BIRMINGHAM, Ala., March 4 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced financial results for the fourth quarter and year ended December 31, 2007.
"In 2007, we gained greater clarity in terms of the progress made in each of our lead product programs, peramivir, forodesine HCl and BCX-4208," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "Each program is now either in mid-stage clinical testing or, in the case of forodesine HCl, a pivotal trial. Over the course of the year, we have assembled a strong management team to execute on our commitments and advance our product candidates in 2008."
Fourth Quarter 2007 Financial Results
The Company reported revenues of $28.2 million in the fourth quarter of 2007, compared to $2.1 million in the fourth quarter of 2006. The increase in revenues is due to revenue from the contract with the U.S. Department of Health and Human Services ("HHS") for the development of peramivir, a $7.0 million milestone payment received from Shionogi & Co., Ltd., and the continuing amortization of deferred revenue from our collaborative agreements.
The net loss for the quarter ended December 31, 2007 was $2.3 million, or $0.06 per share, compared to a net loss of $10.1 million, or $0.34 per share, for the quarter ended December 31, 2006.
Research and development ("R&D") expenses were $29.1 million in the fourth quarter of 2007, compared to $11.2 million in the fourth quarter of 2006. The increase in R&D expenses is primarily attributable to an increase in clinical trial related expenses, manufacturing costs for our lead product candidates and costs related to an increase in the personnel supporting the advanced development of our product candidates.
General and administrative ("G&A") expenses were $2.5 million for the fourth quarter of 2007, compared to $1.6 million for the fourth quarter of 2006. The increase in G&A expenses is primarily due to an increase in personnel related costs as a result of increased headcount, including an increase in the non-cash share-based compensation expense for the quarter and an increase in professional fees.
Year End 2007 Financial Results
The Company reported revenues of $71.2 million for the year ended December 31, 2007, compared to $6.2 million in 2006. The increase in revenues is primarily due to revenue from the contract with HHS for the development of peramivir, a $7 million milestone payment received from Shionogi, and the continuing amortization of deferred revenue from our collaborative agreements.
Net loss applicable to common stockholders for the year ended December 31, 2007 was $29.1 million, or $0.89 per share, as compared to $43.6 million, or $1.50 per share for the year ended December 31, 2006. The net loss for the year ended December 31, 2007 includes non-cash charges of $1.4 million, or $0.04 per share, and stock-based compensation of $5.7 million, or $0.17 per share.
R&D expenses were $94.1 million for the year ended December 31, 2007, compared to $47.1 million for the same period in 2006. The increase in R&D expenses is primarily attributable to an increase in clinical trial related expenses, manufacturing costs for our lead product candidates and costs related to an increase in the personnel supporting the advanced development of our product candidates.
G&A expenses were $9.5 million for the year ended December 31, 2007, compared to $6.1 million for the same period in 2006. The increase in G&A expenses is primarily due to personnel related costs, including an increase of $1.2 million in the non-cash share-based compensation expense for the period, and an increase in professional fees.
As of December 31, 2007, the Company had cash, cash equivalents and
securities of $85.0 million, which is in line with our previous
expectations. For 2008, we expect our net cash use to be between $25.0 and
$30.0 million. This burn rate could vary significantly depending on the
timing of Company expenses and the related reimbursement from HHS.
Recent Corporate and Financial Highlights
-- Peramivir clinical development update
BioCryst conducted an additional review of the data from the Phase II
clinical trial of intramuscular ("i.m.") peramivir. This included a
preliminary analysis of the virologic data, which demonstrated
statistically significant reductions in influenza virus shedding in
both active treatment groups when compared to placebo, with greater
reductions in the 300mg group (p<0.001). The Company's interpretation
of these results is that higher doses of peramivir increase antiviral
activity, and BioCryst believes it is prudent to test the 300mg dose
and a higher dose in a Phase II clinical trial, which is expected to
begin in the next influenza season.
Recently, the Company conducted two pharmacokinetic studies of
peramivir to examine the effect of needle length on adequate drug
exposure. These data showed that a longer needle was necessary for
women who were overweight or obese to achieve adequate levels of drug
exposure. This study will enable BioCryst to ensure that future trials
use the correct needle lengths, and thus maintain consistent drug
exposure in subjects. BioCryst continues to work with HHS to further
advance the peramivir program.
In March, BioCryst entered into an agreement with Shionogi, for the
development and commercialization of peramivir in Japan, for the
treatment of both seasonal and potentially life-threatening human
influenza. Shionogi initiated a Phase II study of intravenous ("i.v.")
peramivir in December 2007, which triggered a $7.0 million milestone
payment to BioCryst.
In the second half of 2008 the Company will initiate the new i.m
peramivir Phase II trial and expect Shionogi to update the progress of
their Phase II i.v. peramivir outpatient trial in March of 2008.
-- Forodesine HCl pivotal trial in patients with cutaneous t-cell lymphoma
In October, BioCryst began enrolling patients in a pivotal,
multinational trial of an oral capsule formulation of its lead oncology
drug candidate, forodesine HCl for cutaneous t-cell lymphoma (CTCL).
As presented at the 2007 American Society of Hematology meeting,
interim data of the Phase I/II clinical trial of forodesine HCl
demonstrated clinical activity as a single agent in refractory CTCL.
The Company expects to have preliminary data from the forodesine HCl
Phase II trial in chronic lymphoid leukemia patients in the fourth
quarter of 2008
-- BCX-4208 clinical development with Roche partnership
In July, BioCryst announced that its partner Roche, for the development
of BCX-4208, initiated a Phase II clinical trial to evaluate BCX-4208
in patients with moderate to severe plaque psoriasis. The trial
continues to enroll patients. BCX-4208 is the lead compound in the
Company's next-generation PNP inhibitor program.
BioCryst intends to file an investigational new drug application in the
third quarter of 2008 for an autoimmune compound the Company retains
worldwide rights to.
-- Key executive management team additions
Several key members have strengthened BioCryst's management team in
2007. In January, Jon P. Stonehouse, former Senior Vice President of
Corporate Development at Merck KGaA, was appointed Chief Executive
Officer. Other key additions to the management team included Stuart
Grant, former Chief Financial Officer at The Serono Group, as Senior
Vice President and Chief Financial Officer; Elliott T. Berger, Ph.D.,
former Vice President, Regulatory Affairs and Quality Assurance, Head
of Global Regulatory Strategy at EMD Pharmaceuticals, as Senior Vice
President of Regulatory Affairs, and Thomas J. Simon, M.D., former Vice
President, Clinical and Quantitative Sciences Administration at Merck &
Co., as interim Chief Medical Officer.
"We are committed to making progress with each of our clinical compounds in 2008, and our overall plan remains focused on moving these compounds closer to market," said Stonehouse. "The next steps are critical - 2008 is a very important year for BioCryst."
Conference Call and Webcast
At 8:30 a.m. Eastern Time today, BioCryst will host a conference call and live webcast to discuss the Company's year end results and provide an update on the Company's programs and business results. Interested parties may access a live webcast of the conference call in the investor relations section of BioCryst's website at 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. Alternately, interested parties may call 1-800-860-2442 (U.S.) or 1-412-858-4600 (international). The audio portion of the webcast will be archived and available for replay for 14 days.
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 transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization of BCX-4208, and 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. to develop and commercialize peramivir in Japan. For more information about BioCryst, please visit the Company's web site at http://www.biocryst.com.
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 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 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
BioCryst's 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.
BIOCRYST PHARMACEUTICALS, INC.
Condensed Statements of Operations (unaudited)
(in thousands, except per share)
Three Months Ended Twelve Months Ended
December 31, December 31,
2007 2006 2007 2006
Collaborative and other
research and development $ 28,172 $ 2,092 $ 71,238 $ 6,212
Research and development 29,114 11,199 94,052 47,083
General and administrative 2,486 1,631 9,466 6,109
Total expenses 31,600 12,830 103,518 53,192
Loss from operations (3,428) (10,738) (32,280) (46,980)
Interest and other income 1,145 688 3,225 3,362
Net loss $ (2,283) $ (10,050) $ (29,055) $ (43,618)
Basic and diluted net loss $ (0.06) $ (0.34) $ (0.89) $ (1.50)
per common share
Weighted average shares
outstanding 37,954 29,240 32,771 29,147
Balance Sheet Data (in thousands)
December 31, 2007 December 31, 2006
Cash, cash equivalents
and securities $ 85,009 $ 46,236
collaborations 39,128 4,556
Total assets 142,717 68,485
Accumulated deficit (224,536) (195,481)
Stockholders' equity 64,905 21,155
|SOURCE BioCryst Pharmaceuticals, Inc.|
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