BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced
financial results for the third quarter ended September 30, 2020,
and provided a corporate update.
“We are 28 days from our PDUFA date and we are
ready to launch ORLADEYO to bring HAE patients the oral, once-daily
medicine they have been waiting for to prevent attacks, reduce
their burden of therapy and live a normal life,” said Jon
Stonehouse, president and chief executive officer of BioCryst.
“In addition to this commercial transformation
of the company, and the revenue it brings, our pipeline of
BioCryst-discovered molecules continues to advance, with several
upcoming near-term data readouts,” Stonehouse added.
Program
Updates and Key
Milestones
Hereditary
Angioedema (HAE) Program
– ORLADEYO: Oral,
once-daily treatment for prevention of HAE attacks
- BioCryst expects three regulatory
approvals for ORLADEYO in Q4 2020 and early 2021.
- The U.S. Food and Drug
Administration (FDA) is reviewing a new drug application for
ORLADEYO and has set an action date of December 3, 2020, under the
Prescription Drug User Fee Act (PDUFA).
- In Japan, ORLADEYO is being
reviewed under Sakigake designation. The Pharmaceutical and Medical
Devices Agency (PMDA) has confirmed their regulatory review
schedule and the company expects a decision on approval in December
2020.
- On March 30, 2020, the company
announced that the European Medicines Agency (EMA) had validated
its marketing authorization application (MAA) submission for
ORLADEYO and begun its formal review of the MAA under the
centralized procedure. The company expects an opinion from the
Committee for Medicinal Products for Human Use (CHMP) within
approximately 12 months from MAA validation.
- BioCryst has completed the
build-out of the commercial infrastructure to support the
successful launch of ORLADEYO in the U.S.
- The company has hired and trained
accomplished U.S. rare disease sales and market access teams and
has deployed a robust patient services support hub.
- The company is well-positioned in
terms of product supply and inventory on-hand to support the launch
and anticipated demand for ORLADEYO.
- On October 30, 2020, the company
announced that the United Kingdom’s Medicines and Healthcare
Products Regulatory Agency (MHRA) has granted oral, once-daily
berotralstat a positive scientific opinion through the Early Access
to Medicines Scheme (EAMS). Under the EAMS, HAE patients in the UK
aged 12 years and older can gain access to berotralstat for the
routine prevention of recurrent attacks of HAE before the drug is
granted marketing authorization by the European Commission.
Medicines included in the EAMS are those that have a high unmet
need, are intended to treat, diagnose or prevent seriously
debilitating or life-threatening conditions where there are no
adequate treatment options, and are likely to offer significant
advantage over methods currently used in the UK.
- On October 28, 2020, the company
announced it will present five abstracts and one Distinguished
Industry Oral Abstract, including 48-week results from the APeX-2
trial and new data on quality of life and the treatment burden of
injectable medication administration, at the upcoming (virtual)
Annual Scientific Meeting of the American College of Allergy,
Asthma & Immunology on November 13-15.
- On October 22, 2020, the company
announced that data from the first 24 weeks of the APeX-2 trial of
oral, once-daily berotralstat in patients with HAE have been
published online by the Journal of Allergy and Clinical
Immunology.
Complement Oral Factor
D Inhibitor
Program –
BCX9930
- The company is completing an ongoing dose ranging trial in
treatment-naïve paroxysmal nocturnal hemoglobinuria (PNH) patients,
and PNH patients with an inadequate response to C5 inhibitors.
- Seven treatment-naïve PNH patients are currently receiving
BCX9930, with four beyond 12 weeks of therapy, including two with
more than 32 weeks on therapy. All seven treatment-naïve patients
are continuing to benefit from BCX9930 treatment.
- Based on the excellent results observed to-date at 400 mg bid
and 500 mg bid, the company plans to add patients at these dose
levels.
- Because the acceleration of COVID-19 in the EU has slowed
start-up of the inadequate responder cohorts, the company expects
to report data from treatment-naïve and inadequate C5 responders
dosed up to 500 mg bid in the first quarter of 2021.
- On September 30, 2020, the company
announced new data from treatment-naïve (no prior treatment with C5
inhibitors) PNH patients receiving doses of oral BCX9930 through
400 mg bid. Oral BCX9930 is driving rapid and dose-dependent
reductions in key biomarkers, including LDH, and increasing
hemoglobin levels in all PNH patients in the trial. Increases in
hemoglobin levels were maintained without transfusions. BCX9930 has
been safe and well tolerated at all doses in the trial. No
drug-related serious adverse events have been reported.
- On August 31, 2020, the company
announced that the FDA has granted Orphan Drug designation for
BCX9930, for the treatment of PNH. Orphan Drug designation
qualifies BCX9930 for various development incentives, including tax
credits for certain clinical costs, a waiver of the new drug
application fee and a designated period of market exclusivity
following approval.
Coronavirus Antiviral
Program – Galidesivir
(BCX4430)
- Part 1 of a clinical trial of
galidesivir in COVID-19 patients in Brazil has completed enrollment
and the company expects to report results in the fourth
quarter.
- The primary endpoint of part 1 is
safety. Data is also being collected on secondary endpoints,
including clinical outcomes and virology. Based on recent
conversations with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health, the
major funding partner for the program, the company understands that
data from part 1 is a gating item for the program and some evidence
of clinical and/or antiviral activity is important for the program
to advance.
Additional
Updates
- The company remains on track
to report data in Q4 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.
- On September 3, 2020, the company
announced that the U.S. Department of Health and Human Services
(HHS) has exercised its option to purchase an additional 10,000
doses of BioCryst’s approved antiviral influenza therapy, RAPIVAB®
(peramivir injection), for approximately $7 million. The order is
part of a $34.7 million contract (Contract No. 75D301-18-C-02984)
the Centers for Disease Control and Prevention awarded in 2018 for
the procurement of up to 50,000 doses of RAPIVAB® (peramivir
injection) over a five-year period for the strategic national
stockpile.
Third Quarter
2020 Financial
Results
For the three months ended September 30, 2020,
total revenues were $6.1 million, compared to $1.8 million in the
third quarter of 2019. The increase was primarily due to an
increase in collaboration revenue under U.S. government development
contracts and higher peramivir product sales to our commercial
partners.
Research and development (R&D) expenses for
the third quarter of 2020 increased to $30.2 million from
$25.1 million in the third quarter of 2019, primarily due to
increased spending on our complement-mediated diseases and
galidesivir programs.
Selling, general and administrative (SG&A)
expenses for the third quarter of 2020 increased to $17.2 million,
compared to $11.7 million in the third quarter of 2019. The
increase was primarily due to increased spending on commercial and
medical affairs activities to support the U.S. commercial launch of
ORLADEYO.
Interest expense was $2.9 million in the
third quarter of 2020, compared to $3.0 million in the third
quarter of 2019.
Net loss for the third quarter of 2020 was
$46.1 million, or $0.26 per share, compared to a net loss of
$37.6 million, or $0.34 per share, for the third quarter of
2019.
Cash, cash equivalents, restricted cash and
investments totaled $148.5 million at September 30, 2020, and
reflect an increase from $137.8 million at December 31, 2019.
Operating cash use for the third quarter of 2020 was $43.1 million.
Net operating cash use for the first nine months of 2020 was $98.0
million, as compared to $77.9 million for the first nine months of
2019.
Financial
Outlook for 2020
BioCryst continues to expect full year 2020 net
operating cash use to be in the range of $150 to $165 million, and
its operating expenses to be in the range of $180 to $195 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 # 3766784. 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 # 3766784.
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 ORLADEYO™ (berotralstat), 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 are identified by use
of terms such as “expect,” “plan,” “anticipate,” “will,” “may,”
“project,” and similar words, although some forward-looking
statements may be expressed differently. 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: 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;
developing and commercializing ORLADEYO or any HAE product
candidate may take longer or may be more expensive than planned;
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;
government contracts contain certain terms and conditions,
including termination provisions, that subject BioCryst to
additional risks; the FDA, EMA, PMDA or other applicable regulatory
agency may require additional studies beyond the studies planned
for 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 product
candidates, may impose a clinical hold with respect to such product
candidates, or may withhold market approval for product candidates;
product candidates, if approved, may not achieve market acceptance;
BioCryst’s ability to successfully commercialize its 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 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 |
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(in thousands, except per share) |
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Statements of Operations (Unaudited) |
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Three Months Ended |
|
|
Nine Months Ended |
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|
September 30, |
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|
September 30, |
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|
|
|
2020 |
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|
2019 |
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2020 |
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2019 |
|
|
Revenues: |
|
|
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|
|
|
|
|
|
|
|
Product sales |
$ |
|
2,478 |
|
|
$ |
335 |
|
|
$ |
|
2,696 |
|
|
$ |
2,014 |
|
|
Royalty revenue |
|
|
254 |
|
|
|
508 |
|
|
|
|
2,243 |
|
|
|
3,526 |
|
|
Collaborative and other research
and development |
|
|
3,370 |
|
|
|
932 |
|
|
|
|
8,857 |
|
|
|
3,570 |
|
|
Total revenues |
|
|
6,102 |
|
|
|
1,775 |
|
|
|
|
13,796 |
|
|
|
9,110 |
|
|
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|
|
|
|
|
|
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|
|
Expenses: |
|
|
|
|
|
Cost of product sales |
|
|
1,517 |
|
|
|
- |
|
|
|
|
1,517 |
|
|
|
1,399 |
|
|
Research and development |
|
|
30,245 |
|
|
|
25,120 |
|
|
|
|
87,610 |
|
|
|
80,294 |
|
|
Selling, general and
administrative |
|
|
17,195 |
|
|
|
11,735 |
|
|
|
|
46,943 |
|
|
|
26,632 |
|
|
Royalty |
|
|
9 |
|
|
|
18 |
|
|
|
|
78 |
|
|
|
131 |
|
|
Total operating expenses |
|
|
48,966 |
|
|
|
36,873 |
|
|
|
|
136,148 |
|
|
|
108,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(42,864 |
) |
|
|
(35,098 |
) |
|
|
|
(122,352 |
) |
|
|
(99,346 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income and
expense |
|
|
(312 |
) |
|
|
402 |
|
|
|
|
8,892 |
|
|
|
1,545 |
|
|
Interest expense |
|
|
(2,927 |
) |
|
|
(3,044 |
) |
|
|
|
(8,892 |
) |
|
|
(8,805 |
) |
|
(Loss) gain on foreign currency
derivative |
|
|
(12 |
) |
|
|
148 |
|
|
|
|
31 |
|
|
|
331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(46,115 |
) |
|
$ |
(37,592 |
) |
|
$ |
|
(122,321 |
) |
|
$ |
(106,275 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
$ |
|
(0.26 |
) |
|
$ |
(0.34 |
) |
|
$ |
|
(0.75 |
) |
|
$ |
(0.96 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
176,521 |
|
|
|
110,416 |
|
|
|
|
164,127 |
|
|
|
110,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Balance Sheet
Data (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
(Unaudited) |
|
(Note 1) |
|
Cash, cash equivalents and
investments |
|
$ |
146,321 |
|
|
|
|
$ |
136,226 |
|
|
|
Restricted cash |
|
|
2,213 |
|
|
|
|
|
1,551 |
|
|
|
Receivables from
collaborations |
|
|
5,422 |
|
|
|
|
|
22,146 |
|
|
|
Total assets |
|
|
176,226 |
|
|
|
|
|
175,282 |
|
|
|
Non-recourse notes payable |
|
|
29,890 |
|
|
|
|
|
29,561 |
|
|
|
Senior credit facility |
|
|
46,041 |
|
|
|
|
|
50,309 |
|
|
|
Accumulated deficit |
|
|
(962,949 |
) |
|
|
|
|
(840,628 |
) |
|
|
Stockholders’ equity |
|
|
33,637 |
|
|
|
|
|
38,252 |
|
|
|
Shares of common stock
outstanding |
|
|
176,566 |
|
|
|
|
|
154,082 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Note 1: Derived from
audited financial statements. |
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