BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported
financial results for the second quarter ended June 30, 2022, and
provided a corporate update.
“With ORLADEYO firmly established in the
marketplace as it steadily grows each quarter towards $1 billion in
peak sales, our pipeline of other oral drugs for rare diseases and
a balance sheet of nearly $500 million alongside our product
revenues, BioCryst is uniquely positioned to bring multiple oral
medicines for rare diseases to patients,” said Jon Stonehouse,
president and chief executive officer of BioCryst.
Program Updates and Key
Milestones
ORLADEYO®
(berotralstat): Oral, Once-daily Treatment for Prevention
of Hereditary Angioedema (HAE) Attacks
U.S. Launch
- ORLADEYO net revenue in the second
quarter of 2022 was $65.2 million.
- In the second quarter, more new
physicians prescribed ORLADEYO than any quarter since the third
quarter of 2021.
- Prescribing from the top 500 HAE
treaters increased in the second quarter with 60 percent of those
physicians now having prescribed ORLADEYO. These top 500 physicians
accounted for two-thirds of new patient prescriptions in the
quarter.
- The majority of patients continue
to be well controlled on ORLADEYO. Even as the patient base has
continued to grow steadily, discontinuations in the second quarter
declined to their smallest number since the third quarter of
2021.
- Patients continue to have broad and
rapid access to ORLADEYO with the median time for a patient to
receive reimbursed product following a prescription now under three
weeks.
- Based on the strong performance of
ORLADEYO in the first half of 2022, and the steady quarterly
ORLADEYO net revenue growth the company expects in the second half
of 2022, the company now expects full year 2022 ORLADEYO net
revenue to be between $255 million and $265 million. The company
expects peak global net ORLADEYO sales of $1 billion.
“More than a year and a half into the launch of
ORLADEYO, we see steady growth and strong momentum, which we expect
to continue. The majority of HAE patients are very satisfied with
their experience using oral, once-daily ORLADEYO and physicians
continue to consistently express their strong intent for future
prescribing, which we see translating directly to our growing
patient numbers quarter after quarter,” said Charlie Gayer, chief
commercial officer of BioCryst.
ORLADEYO: Global Updates
- In the second quarter, ORLADEYO was
approved in Canada and Switzerland. The company expects approvals
and launches in additional countries throughout the year.
- Also in the second quarter, pricing
was finalized in Germany, France and Switzerland.
- On June 9, 2022, the company
announced it had selected Pint Pharma as its commercial partner for
ORLADEYO in Latin America.
Complement Oral Factor D Inhibitor
Program – BCX9930
- On August 4, 2022, the company
announced that the U.S. Food and Drug Administration (FDA) has
lifted its partial clinical hold on the BCX9930 program. The
company will resume enrollment in global clinical trials under
revised protocols at a reduced dose of 400 mg twice daily of
BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in
patients with paroxysmal nocturnal hemoglobinuria (PNH) and the
RENEW proof-of-concept trial in patients with C3 glomerulopathy
(C3G), immunoglobulin A nephropathy (IgAN) and primary membranous
nephropathy (PMN).
- Clinical evidence and recent
laboratory studies have informed the company’s hypothesis that
crystals form in the kidneys of some patients. The company believes
that lowering the dose to 400 mg and ensuring adequate hydration
will dilute the concentration of drug in the urine below the
threshold where crystals can form.
- The company’s goal is to find a
safe and effective dose for BCX9930. The company expects this can
be accomplished in a reasonable time frame after resuming
enrollment, in a relatively small number of patients given the rate
and timing of the serum creatinine rises in patients prior to
the enrollment pause.
- If successful, the company plans to
invest more significantly in BCX9930 to tap the full potential of
reaching many patients suffering from a number of alternative
pathway diseases, and, if not successful, the company will stop
investment in BCX9930 and move on to other molecules in the
pipeline.
Additional Updates
- On April 27, 2022, the company
announced the European Medicines Agency (EMA) had granted PRIME
designation to BioCryst’s ALK-2 inhibitor, BCX9250, for the
treatment of fibrodysplasia ossificans progressiva.
- The EMA also has recently granted
orphan drug designation and the FDA has granted fast track status
for BCX9250.
Second Quarter 2022 Financial
Results
For the three months ended June 30, 2022, total
revenues were $65.5 million, compared to $50.0 million in the
second quarter of 2021 (+31 percent year-over-year (y-o-y)). The
increase was primarily due to $65.2 million in ORLADEYO net revenue
in the second quarter of 2022, compared to $28.5 million in
ORLADEYO net revenue in the second quarter of 2021 (+129 percent
y-o-y). The $65.2 million of ORLADEYO net revenue in the second
quarter of 2022 included approximately $2.2 million of
non-repeating reimbursement related accrual releases.
Research and development expenses for the second
quarter of 2022 increased to $62.0 million from $52.9 million in
the second quarter of 2021 (+17 percent y-o-y), primarily due to
increased investment in the development of our Factor D program,
including BCX9930, as well as other research, preclinical and
development costs.
Selling, general and administrative expenses for
the second quarter of 2022 increased to $38.0 million, compared to
$26.3 million in the second quarter of 2021 (+44 percent y-o-y).
The increase was primarily due to increased investment to support
the commercial launch of ORLADEYO and expanded international
operations.
Interest expense was $24.0 million in the second
quarter of 2022, compared to $13.5 million in the second quarter of
2021 (+78 percent y-o-y). The increase was due to service on the
royalty financings, which were completed in November 2021.
Net loss for the second quarter of 2022 was
$58.9 million, or $0.32 per share, compared to a net loss of $43.2
million, or $0.24 per share, for the second quarter of 2021.
Cash, cash equivalents, restricted cash and
investments totaled $418.9 million at June 30, 2022, compared to
$222.8 million at June 30, 2021. Operating cash use for the second
quarter of 2022 was $27.9 million.
Additionally, on July 29, 2022, having achieved
all required revenue-based milestones, the company drew the
available $75 million tranche under its existing credit facility
from Athyrium Capital Management. On a pro-forma basis, net of
fees, this results in pro-forma cash of approximately $492
million.
Financial Outlook for 2022
Based on the strength of the ORLADEYO launch
through the first half of 2022, and the continued steady growth
from new patient demand the company expects for the remainder of
the year, the company expects full year 2022 net ORLADEYO revenue
to be between $255 million and $265 million.
Based on the reduced spending on the BCX9930
program in the first half of the year, and lower than projected
spending on the program for the remainder of the year, the company
now expects operating expenses for full year 2022, not including
non-cash stock compensation, to be between $390 million and $400
million.
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 866-374-5140 for domestic callers and 404-400-0571 for
international callers and using conference ID 68509725#. 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
replay of the call will be available on the company website.
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 and
multiple global markets. 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) is
approved in the U.S. and multiple global markets, with
post-marketing commitments 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 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; 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 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
commercialize its products and product candidates, 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 revenue,
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. |
|
CONSOLIDATED
FINANCIAL SUMMARY |
|
(in
thousands, except per share) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements of Operations (Unaudited) |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Six Months
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
$ |
|
64,888 |
|
|
$ |
33,430 |
|
|
$ |
|
114,434 |
|
|
$ |
51,301 |
|
|
Royalty revenue |
|
|
540 |
|
|
|
128 |
|
|
|
|
887 |
|
|
|
(769 |
) |
|
Milestone revenue |
|
|
- |
|
|
|
15,000 |
|
|
|
|
- |
|
|
|
15,000 |
|
|
Collaborative and other research and
development |
|
|
104 |
|
|
|
1,401 |
|
|
|
|
134 |
|
|
|
3,486 |
|
|
Total
revenues |
|
|
65,532 |
|
|
|
49,959 |
|
|
|
|
115,455 |
|
|
|
69,018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
Cost of product sales |
|
|
246 |
|
|
|
297 |
|
|
|
|
482 |
|
|
|
6,220 |
|
|
Research and development |
|
|
61,990 |
|
|
|
52,873 |
|
|
|
|
127,350 |
|
|
|
95,308 |
|
|
Selling, general and administrative |
|
|
38,017 |
|
|
|
26,325 |
|
|
|
|
72,299 |
|
|
|
48,439 |
|
|
Royalty |
|
|
1 |
|
|
|
46 |
|
|
|
|
3 |
|
|
|
10 |
|
|
Total
operating expenses |
|
|
100,254 |
|
|
|
79,541 |
|
|
|
|
200,134 |
|
|
|
149,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(34,722 |
) |
|
|
(29,582 |
) |
|
|
|
(84,679 |
) |
|
|
(80,959 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and
other income |
|
|
609 |
|
|
|
13 |
|
|
|
|
663 |
|
|
|
39 |
|
|
Interest
expense |
|
|
(24,022 |
) |
|
|
(13,495 |
) |
|
|
|
(47,859 |
) |
|
|
(26,399 |
) |
|
Foreign
currency gains (losses), net |
|
|
132 |
|
|
|
(134 |
) |
|
|
|
(45 |
) |
|
|
(163 |
) |
|
Loss before
income taxes |
|
|
(58,003 |
) |
|
|
(43,198 |
) |
|
|
|
(131,920 |
) |
|
|
(107,482 |
) |
|
Income tax
expense |
|
|
856 |
|
|
|
- |
|
|
|
|
1,135 |
|
|
|
- |
|
|
Net
loss |
$ |
|
(58,859 |
) |
|
$ |
(43,198 |
) |
|
$ |
|
(133,055 |
) |
|
$ |
(107,482 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share |
$ |
|
(0.32 |
) |
|
$ |
(0.24 |
) |
|
$ |
|
(0.72 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding |
|
|
185,605 |
|
|
|
178,127 |
|
|
|
|
185,253 |
|
|
|
177,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Balance Sheet Data (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31,
2021 |
|
|
(Unaudited) |
|
(Note 1) |
|
Cash, cash
equivalents and investments |
|
$ |
417,483 |
|
|
|
|
$ |
514,430 |
|
|
|
Restricted
cash |
|
|
1,448 |
|
|
|
|
|
3,345 |
|
|
|
Receivables |
|
|
41,491 |
|
|
|
|
|
29,413 |
|
|
|
Total
assets |
|
|
510,538 |
|
|
|
|
|
588,151 |
|
|
|
Secured term
loan |
|
|
144,516 |
|
|
|
|
|
136,082 |
|
|
|
Royalty
financing obligation |
|
|
477,666 |
|
|
|
|
|
449,375 |
|
|
|
Accumulated
deficit |
|
|
(1,340,559 |
) |
|
|
|
|
(1,207,504 |
) |
|
|
Stockholders’ deficit |
|
|
(213,232 |
) |
|
|
|
|
(106,986 |
) |
|
|
Shares of
common stock outstanding |
|
|
185,876 |
|
|
|
|
|
184,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1:
Derived from audited financial statements. |
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