Breaking News Bar

Business News and Information

BioCryst Reports Fourth Quarter and Full Year 2006 Financial Results

BIRMINGHAM, Ala., Feb. 7 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the quarter and year ended December 31, 2006.

Fourth Quarter Results

The Company reported a net loss of $10.1 million, or $0.34 per share, for the fourth quarter of 2006, compared to a net loss of $7.2 million, or $0.27 per share, for the fourth quarter of 2005.

For the three months ended December 31, 2006, the Company reported revenue of $2.1 million as compared to $0.02 million for the three months ended December 31, 2005. Revenues for the fourth quarter of 2006 increased primarily due to amounts earned pursuant to our collaboration agreements with Mundipharma International Holdings Limited (Mundipharma) and Roche and the continuing amortization of the upfront payments from those agreements.

R&D expenses for the fourth quarter of 2006 were $11.2 million as compared to $6.0 million for the same period in 2005. The increase is primarily attributable to the clinical and manufacturing costs of our expanded peramivir and Fodosine(TM) programs, increases in personnel and related costs to support the clinical development of the Company's pipeline, plus a $0.5 million non- cash share-based compensation charge. Statement of Financial Accounting Standards No. 123( R ) ("SFAS 123R") was adopted by the Company on January 1, 2006.

G&A expenses for the fourth quarter of 2006 were $1.6 million, compared to $1.5 million in the same period of 2005. An increase of $0.6 million in share-based compensation expense more than offset decreases in professional fees and other personnel costs.

At December 31, 2006, cash, cash equivalents and investments totaled $46.2 million.

Year-End Results

The Company reported a net loss of $43.6 million, or $1.50 per share, for 2006, compared with a net loss of $26.1 million, or $1.01 per share for 2005.

The Company reported revenue of $6.2 million in 2006 compared to $0.2 million in 2005. Revenues for 2006 include amounts earned during the year pursuant to our collaboration agreements and the continuing amortization of the upfront payments from those agreements.

R&D expenses for 2006 were $47.1 million as compared to $23.6 million in 2005. The reasons for the increase in R&D expenses for the twelve month periods are essentially the same as those discussed for the comparable quarters. The share-based compensation charge included in R&D expense during 2006 was $1.5 million.

G&A expenses for 2006 were $6.1 million compared to $3.7 million in 2005. The primary reasons for the increase in G&A expenses were the share-based compensation charge of $1.8 million, and increases in personnel related costs and professional fees.

    2006 and Recent Corporate Highlights
    -- Initiated Pivotal Phase IIb Fodosine(TM) Clinical Trial
       In January, 2007, BioCryst initiated a pivotal phase IIb clinical trial
       with Fodosine(TM), in the treatment of patients with relapsed or
       refractory T-cell leukemia/lymphoma. Initiation of this trial triggered
       a $5 million event payment from Mundipharma to BioCryst under the terms
       of the collaboration established in February, 2006.

       The multicenter, open-label, non-randomized, repeat-dose registration
       study will be conducted in accordance with a Special Protocol
       Assessment (SPA) agreement between the U.S. Food and Drug
       Administration (FDA) and BioCryst and will test a combination of
       intravenous and oral formulations of Fodosine(TM). Designed to
       determine the rate of complete remission achieved with this regimen of
       Fodosine(TM), the multinational trial will include sites in the United
       States, Eastern and Western Europe, and South America.

       This trial builds on earlier studies, from which, data were presented
       during 2006 at the American Society of Hematology and the American
       Association for Cancer Research meetings.

    -- Initiated Phase II Peramivir Clinical Trial
       Additionally, in January, 2007, BioCryst initiated a Phase II clinical
       trial of peramivir, the company's lead influenza neuraminidase
       inhibitor, to determine the safety and efficacy of an intramuscular
       formulation of the drug in patients with influenza. The double-blind,
       placebo-controlled trial will enroll patients with acute influenza at
       sites in North America, Europe and Southeast Asia. Two different doses
       of peramivir will be tested.

       This most recent study is based on the positive Phase I clinical data
       obtained in 2006 and reported at the 46th Annual ICAAC meeting in
       September 2006.

    -- Awarded $102.6 Million Four-Year Contract from HHS for Development of
       Peramivir
       Also in January, 2007, BioCryst announced that it had been awarded a
       $102.6 million, four-year contract from the U.S. Department of Health
       and Human Services (DHHS) to fund development of peramivir, for the
       treatment of seasonal and life-threatening influenza, including avian
       flu. The award is part of a larger DHHS initiative to pursue the
       development of new therapies and vaccines which may expand the ability
       of the United States to respond quickly to a potential pandemic.
       Receiving this contract from DHHS further highlights the potential
       importance of peramivir as an effective antiviral agent for the
       treatment of seasonal and life-threatening influenza, including avian
       flu.

    -- Recruited Experienced, Industry Veteran as CEO
       On January 8, 2007, BioCryst announced Jon P. Stonehouse, had been
       appointed Chief Executive Officer and a member of the company's Board
       of Directors. Mr. Stonehouse, a pharmaceutical executive for nearly 20
       years, has strong commercialization, financial transaction, business
       development and management experience. He most recently served as
       Senior Vice President of Corporate Development at Merck KGaA with
       responsibility for global licensing and business development, corporate
       mergers and acquisitions, corporate strategic planning and alliance
       management

    -- Recruited Seasoned, Thought-Leader as CMO
       In June, 2006, BioCryst announced W. James Alexander, M.D., M.P.H., had
       joined the company as Senior Vice President, Clinical and Regulatory
       Operations and Chief Medical Officer. Previously Dr. Alexander was
       Global Chief Medical Officer for Inveresk Research Group. Prior to that
       position, he had served as Chief Executive Officer, President and Chief
       Medical Officer at PharmaResearch Corporation with responsibilities for

       medical and regulatory operations. Dr. Alexander was Vice President and
       Worldwide Director for product safety and pharmacovigilance at
       GlaxoWellcome before joining PharmaResearch Corporation. He has
       contributed to the development and regulatory approvals of drugs for
       the treatment of protozoal, bacterial, and viral infections and
       respiratory conditions.

    -- Entered Agreement with Green Cross for Peramivir in Korea
       In June, 2006, BioCryst announced that it had entered an agreement with
       Green Cross Corporation for the development and commercialization of
       peramivir in Korea.

    -- Entered Agreement with Mundipharma for Fodosine(TM)
       In February, 2006, BioCryst announced that it had entered into an
       exclusive license agreement to develop and commercialize Fodosine(TM),
       in markets across Europe, Asia and Australia for use in oncology.

"The progress of 2006 has set the stage for 2007 and beyond," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "With our pipeline of three product candidates in clinical development and a productive and efficient discovery engine, BioCryst is well poised to continue its logical evolution from a research-based organization into a product development company."

BioCryst management will discuss the company's fourth quarter and year-end results and provide an update on the company's other programs and business results.

To access the webcast via the internet, log on to http://www.biocryst.com. Please connect to the website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternately, please call 1-800-817-4887 (U.S.) or 1-913-981-4913 (international). Telephone replay will be available. To access the replay, please call 1-888-203-1112 (U.S.) or 1-719-457-0820 (international) and dial the participant passcode 8445636. The webcast will be archived on http://www.biocryst.com.

About BioCryst

BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including Fodosine(TM) in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization BCX-4208, and is collaborating with Mundipharma for the development and commercialization of Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com.

Forward-looking statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that DHHS could reduce or eliminate funding for peramivir, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future clinical trials may not have positive results, that we may not be able to complete successfully the Phase IIb trial for Fodosine(TM) that is currently planned to be pivotal, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not reach favorable agreements with potential pharmaceutical and biotech partners for further development of its product candidates, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.



                        BIOCRYST PHARMACEUTICALS, INC.
                              FINANCIAL SUMMARY

    Condensed Statements of Operations (unaudited)
      (in thousands, except per share)
                                       Three Months Ended  Twelve Months Ended
                                           December 31,       December 31,
                                         2006       2005     2006       2005
   Revenues:
    Collaborative and other research
     and development                      $2,092      $21    $6,212      $152

    Expenses:
    Research and development              11,199    6,040    47,083    23,643
    General and administrative             1,631    1,469     6,109     3,686
               Total expenses             12,830    7,509    53,192    27,329

    Loss from operations                 (10,738)  (7,488)  (46,980)  (27,177)

    Interest and other income                688      327     3,362     1,078

                Net loss                $(10,050) $(7,161) $(43,618) $(26,099)

    Basic and diluted net loss per
     common share                         $(0.34)  $(0.27)   $(1.50)   $(1.01)

    Weighted average shares outstanding   29,240   26,865    29,147    25,721



    Balance Sheet Data (in thousands)
                                          December 31, 2006  December 31, 2005
                                              (Unaudited)           (Audited)

    Cash, cash equivalents and securities      $46,236               $59,988
    Total assets                                68,485                99,248
    Accumulated deficit                       (195,481)             (151,863)
    Stockholders' equity                        21,155                58,440

Source: BioCryst Pharmaceuticals, Inc.

Data & News supplied by www.cloudquote.io
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.
 
bottom clear