-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OhjyHc8UJI1AYrwzjLmKMqr1CgM5FfyjExwvys5iQYUYDHw4ve8cRsBuA6pOU+Kv SzukEVrO0Rx74FW4gn6dZA== 0001104659-06-049576.txt : 20060728 0001104659-06-049576.hdr.sgml : 20060728 20060728151350 ACCESSION NUMBER: 0001104659-06-049576 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060727 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060728 DATE AS OF CHANGE: 20060728 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARQULE INC CENTRAL INDEX KEY: 0001019695 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043221586 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21429 FILM NUMBER: 06987829 BUSINESS ADDRESS: STREET 1: 19 PRESIDENTIAL WAY CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 781-994-0300 MAIL ADDRESS: STREET 1: 19 PRESIDENTIAL WAY CITY: WOBURN STATE: MA ZIP: 01801 8-K 1 a06-17006_18k.htm CURRENT REPORT OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 27, 2006

ARQULE, INC.

(Exact Name of Issuer as Specified in Charter)

Delaware

000-21429

04-3221586

(State or other jurisdiction

(Commission File Number)

(I.R.S. Employer

of incorporation)

 

Identification No.)

 

19 Presidential Way

Woburn, MA

(Address of principal executive offices)

01801

(Zip code)

(781) 994-0300

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 




 

Section 2 — Financial Information

Item 2.02.             Results of Operations and Financial Condition.

On July 27, 2006, the Registrant issued a press release announcing its financial results for the fiscal quarter ended June 30, 2006.  The press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.

Section 9 — Financial Statements and Exhibits

Item 9.01.             Financial Statements and Exhibits.

(c) Exhibits.

99.1   Text of Press Release dated July 27, 2006.




 

SIGNATURES

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

ARQULE, INC.

 

(Registrant)

 

 

 

 

 

 

/s/ Louise A. Mawhinney

 

Louise A. Mawhinney

 

Vice President, Chief Financial Officer,

 

and Treasurer

 

Date:  July 27, 2006



EX-99.1 2 a06-17006_1ex99d1.htm EX-99

 

Exhibit 99.1

Contact:

William B. Boni
VP, Investor Relations/
Corp. Communications
(781) 994-0300
www.ArQule.com

FOR IMMEDIATE RELEASE:

ARQULE REPORTS SECOND QUARTER 2006 FINANCIAL RESULTS

Woburn, MA, July 27, 2006 — ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the second quarter of 2006.

For the quarter ended June 30, 2006, the Company reported a net loss of $­­­­­7,575,000 or $0.21 per share, compared with a net loss of $2,427,000, or $0.07 per share, for the second quarter of 2005.  For the six-month period ended June 30, 2006, the Company reported a net loss of $3,288,000, or $0.09 per share, compared to a net loss of $3,871,000, or $0.11 per share, for the six-month period ended June 30, 2005.

The Company reported total revenues of $6,570,000 for the quarter ended June 30, 2006, compared to revenues of $13,454,000 for the second quarter of 2005.  Revenues for the six months ended June 30, 2006 were $30,022,000, compared to revenues of $27,397,000 for the six months ended June 30, 2005.

Compound development revenues for both the 2006 and 2005 periods related primarily to chemistry services provided by the Company to Pfizer Inc. The decreased revenues in the second quarter of 2006 followed the Company’s previously announced decision to exit the chemistry services business upon conclusion of the Pfizer agreement in May 2006.  Research and development revenue in the 2006 and 2005 quarters related primarily to financial support from Hoffmann-La Roche related to the Company’s ongoing development of products in its E2F cancer therapy program.

Total costs and expenses for the quarter ended June 30, 2006 were $15,410,000, compared to $16,129,000 for the second quarter of 2005.  Total costs and expenses for the six months ended June 30, 2006 were $35,917,000, compared to $32,019,000 for the same period in 2005.

Cost of compound development revenue for the three and six-month periods ended June 30, 2006, relating to the production of compounds for Pfizer, totaled $2,526,000 and $8,345,000, respectively, compared with $7,674,000 and $15,027,000 for the three and six-month periods ended June 30, 2005.  Research and development costs for the three and six-month periods

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ArQule/2

ended June 30, 2006 were $9,567,000 and $20,093,000, respectively, compared with $6,217,000 and $12,070,000 for the 2005 three and six-month periods.  Marketing, general and administrative costs for the three and six-month periods ended June 30, 2006 were $2,781,000 and $4,981,000, respectively, compared with $2,238,000 and $4,922,000 for the 2005 three and six-month periods.

For the three and six-month periods ended June 30, 2006, the Company recorded restructuring charges of $536,000 and $2,498,000 related to employee severance associated with the termination of its chemistry services business.  As of June 30, 2006 all affected employees have been separated from the Company, and the termination benefits are expected to be fully paid by December 31, 2006.

On January 1, 2006, the Company adopted the provisions of Statement of Financial Accounting Standards No. 123(R) related to share-based awards.  As a result, the Company recorded charges of $896,000 and $1,775,000 in the quarter and six months ended June 30, 2006, respectively, to reflect share-based compensation expense, which is reflected in compound development cost of revenue, research and development expenses and marketing, general and administrative expenses.

At June 30, 2006, the Company had a total of approximately $119,919,000 in cash and marketable securities.

Operational Review

“We are pleased with the patient enrollment in our clinical programs based upon our two lead scientific platforms, checkpoint pathway activation and c-Met inhibition,” said Dr. Stephen A. Hill, president and chief executive officer of ArQule.  “With regard to our checkpoint pathway activation program, patients are being actively enrolled in Phase 2 trials with ARQ 501 as monotherapy in leiomyosarcoma and as combination therapy with gemcitabine in pancreatic cancer.

“We expect to initiate patient enrollment in a second Phase 2 monotherapy trial with ARQ 501 in head and neck cancer in the near future,” said Dr. Hill. “We also plan to begin a Phase 2 combination therapy trial with ARQ 501 and paclitaxel in ovarian cancer later in the year.  With regard to our c-Met inhibition program, patient enrollment continues on schedule in a Phase 1 clinical trial with ARQ 197, an orally administered small molecule, at three centers in the U.S.

“During the quarter, we also reported updated data from Phase 1 combination therapy trials with ARQ 501 and chemotherapeutic agents,” said Dr. Hill.  “These studies demonstrate clinical tolerability, favorable pharmacokinetics and promising signs of anti-tumor activity in patients with a range of advanced solid tumors.”

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ArQule/3

Conference Call and Webcast

ArQule will hold a conference call at 9:00 a.m. eastern time today, July 27, 2006.  Dr. Stephen A. Hill, president and chief executive officer, and Louise A. Mawhinney, chief financial officer, will lead the call.

Date & Time:

Thursday, July 27, 2006 at 9:00 a.m., Eastern Time

 

Conference Call Numbers

 

 

Toll Free:

866.713.8565

 

Toll:

617.597.5324

 

Code:

ArQule

 

Webcast:

www.arqule.com

 

A replay of the conference call will be available for five days and can be accessed by dialing toll-free 888.286.8010, and outside the U.S. 617.801.6888.  The access code is 85879182.

About ArQule

ArQule, Inc. is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics.  The Company’s targeted, broad-spectrum products and research programs are designed to affect key biological processes that are central to cancer. ArQule’s lead clinical-stage products have been generated from two scientific platforms.  The first of these, Activated Checkpoint TherapySM (ACT), is designed to kill cancer cells selectively while sparing normal cells through direct activation of DNA damage response/checkpoint pathways. The Company’s lead ACT program, based on the E2F1 pathway, is partnered with Roche. ArQule’s second cancer platform, Cancer Survival Protein modulation, has generated a clinical-stage product designed to inhibit a molecule known as c-Met, which plays multiple roles in cancer cell growth, survival, invasion, angiogenesis and metastasis.  For more information, please visit www.arqule.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, which provides a safe harbor for forward-looking statements made by or on behalf of ArQule. ArQule and its representatives may from time to time make written or oral forward-looking statements, including statements contained in this press release. Generally, the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “will” and similar expressions identify forward-looking statements. All statements which address operating performance, events or developments that ArQule expects or anticipates will occur in the future, such as projections about its future results of operations or its financial condition, research, development and commercialization of its products and anticipated trends in its business are forward-looking statements within the meaning of the Reform Act. Actual results, including results of ongoing and anticipated clinical trials, may differ materially from those projected in

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ArQule/4

the forward-looking statements or historical performance due to numerous risks and uncertainties that exist in ArQule’s operations, research and development efforts and the general business environment, including without limitation: compounds in clinical trials based on the ACT platform or other, proprietary platforms may not prove to be safe or efficacious; current and future clinical studies may encounter enrollment difficulties and the commencement of anticipated clinical trials may be delayed or the trials may never commence; the results of clinical trials may be disappointing and not lead to commercial products; preclinical efforts associated with the product pipeline may fail or prove disappointing; animal xenograft preclinical studies may be unpredictive of human response; collaborators may terminate their agreements with ArQule because ArQule may fail to satisfy the prescribed terms of the collaboration or for other reasons; and, the risks and uncertainties described in ArQule’s filings with the Securities and Exchange Commission. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product.  The forward-looking statements contained herein represent the judgment of ArQule as of the date of this report. ArQule disclaims any intent or obligation to update any forward-looking statement except to the extent required by law.




 

ArQule/5

ArQule, Inc.
Condensed Statement of Operations
(In Thousands, Except Per Share Amounts)
(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenue:

 

 

 

 

 

 

 

 

 

Compound development revenue

 

$

4,918

 

$

11,802

 

$

26,718

 

$

24,093

 

Research and development revenue

 

1,652

 

1,652

 

3,304

 

3,304

 

Total revenue

 

6,570

 

13,454

 

30,022

 

27,397

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of revenue - compound development

 

2,526

 

7,674

 

8,345

 

15,027

 

Research and development

 

9,567

 

6,217

 

20,093

 

12,070

 

Marketing, general and administrative

 

2,781

 

2,238

 

4,981

 

4,922

 

Restructuring charge

 

536

 

 

2,498

 

 

Total costs and expenses

 

15,410

 

16,129

 

35,917

 

32,019

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(8,840

)

(2,675

)

(5,895

)

(4,622

)

 

 

 

 

 

 

 

 

 

 

Net investment income

 

1,265

 

498

 

2,607

 

1,001

 

Loss on investment

 

 

(250

)

 

(250

)

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(7,575

)

$

(2,427

)

$

(3,288

)

$

(3,871

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.21

)

$

(0.07

)

$

(0.09

)

$

(0.11

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

35,460

 

34,953

 

35,386

 

34,003

 

 

 

June 30,

 

December 31,

 

Balance sheet data (in thousands):

 

2006

 

2005

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

119,919

 

$

140,643

 

Working capital

 

106,414

 

105,646

 

Total assets.

 

130,974

 

156,684

 

Stockholders’ equity.

 

104,858

 

105,458

 

 

# # #



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