—APeX-2 24-week safety and efficacy data
of once-daily oral BCX7353 for prophylaxis of hereditary angioedema
(HAE) attacks on-track for Q2 2019—
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced
financial results for the fourth quarter and full year ended
December 31, 2018, and provided a corporate update.
“In a year with many transformative milestones
for BioCryst, it has been exciting to see so much progress already
in the first two months of the year. The strong Phase 2 clinical
data from our now-completed ZENITH-1 trial propels our BCX7353
acute program for HAE into Phase 3 development. With the very
favorable preclinical profile of BCX9930, another novel
BioCryst-invented oral drug for rare diseases, we are advancing
that program into the clinic in the second quarter for the
treatment of complement-mediated diseases. We also added further
rare disease expertise to our board and increased our financial
flexibility with a $100 million debt agreement,” said Jon
Stonehouse, president and chief executive officer of BioCryst.
“We remain on-track for the readout of our
APeX-2 trial next quarter, and an NDA filing of BCX7353 for HAE
prophylaxis by the end of the year. We are thoughtfully building
our commercial leadership and infrastructure to execute a
successful launch that meets the urgent demand for a once-daily
oral therapy that will allow HAE patients to live a more normal
life,” Stonehouse added.
Recent Milestones
- The company has 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.
Fourth Quarter 2018 Corporate Developments
- On November 20, 2018, BioCryst announced that it had appointed
Theresa Heggie to its board of directors.
- On November 16, 2018, BioCryst presented data that showed an
oral formulation of BCX7353 was rapidly absorbed and exhibited a
long half-life, two important characteristics of desired new acute
treatments for HAE attacks, at the annual scientific meeting of the
American College of Allergy, Asthma & Immunology.
Upcoming Key Milestones
HAE Program – BCX7353
- Report 24-week safety and efficacy
results from the APeX-2 clinical trial (Q2 2019)
- Begin a Phase 3 clinical trial of
oral BCX7353 for the acute treatment of HAE (Summer
2019)
- File a new drug application (NDA)
for oral BCX7353 for the prevention of HAE attacks with the U.S.
Food and Drug Administration (FDA) (Q4 2019)
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
fibrodysplasia ossificans progressiva, in healthy subjects (2H
2019)
Fourth Quarter 2018 Financial Results
For the three months ended December 31, 2018,
total revenues were $2.7 million, compared to $3.9 million in the
fourth quarter of 2017. The decrease was primarily due to a
reduction of royalty revenue associated with differences in the
onset and severity of the influenza seasons between the two
periods. This decrease was partially offset by increased revenue
from government contracts for galidesivir development, which was
higher in the fourth quarter of 2018.
Research and development (R&D) expenses for
the fourth quarter of 2018 increased to $23.4 million from
$16.9 million in the fourth quarter of 2017, primarily due to
increased spending on the company’s HAE and preclinical
programs.
General and administrative (G&A) expenses
for the fourth quarter of 2018 decreased slightly to $4.5 million,
compared to $4.7 million in the fourth quarter of 2017. The
decrease was primarily due to the lack of merger-related costs in
the fourth quarter of 2018 associated with the company’s terminated
merger with Idera Pharmaceuticals, Inc. (Idera). The decrease in
G&A expense due to the lack of merger expenses was largely
offset by higher commercial and medical affairs expenses in the
fourth quarter of 2018.
Interest expense was $2.4 million in the
fourth quarter of 2018, compared to $2.2 million in the fourth
quarter of 2017 and was associated with enhancing our secured
credit facility in July 2018.
Net loss for the fourth quarter of 2018 was
$27.4 million, or $0.25 per share, compared to a net loss of
$19.5 million, or $0.20 per share, for the fourth quarter of
2017.
Cash, cash equivalents and investments totaled
$128.4 million at December 31, 2018, and reflect a decrease from
$159.0 million at December 31, 2017. Cash and investments reflect
the proceeds from a July 2018 enhancement to our secured credit
facility and an August 2018 public equity offering, offset by
normal operating expenses and merger-related costs incurred in the
12-month period. Operating cash use for the fourth quarter of 2018
was $22.6 million, and for the full year of 2018 was $93.4
million.
On February 6, 2019, the company announced it
had 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
provided additional financial flexibility by providing the ability
to draw another $50 million of milestone-based non-dilutive
capital.
Full Year 2018 Financial
Results
For the full year ended December 31, 2018, total
revenues were $20.7 million, compared to $25.2 million in the full
year ended December 31, 2017. The decrease in revenue was primarily
associated with infrequent revenue events that occurred in 2017
that did not recur in 2018, as well as a $2.1 million decrease in
revenue associated with development activities under U.S.
government contracts in 2018. The non-recurring 2017 events were
the recognition of $4.1 million of royalty revenue from Japanese
government stockpiling of RAPIACTA® and the recognition of $1.5
million of peramivir product sales from the company’s commercial
partner, Green Cross Corporation. These decreases were partially
offset by a $5.0 million milestone associated with the European
Medicines Agency’s (EMA) approval of peramivir (ALPIVABTM)
recognized in the second quarter of 2018.
R&D expenses in 2018 increased to $84.9
million from $67.0 million in 2017, primarily due to increased
spending on our HAE and preclinical programs. These increases were
partially offset by a decrease in the company’s peramivir and
galidesivir development spending in 2018.
G&A expenses in 2018 increased to $29.5
million, compared to $13.9 million in 2017. The increase was
primarily due to approximately $11 million of merger-related costs
associated with the company’s terminated merger with Idera and a
$4.9 million reserve for collectability of the EMA approval
milestone of peramivir.
Interest expense was $9.2 million in 2018,
compared to $8.6 million in 2017.
Net loss for 2018 was $101.3 million, or
$0.98 per share, compared to a net loss of $65.8 million, or
$0.78 per share, for 2017.
Financial Outlook for
2019
BioCryst expects 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 # 1271286. 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# 1271286.
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 second generation 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) |
|
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Statements of Operations (Unaudited) |
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|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Twelve Months Ended |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,501 |
|
Royalty
revenue |
|
1,775 |
|
|
|
3,291 |
|
|
|
6,101 |
|
|
|
10,543 |
|
Collaborative and other research and development |
|
954 |
|
|
|
599 |
|
|
|
14,552 |
|
|
|
13,142 |
|
Total revenues |
|
2,729 |
|
|
|
3,890 |
|
|
|
20,653 |
|
|
|
25,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
Cost of
product sales |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,142 |
|
Research and
development |
|
23,431 |
|
|
|
16,924 |
|
|
|
84,888 |
|
|
|
66,962 |
|
General and
administrative |
|
4,490 |
|
|
|
4,698 |
|
|
|
29,514 |
|
|
|
13,933 |
|
Royalty |
|
70 |
|
|
|
129 |
|
|
|
471 |
|
|
|
560 |
|
Total operating
expenses |
|
27,991 |
|
|
|
21,751 |
|
|
|
114,873 |
|
|
|
82,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(25,262 |
) |
|
|
(17,861 |
) |
|
|
(94,220 |
) |
|
|
(57,411 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income |
|
686 |
|
|
|
478 |
|
|
|
2,252 |
|
|
|
1,015 |
|
Interest expense |
|
(2,414 |
) |
|
|
(2,231 |
) |
|
|
(9,176 |
) |
|
|
(8,565 |
) |
(Loss) gain on foreign
currency derivative |
|
(442 |
) |
|
|
71 |
|
|
|
(108 |
) |
|
|
(821 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(27,432 |
) |
|
$ |
(19,543 |
) |
|
$ |
(101,252 |
) |
|
$ |
(65,782 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss
per common share |
$ |
(0.25 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.98 |
) |
|
$ |
(0.78 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
109,802 |
|
|
|
98,402 |
|
|
|
103,185 |
|
|
|
84,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
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|
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|
Balance Sheet
Data (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018 |
|
|
December 31, 2017 |
|
|
(Unaudited) |
|
|
(Note 1) |
|
Cash, cash equivalents and
investments |
|
$ 126,843 |
|
|
|
|
|
$ 155,692 |
|
|
|
Restricted cash |
|
1,544 |
|
|
|
|
|
3,286 |
|
|
|
Receivables from
collaborations |
|
4,293 |
|
|
|
|
|
6,117 |
|
|
|
Total assets |
|
146,841 |
|
|
|
|
|
178,259 |
|
|
|
Non-recourse notes
payable |
|
29,121 |
|
|
|
|
|
28,682 |
|
|
|
Senior credit
facility |
|
29,952 |
|
|
|
|
|
23,214 |
|
|
|
Accumulated deficit |
|
(731,969 |
) |
|
|
|
|
(631,843 |
) |
|
|
Stockholders’ equity |
|
49,235 |
|
|
|
|
|
83,767 |
|
|
|
Shares of common stock
outstanding |
|
110,063 |
|
|
|
|
|
98,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Note 1: Derived
from audited financial statements. |
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