Filed by Bowne Pure Compliance
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): October 31, 2008
BioCryst Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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000-23186 |
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62-1413174 |
(State or other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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2190 Parkway Lake Drive, Birmingham, Alabama
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35244 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrants telephone number, including area code: (205) 444-4600
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(Former name or former address if changed since last report.) |
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:
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))
1
Item 2.02. Results of Operations and Financial Condition:
On October 31, 2008, the Company issued a news release announcing its financial results for the quarter ended
September 30, 2008, 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 October 31, 2008 entitled BioCryst Reports
Third Quarter 2008 Financial Results and Provides Corporate
Update. |
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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: October 31, 2008
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BioCryst Pharmaceuticals, Inc.
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By: |
/s/ Michael A. Darwin |
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Michael A. Darwin |
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Principal 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 October 31, 2008 entitled BioCryst Reports Third
Quarter 2008 Financial Results and Provides Corporate Update. |
4
Filed by Bowne Pure Compliance
Exhibit 99.1
BIOCRYST PHARMACEUTICALS, INC.
2190 PARKWAY LAKE DRIVE
BIRMINGHAM, AL 35244
205-444-4600 205-444-4640 FAX
www.biocryst.com
BioCryst Reports Third Quarter 2008 Financial Results and Provides Corporate Update
BIRMINGHAM, Ala. October 31, 2008 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today
announced financial results for the quarter ended September 30, 2008.
Third Quarter 2008 Financial Results
For the three months ended September 30, 2008, the Company reported collaborative and other
research and development revenues of $8.9 million compared to $20.5 million for the three months
ended September 30, 2007. This decrease is driven by a reduction in peramivir clinical development
costs and associated revenue from the contract with the U.S. Department of Health and Human
Services (HHS) for the development of peramivir. Currently, the majority of the Companys revenues
are derived from the reimbursement of costs under the contract with HHS.
Research and development (R&D) expenses were $16.0 million for the three months ended September 30,
2008, compared to $29.7 million for the three months ended September 30, 2007. The decrease in R&D
expenses is primarily attributable to a reduction in clinical development costs associated with the
peramivir program, a reduction in manufacturing costs associated with both the peramivir and
forodesine HCl program and a reduction in costs incurred related to the Companys preclinical
programs. These reductions were partially offset by an increase in BioCrysts clinical development
costs in the forodesine HCl program.
General and administrative (G&A) expenses were $2.5 million for the three months ended September
30, 2008, compared to $2.6 million for the three months ended September 30, 2007.
The net loss for the quarter ended September 30, 2008 was $9.0 million, or $0.24 per share,
compared to a net loss for the quarter ended September 30, 2007 of $11.0 million or $0.32 per
share.
As of September 30, 2008, the Company held cash, cash equivalents and investments of $67.9 million.
Year-to-Date 2008 Financial Results
Collaborative and other research and development revenues were $22.3 million for the nine months
ended September 30, 2008, compared to $43.1 million for the nine months ended September 30, 2007.
This decrease is driven by a reduction in peramivir related clinical development costs leading to a
reduction in costs and associated revenue from HHS, plus the $4.9 million reserve taken in the
second quarter of 2008 for amounts BioCryst previously expected to receive from HHS related to costs
incurred in the Phase 3 program in intramuscular peramivir for outpatient influenza. These costs
were associated with the Phase 3 program for peramivir that was voluntarily discontinued earlier
this year and reimbursement of these costs is under discussion with HHS.
R&D expenses were $51.3 million for the nine months ended September 30, 2008, compared to $64.9
million for the nine months ended September 30, 2007. The decrease in R&D expenses is due to a
reduction in the clinical development costs and toxicology costs associated with the peramivir
program and a reduction in manufacturing costs associated with both the peramivir and forodesine
HCl programs. These reductions were partially offset by an increase in the Companys clinical
development costs for forodesine HCl and increases in personnel related costs and professional
services.
G&A expenses were $8.0 million for the nine months ended September 30, 2008, compared to $7.0
million for the nine months ended September 30, 2007. The higher expenses were primarily due to an
increase in professional fees and personnel related costs.
The net loss for the nine months ended September 30, 2008 was $34.8 million, or $0.91 per share,
compared to a net loss for the nine months ended September 30, 2007 of $26.8 million or $0.86 per
share.
As a result of prudent cash control, we reconfirm that the cash burn for the year ended December
31, 2008 will remain at the lower end of $25 to $30 million guidance provided earlier this year,
said Stuart Grant, BioCrysts Chief Financial Officer. We have implemented strategic initiatives,
including a recent 20 percent reduction in our workforce, to focus the Companys resources on the
execution of our late-stage clinical trials and the development of our most promising pre-clinical
compounds. We have full funding of our peramivir program through Phase 2 clinical trials from HHS
and a strong cash position that will allow us to execute on our plan without depending on the
capital markets.
We have recently made significant advancements in our clinical programs and are encouraged by the
positive peramivir efficacy data reported in the Phase 2 study we conducted in subjects with
influenza requiring hospitalization, and the Phase 2 study in subjects with acute uncomplicated
influenza conducted by our partner, Shionogi & Co., Ltd, said Jon Stonehouse, President and Chief
Executive Officer of BioCryst. Over the next year, we have several key value-driving milestones
for both our peramivir and PNP programs and remain committed to advancing our products towards
market.
Corporate Update
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A poster entitled A Double-Blind, Placebo-Controlled Study of Intravenous Peramivir in
Acute Influenza Patients was presented at the 48th Annual Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC), detailing the results of a Shionogi & Co.,
Ltd.-sponsored, placebo-controlled, Phase 2 study of intravenous (i.v.) peramivir, a
neuraminidase inhibitor, in outpatients with acute, uncomplicated influenza. The study met
its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046)
and 600 mg dose (p=0.0046) (hazard ratios were 0.681 for 300 mg dose and 0.666 for the 600
mg dose). The median time to alleviation of symptoms was 59.1 hours for those receiving
the 300 mg dose, 59.9 hours for those receiving the 600 mg dose and 81.8 hours for those
receiving placebo. The study also met all secondary endpoints. Peramivir was generally well-tolerated in the study, with a
similar adverse event profile to that of placebo. Shionogi is currently preparing to
initiate a Phase 3 program with i.v. peramivir in the outpatient setting. |
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BioCryst reported results of an exploratory Phase 2 trial of i.v. peramivir in subjects
hospitalized for acute serious or potentially life-threatening influenza. The Phase 2
trial compared the efficacy and safety of five days of therapy with either 200 mg i.v.
peramivir per day, 400 mg i.v. peramivir per day or 75 mg oral oseltamivir twice a day, in
subjects who required hospitalization related to influenza. The primary objective of the
study was to evaluate a novel composite endpoint, time to clinical stability, which is
comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic
blood pressure and heart rate. Secondary objectives of the study included evaluation of
viral shedding, mortality, clinical relapse and time to resumption of usual activities. In
the primary efficacy population, for all groups combined, the study demonstrated a median
of 25.3 hours to clinical stability, a median of 2.0 log reduction in time weighted change
from baseline in viral titer, zero mortality, no clinical relapse and a median of 10.8 days
of time to resumption of usual activities. There were no statistically significant
differences in any of the efficacy endpoints between the three treatment arms. Peramivir
was generally safe and well-tolerated at these dose levels. Detailed results will be
submitted to an upcoming medical meeting. |
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BioCryst reported top-line results from the completed Phase 2a trial of BCX-4208 in
subjects with moderate to severe plaque psoriasis were consistent with interim findings.
BCX-4208, a potent, rationally designed, orally available purine nucleoside phosphorylase
inhibitor, met its primary endpoint of safety and tolerability and displayed dose-dependant
reductions in peripheral blood lymphocyte counts. The pharmacokinetic and pharmacodynamic
results suggest that BCX-4208 may have utility in diseases dependant on T-cells, B-cells or
uric acid. The Phase 2a results has been accepted for presentation at the 50th
American Society of Hematology Annual Meeting and Exposition (ASH), which will be held in
San Francisco, December 6-9, 2008. |
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The forodesine HCl pivotal trial in cutaneous T-cell lymphoma (CTCL) continues to enroll
subjects with CTCL stages IIB through IVA who have failed three systemic therapies. The
multinational study is evaluating once daily oral forodesine HCL treatment and is being
conducted in accordance with a Special Protocol Assessment agreement between the U.S. Food
and Drug Administration and BioCryst. A laboratory study of forodesine HCl in leukemia
cells has been accepted for presentation at ASH. |
Conference Call and Web cast
BioCrysts management team will host a conference call and Web cast on Friday, October 31, 2008, at
8:30 a.m. Eastern Time to discuss the financial results and recent developments within the
Companys programs. To participate in the conference call, please dial 1-800-860-2442 (United
States) or 1-412-858-4600 (International). No passcode is needed for the call. The Web cast can
be accessed by logging onto http://www.biocryst.com. Please connect to the Web site at least 15
minutes prior to the start of the conference call to ensure adequate time for any software download
that may be necessary.
About BioCryst
BioCryst is an integrated biopharmaceutical company utilizing crystallography and structure-based
drug design to develop a deep pipeline of novel therapeutics targeting major illnesses. BioCryst
is currently advancing investigational new drugs discovered in-house in late-stage clinical trials
for influenza and lymphoma. In addition, the Company has a pre-clinical portfolio of novel
compounds, directed against infectious, cardiovascular, and autoimmune disease targets, to create
long-term sustainable value. The Companys strategic alliances with the U.S Department of Health
and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International
Holdings Ltd. validate its scientific foundation and the utility of its product candidates. For
more information, please visit the Companys website at 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 our belief
that many subjects in the Phase II clinical trials of peramivir did not receive adequate dosing by
intramuscular injection may not be correct, that HHS and the Food & Drug Administration (FDA) may
not agree with our analysis, that HHS may further condition, reduce or eliminate future funding of
the peramivir program, that ongoing peramivir clinical trials may not be successful, that the
peramivir program may not be successful, that the pivotal trial with forodesine HCl in cutaneous
T-cell lymphoma (CTCL) may not meet its endpoint, that development and commercialization of
forodesine HCl in CTCL may not be successful, 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
preclinical and clinical development may not have positive results, 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 be able to retain its current pharmaceutical and biotechnology
partners for further development of its product candidates or it may not reach favorable agreements
with potential pharmaceutical and biotechnology partners for further development of its product
candidates, that our projected burn rate may not be consistent with our expectations, 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, most recent Registration Statement on Form S-3 (File No. 333-145638), 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.
###
BCRXW
BIOCRYST PHARMACEUTICALS, INC.
FINANCIAL SUMMARY
Statements of Operations (Unaudited)
(in thousands, except per share)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues: |
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Collaborative and other research and
development |
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$ |
8,894 |
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$ |
20,463 |
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$ |
22,321 |
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$ |
43,066 |
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Expenses: |
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Research and development |
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15,996 |
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29,730 |
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51,267 |
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64,938 |
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General and administrative |
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2,471 |
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2,595 |
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8,023 |
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6,980 |
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Total expenses |
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18,467 |
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32,325 |
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59,290 |
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71,918 |
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Loss from operations |
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(9,573 |
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(11,862 |
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(36,969 |
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(28,852 |
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Interest and other income |
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578 |
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878 |
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2,167 |
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2,080 |
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Net loss |
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$ |
(8,995 |
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$ |
(10,984 |
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$ |
(34,802 |
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$ |
(26,772 |
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Basic and diluted net loss per
common share |
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$ |
(0.24 |
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$ |
(0.32 |
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$ |
(0.91 |
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$ |
(0.86 |
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Weighted average shares outstanding |
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38,095 |
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34,277 |
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38,040 |
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31,024 |
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Balance Sheet Data (in thousands)
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September 30, 2008 |
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December 31, 2007 |
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(Unaudited) |
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(Audited) |
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Cash, cash equivalents and securities |
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$ |
67,928 |
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$ |
85,008 |
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Receivables from collaborations |
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13,102 |
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39,128 |
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Total assets |
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99,351 |
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142,717 |
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Accumulated deficit |
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(259,338 |
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(224,536 |
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Stockholders equity |
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35,008 |
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64,905 |
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Contact: Stuart Grant, CFO of BioCryst Pharmaceuticals (205) 444-4600