BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced
financial results for the first quarter ended March 31, 2021, and
provided a corporate update.
“Our commercial team is off to an outstanding
start with the U.S. launch of ORLADEYO. In this highly
competitive market, we are demonstrating what we have known for
some time now, HAE patients have been waiting to switch to an oral,
once-daily therapy to reduce their attacks and burden of therapy,”
said Jon Stonehouse, president and chief executive officer of
BioCryst.
“Our early launch performance is the latest
piece of evidence that BioCryst’s differentiated strategy to
discover, develop and, now, successfully commercialize unique oral
medicines for rare diseases has the potential to create greater and
greater value. We are doing this first in HAE and will next apply
what we have learned to patients suffering from complement-mediated
diseases,” Stonehouse added.
Program Updates and Key
Milestones
ORLADEYO™ (berotralstat): Oral,
Once-daily Treatment for Prevention of Hereditary Angioedema (HAE)
Attacks
- ORLADEYO net revenue in the first
quarter of 2021, the first full quarter of launch in the United
States, was $10.9 million.
- The majority of ORLADEYO revenue in
the first quarter of 2021 came from new patients who switched to
ORLADEYO from either injectable/infused prophylactic medications or
from acute-only treatment. The remainder came from patients
transitioning from clinical trials and the company’s early access
program.
European Approvals and Launches
- On April 30, 2021, the company
announced that the European Commission (EC) had approved oral,
once-daily ORLADEYO for the prevention of recurrent hereditary
angioedema (HAE) attacks in HAE patients 12 years and older. The EC
approval of ORLADEYO is applicable to all European Union member
states plus Iceland, Norway and Liechtenstein.
- BioCryst has its European
commercial team in place and expects to launch ORLADEYO in the
second quarter in Germany, with launches in other European markets
to follow. HAE patients in France currently have access to ORLADEYO
through an Autorisation Temporaire d'Utilisation de cohorte (cohort
ATU).
- On March 2, 2021, the company
announced the submission of a marketing authorization application
(MAA) to the United Kingdom’s Medicines and Healthcare products
Regulatory Agency (MHRA) seeking approval of ORLADEYO for the
prevention of recurrent HAE attacks in HAE patients 12 years and
older. The MAA was submitted under the MHRA’s new European
Commission Decision Reliance Procedure. If approved, ORLADEYO would
be the first oral, once-daily therapy in the United Kingdom to
treat patients with HAE.
Japanese Approval and Launch
- On January 22, 2021, the company
announced that the Ministry of Health, Labor and Welfare (MHLW) in
Japan had granted marketing and manufacturing approval for oral,
once-daily ORLADEYO 150 mg for prophylactic treatment of HAE in
adults and pediatric patients 12 years and older.
- On April 14, 2021, the company
announced that the Japanese National Health Insurance System (NHI)
approved the addition of oral, once-daily ORLADEYO™ (berotralstat)
to the NHI drug price list on April 21, 2021. This triggered a $15
million milestone payment to BioCryst from Torii Pharmaceutical
Co., Ltd., the company’s commercial partner in Japan.
- ORLADEYO is the first and only
prophylactic HAE medication approved in Japan. Torii launched
ORLADEYO in Japan on April 23, 2021. BioCryst will receive tiered
royalties ranging from 20 percent to 40 percent of Japanese net
sales.
Complement Oral Factor D Inhibitor
Program – BCX9930
- BioCryst has reached agreement with
the U.S. Food and Drug Administration (FDA) that the primary
endpoint for the upcoming pivotal trials in paroxysmal nocturnal
hemoglobinuria (PNH) is change from baseline in hemoglobin. On
March 22, 2021 the company announced that BCX9930 increased
hemoglobin from baseline by a mean of 3.3 g/dL in C5 inadequate
response (no prior treatment with C5 inhibitors) patients and 3.5
g/dL in treatment-naïve patients and reduced transfusions in an
ongoing dose-ranging trial in PNH patients. BCX9930 was safe and
generally well-tolerated in the trial.
- In the second half of 2021, the
company plans to advance directly into PNH pivotal trials with oral
BCX9930, at a dose of 500 mg bid, in patients naïve to C5
inhibitors, and patients with an inadequate response to C5
inhibitors. The goal of the pivotal trials is to achieve a broad
indication for BCX9930 to treat PNH as oral monotherapy. Also in
the second half of 2021, the company plans to initiate a proof of
concept trial of oral BCX9930 (500 mg bid) in renal
complement-mediated diseases.
Additional Updates
- On February 3, 2021, the company
announced that the FDA had approved a supplemental new drug
application for RAPIVAB® (peramivir injection) expanding the
patient population of RAPIVAB for the treatment of acute
uncomplicated influenza to include patients six months and older
who have been symptomatic for no more than two days. Prior to this
approval, RAPIVAB had been indicated for patients two years and
older.
- On March 19, 2021, the company
announced the appointment of Helen Thackray, M.D., FAAP, to the
newly created position of chief research and development
officer.
First Quarter 2021 Financial
Results
For the three months ended March 31, 2021, total
revenues were $19.1 million, compared to $4.8 million in the first
quarter of 2020. The increase was primarily due to $10.9 million in
ORLADEYO net revenue in the first quarter of 2021.
Research and development (R&D) expenses for
the first quarter of 2021 increased to $42.4 million from
$29.9 million in the first quarter of 2020, primarily due to
increased investment in the development of
BCX9930 as well as other research, preclinical and
development costs, offset by a reduction in spend on
the ORLADEYO program following our commercial
launch in December 2020.
Selling, general and administrative (SG&A)
expenses for the first quarter of 2021 increased to $22.1 million,
compared to $15.9 million in the first quarter of 2020. The
increase was primarily due to increased investment in to support
the U.S. commercial launch of ORLADEYO and expanded
international operations.
Interest and other income in the first quarter
of 2021 was $6.4 million lower than the first quarter of 2020,
primarily due to the partial arbitration award in the first quarter
of 2020 related to our Seqirus dispute.
Interest expense was $12.9 million in the first
quarter of 2021, compared to $3.0 million in the first quarter
of 2020. The increase was due to service on the royalty and debt
financings which were completed in December 2020.
Net loss for the first quarter of 2021 was
$64.3 million, or $0.36 per share, compared to a net loss of
$37.6 million, or $0.24 per share, for the first quarter of
2020.
Cash, cash equivalents, restricted cash and
investments totaled $244.4 million at March 31, 2021, compared to
$114.6 million at March 31, 2020. Operating cash use for the first
quarter of 2021 was $60.0 million.
Financial Outlook for
2021
In the launch period for ORLADEYO, the company
is not providing specific revenue or operating expense guidance.
Based on our expectations for revenue, operating expenses, and our
option to access an additional $75 million from our existing credit
facility, we believe our current cash runway takes us into
2023.
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 # 2660434. 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 # 2660434.
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. Oral, once-daily
ORLADEYO™ (berotralstat) is approved in the United States, European
Union, and Japan for the prevention of HAE attacks in adults and
pediatric patients 12 years and older, and under regulatory review
for approval in the United Kingdom. BioCryst has several ongoing
development programs including BCX9930, an oral Factor D inhibitor
for the treatment of complement-mediated diseases, BCX9250, an
ALK-2 inhibitor for the treatment of fibrodysplasia ossificans
progressiva, and galidesivir, a potential treatment for Marburg
virus disease and Yellow Fever. RAPIVAB® (peramivir injection), a
viral neuraminidase inhibitor for the treatment of influenza, has
received regulatory approval in the U.S., Canada, Australia, Japan,
Taiwan and Korea. 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, performance 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: the ongoing COVID-19 pandemic, which
could create challenges in all aspects of BioCryst’s business,
including without limitation delays, stoppages, difficulties and
increased expenses with respect to BioCryst’s and its partners’
development, regulatory processes and supply chains, negatively
impact BioCryst’s ability to access the capital or credit markets
to finance its operations, or have the effect of heightening many
of the risks described below or in the documents BioCryst files
periodically with the Securities and Exchange Commission;
BioCryst’s ability to successfully implement its commercialization
plans for, and to commercialize ORLADEYO, which could take longer
or be more expensive than planned; the results of BioCryst’s
partnerships with third parties, including Torii, may not meet
BioCryst’s current expectations; risks related to government
actions, including that decisions and other actions, including as
they relate to pricing, may not be taken when expected or at all,
or that the outcomes of such decisions and other actions may not be
in line with BioCryst’s current expectations; the commercial
viability of ORLADEYO, including its ability to achieve market
acceptance, which could also impact the amount of any related
royalties BioCryst would be entitled to receive from Torii; ongoing
and future preclinical and clinical development of BCX9930, BCX9250
and galidesivir may not have positive results; BioCryst may not be
able to enroll the required number of subjects in planned clinical
trials of product candidates; BioCryst may not advance human
clinical trials with product candidates as expected; the FDA, EMA,
PMDA or other applicable regulatory agency may require additional
studies beyond the studies planned for products and product
candidates, may not provide regulatory clearances which may result
in delay of planned clinical trials, may impose certain
restrictions, warnings, or other requirements on products and
product candidates, may impose a clinical hold with respect to
product candidates, or may withhold, delay or withdraw market
approval for products and product candidates; product candidates,
if approved, may not achieve market acceptance; BioCryst’s ability
to successfully manage its growth and compete effectively; risks
related to the international expansion of BioCryst’s business; and
actual financial results may not be consistent with expectations,
including that 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
Investors:John Bluth+1 919 859
7910jbluth@biocryst.com
Media:Catherine Collier
Kyroulis+1 917 886 5586ckyroulis@biocryst.com
BIOCRYST PHARMACEUTICALS, INC. |
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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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March 31, |
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2021 |
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2020 |
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Revenues: |
|
|
|
|
|
|
|
|
|
Product sales |
$ |
17,871 |
|
|
|
$ |
218 |
|
|
Royalty revenue |
|
(897 |
) |
|
|
|
1,945 |
|
|
Collaborative and other research and development |
|
2,085 |
|
|
|
|
2,660 |
|
|
Total revenues |
|
19,059 |
|
|
|
|
4,823 |
|
|
|
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|
|
|
|
|
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Expenses: |
|
|
|
|
Cost of product sales |
|
5,923 |
|
|
|
|
- |
|
|
Research and development |
|
42,435 |
|
|
|
|
29,867 |
|
|
Selling, general and administrative |
|
22,114 |
|
|
|
|
15,865 |
|
|
Royalty |
|
(36 |
) |
|
|
|
69 |
|
|
Total operating expenses |
|
70,436 |
|
|
|
|
45,801 |
|
|
|
|
|
|
|
|
|
|
|
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Loss from operations |
|
(51,377 |
) |
|
|
|
(40,978 |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
26 |
|
|
|
|
6,446 |
|
|
Interest expense |
|
(12,904 |
) |
|
|
|
(3,047 |
) |
|
Loss on foreign currency |
|
(29 |
) |
|
|
|
(20 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(64,284 |
) |
|
|
$ |
(37,599 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
$ |
(0.36 |
) |
|
|
$ |
(0.24 |
) |
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|
|
|
|
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|
Weighted average shares
outstanding |
|
177,343 |
|
|
|
|
154,156 |
|
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Balance Sheet Data (in thousands) |
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|
March 31, 2021 |
|
December 31, 2020 |
|
(Unaudited) |
|
(Note 1) |
Cash, cash equivalents and
investments |
|
$ 240,356 |
|
|
|
$ 300,366 |
|
Restricted cash |
|
4,008 |
|
|
|
2,221 |
|
Receivables |
|
18,386 |
|
|
|
8,646 |
|
Total assets |
|
284,431 |
|
|
|
334,715 |
|
Non-recourse notes payable |
|
30,000 |
|
|
|
30,000 |
|
Secured term loan |
|
123,039 |
|
|
|
119,735 |
|
Royalty financing obligation |
|
131,296 |
|
|
|
124,717 |
|
Accumulated deficit |
|
|
(1,087,726 |
) |
|
|
|
(1,023,442 |
) |
Stockholders’ deficit |
|
|
(74,988 |
) |
|
|
|
(19,262 |
) |
Shares of common stock
outstanding |
|
177,670 |
|
|
|
176,883 |
|
|
|
|
|
|
|
|
|
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|
Note 1: Derived from
audited financial statements. |
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