BCX7353 Phase 3 program agreed with FDA and
EMA
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today
financial results for the third quarter ended September 30, 2017.
“Now that we have completed our end of Phase 2
regulatory interactions with the FDA and EMA and have agreement on
the requirements for marketing authorization applications of
BCX7353, we are focused on executing the Phase 3 program to support
NDA and MAA filings in 2019,” said Jon P. Stonehouse, President
& Chief Executive Officer. "We expect to start the single
required Phase 3 efficacy and the long-term safety trials in first
quarter 2018."
Third Quarter Financial Results
For the three months ended September 30, 2017,
revenues increased to $8.8 million from $7.8 million in the third
quarter of 2016. The increase in revenue was primarily due to
a $5.0 million milestone payment associated with the U.S. Food and
Drug Administration (FDA) approval of a supplemental New Drug
Application (sNDA) for RAPIVAB® (peramivir
injection), extending its availability for the treatment of acute
uncomplicated influenza to pediatric patients two years and older,
and the recognition of $1.5 million of peramivir product sales to
the Company’s commercial partner, Green Cross Corporation. These
increases were offset by a $3.1 million decrease in RAPIACTA®
royalties primarily due to lower government stockpiling sales by
the Company’s commercial partner in Japan, Shionogi & Co. Ltd.
(Shionogi), and lower collaboration revenue under U.S. Government
development contracts.
Research and Development (R&D) expenses for
the third quarter of 2017 increased to $17.5 million from
$14.1 million in the third quarter of 2016, primarily due to
increased spending on the Company’s hereditary angioedema (HAE)
portfolio, including the achievement of a performance-based stock
option grant related to the successful completion of the APeX-1
clinical trial. These increases were offset by a decrease in
the Company’s galidesivir expenses under U.S. Government
development contracts.
General and administrative (G&A) expenses
for the third quarter of 2017 increased to $3.3 million compared to
$2.8 million of expense in the third quarter of 2016.
The increase was primarily due to the achievement of a
performance-based stock option grant related to the successful
completion of the APeX-1 clinical trial.
Interest expense was $2.1 million in the
third quarter of 2017 as compared to $1.5 million in the third
quarter of 2016, an increase related primarily to the September
2016 closing of a $23 million senior credit facility. Also, a
$84,000 mark-to-market gain on the Company’s foreign currency hedge
was recognized in the third quarter of 2017, as compared to a
$931,000 mark-to-market loss in the third quarter of 2016.
These changes result from periodic changes in the U.S.
dollar/Japanese yen exchange rate. During the third quarter of
2017, the Company also realized a currency gain of $45,000 from the
exercise of a U.S. Dollar/Japanese yen currency option within its
foreign currency hedge.
The net loss for the third quarter of 2017 was
$15.1 million, or $0.18 per share, compared to a net loss of
$11.5 million, or $0.16 per share, for the third quarter
2016.
Cash, cash equivalents and investments totaled
$169.3 million at September 30, 2017, and reflect an increase from
$65.1 million at December 31, 2016. Net operating cash use for the
third quarter of 2017 was $10.6 million, and was $31.6 million for
the first nine months of 2017, which excludes net proceeds from the
March 2017 ($47.8 million) and September 2017 ($85.8 million)
public offerings.
Year to Date Financial Results
For the nine months ended September 30, 2017,
revenues increased to $21.3 million from $17.4 million in the first
nine months of 2016. The increase in revenue was primarily
due to $7.0 million of milestone payments associated with the
Canadian regulatory and FDA sNDA approvals of RAPIVAB, and to a
lesser extent a $1.2 million increase in royalty revenue from
Shionogi & Co. Ltd., Green Cross Corporation and Seqirus.
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 offset by a $5.5 million decrease in collaboration
revenue under U.S. Government development contracts.
R&D expenses for the nine months of 2017
increased to $50.0 million from $48.9 million in the first
nine months of 2016, primarily due to the achievement of a
performance-based stock option grant related to the successful
completion of the APeX-1 clinical trial. These increases were
offset by a decrease in galidesivir expenses under U.S. Government
development contracts.
G&A expenses for the nine months of 2017
increased to $9.2 million compared to $8.7 million in the
first nine months of 2016. The increase was due to the
achievement of a performance-based stock option grant related to
the successful completion of the APeX-1 clinical trial.
In the nine months of 2017 and 2016, interest
expense was $6.3 million and $4.4 million, respectively.
The increase in interest expense was 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 nine months of 2017, as compared
to a $7.4 million mark-to-market loss in the first nine months 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 $966,000 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 nine months of 2017 was
$46.2 million, or $0.58 per share, compared to a net loss of
$50.6 million, or $0.69 per share for the same period last
year.
Clinical Development Update &
Outlook
- In the fourth quarter, BioCryst completed end of Phase 2
regulatory interactions with the FDA and European Medicines Agency
(EMA) resulting in finalizing the marketing authorization
requirements, including agreement on the design of a single Phase 3
clinical trial and the details regarding a long-term safety
trial.
- On November 1, 2017, the FDA granted orphan drug designation to
BCX7353 for the prevention and treatment of angioedema attacks in
patients diagnosed with HAE.
- On September 5, BioCryst announced positive final results from
its Phase 2 APeX-1 clinical trial in HAE. APeX-1 was a 3-part dose
ranging trial designed to evaluate the efficacy, safety,
tolerability, pharmacokinetics and pharmacodynamics of orally
administered once-daily BCX7353 for 28 days, as a preventative
treatment to reduce the frequency of attacks in HAE patients.
- On September 15, BioCryst announced the completion of an
underwritten public offering of 17,864,078 shares of its common
stock, including 2,330,097 shares sold pursuant to the exercise in
full of the underwriters' option to purchase additional
shares. The gross proceeds from this offering, including from
the shares sold pursuant to the underwriters' option to purchase
additional shares, were $92 million before deducting underwriting
discounts and commissions and other estimated offering
expenses.
- On September 21, BioCryst announced that the U.S. FDA approved
a sNDA for RAPIVAB (peramivir injection), an intravenous (i.v.)
neuraminidase inhibitor, extending its availability for the
treatment of acute uncomplicated influenza to pediatric patients
two years and older who have been symptomatic for no more than two
days.
Financial Outlook for
2017
Based upon development plans and our awarded
government contracts, BioCryst expects its 2017 net operating cash
use to be in the upper half of its previously disclosed range of
$30 to $50 million, and its 2017 operating expenses to be in the
upper half of its previously disclosed 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 Tuesday, November 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 was
generally safe and well tolerated in the recently completed Phase 2
APeX-1 clinical trial for the prophylaxis of angioedema attacks in
patients with HAE and in clinical pharmacology studies in healthy
volunteers.
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB
(peramivir injection) is an intravenous viral neuraminidase
inhibitor approved for the treatment of acute uncomplicated
influenza in patients two years and older who have been symptomatic
for no more than two days. Efficacy of RAPIVAB is based on clinical
trials of naturally occurring influenza in which the predominant
influenza infections were influenza A virus and a limited number of
patients infected with influenza B virus. Visit
http://www.rapivab.com to learn more.
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 commitments 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 ZENITH-1 and APeX-2) 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 and EMA 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
CONTACT: Thomas Staab, BioCryst Pharmaceuticals,
+1-919-859-7910
|
BIOCRYST PHARMACEUTICALS, INC. |
CONSOLIDATED FINANCIAL
SUMMARY |
(in thousands, except per share) |
|
|
|
|
|
|
|
|
|
|
|
|
Statements of Operations (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
$ |
|
1,501 |
|
|
$ |
- |
|
|
$ |
|
1,501 |
|
|
$ |
- |
|
Royalty
revenue |
|
|
442 |
|
|
|
3,501 |
|
|
|
|
7,252 |
|
|
|
6,020 |
|
Collaborative and other research and development |
|
|
6,817 |
|
|
|
4,262 |
|
|
|
|
12,543 |
|
|
|
11,350 |
|
Total revenues |
|
|
8,760 |
|
|
|
7,763 |
|
|
|
|
21,296 |
|
|
|
17,370 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
Cost of
products sold |
|
1,142 |
|
- |
|
|
1,142 |
|
- |
|
Research
and development |
|
|
17,509 |
|
|
|
14,105 |
|
|
|
|
50,038 |
|
|
|
48,850 |
|
General
and administrative |
|
|
3,343 |
|
|
|
2,756 |
|
|
|
|
9,235 |
|
|
|
8,692 |
|
Royalty |
|
|
115 |
|
|
|
143 |
|
|
|
|
431 |
|
|
|
247 |
|
Total operating
expenses |
|
|
22,109 |
|
|
|
17,004 |
|
|
|
|
60,846 |
|
|
|
57,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(13,349 |
) |
|
|
(9,241 |
) |
|
|
|
(39,550 |
) |
|
|
(40,419 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income |
|
|
225 |
|
|
|
109 |
|
|
|
|
537 |
|
|
|
695 |
|
Interest expense |
|
|
(2,140 |
) |
|
|
(1,465 |
) |
|
|
|
(6,334 |
) |
|
|
(4,356 |
) |
Gain (loss) on foreign
currency derivative |
|
|
130 |
|
|
|
(931 |
) |
|
|
|
(892 |
) |
|
|
(6,561 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(15,134 |
) |
|
$ |
(11,528 |
) |
|
$ |
|
(46,239 |
) |
|
$ |
(50,641 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share |
$ |
|
(0.18 |
) |
|
$ |
(0.16 |
) |
|
$ |
|
(0.58 |
) |
|
$ |
(0.69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
83,570 |
|
|
|
73,734 |
|
|
|
|
79,749 |
|
|
|
73,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet
Data (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
|
(Unaudited) |
|
(Note 1) |
Cash, cash equivalents
and investments |
|
$ |
166,163 |
|
|
|
|
$ |
63,576 |
|
|
Restricted cash |
|
|
3,122 |
|
|
|
|
|
1,546 |
|
|
Receivables from
collaborations |
|
|
8,985 |
|
|
|
|
|
8,768 |
|
|
Total assets |
|
|
191,492 |
|
|
|
|
|
89,847 |
|
|
Non-recourse notes
payable |
|
|
28,572 |
|
|
|
|
|
28,243 |
|
|
Senior credit
facility |
|
|
23,106 |
|
|
|
|
|
22,777 |
|
|
Accumulated
deficit |
|
|
(612,300 |
) |
|
|
|
|
(566,061 |
) |
|
Stockholders’
equity |
|
|
100,632 |
|
|
|
|
|
1,578 |
|
|
Shares of common stock
outstanding |
|
|
98,389 |
|
|
|
|
|
73,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Derived
from audited financial statements. |
|
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