BioCryst Reports Fourth Quarter and Full Year 2012 Financial Results
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the fourth quarter and full year ended December 31, 2012.
“Our team is focused on achieving near-term milestones to rebuild
shareholder value. Our primary goal is to advance our potentially
ground-breaking oral kallikrein inhibitors for hereditary angioedema.
Phase 1 clinical trials for the lead compound, BCX4161,
are scheduled to begin in the next few months and we are finalizing lead
optimization for our second generation compound,” said Jon
P. Stonehouse, President & Chief Executive Officer.
“Furthermore, we are advancing BCX4430, a broad spectrum antiviral that
could fill an important gap in the U.S. Government’s medical
countermeasure stockpile. Based on BCX4430’s
efficacy in treating various hemorrhagic fever viruses in animals, this
compound could satisfy this important unmet need.”
Fourth Quarter Financial Results
For the three months ended December 31, 2012, revenues decreased to
$4.1 million, from $5.2 million in the fourth quarter of 2011. This
decrease resulted primarily from a reduction in collaboration revenue
from a contract with the Biomedical Advanced Research and Development
Authority, within the U.S. Department of Health and Human Services
(BARDA/HHS), for the development of peramivir.
Research and development (R&D) expenses for the fourth quarter of 2012
decreased to $11.1 million from $14.2 million in the fourth quarter of
2011. In 2012, lower development costs associated with the peramivir and ulodesine
programs were partially offset by higher development costs associated
with the preclinical BCX5191
and BCX4161 programs.
General and administrative (G&A) expenses for the fourth quarter of 2012
decreased to $1.9 million compared to $2.1 million in the fourth quarter
of 2011, largely due to reductions in administrative expenses during
2012 associated with the continued realization of cost containment
measures and the Company’s restructuring of its operations. Fourth
quarter 2012 expenses included a $1.8 million charge related to the
corporate restructuring announced in December 2012.
Interest expense related to non-recourse notes was $1.2 million in the
fourth quarter of 2012 and 2011. In addition, a $0.8 million
mark-to-market gain on the Company’s foreign currency hedge was
recognized in the fourth quarter of 2012, compared to a $1.1 million
mark-to-market loss in the fourth quarter of 2011. These hedge gains and
losses resulted from changes in the U.S. dollar/Japanese yen exchange
rate related to a foreign currency hedge arrangement entered into in
conjunction with the RAPIACTA® royalty monetization
transaction.
The net loss for the fourth quarter 2012 was $11.1 million, or $0.22 per
share, compared to a net loss of $13.2 million, or $0.29 per share, for
the fourth quarter 2011.
2012 Financial Results
For the year ended December 31, 2012, total revenues increased to $26.3
million from $19.6 million in 2011. The increase was due to the
recognition of $7.8 million of previously deferred forodesine-related
revenue in the first quarter 2012, as well as the recognition of $3.3
million royalty revenue from Shionogi & Co., Ltd. related to RAPIACTA®
sales in the second half of 2012. The aggregate revenue increase was
partially offset by a decrease in peramivir collaboration revenue from
BARDA/HHS due to a reduction of peramivir development activity in 2012,
as compared to 2011.
R&D expenses decreased to $51.5 million for 2012 from $57.2 million in
2011. A decrease in 2012 development costs related to the ulodesine and
peramivir programs were partially offset by higher BCX5191 and BCX4161
development costs, as compared to 2011. Expenses for 2012 included the
recognition of $1.9 million of non-cash, previously deferred expenses
associated with the transfer of forodesine development activity to
Mundipharma International Holdings Ltd. in the first quarter of 2012.
G&A expenses decreased significantly to $6.8 million in 2012 from
$12.0 million in 2011, due to realization of cost containment measures,
and the relocation of BioCryst’s corporate headquarters in 2011. Total
operating expenses decreased to $60.2 million in 2012 from $69.2 million
in 2011.
The net loss for 2012 decreased to $39.1 million, or $0.79 per share,
compared to a net loss of $56.9 million, or $1.26 per share for 2011.
Cash and investments totaled $37.1 million at December 31, 2012, a $20.6
million decrease from the $57.7 million balance at December 31, 2011.
Net operating cash use for the fourth quarter of 2012 was $7.1 million
and excludes $0.3 million of collateral received under the Company’s
foreign currency hedge arrangement. Net operating cash use for 2012 was
$36.8 million, which was at the low end of BioCryst’s net operating cash
use guidance of $37 to $43 million, and total cash use was $38.5 million.
Clinical Development Update & Outlook
In December, BioCryst restructured its operations and implemented a
focused R&D strategy to advance its hereditary angioedema (HAE) and
antiviral programs. The restructuring and R&D focus significantly
reduced BioCryst's future cost structure. The Company expects to
reduce its operating cash burn by 30% to 40% and its operating
expenses by 40% to 60% in 2013, as compared to 2012. These reductions
enable the Company to extend its cash runway to achieve important
near-term milestones in its oral HAE and broad spectrum antiviral
programs.
In January, the Company announced the termination of its antiviral
development program for treatment of the hepatitis C virus (HCV).
Following seven days of treating HCV-infected animals with BCX5191,
the viral load reduction observed was insufficient to justify
continued development.
BioCryst plans to initiate its BCX4161 Phase 1 program for HAE around
the end of the first quarter 2013. The main success factors for the
BCX4161 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
later in 2013.
Proof-of-principle data demonstrating that BCX4430 was efficacious and
well tolerated in a preclinical yellow fever virus infection disease
model was presented at the 2nd Antivirals Congress in Cambridge in
November. 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. BioCryst expects to provide additional
BCX4430 updates throughout 2013.
In November, the independent data monitoring committee (DMC)
overseeing the peramivir Phase
3 clinical trial in hospitalized influenza patients informed the
Company that the recalculated sample size for the clinical trial had
crossed the pre-specified futility boundary of 320 subjects. Following
this notification, BioCryst terminated the clinical trial, completed
its analysis of the Phase 3 results and shared the data and findings
with BARDA/HHS. In the coming months, the Company plans to have
additional discussions with BARDA/HHS and the Food and Drug
Administration to determine the future of the U.S. peramivir program.
Financial Outlook for 2013
Based upon current trends and assumptions, as well as the Company’s
restructured operations, BioCryst expects 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.
Conference Call and Webcast
BioCryst's leadership team will now host a conference call and webcast
today, February 19, 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 planned 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 or may not
provide regulatory clearances which may result in delay of planned
clinical trials, 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 future
development of current 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
BIOCRYST PHARMACEUTICALS, INC.
FINANCIAL SUMMARY
(in thousands, except per share amounts)
Statements of Operations
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2012
2011
2012
2011
Revenues:
Royalty revenue
$
469
$-
$
3,317
$
-
Collaborative and other research and development
3,632
5,224
22,976
19,643
Total revenues
4,101
5,224
26,293
19,643
Expenses:
Research and development
11,090
14,198
51,464
57,249
General and administrative
1,929
2,068
6,826
11,981
Royalty expense
18
-
132
-
Restructuring costs
1,759
-
1,759
-
Total expenses
14,796
16,266
60,181
69,230
Loss from operations
(10,695
)
(11,042
)
(33,888
)
(49,587
)
Interest and other income
40
84
222
413
Interest expense
(1,180
)
(1,160
)
(4,666
)
(3,774
)
Loss on foreign currency derivative
782
(1,074
)
(749
)
(4,000
)
Net loss
$
(11,053
)
$(13,192
)
$
(39,081
)
$
(56,948
)
Basic and diluted net loss per common share
$
(0.22
)
$(0.29
)
$
(0.79
)
$
(1.26
)
Weighted average shares outstanding
50,883
45,266
49,474
45,144
Balance Sheet Data
December 31, 2012
December 31, 2011
Cash, cash equivalents and securities
$
36,750
$
57,100
Restricted cash
308
625
Receivables from collaborations
4,562
5,831
Total assets
57,439
82,208
Non-recourse notes payable
30,000
30,000
Accumulated deficit
(392,601)
(353,520)
Stockholders’ (deficit) equity
(454)
14,806
BioCryst Pharmaceuticals Robert Bennett, +1-919-859-7910
Press Release $BCRX BioCryst Pharmaceuticals, Inc.
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2012.
“Our team is focused on achieving near-term milestones to rebuild shareholder value. Our primary goal is to advance our potentially ground-breaking oral kallikrein inhibitors for hereditary angioedema. Phase 1 clinical trials for the lead compound, BCX4161, are scheduled to begin in the next few months and we are finalizing lead optimization for our second generation compound,” said Jon P. Stonehouse, President & Chief Executive Officer. “Furthermore, we are advancing BCX4430, a broad spectrum antiviral that could fill an important gap in the U.S. Government’s medical countermeasure stockpile. Based on BCX4430’s efficacy in treating various hemorrhagic fever viruses in animals, this compound could satisfy this important unmet need.”
Fourth Quarter Financial Results
For the three months ended December 31, 2012, revenues decreased to $4.1 million, from $5.2 million in the fourth quarter of 2011. This decrease resulted primarily from a reduction in collaboration revenue from a contract with the Biomedical Advanced Research and Development Authority, within the U.S. Department of Health and Human Services (BARDA/HHS), for the development of peramivir.
Research and development (R&D) expenses for the fourth quarter of 2012 decreased to $11.1 million from $14.2 million in the fourth quarter of 2011. In 2012, lower development costs associated with the peramivir and ulodesine programs were partially offset by higher development costs associated with the preclinical BCX5191 and BCX4161 programs.
General and administrative (G&A) expenses for the fourth quarter of 2012 decreased to $1.9 million compared to $2.1 million in the fourth quarter of 2011, largely due to reductions in administrative expenses during 2012 associated with the continued realization of cost containment measures and the Company’s restructuring of its operations. Fourth quarter 2012 expenses included a $1.8 million charge related to the corporate restructuring announced in December 2012.
Interest expense related to non-recourse notes was $1.2 million in the fourth quarter of 2012 and 2011. In addition, a $0.8 million mark-to-market gain on the Company’s foreign currency hedge was recognized in the fourth quarter of 2012, compared to a $1.1 million mark-to-market loss in the fourth quarter of 2011. These hedge gains and losses resulted from changes in the U.S. dollar/Japanese yen exchange rate related to a foreign currency hedge arrangement entered into in conjunction with the RAPIACTA® royalty monetization transaction.
The net loss for the fourth quarter 2012 was $11.1 million, or $0.22 per share, compared to a net loss of $13.2 million, or $0.29 per share, for the fourth quarter 2011.
2012 Financial Results
For the year ended December 31, 2012, total revenues increased to $26.3 million from $19.6 million in 2011. The increase was due to the recognition of $7.8 million of previously deferred forodesine-related revenue in the first quarter 2012, as well as the recognition of $3.3 million royalty revenue from Shionogi & Co., Ltd. related to RAPIACTA® sales in the second half of 2012. The aggregate revenue increase was partially offset by a decrease in peramivir collaboration revenue from BARDA/HHS due to a reduction of peramivir development activity in 2012, as compared to 2011.
R&D expenses decreased to $51.5 million for 2012 from $57.2 million in 2011. A decrease in 2012 development costs related to the ulodesine and peramivir programs were partially offset by higher BCX5191 and BCX4161 development costs, as compared to 2011. Expenses for 2012 included the recognition of $1.9 million of non-cash, previously deferred expenses associated with the transfer of forodesine development activity to Mundipharma International Holdings Ltd. in the first quarter of 2012.
G&A expenses decreased significantly to $6.8 million in 2012 from $12.0 million in 2011, due to realization of cost containment measures, and the relocation of BioCryst’s corporate headquarters in 2011. Total operating expenses decreased to $60.2 million in 2012 from $69.2 million in 2011.
The net loss for 2012 decreased to $39.1 million, or $0.79 per share, compared to a net loss of $56.9 million, or $1.26 per share for 2011.
Cash and investments totaled $37.1 million at December 31, 2012, a $20.6 million decrease from the $57.7 million balance at December 31, 2011. Net operating cash use for the fourth quarter of 2012 was $7.1 million and excludes $0.3 million of collateral received under the Company’s foreign currency hedge arrangement. Net operating cash use for 2012 was $36.8 million, which was at the low end of BioCryst’s net operating cash use guidance of $37 to $43 million, and total cash use was $38.5 million.
Clinical Development Update & Outlook
Financial Outlook for 2013
Based upon current trends and assumptions, as well as the Company’s restructured operations, BioCryst expects 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.
Conference Call and Webcast
BioCryst's leadership team will now host a conference call and webcast today, February 19, 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 planned 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 or may not provide regulatory clearances which may result in delay of planned clinical trials, 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 future development of current 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
December 31, 2012
BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
Source: BioCryst Pharmaceuticals