business. We have limited or no control over the amount and timing of resources that our current or any future collaborators may devote to our programs or potential products. Our collaborators may decide not to devote the necessary resources to the commercialization of our flavor ingredients, or may pursue a competitor’s product if our flavor ingredients do not have the characteristics desired by the collaborator. These characteristics include, among other things, enhancement properties, temperature stability, solubility, taste and cost. If these collaborators fail to conduct their commercialization, sales and marketing or distribution activities successfully and in a timely manner, we will earn little or no royalty revenues from our flavor ingredients and we will not be able to achieve our objectives or build a sustainable or profitable business.

 

Our present and any future product discovery and development collaboration opportunities could be harmed if:

 

      our existing or any future collaborators terminate their collaboration agreements with us prior to the expiration of the agreements;

      we do not achieve our research and development objectives under our collaboration agreements prior to the termination of the collaboration periods;

      we disagree with our collaborators as to the parties’ respective licensing rights to our flavor ingredients, methods or other intellectual property we develop;

      we are unable to manage multiple simultaneous collaborations;

      potential collaborators fail to spend their resources on research and development or commercialization of our flavor ingredients due to general market conditions or for any other reason; or

      consolidation in our target markets limits the number of potential collaborators.

 

We may not be able to negotiate additional collaboration agreements having terms satisfactory to us or at all.

 

We may not be able to enter into additional product discovery and development collaborations due to the exclusive nature of our current product discovery and development collaborations. Each of our current collaboration agreements provides that we will conduct research and development on flavor ingredients for use within one or more defined packaged food and beverage product fields on an exclusive or co-exclusive basis for the respective collaborator during the collaborative period specified in the agreement. Because each of these agreements is exclusive or co-exclusive, we will not be able to enter into a collaboration agreement with any other food and beverage company covering the same product field during the applicable collaborative period. In addition, our collaborators’ competitors may not wish to do business with us at all due to our relationship with our collaborators. If we are unable to enter into additional product discovery and development collaborations, our ability to sustain or expand our business will be significantly diminished.

 

We may not be successful in developing flavor ingredients useful for formulation into products.

 

We may not succeed in developing flavor ingredients with the appropriate attributes required for use in successful commercial products. Successful flavor ingredients require, among other things, appropriate biological activity, including the correct taste property for the product application, an acceptable safety profile, including lack of toxicity or allergenicity, and appropriate physical or chemical properties, including relative levels of stability, volatility and resistance to heat. Successful flavor ingredients must also be cost-efficient for our collaborators. We may not be able to develop flavor ingredients that meet these criteria.

 

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If we or our collaborators are unable to obtain and maintain the GRAS determination or other regulatory approval required before certain of our flavor ingredients can be incorporated into products that are sold, we would be unable to commercialize our flavor ingredients and our business would be adversely affected.*

 

In March 2005, we obtained a Generally Recognized as Safe, or GRAS, determination for four of our savory flavor ingredients. Apart from these flavor ingredients, we do not have GRAS determination or other regulatory approval for any other flavor ingredient at this time. In the United States, the development, sale and incorporation of our flavor ingredients into products are subject to regulation by the Food and Drug Administration, or FDA, and in some instances other government bodies. Obtaining and maintaining a GRAS determination or other regulatory approval can be costly and take many years.

 

Depending on the amount or intended use of a particular flavor ingredient added to a product and the number of product categories in which the flavor ingredient will be incorporated, specific safety assessment protocols and regulatory processes must be satisfied before we or our collaborators can commercially market and sell products containing any flavor ingredients that we may discover. A key element of our strategy is to develop flavor ingredients that may be subject to review under the Flavor and Extract Manufacturers Association, or FEMA, GRAS process. In our experience with the savory program, safety studies, preparation and FEMA GRAS review took approximately 12 months and cost less than $1 million. This experience may not be representative of the timing and cost for future programs. This approach is less expensive than the alternative of filing a food additive petition with the FDA, approval of which can take up to four years. The FEMA GRAS process may take longer than 12 months and cost more than $1 million depending on the properties of the flavor ingredient, and if additional safety studies are requested by the FEMA Expert Panel or are necessary to explain unexpected safety study findings. There is a risk that one or more of our product candidates for which we seek FEMA GRAS determination may not qualify for a FEMA GRAS determination. This may occur for a variety of reasons, including the flavor ingredient’s intended use, the amount of the flavor ingredient intended to be added to packaged foods and beverages, the number of product categories in which the flavor ingredient will be incorporated, whether the flavor ingredient imparts sweetness, the safety profile of the flavor ingredient and the FEMA Expert Panel’s interpretation of the safety data. Even if we obtain a GRAS determination with respect to a flavor ingredient, the FDA has the ability to challenge such determination, which could materially adversely affect our ability to market products on schedule or at all. In the event that a particular flavor ingredient does not qualify for FEMA GRAS determination, we could be required to pursue a lengthy FDA approval process or dedicate our development efforts to alternative ingredients, which would further delay commercialization. In addition, laws, regulations or FDA practice governing the regulatory approval process, the availability of the GRAS determination process or the manufacture or labeling of such products, may change in a manner that could adversely affect our ability to commercialize products on schedule or at all.

 

Sales of our flavor ingredients outside of the United States will be subject to foreign regulatory requirements. In most cases, whether or not a GRAS determination has been obtained, approval of a product by the comparable regulatory authorities of foreign countries must still be obtained prior to manufacturing or marketing the product in those countries. A GRAS determination in the United States or in any other jurisdiction does not ensure approval in other jurisdictions because the requirements from jurisdiction to jurisdiction may vary widely. Obtaining foreign approvals could result in significant delays, difficulties and costs for us and require additional safety studies and additional expenses. If we fail to comply with these regulatory requirements or to obtain and maintain required approvals, our ability to generate revenue will be diminished.

 

We and our collaborators may not be successful in overcoming these regulatory hurdles, which could result in product launch delays, unanticipated expenses, termination of collaborations and flavor ingredients not being approved for incorporation into consumer products. These consequences would have a material adverse effect on our business financial condition and results of operations.

 

If we or our collaborators are unable to obtain and maintain the regulatory approval required before any high potency sweeteners can be incorporated into products that are sold, we would be unable to commercialize our high potency sweeteners and our business would be adversely affected.*

 

In the United States, the development, sale and incorporation of our high potency sweeteners into products are subject to regulation by the FDA and in some instances other government bodies. Obtaining and maintaining regulatory approval can be costly and take many years.

 

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Depending on the amount or intended use of a particular high potency sweetener added to a product and the number of product categories in which the high potency sweetener will be incorporated, specific safety assessment protocols and regulatory processes must be satisfied before we or our collaborators can commercially market and sell products containing any high potency sweeteners that we may discover. An element of our strategy is to develop high potency sweeteners that may be subject to review under the Food Additive Petition process, which encompasses filing a food additive petition with the FDA, approval of which can take up to four years or more and may cost up to $7 million or more. Government resource constraints may also slow the review and approval process. In addition, laws, regulations or FDA practice governing the regulatory approval process, the availability of the Food Additive Petition process or the manufacture or labeling of such products, may change in a manner that could adversely affect our ability to commercialize products on schedule or at all.

 

Sales of our high potency sweeteners outside of the United States will be subject to foreign regulatory requirements. In most cases, whether or not FDA approval has been obtained, approval of a product by the comparable regulatory authorities of foreign countries must still be obtained prior to manufacturing or marketing the product in those countries. FDA approval in the United States or regulatory approval in any other jurisdiction does not ensure similar approval in other jurisdictions because the requirements from jurisdiction to jurisdiction may vary widely. Obtaining foreign approvals could result in significant delays, difficulties and costs for us and require additional safety studies and additional expenses. If we fail to comply with these regulatory requirements or to obtain and maintain required approvals, our ability to generate revenue will be diminished.

 

We and our collaborators may not be successful in overcoming these regulatory hurdles, which could result in product launch delays, unanticipated expenses, termination of collaborations and high potency sweeteners not being approved for incorporation into consumer products. These consequences would have a material adverse effect on our business financial condition and results of operations.

 

Even if we or our collaborators receive regulatory approval and incorporate our flavor ingredients into products, those products may never be commercially successful.

 

Even if we discover and develop flavor ingredients that obtain the necessary GRAS determination or other regulatory approval, our success depends to a significant degree upon the commercial success of packaged food and beverage products incorporating those flavor ingredients. If these products fail to achieve or subsequently maintain market acceptance or commercial viability, our business would be significantly harmed because our royalty revenue is dependent upon consumer sales of these products. In addition, we could be unable to maintain our existing collaborations or attract new product discovery and development collaborators. Many factors may affect the market acceptance and commercial success of any potential products incorporating flavor ingredients that we may discover, including:

 

      health concerns, whether actual or perceived, or unfavorable publicity regarding our flavor ingredients or those of our competitors;

      the timing of market entry as compared to competitive products;

      the rate of adoption of products by our collaborators and other companies in the flavor industry; and

      any product labeling that may be required by the FDA or other United States or foreign regulatory agencies for products incorporating our flavor ingredients.

 

We have a history of operating losses and we may not achieve or maintain profitability.*

 

We have not been profitable and have generated substantial operating losses since we were incorporated in September 1998. We incurred net losses of approximately $17.2 million for the nine months ended September 30, 2007. As of September 30, 2007, we had an accumulated deficit of approximately $144.5 million. We expect to incur additional losses for at least the next two years. The extent of our future losses will depend, in part, on the rate of increase in our operating expenses and the rate of growth, if any, in our revenue from our existing and any future product discovery and development collaborations as well as from other sources that may become available to us in the future and on the level of our expenses. To date, our revenue has come solely from research and development funding, upfront fees, cost reimbursement and milestone payments under our product discovery and development collaboration agreements with Ajinomoto, Cadbury, Campbell, Coca-Cola, Kraft Foods, Nestlé and Solae. In order for us to generate royalty revenue and become profitable, we must substantially retain our existing product discovery and development collaborations and our collaborators must commercialize products incorporating one or more of our flavor ingredients, from which we can derive royalty revenues. Our ability to generate royalty revenue is uncertain and will depend upon our ability to meet particular research, development and commercialization objectives.

 

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We expect that our results of operations will fluctuate from period to period, and this fluctuation could cause our stock price to decline.

 

Our operating results have fluctuated in the past and are likely to vary significantly in the future based upon a number of factors, many of which we have little or no control over. We operate in a highly dynamic industry and future results could be subject to significant fluctuations. These fluctuations could cause us to fail to meet or exceed financial expectations of securities analysts or investors, which could cause our stock price to decline rapidly and significantly. Revenue and expenses in future periods may be greater or less than revenue and expenses in the immediately preceding period or in the comparable period of the prior year. Therefore, period-to-period comparisons of our operating results are not necessarily a good indication of our future performance. Some of the factors that could cause our operating results to fluctuate include:

 

      termination of any of our product discovery and development collaboration agreements;

      our ability to discover and develop flavor ingredients or the ability of our product discovery and development collaborators to incorporate them into packaged food and beverage products;

      our receipt of milestone payments in any particular period;

      the ability and willingness of collaborators to commercialize products incorporating our flavor ingredients on expected timelines, or at all;

      our ability to enter into new product discovery and development collaborations and technology collaborations or to extend the terms of our existing collaboration agreements and our payment obligations, expected revenue and other terms of any other agreements of this type;

      our ability, or our collaborators’ ability, to successfully satisfy all pertinent regulatory requirements;

      the demand for our collaborators’ products containing our flavor ingredients; and

      general and industry specific economic conditions, which may affect our collaborators’ research and development expenditures.

 

Changes in financial accounting standards related to stock-based compensation expenses have had and are expected to have a significant effect on our reported results.*

 

On January 1, 2006 we adopted SFAS No. 123R, which requires that we record compensation expense in the statement of operations for stock-based payments, such as employee stock options, using the fair value method. The adoption of the standard is expected to continue to have a significant effect on our reported earnings, although it will not affect our cash flows, and could adversely impact our ability to provide accurate guidance on our projected future financial results due to the variability of the factors used to establish the value of stock options. If factors change and we employ different assumptions or different valuation methods in the application of SFAS No. 123R in future periods, the compensation expense that we record under SFAS No. 123R may differ significantly from what we have recorded in the current period, which could negatively affect our stock price and our stock price volatility.

 

Compliance with regulation of corporate governance and public disclosure may result in additional expenses.

 

Laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, SEC regulations and NASDAQ Stock Market rules, are costly to comply with. Our efforts to comply with these laws, regulations and standards have resulted in, and are likely to continue to result in, general and administrative expense and management time related to compliance activities. In particular, our efforts to comply with Section 404 of the Sarbanes-Oxley Act of 2002 and the related regulations regarding our required assessment of our internal controls over financial reporting and our external auditors’ audit of that assessment requires the commitment of significant financial and managerial resources. If our efforts to comply with laws, regulations and standards differ from the activities intended by regulatory or governing bodies, our reputation may be harmed and we might be subject to sanctions or investigation by regulatory authorities, such as the SEC. Any such action could adversely affect our financial results and the market price of our common stock.

 

We may need to obtain additional capital to fund our operations.

 

If we are unable to successfully commercialize our flavor ingredients, we may need to obtain additional capital or change our strategy to continue our operations. In addition, our business and operations may change in a manner that would consume available resources at a greater rate than anticipated. In such event, we may need to raise substantial additional capital to, among other things:

 

      fund new research, discovery or development programs;

      advance additional product candidates into and through the regulatory approval process; and

      acquire rights to products or product candidates, technologies or businesses.

 

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If we require additional capital to continue our operations, we cannot assure you that additional financing will be available on terms acceptable to us, or at all. If adequate funds are not available or are not available on acceptable terms, our ability to fund our operations, take advantage of opportunities, identify and develop flavor ingredients, develop technologies or otherwise respond to competitive pressures could be significantly limited. In addition, if financing is not available, we may need to alter our strategy or cease operations. In addition, issuances of debt or additional equity could impact the rights of the holders of our common stock, may dilute our stockholders’ ownership and may impose restrictions on our operations. These restrictions could include limitations on additional borrowing, specific restrictions on the use of our assets as well as prohibitions on our ability to create liens, pay dividends, redeem our stock or make investments.

 

If we lose our key personnel or are unable to attract and retain qualified personnel, it could adversely affect our business.*

 

Our success depends to a significant degree upon the continued contributions of our executive officers, management and scientific staff. If we lose the services of one or more of these people and, in particular, Kent Snyder, our President and Chief Executive Officer, or Mark Zoller, Ph.D., our Executive Vice President of Discovery & Development and Chief Scientific Officer, the relationships we have with our collaborators would likely be negatively impacted and we may be delayed or unable to develop new product candidates, commercialize our existing product candidates or achieve our other business objectives, any of which could cause our stock price to decline. We have entered into employment letter agreements with the following executive officers: Kent Snyder, Mark Zoller, Ph.D., John Poyhonen, our Senior Vice President, Chief Financial and Business Officer and Sharon Wicker, our Senior Vice President and Chief Strategy Officer. All of our employees are at-will employees, which means that either we or the employee may terminate their employment at any time. We currently have no key person insurance.

 

In addition, our discovery and development programs depend on our ability to attract and retain highly skilled scientists, including molecular biologists, biochemists, chemists and engineers. We may not be able to attract or retain qualified employees in the future due to the intense competition for qualified personnel among technology-based businesses, particularly in the San Diego area. We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific and management personnel. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will adversely affect our ability to meet the demands of our current or any future product discovery and development collaborators in a timely fashion or to support our independent discovery and development programs.

 

We may encounter difficulties managing our growth, which could adversely affect our business.*

 

Our strategy includes entering into and working on simultaneous flavor ingredient discovery and development programs across multiple markets. We increased the number of our full-time employees from seven on December 31, 1999 to 116 on September 30, 2007 and we expect to continue to grow to meet our strategic objectives. If our growth continues, it will continue to place a strain on us, our management and our resources. Our ability to effectively manage our operations, growth and various projects requires us to continue to improve our operational, financial and management controls, reporting systems and procedures and to attract and retain sufficient numbers of talented employees. We may not be able to successfully implement these tasks on a larger scale and, accordingly, we may not achieve our research, development and commercialization goals. If we fail to improve our operational, financial and management information systems, or fail to effectively monitor or manage our new and future employees or our growth, our business would suffer significantly. In addition, no assurance can be made that we will be able to maintain adequate facilities to house our staff, conduct our research or achieve our business objectives.

 

We will rely on third parties to manufacture our flavor ingredients on a commercial scale.*

 

We do not have experience in manufacturing, nor do we have the resources or facilities to manufacture, flavor ingredients on a commercial scale. Therefore, the commercialization of our flavor ingredients will depend in part on our or our collaborators’ ability to contract with third-party manufacturers of our flavor ingredients on a large scale, at a competitive cost, with the specified quality and in accordance with relevant food and beverage regulatory requirements. Any such third-party manufacturers may encounter manufacturing difficulties at any time that could result in delays in the commercialization of potential flavor ingredients. Our inability to find capable third-party manufacturers or to enter into agreements on acceptable terms with third-party manufacturers could delay commercialization of any products we may develop and may harm our relationships with our existing and any future product discovery and development collaborators and our customers. Moreover, if we are required to change from one third-party manufacturer to another for any reason, the commercialization of our products may be delayed further. In addition, if third-party manufacturers fail to comply with the FDA’s good manufacturing practice regulations or similar regulations in other countries, then we may be subject to adverse regulatory action including product recalls, warning letters and withdrawal of our products, or our collaborators’ or customers’ products, from the market.

 

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Further, because our flavor ingredients are regulated as food products under the Federal Food, Drug and Cosmetic Act, or FD&C Act, we and the third parties with which we collaborate or contract to manufacture, process, pack, import or otherwise handle our products or our product ingredients, may be required to comply with certain registration, prior notice submission, recordkeeping and other regulatory requirements. Failure of any party in the chain of distribution to comply with any applicable requirements under the FD&C Act or the FDA’s implementing regulations, or similar regulations in other countries, may adversely affect the manufacture and/or distribution of our products in commerce.

 

If we acquire products, technologies or other businesses, we will incur a variety of costs, may have integration difficulties and may experience numerous other risks that could adversely affect our business.

 

If appropriate opportunities become available, we may consider acquiring businesses, technologies or products that we believe are a strategic fit with our business. We currently have no commitments or agreements with respect to, and are not actively seeking, any material acquisitions. We have limited experience in identifying acquisition targets, successfully acquiring them and integrating them into our current infrastructure. We may not be able to successfully integrate any businesses, products, technologies or personnel that we might acquire in the future without a significant expenditure of operating, financial and management resources, if at all. In addition, future acquisitions might be funded by issuances of additional debt or equity, which could impact your rights as a holder of our common stock and may dilute your ownership percentage. Any of the foregoing could have a significant adverse effect on our business, financial condition and results of operations.

 

Risks Related To Our Industry

 

Our ability to compete in the flavor ingredient market may decline if we do not adequately protect our proprietary technologies.

 

Our success depends in part on our ability to obtain and maintain intellectual property that protects our technologies and flavor ingredients. Patent positions may be highly uncertain and may involve complex legal and factual questions, including the ability to establish patentability of sequences relating to taste receptors, proteins, chemical synthesis techniques, compounds and methods for using them to modulate taste for which we seek patent protection. No consistent standard regarding the allowability or enforceability of claims in many of our pending patent applications has emerged to date. As a result, we cannot predict the breadth of claims that will ultimately be allowed in our patent applications, if any, including those we have in-licensed or the extent to which we may enforce these claims against our competitors. The degree of future protection for our proprietary rights is therefore highly uncertain and we cannot assure you that:

 

      we were the first to file patent applications or to invent the subject matter claimed in patent applications relating to the technologies upon which we rely;

      others will not independently develop similar or alternative technologies or duplicate any of our technologies;

      others did not publicly disclose our claimed technology before we conceived the subject matter included in any of our patent applications;

      any of our patent applications will result in issued patents;

      any of our patent applications will not result in interferences or disputes with third parties regarding priority of invention;

      any patents that have issued or may be issued to us, our collaborators or our licensors will provide a basis for commercially viable products or will provide us with any competitive advantages or will not be challenged by third parties;

      we will develop additional proprietary technologies that are patentable;

      the patents of others will not have an adverse effect on our ability to do business; or

      new proprietary technologies from third parties, including existing licensors, will be available for licensing to us on reasonable commercial terms, if at all.

 

In addition, patent law outside the United States is uncertain and in many countries intellectual property laws are undergoing review and revision. The laws of some countries do not protect intellectual property rights to the same extent as domestic laws. It may be necessary or useful for us to participate in opposition proceedings to determine the validity of our competitors’ patents or to defend the validity of any of our or our licensors’ future patents, which could result in substantial costs and would divert our efforts and attention from other aspects of our business.

 

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Technologies licensed to us by others, or in-licensed technologies, are important to our business. In particular, we depend on high-throughput screening technologies that we licensed from Aurora Biosciences, technology related to certain taste receptor sequences that we license from the University of California and others and technology related to compound libraries that we license from third parties. In addition, we may in the future acquire rights to additional technologies by licensing such rights from existing licensors or from third parties. Such in-licenses may be costly. Also, we generally do not control the patent prosecution, maintenance or enforcement of in-licensed technologies. Accordingly, we are unable to exercise the same degree of control over this intellectual property as we do over our internally developed technologies. Moreover, some of our academic institution licensors, collaborators and scientific advisors have rights to publish data and information to which we have rights. If we cannot maintain the confidentiality of our technologies and other confidential information in connection with our collaborations, our ability to protect our proprietary information or obtain patent protection in the future may be impaired, which could have a significant adverse effect on our business, financial condition and results of operations.

 

Many of the patent applications we and our licensors have filed have not yet been substantively examined and may not result in patents being issued.*

 

Many of the patent applications filed by us and our licensors were filed recently with the United States Patent and Trademark Office and most have not been substantively examined and may not result in patents being issued. Some of these patent applications claim sequences that were identified from different publicly available sequence information sources such as the High-Throughput Genomic Sequences division of GenBank. It is difficult to predict whether any of our or our licensors’ applications will ultimately be found to be patentable or, if so, to predict the scope of any allowed claims. In addition, the disclosure in our or our licensors’ patent applications, particularly in respect of the utility of our claimed inventions, may not be sufficient to meet the statutory requirements for patentability in all cases. Furthermore, recent changes in rules promulgated by the United States Patent and Trademark Office may adversely affect the patentability of our and our licensors’ patent applications. As a result, it is difficult to predict whether any of our or our licensors’ applications will be allowed, or, if so, to predict the scope of any allowed claims or the enforceability of the patents. Even if enforceable, others may be able to design around any patents or develop similar technologies that are not within the scope of such patents. Our and our licensors’ patent applications may not issue as patents that will provide us with any protection or competitive advantage.

 

Disputes concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and extremely costly and could delay our research and development efforts.*

 

Our commercial success, if any, will be significantly harmed if we infringe the patent rights of third parties or if we breach any license or other agreements that we have entered into with regard to our technology or business.

 

We are aware of other companies and academic institutions that have been performing research in the areas of taste modulation and flavor ingredients. In particular, other companies and academic institutions have announced that they have conducted taste-receptor or ion channel research and have published data on taste receptor sequence information and taste receptors or filed patent applications or obtained patent protection on taste modulation or taste receptors and their uses, including Ajinomoto, Cargill, Duke University, Firmenich, the German Institute of Human Nutrition, Givaudan SA, International Flavors & Fragrances Inc., Johannes Gutenberg University, Monell Chemical Senses Corp., Mount Sinai School of Medicine, Nestlé, NutraSweet, Pfizer, Inc., Redpoint Bio, Symrise, Tate & Lyle, The Scripps Research Institute, Unilever, and the University of California. To the extent any of these companies or academic institutions currently have, or obtain in the future, broad patent claims, such patents could block our ability to use various aspects of our discovery and development process and might prevent us from developing or commercializing newly discovered flavor ingredients or otherwise conducting our business. The University of California, for example, claims certain patent rights relating to the coexpression of T1R receptors that may not have been licensed to us. While our technology is focused on the use of human T1R receptors, we cannot assure you that it does not infringe such patent rights.  In such event, if we are not able to amend our license with the University of California to include such patent rights and our technology is found to interfere with or infringe such patent rights, our business, financial condition and results of operations could suffer a significant adverse effect. In addition, it is possible that some of the flavor ingredients that are discovered using our technology may not be patentable or may be covered by intellectual property of third parties.

 

We are not currently a party to any litigation, interference, opposition, protest, reexamination, reissue or any other potentially adverse governmental, ex parte or inter-party proceeding with regard to our patent or trademark positions.  However, the life sciences and other technology industries are characterized by extensive litigation regarding patents and other intellectual property rights. Many life sciences and other technology companies have employed intellectual property litigation as a way to gain a competitive advantage. If we become involved in litigation, interference proceedings,

 

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oppositions, reexamination, protest or other potentially adverse intellectual property proceedings as a result of alleged infringement by us of the rights of others or as a result of priority of invention disputes with third parties, we might have to spend significant amounts of money, time and effort defending our position and we may not be successful. In addition, any claims relating to the infringement of third-party proprietary rights or proprietary determinations, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources, or require us to enter into royalty or license agreements that are not advantageous to us.

 

Should any person have filed patent applications or obtained patents that claim inventions also claimed by us, we may have to participate in an interference proceeding declared by the relevant patent regulatory agency to determine priority of invention and, thus, the right to a patent for these inventions in the United States. Such a proceeding could result in substantial cost to us even if the outcome is favorable. Even if successful on priority grounds, an interference action may result in loss of claims based on patentability grounds raised in the interference action. Litigation, interference proceedings or other proceedings could divert management’s time and efforts. Even unsuccessful claims could result in significant legal fees and other expenses, diversion of management’s time and disruption in our business. Uncertainties resulting from initiation and continuation of any patent proceeding or related litigation could harm our ability to compete and could have a significant adverse effect on our business, financial condition and results of operations.

 

An adverse ruling arising out of any intellectual property dispute, including an adverse decision as to the priority of our inventions, could undercut or invalidate our intellectual property position. An adverse ruling could also subject us to significant liability for damages, including possible treble damages, prevent us from using technologies or developing products, or require us to negotiate licenses to disputed rights from third parties. Although patent and intellectual property disputes in the technology area are often settled through licensing or similar arrangements, costs associated with these arrangements may be substantial and could include license fees and ongoing royalties. Furthermore, necessary licenses may not be available to us on satisfactory terms, if at all. Failure to obtain a license in such a case could have a significant adverse effect on our business, financial condition and results of operations.

 

If we are unable to protect our trade secrets and other proprietary information, we could lose any competitive advantage we may have, which could adversely affect our business.

 

We rely in part on trade secret protection for our confidential and proprietary information, know how and processes. Our policy is to execute proprietary information and invention agreements with our employees and consultants upon the commencement of an employment or consulting relationship. These agreements generally require that all confidential information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not be disclosed to third parties. These agreements also generally provide that inventions conceived by the individual in the course of their employment shall be our exclusive property. There can be no assurance that we will be able to effectively enforce these agreements or that proprietary information is our exclusive property. There can be no assurance that the subject proprietary information will not be disclosed, that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or that we can meaningfully protect our trade secrets. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

 

Many potential competitors, including those who have greater resources and experience than we do, may develop products or technologies that make ours obsolete or noncompetitive.*

 

The life sciences and other technology industries are characterized by rapid technological change, and the area of sensory or taste receptor research is a rapidly evolving field. Our future success will depend on our ability to maintain a competitive position with respect to technological advances. Technological developments by others may result in our flavor ingredients and technologies becoming obsolete.

 

In particular, we face substantial competition from companies pursuing the commercialization of products and services relevant to taste using more traditional methods for the discovery of flavor ingredients, or for the reduction of salt, sugar, monosodium glutamate, or MSG, or bitter taste. These competitors include leading flavor companies, such as Firmenich, Givaudan SA, International Flavors & Fragrances Inc. and Symrise. We currently compete and will continue to compete in the future with these companies in collaborating with and selling flavor products and technologies to manufacturers of packaged food and beverage products. Many of these companies have substantially greater capital resources, research and development resources and experience, manufacturing capabilities, regulatory expertise, sales and marketing resources, established relationships with consumer products companies and production facilities.

 

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Savory flavor enhancers, particularly inosine monophosphate, or IMP, are commercially available, and we will compete with the companies that produce these flavors. IMP is widely available and is a generally accepted food additive by the packaged food and beverage industry. As a result, our existing and future collaborators may choose to incorporate IMP or similar savory flavor enhancers into their packaged food and beverage products instead of our savory flavor ingredients.  In addition, we may compete with bitter masking or bitter blocking compounds, such as adenosine 5’ monophosphate, or AMP.

 

We may in the future face competition from life sciences and other technology companies and other commercial enterprises. These entities engage as we do in biotechnology, biology or chemistry research and could apply this technology to the discovery and development of flavor ingredients. We are aware of one other company, Redpoint Bio,, that is involved in research on sweetness potentiators, salt substitutes and bitter blockers, specifically AMP. We cannot guarantee that products developed as a result of our competitors’ existing or future collaborations will not compete with our flavor ingredients.

 

Universities and public and private research institutions are also potential competitors. While these organizations primarily have educational objectives, they may develop proprietary technologies related to the sense of taste or secure patent protection that we may need for the development of our technologies and products. We may attempt to license these proprietary technologies, but these licenses may not be available to us on acceptable terms, if at all.

 

Our competitors, either alone or with their collaborative partners, may succeed in developing technologies or discovering flavor ingredients that are more effective, safer, more affordable or more easily commercialized than ours, and our competitors may obtain intellectual property protection or commercialize products sooner than we do. Developments by others may render our product candidates or our technologies obsolete. In addition, our current product discovery and development collaborators are not prohibited from entering into research and development collaboration agreements with third parties in any product field. Our failure to compete effectively would have a significant adverse effect on our business, financial condition and results of operations.

 

We may be sued for product liability, which could adversely affect our business.*

 

Because our business strategy involves the development and sale by our collaborators of commercial products incorporating our flavor ingredients, we may be sued for product liability. We may be held liable if any product we develop and commercialize, or any product our collaborators commercialize that incorporates any of our flavor ingredients, causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or consumer use. In addition, the safety studies we must perform and the regulatory approvals we must obtain prior to incorporating our flavor ingredients into a commercial product will not protect us from any such liability.

 

Our product liability insurance may not fully cover our potential liabilities associated with the sale of commercial products incorporating any of our flavor ingredients. Inability to obtain sufficient insurance coverage to protect against potential product liability claims could prevent or inhibit the commercialization of products developed by us or our product discovery and development collaborators. We may be obligated to indemnify our product discovery and development collaborators for product liability or other losses they incur as a result of our flavor ingredients. Any indemnification we receive from such collaborators for product liability that does not arise from our flavor ingredients may not be sufficient to satisfy our liability to injured parties. If we are sued for any injury caused by our flavor ingredients or products incorporating our flavor ingredients, our liability could exceed our total assets.

 

We use hazardous materials. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.

 

Our discovery and development process requires our employees to routinely handle hazardous chemical, radioactive and biological materials. Our operations also produce hazardous waste products. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of these materials. As a result of the increase in size of our operations, we are now classified as a large quantity generator of hazardous waste. This classification may result in increased scrutiny of our operations by the Environmental Protection Agency. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental regulations may impair our discovery and development efforts.

 

In addition, we cannot entirely eliminate the risk of accidental contamination or discharge and any resultant injury from these materials. Our insurance policies have limited coverage for damages or cleanup costs related to hazardous waste disposal or contamination. We may be forced to curtail operations or be sued for any injury or contamination that results from our use or the use by others of these materials, and our liability may exceed our total assets.

 

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Risks Related To Our Common Stock

 

The price of our common stock is volatile.

 

The market prices for securities of biotechnology companies historically have been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. Since our initial public offering in June 2004, the price of our common stock has ranged from approximately $5 per share to approximately $23 per share. The market price of our common stock may fluctuate in response to many factors, including:

 

      developments concerning our collaborative agreements;

      delays in commercialization of our flavor ingredients;

      results of safety evaluation of our flavor ingredients;

      developments related to the United States and international regulatory approval of our products;

      results of consumer acceptance testing of our flavor ingredients by our collaborators;

      announcements of technological innovations by us or others;

      developments in patent or other proprietary rights;

      future sales of our common stock by existing stockholders;

      comments by securities analysts;

      general market conditions;

      fluctuations in our operating results;

      government regulation;

      failure of any of our flavor ingredients, if approved, to achieve commercial success; and

      public concern as to the safety of our flavor ingredients.

 

Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us more complicated and the removal and replacement of our directors and management more difficult.

 

Provisions of our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders. These provisions may also make it difficult for stockholders to remove and replace our board of directors and management. These provisions:

 

      authorize the issuance of “blank check” preferred stock by our board of directors, without stockholder approval, which could increase the number of outstanding shares and prevent or delay a takeover attempt;

      limit who may call a special meeting of stockholders;

      prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and

      establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.

 

In addition, the requirements of Section 203 of the Delaware General Corporation Law may discourage, delay or prevent a third party from acquiring us.

 

Our shareholder rights plan may hinder or prevent change of control transactions.

 

Our shareholder rights plans may discourage transactions involving an actual or potential change in our ownership. In addition, our board of directors may issue shares of preferred stock without any further action by you. Such issuances may have the effect of delaying or preventing a change in our ownership. If changes in our ownership are discouraged, delayed or prevented, it would be more difficult for our current board of directors to be removed and replaced, even if you and other stockholders believe such actions are in the best interests of us and our stockholders.

 

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We have never paid cash dividends on our capital stock and we do not anticipate paying dividends in the foreseeable future.

 

We have paid no cash dividends on any of our classes of capital stock to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of any future debt or credit facility may preclude us from paying any dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of potential gain for the foreseeable future.

 

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ITEM 6.  EXHIBITS

 

Exhibit
Number

 

Description of Document

 

 

 

3.1

 

Amended and Restated Certificate of Incorporation as currently in effect (filed as Exhibit 3.1 to Registration Statement File No. 333-113998).

 

 

 

3.2

 

Amended and Restated Bylaws as currently in effect (filed as Exhibit 3.2 to Registration Statement File No. 333-113998).

 

 

 

3.3

 

Certificate of Designation of Series A Junior Participating Preferred Stock, as filed with the Secretary of State of Delaware on February 14, 2005 (filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the SEC on February 15, 2005).

 

 

 

4.1

 

Form of Common Stock Certificate (filed as Exhibit 4.1 to Registration Statement File No. 333-113998).

 

 

 

4.2

 

Form of Rights Certificate (filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the SEC on February 15, 2005).

 

 

 

4.3

 

Rights Agreement, dated February 14, 2005 by and between Senomyx, Inc. and Mellon Investor Services LLP (filed as Exhibit 4.2 to our Current Report on Form 8-K filed with the SEC on February 15, 2005).

 

 

 

10.1*

 

Sixth Amendment dated July 18, 2007 to the Collaborative Research and License Agreement dated December 6, 2000, as amended May 2, 2002, April 29, 2005, July 29, 2005, December 9, 2005 and October 29, 2006 between Senomyx, Inc. and Kraft Foods.

 

 

 

10.2*

 

Third Amendment dated August 1, 2007 to the Collaborative Research, Development, Commercialization and License Agreement dated March 23, 2006 between Senomyx, Inc. and Ajinomoto Co., Inc.

 

 

 

31.1

 

Certification of Kent Snyder, Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2

 

Certification of John Poyhonen, Chief Financial and Business Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1

 

Certification of Kent Snyder, Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.2

 

Certification of John Poyhonen, Chief Financial and Business Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 


*              Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.

 

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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.

 

 

Senomyx, Inc.

 

 

Date: November 2, 2007

By:

/S/ KENT SNYDER

 

 

Kent Snyder
President and Chief Executive Officer
(on behalf of the registrant and as the
registrant’s Principal Executive Officer)

 

 

 

 

By:

/S/ JOHN POYHONEN

 

 

John Poyhonen
Senior Vice President and Chief Financial and Business Officer
(on behalf of the registrant and as the
registrant’s Principal Financial and Accounting Officer)

 

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