BioCryst Provides Corporate Update and Reports Second Quarter 2012 Financial Results
Hepatitis C and hereditary angioedema programs advancing into
clinical trials
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial
results for the second quarter and six months ended June 30, 2012.
"Following the completion of the preclinical safety studies of both BCX5191
for hepatitis C and BCX4161
for hereditary angioedema, we are now taking the final steps to move
these promising programs into the clinic before the end of this year,"
said Jon
P. Stonehouse, President & Chief Executive Officer of BioCryst.
"Furthermore, we are extremely pleased with the favorable ulodesine
gout safety and efficacy profile, confirmed by over 115 patient-years of
drug exposure in our recently announced 52-week results. This robust
data substantially reduces the risk associated with ulodesine's Phase 3
development and will enhance its appeal to potential development
partners."
Second Quarter Financial Results
For the three months ended June 30, 2012, revenues increased to
$4.2 million from $3.7 million in last year's quarter as a result of an
increase in collaboration revenue from the Biomedical Advanced Research
and Development Authority/Department of Health and Human Services
(BARDA/HHS) under the contract for the continued development of peramivir.
Research and development (R&D) expenses for the second quarter decreased
to $12.8 million from $14.4 million in the second quarter of 2011. In
the recent quarter, lower development costs associated with the
ulodesine (BCX4208) program were partially offset by higher development
costs associated with the BCX5191 and BCX4161 preclinical programs.
General and administrative (G&A) expenses for the second quarter
decreased to $1.6 million compared to $3.5 million in the second quarter
of 2011, primarily due to reductions in administrative expenses during
2012.
Interest expense related to the non-recourse notes was $1.2 million in
the second quarter of 2012, in-line with last year's quarter. In
addition, a $1.0 million mark-to-market loss on the foreign currency
hedge was recognized in the second quarter of 2012, similar to the loss
of $1.0 million in the second quarter of 2011. The 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 transaction.
The net loss for the second quarter 2012 was $12.3 million, or $0.25 per
share, compared to a net loss of $16.3 million, or $0.36 per share, for
the second quarter 2011.
Cash and investments totaled $53.5 million at June 30, 2012, and $57.7
million at December 31, 2011. Net operating cash use for the second
quarter of 2012 was $8.1 million, and excludes $3.7 million in proceeds
from sales of common stock through the Company's at-the-market offering
(ATM) during the quarter, $1.6 million in royalties received during the
quarter from RAPIACTA® sales designated for interest on the
non-recourse notes, as well as collateral payments under the foreign
currency hedge agreement. Net operating cash use for the first six
months of 2012 was $20.1 million.
Year to Date Financial Results
For the six months ended June 30, 2012, total revenues increased to
$16.4 million from $9.2 million in the first half of 2011. The increase
was primarily due to the recognition of $7.8 million of previously
deferred forodesine-related revenue during the first quarter 2012,
resulting from the restructuring of the license agreement between
BioCryst and Mundipharma.
R&D expenses increased modestly to $28.3 million for the first half of
2012 from $27.9 million in the same period of 2011. Expenses for 2012
included the recognition of $1.9 million of previously deferred expenses
associated with forodesine and the Mundipharma agreement. Excluding
these non-cash forodesine expenses, lower 2012 development costs related
to ulodesine substantially offset higher 2012 costs associated with the
BCX5191, BCX4161 and peramivir development programs, as compared to
levels in the first half of 2011.
G&A expenses decreased significantly to $3.3 million for the six months
ended June 30, 2012 from $7.0 million for the six months ended June 30,
2011, due to the 2011 relocation of BioCryst's corporate headquarters
and to lower third party professional expenses during 2012 associated
with the realization of cost containment measures.
The net loss for the six months ended June 30, 2012 decreased to
$18.3 million, or $0.38 per share, compared to a net loss of
$29.3 million, or $0.65 per share for the same period last year.
Clinical Development Update & Outlook
In July, the Company completed IND-enabling nonclinical safety studies
of BCX5191
for hepatitis C and BCX4161
for hereditary angioedema. The Company is completing Phase 1 planning
for both programs, which remain on track for the initiation of
first-in-human trials before the end of the 2012. The main success
factors for the BCX5191 Phase 1 trial will be to confirm that low
doses can be administered safely and deliver activity against the
hepatitis C virus. The main success factors for the BCX4161 Phase 1
trial will be to demonstrate safety, adequate drug exposure via oral
administration and pharmacodynamic effect on kallikrein inhibition.
Also in July, BioCryst reported favorable 52-week results from the
extension phase of its randomized Phase 2b trial of ulodesine added to
allopurinol in patients with gout who had failed to reach the serum
uric acid (sUA) therapeutic goal of < 6 mg/dL on allopurinol alone, as
well as positive Phase 2 safety results in patients with mild- to
moderate-renal impairment. The results of the safety extension confirm
that ulodesine was generally safe and well-tolerated. In addition, the
Company has also initiated the Scientific Advice Process with the
European Medicines Agency and expects feedback in the third quarter of
2012.
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 expects net operating cash use to be in the
range of $37 to $43 million, reflecting an increase of $5 million from
previous projections, and its total operating expenses to be in the
range of $57 to $69 million, unchanged from previous projections. The $5
million increase in the Company's operating cash forecast is due
primarily to an anticipated increase in R&D investment for the
development of the hepatitis C program, as well as a lower net margin
contribution related to peramivir development under the BARDA/HHS
advanced development contract. 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
Thursday, August 2, 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 ulodesine
(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)
Statements of Operations (Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2012
2011
2012
2011
Revenues:
Collaborative and other research and development
$
4,210
$
3,735
$
16,431
$
9,170
Total revenues
4,210
3,735
16,431
9,170
Expenses:
Research and development
12,777
14,442
28,302
27,941
General and administrative
1,609
3,536
3,306
6,971
Total expenses
14,386
17,978
31,608
34,912
Loss from operations
(10,176
)
(14,243
)
(15,177
)
(25,742
)
Interest and other income
57
136
128
239
Interest expense
(1,160
)
(1,166
)
(2,320
)
(1,455
)
Loss on foreign currency derivative
(997
)
(998
)
(959
)
(2,340
)
Net loss
$
(12,276
)
$
(16,271
)
$
(18,328
)
$
(29,298
)
Basic and diluted net loss per common share
$
(0.25
)
$
(0.36
)
$
(0.38
)
$
(0.65
)
Weighted average shares outstanding
49,218
45,111
48,161
45,063
Note: Legal patent costs are now classified as Research and
Development expense, whereas previously, they were
classified as General and Administrative expense.
Balance Sheet Data
June 30, 2012
December 31, 2011
(Unaudited)
(Note 1)
Cash, cash equivalents and investments
$
51,233
$
57,100
Restricted cash
2,230
625
Receivables from collaborations
5,084
5,831
Total assets
76,236
82,208
Non-recourse notes payable
30,000
30,000
Accumulated deficit
(371,848)
(353,520)
Stockholders' equity
15,659
14,806
Note 1: Derived from audited financial statements.
BioCryst Pharmaceuticals Investors: Robert Bennett,
+1-919-859-7910 or WCG Media: Catherine Kyroulis,
+1-212-301-7174
