RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the third quarter ended September 30, 2013.
"Throughout 2013, we have continued to make progress and create value in
our core development programs, while we prudently managed our operations
with financial discipline. Our recent accomplishments include the
initiation of patient screening for the Phase 2a proof of concept
clinical trial of BCX4161
for HAE and securing government funding for the development of BCX4430
as a potential treatment for Marburg virus disease," said Jon
P. Stonehouse, President & Chief Executive Officer of BioCryst.
"Furthermore, our regulatory team is working towards a goal of
submitting the peramivir
NDA filing by the end of 2013 in order to make peramivir available to
influenza patients in the 2014-15 Northern Hemisphere flu season."
Third Quarter Financial Results
For the three months ended September 30, 2013, net revenues decreased to
$2.4 million from $5.8 million in the third quarter of 2012. This
decrease resulted primarily from the recognition of $2.8 million of
previously deferred RAPIACTA® royalty revenue in the third
quarter of 2012. In addition, Biomedical Advanced Research and
Development Authority (BARDA/HHS) revenue decreased approximately
$532,000 in the third quarter of 2013, as compared to the third quarter
of 2012, due to a decline in reimbursable peramivir expenses.
Research and development expenses for the quarter decreased to
$8.0 million from $12.1 million in the third quarter 2012, due primarily
to lower expenses associated with the ulodesine and BCX5191 programs,
reduced R&D infrastructure costs and the conclusion of the development
program for peramivir and its transition to New Drug Application (NDA)
preparation. These reductions were partially offset by higher
development expenses for BCX4161 in advancing our hereditary angioedema
(HAE) program.
General and administrative expenses for the third quarter 2013 decreased
to $1.3 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 third 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 $97,000
was recognized in the third quarter of 2013, as compared to a loss of
$572,000 in the third quarter of 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 third quarter of 2013 decreased to $8.0 million, or
$0.14 per share, from a net loss of $9.7 million, or $0.19 per share,
for the third quarter of 2012.
Cash, cash equivalents and investments totaled $43.4 million at
September 30, 2013, compared to $37.1 million at December 31, 2012. In
August 2013, BioCryst closed a public offering of 4,600,000 shares of
common stock at a price of $4.40 per share, yielding net proceeds of
approximately $18.5 million. Net operating cash use for the third
quarter 2013 was $5.3 million. Net operating cash use for the first nine
months of 2013 was $18.4 million, as compared to $29.7 million for the
same period of 2012, reflecting an $11.3 million decrease despite a
significant reduction in BARDA/HHS collaborative revenue.
Year to Date Financial Results
For the nine months ended September 30, 2013, total revenues decreased
to $6.8 million from $22.2 million in the same period 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 International Holdings Limited
(Mundipharma), as well a $6.9 million decrease in collaboration revenue
for the development of peramivir.
R&D expenses decreased to $27.1 million for the nine months of 2013 from
$40.4 million in the same period of 2012. Lower 2013 development costs
were associated with spending decreases in the BCX5191 and peramivir
programs, as well as reduced R&D infrastructure costs that were
partially offset by higher BCX4161 and BCX4430 costs. In addition, R&D
expenses in 2012 included the recognition of $1.9 million of previously
deferred expenses associated with forodesine and the restructuring of
the Mundipharma agreement.
G&A expenses decreased to $4.0 million for the nine months ended
September 30, 2013 from $4.9 million for the nine months ended
September 30, 2012, due primarily to a December 2012 corporate
restructuring that reduced BioCryst's cost structure and operations.
In the nine-month period of 2013 and 2012, net interest expense was
$3.5 million and related to the Company's non-recourse notes payable. In
addition, a mark-to-market gain on our foreign currency hedge of $3.2
million was recognized in the first nine months of 2013, as compared to
a loss of $1.5 million in the same period of 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 nine months ended September 30, 2013 decreased to
$24.7 million, or $0.46 per share, compared to a net loss of
$28.0 million, or $0.57 per share for the nine months ended September
30, 2012.
Corporate Update & Outlook
-
In late October, BioCryst initiated screening of HAE patients for
enrollment in OPuS-1 (Oral ProphylaxiS-1), a
Phase 2a proof of concept clinical trial of orally-administered BCX4161
in patients with HAE. The OPuS-1 trial will test 400 mg of BCX4161
administered three times daily for 28 days in up to 25 HAE patients
who have a high frequency of attacks (≥ 1 per week), in a randomized,
placebo-controlled, two-period cross-over design. The main goals for
the OPuS-1 trial are to estimate BCX4161's degree of efficacy in
reducing the frequency of angioedema attacks, and to evaluate the
safety and tolerability of 28 days of BCX4161 treatment.
-
The Company announced in September that the National
Institute of Allergy and Infectious Diseases (NIAID) has
contracted with BioCryst for the development of BCX4430 as a treatment
for Marburg virus disease. NIAID, part of the National Institutes of
Health, has made an initial award of $5.0 million to BioCryst. The
total funding could be up to $22.0 million, if all contract options
are exercised. The goals of this contract are to file investigational
new drug applications (INDs) for intravenous (i.v.) and intramuscular
(i.m.) BCX4430 for the treatment of Marburg virus disease, and to
conduct an initial Phase 1 human clinical trial.
-
BioCryst's second generation kallikrein inhibitor program for HAE has
met its primary goal of improving oral bioavailability while retaining
high potency and high selectivity, as compared to BCX4161. Management
expects to select one or more lead compound to advance into
preclinical development before the end of 2013.
-
BioCryst remains on track to submit its peramivir NDA to the U.S. Food
& Drug Administration before the end of 2013. The Company is seeking
an indication for the treatment of acute uncomplicated influenza.
Financial Outlook for 2013
Based upon current trends and assumptions, as well as the Company's
restructured operations, BioCryst continues to expect 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. Consistent with
guidance provided in August 2013, our 2013 operating expenses are
expected to be in the range of $45 to $55 million.
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
Tuesday, November 5, 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's core development programs include
BCX4161 and a next generation oral inhibitor of plasma kallikrein for
hereditary angioedema; peramivir,
a viral neuraminidase inhibitor for the treatment of influenza; 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 may not be able to enroll the required number of subjects
in its planned Phase 2a clinical trial for BCX4161; that BioCryst or its
licensees may not be able to enroll the required number of subjects in
planned clinical trials of other product candidates; that the Phase 2a
clinical trial for BCX4161 may not have a favorable outcome or be
successfully completed; that the Phase 2a clinical trial for BCX4161 may
take longer or cost more than expected; that the Company or its
licensees may not advance human clinical trials with product candidates
as expected; 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 further support the development of BCX4430
or peramivir; that BARDA/HHS and NIAID may further condition, reduce or
eliminate future funding; that BioCryst's peramivir NDA filing may be
delayed or may not occur; 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 ongoing and future
preclinical and clinical development of HAE second generation candidates
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,
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
|
BIOCRYST PHARMACEUTICALS, INC.
|
|
CONSOLIDATED FINANCIAL SUMMARY
|
|
(in thousands, except per share)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements of Operations (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
Nine Months Ended
|
|
|
|
|
|
|
|
September 30,
|
|
|
|
|
September 30,
|
|
|
|
|
|
|
|
2013
|
|
|
2012
|
|
|
|
|
2013
|
|
|
2012
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty revenue
|
|
|
|
|
$
|
|
8
|
|
|
$
|
2,848
|
|
|
|
|
$
|
|
2,042
|
|
|
$
|
2,848
|
|
|
Collaborative and other research and development
|
|
|
|
|
|
|
2,381
|
|
|
|
2,913
|
|
|
|
|
|
|
4,722
|
|
|
|
19,344
|
|
|
Total revenues
|
|
|
|
|
|
|
2,389
|
|
|
|
5,761
|
|
|
|
|
|
|
6,764
|
|
|
|
22,192
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
|
7,977
|
|
|
|
12,072
|
|
|
|
|
|
|
27,116
|
|
|
|
40,374
|
|
|
General and administrative
|
|
|
|
|
|
|
1,337
|
|
|
|
1,591
|
|
|
|
|
|
|
3,950
|
|
|
|
4,897
|
|
|
Royalty
|
|
|
|
|
|
|
-
|
|
|
|
114
|
|
|
|
|
|
|
81
|
|
|
|
114
|
|
|
Total expenses
|
|
|
|
|
|
|
9,314
|
|
|
|
13,777
|
|
|
|
|
|
|
31,147
|
|
|
|
45,385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
|
|
(6,925
|
)
|
|
|
(8,016
|
)
|
|
|
|
|
|
(24,383
|
)
|
|
|
(23,193
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
|
|
|
|
18
|
|
|
|
54
|
|
|
|
|
|
|
72
|
|
|
|
182
|
|
|
Interest expense
|
|
|
|
|
|
|
(1,191
|
)
|
|
|
(1,166
|
)
|
|
|
|
|
|
(3,536
|
)
|
|
|
(3,486
|
)
|
|
Gain (loss) on foreign currency derivative
|
|
|
|
|
|
|
97
|
|
|
|
(572
|
)
|
|
|
|
|
|
3,168
|
|
|
|
(1,531
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$
|
|
(8,001
|
)
|
|
$
|
(9,700
|
)
|
|
|
|
$
|
|
(24,679
|
)
|
|
$
|
(28,028
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
|
|
|
$
|
|
(0.14
|
)
|
|
$
|
(0.19
|
)
|
|
|
|
$
|
|
(0.46
|
)
|
|
$
|
(0.57
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
|
|
|
|
57,124
|
|
|
|
50,661
|
|
|
|
|
|
|
53,910
|
|
|
|
49,001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2013
|
|
|
|
December 31, 2012
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
(Note 1)
|
|
Cash, cash equivalents and investments
|
|
|
|
|
|
$
|
43,271
|
|
|
|
|
|
|
|
|
$
|
36,750
|
|
|
|
|
|
Restricted cash
|
|
|
|
|
|
|
150
|
|
|
|
|
|
|
|
|
|
308
|
|
|
|
|
|
Receivables from collaborations
|
|
|
|
|
|
|
2,369
|
|
|
|
|
|
|
|
|
|
4,562
|
|
|
|
|
|
Total assets
|
|
|
|
|
|
|
53,205
|
|
|
|
|
|
|
|
|
|
57,439
|
|
|
|
|
|
Non-recourse notes payable
|
|
|
|
|
|
|
30,000
|
|
|
|
|
|
|
|
|
|
30,000
|
|
|
|
|
|
Accumulated deficit
|
|
|
|
|
|
|
(417,280
|
)
|
|
|
|
|
|
|
|
|
(392,601
|
)
|
|
|
|
|
Stockholders' equity (deficit)
|
|
|
|
|
|
|
3,410
|
|
|
|
|
|
|
|
|
|
(454
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Derived from audited financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioCryst Pharmaceuticals
Robert Bennett, 919-859-7910
Source: BioCryst Pharmaceuticals
News Provided by Acquire Media