BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced
financial results for the first quarter ended March 31, 2019 and
provided a corporate update.
“In a year with many milestones across our
multiple advancing programs of oral medicines for rare diseases,
BioCryst has achieved significant progress in the first quarter and
we look forward to reporting data from our APeX-2 trial in the
second quarter and filing a new drug application by the end of the
year,” said Jon Stonehouse, president and chief executive officer
of BioCryst.
“We believe that oral BCX7353 could be
transformative for many HAE patients and provide them with the
opportunity for a normal life without the burden and discomfort of
frequent injections and infusions,” Stonehouse added.
First Quarter 2019 Corporate
Developments
- The company dosed the first patients in its APeX-J trial in
Japan, designed to support potential Japanese approval of BCX7353
for the prevention of HAE attacks.
- On March 4, 2019, the company announced that it is advancing
BCX9930, an oral Factor D inhibitor, into Phase 1 clinical
development in the second quarter of 2019 for the treatment of
complement-mediated diseases.
- On February 23, 2019, the company announced data from the
completed ZENITH-1 trial (including the 250 mg and 500 mg dose
cohorts) of BCX7353 for the acute treatment of HAE attacks at the
annual meeting of the American Academy of Allergy, Asthma &
Immunology. The company plans to commence a Phase 3 trial,
ZENITH-2, in the summer of 2019.
- On February 6, 2019, the company announced it had entered into
a $100 million secured credit facility with MidCap Financial Trust
pursuant to the terms and conditions of an amended and restated
credit and security agreement.
- On January 4, 2019, the company announced it had appointed
Steve Aselage to its board of directors.
- On January 2, 2019, the company announced the dosing of the
first subject in a randomized, placebo-controlled Phase 1 clinical
trial to evaluate intravenous galidesivir, its investigational
broad-spectrum antiviral drug, in healthy volunteers.
Upcoming Key Milestones
HAE
Program – BCX7353
- Report 24-week safety and efficacy results from the Phase
3 APeX-2 clinical trial (Q2 2019)
- Begin ZENITH-2, a Phase 3 clinical trial of oral BCX7353 (750
mg) for the acute treatment of HAE (Summer 2019)
- File a new drug application for oral BCX7353 for the prevention
of HAE attacks with the U.S. Food and Drug Administration (FDA) (Q4
2019)
- File a marketing authorization application for oral BCX7353 for
the prevention of HAE attacks with the European Medicines Agency
(EMA) (Q1 2020)
Complement Factor D Inhibitor Program –
BCX9930
- Begin a Phase 1 trial of BCX9930, an oral Factor D inhibitor
for treatment of complement-mediated diseases, in healthy subjects
(Q2 2019)
- Report Phase 1 results (Q4 2019)
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)
First Quarter 2019 Financial Results
For the three months ended March 31, 2019, total
revenues were $5.9 million, compared to $4.0 million in the first
quarter of 2018. The increase was primarily due to the recognition
of $1.7 million of peramivir product sales to Green Cross, the
company’s commercial partner in Korea, and an increase in revenue
from galidesivir development under U.S. government contracts, and
partially offset by lower royalty revenue.
Research and development (R&D) expenses for the first
quarter of 2019 increased to $27.5 million from $18.4 million
in the first quarter of 2018, primarily due to increased spending
on the HAE, preclinical and galidesivir programs.
General and administrative (G&A) expenses
for the first quarter of 2019 decreased to $6.2 million, compared
to $7.6 million in the first quarter of 2018. The decrease was
primarily due to approximately $4.7 million of merger-related costs
that were incurred in the first quarter of 2018 but did not recur
in 2019, offset by an overall increase in G&A expenses as the
company prepares for the commercial launch of BCX7353.
Interest expense was $2.7 million in the
first quarter of 2019, compared to $2.2 million in the first
quarter of 2018 and was primarily associated with enhancements to
the company’s secured credit facility in July 2018 and February
2019.
Net loss for the first quarter of 2019 was
$31.1 million, or $0.28 per share, compared to a net loss of
$25.8 million, or $0.26 per share, for the first quarter of
2018.
Cash, cash equivalents and investments totaled
$121.6 million at March 31, 2019, and reflect a decrease from
$128.4 million at December 31, 2018. Cash and investments
reflect the proceeds from an enhancement to our secured credit
facility in February 2019 and were partially offset by normal
operating expenses. Operating cash use for the first quarter of
2019 was $27.1 million.
In February 2019, the company entered into a
$100 million secured credit facility with MidCap Financial Trust
which further enhanced the company’s cash position with $20 million
of immediate additional non-dilutive capital and also provided
additional financial flexibility through the ability to draw
another $50 million of milestone-based non-dilutive capital.
Financial Outlook for
2019
BioCryst continues to expect net operating cash
use to be in the range of $105 to $130 million, and its 2019
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.
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 # 1777029. A live
webcast of the call and any slides 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 # 1777029.
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-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; 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) |
|
|
|
|
|
|
|
|
|
|
|
|
Statements of
Operations (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
Three Months Ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product sales |
$ |
1,679 |
|
|
$ |
- |
|
|
|
|
|
Royalty revenue |
|
2,322 |
|
|
|
3,661 |
|
|
|
|
|
Collaborative and other research and development |
|
1,886 |
|
|
|
315 |
|
|
|
|
|
Total revenues |
|
5,887 |
|
|
|
3,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Cost of product sales |
|
1,399 |
|
|
|
- |
|
|
|
|
|
Research and development |
|
27,493 |
|
|
|
18,441 |
|
|
|
|
|
General and administrative |
|
6,238 |
|
|
|
7,609 |
|
|
|
|
|
Royalty |
|
87 |
|
|
|
140 |
|
|
|
|
|
Total operating expenses |
|
35,217 |
|
|
|
26,190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(29,330 |
) |
|
|
(22,214 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
596 |
|
|
|
462 |
|
|
|
|
|
Interest expense |
|
(2,726 |
) |
|
|
(2,221 |
) |
|
|
|
|
Gain (loss) on foreign
currency derivative |
|
406 |
|
|
|
(1,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(31,054 |
) |
|
$ |
(25,777 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
$ |
(0.28 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
110,167 |
|
|
|
98,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Balance Sheet
Data (in thousands) |
|
|
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|
|
|
|
|
|
|
|
|
March 31, 2019 |
|
|
December 31, 2018 |
|
(Unaudited) |
|
|
(Note 1) |
Cash, cash equivalents and
investments |
$ |
119,212 |
|
|
|
$ |
126,843 |
|
Restricted cash |
|
2,394 |
|
|
|
|
1,544 |
|
Receivables from
collaborations |
|
5,002 |
|
|
|
|
4,293 |
|
Total assets |
|
142,338 |
|
|
|
|
146,841 |
|
Non-recourse notes
payable |
|
29,231 |
|
|
|
|
29,121 |
|
Senior credit facility |
|
49,616 |
|
|
|
|
29,952 |
|
Accumulated deficit |
|
(762,785 |
) |
|
|
|
(731,969 |
) |
Stockholders’ equity |
|
22,507 |
|
|
|
|
49,235 |
|
Shares of common stock
outstanding |
|
110,270 |
|
|
|
|
110,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: Derived from
audited financial statements. |
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