RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the second quarter ended June 30, 2013.
"The fact that we met all of our goals for the BCX4161
Phase 1 trial and secured government funding for the peramivir
NDA filing represents a significant step forward for BioCryst," said Jon
P. Stonehouse, President & Chief Executive Officer of BioCryst.
"We look forward to initiating the BCX4161 Phase 2a clinical trial and
to submitting a peramivir NDA by year end. Our very successful recent
financing has allowed us to attract additional high quality investors
into the company and has provided us the cash runway to carry us into
2015."
Second Quarter Financial Results
For the three months ended June 30, 2013, revenues decreased to $821,000
from $4.2 million in the second quarter of 2012. BARDA/HHS revenue
decreased in the second quarter of 2013 due to a decline in reimbursable
peramivir expenses, compared to the second quarter of 2012.
Research and development expenses for the quarter decreased to
$11.7 million from $12.8 million in the second quarter 2012, due
primarily to lower development expenses associated with the peramivir
and BCX5191 programs, which were largely offset by a $5.0 million
non-cash write-off of a "deferred collaboration costs" asset associated
with BioCryst's Purine Nucleoside Phosphorylase Inhibitor ("PNP")
licensing agreement.
General and administrative expenses for the second quarter 2013
decreased to $1.2 million compared to $1.6 million in 2012, due
primarily to the December 2012 corporate restructuring that reduced
BioCryst's cost structure and operations.
In the second 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 $1.1
million was recognized in the second quarter 2013, compared to a loss of
$1.0 million in the second quarter 2012. These gains/losses result from
periodic changes in the U.S. dollar/Japanese yen exchange rate and the
related mark-to-market valuation of our underlying hedge arrangement.
The net loss for the second quarter of 2013 was $12.2 million, or $0.23
per share, compared to a net loss of $12.3 million, or $0.25 per share,
for the second quarter of 2012.
Cash, cash equivalents and investments totaled $31.3 million at June 30,
2013, compared to $28.9 million at March 31, 2013 and $37.1 million at
December 31, 2012. Net operating cash use for the second quarter of 2013
was $4.1 million, as compared to $8.1 million for the second quarter of
2012. Net operating cash use for the first six months of 2013 was $13.0
million.
Year to Date Financial Results
For the six months ended June 30, 2013, total revenues decreased to $4.4
million from $16.4 million in the first half of 2012. The decrease in
2013 was primarily due to the recognition of $7.8 million of previously
deferred forodesine-related revenue during the first quarter of 2012,
resulting from the restructuring of the license agreement between
BioCryst and Mundipharma, as well as lower collaboration revenue for the
development of peramivir in 2013.
R&D expenses decreased to $19.1 million for the first half of 2013 from
$28.3 million in the same period of 2012. Lower 2013 development costs
associated with the peramivir and BCX5191 programs were partially offset
by higher ulodesine costs, which included a second quarter write-off of
a related "deferred collaboration costs" asset. In addition, R&D
expenses in 2012 included the recognition of $1.9 million of previously
deferred expenses associated with forodesine and the Mundipharma
agreement.
G&A expenses decreased to $2.6 million for the six months ended June 30,
2013 from $3.3 million for the six months ended June 30, 2012, due
primarily to a December 2012 corporate restructuring that reduced
BioCryst's cost structure and operations.
The net loss for the six months ended June 30, 2013 decreased to
$16.7 million, or $0.32 per share, compared to a net loss of
$18.3 million, or $0.38 per share for the same period last year.
Corporate Update & Outlook
-
On August 6, BioCryst closed its public offering of 4,600,000 shares
of common stock at a price of $4.40 per share, which included the full
exercise of the underwriters' over-allotment option. Net proceeds to
BioCryst are expected to be $18.5 million.
-
On July 31, BioCryst was notified by the United States Food and Drug
Administration ("FDA") that it had removed the clinical hold placed on
BCX4161 in November 2012. This notification allows the inclusion of
U.S. clinical sites in future BCX4161 clinical trials.
-
In July, BioCryst announced that the randomized, placebo-controlled,
Phase 1 clinical trial of orally-administered BCX4161 in healthy
volunteers successfully met all of its objectives. The safety,
tolerability, drug exposure and on-target kallikrein inhibition
results of this Phase 1 trial strongly support advancing the
development program into a Phase 2a trial in high-attack frequency
hereditary angioedema (HAE) patients. This Phase 2a trial is planned
to start in 2013.
-
In July, BioCryst reported that Biomedical Advanced Research and
Development Authority (BARDA/HHS) released funding of no more than
$12.8 million under the current $234.8 million contract to fund
predominantly all activities necessary to file a peramivir New Drug
Application (NDA). BioCryst is seeking an indication for the treatment
of acute uncomplicated influenza and expects to submit the peramivir
NDA by the end of 2013.
-
BioCryst completed a pre-NDA meeting with the FDA regarding peramivir
in June. BioCryst reached agreement with the FDA regarding all
requirements for a complete NDA submission.
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, unchanged from the
guidance originally provided in February 2013. 2013 operating expenses
are now expected to be in the range of $45 to $55 million, compared to
the previous operating expense guidance of $25 to $35 million. The
operating expense range increase of $20 million reflects anticipated
incremental operating expenses associated with the pending peramivir NDA
filing and the write-off of a "deferred collaboration costs" asset
associated with our PNP agreement. It is anticipated that predominantly
all of the incremental peramivir filing expenses will be reimbursed by
BARDA/HHS.
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
Thursday, August 8, 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 are 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, 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, 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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CONSOLIDATED FINANCIAL SUMMARY
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(in thousands, except per share)
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Statements of Operations (Unaudited)
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2013
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2012
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2013
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2012
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Revenues:
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Royalty revenue
|
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$
|
110
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$
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-
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$
|
2,034
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$
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-
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Collaborative and other research and development
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|
711
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4,210
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2,341
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16,431
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Total revenues
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821
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4,210
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4,375
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16,431
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Expenses:
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Research and development
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11,728
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12,777
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19,139
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28,302
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General and administrative
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1,231
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1,609
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2,613
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3,306
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Royalty
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4
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-
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81
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-
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Total operating expenses
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12,963
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14,386
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21,833
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31,608
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Loss from operations
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(12,142
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)
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(10,176
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)
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(17,458
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)
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(15,177
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)
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Interest and other income
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|
21
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|
57
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54
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128
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Interest expense
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|
(1,165
|
)
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(1,160
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)
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(2,345
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)
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(2,320
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)
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Gain (loss) on foreign currency derivative
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1,114
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(997
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)
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3,071
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(959
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)
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Net loss
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|
$
|
(12,172
|
)
|
|
|
$
|
(12,276
|
)
|
|
|
$
|
(16,678
|
)
|
|
|
$
|
(18,328
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)
|
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Basic and diluted net loss per common share
|
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|
$
|
(0.23
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)
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$
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(0.25
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)
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$
|
(0.32
|
)
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|
$
|
(0.38
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)
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Weighted average shares outstanding
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53,468
|
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49,218
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52,277
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48,161
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Balance Sheet Data (in thousands)
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June 30, 2013
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December 31, 2012
|
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(Unaudited)
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(Note 1)
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Cash, cash equivalents and investments
|
|
|
|
$
|
29,125
|
|
|
|
$
|
36,750
|
|
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Restricted cash
|
|
|
|
|
2,129
|
|
|
|
|
308
|
|
|
Receivables from collaborations
|
|
|
|
|
1,024
|
|
|
|
|
4,562
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Total assets
|
|
|
|
|
39,916
|
|
|
|
|
57,439
|
|
|
Non-recourse notes payable
|
|
|
|
|
30,000
|
|
|
|
|
30,000
|
|
|
Accumulated deficit
|
|
|
|
|
(409,279
|
)
|
|
|
|
(392,601
|
)
|
|
Stockholders' deficit
|
|
|
|
|
(9,047
|
)
|
|
|
|
(454
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)
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Note 1: Derived from audited financial statements.
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BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
Source: BioCryst Pharmaceuticals, Inc.
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