BioCryst Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2011 Financial Results
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the third quarter and nine months ended September 30, 2011.
"We are pleased with the recent results of our 12-week Phase 2b gout
study, which showed that adding low doses of BCX4208
to allopurinol doubled the proportion of patients reaching therapeutic
goal compared to the standard of care of allopurinol alone," said Jon
P. Stonehouse, President and Chief Executive Officer of BioCryst
Pharmaceuticals. "BCX4208 has been shown to work synergistically with
allopurinol and represents an innovative new class of compound that is
differentiated from other approved and experimental gout treatments.
BCX4208 has been safely studied in a wide range of patients with gout,
including patients with co-morbid diseases and kidney stones. Our
ongoing development program is intended to confirm BCX4208 is not
metabolized and should not impact patient's other medications. BCX4208
represents a unique late-stage opportunity with the potential to address
the high unmet medical needs of the large and expanding gout population."
Third Quarter Financial Results
For the three months ended September 30, 2011, revenues decreased to
$5.2 million from $12.0 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 from the completion of peramivir clinical studies. All revenue
in both periods related to reimbursement of peramivir development costs
by HHS/BARDA.
Third quarter 2011 research and development (R&D) expenses decreased to
$14.8 million from $19.2 million in the third 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 associated with increased clinical
activity in that program.
General and administrative (G&A) expenses for the third quarter of 2011
decreased to $3.3 million compared to $3.8 million in last year's
quarter, due to lower third-party professional expenses.
During the third quarter 2011, the Company realized financing costs
associated with its non-dilutive peramivir royalty monetization
transaction completed in the first quarter of 2011. These costs relate
to a $0.6 million mark-to-market loss on its foreign currency hedge,
resulting from changes in the U.S. dollar/yen exchange rate and a $1.2
million interest expense related to the non-recourse notes issued in
conjunction with the financing transaction.
The net loss for the third quarter 2011 was $14.5 million, or $0.32 per
share, compared to a net loss of $10.9 million, or $0.24 per share, for
the three months ended September 30, 2010.
As of September 30, 2011, the Company held cash, cash equivalents and
investments of $61.0 million, compared to $66.3 million as of December
31, 2010. Net operating cash use for the recent quarter was $10.4
million and $25.3 million through nine months of 2011. Operating cash
use for the three and nine months ending September 30, 2011 excludes
$0.6 million and $3.0 million, respectively, 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
For the nine months ended September 30, 2011, total revenues were $14.4
million, reflecting a $16.4 million decrease in HHS/BARDA collaboration
revenue compared to the same period last year. Nine month 2010 revenue
of $45.7 million also included a $7.0 million milestone payment from the
Company's partner, Shionogi & Co., Ltd., and the sale of $6.4 million of
peramivir active pharmaceutical ingredient (API) to Shionogi and Green
Cross Corporation.
R&D expenses decreased to $41.7 million for the first nine months of
2011 from $58.9 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. Additionally, R&D expenses in the same period last year
included $6.3 million of manufacturing costs related to production of
peramivir API for collaborators Shionogi and Green Cross Corp. This API
expense did not recur in 2011.
G&A expenses of $11.3 million for the nine months ended September 30,
2011 were approximately equivalent to the $10.8 million for the same
period in 2010.
The net loss for the nine months ended September 30, 2011 was
$43.8 million, or $0.97 per share, compared to a net loss of
$23.7 million, or $0.53 per share, for the same period last year.
Clinical Development Update & Outlook
In October, BioCryst announced positive top-line results from its
279-patient Phase 2b randomized, double-blind, dose-response study of BCX4208
added to allopurinol 300 mg in gout patients who had failed to reach
the clinically important serum uric acid (sUA) goal of <6 mg/dL on
allopurinol alone. BCX4208 doses evaluated in the study showed
response rates ranging from 33% to 49%, approximately doubling the
proportion of patients reaching goal on placebo (18%). BCX4208 added
to allopurinol was generally safe and well-tolerated at all doses
studied. Over half of the patients originally randomized into this
study continued treatment into a 3-month extension phase, totaling
6-months of uninterrupted BCX4208 add-on treatment. The Company is
also conducting a Phase 1 study to evaluate the metabolic profile of
BCX4208. Results from both of these studies are expected in January
2012
Additional results from the BCX4208
Phase 2b study have been accepted as a late-breaker oral presentation
at the 2011 American College of Rheumatology and the Association of
Rheumatology Health Professionals (ACR/ARHP) Annual Scientific
Meeting. The oral presentation of the study results is titled "BCX4208
Combined With Allopurinol Increases Response Rates in Patients With
Gout Who Fail to Reach Goal Range Serum Urate on Allopurinol Alone: A
Randomized, Double-Blind, Placebo-Controlled Trial" and is scheduled
for November 8, 2011 at 2:30-4:30 p.m. Central Time (Presentation
Number L10)
BioCryst has opened enrollment of patients into its 12-week Phase 2
study of BCX4208 in patients with gout and moderately impaired renal
function
BioCryst has activated approximately 50 additional clinical sites to
support enrollment in the ongoing Phase 3 efficacy study of the
influenza anti-viral i.v. peramivir. Sites in Europe, North America
and India are prepared to enroll patients during the upcoming Northern
Hemisphere flu season. A planned interim analysis to confirm or revise
the study's current enrollment target of 160 patients for the primary
efficacy analysis population is expected to be conducted no later than
mid-2012
The Company continues to advance both of its leading pre-clinical
assets towards IND filings during the second half of 2012. These novel
compounds include BCX4161, a potent inhibitor of kallikrein for
potential development as an oral, prophylactic treatment for
hereditary angioedema, and BCX5191, a potent and selective nucleoside
analog targeting RNA polymerase for the potential treatment of
hepatitis C
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
Wednesday, November 2, 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 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 forhematological
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
Nine Months Ended
September 30,
September 30,
2011
2010
2011
2010
Revenues:
Product sales
$
-
$
-
$
-
$
325
Royalties
-
-
-
711
Collaborative and other research and development
5,249
12,000
14,419
44,651
Total revenues
5,249
12,000
14,419
45,687
Expenses:
Cost of products sold
-
-
-
86
Research and development
14,772
19,197
41,687
58,851
General and administrative
3,282
3,793
11,277
10,799
Total expenses
18,054
22,990
52,964
69,736
Loss from operations
(12,805
)
(10,990
)
(38,545
)
(24,049
)
Interest and other income
92
126
329
397
Interest expense
(1,160
)
-
(2,614
)
-
Loss on foreign currency derivative
(586
)
-
(2,926
)
-
Net loss
$
(14,459
)
$
(10,864
)
$
(43,756
)
$
(23,652
)
Basic and diluted net loss per common share
$
(0.32
)
$
(0.24
)
$
(0.97
)
$
(0.53
)
Weighted average shares outstanding
45,178
44,884
45,103
44,445
Balance Sheet Data (in thousands)
September 30, 2011
December 31, 2010
(Unaudited)
(Note 1)
Cash, cash equivalents and securities
$
61,040
$
66,341
Receivables from collaborations
11,634
30,227
Total assets
92,511
109,447
Non-recourse notes payable
30,000
-
Accumulated deficit
(340,328
)
(296,572
)
Stockholders' equity
26,042
65,503
Note 1: Derived from audited financial statements.
BioCryst Pharmaceuticals Robert Bennett, 919-859-7910 (Investors) or WCG Catherine
Kyroulis, 212-301-7174 (Media)
