RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the first quarter ended March 31, 2013.
"We are pleased that our recent interactions with the FDA have defined a
pathway to file a peramivir
NDA for regulatory approval in the U.S.," said Jon
P. Stonehouse, President & Chief Executive Officer of BioCryst.
"In addition, our Phase 1 clinical trial of BCX4161
in healthy subjects is progressing. We expect to complete this clinical
trial and report results this summer. If this trial is successful, we
plan to initiate a Phase 2 program in hereditary angioedema patients
this year."
First Quarter Financial Results
For the three months ended March 31, 2013, revenues decreased to
$3.6 million from $12.2 million in last year's quarter. The decrease in
2013 revenue relates primarily to the one-time recognition of $7.8
million of forodesine-related
revenue in 2012, and to a lesser extent, a reduction in 2013 revenue
associated with decreased intravenous (i.v.) peramivir development
activity.
Research and development expenses for the quarter decreased to
$7.4 million from $15.5 million in the first quarter 2012, due primarily
to lower development expenses associated with the peramivir, ulodesine
and BCX5191 programs, as well as $1.9 million of deferred expenses
associated with the one-time forodesine revenue recognized in the first
quarter 2012.
General and administrative expenses for the quarter decreased to
$1.4 million compared to $1.7 million in 2012, due primarily to a
December 2012 corporate restructuring that reduced BioCryst's cost
structure and operations.
In the first quarter of both 2013 and 2012, interest expense was
$1.2 million and related to the Company's non-recourse notes payable. In
addition, a mark-to-market gain on our foreign currency hedge of $2.0
million and $38,000 was recognized in the first quarter of 2013 and 2012
respectively, resulting from periodic changes in the U.S.
dollar/Japanese yen exchange rate.
The net loss for the first quarter of 2013 was $4.5 million, or $0.09
per share, compared to a net loss of $6.1 million, or $0.13 per share,
for the first quarter of 2012.
Cash, cash equivalents and investments totaled $28.9 million at March
31, 2013, compared to $37.1 million at December 31, 2012. Net operating
cash use for the first quarter of 2013 was $8.9 million, as compared to
$12.0 million for the first quarter of 2012.
Clinical Development Update & Outlook
-
In April, BioCryst held a Type C meeting regarding i.v. peramivir
with the U.S. Food & Drug Administration (FDA). At the meeting, the
FDA confirmed that BioCryst's proposed peramivir New Drug Application
(NDA) content supports a reviewable NDA submission for the indication
of acute uncomplicated influenza. The Company has scheduled a pre-NDA
meeting to reach agreement on a complete NDA submission.
-
BioCryst will announce its future plans under the peramivir advanced
development contract upon receiving formal guidance from Biomedical
Advanced Research and Development Authority (BARDA/HHS) following its
recently completed In-Process Review.
-
In March, BioCryst initiated a Phase 1 clinical trial with BCX4161 to
support its development as a treatment for hereditary
angioedema (HAE). The main objectives of the Phase 1 clinical
trial are to demonstrate safety, adequate and consistent drug
exposure, and pharmacodynamic effects after oral administration. In
addition, BioCryst has identified several second generation oral HAE
compounds, and plans to select a lead candidate for preclinical
development later in 2013.
-
BioCryst is continuing its collaboration with the U.S. Army Medical
Research Institute of Infectious Diseases (USAMRIID) regarding
filoviruses, while seeking additional U.S. Government funding for the
further development of BCX4430
as a broad spectrum antiviral medical countermeasure.
Financial Outlook for 2013
Based upon current trends and assumptions, as well as the Company's
restructured operations, BioCryst expects its 2013 net operating cash
use to be in the range of $22 to $26 million, and its 2013 operating
expenses to be in the range of $25 to $35 million. This outlook is
unchanged from the guidance provided in February 2013.
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
Tuesday, May 7, 2013 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 drugs that block key enzymes involved in infectious and
inflammatory diseases, with the goal of addressing unmet medical needs
of patients and physicians. BioCryst currently has two late-stage
development programs: peramivir, a viral neuraminidase inhibitor for the
treatment of influenza, and ulodesine, a purine nucleoside phosphorylase
(PNP) inhibitor for the treatment of gout. In addition, BioCryst has
several early-stage programs: BCX4161 and a next generation oral
inhibitor of plasma kallikrein for hereditary angioedema and BCX4430, a
broad spectrum antiviral for hemorrhagic fevers. 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 BioCryst's 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 BioCryst or its licensees may not be able to enroll the required
number of subjects in planned clinical trials of its product candidates
and that such clinical trials, including the ongoing Phase 1 clinical
trial for BCX4161, may not be successfully completed; that the Company
or its licensees may not commence as expected additional human clinical
trials with product candidates; that the FDA may require additional
studies beyond the studies planned for product candidates, including
peramivir, or may not provide regulatory clearances which may result in
delay of planned clinical trials, or may impose a clinical hold with
respect to such product candidate, or withhold market approval for
product candidates; that BioCryst may not receive government funding to
support the further development of BCX4430; that BARDA/HHS may further
condition, reduce or eliminate future funding of the peramivir program;
that peramivir may never be approved for any use by the FDA; that
ongoing and future preclinical and clinical development may not have
positive results; that the Company or its licensees may not be able to
continue development of ongoing and future development programs; that
such development programs may never result in future product, license or
royalty payments being received; that the Company may not be able to
retain its current pharmaceutical and biotechnology partners for further
development of its product candidates or may not reach favorable
agreements with potential pharmaceutical and biotechnology partners for
further development of product candidates, including ulodesine; that its
actual financial results may not be consistent with its expectations,
including that 2013 operating expenses and cash usage may not be within
management's expected ranges. 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 BioCryst's projections and
forward-looking statements.
BCRXW
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BIOCRYST PHARMACEUTICALS, INC.
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FINANCIAL SUMMARY
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(in thousands, except per share numbers)
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|
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Statements of Operations (Unaudited)
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Three Months Ended
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March 31,
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2013
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2012
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Revenues:
|
|
|
|
|
|
|
|
Royalty revenue
|
|
|
$
|
1,924
|
|
|
|
$
|
—
|
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Collaborative and other research and development
|
|
|
|
1,630
|
|
|
|
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12,221
|
|
|
Total revenues
|
|
|
|
3,554
|
|
|
|
|
12,221
|
|
|
|
|
|
|
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Expenses:
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|
|
|
|
|
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Research and development
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|
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7,411
|
|
|
|
|
15,525
|
|
|
General and administrative
|
|
|
|
1,382
|
|
|
|
|
1,697
|
|
|
Royalty
|
|
|
|
77
|
|
|
|
|
-
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|
Total expenses
|
|
|
|
8,870
|
|
|
|
|
17,222
|
|
|
|
|
|
|
|
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Loss from operations
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|
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|
(5,316
|
)
|
|
|
|
(5,001
|
)
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
|
33
|
|
|
|
|
71
|
|
|
Interest expense
|
|
|
|
(1,180
|
)
|
|
|
|
(1,160
|
)
|
|
Gain on foreign currency derivative
|
|
|
|
1,957
|
|
|
|
|
38
|
|
|
|
|
|
|
|
|
|
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Net loss
|
|
|
$
|
(4,506
|
)
|
|
|
$
|
(6,052
|
)
|
|
|
|
|
|
|
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Basic and diluted net loss per common share
|
|
|
$
|
(0.09
|
)
|
|
|
$
|
(0.13
|
)
|
|
|
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|
|
|
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Weighted average shares outstanding
|
|
|
|
51,073
|
|
|
|
|
47,105
|
|
|
|
|
|
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Note: For the three months ended March 31, 2012, $84 has been
reclassified to reflect that certain facilities expenses related
to our Birmingham facility are now classified as Research &
Development expense. Previously, this was classified as General &
Administrative expense.
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Balance Sheet Data (in thousands)
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March 31, 2013
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|
December 31, 2012
|
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(Unaudited)
|
|
|
(Note 1)
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Cash, cash equivalents and investments
|
|
|
$
|
28,267
|
|
|
|
$
|
36,750
|
|
|
Restricted cash
|
|
|
|
616
|
|
|
|
|
308
|
|
|
Receivables from collaborations
|
|
|
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4,325
|
|
|
|
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4,562
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Total assets
|
|
|
|
46,899
|
|
|
|
|
57,439
|
|
|
Non-recourse notes payable
|
|
|
|
30,000
|
|
|
|
|
30,000
|
|
|
Accumulated deficit
|
|
|
|
(397,107
|
)
|
|
|
|
(392,601
|
)
|
|
Stockholders' deficit
|
|
|
|
(2,840
|
)
|
|
|
|
(454
|
)
|
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|
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|
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Note 1: Derived from audited financial statements.
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BioCryst Pharmaceuticals, Inc.
Robert Bennett, +1-919-859-7910
Source: BioCryst Pharmaceuticals, Inc.
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