e8vk
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: February 7, 2007
BioCryst Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware
(State or other jurisdiction
of incorporation)
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000-23186
(Commission
File Number)
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62-1413174
(IRS Employer
Identification #) |
2190 Parkway Lake Drive, Birmingham, Alabama 35244
(Address of Principal Executive Office)
(205) 444-4600
(Registrants 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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 210.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition:
On February 7, 2007, the Company issued a news release announcing its financial results for
the fourth quarter and year ended December 31, 2006, which also referenced a conference call to
discuss these results and provide an update on the status of the Companys programs. A copy of the
news release is furnished as exhibit 99.1 hereto and is incorporated by reference into Item 9.01 of
Form 8-K.
Item 9.01. Financial Statements and Exhibits:
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Exhibit No. |
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Description |
99.1
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Press release dated February 7, 2007 entitled BioCryst Reports
Fourth Quarter and Full Year 2006 Financial Results. |
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.
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Dated: February 7, 2007 |
BioCryst Pharmaceuticals, Inc.
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By: |
/s/ Michael A. Darwin
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Michael A. Darwin |
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Chief Financial Officer and Chief
Accounting Officer |
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EXHIBIT INDEX
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Item |
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Description |
99.1
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Press release dated February 7, 2007 entitled BioCryst Reports
Fourth Quarter and Full Year 2006 Financial Results. |
exv99w1
Exhibit 99.1
BIOCRYST PHARMACEUTICALS, INC.
2190 PARKWAY LAKE DRIVE
BIRMINGHAM, AL 35244
205-444-4600 205-444-4640 FAX
www.biocryst.com
Contact:
BioCryst Pharmaceuticals, Inc.
Jonathan M. Nugent
V.P. Corporate Communications
(205) 444-4633
FOR IMMEDIATE RELEASE
BIOCRYST REPORTS FOURTH QUARTER AND FULL YEAR 2006
FINANCIAL RESULTS
Birmingham, Alabama February 7, 2007 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 programs, increases in personnel and related costs to
support the clinical development of the Companys 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
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Initiated Pivotal Phase IIb Fodosine Clinical Trial
In January, 2007, BioCryst initiated a pivotal phase IIb clinical trial with Fodosine, 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. |
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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. Designed to determine the rate of complete remission
achieved with this regimen of Fodosine, the multinational trial will include sites in the
United States, Eastern and Western Europe, and South America. |
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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. |
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Initiated Phase II Peramivir Clinical Trial
Additionally, in January, 2007, BioCryst initiated a Phase II clinical trial of peramivir,
the companys 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. |
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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. |
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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. |
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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 companys 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 |
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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. |
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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. |
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Entered Agreement with Mundipharma for Fodosine
In February, 2006, BioCryst announced that it had entered into an exclusive license
agreement to develop and commercialize Fodosine, 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 companys fourth quarter and year-end results and provide an
update on the companys 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 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 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
companys 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 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 BioCrysts 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)
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Three Months Ended |
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Twelve Months Ended |
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December 31, |
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December 31, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Collaborative and other research and
development |
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$ |
2,092 |
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$ |
21 |
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$ |
6,212 |
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$ |
152 |
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Expenses: |
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Research and development |
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11,199 |
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6,040 |
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47,083 |
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23,643 |
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General and administrative |
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1,631 |
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1,469 |
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6,109 |
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3,686 |
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Total expenses |
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12,830 |
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7,509 |
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53,192 |
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27,329 |
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Loss from operations |
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(10,738 |
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(7,488 |
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(46,980 |
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(27,177 |
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Interest and other income |
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688 |
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327 |
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3,362 |
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1,078 |
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Net loss |
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$ |
(10,050 |
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$ |
(7,161 |
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$ |
(43,618 |
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$ |
(26,099 |
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Basic and diluted net loss per
common share |
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$ |
(0.34 |
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$ |
(0.27 |
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$ |
(1.50 |
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$ |
(1.01 |
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Weighted average shares outstanding |
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29,240 |
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26,865 |
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29,147 |
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25,721 |
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Balance Sheet Data (in thousands)
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December 31, 2006 |
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December 31, 2005 |
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(Unaudited) |
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(Audited) |
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Cash, cash equivalents and securities |
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$ |
46,236 |
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$ |
59,988 |
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Total assets |
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68,485 |
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99,248 |
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Accumulated deficit |
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(195,481 |
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(151,863 |
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Stockholders equity |
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21,155 |
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58,440 |
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