BioCryst Provides Corporate Update and Reports Third Quarter 2012 Financial Results

  BioCryst Provides Corporate Update and Reports Third Quarter 2012 Financial

   Third quarter 2012 results call now scheduled November 8 at 8:30 a.m. ET

Business Wire

RESEARCH TRIANGLE PARK, N.C. -- November 08, 2012

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results
for the third quarter and nine months ended September 30, 2012.

“Despite the recent setbacks, we are focused on advancing the other promising
assets in our portfolio. We are evaluating operational changes to decrease our
cost structure and to best position us to achieve value creating milestones.
In addition, we are continuing to work on the Presidio Pharmaceuticals
merger,” said Jon P. Stonehouse, President & Chief Executive Officer.

Third Quarter Financial Results

For the three months ended September 30, 2012, revenues increased to
$5.8million, from $5.2 million in the third quarter of 2011. This increase
resulted primarily from the recognition of $2.8 million of deferred royalty
revenue from Shionogi related to RAPIACTA^® sales, and was largely offset by a
decrease in collaboration revenue from the Department of Health and Human
Services/Biomedical Advanced Research and Development Authority (HHS/BARDA)
contract for the continued development of peramivir. The recognition of
RAPIACTA^® royalty revenue had no impact on the Company’s cash balance, as the
underlying royalty payments are directed to pay interest expense on the
Company’s non-recourse notes payable.

Research and development (R&D) expenses for the third quarter decreased to
$12.1million from $15.1million in the third 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 third quarter decreased to
$1.6million compared to $3.0million in the third quarter of 2011, largely
due to reductions in administrative expenses during 2012 associated with the
continued realization of cost containment measures.

Interest expense related to the non-recourse notes was $1.2million in the
third quarter of 2012 and 2011. In addition, a $0.6 million mark-to-market
loss on the foreign currency hedge was recognized in both the third quarter of
2012 and 2011. These hedge losses resulted from changes in the U.S.
dollar/Japanese yen exchange rate related to the foreign currency hedge
agreement entered into in conjunction with the RAPIACTA^® royalty monetization

The net loss for the third quarter 2012 was $9.7million, or $0.19 per share,
compared to a net loss of $14.5million, or $0.32 per share, for the third
quarter 2011.

Cash and investments totaled $43.8 million at September 30, 2012, a $13.9
million decrease from the $57.7 million balance at December 31, 2011. Net
operating cash use for the third quarter of 2012 was $9.7 million and excludes
$2.5 million in proceeds from sales of common stock through the Company’s
at-the-market offering during the quarter, as well as collateral payments
under the foreign currency hedge agreement. Net operating cash use for the
first nine months of 2012 was $29.7 million.

Year to Date Financial Results

For the nine months ended September30, 2012, total revenues increased to
$22.2 million from $14.4 million in the same period of 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 $2.8 million deferred royalty revenue from Shionogi related to
RAPIACTA^® sales in the third quarter of 2012. The aggregate revenue increase
was partially offset by a decrease in peramivir collaboration revenue from
HHS/BARDA due to a reduction of peramivir development activity in 2012, as
compared to 2011.

R&D expenses decreased to $40.4million for the nine months of 2012 from $43.0
million in the same period of 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 the same period
of 2011. Expenses for 2012 included the recognition of $1.9 million of
non-cash, previously deferred expenses associated with forodesine and the
related transfer of development activity to Mundipharma International Holdings
Ltd. in the first quarter of 2012.

G&A expenses decreased significantly to $4.9million for the nine months ended
September30, 2012 from $9.9million for the nine months ended September 30,
2011, due to the 2011 relocation of BioCryst’s corporate headquarters and to
lower third party professional expenses in 2012 associated with the continued
realization of cost containment measures.

The net loss for the nine months ended September30, 2012 decreased to
$28.0million, or $0.57 per share, compared to a net loss of $43.8million, or
$0.97 per share for the same period last year.

Clinical Development Update & Outlook

  *In a separate press release issued yesterday, BioCryst announced that the
    independent Data Monitoring Committee (DMC) overseeing the Company's Phase
    3 clinical trial of intravenous (i.v.) peramivir completed its review of
    the planned interim analysis. The DMC reported that the recalculated
    sample size is greater than the predefined futility boundary of 320
    subjects and recommended that the study be terminated for futility.
  *In October, BioCryst and privately held Presidio Pharmaceuticals, Inc.
    signed a definitive merger agreement to create a focused, clinical stage
    biopharmaceutical company with lead programs in high-value antivirals and
    orphan disease indications, initially focused on chronic hepatitis C virus
    (HCV) infection and hereditary angioedema (HAE).
  *Last week, BioCryst announced the withdrawal of its Investigational New
    Drug application (IND) for the antiviral nucleoside BCX5191, following a
    discussion with the U.S Food and Drug Administration (FDA). The Company
    intends to initiate additional preclinical studies in animals with HCV
    infection before the end of 2012 and to then decide whether to continue
    development of BCX5191, based on the results of the studies.
  *Additional preclinical results regarding BCX5191 will be presented at The
    Liver Meeting®, the 63rd Annual Meeting of the American Association for
    the Study of Liver Diseases (AASLD) in Boston, November 9 to 13, 2012.
  *In September, the Company concluded the Scientific Advice Process for
    ulodesine with the European Medicines Agency. Based on this feedback, the
    ulodesine Phase 3 development plan has undergone modest revision. The
    Company continues to seek a partner for Phase 3 development and
  *The Company remains on track to initiate its BCX4161 for hereditary
    angioedema Phase 1 program before the end of 2012. The main success
    factors for the BCX4161 Phase 1 trial are to demonstrate safety, adequate
    drug exposure via oral administration and pharmacodynamic effect on
    kallikrein inhibition.
  *Promising preclinical results for BCX4430, a broad-spectrum antiviral
    nucleoside analog that has demonstrated activity against multiple viruses,
    will be presented at the 2nd Antivirals Congress in Cambridge, MA,
    November 11 to 13, 2012. The presentation will describe the antiviral
    activity of BCX4430 in the currently accepted model for demonstrating
    potential efficacy against yellow fever virus infection.

Financial Outlook for 2012

Based upon current trends and assumptions, as well as the Company’s planned
operations, BioCryst expects 2012 net operating cash use to be in the range of
$37 to $43 million, and its 2012 total operating expenses to be in the range
of $57 to $69 million, unchanged from previous guidance announced in August
2012. BioCryst’s 2012 financial results are heavily dependent on
peramivir-related operating expenses, which are largely a function of the rate
of enrollment in the Company’s Phase 3 clinical trial.

Conference Call and Webcast

BioCryst's leadership team will now host a conference call and webcast today,
November 8, 2012 at 8:30 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.
BioCryst currently has two late-stage development programs: peramivir, a viral
neuraminidase inhibitor for the treatment of influenza, and ulodesine
(BCX4208), a purine nucleoside phosphorylase (PNP) inhibitor for the treatment
of gout. In addition, BioCryst is developing two preclinical compounds:
BCX5191, a nucleoside analog inhibitor of HCV RNA polymerase (NS5B) for
hepatitis C, and BCX4161, an oral inhibitor of plasma kallikrein for
hereditary angioedema. Utilizing state-of-the-art structure-guided drug design
and crystallography, BioCryst continues to discover innovative compounds with
the goal of addressing unmet medical needs of patients and physicians. For
more information, please visit the Company's website at

About the BioCryst-Presidio Merger

BioCryst and privately held Presidio Pharmaceuticals, Inc. recently announced
the signing of a definitive merger agreement to create a focused, clinical
stage biopharmaceutical company with lead programs in high-value infectious
and orphan disease indications: specifically HCV and hereditary angioedema

Important Additional Information and Where to Find It

BioCryst intends to file with the Securities and Exchange Commission (“SEC”) a
registration statement on Form S-4, which will also include a proxy statement
and prospectus with respect to its proposed acquisition of Presidio. The final
proxy statement/prospectus will be mailed to the stockholders of BioCryst and
Presidio. Investors and security holders are urged to read the proxy
statement/prospectus regarding the proposed transaction carefully and in its
entirety when it becomes available because it will contain important
information regarding BioCryst, Presidio and the proposed merger. Investors
will be able to obtain a free copy of the proxy statement/prospectus, as well
as other filings containing information about BioCryst, without charge, at the
SEC’s website ( Investors may also obtain these
documents, without charge, from BioCryst’s website at

This communication shall not constitute an offer to sell or the solicitation
of an offer to buy any securities in the equity financing connected to the
proposed acquisition of Presidio.

Participants in the Merger Solicitation

BioCryst and its directors, executive officers and other members of management
and employees may be deemed to be participants in the solicitation of proxies
from shareholders with respect to the transactions contemplated by the
definitive merger agreement signed by Presidio. Information regarding
BioCryst’s directors and executive officers is contained in BioCryst’s 2011
Annual Report on Form 10-K filed with the SEC on March 6, 2012 and its
definitive proxy statement filed with the SEC on April 9, 2012 in connection
with its 2012 meeting of stockholders. Other information regarding the
participants in the proxy solicitation and a description of their direct and
indirect interests, by security holdings or otherwise, will be contained in
the proxy statement/prospectus and other relevant materials to be filed with
the SEC when they become available.

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 the merger might not be completed for any number of reasons, most of
which are outside of the control of BioCryst; that BioCryst may not be able to
obtain the requisite financing on commercially reasonable terms or that or
that the financing may be raised at prices below the currently prevailing
price for BioCryst common stock; that integration of BioCryst and Presidio may
prove more challenging than anticipated or that anticipated benefits of the
merger may not be achieved, or may be achieved less rapidly than anticipated;
the outcome of any legal proceedings that may be instituted against BioCryst
or Presidio; risks relating to any unforeseen liabilities, future capital
expenditures, revenues, expenses, earnings, economic performance,
indebtedness, financial condition, losses and future prospects, business and
management strategies or the expansion and growth of Presidio’s operations;
BioCryst’s ability to integrate Presidio’s business successfully after the
closing of the merger agreement; and the risk that disruptions from the merger
agreement will harm BioCryst’s or Presidio’s businesses. There can be no
assurance that the proposed merger and financing will in fact be consummated.
Other important factors include: that there can be no assurance that
BioCryst’s or Presidio’s compounds will prove effective in clinical trials;
that development and commercialization of BioCryst’s or Presidio’s compounds
may not be successful; that BARDA/HHS may further condition, reduce or
eliminate future funding of the peramivir program; that BioCryst, Presidio or
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 companies or 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, clinical hold with respect to such
product candidate or the lack of market approval for such product candidate;
that ongoing and future preclinical and clinical development may not have
positive results; that the companies or 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 companies may not be able to retain their
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 their actual cash burn rate may not be consistent with its
expectations; that 2012 operating expenses and cash usage will be within
management’s expected ranges; that BioCryst or Presidio may not have
sufficient cash to continue funding the development, manufacturing, marketing
or distribution of products and that additional funding, if necessary, may not
be available at all or on terms acceptable to BioCryst or Presidio. 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)
Statements of
                       Three Months Ended             Nine Months Ended
                       September 30,                  September 30,
                       2012           2011            2012            2011
Royalty revenue     $  2,848       $  -            $  2,848        $  -
and other              2,913          5,249           19,344          14,419
research and
Total revenues         5,761          5,249           22,192          14,419
Research and           12,072         15,101          40,374          43,042
General and            1,591          2,953           4,897           9,922
Royalty expense        114            -               114             -
Total expenses         13,777         18,054          45,385          52,964
Loss from              (8,016)        (12,805)        (23,193)        (38,545)
Interest and           54             92              182             329
other income
Interest expense       (1,166)        (1,160)         (3,486)         (2,614)
Loss on foreign
currency               (572)          (586)           (1,531)         (2,926)
Net loss            $  (9,700)     $  (14,459)     $  (28,028)     $  (43,756)
Basic and
diluted net loss    $  (0.19)      $  (0.32)       $  (0.57)       $  (0.97)
per common share
Weighted average
shares                 50,661         45,178          49,001          45,103
Note: Patent costs have been reclassified as Research and Development expense,
whereas in previous years, these costs were classified as General and
Administrative expense.
Balance Sheet
                    September 30, 2012             December 31, 2011
                    (Unaudited)                    (Note 1)
Cash, cash
equivalents and     $  43,534                      $  57,100
Restricted cash        300                            625
Receivables from       3,768                          5,831
Total assets           64,094                         82,208
Non-recourse           30,000                         30,000
notes payable
Accumulated            (381,548)                      (353,520)
Stockholders’          9,784                          14,806
Note 1: Derived from audited financial statements.


BioCryst Pharmaceuticals, Inc.
Robert Bennett, 919-859-7910 (Investors)
Catherine Kyroulis, 212-301-7174 (Media)
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