UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): February 24, 2011
BioCryst Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware (State or other jurisdiction of incorporation) |
000-23186 (Commission File Number) |
62-1413174 (IRS Employer Identification No.) |
| 4505 Emperor Blvd., Suite 200, Durham, North Carolina 27703 (Address of Principal Executive Offices) (Zip Code) |
(Registrant’s telephone number, including area code): (919) 859-1302
(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)) |
| Item 1.01 | Entry into a Material Definitive Agreement |
On February 24, 2011, BioCryst Pharmaceuticals, Inc. (the “Company”) announced that it had been
awarded a $55.0 million contract modification by the U.S. Department of Health & Human Services
(“HHS”) intended to fund to completion the Phase 3 development of its neuraminidase inhibitor,
intravenous (i.v.) peramivir, for the treatment of patients hospitalized with influenza. This
contract modification brings the total award from HHS to $234.8 million, providing funding through
completion of Phase 3 development and the filing of a new drug application for i.v. peramivir in
the U.S. It also extends the contract term by 24 months through December 31, 2013.
| Item 7.01 | Regulation FD Disclosure |
On February 24, 2011, the Company issued a news release with respect to the modification. The news
release is furnished as Exhibit 99.1 hereto and is incorporated by reference.
The information furnished is not deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not
deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |||
| 99.1 | Press release dated February 24, 2011 entitled “BioCryst Awarded Additional $55.0 million by
the U.S. Department of Health & Human Services to Complete Peramivir Phase 3 Program” |
|||
SIGNATURE
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 thereunto duly authorized.
| BioCryst Pharmaceuticals, Inc. |
||||
| By: | /s/ Alane Barnes | |||
| Name: | Alane Barnes | |||
| Title: | General Counsel, Corporate Secretary | |||
Date: February 24, 2011
INDEX TO EXHIBITS
| Exhibit No. | Description | |||
| 99.1 | Press release dated February 24, 2011 entitled “BioCryst Awarded Additional $55.0 million by
the U.S. Department of Health & Human Services to Complete Peramivir Phase 3 Program” |
|||
Exhibit 99.1
BIOCRYST AWARDED ADDITIONAL $55.0 MILLION BY THE U.S. DEPARTMENT
OF HEALTH & HUMAN SERVICES TO COMPLETE PERAMIVIR PHASE 3 PROGRAM
OF HEALTH & HUMAN SERVICES TO COMPLETE PERAMIVIR PHASE 3 PROGRAM
| • | BioCryst to host a call to discuss contract modification and updates to the clinical program at 8:30 a.m. Eastern Time Friday, February 25 |
Research Triangle Park, North Carolina — February 24, 2011 — BioCryst Pharmaceuticals, Inc.
(NASDAQ: BCRX) today announced that it has been awarded a $55.0 million contract modification by
the U.S. Department of Health & Human Services (HHS) intended to fund to completion the Phase 3
development of its neuraminidase inhibitor, intravenous (i.v.) peramivir, for the treatment of
patients hospitalized with influenza.
“The shared goal of HHS/BARDA and BioCryst is to achieve approval for peramivir for seriously-ill
influenza patients. We value our long-standing relationship with HHS and their continued support,”
said Jon P. Stonehouse, President and Chief Executive Officer, BioCryst Pharmaceuticals. “This
contract modification allows us to significantly increase the number of enrolling sites for our
ongoing efficacy study and to drive it to completion. Additionally, the FDA and HHS have agreed to
changes in the study that we believe greatly improve the likelihood of demonstrating an improvement
over standard of care. Our first priority is to complete the Phase 3 program and we believe these
changes should help us reach that goal.”
This contract modification brings the total award from HHS to $234.8 million, providing funding
through completion of Phase 3 development and the filing of a new drug application (NDA) for i.v.
peramivir in the U.S. It also extends the contract term by 24 months through December 31, 2013. A
change of indirect rates for prior years resulting from the contract modification has led to
adjustments to BioCryst’s financial results for 2010, as explained in detail below. In January
2007, BioCryst was originally awarded a $102.6 million, four-year contract from HHS to develop
peramivir for the treatment of influenza. During 2009, peramivir clinical development for U.S.
registration shifted to focus on intravenous delivery and the treatment of hospitalized influenza
patients. To support this focus, a September 2009 contract modification was awarded to extend the
program by 12 months and to increase funding by $77.2 million. Through December 31, 2010, $157.6
million has been recognized as revenue under the contract with HHS to support activities related to
the peramivir development program.
Phase 3 Development of Peramivir
To improve the likelihood of a positive clinical outcome, BioCryst has amended the primary efficacy
analysis of its multi-center, randomized, double-blind, controlled study to evaluate the efficacy
and safety of 600 mg i.v. peramivir administered once-daily for five days in addition to standard
of care (SOC), compared to SOC alone, in adults and adolescents who are hospitalized due to serious
influenza. Implementation of the following is supported by the HHS contract modification announced
today:
| • | Changing the primary efficacy analysis of the study to focus on a subset of approximately 160 patients not treated with neuraminidase inhibitors as SOC, in order to provide the greatest opportunity to demonstrate a statistically significant peramivir treatment effect |
| • | Increasing the total study target enrollment up to 600 subjects from the current target of 445 subjects |
| • | Adding at least 45 more clinical site locations in additional countries |
The actual time to reach completion of enrollment will depend on the prevalence and severity of
influenza, as well as the ability of the more than 265 investigator sites to successfully enroll
patients. Further details regarding this Phase 3 study is available at:
http://clinicaltrials.gov/ct2/show/NCT00958776
http://clinicaltrials.gov/ct2/show/NCT00958776
Resulting Adjustment to 2010 Financial Results
In connection with the contract modification, HHS and BioCryst agreed to settle on final indirect
rates for years 2007, 2008 and 2009. As a result, BioCryst will receive a $4.9 million cash
payment from HHS related to the difference between the actual indirect costs incurred against the
contract and the indirect costs that were invoiced at a provisional billing rate during those
years. In order to reach agreement regarding the modification, the Company agreed to reductions of
approximately $1.1 million of indirect costs relating to 2008 and 2009. As this subsequent event
occurred after BioCryst’s release of fourth quarter and full year 2010 financial results but prior
to issuance of its annual financial statements to be included in Form 10-K, the Company will adjust
the financial results previously reported in its February 10, 2011 press release. Accordingly,
collaborative and other research and development revenues for the three and twelve months ended
December 31, 2010 will be reduced to $17.4 million and $62.1 million, respectively. Net loss and
loss per share for the three months ended December 31, 2010 will increase to $10.2 million and
$0.23 per share. Net loss and loss per share for the twelve months ended December 31, 2010 will
increase to $33.9 million and $0.76 per share. Receivables from collaborations, total assets, and
stockholders’ equity as of December 31, 2010 will be reduced to $30.2 million, $109.4 million and
$65.5 million, respectively. Accumulated deficit as of December 31, 2010 will increase to $296.6
million. An adjusted financial table is available at:
http://investor.shareholder.com/biocryst/releases.cfm
http://investor.shareholder.com/biocryst/releases.cfm
Conference Call and Webcast
BioCryst’s management team will host a conference call and webcast on Friday, February 25, 2011 at
8:30 a.m. Eastern Time to discuss the contract modification and clinical program changes. To
participate in the conference call, please dial 1-877-303-8027 (United States) or
1-760-536-5165 (International). No passcode is needed for the call. The webcast can be
accessed by logging onto www.biocryst.com. Please connect to the website 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 peramivir
Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly
delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir
inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of
influenza within a host. In laboratory tests, peramivir has shown activity against multiple
influenza strains, including pandemic H1N1 swine origin flu viral strains. In January 2010,
Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in Japan under the name
RAPIACTA® to treat patients with influenza and in August 2010, Green Cross Corporation
announced that it had received marketing and manufacturing authorization for i.v. peramivir in
Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more
information about peramivir please visit BioCryst’s Web site at www.biocryst.com/peramivir.
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that
block key enzymes involved in infectious diseases, inflammatory diseases and cancer. BioCryst
currently has three novel late-stage compounds in development: peramivir, a neuraminidase inhibitor
for the treatment of influenza, BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the
treatment of gout, and forodesine, an orally-available PNP inhibitor for hematological
malignancies. Utilizing crystallography and structure-based drug design, BioCryst continues to
discover additional compounds and to progress others through pre-clinical and early development to
address the unmet medical needs of patients and physicians. For more information, please visit the
Company’s Web site 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 there
can be no assurance that our compounds will prove effective in clinical studies; that development
and commercialization of our compounds may not be successful; that HHS may further condition,
reduce or eliminate future funding of the peramivir program; 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 pre-clinical 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 actual cash 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 BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
current reports on Form 8-K, all of which identify important factors that could cause the actual
results to differ materially from those contained in our projections and forward-looking
statements.
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BCRXW
| CONTACT: | Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910 (investors) Catherine Collier Kyroulis, WCG, +1-212-301-7174 (media) |