BioCryst Pharmaceuticals Inc.
Aug 4, 2011
PDF

CORRECTING and REPLACING BioCryst Provides Corporate Update and Reports Second Quarter 2011 Financial Results

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Please replace the release with the following corrected version. Please note that the following press release contains corrections to the net operating cash use for both the recent quarter and year to date, which appeared in BioCryst's earnings release issued earlier today. No further information has been changed.

The corrected release reads:

BIOCRYST PROVIDES CORPORATE UPDATE AND REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the second quarter and six months ended June 30, 2011.

"BioCryst continues to execute the expanded BCX4208 Phase 2 gout plan we announced three months ago. We expect this robust program to support discussions with both potential partners and with regulators, and we are on track to report top-line results from the Phase 2b study early in the fourth quarter," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "We have made substantial progress towards our goal of activating at least 45 additional clinical sites, primarily in India, to drive the peramivir Phase 3 study to completion. Early experience from these new sites suggests that we are enrolling more of the subjects that are required for the study's primary efficacy analysis."

Second Quarter Financial Results

For the three months ended June 30, 2011, research and development (R&D) expenses decreased to $14.0 million from $14.7 million in the second quarter of 2010. This decrease was driven by lower development costs associated with the peramivir and forodesine clinical programs following the completion of various clinical studies during 2010, partially offset by higher BCX4208 gout program development costs.

Second quarter 2011 total revenues decreased to $3.7 million from $7.6 million in last year's quarter due to lower collaboration revenue from the Department of Health and Human Services/ Biomedical Advanced Research and Development Authority (HHS/BARDA) under the contract for the continued development of peramivir, resulting primarily from the completion of various clinical studies.

General and administrative (G&A) expenses for the second quarter of 2011 increased to $4.0 million compared to $3.2 million in last year's quarter, due primarily to the relocation of BioCryst's corporate headquarters and to higher third party professional expenses.

During the second quarter 2011, the Company recognized a $1.0 million mark-to-market loss on its foreign currency hedge associated with the non-dilutive peramivir royalty monetization transaction completed in March, which resulted from changes in the U.S. dollar/yen exchange rate. The Company also incurred $1.2 million in interest expenses related to the non-recourse notes issued in conjunction with the financing transaction.

The net loss for the second quarter 2011 was $16.3 million, or $0.36 per share, compared to a net loss of $10.2 million, or $0.23 per share, for the three months ended June 30, 2010.

As of June 30, 2011, the Company held cash, cash equivalents and securities of $72.0 million, compared to $66.3 million as of December 31, 2010. Net operating cash use for the recent quarter was $3.7 million and year to date was $14.9 million. Operating cash use for the six months ending June 30, 2011 excludes $2.5 million in cash used as hedge collateral. BioCryst continues to expect net operating cash use in 2011 to be approximately $35 million.

Year to Date Financial Results

R&D expenses decreased to $26.9 million for the first half of 2011 from $39.7 million in the same period of 2010, primarily due to lower development costs associated with the peramivir and forodesine clinical programs following the completion of various clinical studies during 2010. In addition, first half 2010 R&D expenses included $6.3 million of manufacturing costs related to production of peramivir active pharmaceutical ingredient (API) for collaborators Shionogi & Co., Ltd. and Green Cross Corporation.

For the six months ended June 30, 2011, total revenues were $9.2 million. Following the completion of various peramivir clinical studies during 2010, collaboration revenue associated with the peramivir development contract with HHS decreased by $9.8 million during the first half of 2011 compared to the same period last year. First half 2010 revenue of $33.7 million also included a $7.0 million milestone payment from the Company's partner, Shionogi, and the sale of $6.4 million of peramivir API to Shionogi and Green Cross Corp.

G&A expenses increased to $8.0 million for the six months ended June 30, 2011 from $7.0 million for the six months ended June 30, 2010, due primarily to the relocation of BioCryst's corporate headquarters and to higher third party professional expenses.

The net loss for the six months ended June 30, 2011 was $29.3 million, or $0.65 per share, compared to a net loss of $12.8 million, or $0.29 per share, for the same period last year.

Clinical Development Update & Outlook

Other Corporate Updates

Conference Call and Webcast

BioCryst's leadership team will host a conference call and webcast on Thursday, August 4, 2011 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. 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 http://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 BioCryst Pharmaceuticals

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: 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 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 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 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 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.

BCRXW

BIOCRYST PHARMACEUTICALS, INC.
FINANCIAL SUMMARY
       
Statements of Operations (Unaudited)
(in thousands, except per share)
 
Three Months Ended Six Months Ended
June 30, June 30,
2011   2010   2011   2010  
Revenues:
Product sales $ - $ - $ - $ 325
Royalties - - - 711
Collaborative and other research and development 3,735   7,616   9,170   32,651  
Total revenues 3,735 7,616 9,170 33,687
 
Expenses:
Cost of products sold - - - 86
Research and development 13,975 14,737 26,907 39,654
General and administrative 4,003   3,209   8,005   7,006  
Total expenses 17,978   17,946   34,912   46,746  
 
Loss from operations (14,243 ) (10,330 ) (25,742 ) (13,059 )
 
Interest and other income 136 137 239 271
Interest expense (1,166 ) - (1,455 ) -
Loss on foreign currency derivative (998 ) -   (2,340 ) -  
 
Net loss $ (16,271 ) $ (10,193 ) $ (29,298 ) $ (12,788 )
 
 
Basic and diluted net loss per common share $ (0.36 ) $ (0.23 ) $ (0.65 ) $ (0.29 )
 
Weighted average shares outstanding 45,111 44,517 45,063 44,222
 
                         
 
Balance Sheet Data (in thousands)
June 30, 2011 December 31, 2010
(Unaudited) (Note 1)
Cash, cash equivalents and securities (Note 2) $ 71,991 $ 66,341
Receivables from collaborations 15,961 30,227
Total assets 108,412 109,447
Non-recourse notes payable 30,000 -
Accumulated deficit (325,870) (296,572)
Stockholders' equity 39,266 65,503
 
 
Note 1: Derived from audited financial statements.
Note 2: At June 30, includes restricted cash of $1,416 in 2011 and $625 in 2010

BioCryst Pharmaceuticals
Robert Bennett, 919-859-7910 (Investors)
or
WCG
Catherine Kyroulis, 212-301-7174 (Media)

Source: BioCryst Pharmaceuticals, Inc.

News Provided by Acquire Media