BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today
financial results for the second quarter ended June 30, 2018.
“Building on the clear direction from our
shareholders and a strong conviction in the medical community that
BCX7353 is a highly differentiated asset which can deliver enormous
value to patients and shareholders, we have made substantial
progress advancing our prophylactic and acute BCX7353 clinical
programs, and significantly strengthened our balance sheet,” said
Jon P. Stonehouse, BioCryst’s President and Chief Executive
Officer.
“Enrollment in the ZENITH-1 trial has completed,
and we look forward to reporting Part 1 results later this
quarter. Enrollment in the APeX-2 and APeX-S trials continues
to go extremely well, and we are confident that we will report
top-line safety and efficacy in the second quarter of next year. We
believe we have the programs, the focused commitment of an
experienced team and the financial resources to deliver significant
value to patients and shareholders with our existing portfolio and
we are excited about the clinical and regulatory milestones ahead
of us in the next 12 months,” Stonehouse added.
Second Quarter 2018 Financial Results
For the three months ended June 30, 2018, total
revenues were $12.5 million, compared to $3.1 million in the second
quarter of 2017. The increase in revenue was primarily associated
with the recognition of $7.0 million of deferred revenue and a $5.0
million milestone, both associated with the European Medicines
Agency’s (EMA) approval of peramivir (ALPIVABTM). These revenues
were partially offset by lower collaboration revenue under U.S.
Government development contracts.
Research and Development (R&D) expenses for
the second quarter of 2018 increased to $21.0 million from
$15.8 million in the second quarter of 2017, primarily due to
increased spending on the Company’s hereditary angioedema (HAE) and
preclinical programs, as well as additions in R&D personnel.
These increases were partially offset by decreased activity under
U.S. Government development contracts.
General and administrative (G&A) expenses
for the second quarter of 2018 increased to $9.5 million, compared
to $2.8 million in the second quarter of 2017. The increase
was primarily due to a $4.9 million reserve recorded for concern
regarding the collectability of the EMA approval milestone, as well
as incurred merger-related costs. As previously disclosed, BioCryst
and Seqirus are engaged in a formal dispute resolution that
involves many items under the contract including, but not limited
to, the EMA approval milestone.
Interest expense was $2.2 million in the
second quarter of 2018, compared to $2.1 million in the second
quarter of 2017. Also, a $619,000 mark-to-market gain on the
Company’s foreign currency hedge was recognized in the second
quarter of 2018, as compared to a $400,000 mark-to-market loss in
the second quarter of 2017. These changes result from periodic
changes in the U.S. dollar/Japanese yen exchange rate. During the
second quarters of 2018 and 2017, the Company also realized
currency gains of $889,000 and $921,000, respectively, from the
exercise of a U.S. Dollar/Japanese yen currency option within its
foreign currency hedge.
Net loss for the second quarter of 2018 was
$18.5 million, or $0.19 per share, compared to a net loss of
$16.9 million, or $0.21 per share, for the second quarter
2017.
Cash, cash equivalents and investments totaled
$122.1 million at June 30, 2018, and reflect a decrease from $159.0
million at December 31, 2017. Net operating cash use for the second
quarter 2018 was $18.4 million, and the first six months of 2018
was $41.3 million.
Year to Date 2018 Financial Results
For the six months ended June 30, 2018, total
revenues were $16.5 million, compared to $12.5 million in the first
half of 2017. The increase in revenue was primarily associated with
the recognition of $7.0 million of deferred revenue and a $5.0
million milestone payment, both associated with the EMA approval of
peramivir. These revenues were offset by infrequent revenue events
that occurred in 2017 that did not recur in 2018. Those 2017
events were the recognition of $4.1 million of royalty revenue from
Japanese government stockpiling of RAPIACTA® and a $2.0 million
payment for the Canadian regulatory approval of RAPIVAB®. The
increase in revenues was partially offset by lower collaboration
revenue under U.S. Government development contracts.
R&D expenses increased to $39.5 million from
$32.5 million in the first half of 2017, primarily due to
increased spending on our HAE and preclinical programs. These
increases were partially offset by a decrease in the Company’s
peramivir and galidesivir development spending in 2018.
G&A expenses for the first half of 2018
increased to $17.1 million, compared to $5.9 million in the
first half of 2017. The increase was primarily due to approximately
$6.4 million of merger-related costs associated with the Company’s
failed merger with Idera Pharmaceuticals, Inc. (Idera) and a $4.9
million reserve for collectability of the EMA approval milestone of
peramivir.
Interest expense was $4.4 million in the
first half of 2018, compared to $4.2 million in the first half
of 2017. Also, a $1.2 million mark-to-market loss on the Company’s
foreign currency hedge was recognized in the first half of 2018, as
compared to a $1.9 million mark-to-market loss in the first half of
2017. These changes result from periodic changes in the U.S.
dollar/Japanese yen exchange rate. During 2018 and 2017, the
Company also realized currency gains of $889,000 and $921,000,
respectively, from the exercise of a U.S. Dollar/Japanese yen
currency option within its foreign currency hedge.
Net loss for the first half of 2018 was
$44.2 million, or $0.45 per share, compared to a net loss of
$31.1 million, or $0.40 per share, for the first half
2017.
Clinical Development Update &
Outlook
- On August 6, 2018, BioCryst announced it had received Fast
Track Designation by the U.S. Food and Drug Administration (FDA)
for BCX7353 for the prevention of angioedema attacks in patients
with HAE.
- On August 6, 2018, BioCryst announced the full exercise of the
underwriters’ option to purchase additional shares and the
completion of its public offering resulting in the sale of
10,454,546 shares of its common stock at a price of $5.50 per
share. The net proceeds from this offering are approximately $53.5
million, after deducting underwriting discounts and commissions and
other estimated offering expenses.
- On July 11, 2018, BioCryst announced it had completed
enrollment in all three cohorts of its ZENITH-1 clinical trial, a
proof-of-concept Phase 2 clinical trial liquid formulation of
BCX7353 for treatment of acute HAE attacks.
- On July 25, 2018, BioCryst announced that results from the
Phase 2, APeX-1 trial of BCX7353 for the prevention of attacks in
patients with HAE were published in the July 26th issue of The New
England Journal of Medicine.
- On July 20, 2018, BioCryst entered into a $30 million secured
loan facility with MidCap Financial Trust as administrative agent
and lender (MidCap), pursuant to the terms and conditions of that
certain Amended and Restated Credit and Security Agreement.
The Credit Agreement replaces the Credit and Security Agreement
dated as of September 23, 2016.
- On July 10, 2018, BioCryst announced that it had terminated the
previously announced merger agreement with Idera following the
Company’s stockholders’ failure to approve the adoption of the
merger agreement. Pursuant to the merger agreement, the Company
reimbursed Idera $6 million in July.
- On June 25, 2018, BioCryst announced that the Company had
reached agreement on the design of a Phase 3 trial and regulatory
requirements for marketing authorization of BCX7353 for HAE with
the Pharmaceuticals and Medical Devices Agency in Japan.
- On May 24, 2018, BioCryst announced that the EMA Committee for
Orphan Medicinal Products issued a positive opinion on BioCryst’s
application for orphan designation of BCX7353 for the treatment of
HAE. In addition, the United Kingdom’s Medicines and Healthcare
products Regulatory Agency has granted a Promising Innovative
Medicine designation to BCX7353.
Financial Outlook for
2018
Based upon development plans, merger-related
incurred costs from the recently terminated merger agreement with
Idera and awarded government contracts, BioCryst expects its 2018
net operating cash use to be in the range of $85 to $105 million,
and its 2018 operating expenses to be in the range of $90 to $110
million. The Company’s 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, August 7, 2018 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 live or in archived form in the “Investors” section
of the Company’s website at www.BioCryst.com. An accompanying slide
presentation may also be accessed via the BioCryst website. 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 Phase 2 APeX-1 clinical
trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical
trial and the long-term safety APeX-S clinical trial, both
evaluating two dosage strengths of BCX7353 administered orally
once-daily as a preventive treatment to reduce the frequency of
attacks in patients with HAE. BioCryst is also conducting the
ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2
clinical trial testing an oral liquid formulation of BCX7353 for
the treatment of acute angioedema attacks.
About BioCryst
Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and
develops novel small-molecule medicines that address both common
and rare conditions. BioCryst has several ongoing development
programs including BCX7353, an oral treatment for hereditary
angioedema, galidesivir, a potential treatment for filoviruses, and
a preclinical program to develop oral ALK-2 inhibitors for the
treatment of fibrodysplasia ossificans progressiva. 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, Australia,
Japan, Taiwan, Korea and the European Union. Post-marketing
commitments for RAPIVAB are ongoing. 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 product 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, APeX-2, APeX-S and
APeX-J) 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, EMA or other applicable regulatory agency 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. 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 |
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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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|
|
|
2018 |
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2017 |
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2018 |
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2017 |
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Revenues: |
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Royalty
revenue |
$ |
|
142 |
|
|
$ |
489 |
|
|
$ |
|
3,803 |
|
|
$ |
6,810 |
|
|
Collaborative and other research and development |
|
|
12,352 |
|
|
|
2,610 |
|
|
|
|
12,667 |
|
|
|
5,726 |
|
|
Total revenues |
|
|
12,494 |
|
|
|
3,099 |
|
|
|
|
16,470 |
|
|
|
12,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
Research
and development |
|
|
21,010 |
|
|
|
15,759 |
|
|
|
|
39,451 |
|
|
|
32,529 |
|
|
General
and administrative |
|
|
9,492 |
|
|
|
2,834 |
|
|
|
|
17,101 |
|
|
|
5,892 |
|
|
Royalty |
|
|
243 |
|
|
|
22 |
|
|
|
|
383 |
|
|
|
316 |
|
|
Total operating
expenses |
|
|
30,745 |
|
|
|
18,615 |
|
|
|
|
56,935 |
|
|
|
38,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(18,251 |
) |
|
|
(15,516 |
) |
|
|
|
(40,465 |
) |
|
|
(26,201 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income |
|
|
493 |
|
|
|
203 |
|
|
|
|
955 |
|
|
|
312 |
|
|
Interest expense |
|
|
(2,195 |
) |
|
|
(2,094 |
) |
|
|
|
(4,416 |
) |
|
|
(4,194 |
) |
|
Gain (loss) on foreign
currency derivative |
|
|
1,507 |
|
|
|
521 |
|
|
|
|
(297 |
) |
|
|
(1,022 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(18,446 |
) |
|
$ |
(16,886 |
) |
|
$ |
|
(44,223 |
) |
|
$ |
(31,105 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share |
$ |
|
(0.19 |
) |
|
$ |
(0.21 |
) |
|
$ |
|
(0.45 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
98,787 |
|
|
|
80,418 |
|
|
|
|
98,690 |
|
|
|
77,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Balance Sheet
Data (in thousands) |
|
|
|
|
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|
|
|
|
|
|
|
|
June 30, 2018 |
|
December 31, 2017 |
|
|
(Unaudited) |
|
(Note 1) |
|
Cash, cash equivalents
and investments |
|
$ |
114,484 |
|
|
|
|
$ |
155,692 |
|
|
|
Restricted cash |
|
|
7,625 |
|
|
|
|
|
3,286 |
|
|
|
Receivables from
collaborations |
|
|
2,342 |
|
|
|
|
|
6,117 |
|
|
|
Total assets |
|
|
136,644 |
|
|
|
|
|
178,259 |
|
|
|
Non-recourse notes
payable |
|
|
28,902 |
|
|
|
|
|
28,682 |
|
|
|
Senior credit
facility |
|
|
19,999 |
|
|
|
|
|
23,214 |
|
|
|
Accumulated
deficit |
|
|
(674,940 |
) |
|
|
|
|
(631,843 |
) |
|
|
Stockholders’
equity |
|
|
46,184 |
|
|
|
|
|
83,767 |
|
|
|
Shares of common stock
outstanding |
|
|
98,928 |
|
|
|
|
|
98,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Derived
from audited financial statements. |
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