BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today
financial results for the second quarter ended June 30, 2017.
“We are excited by the positive results
previously reported in Parts 1 and 2 of the APeX-1 clinical trial
that indicate we have an active oral drug, and look forward to
completing the trial and reporting complete trial results in the
third quarter of this year,” said Jon P. Stonehouse, President
& Chief Executive Officer. "These trial results should give us
additional information to determine what doses we propose to
regulatory authorities later this year for the Phase 3 program,
with the goal of starting a pivotal trial early next
year.”
Second Quarter Financial Results
For the three months ended June 30, 2017,
revenues decreased to $3.1 million from $4.8 million in the second
quarter of 2016. The decrease in revenue was primarily due to
a decrease in collaboration revenue under U.S. Government
development contracts.
Research and Development (R&D) expenses for
the second quarter of 2017 increased to $15.8 million from
$14.2 million in the second quarter of 2016, primarily due to
increased spending on the Company’s hereditary angioedema (HAE)
portfolio.
General and administrative (G&A) expenses
for the second quarter of 2017 of $2.8 million were in line with
$2.7 million of G&A expense in the second quarter of
2016.
Interest expense was $2.1 million in the
second quarter of 2017 as compared to $1.4 million in the
second quarter of 2016, an increase related primarily to the
September 2016 closing of a $23 million senior credit
facility. Also, a $400,000 mark-to-market loss on the
Company’s foreign currency hedge was recognized in the second
quarter of 2017, as compared to a $3.7 million mark-to-market loss
in the second quarter of 2016. These losses result from
periodic changes in the U.S. dollar/Japanese yen exchange rate.
During the second quarters of 2017 and 2016, we also realized
currency gains of $921,000 and $811,000, respectively, from the
exercise of a U.S. Dollar/Japanese yen currency option within our
foreign currency hedge.
The net loss for the second quarter of 2017 was
$16.9 million, or $0.21 per share, compared to a net loss of
$16.3 million, or $0.22 per share, for the second quarter
2016.
Cash, cash equivalents and investments totaled
$95.6 million at June 30, 2017, and reflect an increase from $65.1
million at December 31, 2016. Net operating cash use for the
second quarter of 2017 was $12.2 million, and the first six months
of 2017 was $21.0 million, which excludes the impact of $47.8
million of net proceeds from our March 2017 public offering.
Year to Date Financial Results
For the six months ended June 30, 2017, revenues
increased to $12.5 million from $9.6 million in the first half of
2016. The increase in revenue was primarily due to a $4.3
million increase in royalty revenue from Shionogi & Co. Ltd.,
Green Cross Corporation and Seqirus, and a $2.0 million milestone
payment from Seqirus associated with the Canadian regulatory
approval of RAPIVAB®. The increase in
royalty revenue was largely the result of continued Japanese
Government stockpiling of RAPIACTA®. Future
government stockpiling orders are difficult to predict, as they are
subject to the relevant appropriation and stockpiling processes.
These revenue increases were partially offset by a decrease in
collaboration revenue under U.S. Government development
contracts.
R&D expenses decreased to $32.5 million from
$34.7 million in the first half of 2016, primarily due to
lower development costs for the HAE portfolio of product candidates
and, to a lesser extent, a decrease in galidesivir expenses under
U.S. Government development contracts.
G&A expenses for the first half of 2017 of
$5.9 million were in line with $5.9 million of G&A expense
in the first half of 2016.
Interest expense was $4.2 million in the
first half of 2017 as compared to $2.9 million in the first
half of 2016, an increase related primarily to the September 2016
closing of a $23 million senior credit facility. A $1.9 million
mark-to-market loss on the Company’s foreign currency hedge was
recognized in the first half of 2017, as compared to a $6.4 million
mark-to-market loss in the first half of 2016. These losses
result from periodic changes in the U.S. dollar/Japanese yen
exchange rate. During 2017 and 2016, we also realized currency
gains of $921,000 and $811,000, respectively, from the exercise of
a U.S. Dollar/Japanese yen currency option within our foreign
currency hedge.
The net loss for the first half of 2017 was
$31.1 million, or $0.40 per share, compared to a net loss of
$39.1 million, or $0.53 per share, for the first half
2016.
Clinical Development Update &
Outlook
- On May 25, BioCryst announced positive results from a second
interim analysis of its Phase 2 APeX-1 clinical trial in HAE. This
second interim analysis of pooled data from Parts 1 and 2 evaluated
doses of BCX7353 125 mg (n=7), 250 mg (n=6) and
350 mg (n=18) QD versus placebo (n=20) for 28 days. The
pre-specified per-protocol (PP) interim analysis included data on a
total of 44 subjects with confirmed Type 1 or Type 2 HAE completing
28 days of treatment. The percentage reductions by treatment group
in the mean rate of independently-adjudicated angioedema attacks
for the pre-defined effective dosing period (weeks 2 through 4) in
BCX7353 treated subjects were: 125 mg QD, 73% (p=0.002);
250 mg QD, 37% (p=0.128) and 350 mg QD, 58%
(p=0.001) compared to placebo. In the intent-to-treat (ITT)
population, corresponding reductions by treatment group were:
125 mg QD, 73% (p=0.004); 250 mg QD, 44%
(p=0.090) and 350 mg QD, 45% (p=0.014) compared to
placebo.Oral BCX7353 once-daily for 28 days was generally safe and
well tolerated in subjects with HAE. There were no serious AEs and
no severe AEs. Three subjects in the BCX7353 350 mg treatment
arm discontinued study drug before day 28. The most common
treatment-emergent adverse events were the common cold and
diarrhea. The gastrointestinal AEs previously observed in the 350
mg arm were not seen at the 125 mg dose. Additionally, no
significant laboratory abnormalities were observed in the two lower
dose groups.
- On August 2, BioCryst announced the dosing of the first subject
into ZENITH-1, a clinical trial studying up to three dosage
strengths of a liquid formulation of BCX7353 given as a single oral
dose for the acute treatment of angioedema attacks in patients with
HAE.
- On June 5, BioCryst announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the supplemental New
Drug Application (sNDA) for a pediatric indication of RAPIVAB®
(peramivir injection), which was submitted in March 2017. The
sNDA has been classified by the FDA as a priority review and has a
Prescription Drug User Fee Act (PDUFA) goal date for a decision by
the end of September 2017.
- After discussions with the FDA, NIAID and BARDA, we have
delayed the initiation of the galidesivir IV Phase 1 clinical
trial. Based upon ongoing conversations, we expect the next
step in galidesivir’s development will be to conduct an additional
nonclinical efficacy study in a delayed treatment setting in Ebola
disease before finalizing the Phase 1 clinical trial protocol
design.
- On May 30, BioCryst announced the appointment of Robert A.
Ingram as Chairman of its Board of Directors.
Financial Outlook for
2017
Based upon development plans and our awarded
government contracts, BioCryst continues to expect its 2017 net
operating cash use to be in the range of $30 to $50 million, and
its 2017 operating expenses to be in the range of $53 to $73
million. Our operating expense range excludes equity-based
compensation expense due to the difficulty in reliably projecting
this expense, as it is impacted by the volatility and price of the
Company’s stock, as well as by the vesting of the Company’s
outstanding performance-based stock options.
Conference Call and Webcast
BioCryst's leadership team will host a
conference call and webcast Monday, August 7, 2017 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 BCX7353
Discovered by BioCryst, BCX7353 is a novel,
oral, once-daily, selective inhibitor of plasma kallikrein
currently in development for the prevention and treatment of
angioedema attacks in patients diagnosed with HAE. BCX7353 has been
generally safe and well tolerated in the ongoing Phase 2 APeX-1
clinical trial for prophylaxis and in clinical pharmacology studies
in healthy volunteers.
About BioCryst
Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and
develops novel small molecule drugs that block key enzymes involved
in rare diseases. BioCryst has several ongoing development
programs: BCX7353 and other second generation oral inhibitors of
plasma kallikrein for hereditary angioedema, and galidesivir, a
broad spectrum viral RNA polymerase inhibitor that is a potential
treatment for filoviruses. RAPIVAB® (peramivir injection), a viral
neuraminidase inhibitor for the treatment of influenza, is
BioCryst's first approved product and has received regulatory
approval in the U.S., Canada, Japan, Taiwan and Korea.
Post-marketing commitment development activities for RAPIVAB are
ongoing, as well as activities to support regulatory approvals in
other territories. 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 developing any HAE drug candidate
may take longer or may be more expensive than planned; that ongoing
and future preclinical and clinical development of HAE second
generation drug candidates (including APeX-1 and ZENITH-1) may not
have positive results; that BioCryst may not be able to enroll the
required number of subjects in planned clinical trials of product
candidates; that the Company may not advance human clinical trials
with product candidates as expected; 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 additional government funding to further support the
development of galidesivir; that galidesivir development may not be
successful; that BARDA and/or NIAID may further condition, reduce
or eliminate future funding; that revenue from peramivir injection
is unpredictable and may never result in significant revenue for
the Company; that the Company may not be able to continue
development of ongoing and future development programs; that such
development programs may never result in future products; that
actual financial results may not be consistent with expectations,
including that 2017 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
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BIOCRYST PHARMACEUTICALS, INC. |
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CONSOLIDATED FINANCIAL
SUMMARY |
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(in thousands, except per share) |
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Statements of Operations (Unaudited) |
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Three Months Ended |
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Six Months Ended |
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June 30, |
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|
June 30, |
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|
2017 |
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2016 |
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2017 |
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2016 |
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Revenues: |
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Royalty
revenue |
$ |
|
489 |
|
|
$ |
629 |
|
|
$ |
|
6,810 |
|
|
$ |
2,519 |
|
|
Collaborative
and other research and development |
|
|
2,610 |
|
|
|
4,158 |
|
|
|
|
5,726 |
|
|
|
7,088 |
|
|
Total revenues |
|
|
3,099 |
|
|
|
4,787 |
|
|
|
|
12,536 |
|
|
|
9,607 |
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Expenses: |
|
|
|
|
|
Research and
development |
|
15,759 |
|
14,166 |
|
|
32,529 |
|
34,745 |
|
|
General and
administrative |
|
|
2,834 |
|
|
|
2,724 |
|
|
|
|
5,892 |
|
|
|
5,936 |
|
|
Royalty |
|
|
22 |
|
|
|
27 |
|
|
|
|
316 |
|
|
|
104 |
|
|
Total operating
expenses |
|
|
18,615 |
|
|
|
16,917 |
|
|
|
|
38,737 |
|
|
|
40,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(15,516 |
) |
|
|
(12,130 |
) |
|
|
|
(26,201 |
) |
|
|
(31,178 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income |
|
|
203 |
|
|
|
147 |
|
|
|
|
312 |
|
|
|
586 |
|
|
Interest expense |
|
|
(2,094 |
) |
|
|
(1,421 |
) |
|
|
|
(4,194 |
) |
|
|
(2,891 |
) |
|
Gain (loss) on foreign
currency derivative |
|
|
521 |
|
|
|
(2,877 |
) |
|
|
|
(1,022 |
) |
|
|
(5,630 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(16,886 |
) |
|
$ |
(16,281 |
) |
|
$ |
|
(31,105 |
) |
|
$ |
(39,113 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted net
loss per common share |
$ |
|
(0.21 |
) |
|
$ |
(0.22 |
) |
|
$ |
|
(0.40 |
) |
|
$ |
(0.53 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
80,418 |
|
|
|
73,695 |
|
|
|
|
77,807 |
|
|
|
73,648 |
|
|
|
|
|
|
|
|
|
|
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|
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|
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Balance Sheet
Data (in thousands) |
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|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
(Unaudited) |
|
(Note 1) |
|
Cash, cash equivalents
and investments |
|
$ |
90,276 |
|
|
|
|
$ |
63,576 |
|
|
|
Restricted cash |
|
|
5,357 |
|
|
|
|
|
1,546 |
|
|
|
Receivables from
collaborations |
|
|
3,325 |
|
|
|
|
|
8,768 |
|
|
|
Total assets |
|
|
113,509 |
|
|
|
|
|
89,847 |
|
|
|
Non-recourse notes
payable |
|
|
28,463 |
|
|
|
|
|
28,243 |
|
|
|
Senior credit
facility |
|
|
22,996 |
|
|
|
|
|
22,777 |
|
|
|
Accumulated
deficit |
|
|
(597,166 |
) |
|
|
|
|
(566,061 |
) |
|
|
Stockholders’
equity |
|
|
24,076 |
|
|
|
|
|
1,578 |
|
|
|
Shares of common stock
outstanding |
|
|
80,428 |
|
|
|
|
|
73,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Note 1: Derived
from audited financial statements. |
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CONTACT: Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910
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