BioCryst Provides Corporate Update and Reports First Quarter 2013 Financial Results

  BioCryst Provides Corporate Update and Reports First Quarter 2013 Financial

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 $3.6million
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 $7.4million
from $15.5million 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 $1.4million
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 $1.2million
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 $4.5million, or $0.09 per
share, compared to a net loss of $6.1million, 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

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 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

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


(in thousands, except per share numbers)
Statements of
Operations (Unaudited)
                               Three Months Ended
                               March 31,
                               2013                       2012
Royalty revenue                $   1,924                  $    —
Collaborative and
other research and                1,630                     12,221      
Total revenues                     3,554                       12,221
Research and                       7,411                       15,525
General and                        1,382                       1,697
Royalty                           77                        -           
Total expenses                    8,870                     17,222      
Loss from operations               (5,316     )                (5,001      )
Interest and other                 33                          71
Interest expense                   (1,180     )                (1,160      )
Gain on foreign                   1,957                     38          
currency derivative
Net loss                       $   (4,506     )           $    (6,052      )
Basic and diluted net          $   (0.09      )           $    (0.13       )
loss per common share
Weighted average                   51,073                      47,105
shares outstanding
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.
Balance Sheet Data (in
                               March 31, 2013             December 31, 2012
                               (Unaudited)                (Note 1)
Cash, cash equivalents         $   28,267                 $    36,750
and investments
Restricted cash                    616                         308
Receivables from                   4,325                       4,562
Total assets                       46,899                      57,439
Non-recourse notes                 30,000                      30,000
Accumulated deficit                (397,107   )                (392,601    )
Stockholders’ deficit              (2,840     )                (454        )
Note 1: Derived from
audited financial


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