BioCryst Reports Fourth Quarter and Full Year 2011 Financial Results
- Management to provide corporate update and discuss BCX5191 hepatitis C preclinical results
"As we move forward into 2012, BioCryst has the most promising pipeline
in its history. Today our portfolio is balanced with both late- and
early-stage assets, including a Phase 3 influenza program that is fully
funded by the
Fourth Quarter Financial Results
For the three months ended
Fourth quarter 2011 research and development expenses decreased to
General and administrative expenses for the fourth quarter of 2011
decreased to
During the fourth quarter 2011, the Company incurred financing costs
associated with its non-dilutive peramivir royalty monetization
transaction completed in the first quarter of 2011. These costs relate
to a
The net loss for the fourth quarter 2011 was
Full Year 2011 Financial Results
For the year ended
Research and development expenses decreased to
General and administrative expenses of
During 2011, the Company realized financing costs associated with its
peramivir royalty monetization transaction noted above, including a
The net loss for the year ended
Cash, cash equivalents and investments totaled
Clinical Development Update & Outlook
- Yesterday BioCryst announced positive preclinical results for BCX5191, a potent and selective nucleoside analog targeting RNA polymerase for the potential treatment of hepatitis C. BioCryst expects to complete toxicology and other preclinical studies, and to be ready to file for first-in-human studies during the fourth quarter of 2012.
-
In
January 2012 , BioCryst announced positive long-term results from the extension phase of its randomized Phase 2b study of BCX4208 added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of < 6 mg/dL on allopurinol alone. The results of this 24-week, blinded safety extension confirm that BCX4208 was generally safe and well-tolerated, and sustained sUA control over time. These results are consistent with the previously reported positive findings at the 12-week primary efficacy time point. In a sub-study to assess responses to a vaccine challenge after 16 or 20 weeks of BCX4208 treatment, patients generated a healthy immune response. - BioCryst is preparing for upcoming BCX4208 end of Phase 2 regulatory discussions. In addition, the Company is actively evaluating potential partners to fund Phase 3 development and commercialization.
- BioCryst continues to enroll patients in the ongoing Phase 3 efficacy study of the influenza antiviral i.v. peramivir. The Company plans to provide an update following the planned interim analysis, which has been amended to include an assessment of futility as well as a change in timing. This analysis is now scheduled to be conducted at the earlier of the following: the conclusion of the 2012 Southern Hemisphere flu season or reaching 70% of the current enrollment goal of 160 patients for the primary efficacy analysis population.
- The Company continues to advance BCX4161, a potent inhibitor of kallikrein for potential development as an oral, prophylactic treatment for hereditary angioedema to be ready to file for first-in-human studies during the second half of 2012.
Financial Outlook for 2012
Based upon current trends and assumptions, as well as the Company's
planned operations, BioCryst expects net operating cash use to be in the
range of
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
About
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 trials;
that development and commercialization of our compounds may not be
successful; that HHS/BARDA 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
BCRXW
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| CONSOLIDATED FINANCIAL SUMMARY | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| Statements of Operations | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
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December 31, | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales | $ | - | $ | - | $ | - | $ | 325 | ||||||||
| Royalties | - | (711 | ) | - | - | |||||||||||
| Collaborative and other research and development | 5,224 | 17,405 | 19,643 | 62,056 | ||||||||||||
| Total revenue | 5,224 | 16,694 | 19,643 | 62,381 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of products sold | - | - | - | 86 | ||||||||||||
| Research and development | 14,116 | 24,068 | 56,898 | 83,900 | ||||||||||||
| General and administrative | 2,150 | 2,934 | 12,332 | 12,752 | ||||||||||||
| Total expenses | 16,266 | 27,002 | 69,230 | 96,738 | ||||||||||||
| Loss from operations | (11,042 | ) | (10,308 | ) | (49,587 | ) | (34,357 | ) | ||||||||
| Interest and other income | 84 | 107 | 413 | 504 | ||||||||||||
| Interest expense | (1,160 | ) | - | (3,774 | ) | - | ||||||||||
| Loss on foreign currency derivative | (1,074 | ) | - | (4,000 | ) | - | ||||||||||
| Net loss | $ | (13,192 | ) | $ | (10,201 | ) | $ | (56,948 | ) | $ | (33,853 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.29 | ) | $ | (0.23 | ) | $ | (1.26 | ) | $ | (0.76 | ) | ||||
| Weighted average shares outstanding | 45,266 | 44,918 | 45,144 | 44,564 | ||||||||||||
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Note: Legal patent costs are now classified as Research &
Development expense, whereas previously they were classified as General & Administrative expense. |
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| Balance Sheet Data | ||||||||||||||||
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| Cash, cash equivalents and securities | $ | 57,725 | $ | 66,341 | ||||||||||||
| Receivables from collaborations | 5,831 | 30,227 | ||||||||||||||
| Total assets | 82,208 | 109,447 | ||||||||||||||
| Non-recourse notes payable | 30,000 | - | ||||||||||||||
| Accumulated deficit | (353,520 | ) | (296,572 | ) | ||||||||||||
| Stockholders' equity | 14,806 | 65,503 | ||||||||||||||
Investors:
or
Media:
Catherine Kyroulis, WCG,
+1-212-301-7174
Source:
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