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): August 7, 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) |
Registrant’s 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 August 7,
2008, the Company issued a news release announcing its financial results for
the quarter ended June 30, 2008, which also referenced a conference call to
discuss these results and provide an update on the status of the
Company’s 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 August 7, 2008
entitled “BioCryst Reports Second 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: August 7, 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 August 7, 2008
entitled “BioCryst Reports Second 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 Second Quarter 2008 Financial Results and Provides Corporate Update
BIRMINGHAM, Ala., August 7, 2008 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced
financial results for the quarter ended June 30, 2008.
Second Quarter 2008 Financial Results
For the three months ended June 30, 2008, the Company reported collaborative and other
research and development revenues of $2.7 million compared to $13.4 million for the three months
ended June 30, 2007. This decrease is driven by a reduction in peramivir related activities
leading to a reduction in 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.
In addition, for the three months ended June 30,
2008, BioCryst recorded a $4.9 million reserve against revenue
in the current quarter for amounts BioCryst previously expected to
receive from HHS related to costs incurred in the Phase III program for intramuscular (i.m.)
peramivir, which was voluntarily discontinued earlier this year. The reimbursement of these costs
is under discussion with HHS.
Research and development (R&D) expenses were $13.4 million for the three months ended June 30,
2008, compared to R&D expenses of $19.0 million for the three months ended June 30, 2007. The
decrease is primarily attributable to a reduction in manufacturing costs associated with our
peramivir program and a reduction in toxicology expenses.
General and administrative (G&A) expenses were $2.7 million for the three months ended June 30,
2008, compared to $2.0 million for the three months ended June 30, 2007. The
higher expenses were primarily due to an increase in professional fees and personnel related
costs.
The net loss for the quarter ended June 30, 2008 was $12.7 million, or $0.33 per share, compared to
a net loss for the quarter ended June 30, 2007 of $7.0 million or $0.24 per share.
As of
June 30, 2008, the Company held cash, cash equivalents and
investments of $74.2 million.
Year-to-Date 2008 Financial Results
Collaborative and other research and development revenues were $13.4 million for the six months
ended June 30, 2008, compared to $22.6 million for the six months ended June 30, 2007. This
decrease is driven by a reduction in peramivir related activities leading to a reduction in costs
and associated revenue from HHS, plus the $4.9 million reserve taken in the second quarter of 2008.
R&D expenses were $35.3 million for the six months ended June 30, 2008, compared to $35.2 million for the six months ended June 30, 2007. Increases in clinical, personnel and
professional costs were offset by decreases in manufacturing and toxicology costs.
G&A
expenses were $5.6 million for the six months ended June 30, 2008, compared to $4.4 million for the six months ended June 30, 2007. The higher expenses were primarily due to
an increase in professional fees and personnel related costs.
The net loss for the six months ended June 30, 2008 was $25.8 million, or $0.68 per share, compared
to a net loss for the six months ended June 30, 2007 of $15.8 million or $0.54 per share.
We have
previously provided cash burn guidance of between $25 and $30 million for the year ended
December 31, 2008, said Stuart Grant, Chief Financial
Officer of BioCryst. As our clinical programs evolve and as we maintain a tight focus on costs, we now expect our burn
rate to be closer to the low end of our original guidance. This anticipated burn does include the potential loss of $4.9 million of HHS
revenue associated with the costs of the voluntarily discontinued Phase III peramivir program.
Over the past few months, we achieved significant clinical milestones in both our intravenous and
intramuscular peramivir programs for the treatment of seasonal influenza, said Jon P. Stonehouse,
Chief Executive Officer of BioCryst. We reported positive Phase II study results for intravenous
peramivir in the outpatient setting and initiated a Phase II trial for intramuscular peramivir in
the outpatient setting. We remain encouraged by the recent peramivir data and continue to
aggressively advance this program and the development of our other product candidates.
Recent Corporate Highlights
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BioCryst reported preliminary results of a Phase II study of intravenous (i.v.)
peramivir administered via a single-dose injection in the outpatient setting for the
treatment of seasonal influenza. The trial, conducted by BioCrysts partner, Shionogi &
Co., Ltd. in Japan, met its primary endpoint of improvement in the median time to
alleviation of symptoms in subjects with confirmed, acute, uncomplicated influenza
infection, compared to placebo alone. This result was highly statistically significant.
Further, safety assessments confirmed that peramivir was generally well-tolerated. Based
on the studys preliminary results, Shionogi has commenced preparations for a Phase III
trial of i.v. peramivir in the outpatient setting. |
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Results from Phase I pharmacokinetic (PK) studies of peramivir comparing a new, 150
mg/mL formulation to the previously used 75 mg/mL formulation, demonstrated similar
bioavailability between the two formulations, supporting the use of the new more
concentrated 150 mg/mL formulation in clinical trials. The new formulation of peramivir
was also shown to be safe and generally well tolerated at the 600 mg dose level. |
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BioCryst initiated a Phase II study of i.m. peramivir in the outpatient setting for the
treatment of seasonal influenza. The double-blind, placebo-controlled, parallel-group
Phase II trial compares the efficacy of a single 600 mg injection of i.m. peramivir to
placebo in the treatment of seasonal influenza in the outpatient setting. This study will
utilize the 150 mg/mL formulation established in the recently conducted PK studies. The
primary endpoint of the Phase II trial is improvement in time to alleviation of symptoms in
patients. Secondary endpoints include reduction in viral titers and safety and
tolerability. The trial is expected to enroll approximately 320 patients and is currently
ongoing in the Southern Hemisphere. |
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BioCryst appointed William P. Sheridan, MB BS, as Chief Medical Officer, effective July
1, 2008. Dr. Sheridan is a seasoned biotechnology professional, most recently serving as
Vice President of North American Medical Affairs at Amgen, Inc. |
Conference Call and Webcast
The Company will sponsor a conference call at 8:30 a.m. Eastern Time on August 7, 2008 to discuss
the financial results and the status of each of our programs in more detail. This call is open to
the public and can be accessed live either over the Internet from www.biocryst.com or by dialing
1-800-860-2442 (U.S.). No passcode is needed for the call.
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 forodesine HCl in oncology, BCX-4208 in psoriasis and
peramivir in seasonal and life-threatening influenza. BioCryst is collaborating with Mundipharma
for the development and commercialization of forodesine HCl in markets across Europe, Asia,
Australia and certain neighboring countries. In January 2007, the U.S. Department of Health and
Human Services (HHS) awarded a $102.6 million, four-year contract to BioCryst to advance
development of peramivir to treat seasonal and life-threatening influenza. In February 2007,
BioCryst established a partnership with Shionogi & Co., Ltd. to develop and commercialize peramivir
in Japan. 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 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 the
Phase II trial of BCX-4208 for psoriasis may not be successfully completed, 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
Contact: Stuart Grant, CFO of BioCryst Pharmaceuticals (205) 444-4600
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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Six Months Ended |
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June 30, |
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June 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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$ |
2,659 |
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$ |
13,444 |
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$ |
13,427 |
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$ |
22,603 |
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Expenses: |
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Research and development |
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13,373 |
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19,013 |
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35,271 |
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35,208 |
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General and administrative |
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2,666 |
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2,013 |
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5,552 |
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4,385 |
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Total expenses |
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16,039 |
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21,026 |
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40,823 |
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39,593 |
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Loss from operations |
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(13,380 |
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(7,582 |
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(27,396 |
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(16,990 |
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Interest and other income |
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671 |
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619 |
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1,589 |
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1,202 |
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Net loss |
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$ |
(12,709 |
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$ |
(6,963 |
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$ |
(25,807 |
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$ |
(15,788 |
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Basic and diluted net loss per
common share |
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$ |
(0.33 |
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$ |
(0.24 |
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$ |
(0.68 |
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$ |
(0.54 |
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Weighted average shares outstanding |
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38,117 |
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29,420 |
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38,088 |
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29,371 |
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Balance Sheet Data (in thousands)
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June 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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$ |
74,247 |
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$ |
85,009 |
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Receivables from collaborations |
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14,850 |
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39,128 |
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Total assets |
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107,649 |
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142,717 |
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Accumulated deficit |
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(250,343 |
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(224,536 |
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Stockholders equity |
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42,423 |
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64,905 |
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