BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced
financial results for the second quarter ended June 30, 2019 and
provided a corporate update.
“We have just returned from the 2019 HAEA
National Patient Summit with more than 1,000 attendees from the
U.S. and around the world. Patients’ excitement about BCX7353 was
resounding as they told us an oral option with our safety and
efficacy profile could change their lives and the lives of their
family members with HAE. Our customers want our product, and we
cannot wait to deliver it to them next year,” said Jon Stonehouse,
president and chief executive officer of BioCryst.
“We are on-track to submit an NDA to the FDA in
the fourth quarter, followed by regulatory submissions in Europe
and Japan in the first quarter of 2020. We are also preparing for
the commercial launch of BCX7353 in the U.S. later in 2020, and we
look forward to seeing informative clinical data with our oral
Factor-D inhibitor, BCX9930, next quarter,” Stonehouse added.
Upcoming Key Milestones
HAE
Program – BCX7353
- Submit a new drug application (NDA) for oral once-daily BCX7353
for the prevention of HAE attacks with the FDA (Q4 2019)
- Submit a marketing authorization application for oral
once-daily BCX7353 for the prevention of HAE attacks with the
European Medicines Agency (EMA) and Japanese Pharmaceuticals and
Medical Devices Agency (PMDA) (Q1 2020)
- The company now plans to begin ZENITH-2, a Phase 3 clinical
trial of oral BCX7353 (750 mg) for the acute treatment of HAE in
2020, pending the completion of its interactions with regulators on
the Phase 3 program and additional CMC formulation work on the
acute oral formulation. The company had previously planned to begin
ZENITH-2 this summer.
Complement Oral Factor D Inhibitor
Program – BCX9930
- Report results from ongoing Phase 1 trial of BCX9930 (Q4 2019).
The Phase 1 data will inform plans for a proof of concept study in
PNH patients in 2020.
ALK-2 Inhibitor Program –
BCX9250
- Begin a Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase
inhibitor for treatment of FOP, in healthy subjects (2H 2019)
Recent Corporate
Developments
- On July 1, 2019, the company
announced it had appointed Megan Sniecinski as chief business
officer.
- On June 27, 2019, the company
announced it had begun enrollment of a Phase 1 trial of BCX9930, an
oral Factor D inhibitor discovered and developed by BioCryst, for
the treatment of complement-mediated diseases. The trial will
evaluate the safety and tolerability and characterize the
pharmacokinetic and pharmacodynamic profiles of BX9930 in single
and multiple ascending doses of BCX9930 in healthy
subjects.
- On May 21, 2019, the company
announced the successful outcome of APeX-2, a Phase 3 randomized,
double-blind, placebo-controlled trial of once-daily, oral BCX7353
for the prevention of hereditary angioedema (HAE) attacks.
- On May 10, 2019, the company
announced the successful outcome of a randomized,
placebo-controlled Phase 1 clinical trial to evaluate intravenous
(IV) galidesivir in healthy volunteers.
Second Quarter 2019 Financial
Results
For the three months ended June 30, 2019, total
revenues were $1.4 million, compared to $12.5 million in the second
quarter of 2018. The decrease was primarily due to $7.0 million of
deferred revenue and a $5.0 million milestone recognized in the
second quarter of 2018, both associated with the EMA’s approval of
peramivir (ALPIVABTM).
Research and development (R&D) expenses for the second
quarter of 2019 increased to $27.7 million from $21.0 million
in the second quarter of 2018, primarily due to increased spending
as our HAE programs have progressed and our complement-mediated
diseases program entered clinical testing. In addition, the company
began recognizing stock option expense for two tranches of
performance-based options totaling approximately $2.0 million of
expense in the second quarter of 2019. While this expense is
allocated to both R&D and G&A, it had a more meaningful
impact on R&D expenses for the quarter.
General and administrative (G&A) expenses
for the second quarter of 2019 decreased to $8.7 million, compared
to $9.5 million in the second quarter of 2018. The decrease was
primarily due to a $4.9 million reserve recorded in the second
quarter of 2018 for concern regarding the collectability of the EMA
approval milestone for peramivir, as well as merger-related costs.
These decreases were partially offset by an overall increase in
G&A expenses as we prepare for the commercial launch of BCX7353
and an increase in legal costs associated with our ongoing Seqirus
UK Limited (Seqirus) dispute.
Interest expense was $3.0 million in the
second quarter of 2019, compared to $2.2 million in the second
quarter of 2018. The increase was primarily associated with
enhancements to the company’s secured credit facility in July 2018
and February 2019.
Net loss for the second quarter of 2019 was
$37.6 million, or $0.34 per share, compared to a net loss of
$18.5 million, or $0.19 per share, for the second quarter of
2018.
Cash, cash equivalents and investments totaled
$97.5 million at June 30, 2019, and reflect a decrease from $128.4
million at December 31, 2018. Operating cash use for the
second quarter of 2019 was $26.3 million. Net operating cash use
for the first six months of 2019 was $53.4 million as compared to
$41.3 million for the first six months of 2018.
Financial Outlook for
2019
BioCryst continues to expect net operating cash
use to be in the range of $105 to $130 million, and its operating
expenses to be in the range of $120 to $145 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. Although not in our operating
expense guidance above, approximately $3.5 million of stock option
expense will be recognized in the remaining two quarters of 2019
associated with the two tranches of performance-based options
mentioned above.
Conference Call and Webcast
BioCryst management will host a conference call
and webcast at 8:30 a.m. ET today to discuss the financial results
and provide a corporate update. The live call may be accessed by
dialing 877-303-8027 for domestic callers and 760-536-5165 for
international callers and using conference ID # 8954869. A live
webcast of the call will be available online at the investors
section of the company website at www.biocryst.com. A telephone
replay of the call will be available by dialing 855-859-2056 for
domestic callers or 404-537-3406 for international callers and
entering the conference ID # 8954869.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral
small-molecule medicines that treat rare diseases in which
significant unmet medical needs exist and an enzyme plays a key
role in the biological pathway of the disease. BioCryst has several
ongoing development programs including BCX7353, an oral treatment
for hereditary angioedema, BCX9930, an oral Factor D inhibitor for
the treatment of complement-mediated diseases, galidesivir, a
potential treatment for Marburg virus disease and Yellow Fever, 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 BCX9930, BCX9250
and our HAE drug candidates (including APeX-S, APeX-J, and
the BCX9930 Phase 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, EMA, PMDA 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; that actual financial
results may not be consistent with expectations, including that
2019 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:John Bluth+1 919 859
7910jbluth@biocryst.com
BIOCRYST PHARMACEUTICALS, INC. |
CONSOLIDATED FINANCIAL
SUMMARY |
(in
thousands, except per share) |
|
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|
|
|
|
|
|
|
|
Statements of Operations (Unaudited) |
|
|
|
|
|
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|
Three Months Ended |
|
|
Six
Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2019 |
|
2018 |
|
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product sales |
$ |
|
- |
|
|
$ |
- |
|
|
$ |
|
1,679 |
|
|
$ |
- |
|
Royalty revenue |
|
|
696 |
|
|
|
142 |
|
|
|
|
3,018 |
|
|
|
3,803 |
|
Collaborative and other research and development |
|
|
752 |
|
|
|
12,352 |
|
|
|
|
2,638 |
|
|
|
12,667 |
|
Total revenues |
|
|
1,448 |
|
|
|
12,494 |
|
|
|
|
7,335 |
|
|
|
16,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
Cost of product sales |
|
|
- |
|
|
|
- |
|
|
|
|
1,399 |
|
|
|
- |
|
Research and development |
|
|
27,681 |
|
|
|
21,010 |
|
|
|
|
55,174 |
|
|
|
39,451 |
|
General and administrative |
|
|
8,659 |
|
|
|
9,492 |
|
|
|
|
14,897 |
|
|
|
17,101 |
|
Royalty |
|
|
26 |
|
|
|
243 |
|
|
|
|
113 |
|
|
|
383 |
|
Total operating expenses |
|
|
36,366 |
|
|
|
30,745 |
|
|
|
|
71,583 |
|
|
|
56,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(34,918 |
) |
|
|
(18,251 |
) |
|
|
|
(64,248 |
) |
|
|
(40,465 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
|
547 |
|
|
|
493 |
|
|
|
|
1,143 |
|
|
|
955 |
|
Interest expense |
|
|
(3,035 |
) |
|
|
(2,195 |
) |
|
|
|
(5,761 |
) |
|
|
(4,416 |
) |
(Loss) gain on foreign currency
derivative |
|
|
(223 |
) |
|
|
1,507 |
|
|
|
|
183 |
|
|
|
(297 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(37,629 |
) |
|
$ |
(18,446 |
) |
|
$ |
|
(68,683 |
) |
|
$ |
(44,223 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
$ |
|
(0.34 |
) |
|
$ |
(0.19 |
) |
|
$ |
|
(0.62 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
110,338 |
|
|
|
98,787 |
|
|
|
|
110,253 |
|
|
|
98,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
Balance Sheet
Data (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
|
(Unaudited) |
|
(Note 1) |
Cash, cash equivalents and
investments |
|
$ |
92,888 |
|
|
|
|
$ |
126,843 |
|
|
Restricted cash |
|
|
4,629 |
|
|
|
|
|
1,544 |
|
|
Receivables from
collaborations |
|
|
3,602 |
|
|
|
|
|
4,293 |
|
|
Total assets |
|
|
116,344 |
|
|
|
|
|
146,841 |
|
|
Non-recourse notes payable |
|
|
29,341 |
|
|
|
|
|
29,121 |
|
|
Senior credit facility |
|
|
49,847 |
|
|
|
|
|
29,952 |
|
|
Accumulated deficit |
|
|
(800,414 |
) |
|
|
|
|
(731,969 |
) |
|
Stockholders’ (deficit)
equity |
|
|
(9,193 |
) |
|
|
|
|
49,235 |
|
|
Shares of common stock
outstanding |
|
|
110,370 |
|
|
|
|
|
110,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Derived from
audited financial statements. |
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