BioCryst Provides Corporate Update and Reports Second Quarter 2013 Financial Results

  BioCryst Provides Corporate Update and Reports Second Quarter 2013 Financial
  Results

Business Wire

RESEARCH TRIANGLE PARK, N.C. -- August 8, 2013

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 $11.7million
from $12.8million 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
$1.2million 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 $1.2million
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 $12.2million, or $0.23 per
share, compared to a net loss of $12.3million, 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 June30, 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 $19.1million 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 $2.6million for the six months ended June30, 2013
from $3.3million for the six months ended June30, 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 June30, 2013 decreased to
$16.7million, or $0.32 per share, compared to a net loss of $18.3million, 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 July31, 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


BIOCRYST PHARMACEUTICALS, INC.
CONSOLIDATED FINANCIAL SUMMARY
(in thousands, except per share)

Statements of
Operations       
(Unaudited)
                                                              
                     Three Months Ended              Six Months Ended
                     June 30,                        June 30,
                     2013            2012            2013            2012
Revenues:
Royalty              $ 110           $ -             $ 2,034         $ -
revenue
Collaborative
and other             711           4,210         2,341         16,431  
research and
development
Total revenues         821             4,210           4,375           16,431
                                                                     
Expenses:
Research and           11,728          12,777          19,139          28,302
development
General and            1,231           1,609           2,613           3,306
administrative
Royalty               4             -             81            -       
Total
operating             12,963        14,386        21,833        31,608  
expenses
                                                                     
Loss from              (12,142 )       (10,176 )       (17,458 )       (15,177 )
operations
                                                                     
Interest and           21              57              54              128
other income
Interest               (1,165  )       (1,160  )       (2,345  )       (2,320  )
expense
Gain (loss) on
foreign               1,114         (997    )      3,071         (959    )
currency
derivative
                                                                     
Net loss             $ (12,172 )     $ (12,276 )     $ (16,678 )     $ (18,328 )
                                                                     
                                                                     
Basic and
diluted net          $ (0.23   )     $ (0.25   )     $ (0.32   )     $ (0.38   )
loss per
common share
                                                                     
Weighted
average shares         53,468          49,218          52,277          48,161
outstanding
                                                                               



Balance Sheet Data (in thousands)      
                                           June 30, 2013   December 31, 2012
                                           (Unaudited)       (Note 1)
Cash, cash equivalents and                 $  29,125         $   36,750
investments
Restricted cash                               2,129              308
Receivables from collaborations               1,024              4,562
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       )
                                                             
                                                             
Note 1: Derived from audited
financial statements.
                                                             

Contact:

BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
 
Press spacebar to pause and continue. Press esc to stop.