Message #1 From:
Jason Date: May 29, 2007 03:36:45 PM
COLY, Coley Pharmaceutical Group Reports First Quarter Financial Results
Coley Pharmaceutical Group, Inc. (Nasdaq: COLYForum Stocks), a biopharmaceutical company discovering and developing a novel class of drug candidates known as TLR Therapeutics(TM), today reported financial results for the first quarter of 2007.
FINANCIAL UPDATES
First Quarter Results
Coley reported a net loss in the first quarter of 2007 of $7.7 million, which is substantially unchanged versus the same period of 2006.
Coley reported charges in the first quarter of 2007 of $1.5 million associated with the company's January 2007 decision to suspend its independent clinical development of ACTILON(TM) for the treatment of Hepatitis C virus (HCV). The $1.5 million charge is comprised of $1.2 million in employee severance costs and outplacement support services, as well as $0.3 million in non-cash stock compensation expense.
Total revenues were $5.5 million in the first quarter of 2007 compared to $5.0 million in the first quarter of 2006. Revenues increased in the first quarter primarily as a result of reimbursement from Pfizer for development services incurred on its behalf.
Research and development (R&D) expenses totaled $10.0 million for the first quarter of 2007 versus $10.8 million in the first quarter of 2006, or a decrease of 7.3%, primarily due to the suspension of the clinical development of ACTILON. Consistent with Coley's strategy to pioneer the development of second-generation TLR Therapeutics, discovery research and preclinical expenses within R&D increased approximately 19.0% in the first quarter, or $0.8 million, over the same quarter in the prior year. Offsetting this increase was a $1.8 million decline in ACTILON clinical development expenses over the first quarter of 2006.
General and administrative (G&A) expenses were $3.9 million in the first quarter of 2007 versus $2.9 million in the first quarter of 2006. The $1.0 million increase in G&A expenses is primarily attributable to employee severance costs and non-cash stock compensation expense associated with the suspension of ACTILON clinical development.
As of March 31, 2007, cash, cash equivalents and marketable securities totaled $97.8 million compared to $107.0 million at December 31, 2006. Common shares outstanding at March 31, 2007 were approximately 26.5 million.
Clinical and Business Development Updates
The first quarter of 2007 was marked by progress for each of Coley's current clinical-stage compounds.
PF-3512676 for Cancer
-- In early April 2007, Pfizer achieved target patient enrollment of
approximately 800 patients in a Phase III clinical trial designed to
assess the efficacy and safety of PF-3512676 administered in
combination with standard-of-care chemotherapy, paclitaxel/carboplatin,
compared to the efficacy and safety of chemotherapy alone, for the
first-line treatment of advanced Stage IIIb/IV non-small cell lung
cancer (NSCLC).
- In December 2006, Pfizer achieved target patient enrollment of
approximately 800 patients in a separate Phase III clinical trial
designed to assess the safety and efficacy of PF-3512676 administered
in combination with standard-of-care chemotherapy,
gemcitabine/cisplatin, compared to chemotherapy alone, also for the
first line treatment of advanced NSCLC.
- The primary endpoint for these Phase III clinical trials is overall
survival. Historically, median survival with standard-of-care
chemotherapy is 7 to 10 months.
-- Also in the first quarter of 2007, Pfizer expanded the breadth of its
clinical investigation of PF-3512676. Pfizer has initiated a Phase I
clinical trial of PF-3512676 combined with their anti-CTLA-4 (cytotoxic
T lymphocyte antigen-4) targeted monoclonal antibody in patients with
advanced malignant melanoma.
AVE-0675 for Allergy and Asthma
-- In January, Coley was notified by its partner, sanofi-aventis, that the
US Food and Drug Administration (FDA) lifted its clinical hold on a
Phase I clinical trial of AVE-0675. A Phase I clinical trial has now
been initiated by sanofi-aventis to assess the safety of AVE-0675, a
first-in-class TLR9 agonist monotherapy delivered via inhalation, for
the treatment of allergy and allergic rhinitis.
VaxImmune(TM)
-- Coley added two new licensees to its expanding roster of blue-chip
vaccine developers using the company's vaccine adjuvant, VaxImmune.
- Merck & Co., Inc. licensed VaxImmune for incorporation into vaccines
being developed for certain infectious diseases and Alzheimer's
disease. In exchange for a worldwide, non-exclusive license, Merck
will pay Coley an upfront license fee of $4.0 million. Coley is also
eligible to receive milestone payments of up to $33 million, as well
as royalties from the sale of any products that are commercialized
under the agreement.
- Coley signed a non-exclusive license agreement with Emergent
BioSolutions for the incorporation of VaxImmune in the development of
Emergent's new anthrax vaccines.
2007 Financial Guidance
Coley's 2007 financial guidance remains unchanged from that previously provided in February 2007. Based on our current operating plan, Coley continues to expect its full-year net loss to be from approximately $25.0 million to $29.0 million and its estimated cash burn to be between $35.0 million and $39.0 million in 2007. As a result, Coley continues to expect unrestricted cash, cash equivalents and marketable securities to be in the range of $68.0 million to $72.0 million at the end of 2007.
Investor Update Call
Coley will be hosting a conference call and webcast today, May 3, 2007 at 4:30 p.m. U.S. Eastern Daylight Time with company management to discuss first quarter results.
To access the live audio broadcast or the subsequent archived recording, visit the Investor Center section of the Coley website located at http://www.coleypharma.com . Please log onto Coley's website several minutes prior to the start of the call to ensure adequate time for any software download that may be required. The webcast is also being distributed through the Thomson StreetEvents Network to both institutional and individual investors. Individual investors can listen to the call at
Investors may participate in the conference call by dialing either +1-866-510-0710 in the U.S. or +1-617-597-5378 outside the U.S. and typing in the passcode 60238934. A replay of the call may also be accessed via telephone by dialing +1-888-286-8010 (U.S.) or +1-617-801-6888 (international) with the passcode 43210799. The archived webcast and replay of the call will be available through May 17, 2007.
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, allergy and asthma disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck, Novartis Vaccines and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com .
