ArQule, Inc.
ARQULE INC (Form: 10-Q, Received: 08/07/2009 11:05:58)

Table of Contents

 

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

 

FORM 10-Q

 

Quarterly report pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

 

For the Quarter Ended June 30, 2009

 

Commission File No. 000-21429

 

ArQule, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

04-3221586

(State of Incorporation)

 

(I.R.S. Employer Identification Number)

 

19 Presidential Way, Woburn, Massachusetts 01801

(Address of Principal Executive Offices)

 

(781) 994-0300

(Registrant’s Telephone Number, including Area Code)

 

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 Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.       Yes  x   No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

Yes  o   No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer o

 

Accelerated filer  x

 

 

 

Non-accelerated filer o

 

Smaller reporting company  o

(Do not check if a smaller reporting company)

 

 

 

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

 

Number of shares outstanding of the registrant’s Common Stock as of July 31, 2009:

 

Common Stock, par value $.01

 

44,675,365 shares outstanding

 

 

 

 



Table of Contents

 

ARQULE, INC.

 

QUARTER ENDED JUNE 30, 2009

 

TABLE OF CONTENTS

 

PART I - FINANCIAL INFORMATION

 

 

 

Item 1. – Unaudited Condensed Consolidated Financial Statements

 

 

 

 

 

Condensed Consolidated Balance Sheets (Unaudited) June 30, 2009 and December 31, 2008

3

 

 

 

 

Condensed Consolidated Statements of Operations (Unaudited) Three and six months ended June 30, 2009 and 2008

4

 

 

 

 

Condensed Consolidated Statements of Cash Flows (Unaudited) Six months ended June 30, 2009 and 2008

5

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

 

 

 

Item 2. – Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

 

 

Item 3. – Quantitative and Qualitative Disclosures about Market Risk

24

 

 

Item 4. – Controls and Procedures

25

 

 

PART II - OTHER INFORMATION

 

 

 

Item 1. – Legal Proceedings

25

 

 

Item 1A. – Risk Factors

25

 

 

Item 2. – Changes in Securities and Use of Proceeds

25

 

 

Item 3. – Defaults Upon Senior Securities

25

 

 

Item 4. – Submission of Matters to a Vote of Security Holders

25

 

 

Item 6. – Exhibits

26

 

 

SIGNATURES

 

 

 

EX-31.1 Section 302 Certification of the Chief Executive Officer

 

 

 

EX-31.2 Section 302 Certification of the Principal Financial Officer

 

 

 

EX-32 Section 906 Certification of the Chief Executive Officer and Principal Financial Officer

 

 

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Table of Contents

 

ARQULE, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

 

 

 

June  30,
2009

 

December 31,
2008

 

 

 

(IN THOUSANDS,
EXCEPT SHARE AND
PER SHARE DATA)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

73,971

 

$

141,890

 

Marketable securities-short term

 

43,402

 

 

Prepaid expenses and other current assets

 

950

 

772

 

Total current assets

 

118,323

 

142,662

 

Marketable securities-long term

 

68,368

 

64,219

 

Property and equipment, net

 

5,035

 

5,620

 

Other assets

 

1,674

 

1,711

 

Total assets

 

$

193,400

 

$

214,212

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

12,860

 

$

14,260

 

Note payable

 

47,750

 

47,750

 

Current portion of deferred revenue

 

22,207

 

20,420

 

Current portion of deferred gain on sale leaseback

 

552

 

552

 

Total current liabilities

 

83,369

 

82,982

 

Restructuring accrual, net of current portion

 

 

78

 

Deferred revenue, net of current portion

 

79,626

 

84,693

 

Deferred gain on sale leaseback, net of current portion

 

2,715

 

2,992

 

Total liabilities

 

165,710

 

170,745

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.01 par value; 1,000,000 shares authorized; no shares issued or outstanding

 

 

 

Common stock, $0.01 par value; 100,000,000 shares authorized; 44,661,013 and 44,153,237 shares issued and outstanding at June 30, 2009 and December 31, 2008, respectively

 

447

 

442

 

Additional paid-in capital

 

377,821

 

375,478

 

Accumulated other comprehensive loss

 

55

 

 

Accumulated deficit

 

(350,633

)

(332,453

)

Total stockholders’ equity

 

27,690

 

43,467

 

Total liabilities and stockholders’ equity

 

$

193,400

 

$

214,212

 

 

The accompanying notes are an integral part of these interim unaudited financial statements.

 

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ARQULE, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

 

 

 

THREE MONTHS ENDED
June 30,

 

SIX MONTHS ENDED
June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

(IN THOUSANDS, EXCEPT PER SHARE DATA)

 

 

 

 

 

 

 

 

 

 

 

Research and development revenue

 

$

6,056

 

$

2,583

 

$

11,476

 

$

6,110

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

12,678

 

14,980

 

24,012

 

28,432

 

General and administrative

 

3,203

 

4,289

 

6,863

 

9,923

 

Total costs and expenses

 

15,881

 

19,269

 

30,875

 

38,355

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(9,825

)

(16,686

)

(19,399

)

(32,245

)

 

 

 

 

 

 

 

 

 

 

Interest income

 

306

 

646

 

667

 

2,291

 

Interest expense

 

(170

)

 

(336

)

 

Other income (expense)

 

1,417

 

 

888

 

 

Net loss

 

$

(8,272

)

$

(16,040

)

$

(18,180

)

$

(29,954

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share:

 

 

 

 

 

 

 

 

 

Net loss per share

 

$

(0.19

)

$

(0.37

)

$

(0.41

)

$

(0.68

)

 

 

 

 

 

 

 

 

 

 

Weighted average basic and diluted common shares outstanding

 

44,120

 

43,824

 

44,073

 

43,797

 

 

The accompanying notes are an integral part of these interim unaudited financial statements.

 

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ARQULE, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

 

 

 

SIX MONTHS ENDED
June 30,

 

 

 

2009

 

2008

 

 

 

(IN THOUSANDS)

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(18,180

)

$

(29,954

)

 

 

 

 

 

 

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

 

 

 

 

 

Depreciation and amortization

 

862

 

778

 

Amortization of premium/discount on marketable securities

 

286

 

20

 

Amortization of deferred gain on sale leaseback

 

(277

)

(276

)

Non-cash stock compensation

 

1,994

 

4,231

 

Gain on auction rate securities

 

(1,884

)

 

Impairment on auction rate securities put option

 

996

 

 

Loss on disposal of property and equipment

 

 

21

 

Changes in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other current assets

 

(178

)

13

 

Other assets

 

37

 

66

 

Accounts payable and accrued expenses

 

(1,400

)

1,244

 

Restructuring accrual, net of current portion

 

(78

)

(328

)

Deferred revenue

 

(3,280

)

(1,111

)

Net cash used in operating activities

 

(21,102

)

(25,296

)

Cash flows from investing activities:

 

 

 

 

 

Purchases of marketable securities

 

(46,981

)

(8,832

)

Proceeds from sale or maturity of marketable securities

 

87

 

67,676

 

Additions to property and equipment

 

(277

)

(3,519

)

Proceeds from disposal of property and equipment

 

 

87

 

Net cash provided by (used in) investing activities

 

(47,171

)

55,412

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from issuance of common stock

 

354

 

240

 

Net cash provided by financing activities

 

354

 

240

 

Net increase (decrease) in cash and cash equivalents

 

(67,919

)

30,356

 

Cash and cash equivalents, beginning of period

 

141,890

 

10,835

 

Cash and cash equivalents, end of period

 

$

73,971

 

$

41,191

 

 

The accompanying notes are an integral part of these interim unaudited financial statements.

 

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ARQULE, INC.

 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)

 

1.  NATURE OF OPERATIONS AND BASIS OF PRESENTATION

 

We are a clinical-stage biotechnology company organized as a Delaware corporation in 1993 and engaged in the research and development of innovative cancer therapeutics directed toward molecular targets that we believe play critical roles in the development of human cancers. Our mission is to discover and develop novel products that target multiple tumor types, act selectively against cancer cells and are well tolerated by patients.

 

Our lead product is ARQ 197, an orally administered inhibitor of the c-Met receptor tyrosine kinase. ARQ 197 is currently being evaluated as monotherapy and in combination therapy in a Phase 2 clinical development program. We have licensed commercial rights to ARQ 197 for human cancer indications to Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where we have licensed commercial rights to Kyowa Hakko Kirin Co. Ltd. (“Kyowa Hakko Kirin”).

 

Our product pipeline offers the potential for multiple therapeutic candidates based on diverse biological targets, mechanisms of action and chemistry. The most advanced of these programs is focused on the development of inhibitors of the Eg5 kinesin motor protein, which include ARQ 621, in Phase 1 clinical development.

 

Our drug discovery efforts are focused primarily on the ArQule Kinase Inhibitor Platform (“AKIP™”) which we are leveraging to generate compounds designed to inhibit a variety of kinases potently, selectively and without competing with adenosine triphosphate (“ATP”), an energy source for cells. We have maintained the know-how associated with our combinatorial chemistry expertise, developed and validated in the course of our previous chemistry services collaborations with companies in the pharmaceutical and biotechnology industries, and combined it with our biology expertise.

 

We have prepared the accompanying condensed consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).  Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to these rules and regulations.  These condensed consolidated financial statements should be read in conjunction with our audited financial statements and footnotes related thereto for the year ended December 31, 2008 included in our annual report on Form 10-K filed with the SEC on March 6, 2009.

 

The unaudited condensed consolidated financial statements include, in our opinion, all adjustments (consisting only of normal recurring adjustments) necessary to present fairly our financial position as of June 30, 2009, and the results of our operations and cash flows for the three and six months ended June 30, 2009 and June 30, 2008. The results of operations for such interim periods are not necessarily indicative of the results to be achieved for the full year.

 

2. COLLABORATIONS AND ALLIANCES

 

Daiichi Sankyo Co., Ltd. Kinase Inhibitor Discovery Agreement

 

On November 7, 2008, we entered into a research collaboration, exclusive license and co-commercialization agreement with Daiichi Sankyo under which we will apply our proprietary technology and know-how from our AKIP™ platform for the discovery of therapeutic compounds that selectively inhibit certain kinases. The agreement defines two such kinase targets and Daiichi Sankyo will have an option to license compounds directed to these targets following the completion of certain pre-clinical studies.

 

The agreement provides for a $15 million upfront payment, which we received in November 2008, research support payments for the first two years of the collaboration, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and royalty payments on net sales of compounds from the collaboration. We retain the option to co-commercialize licensed products developed under this agreement in the U.S.

 

The duration and termination of the agreement is tied to future events. Unless earlier terminated due to breach, insolvency or upon 90 days notice by Daiichi Sankyo, the agreement terminates on the later of (i) the expiration of the research collaboration period, or (ii) various periods specified in the agreement for development and commercialization of products. If Daiichi Sankyo has

 

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commercialized a licensed product or products, the agreement will continue in force until such time as all royalty terms for all licensed products have ended. The royalty term, on a country-by country basis for a product, ends as of the later of (i) the expiration of the last valid claim under a patent covering the manufacture, use, or sale of a licensed product or (ii) a certain number of years from the date of the commercial sale of the licensed product in such country.

 

Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated performance period through November 2012. For the quarter and six months ended June 30, 2009, $1.7 million and $3.1 million was recognized as revenue. As of June 30, 2009, $19.3 million remains in deferred revenue.

 

Daiichi Sankyo Co., Ltd. ARQ 197 Agreement

 

On December 18, 2008, we entered into a license, co-development and co-commercialization agreement with Daiichi Sankyo to conduct research, clinical trials and commercialization of ARQ 197 in human cancer indications in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin has exclusive rights for development and commercialization.

 

The agreement provides for a $60 million cash upfront licensing payment from Daiichi Sankyo to us, which we received in December 2008, and an additional $560 million in potential development and sales milestone payments. We and Daiichi Sankyo will share equally the costs of Phase 2 and Phase 3 clinical studies, with our share of Phase 3 costs payable solely from milestone and royalty payments from Daiichi Sankyo. Upon commercialization, we will receive tiered, double-digit royalties from Daiichi Sankyo on net sales of ARQ 197 commensurate with the magnitude of the transaction. We retain the option to participate in the commercialization of ARQ 197 in the U.S.

 

The duration and termination of the agreement is tied to future events. Unless earlier terminated due to breach, insolvency or upon 90 days notice if prior to phase 3 clinical trials or 180 days notice if on or after the beginning of phase 3 clinical trials by Daiichi Sankyo, the agreement shall continue until the later of (i) such time as Daiichi Sankyo is no longer developing at least one licensed product or (ii) if Daiichi Sankyo has commercialized a licensed product or products, such time as all royalty terms for all licensed products have ended. The royalty term, on a country-by country basis for a product, ends as of the later of (i) the expiration of the last valid claim under a patent covering the manufacture, use, or sale of a licensed product or (ii) a certain number of years from the date of the commercial sale of the licensed product in such country.

 

Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated development period through December 2013. For the quarter and six months ended June 30, 2009, $3.3 million and $6.3 million was recognized as revenue. As of June 30, 2009, $56.1 million remains in deferred revenue.

 

Kyowa Hakko Kirin Co., Ltd. Licensing Agreement

 

On April 27, 2007, we entered into an exclusive license agreement with Kyowa Hakko Kirin to develop and commercialize ARQ 197 in Japan and parts of Asia. A $3 million portion of an upfront licensing fee was received by the Company under this agreement in the first quarter of 2007 and an additional $27 million in upfront licensing fees was received on May 7, 2007. The agreement includes $123 million in upfront and potential development milestone payments from Kyowa Hakko Kirin to ArQule, including the $30 million cash upfront licensing payments. In February 2008, we received a $3 million milestone payment from Kyowa Hakko Kirin. Upon commercialization, ArQule will receive tiered royalties in the mid-teen to low-twenty percent range from Kyowa Hakko Kirin on net sales of ARQ 197. Kyowa Hakko Kirin will be responsible for all clinical development costs and commercialization of the compound in certain Asian countries, consisting of Japan, China (including Hong Kong), South Korea and Taiwan.

 

In addition to the upfront and possible regulatory milestone payments totaling $123 million, the Company will be eligible for future milestone payments based on the achievement of certain levels of net sales. The Company will recognize the payments, if any, as revenue in accordance with its revenue recognition policies. As of June 30, 2009, the Company has not recognized any revenue from these sales milestone payments, and there can be no assurance that it will do so in the future.

 

The duration and termination of the agreement is tied to future events. Unless earlier terminated due to breach, insolvency or upon 90 days notice by Kyowa Hakko Kirin, the agreement terminates on the date that the last royalty term expires in all countries in the territory. The royalty term ends as of the later of (i) the expiration of the last pending patent application or expiration of the patent in the country covering the manufacture, use, or sale of a licensed product or (ii) a certain number of years from the date of the commercial launch in such country of such license product.

 

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Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated development period through April 2016. For the quarter and six months ended June 30, 2009, $1.1 million and $2.1 million was recognized as revenue. As of June 30, 2009, $26.4 million remains in deferred revenue.

 

3.  MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS

 

We account for our marketable securities in accordance with SFAS No. 115. We generally classify our marketable securities as available-for-sale at the time of purchase and re-evaluate such designation as of each consolidated balance sheet date.  Since we generally intend to convert them into cash as necessary to meet our liquidity requirements our marketable securities are classified as cash equivalents if the original maturity, from the date of purchase, is ninety days or less and as short-term investments if the original maturity, from the date of purchase, is in excess of ninety days but less than one year. Our marketable securities are classified as long-term investments if the maturity date, is in excess of one year of the balance sheet date.

 

We report available-for-sale investments at fair value as of each balance sheet date and include any unrealized gains and, to the extent deemed temporary, unrealized losses in stockholders’ equity. Realized gains and losses are determined using the specific identification method and are included in other income (expense) in the statement of operations.   Certain of our marketable securities are classified as trading securities and any changes in the fair value of those securities are recorded as other income (expense) in the statement of operations.

 

Investments are considered to be impaired when a decline in fair value below cost basis is determined to be other-than-temporary. We evaluate whether a decline in fair value below cost basis is other-than-temporary using available evidence regarding our investments. In the event that the cost basis of a security exceeds its fair value, we evaluate, among other factors, the duration of the period that, and extent to which, the fair value is less than cost basis, the financial health of and business outlook for the issuer, including industry and sector performance, and operational and financing cash flow factors, overall market conditions and trends, our intent to sell the investment and if it is more likely than not that we would be required to sell the investment before its anticipated recovery. Once a decline in fair value is determined to be other-than-temporary, a write-down is recorded in the condensed consolidated statements of operations and a new cost basis in the security is established. In April 2009, we adopted Financial Accounting Standards Board, or FASB, Staff Position, or FSP, FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairment. This standard provides additional guidance in assessing the credit and noncredit component of an other-than-temporary impairment event for debt securities and modifies the presentation and disclosures when an other-than-temporary impairment event for debt securities has occurred. The adoption of this standard did not have a significant impact on our financial statements.

 

We invest our available cash primarily in money market mutual funds, commercial paper fully guaranteed by the FDIC under the Temporary Liquidity Guarantee Program (TLGP), commercial paper, and U.S. federal and state agency backed certificates, including auction rate securities, that have strong credit ratings. Auction rate securities are structured with short-term interest reset dates of generally less than 90 days, but with contractual maturities that can be well in excess of ten years. At the end of each reset period, which occurs every seven to twenty-eight days, investors can sell or continue to hold the securities at par value. If any of our auction rate securities were to fail an auction, due to sell orders exceeding buy orders, the funds associated with a failed auction would not be accessible until a successful auction occurred, a buyer was found outside the auction process, the underlying securities matured or a settlement with the underwriter is reached.

 

Beginning in the first quarter of 2008 and continuing through the second quarter of 2009, certain auction rate securities failed auction due to sell orders exceeding buy orders. On November 3, 2008, the Company accepted an offer (“Offering”) by UBS AG (“UBS”) of certain rights (“Put Option”) to cause UBS to purchase auction rate securities owned by the Company. The repurchase rights were offered in connection with UBS’s obligations under settlement agreements with the U.S. Securities and Exchange Commission and other federal and state regulatory authorities. The offering, the settlement agreements, and the respective rights and obligations of the parties, including a release by the Company of UBS and its employees and agents from all claims except claims for consequential damages relating to UBS’s marketing and sale of auction rate securities, are described in a prospectus issued by UBS dated October 7, 2008.

 

As a result of accepting the Offering, the Company received a Put Option from UBS to repurchase the securities at par value at any time during the period from June 30, 2010 through July 2, 2012, if the Company’s auction rate securities have not previously been sold by the Company or by UBS on its behalf. The Company has accounted for the Put Option as a freestanding financial instrument and elected to record the value under the fair value option of SFAS No. 159.  Pursuant to SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities , the Company has classified its auction rate securities as trading securities reflecting the Company’s intent to exercise the Put Option during the period June 30, 2010 to July 2, 2012. The increase in value of our Put

 

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Option and auction rate securities totaling $1.4 million and $0.9 million in the three and six months ended June 30, 2009, respectively, was recorded as a gain in other income (expense) in the statement of operations.

 

ArQule’s marketable securities portfolio as of December 31, 2008 included $65.3 million (at cost) and $65.2 million (at cost) at June 30, 2009 invested in auction rate securities all of which were associated with auctions that failed subsequent to February 12, 2008.

 

On July 8, 2008, we entered into a collateralized, revolving credit line agreement for up to $47.5 million with UBS Bank USA (the “Facility”). In July 2008, we drew down $46.1 million under the Facility.  In accordance with the Offering by UBS, the Facility remains payable on demand; however, if UBS Bank USA should exercise its right to demand repayment of any portion of the Company’s indebtedness prior to the date the Company can exercise its repurchase rights (other than for reasons specified in the prospectus), UBS and certain of its affiliates will arrange for alternative financing on terms and conditions substantially the same as those contained in the Facility. If alternative financing cannot be established, then UBS or one of its affiliates will purchase the Company’s pledged auction rate securities at par.

 

The following is a summary of the fair value of available-for-sale marketable securities we held at June 30, 2009. The Company had no available-for-sale marketable securities at December 31, 2008.

 

June 30, 2009

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

Security type

 

 

 

 

 

 

 

 

 

U.S. Federal Treasury and U.S. government agencies securities

 

$

38,417

 

$

51

 

$

 

$

38,468

 

Corporate debt securities-short term

 

4,923

 

11

 

 

4,934

 

 

 

43,340

 

62

 

 

43,402

 

Corporate debt securities-long term

 

3,626

 

 

(7

)

3,619

 

Total available-for-sale marketable securities

 

$

46,966

 

$

62

 

$

(7

)

$

47,021

 

 

The following is a summary of the fair value of trading securities we held at June 30, 2009 and December 31, 2008:

 

June 30, 2009

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

Security type

 

 

 

 

 

 

 

 

 

Auction rate securities

 

$

65,189

 

$

 

$

(6,128

)

$

59,061

 

Auction rate put option

 

 

5,688

 

 

5,688

 

Total trading securities

 

$

65,189

 

$

5,688

 

$

(6,128

)

$

64,749

 

 

December 31, 2008

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

Security type

 

 

 

 

 

 

 

 

 

Auction rate securities

 

$

65,547

 

$

 

$

(8,012

)

$

57,535

 

Auction rate put option

 

 

6,684

 

 

6,684

 

Total trading securities

 

$

65,547

 

$

6,684

 

$

(8,012

)

$

64,219

 

 

The underlying collateral of our auction rate securities consists primarily of student loans, the majority of which are supported by the federal government as part of the Federal Family Education Loan Program (FFELP). The credit ratings for all of our auction rate securities were AAA when originally purchased. At June 30, 2009, $53.0 million at par value were rated AAA $1.2 million at par value were rated AA and $11.0 million at par value were rated A.

 

The Company’s marketable securities long-term at June 30, 2009 and December 31, 2008 include auction rate securities and auction rate put option which are classified as trading securities and any future gains and losses will be recorded as other income (expense) in the statement of operations.

 

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Effective January 1, 2009, we implemented Statement of Financial Accounting Standards (“SFAS”) No. 157, Fair Value Measurements , or SFAS 157, for our nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis. The adoption of SFAS 157 for our nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis did not impact our financial position or results of operations; however, could have an impact in future periods.

 

The following tables present information about our assets that are measured at fair value on a recurring basis for the periods presented and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs are unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability:

 

 

 

June 30,
2009

 

Quoted Prices in
Active Markets
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Cash equivalents

 

$

72,835

 

$

72,835

 

$

 

$

 

Marketable securities

 

43,402

 

43,402

 

 

 

Marketable securities—long term

 

68,368

 

3,619

 

 

64,749

 

Total

 

$

184,605

 

$

119,856

 

$

 

$

64,749

 

 

 

 

December 31,
2008

 

Quoted Prices in
Active Markets
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Cash equivalents

 

$

139,370

 

$

139,370

 

$

 

$

 

Marketable securities—long term

 

64,219

 

 

 

64,219

 

Total

 

$

203,589

 

$

139,370

 

$

 

$

64,219

 

 

Certain of our marketable securities-long term consist of auction rate securities and the related Put Option. Due to the lack of market quotes relating to our auction rate securities, the fair value measurements for our auction rate securities have been estimated using an income approach model (discounted cash flow analysis), which is exclusively based on Level 3 inputs. The model considers factors that reflect assumptions market participants would use in pricing including, among others, the collateralization underlying the investments, the creditworthiness of the counterparty, the expected future cash flows, liquidity premiums, the probability of successful auctions in the future, and interest rates. The assumptions used are subject to volatility and may change as the underlying sources of these assumptions and markets conditions change.

 

Due to the lack of market quotes relating to our Put Option, the fair value measurements for our Put Option have been estimated using a valuation approach commonly used for forward contracts in which one party agrees to sell a financial instrument (generating cash flows) to another party at a particular time for a predetermined price, which is based on Level 3 inputs. In this approach the present value of all expected future cash flows is subtracted from the current fair value of the security, and the resulting value is calculated as a future value at an interest rate reflective of counterparty risk. The assumptions used are subject to volatility and may change as the underlying sources of these assumptions and markets conditions change.

 

The following tables roll forward the fair value of our auction rate securities, whose fair value is determined by Level 3 inputs for the 2009 periods presented:

 

 

 

Amount
($ in millions)

 

Balance at December 31, 2008

 

$

64.2

 

Gain on auction rate securities and put option

 

0.9

 

Settlements

 

(0.4

)

Balance at June 30, 2009

 

$

64.7

 

 

 

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Amount
($ in millions)

 

Balance at March 31, 2009

 

$

63.5

 

Gain on auction rate securities and put option

 

1.4

 

Settlements

 

(0.2

)

Balance at June 30, 2009

 

$

64.7

 

 

The following tables roll forward the fair value of our auction rate securities, whose fair value is determined by Level 3 inputs for the 2008 periods presented:

 

 

 

Amount
($ in millions)

 

 

 

 

 

Balance at December 31, 2007

 

$

 92.9

 

Total unrealized losses included in other comprehensive income

 

(4.1

)

Settlements

 

(27.5

)

Balance at June 30, 2008

 

$

 61.3

 

 

 

 

Amount
($ in millions)

 

 

 

 

 

Balance at March 31, 2008

 

$

 63.0

 

Total unrealized losses included in other comprehensive income

 

(0.4

)

Settlements

 

(1.3

)

Balance at June 30, 2008

 

$

 61.3

 

 

4.  COMPREHENSIVE LOSS

 

Comprehensive loss is comprised of net loss and other comprehensive gain (loss).  Other comprehensive gain (loss) includes unrealized gains (losses) on our available-for-sale securities that are excluded from net loss.  Total comprehensive loss for the three and six months ended June 30, 2009 and June 30, 2008 was as follows:

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Net loss

 

$

(8,272

)

$

(16,040

)

$

(18,180

)

$

(29,954

)

Unrealized gain (loss) on marketable securities

 

80

 

(358

)

55

 

(4,054

)

Comprehensive loss

 

$

(8,192

)

$

(16,398

)

$

(18,125

)

$

(34,008

)

 

5.  ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expenses include the following at June 30, 2009 and December 31, 2008:

 

 

 

June 30,
2009

 

December 31,
2008

 

Accounts payable

 

$

341

 

$

495

 

Accrued payroll

 

1,738

 

2,671

 

Accrued outsourced pre-clinical and clinical fees

 

8,501

 

8,669

 

Accrued professional fees

 

487

 

1,037

 

Accrued restructuring-current portion

 

410

 

660

 

Other accrued expenses

 

1,383

 

728

 

 

 

$

12,860

 

$

14,260

 

 

 

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6.  RESTRUCTURING CHARGES

 

In 2002, we recorded a restructuring charge associated with abandoning our facility in Redwood City, California, which was comprised of the difference between the remaining lease obligation, which runs through 2010, and our estimate of potential future sublease income.  The accrual balance was adjusted in 2003 to reflect a change in estimate due to continued deterioration in the local real estate market.  The accrual balance was adjusted again in 2004 as a result of us entering into a sublease for the facility.  The remaining facility-related restructuring accrual is primarily comprised of the difference between our lease obligation for this facility, which will be paid out through 2010, and the amount of sublease payments we will receive under our sublease agreement.

 

Activities against the restructuring accrual in the six months ended June 30, 2009 and June 30, 2008 were as follows:

 

 

 

Balance as of
December 31, 2008

 

2009
Provisions

 

2009
Payments

 

Balance as of
June 30, 2009

 

Facility-related

 

$

738

 

$

 

$

(328

)

$

410

 

 

 

 

Balance as of
December 31, 2007

 

2008
Provisions

 

2008
Payments

 

Balance as of
June 30, 2008

 

Facility-related

 

$

1,366

 

$

 

$

(313

)

$

1,053

 

 

7.  NET LOSS PER SHARE

 

Net loss per share is computed using the weighted average number of common shares outstanding. Basic and diluted net loss per share amounts are equivalent for the periods presented as the inclusion of potential common shares in the number of shares used for the diluted computation would be anti-dilutive to loss per share. Potential common shares, the shares that would be issued upon the exercise of outstanding stock options, were 5,306,991 and 5,730,537 for the three and six months ended June 30, 2009 and 2008, respectively.

 

8.  STOCK-BASED COMPENSATION AND STOCK PLANS

 

Effective January 1, 2006, we adopted the provisions of SFAS No.123(R), “Share-Based Payment”  (“SFAS 123 (R)”), which establishes accounting for equity instruments exchanged for employee services. Under the provisions of SFAS 123(R), stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense over the employees’ requisite service period (generally the vesting period of the equity grant).

 

We estimate the fair value of stock options using the Black-Scholes valuation model. Key input assumptions used to estimate the fair value of stock options include the exercise price of the award, expected option term, expected volatility of our stock over the option’s expected term, risk-free interest rate over the option’s expected term, and the expected annual dividend yield. We believe that the valuation technique and approach utilized to develop the underlying assumptions are appropriate in calculating the fair values of our stock options granted in the three and six months ended June 30, 2009 and June 30, 2008.

 

The following table presents stock-based compensation expense included in our Condensed Consolidated Statements of Operations:

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Research and development

 

$

353

 

$

409

 

$

754

 

$

846

 

General and administrative

 

575

 

919

 

1,240

 

3,385

 

Total stock-based compensation expense

 

$

928

 

$

1,328

 

$

1,994

 

$

4,231

 

 

In the three and six months ended June 30, 2009 and June 30, 2008, no stock-based compensation expense was capitalized and there were no recognized tax benefits associated with the stock-based compensation expense.  Stock-based compensation expense of $542, included in general and administrative in the three months ended June 30, 2008 was related to the June 2008 employment agreement of the new CEO. Stock-based compensation expense of $2,237, included in general and administrative in the six months ended June 30, 2008, resulted from amendments to the former CEO’s employment agreement in October 2007 and January 2008.

 

 

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Option activity under our stock plans for the six months ended June 30, 2009 was as follows:

 

Stock Options

 

 

Number of
Shares

 

Weighted Average
Exercise Price

 

Outstanding as of December 31, 2008

 

5,600,583

 

$

5.99

 

Granted

 

130,000

 

3.86

 

Exercised

 

(24,164

)

4.94

 

Cancelled

 

(399,428

)

4.88

 

 

 

 

 

 

 

Outstanding as of June 30, 2009

 

5,306,991

 

$

6.03

 

 

 

 

 

 

 

Exercisable as of June 30, 2009

 

3,424,646

 

$

6.65

 

 

The aggregate intrinsic value of options outstanding at June 30, 2009 was $4,908 of which $2,362 related to exercisable options. The weighted average fair value of options granted in the six months ended June 30, 2009 and 2008 was $2.24 and $1.35 per share, respectively. The intrinsic value of options exercised in the six months ended June 30, 2009 and 2008 was $14 and zero, respectively.

 

The total compensation cost not yet recognized as of June 30, 2009 related to non-vested option awards was $5.1 million, which will be recognized over a weighted-average period of 2.7 years. During the six months ended June 30, 2009, there were 10,225 shares forfeited with a weighted average grant date fair value of $3.40 per share. The weighted average remaining contractual life for options exercisable at June 30, 2009 was 5.2 years.

 

In January 2009 and 2008, we granted 412,200 and 103,316 shares, respectively, of restricted stock to employees, vesting annually over a four year period. Through June 30, 2009, 24,783 shares were forfeited, and 146,127 shares have vested.  The shares of restricted stock were issued at no cost to the recipients. The fair value of the restricted stock at the time of grant in January 2009 and 2008 was $3.54 and $4.75 respectively, per share, and is being expensed ratably over the vesting period. We recognized share-based compensation expense related to restricted stock of $236,449 and $50,973 for the six months ended June 30, 2009 and 2008, respectively.

 

9.  INCOME TAXES

 

As of December 31, 2008, we had federal net operating losses (“NOL”), state NOL, and research and development credit carryforwards of approximately $203,285, $138,319 and $18,250 respectively, which can be used to offset future federal and state income tax liabilities and expire at various dates through 2028. Federal net capital loss carryforwards of approximately $5,000 can be used to offset future federal capital gains and expire in 2010. Approximately $17,450 of our federal NOL and $1,508 of our state NOL were generated from excess tax deductions from share-based awards, the tax benefit of which will be credited to additional paid-in-capital when the deductions reduce current taxes payable.

 

We adopted the provisions of FASB Interpretation No. 48 (“FIN 48”) Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109 (“SFAS 109”) on January 1, 2007. As a result of the implementation of FIN 48, we recorded no adjustment for unrecognized income tax benefits. At the adoption date of January 1, 2007, at December 31, 2008, and June 30, 2009 we had no unrecognized tax benefits. We do not expect that the total amount of unrecognized tax benefits will significantly increase in the next twelve months. We recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2008 and June 30, 2009, we had no accrued interest or penalties related to uncertain tax positions. The tax years 2005 through 2008 remain open to examination by the major taxing jurisdictions to which we are subject, which is primarily the U.S. Prior tax years remain open to the extent of net operating loss and tax credit carryforwards.

 

Utilization of NOL and R&D credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future pursuant to Section 382 of the Internal Revenue Code of 1986, as amended, as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. Since the Company’s formation, the Company has raised capital through the issuance of capital stock on several occasions which, combined with the purchasing shareholders’ subsequent disposition of those shares, may have resulted in a change of control, as defined by Section 382, or could result in a change of control in the future upon subsequent disposition. The Company has not currently completed a study to assess whether a change of control has

 

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occurred or whether there have been multiple changes of control since the Company’s formation due to the significant complexity and cost associated with such study and that there could be additional changes in control in the future. If we have experienced a change of control at any time since Company formation, utilization of our NOL or R&D credit carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the NOL or R&D credit carryforwards before utilization. Further, until a study is completed and any limitation known, no amounts are being presented as an uncertain tax position under FIN 48.

 

10.  NOTES PAYABLE

 

On July 8, 2008, we entered into a collateralized, revolving credit line agreement for up to $47.5 million with UBS Bank USA (the “Facility”). The Facility is secured by a first priority lien and security interest in the auction rate securities held by us in an account with UBS Financial Services Inc., an affiliate of UBS Bank USA. The credit line is uncommitted and any outstanding balance, including interest, is payable upon demand. Variable rate advances under the Facility currently bear interest at LIBOR plus 100 basis points and interest is payable monthly. The Facility replaced the $15 million standard margin loan agreement with UBS Financial Services Inc. that we entered into on May 8, 2008. The funds are available for research and development efforts, including clinical trials, and for general corporate purposes, including working capital. In July 2008, we drew down $46.1 million under the Facility and that amount is reported as a note payable.

 

On November 3, 2008, the Company accepted an offer (“Offering”) by UBS of certain rights to cause UBS to purchase auction rate securities owned by the Company. The repurchase rights were offered in connection with UBS’s obligations under settlement agreements with the U.S. Securities and Exchange Commission and other federal and state regulatory authorities. The offering, the settlement agreements, and the respective rights and obligations of the parties, including a release by the Company of UBS and its employees and agents from all claims except claims for consequential damages relating to UBS’s marketing and sale of auction rate securities, are described in a prospectus issued by UBS dated October 7, 2008.

 

In accordance with the offering by UBS, the Facility will be treated as a “no net cost loan” as defined in the prospectus. As such, the Facility will remain payable on demand; however, if UBS Bank USA should exercise its right to demand repayment of any portion of the Company’s indebtedness prior to the date the Company can exercise its repurchase rights (other than for reasons specified in the prospectus), UBS and certain of its affiliates will arrange for alternative financing on terms and conditions substantially the same as those contained in the Facility. If alternative financing cannot be established, then UBS or one of its affiliates will purchase the Company’s pledged auction rate securities at par.

 

In October 2008, we entered into a margin loan agreement with another financial institution collateralized by $2.9 million of our auction rate securities and borrowed $1.7 million which is the maximum amount allowed under this facility. Interest expense from notes payable was $0.2 million and $0.3 million for the three and six months ended June 30, 2009, respectively. There was no interest expense for the three and six months ended June 30, 2008. The carrying amount of notes payable at June 30, 2009 and December 31, 2008 approximates fair values.

 

11.  RECENT ACCOUNTING PRONOUNCEMENTS

 

Effective January 1, 2009, we implemented SFAS No. 157, Fair Value Measurements , or SFAS 157, for our nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis. The adoption of SFAS 157 for our nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis did not impact our financial position or results of operations; however, could have an impact in future periods.

 

On December 12, 2007, Emerging Issues Task Force (“EITF”) 07-01, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property , or EITF 07-01, was issued. EITF- 07-01 prescribes the accounting for collaborations. It requires certain transactions between collaborators to be recorded in the income statement on either a gross or net basis within expenses when certain characteristics exist in the collaboration relationship. EITF 07-01 is effective for all of our collaborations existing after January 1, 2009. The adoption of this standard did not have a material impact on our financial statements or results of operations.

 

On December 4, 2007, SFAS No. 141(R), Business Combinations , or SFAS 141(R), was issued. This Standard will require an acquiring company to measure all assets acquired and liabilities assumed, including contingent considerations and all contractual contingencies, at fair value as of the acquisition date. In addition, an acquiring company is required to capitalize IPR&D and either amortize it over the life of the product, or write it off if the project is abandoned or impaired. The Standard is effective for transactions occurring on or after January 1, 2009. There was no significant impact to the Company’s Consolidated Financial Statements from the adoption of SFAS 141(R).

 

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In April 2009, the Financial Accounting Standards Board (“FASB”) issued the following new accounting standards:

 

i.                FASB Staff Position FAS 157-4, Determining Whether a Market Is Not Active and a Transaction Is Not Distressed, or FSP FAS 157-4.  FSP FAS 157-4 provides guidelines for making fair value measurements more consistent with the principles presented in SFAS 157. FSP FAS 157-4 provides additional authoritative guidance in determining whether a market is active or inactive and whether a transaction is distressed, is applicable to all assets and liabilities (i.e. financial and nonfinancial) and will require enhanced disclosures.

 

ii.             FASB Staff Position FAS 115-2, FAS 124-2, and EITF 99-20-2, Recognition and Presentation of Other-Than-Temporary Impairments , or FSP FAS 115-2, FAS 124-2, and EITF 99-20-2.  FSP FAS 115-2, FAS 124-2, and EITF 99-20-2 provides additional guidance to provide greater clarity about the credit and noncredit component of an other-than-temporary impairment event and to more effectively communicate when an other-than-temporary impairment event has occurred. This FSP applies to debt securities.

 

iii.          FASB Staff Position FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments , or FSP FAS 107-1 and APB 28-1.  FSP FAS 107-1 and APB 28-1, amends FASB Statement No. 107, Disclosures about Fair Value of Financial Instruments , to require disclosures about fair value of financial instruments in interim as well as in annual financial statements. This FSP also amends APB Opinion No. 28, Interim Financial Reporting , to require those disclosures in all interim financial statements

 

These standards were effective for periods ending after June 15, 2009. There was no significant impact to the Company’s Consolidated Financial Statements from the adoption of these standards.

 

In June 2009, we adopted Statement of Financial Accounting Standards, or SFAS, No. 165, Subsequent Events, or SFAS No. 165. This standard establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued. The adoption of this statement did not impact our financial statements. We evaluated all events or transactions that occurred after June 30, 2009 through August 7, 2009, the date we issued these financial statements. During this period we did not have any material recognizable subsequent events.

 

In June 2009, SFAS No. 168, The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles, a replacement of FASB Statement No. 162 , or SFAS No. 168, was issued. This standard establishes the FASB Accounting Standards Codification as the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities in preparation of financial statements in conformity with generally accepted accounting principles in the United States. All accounting guidance that is not included in the Codification will be considered to be non-authoritative. SFAS No. 168 is effective for interim and annual periods ending after September 15, 2009. We do not expect the adoption of this standard to have an impact on our financial position or results of operations.

 

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

 

OVERVIEW

 

We are a clinical-stage biotechnology company organized as a Delaware corporation in 1993 and engaged in the research and development of innovative cancer therapeutics directed toward molecular targets that we believe play critical roles in the development of human cancers. Our mission is to discover and develop novel products that target multiple tumor types, act selectively against cancer cells and are well tolerated by patients. We believe our clinical stage products represent potential best-in-class or first-in-class small molecule candidates with differentiated mechanisms of action.

 

Our products and research programs are based on our understanding of biological processes that lead to the proliferation and metastasis of cancer cells, combined with our ability to generate product candidates possessing certain pre-selected, drug-like properties and designed to act with specificity against cancer cells. We believe that these qualities, when present from the earliest stages of product development, increase the likelihood of producing safe, effective and marketable drugs. We believe that our combined expertise in cancer biology and chemistry differentiates us from many companies at a similar stage of development.

 

Our lead product is ARQ 197, an orally administered inhibitor of the c-Met receptor tyrosine kinase. ARQ 197 is currently being evaluated as monotherapy and in combination therapy in a Phase 2 clinical development program that includes trials in Microphthalmia Transcription Factor (“MiT”)-associated tumors, non-small cell lung cancer (“NSCLC”), pancreatic adenocarcinoma

 

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and hepatocellular carcinoma (“HCC”).  We have licensed commercial rights to ARQ 197 for human cancer indications to Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where we have licensed commercial rights to Kyowa Hakko Kirin Co., Ltd. (“Kyowa Hakko Kirin”). Our separate agreements with these partners provide for possible future milestone payments, royalties on product sales, and development funding, in addition to payments that we have already received.

 

Our product pipeline offers the potential for multiple therapeutic candidates based on diverse biological targets, mechanisms of action and chemistry. The most advanced of these programs is focused on the development of inhibitors of the Eg5 kinesin motor protein, which include ARQ 621, in Phase 1 clinical development.  We have completed certain Phase 2 proof-of-principle trials with ARQ 501, a first-generation, intravenously administered novel activator of the cell’s DNA damage response mechanism mediated by the E2F-1 transcription factor, and we have filed an IND for ARQ 761, a second-generation molecule from our E2F-1 program. We are in pre-clinical development with an inhibitor of the BRAF kinase.

 

Our drug discovery efforts are focused primarily on the ArQule Kinase Inhibitor Platform (“AKIP™”), which we employ to generate compounds designed to inhibit a variety of kinases potently, selectively and without competing with adenosine triphosphate (“ATP”), an energy source for cells. We are currently assessing the potential of multiple kinases in oncology and other therapeutic areas as targets for this drug discovery platform, and we are seeking to generate and validate compounds that inhibit these kinase targets. We have signed a drug discovery agreement with Daiichi Sankyo that utilizes the capabilities of the AKIP platform to discover compounds that inhibit two such kinase targets in the field of oncology.

 

Our drug discovery efforts, including our kinase platform, are supported by the expertise we have derived from our heritage as a combinatorial chemistry company. This expertise, which has been validated through collaborations with Pfizer Inc., Wyeth, Solvay and other corporate partners, is married to innovative biology to create a discovery engine marked by speed, efficiency and flexibility.

 

We have incurred a cumulative deficit of $351 million from inception through June 30, 2009. We expect research and development costs to increase during the course of 2009, due to clinical testing of our lead product candidates. We recorded a net loss for 2006, 2007 and 2008, and expect a net loss for 2009.

 

Our revenue consists primarily of development funding from our alliances with Daiichi Sankyo and Kyowa Hakko Kirin. Revenue and expenses fluctuate from quarter to quarter based upon a number of factors, notably: the timing and extent of our cancer related research and development activities together with the length and outcome of our clinical trials. On December 17, 2008, Roche notified the Company of its intention not to exercise its option to license the E2F program. Roche’s rights to develop and commercialize potential drugs under the agreement terminated as of December 31, 2008. As a result, the Company will not receive any further payments under this agreement.

 

On December 18, 2008, we entered into a license, co-development and co-commercialization agreement with Daiichi Sankyo to conduct research, clinical trials and commercialization of ARQ 197 in human cancer indications in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin has exclusive rights for development and commercialization. The agreement provides for a $60 million cash upfront licensing payment from Daiichi Sankyo to us, which we received in December 2008, and an additional $560 million in potential development and sales milestone payments. We and Daiichi Sankyo will share equally the costs of Phase 2 and Phase 3 clinical studies, with our share of Phase 3 costs payable solely from milestone and royalty payments by Daiichi Sankyo. Upon commercialization, we will receive tiered, double-digit royalties from Daiichi Sankyo on net sales of ARQ 197 commensurate with the magnitude of the transaction. We retain the option to participate in the commercialization of ARQ 197 in the U.S. Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated development period through December 2013.

 

On November 7, 2008, we entered into a research collaboration, exclusive license and co-commercialization agreement with Daiichi Sankyo under which we will apply our proprietary technology and know-how from our AKIP™ platform for the discovery of therapeutic compounds that selectively inhibit certain kinases. The agreement defines two such kinase targets, and Daiichi Sankyo will have an option to license compounds directed to these targets following the completion of certain pre-clinical studies. The agreement provides for a $15 million upfront payment, which we received in November 2008, research support payments for the first two years of the collaboration, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and royalty payments on net sales of compounds from the collaboration. We retain the option to co-commercialize licensed products developed under this agreement in the U.S. Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated performance period through November 2012.

 

On April 27, 2007, we entered into an exclusive license agreement with Kyowa Hakko Kirin to develop and commercialize ARQ 197, a small molecule, selective inhibitor of the c-Met receptor tyrosine kinase, in Japan and parts of Asia. A $3 million portion

 

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of an upfront licensing fee was received by the Company under this agreement in the first quarter of 2007, and an additional $27 million in upfront licensing fees was received on May 7, 2007. The agreement includes $123 million in upfront and potential development milestone payments from Kyowa Hakko Kirin to ArQule, including the $30 million cash upfront licensing payments. In February 2008, we received a $3 million milestone payment from Kyowa Hakko Kirin. Upon commercialization, ArQule will receive tiered royalties in the mid-teen to low-twenty percent range from Kyowa Hakko Kirin on net sales of ARQ 197. Kyowa Hakko Kirin will be responsible for all clinical development costs and commercialization of the compound in certain Asian countries, consisting of Japan, China (including Hong Kong), South Korea and Taiwan. In addition to the upfront and possible regulatory milestone payments totaling $123 million, the Company will be eligible for future milestone payments based on the achievement of certain levels of net sales. The Company will recognize the payments, if any, as revenue in accordance with its revenue recognition policies. As of December 31, 2008, the Company has not recognized any revenue from these sales milestone payments, and there can be no assurance that it will do so in the future. Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated development period through April 2016.

 

LIQUIDITY AND CAPITAL RESOURCES

 

 

 

June 30,

 

December 31,

 

Increase (decrease)

 

 

 

2009

 

2008

 

$

 

%

 

 

 

(in millions)

 

Cash, cash equivalents and marketable securities-short term

 

$

117.4

 

$

141.9

 

$

(24.5

)

(17.3

)%

Marketable securities- long term

 

68.4

 

64.2

 

4.2

 

6.5

%

Notes payable

 

47.8

 

47.8

 

 

 

Working capital

 

35.0

 

59.7

 

(24.7

)

(41.4

)%

 

 

 

Six Months Ended

 

 

 

 

 

June 30,

 

June 30,

 

 

 

 

 

2009

 

2008

 

Increase (decrease)

 

 

 

(in millions)

 

Cash flow from:

 

 

 

 

 

 

 

Operating activities

 

$

(21.1

)

$

(25.3

)

$

4.2

 

Investing activities

 

(47.2

)

55.4

 

(102.6

)

Financing activities

 

0.4

 

0.2

 

0.2

 

 

Cash flow from operating activities.   Our uses of cash for operating activities have primarily consisted of salaries and wages for our employees, facility and facility-related costs for our offices and laboratories, fees paid in connection with preclinical and clinical studies, laboratory supplies and materials, and professional fees. The sources of our cash flow from operating activities have consisted primarily of payments from our collaborators for services performed or upfront payments for future services.  For the six months ended June 30, 2009, our net use of cash was primarily driven by the difference between cash receipts from our collaborators and payments for operating expenses, which resulted in a net cash outflow of $21.1 million.

 

Cash flow from investing activities.   Our net cash used by investing activities of $47.2 million in the six months ended June 30, 2009 was predominantly comprised of net purchases of marketable securities. The composition and mix of cash, cash equivalents and marketable securities may change frequently as a result of the Company’s constant evaluation of conditions in financial markets, the maturity of specific investments, and our near term liquidity needs.

 

Our cash equivalents and marketable securities include U.S.Treasury bill funds, money market funds, commercial paper fully guaranteed by the FDIC under the Temporary Liquidity Guarantee Program (TLGP), commercial paper, and U.S.federal and state agency backed certificates, including auction rate securities that have investment grade ratings.

 

Our cash equivalents and our portfolio of marketable securities are subject to market risk due to changes in interest rates. Fixed rate interest securities may have their market value adversely impacted due to a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future investment income may fall short of expectation due to changes in interest rates or we may suffer losses in principal if we are forced to sell securities that decline in market value due to changes in interest rates.

 

Auction rate securities are structured with short-term interest reset dates of generally less than 90 days, but with contractual maturities that can be well in excess of ten years. At the end of each reset period, which occurs every seven to twenty-eight days, investors can sell or continue to hold the securities at par value. If any of our auction rate securities were to fail an auction, due to sell orders exceeding buy orders, the funds associated with a failed auction would not be accessible until a successful auction occurred, a buyer was found outside the auction process, the underlying securities matured or a settlement with the underwriter is reached.

 

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Beginning in the first quarter of 2008 and continuing through the second quarter of 2009, certain auction rate securities failed auction due to sell orders exceeding buy orders. On November 3, 2008, the Company accepted an offer (the “Offering”) by UBS AG (“UBS”) of certain rights (“Put Option”) to cause UBS to purchase auction rate securities owned by the Company. The repurchase rights were offered in connection with UBS’s obligations under settlement agreements with the U.S. Securities and Exchange Commission and other federal and state regulatory authorities. The Offering, the settlement agreements, and the respective rights and obligations of the parties, including a release by the Company of UBS and its employees and agents from all claims except claims for consequential damages relating to UBS’s marketing and sale of auction rate securities, are described in a prospectus issued by UBS dated October 7, 2008.

 

As a result of accepting the Offering, the Company received a Put Option from UBS to repurchase the securities at par value at any time during the period from June 30, 2010 through July 2, 2012, if the Company’s auction rate securities have not previously been sold by the Company or by UBS on its behalf. The Company has accounted for the Put Option as a freestanding financial instrument and elected to record the value under the fair value option of SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities.   Pursuant to SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities , the Company has classified its auction rate securities as trading securities reflecting the Company’s intent to exercise the Put Option during the period June 30, 2010 to July 2, 2012. The increase in value of our Put Option and auction rate securities totaling $1.4 million in the three months and $0.9 million in the six months ended June 30, 2009, respectively, was recorded as a gain in other income (expense) in the statement of operations.

 

Our marketable securities portfolio as of December 31, 2008 included $65.3 million (at cost) and $65.2 million (at cost) at June 30, 2009 invested in auction rate securities all of which were associated with auctions that failed subsequent to February 12, 2008.

 

On July 8, 2008, we entered into a collateralized, revolving credit line agreement for up to $47.5 million with UBS Bank USA (the “Facility”). The Facility is secured by a first priority lien and security interest in the auction rate securities held by us in an account with UBS Financial Services Inc., an affiliate of UBS Bank USA. The credit line is uncommitted and any outstanding balance, including interest, is payable upon demand. Variable rate advances under the Facility currently bear interest at LIBOR plus 100 basis points and interest will be payable monthly. The Facility replaced the $15 million standard margin loan agreement with UBS Financial Services Inc. that we entered into on May 8, 2008. In July 2008, we drew down $46.1 million under the Facility. The funds will be available for research and development efforts, including clinical trials, and for general corporate purposes, including working capital.

 

In accordance with the Offering by UBS, the $46.1 million borrowed under the Facility remains payable on demand; however, if UBS Bank USA should exercise its right to demand repayment of any portion of the Company’s indebtedness prior to the date the Company can exercise its repurchase rights (other than for reasons specified in the prospectus), UBS and certain of its affiliates will arrange for alternative financing on terms and conditions substantially the same as those contained in the Facility. If alternative financing cannot be established, then UBS or one of its affiliates will purchase the Company’s pledged auction rate securities at par.

 

In light of the above arrangement with our auction rate securities and the financial impact of our two agreements with Daiichi Sankyo, including a cumulative $75 million in cash and upfront payments received in the quarter ended December 31, 2008 and certain anticipated milestone and cost-sharing provisions, we expect that our available cash and cash equivalents, including cash received under our auction rate security credit line agreement (as described above), together with cash from operations and investment income, will be sufficient to finance our working capital and capital requirements through at least the end of 2011.

 

Our cash requirements may vary materially from those now planned depending upon the results of our drug discovery and development strategies, our ability to enter into additional corporate collaborations and the terms of such collaborations, results of research and development, unanticipated required capital expenditures, competitive and technological advances, acquisitions and other factors. We cannot guarantee that we will be able to develop any of our drug candidates into a commercial product. It is likely we will need to raise additional capital or incur indebtedness to continue to fund our operations in the future. Our ability to raise additional funds will depend on financial, economic and market conditions and due to global capital and credit market conditions or for other reasons, we may be unable to raise capital when needed, or on terms favorable to us. If necessary funds are not available, we may have to delay, reduce the scope of, or eliminate some of our development programs, potentially delaying the time to market for any of our product candidates.

 

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Our contractual obligations were comprised of the following as of June 30, 2009 (in thousands):

 

 

 

Payment due by period

 

Contractual Obligations

 

Total

 

Less than
1 year

 

1 - 3 years

 

3 - 5 years

 

More than
5 years

 

Notes payable

 

$

47,750

 

$

47,750

 

$

 

$

 

$

 

Operating lease obligations

 

19,890

 

3,729

 

7,048

 

6,452

 

2,661

 

Purchase obligations

 

8,995

 

8,995

 

 

 

 

Total

 

$

76,635

 

$

60,474

 

$

7,048

 

$

6,452

 

$

2,661

 

 

Included in the total minimum payments for operating leases is approximately $410 related to abandoned real estate in California, net of contractual sublease income. This net amount has been accrued as a liability as a part of the Company’s restructuring charge in 2002 and subsequently adjusted in 2003 and 2004. Purchase obligations are comprised primarily of outsourced preclinical and clinical trial expenses and payments to license certain intellectual property to support the Company’s research efforts. Interest on notes payable is variable and is excluded from the table above. Notes payable of $46.1 million currently bear interest at a rate not to exceed our weighted average auction rate security coupon rate and $1.7 million currently bear interest at LIBOR plus 125 basis points.

 

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

 

A “critical accounting policy” is one which is both important to the portrayal of the Company’s financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For additional information, please see the discussion of our significant accounting policies in Note 2 to the Consolidated Financial Statements included in our Annual Report on Form 10-K filed with the SEC on March 6, 2009.

 

Research and Development Revenue

 

The Company’s revenue recognition policies are in accordance with the SEC’s Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements , as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition , and for revenue arrangements entered into after June 30, 2003, Emerging Issues Task Force (“EITF”) Issue No. 00-21, Revenue Arrangements with Multiple Deliverables (“EITF 00-21”).

 

Research and development revenue is generated primarily through collaborative research and development agreements. The terms of the agreements may include nonrefundable upfront payments, funding for research and development, milestone payments and royalties on any product sales derived from collaborations.

 

Research and development payments from our collaborators are recognized as research and development revenue using the contingency adjusted performance model. Under this model, when payments are earned, revenue is immediately recognized on a pro-rata basis in the period we achieve the milestone based on the time elapsed from inception of the agreement to the time the milestone is earned over the estimated duration of the development period under the agreement. Thereafter, the remaining portion of the milestone payment is recognized on a straight-line basis over the remaining estimated development period under the agreement. This estimated development period may ultimately be shorter or longer depending upon the outcome of the development work, resulting in accelerated or deferred recognition of the development revenue. Royalty payments will be recognized as revenue when earned. The costs associated with satisfying research and development contracts are included in research and development expense as incurred.

 

RESULTS OF OPERATIONS

 

The following are the results of operations for the three and six months ended June 30, 2009 and 2008:

 

Revenue

 

 

 

 

 

 

 

Increase (decrease)

 

 

 

2009

 

2008

 

$

 

%

 

 

 

(in millions)

 

 

 

 

 

For the three months ended June 30:

 

 

 

 

 

 

 

 

 

Research and development revenue

 

$

6.1

 

$

2.6

 

$

3.5

 

134

%

 

 

 

 

 

 

 

 

 

 

For the six months ended June 30:

 

 

 

 

 

 

 

 

 

Research and development revenue

 

$

11.5

 

$

6.1

 

$

5.4

 

88

%

 

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Table of Contents

 

Research and development revenue in the three and six months ended June 30, 2009 is comprised of revenue from the Daiichi Sankyo development and research collaborations agreements entered into in 2008 and the Kyowa Hakko exclusive license agreement. The increase in the three and six month periods is primarily due to revenue from Daiichi Sankyo. Revenue of $1.7 million and $3.3 million was recognized in the comparable three and six month periods of 2008, respectively from the Roche alliance agreement that was terminated in December 2008.

 

Research and development

 

 

 

 

 

 

 

Increase (decrease)

 

 

 

2009

 

2008

 

$

 

%

 

 

 

(in millions)

 

 

 

 

 

For the three months ended June 30:

 

 

 

 

 

 

 

 

 

Research and development

 

$

12.7

 

$

15.0

 

$

(2.3

)

(15)

%

 

 

 

 

 

 

 

 

 

 

For the six months ended June 30:

 

 

 

 

 

 

 

 

 

Research and development

 

$

24.0

 

$

28.4

 

$

(4.4

)

(16)

%

 

Overview

 

Our research and development expense consists primarily of salaries and related expenses for personnel, costs of contract manufacturing services, costs of facilities and equipment, fees paid to professional service providers in conjunction with our clinical trials, fees paid to research organizations in conjunction with pre-clinical animal studies, costs of materials used in research and development, consulting, license, and sponsored research fees paid to third parties and depreciation of associated laboratory equipment. We expect our research and development expense to increase as we continue to develop our portfolio of oncology programs.

 

We have not accumulated and tracked our internal historical research and development costs or our personnel and personnel-related costs on a program-by-program basis. Our employee and infrastructure resources are allocated across several projects, and many of our costs are directed to broadly applicable research endeavors. As a result, we cannot state the costs incurred for each of our oncology programs on a program-by-program basis. The expenses incurred by us to third parties for pre-clinical and clinical trials in the current quarter and since inception of our lead clinical stage program were as follows (in millions):

 

Oncology program

 

Current status

 

Six Months Ended
June 30, 2009

 

Program-to-date

 

c-Met program—ARQ 197

 

Phase 2

 

$9.6

 

$43.8

 

 

Our future research and development expenses in support of our current and future programs will be subject to numerous uncertainties in timing and cost to completion. We test potential products in numerous pre-clinical studies for safety, toxicology, and efficacy. We may conduct multiple clinical trials for each product. As we obtain results from trials, we may elect to discontinue or delay clinical trials for certain products in order to focus our resources on more promising products. Completion of, clinical trials may take several years or more, but the length of time generally varies substantially according to the type, complexity novelty, and intended use of a product. It is not unusual for the pre-clinical and clinical development of these types of products to each take nine years or more, and for total development costs to exceed $500 million for each product.

 

We estimate that clinical trials of the type generally needed to secure new drug approval are typically completed over the following timelines:

 

Clinical Phase

 

Estimated Completion Period

 

Phase 1

 

1-2 years

 

Phase 2

 

2-3 years

 

Phase 3

 

2-4 years

 

 

The duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others, the following:

 

·   the number of clinical sites included in the trials;

 

·   the length of time required to enroll suitable patients;

 

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·        the number of patients that ultimately participate in the trials;

 

·        the duration of patient follow-up to ensure the absence of long-term product-related adverse events; and

 

·        the efficacy and safety profile of the product.

 

An element of our business strategy is to pursue the research and development of a broad pipeline of products. This is intended to allow us to diversify the risks associated with our research and development expenditures. As a result, we believe our future capital requirements and future financial success are not substantially dependent on any one product. To the extent we are unable to build and maintain a broad pipeline of products, our dependence on the success of one or a few products increases.

 

Our strategy includes entering into alliance arrangements with third parties to participate in the development and commercialization of our products, such as our collaboration agreements with Daiichi Sankyo and Kyowa Hakko Kirin. In the event that third parties have control over the clinical trial process for a product, the estimated completion date would be under control of that third party rather than under our control. We cannot forecast with any degree of certainty whether our products will be subject to future collaborative arrangements or how such arrangements would affect our development plans or capital requirements.

 

As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our oncology programs or when and to what extent we will receive cash inflows from the commercialization and sale of a product. Our inability to complete our oncology programs in a timely manner or our failure to enter into appropriate collaborative agreements could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could force us to seek additional, external sources of financing from time-to-time in order to continue with our product development strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.

 

Research and development expense in the second quarter of 2009 decreased by $2.3 million. The decrease is primarily due to a $2.1 million decrease in clinical and preclinical costs related to ARQ 501 and ARQ 621.

 

Research and development expense in the first six months of 2009 decreased by $4.4 million. The decrease is primarily due to a $3.7 million decrease in clinical and preclinical costs related to ARQ 501 and ARQ 621, and a $0.6 million decrease in labor and related costs.  At June 30, 2009 we had 81 employees dedicated to our research and development program, compared to 84 at June 30, 2008.

 

General and administrative

 

 

 

 

 

 

 

Increase (decrease)

 

 

 

2009

 

2008

 

$

 

%

 

 

 

(in millions)

 

 

 

 

 

For the three months ended June 30:

 

 

 

 

 

 

 

 

 

General and administrative

 

$

3.2

 

$

4.3

 

(1.1

)

(25)

%

 

 

 

 

 

 

 

 

 

 

For the six months ended June 30:

 

 

 

 

 

 

 

 

 

General and administrative

 

$

6.9

 

$

9.9

 

(3.0

)

(31)

%

 

General and administrative expense in the second quarter of 2009 decreased by $1.1 million primarily due to $0.5 million incurred in the second quarter of 2008 for personnel and stock compensation expense related to the hiring of the CEO, and lower professional fees of $0.3 million.

 

General and administrative expense in the first six months of 2009 decreased by $3 million principally due to $2.2 million stock-based compensation expense incurred in the first quarter of 2008 resulting from senior management transitions that did not recur in the first quarter of 2009, and $0.5 million incurred in the second quarter of 2008 for personnel and stock compensation expense related to the hiring of the CEO. General and administrative headcount was 30 at June 30, 2009, compared to 32 at June 30, 2008.

 

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Table of Contents

 

Interest income , interest expense and other income (expense)

 

 

 

 

 

 

 

Increase (decrease)

 

 

 

2009

 

2008

 

$

 

%

 

 

 

(in millions)

 

 

 

 

 

For the three months ended June 30:

 

 

 

 

 

 

 

 

 

Interest income

 

$

0.3

 

$

0.6

 

$

(0.3

)

(53

)%

Interest expense

 

(0.2

)

 

0.2

 

 

Other income (expense)

 

1.4

 

 

1.4

 

 

 

 

 

 

 

 

 

 

 

 

For the six months ended June 30:

 

 

 

 

 

 

 

 

 

Interest income

 

$

0.7

 

$

2.3

 

$

(1.6

)

(71

)%

Interest expense

 

(0.3

)

 

0.3

 

 

Other income (expense)

 

0.9

 

 

0.9

 

 

 

Interest income is comprised primarily of interest income derived from our portfolio of cash, cash equivalents and investments. Interest income decreased in the three and six month periods of 2009 due to lower interest rates earned on our portfolio. Interest expense in 2009 was incurred on our notes payable. Other income (expense) in the three and six months ended June 30, 2009 includes a $1.4 million gain and a $0.9 million gain, respectively, from recording our auction rate securities and Put Option at fair value.

 

RECENT ACCOUNTING PRONOUNCEMENTS

 

Effective January 1, 2009, we implemented Statement of Financial Accounting Standards No. 157, Fair Value Measurements , or SFAS 157, for our nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis. The adoption of SFAS 157 for our nonfinancial assets and liabilities that are remeasured at fair value on a non-recurring basis did not impact our financial position or results of operations; however, could have an impact in future periods.

 

On December 12, 2007, EITF 07-01, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property , or EITF 07-01, was issued. EITF- 07-01 prescribes the accounting for collaborations. It requires certain transactions between collaborators to be recorded in the income statement on either a gross or net basis within expenses when certain characteristics exist in the collaboration relationship. EITF 07-01 is effective for all of our collaborations existing after January 1, 2009. The adoption of this standard did not have a material impact on our financial statements or results of operations.

 

On December 4, 2007, SFAS No. 141(R), Business Combinations , or SFAS 141(R), was issued. This Standard will require an acquiring company to measure all assets acquired and liabilities assumed, including contingent considerations and all contractual contingencies, at fair value as of the acquisition date. In addition, an acquiring company is required to capitalize IPR&D and either amortize it over the life of the product, or write it off if the project is abandoned or impaired. The Standard is effective for transactions occurring on or after January 1, 2009. There was no significant impact to the Company’s Consolidated Financial Statements from the adoption of SFAS 141(R).

 

In April 2009, the FASB issued the following new accounting standards:

 

i.                   FASB Staff Position FAS 157-4, Determining Whether a Market Is Not Active and a Transaction Is Not Distressed, or FSP FAS 157-4.  FSP FAS 157-4 provides guidelines for making fair value measurements more consistent with the principles presented in SFAS 157. FSP FAS 157-4 provides additional authoritative guidance in determining whether a market is active or inactive and whether a transaction is distressed, is applicable to all assets and liabilities (i.e. financial and nonfinancial) and will require enhanced disclosures.

 

ii.                FASB Staff Position FAS 115-2, FAS 124-2, and EITF 99-20-2, Recognition and Presentation of Other-Than-Temporary Impairments , or FSP FAS 115-2, FAS 124-2, and EITF 99-20-2.  FSP FAS 115-2, FAS 124-2, and EITF 99-20-2 provides additional guidance to provide greater clarity about the credit and noncredit component of an other-than-temporary impairment event and to more effectively communicate when an other-than-temporary impairment event has occurred. This FSP applies to debt securities.

 

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iii.             FASB Staff Position FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments , or FSP FAS 107-1 and APB 28-1.  FSP FAS 107-1 and APB 28-1, amends FASB Statement No. 107, Disclosures about Fair Value of Financial Instruments , to require disclosures about fair value of financial instruments in interim as well as in annual financial statements. This FSP also amends APB Opinion No. 28, Interim Financial Reporting , to require those disclosures in all interim financial statements

 

These standards were effective for periods ending after June 15, 2009. There was no significant impact to the Company’s Consolidated Financial Statements from the adoption of these standards.

 

In June 2009, we adopted Statement of Financial Accounting Standards, or SFAS, No. 165, Subsequent Events, or SFAS No. 165. This standard establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued. The adoption of this statement did not impact our financial statements. We evaluated all events or transactions that occurred after June 30, 2009 through August 7, 2009, the date we issued these financial statements. During this period we did not have any material recognizable subsequent events.

 

 

In June 2009, SFAS No. 168, The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles, a replacement of FASB Statement No. 162 , or SFAS No. 168, was issued. This standard establishes the FASB Accounting Standards Codification as the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities in preparation of financial statements in conformity with generally accepted accounting principles in the United States. All accounting guidance that is not included in the Codification will be considered to be non-authoritative. SFAS No. 168 is effective for interim and annual periods ending after September 15, 2009. We do not expect the adoption of this standard to have an impact on our financial position or results of operations.

 

FORWARD LOOKING STATEMENTS

 

In addition to historical information, this report contains forward-looking statements. You can identify these forward-looking statements by their use of words such as “anticipate,” “assume,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “target,” “will” and other words and terms of similar meaning. You also can identify them by the fact that they do not relate strictly to historical or current facts.  All statements which address operating performance, events or developments that the Company expects or anticipates will occur in the future, such as projections about its future results of operations, its financial condition, research, development and commercialization of its products and anticipated trends in its business are forward-looking statements.

 

In this report we make forward-looking statements regarding our drug development pipeline and our clinical trials involving ARQ 197. Additional forward-looking statements relate to our agreements with Kyowa Hakko Kirin and Daiichi Sankyo, including potential future milestones and royalty payments that could result from the future development of ARQ 197.

 

Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product.  For example, pre-clinical efforts associated with our product pipeline may fail or prove disappointing because our technology platform did not produce candidates with the desired characteristics. Animal xenograft pre-clinical studies may be unpredictive of human response.  Positive information about early stage clinical trial results will not ensure that later stage or larger scale clinical trials will be successful.

 

Furthermore, our drugs may not demonstrate promising therapeutic effects; in addition, they may not demonstrate appropriate safety profiles in ongoing or later stage or larger scale clinical trials as a result of known or as yet unidentified side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing our drugs that could lead us or our partner to discontinue development.

 

Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from analysis of data or from additional data or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. Also, the planned timing of initiation of clinical trials and the duration and conclusion of such trials for our drugs are subject to the ability of the company to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved.

 

We also make forward-looking statements regarding the adequacy of our financial resources.  Our capital resources may not be adequate because our cash requirements may vary materially from those now planned depending upon the results of our drug discovery and development strategies, the outcomes of our clinical trials, our ability to enter into additional corporate collaborations in

 

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the future and the terms of such collaborations, results of research and development, the need for currently unanticipated capital expenditures, competitive and technological advances, acquisitions, financial market conditions, our ability to liquidate our investments in auction rate securities and other factors.  Additionally, our corporate collaborators may terminate their agreements with us, thereby eliminating that source of funding, because we may fail to satisfy the prescribed terms of the collaborations or for other reasons.  Finally, we can not assure that UBS will have adequate financial resources to fulfill its repurchase obligations to us.

 

We cannot guarantee that we will be able to develop any of our drug candidates into a commercial product generating revenues.  If we experience increased losses, we may have to seek additional financing from public and private sales of our securities, including equity securities.  There can be no assurance that additional funding will be available when needed or on acceptable terms.

 

The factors, risks and uncertainties referred to above and others are more fully described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2008 filed with the SEC on March 6, 2009, as updated from time to time in our subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.  The forward-looking statements contained herein represent the judgment of the Company as of the date of this report.  We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We own financial instruments that are sensitive to market risk as part of our investment portfolio. We have implemented policies regarding the amount and credit ratings of investments. Our investment portfolio is used to preserve our capital until it is used to fund operations, including our research and development activities. Our investments are evaluated quarterly to determine the fair value of the portfolio.

 

Our cash and marketable securities include U.S.Treasury bill funds, money market funds, commercial paper fully guaranteed by the FDIC under the Temporary Liquidity Guarantee Program (TLGP), commercial paper, and U.S. federal and state agency backed certificates, including auction rate securities that have strong credit ratings.

 

Our cash equivalents and our portfolio of marketable securities are subject to market risk due to changes in interest rates. Fixed rate interest securities may have their market value adversely impacted due to a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future investment income may fall short of expectation due to changes in interest rates or we may suffer losses in principal if we are forced to sell securities that decline in market value due to changes in interest rates.

 

Auction rate securities are securities that are structured with short-term interest reset dates of generally less than 90 days, but with contractual maturities that can be well in excess of ten years. At the end of each reset period, which occurs every seven to twenty-eight days, investors can sell or continue to hold the securities at par value. If any of our auction rate securities were to fail an auction, due to sell orders exceeding buy orders, the funds associated with a failed auction would not be accessible until a successful auction occurred, a buyer was found outside the auction process, the underlying securities matured or a settlement with the underwriter is reached.

 

Beginning in the first quarter of 2008 and continuing through the second quarter of 2009, certain auction rate securities failed auction due to sell orders exceeding buy orders. On November 3, 2008, the Company accepted an offer (the “Offering”) by UBS AG (“UBS”) of certain rights (“Put Option”) to cause UBS to purchase auction rate securities owned by the Company. The repurchase rights were offered in connection with UBS’s obligations under settlement agreements with the U.S. Securities and Exchange Commission and other federal and state regulatory authorities. The offering, the settlement agreements, and the respective rights and obligations of the parties, including a release by the Company of UBS and its employees and agents from all claims except claims for consequential damages relating to UBS’s marketing and sale of auction rate securities, are described in a prospectus issued by UBS dated October 7, 2008.

 

As a result of accepting the Offering, the Company received a Put Option from UBS to repurchase the securities at par value at any time during the period from June 30, 2010 through July 2, 2012, if the Company’s auction rate securities have not previously been sold by the Company or by UBS on its behalf. The Company has accounted for the Put Option as a freestanding financial instrument and elected to record the value under the fair value option of SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities .  Pursuant to SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities , the Company has classified its auction rate securities as trading securities reflecting the Company’s intent to exercise the Put Option during the period June 30, 2010 to July 2, 2012. The increase in value of our Put Option and auction rate securities totaling $1.4 million in the three months ended June 30, 2009 was recorded as a gain in other income (expense) in the statement of operations.

 

24



Table of Contents

 

ArQule’s marketable securities portfolio as of December 31, 2008 included $65.3 million (at cost) and $65.2 million (at cost) at June 30, 2009 invested in auction rate securities all of which were associated with auctions that failed subsequent to February 12, 2008.

 

On July 8, 2008, we entered into a collateralized, revolving credit line agreement for up to $47.5 million with UBS Bank USA (the “Facility”). In July 2008, we drew down $46.1 million under the Facility.  In accordance with the offering by UBS, the Facility remains payable on demand; however, if UBS Bank USA should exercise its right to demand repayment of any portion of the Company’s indebtedness prior to the date the Company can exercise its repurchase rights (other than for reasons specified in the prospectus), UBS and certain of its affiliates will arrange for alternative financing on terms and conditions substantially the same as those contained in the Facility. If alternative financing cannot be established, then UBS or one of its affiliates will purchase the Company’s pledged auction rate securities at par.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

Our management, with the participation of our Chief Executive Officer (Principal Executive Officer) and President and Chief Operating Officer (Principal Financial Officer), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2009. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2009, our Chief Executive Officer (Principal Executive Officer) and President and Chief Operating Officer (Principal Financial Officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 

There have been no changes in the Company’s internal control over financial reporting during the most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

PART II — OTHER INFORMATION

 

ITEM 1. — LEGAL PROCEEDINGS.   None.

 

ITEM 1A. — RISK FACTORS.

 

For information regarding factors that could affect the Company’s results of operations, financial condition and liquidity, see the risk factors discussion provided under “Risk Factors” in Item 1A of ArQule’s Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 6, 2009, as updated from time to time in our subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.  See also, “Forward-Looking Statements” included in this Quarterly Report on Form 10-Q.

 

ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS .   None

 

ITEM 3. — DEFAULTS UPON SENIOR SECURITIES.   None.

 

ITEM 4. — SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.

 

The Company filed a current report on Form 8-K on July 8, 2009 to report the results of matters submitted to a vote at the Annual Meeting of Stockholders held on May 14, 2009, which is incorporated herein by reference.

 

25



Table of Contents

 

ITEM 6. EXHIBITS

 

EXHIBIT
NO.

 

DESCRIPTION

 

 

 

10.1 +

 

Agreement on Milestone Payments and Royalties, effective as of May 25, 2009 by and between ArQule, Inc. and Daiichi Sankyo Co., Ltd., filed herewith.

31.1

 

Rule 13a-14(a) Certificate of Chief Executive Officer, filed herewith.

31.2

 

Rule 13a-14(a) Certificate of Principal Financial Officer, filed herewith.

32

 

Rule 13a-14(b) Certificate of Chief Executive Officer and Chief Financial Officer, filed herewith.


+                                          Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended or Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

26



Table of Contents

 

ARQULE, INC.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ArQule, Inc.

 

 

 

 

 

 

Date: August 7, 2009

 

/s/ PETER S. LAWRENCE

 

 

Peter S. Lawrence
President and Chief Operating Officer
(Principal Financial Officer)

 

 

 

 

 

/s/ ROBERT J. WEISKOPF

 

 

Robert J. Weiskopf
Vice President of Finance,
Corporate Controller and Treasurer
(Principal Accounting Officer)

 

27


 

Exhibit 10.1

 

AGREEMENT ON MILESTONE PAYMENTS AND ROYALTIES

 

This AGREEMENT ON MILESTONE PAYMENTS AND ROYALTIES is entered into by and between ArQule, Inc. and Daiichi Sankyo Co., Ltd. ( collectively, the “Parties”) .

 

WHEREAS, the Parties have enter ed into that certain Collaborative Research, Development and License Agreement (the “Agreement”) on November 7, 2008 ;

 

WHEREAS, Section  5.4 of the Agreement provides that the Parties shall negotiate in good faith and reach agreement on an amendment to the Agreement or a separate agreement to be executed by the Parties setting forth certain milestone payments and royalties to be paid under the License Agreement for each Licensed Product that is Developed and Commercialized under the Agreement and/or a License Agreement and additional provisions relating thereto; and

 

WHEREAS, the Parties have agreed upon the milestone events, the amount of milestone payments and sales milestone payments, and the royalty rates at this time, and to negotiate other provisions later.

 

NOW, THEREFORE, in consideration of the mutual promises set forth herein and for other good and valuable consideration, the receipt and sufficiency of which is acknowledged by the Parties, the Parties hereto, intending to be legally bound, hereby agree as follows:

 

1.             Terms which are defined in the Agreement are used herein as so defined.

 

2              The Parties agree that the timing of milestone payments and the amount of milestone payments and sales milestone payments and the royalty rates to be included in each License Agreement are as attached hereto as Exhibit A.

 

3              The Parties agree that any term and condition described in Exhibit A of this a greement and Schedule 3 of the Agreement (except as modified in Exhibit A of this a greement ) shall be included in each License Agreement.

 

4              Notwithstanding Section 5.4 of the Agreement, the Parties agree to negotiate such additional provisions relating to royalty reports, payment mechanisms and dates, audit rights, overdue payments, taxes, currency conversion rates and other provisions as are usual and customary for inclusion in provisions relating to milestones and royalties at the time of negotiation of each License Agreement . For purpose of clarity, such additional provisions shall supplement and shall not materially expand, limit or change any term and condition agreed in this agreement or set forth in Schedule 3 of the License Agreement (except as modified in Exhibit A of this a greement ).

 

This agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one and the same agreement.

 

*   *   *   *   *   *   *   *

 


[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.  CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.  OMITTED TEXT IS INDICATED BY AN “*”.

 



 

 

ArQule, Inc.

 

 

 

 

 

 

 

By:

/s/ Paolo Pucci

 

 

Name: Paolo Pucci

 

 

Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

Daiichi Sankyo Co., Ltd.

 

 

 

 

 

 

 

By:

/s/ Takashi Shoda

 

 

Name: Takashi Shoda

 

 

Title: President and Chief Executive Office r

 



 

Exhibit A

 

Milestone Payments and Royalties

 

A. Development and Regulatory Milestones

 

Milestone Event

 

Milestone Payment

 

1. *

 

$* million

 

2. *

 

$* million

 

3. *

 

$* million

 

4 . *

 

$* million

 

5 . *

 

$* million

 

6 . *

 

$* million

 

7 . *

 

$* million

 

8 . *

 

$* million

 

9 . *

 

$* million

 

10. *

 

$* million

 

11 . *

 

$* million

 

12 . *

 

$* million

 

13. *

 

$* million

 

14. *

 

$* million

 

15. *

 

$* million

 

1 6 . *

 

$* million

 

1 7 . *

 

$* million

 

19. *

 

$* million

 

20 . *

 

$* million

 

21 . *

 

$* million

 

22 . *

 

$* million

 

 



 

B. Sales Milestones

 

Milestone Event

 

Milestone Payment

 

Annual Net Sales in a Calendar Year of $* million

 

$* million

 

Annual Net Sales in a Calendar Year of $* million

 

$* million

 

Annual Net Sales in a Calendar Year of $* billion

 

$* million

 

Annual Net Sales in a Calendar Year of $* billion

 

$* million

 

 

C. Royalties

 

Annual Net Sales Increment in the Territory

 

Royalty Rate
a
pplicable for such tier

 

Up to $* million

 

*%

 

Above $* million, but less than or equal to $* billion

 

*%

 

Above $* billion

 

*%

 

 


 

Exhibit 31.1

 

CERTIFICATE OF THE CHIEF EXECUTIVE OFFICER

 

I, Paolo Pucci, certify that:

 

1.                I have reviewed this quarterly report on Form 10-Q of ArQule, Inc.;

 

2.                Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.                Based on my knowledge, the financial statements, and other financial information included in this report fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.                The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)               Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)              Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)               Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and

 

d)              Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)               All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)              Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date:  August 7, 2009

 

 

 

/s/ PAOLO PUCCI

 

 

Paolo Pucci

 

 

Chief Executive Officer

 

 

(Principal Executive Officer)

 


 

Exhibit 31.2

 

CERTIFICATE OF THE PRINCIPAL FINANCIAL OFFICER

 

I, Peter S. Lawrence, certify that:

 

1.                I have reviewed this quarterly report on Form 10-Q of ArQule, Inc.;

 

2.                Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.                Based on my knowledge, the financial statements, and other financial information included in this report fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.                The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)               Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)              Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)               Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and

 

d)              Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)               All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)              Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date:  August 7, 2009

 

 

 

/s/ PETER S. LAWRENCE

 

 

Peter S. Lawrence

 

 

President and Chief Operating Officer

 

 

(Principal Financial Officer)

 


 

Exhibit 32

 

ARQULE, INC.

 

CERTIFICATE OF THE CHIEF EXECUTIVE OFFICER AND

PRINCIPAL FINANCIAL OFFICER

 

The undersigned, Paolo Pucci Chief Executive Officer (Principal Executive Officer) of ArQule, Inc. (the “Company”) and Peter S. Lawrence, President and Chief Operating Officer (Principal Financial Officer), of the Company, both duly elected and currently serving, hereby certify that, to the best of his or her knowledge:

 

1.                the quarterly report on Form 10-Q for the period ending June 30, 2009, filed on behalf of the Company pursuant to the Securities Exchange Act of 1934 (the “Exchange Act”) and containing the financial statements of the Company, fully complies with the requirements of section 13(a) of the Exchange Act; and

 

2.                the information contained in such quarterly report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by such quarterly report.

 

This certification accompanies the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2009, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (the “2002 Act”) and shall not be deemed filed by the Company for purposes of Section 18 of the Exchange Act.

 

This certification is being made for the exclusive purpose of compliance by the Principal Executive Officer and Principal Financial Officer of the Company with the requirements of Section 906 of the 2002 Act, and may not be disclosed, distributed or used by any person for any reason other than as specifically required by law.

 

IN WITNESS WHEREOF, the undersigned have executed this Certificate as of the 7th day of August 2009.

 

 

/s/ PAOLO PUCCI

 

 

Name:

Paolo Pucci

 

 

Title:

Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

/s/ PETER S. LAWRENCE

 

 

Name:

Peter S. Lawrence

 

 

Title:

President and Chief Operating Officer

 

 

 

(Principal Financial Officer)