BioCryst Reports Fourth Quarter and Full Year 2012 Financial Results

  BioCryst Reports Fourth Quarter and Full Year 2012 Financial Results

Business Wire

RESEARCH TRIANGLE PARK, N.C. -- February 19, 2013

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
$4.1million, 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 $11.1million from $14.2million 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 $1.9million compared to $2.1million 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 $1.2million 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 $11.1million, or $0.22 per
share, compared to a net loss of $13.2million, 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 $51.5million 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 $6.8million in 2012 from
$12.0million 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 $39.1million, or $0.79 per share, compared
to a net loss of $56.9million, 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        3,632      5,224           22,976       19,643  
development
Total revenues            4,101       5,224            26,293        19,643
                                                                     
Expenses:
Research and              11,090      14,198           51,464        57,249
development
General and               1,929       2,068            6,826         11,981
administrative
Royalty expense           18          -                132           -
Restructuring costs       1,759      -               1,759        -       
Total expenses            14,796     16,266          60,181       69,230  
                                                                     
Loss from                 (10,695 )   (11,042  )       (33,888 )     (49,587 )
operations
                                                                     
Interest and other        40          84               222           413
income
Interest expense          (1,180  )   (1,160   )       (4,666  )     (3,774  )
Loss on foreign           782        (1,074   )       (749    )     (4,000  )
currency derivative
                                                                     
Net loss                $ (11,053 )   $(13,192 )     $ (39,081 )   $ (56,948 )
                                                                     
Basic and diluted
net loss per common     $ (0.22   )   $(0.29   )     $ (0.79   )   $ (1.26   )
share
                                                                     
Weighted average          50,883      45,266           49,474        45,144
shares outstanding
                                                        
Balance Sheet Data
                        December 31, 2012            December 31, 2011
Cash, cash
equivalents and         $ 36,750                     $ 57,100
securities
Restricted cash           308                          625
Receivables from          4,562                        5,831
collaborations
Total assets              57,439                       82,208
Non-recourse notes        30,000                       30,000
payable
Accumulated deficit       (392,601)                    (353,520)
Stockholders’             (454)                        14,806
(deficit) equity

Contact:

BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
 
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