BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced
financial results for the first quarter ended March 31, 2020, and
provided a corporate update.
“This is a transformational year for BioCryst as
we prepare to launch berotralstat in multiple territories to bring
our oral, once-daily prophylactic medicine to HAE patients, and
begin generating significant revenue,” said Jon Stonehouse,
president and chief executive officer of BioCryst.
“We are excited to see the clinical response in
treatment-naïve PNH patents at the 50 mg and 100 mg twice-daily
dose levels, and more than 98 percent suppression of complement in
both alternative pathway assays at the 200 mg and 400 mg
twice-daily levels in healthy volunteers,” said Dr. William
Sheridan, chief medical officer of BioCryst.
“This profile provides strong support for
BCX9930 as an oral monotherapy. We look forward to studying 200 mg
and 400 mg twice-daily in PNH patients and advancing this program
to treat multiple complement-mediated diseases,” Sheridan
added.
Program Updates and Key
Milestones
Hereditary Angioedema (HAE) Program –
Berotralstat (BCX7353): Oral, once-daily treatment for prevention
of HAE attacks
- BioCryst expects three regulatory
approvals for berotralstat in 2020 and early 2021. These timelines
remain on track.
- The U.S. Food and Drug Administration (FDA) is currently
reviewing a new drug application for berotralstat and has set an
action date of December 3, 2020, under the Prescription Drug User
Fee Act (PDUFA).
- In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA)
is reviewing a new drug application (JNDA) for berotralstat under
the Sakigake timeline, and the company expects approval in Japan in
the second half of 2020.
- On March 30, 2020, the company announced that the European
Medicines Agency (EMA) had validated its marketing authorization
application (MAA) submission for berotralstat and begun their
formal review of the MAA under the centralized procedure. An
opinion from the Committee for Medicinal Products for Human Use
(CHMP) is expected within approximately 12 months from MAA
validation.
- Ongoing commercial launch
preparations are on track in the U.S., EU and Japan. The
company does not expect delays due to
COVID-19.
- On May 5, 2020, the company
announced that the United States Patent and Trademark Office issued
a notice of allowance for a new composition of matter patent which
extends patent protection for berotralstat in the U.S. market by
four years through October 2039.
Complement Oral Factor D Inhibitor
Program – BCX9930
- Low dose cohort (50 mg and 100 mg
twice-daily) data in three treatment-naïve paroxysmal nocturnal
hemoglobinuria (PNH) patients who completed 28 days of therapy
shows BCX9930 inhibited complement and was safe and generally well
tolerated.
- Patients were severely ill with pre-treatment LDH from 3.7 to
11× the upper limit of normal (ULN) and low hemoglobin of 6.0 to
8.2 g/dL.
- All patients had dose-dependent reductions in LDH and increases
in hemoglobin.
- No drug-related serious adverse events were
observed.
- No PNH patients experienced rash.
- Based on the investigators’ assessment of clinical benefit, all
three patients continued on therapy with BCX9930 (100 mg
twice-daily) following the 28-day study window.
- With the recent enrollment of a
fourth patient with PNH, enrollment is now complete in
treatment-naïve cohort 1 (50 mg and 100 mg twice-daily).
Treatment-naïve cohort 2 (200 mg and 400 mg twice-daily) is
expected to begin enrollment upon completion of cohort 1, with data
expected in Q3 2020.
- The company plans to begin
enrolling PNH patients resistant to C5 inhibitors in Q3 2020 and
expects to report data from these treatment-resistant patients by
the end of 2020.
- Data from the 200 mg and 400 mg
twice-daily multiple ascending dose (MAD) cohorts in healthy
volunteers shows >98 percent suppression of the alternative
pathway beyond 12 hours and no dose-limiting adverse
events.
Given these data, the company expects to achieve
its goal of monotherapy for PNH patients in cohort 2 (200 mg and
400 mg
twice-daily). Additional
details can be found on slides, which can be accessed at the
Investors’ section of BioCryst’s website at
http://www.biocryst.com.
Coronavirus Antiviral Program –
Galidesivir (BCX4430)
- Patient dosing is underway in
Brazil in a randomized, double-blind, placebo-controlled clinical
trial to assess the safety, clinical impact and antiviral effects
of galidesivir in patients with COVID-19. The trial (NCT03891420)
is being funded by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health.
- Part 1 of the trial is enrolling 24 hospitalized adults
diagnosed with moderate to severe COVID-19 confirmed by PCR. Three
cohorts of eight patients will be randomized to receive intravenous
(IV) galidesivir (n=6) or placebo (n=2) every 12 hours for seven
days. Upon completion of part 1 of the trial, an optimized dosing
regimen of galidesivir will be selected for part 2 of the trial,
based on part 1 results. In part 2 of the trial, up to 42
hospitalized patients with COVID-19 will be randomized 2:1 to
receive IV galidesivir or placebo.
- In vitro testing of galidesivir
against SARS-CoV-2, the virus that causes COVID-19, is underway.
Galidesivir has been shown to be active against more than 20 RNA
viruses in nine different families, including coronaviruses.
- The company also is working closely
with the government to increase the supply of galidesivir.
Additional Updates
- On April 2, 2020, the company
announced the appointment of Anthony Doyle as senior vice president
and chief financial officer.
- The company remains on track
to report data in 2H 2020 from its ongoing Phase 1 clinical trial
of BCX9250, an oral ALK-2 kinase inhibitor for treatment of
fibrodysplasia ossificans progressiva (FOP), in healthy
subjects.
First Quarter 2020 Financial
Results
For the three months ended March 31, 2020, total
revenues were $4.8 million, compared to $5.9 million in the first
quarter of 2019. The decrease was primarily due to reduced
peramivir product sales and lower royalty revenues, partially
offset by amortization of deferred revenue from the Torii
Pharmaceutical, Co. commercialization agreement.
Research and development (R&D) expenses for
the first quarter of 2020 increased to $29.9 million from
$27.5 million in the first quarter of 2019, primarily due to
due to increased spending on the company’s complement-mediated
diseases program and other preclinical development initiatives.
Selling, general and administrative (SG&A)
expenses for the first quarter of 2020 increased to $15.9 million,
compared to $6.2 million in the first quarter of 2019. The
increase was primarily due to increased spending on commercial
activities and medical affairs to support the U.S. commercial
launch of berotralstat in 2020 and contingent legal costs
associated with our Seqirus UK Limited (Seqirus) dispute.
Interest and other income were $6.4 million in
the first quarter of 2020, compared to $0.6 million in the first
quarter of 2019. The increase was primarily due to the partial
arbitration award related to our Seqirus dispute.
Interest expense was $3.0 million in the first
quarter of 2020, compared to $2.7 million in the first quarter
of 2019 and was associated with an increase in the outstanding
balance of the company’s secured credit facility in February 2019
and increased interest expense associated with the company’s
non-recourse notes payable.
Net loss for the first quarter of 2020 was
$37.6 million, or $0.24 per share, compared to a net loss of
$31.1 million, or $0.28 per share, for the first quarter of
2019.
Cash, cash equivalents and investments totaled
$114.6 million at March 31, 2020, and reflect a decrease from
$137.8 million at December 31, 2019. Operating cash use for the
first quarter of 2020 was $23.1 million.
Financial Outlook for
2020
BioCryst expects full year 2020 net operating
cash use to be in the range of $125 to $150 million, and its
operating expenses to be in the range of $135 to $160 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 # 4679821. 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 # 4679821.
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 berotralstat (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 COVID-19, Marburg virus
disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor 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 the ongoing COVID-19 pandemic could
create challenges in all aspects of our business, including without
limitation delays, stoppages, difficulties and increased expenses
with respect to our and our partners’ development, regulatory
processes and supply chains, could negatively impact our ability to
access the capital or credit markets to finance our operations, or
could have the effect of heightening many of the risks described
below or in the documents we file periodically with the Securities
and Exchange Commission; 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 galidesivir 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 BioCryst 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 candidates, or withhold
market approval for product candidates; that actual financial
results may not be consistent with expectations, including that
2020 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) |
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
March 31, |
|
|
2020 |
|
|
|
2019 |
|
Revenues: |
|
|
|
|
Product sales |
$ |
218 |
|
|
$ |
1,679 |
|
Royalty revenue |
|
1,945 |
|
|
|
2,322 |
|
Collaborative and other research and development |
|
2,660 |
|
|
|
1,886 |
|
Total
revenues |
|
4,823 |
|
|
|
5,887 |
|
|
|
|
|
|
Expenses: |
|
|
Cost of product sales |
|
- |
|
|
|
1,399 |
|
Research and development |
|
29,867 |
|
|
|
27,493 |
|
Selling, general and administrative |
|
15,865 |
|
|
|
6,238 |
|
Royalty |
|
69 |
|
|
|
87 |
|
Total
operating expenses |
|
45,801 |
|
|
|
35,217 |
|
|
|
|
|
|
Loss from
operations |
|
(40,978 |
) |
|
|
(29,330 |
) |
|
|
|
|
|
Interest and
other income |
|
6,446 |
|
|
|
596 |
|
Interest
expense |
|
(3,047 |
) |
|
|
(2,726 |
) |
(Loss) gain
on foreign currency derivative |
|
(20 |
) |
|
|
406 |
|
|
|
|
|
|
Net
loss |
$ |
(37,599 |
) |
|
$ |
(31,054 |
) |
|
|
|
|
|
Basic and
diluted net loss per common share |
$ |
(0.24 |
) |
|
$ |
(0.28 |
) |
|
|
|
|
|
Weighted
average shares outstanding |
|
154,156 |
|
|
|
110,167 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data (in thousands) |
|
|
|
|
|
|
March 31, 2020 |
|
December 31,
2019 |
|
(Unaudited) |
|
(Note 1) |
Cash, cash equivalents and investments |
$ |
113,058 |
|
|
$ |
136,226 |
|
Restricted
cash |
|
1,559 |
|
|
|
1,551 |
|
Receivables
from collaborations |
|
5,642 |
|
|
|
22,146 |
|
Total
assets |
|
136,589 |
|
|
|
175,282 |
|
Non-recourse
notes payable |
|
29,671 |
|
|
|
29,561 |
|
Senior
credit facility |
|
50,539 |
|
|
|
50,309 |
|
Accumulated
deficit |
|
(878,227 |
) |
|
|
(840,628 |
) |
Stockholders’ equity |
|
3,648 |
|
|
|
38,252 |
|
Shares of
common stock outstanding |
|
154,192 |
|
|
|
154,082 |
|
|
|
|
|
|
|
|
Note 1: Derived from audited financial statements.
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