2013 cash utilization projected to drop 38-45% versus 2012
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that in response
to recent events and an assessment of its assets, the Company is
restructuring and implementing a focused strategy to advance its
hereditary angioedema (HAE) and antiviral programs. The restructuring is
intended to significantly reduce BioCryst's cost structure and scale the
organization appropriately for its current portfolio. The Company plans
to direct its cash and other resources primarily to enable the
achievement of important near-term milestones for the BCX4161
HAE, BCX4430 broad spectrum antiviral and BCX5191
hepatitis C (HCV) programs.
"The strategic focus and restructuring announced today is based on an
evaluation of our programs and operations, following the setbacks in our peramivir
and BCX5191 programs, as well as the delay in our BCX4161 program," said Jon
P. Stonehouse, President & Chief Executive Officer of BioCryst.
"The restructuring is a necessary but difficult measure that impacts
many talented and dedicated BioCryst employees who will be leaving the
company. We are grateful for their meaningful contributions and
commitment over the years."
Mr. Stonehouse continued, "We have determined the best path forward and
remain committed to advancing our HAE and antiviral programs to rebuild
shareholder value. To succeed, we must significantly decrease our
operating costs and carefully manage cash, while efficiently advancing
our three priority programs. Therefore, we are implementing a
substantial corporate restructuring to decrease our annual cash
utilization and thereby extend our cash runway. The restructuring
provides additional cash runway to reach value inflection points for
these programs."
BioCryst's corporate restructuring includes a workforce reduction of 50
percent of the Company's headcount, or 38 positions. Excluding
restructuring and deal charges, cash savings of $15 to $18 million are
expected in 2013, as compared to an approximate $40 million cash use
expected in 2012. The Company expects to record a restructuring charge
of $2 to $4 million in the fourth quarter of 2012. For 2013, preliminary
cash utilization guidance is in the range of $22 to $25 million,
excluding restructuring and deal related costs. Detailed financial
guidance for 2013 will be provided with the fiscal 2012 results
announcement in February 2013.
Program Updates & Milestones
-
BioCryst is conducting a study to characterize the efficacy of low
doses of BCX5191 in chronically HCV infected chimpanzees, with the
goal of demonstrating meaningful antiviral activity at low doses.
Results from the study are expected in early 2013.
-
By the end of January 2013, BioCryst plans to complete analysis of the
peramivir Phase 3 trial results and to review the conclusions with
HHS/BARDA. After reviewing the totality of peramivir clinical safety
and efficacy data, a decision will be made regarding peramivir's
future.
-
The BCX4161 Phase 1 program is expected to start around the end of the
first quarter 2013. The goal of this program is to demonstrate safety,
adequate drug exposure via oral administration and pharmacodynamic
effect on kallikrein inhibition.
-
A manuscript describing the activity of BCX4430 against certain
filoviruses has recently been submitted to a journal for
consideration. In addition, BioCryst has submitted a proposal to seek
additional government funding for the development of BCX4430 under the
animal rule.
-
The Company's strategy for the ulodesine
gout program remains unchanged. BioCryst intends to secure a partner
to take over the ulodesine Phase 3 development and to commercialize
the product.
BioCryst Conference Call and Webcast
Executives from BioCryst will host a conference call and webcast on
Friday, December 7, 2012 at 10:00 a.m. Eastern Time, to discuss
BioCryst's future strategy and initiatives. 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. The event and slide presentation will be
available prior to the event and archived after in the Investor
Relations section of www.BioCryst.com.
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 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
advancing two preclinical programs: 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 BioCryst's website at www.BioCryst.com.
BioCryst 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. Other important factors include: that there can be no
assurance that BioCryst's compounds will prove safe and effective in
clinical trials; that development and commercialization of BioCryst's
compounds may not be successful; that BARDA/HHS may further condition,
reduce or eliminate future funding of the peramivir program; that
BioCryst or licensees may not be able to enroll the required number of
subjects in clinical trials of their respective product candidates and
that such clinical trials may not be successfully completed; that
BioCryst 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 BioCryst 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 BioCryst 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; that the corporate
restructuring may not result in reductions in operating cash use and
infrastructure expenses, or in the restructuring expenses as projected;
that BioCryst 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. 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
Robert Bennett, 919-859-7910
Source: BioCryst Pharmaceuticals, Inc.
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