BioCryst Provides Corporate Update and Reports First Quarter 2012 Financial Results
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the first quarter ended March 31, 2012.
"We just completed our end of Phase 2 meeting with the FDA regarding our
gout program. The agency provided clear and informative guidance
regarding the path to approval for BCX4208,
and we are now incorporating this advice into the Phase 3 plan. Our goal
is to conclude our partnering process during 2012 to enable Phase 3
trials to start as soon as possible," said Jon
P. Stonehouse, President & Chief Executive Officer of BioCryst.
"We are currently completing nonclinical safety studies for our
preclinical drug candidates to treat hepatitis C and hereditary
angioedema, and both programs remain on track to move into clinical
trials before the end of this year. BioCryst continues to effectively
execute its plan to advance four development programs, each representing
value creation opportunities."
First Quarter Financial Results
For the three months ended March 31, 2012, revenues increased to
$12.2 million from $5.4 million in last year's quarter. The large
increase in revenue for the quarter relates to the recognition of $7.8
million of forodesine-related revenue. The Company completed the
transfer of the forodesine IND and other technical aspects of the
program anticipated in the November 2011 restructuring of the license
agreement between BioCryst and Mundipharma. Upon completion of this
regulatory and technical transfer in the first quarter of 2012, all
previously deferred revenue and expense associated with the Mundipharma
relationship has been recognized. This transfer did not have any impact
on the Company's cash balance.
Research and development expenses for the quarter increased to
$15.4 million from $13.4 million in the first quarter of 2011, primarily
due the recognition of $1.9 million of deferred expenses associated with
forodesine and the Mundipharma agreement. Higher development costs
associated with the preclinical and peramivir
development programs were offset by lower development costs associated
with the BCX4208 gout program.
General and administrative expenses for the quarter decreased to
$1.8 million compared to $3.5 million in last year's quarter. The
decrease of $1.7 million from 2011 is primarily the result of costs
incurred in 2011 relating to the transition of the Company's
headquarters to North Carolina, as well as reductions in other
administrative expenses during 2012.
Interest expense related to the non-recourse notes increased to
$1.2 million in the first quarter of 2012 compared to $0.3 million in
the first quarter of 2011, due to recognizing a full quarter of interest
expense in 2012 compared a partial month in 2011. In addition, a small
mark-to-market gain on our foreign currency hedge was recognized in the
first quarter of 2012, compared to a mark-to-market loss of $1.3 million
in the same quarter in the prior year, resulting from changes in the
U.S. dollar/Japanese yen exchange rate.
The net loss for the first quarter 2012 was $6.1 million, or $0.13 per
share, compared to a net loss of $13.0 million, or $0.29 per share, for
the first quarter 2011.
Cash, cash equivalents and investments totaled $57.3 million at March
31, 2012, in line with $57.7 million at December 31, 2011. Net operating
cash use for the first quarter of 2012 was $11.7 million. Operating cash
use excludes $11.7 million in proceeds from sales of common stock
through the Company's at-the-market offering (ATM) during the first
quarter 2012, as well as collateral receipts/payments under the foreign
currency hedge agreement.
Clinical Development Update & Outlook
In April, BioCryst held an End of Phase 2 meeting with the FDA
regarding BCX4208, which included discussions around its Phase 3
program. The proposed Phase 3 trial plan anticipates enrollment of
approximately 1,800 patients and 12 months of study drug exposure;
BCX4208 administration as add-on treatment to the approved xanthine
oxidase (XO) inhibitors, allopurinol or febuxostat; study population
of gout patients who are not adequately responding to a XO inhibitor
alone; and a primary efficacy endpoint at six months of the proportion
of patients with a serum uric acid (sUA) level that is < 6.0 mg/dL. In
addition, the Company has also initiated the Scientific Advice Process
with the EMA and expects feedback in the third quarter of 2012.
During the third quarter of 2012, BioCryst expects to complete the
extension phase through 52-weeks of its randomized Phase 2b clinical
trial of BCX4208 added to allopurinol in patients with gout who had
failed to reach the sUA goal of < 6 mg/dL on allopurinol alone.
BioCryst also expects to complete its Phase 2 BCX4208 clinical trial
in patients with moderate renal impairment during the third quarter.
The Company has closed enrollment for this study at 20 patients.
The company is completing Good Laboratory Practices (GLP) nonclinical
safety studies of BCX5191
for hepatitis C and BCX4161
for hereditary angioedema. Both programs remain on track for the
initiation of first-in-human trials before the end of the 2012. The
Company has started Phase 1 planning for each drug candidate.
BioCryst continues to enroll patients in the ongoing Phase 3 efficacy
clinical trial of the influenza antiviral i.v. peramivir. The Company
plans to provide an update following the planned interim analysis,
which is expected after the conclusion of the 2012 Southern Hemisphere
flu season.
Financial Outlook for 2012
Based upon current trends and assumptions, as well as the Company's
planned operations, BioCryst continues to expect net operating cash use
to be in the range of $32 to $38 million, and its total operating
expenses to be in the range of $57 to $69 million. The Company's
operating cash forecast excludes any potential cash inflows from
out-licensing or other sources. BioCryst's 2012 financial results will
be heavily dependent on peramivir-related operating expenses, which are
largely a function of the rate of enrollment in the Company's ongoing
Phase 3 clinical trial, which in turn is dependent on the prevalence and
severity of influenza in those geographies where BioCryst has clinical
sites.
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
Monday, May 7, 2012 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. BioCryst currently has two late-stage development
programs: peramivir,
a viral neuraminidase inhibitor for the treatment of influenza, and BCX4208,
a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of
gout. In addition, BioCryst is advancing two preclinical programs
towards IND filings: 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 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 our 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 there can be
no assurance that our compounds will prove effective in clinical trials;
that development and commercialization of our compounds may not be
successful; that BARDA/HHS may further condition, reduce or eliminate
future funding of the peramivir program; that we or our licensees may
not be able to enroll the required number of subjects in planned
clinical trials of our product candidates and that such clinical trials
may not be successfully completed; that BioCryst or its licensees may
not commence as expected additional human clinical trials with our
product candidates; that our product candidates may not receive required
regulatory clearances from the FDA; that ongoing and future preclinical
and clinical development may not have positive results; that we or our
licensees may not be able to continue future development of our current
and future development programs; that our development programs may never
result in future product, license or royalty payments being received by
BioCryst; that BioCryst may not be able to retain its current
pharmaceutical and biotechnology partners for further development of its
product candidates or it may not reach favorable agreements with
potential pharmaceutical and biotechnology partners for further
development of its product candidates; that our actual cash burn rate
may not be consistent with our expectations; that BioCryst may not have
sufficient cash to continue funding the development, manufacturing,
marketing or distribution of its 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 our projections and forward-looking statements.
BCRXW
BIOCRYST PHARMACEUTICALS, INC.
CONSOLIDATED FINANCIAL SUMMARY
(in thousands, except per share numbers)
Consolidated Statements of Operations (Unaudited)
Three Months Ended
March 31,
2012
2011
Revenues:
Collaborative and other research and development
$
12,221
$
5,435
Total revenues
12,221
5,435
Expenses:
Research and development
15,441
13,403
General and administrative
1,781
3,531
Total expenses
17,222
16,934
Loss from operations
(5,001
)
(11,499
)
Interest and other income
71
102
Interest expense
(1,160
)
(288
)
Gain (loss) on foreign currency derivative
38
(1,342
)
Net loss
$
(6,052
)
$
(13,027
)
Basic and diluted net loss per common share
$
(0.13
)
$
(0.29
)
Weighted average shares outstanding
47,105
44,987
Note: Legal patent costs are now classified as Research &
Development expenses, whereas
previously they were classified as General & Administrative
expense.
Consolidated Balance Sheet Data
(Unaudited)
March 31, 2012
December 31, 2011
Cash, cash equivalents and investments
$
57,300
$
57,725
Receivables from collaborations
5,852
5,831
Total assets
80,085
82,208
Non-recourse notes payable
30,000
30,000
Accumulated deficit
(359,572
)
(353,520
)
Stockholders' equity
23,150
14,806
BioCryst Pharmaceuticals Robert Bennett, +1-919-859-7910 (Investors) or WCG Catherine
Kyroulis, +1-212-301-7174 (Media)
