BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported
financial results for the second quarter ended June 30, 2024, and
provided a corporate update.
“The first half of 2024 has been outstanding for
BioCryst due to the success we are having in the marketplace with
ORLADEYO. As a result, we are increasing our full year guidance for
ORLADEYO, advancing multiple programs toward the clinic in the next
18 months and moving the company closer to profitability,” said Jon
Stonehouse, president and chief executive officer of BioCryst.
ORLADEYO®
(berotralstat): Oral, Once-daily Treatment for Prevention
of Hereditary Angioedema (HAE) Attacks
- ORLADEYO net revenue in the second
quarter of 2024 was $108.3 million (+34 percent year-over-year
(y-o-y)).
- Operational improvements drove revenue above expectations for
the second quarter. This included a three percent increase in the
overall rate of paid patients relative to the end of 2023, which
now stands at 74.4 percent.
- New patient starts continued at the
same high rate seen in the prior two quarters, matching the new
patient demand seen in the first three quarters of the launch in
2021, and patient retention remained strong. We continue to see
more than 60 percent of patients on paid therapy staying on for at
least a year.
- A recent market research study
showed that 52 percent of allergist/immunologists are extremely
likely to prescribe ORLADEYO to more patients, up from 29 percent
in early 2023.
- With additional recent approvals
and reimbursement authorizations in Europe and Latin America,
ORLADEYO is now commercially available to patients in more than 20
countries. Ex-U.S. ORLADEYO revenue in the second quarter increased
51 percent y-o-y and accounted for 11 percent of global ORLADEYO
net revenues.
“Our second quarter revenue growth and increased
full year guidance for ORLADEYO reflect strong underlying demand
and favorable patient outcomes, combined with our continuing focus
on improving patient services and market access operations. The
real-world experience of patients who respond to ORLADEYO is
consistent with the 91 percent reduction in attacks from baseline
that we saw in long-term clinical trials. The potential for
patients to have that high level of HAE attack control in a
once-daily pill is a major differentiator in the marketplace that
makes ORLADEYO’s trajectory toward $1 billion in peak sales
increasingly clear,” said Charlie Gayer, chief commercial officer
of BioCryst.
Rare Disease Pipeline
The goal with our pipeline is to build on our
success with ORLADEYO by bringing additional selected, highly
differentiated rare disease products to patients.
- The company remains on track to
submit a regulatory filing in 2025 to expand the ORLADEYO label to
enable children as young as two years of age to receive an oral
granule formulation of ORLADEYO. ORLADEYO would be the first oral
prophylactic therapy for children with HAE.
- The company has completed its
clinical evaluation of its oral Factor D inhibitor, BCX10013. The
drug was safe and well tolerated at all doses studied, however the
level of clinical activity observed was less than other therapies
on the market and potential partners have declined to make the
additional investment required to evaluate higher doses. BioCryst
plans to discontinue development, consistent with its previously
announced plans.
- The company expects to advance
BCX17725, its KLK-5 inhibitor for the treatment of Netherton
syndrome, into the clinic by the end of 2024.
- Netherton syndrome is a serious,
rare, lifelong genetic disorder affecting the skin, hair and immune
system. People with Netherton syndrome often have red, scaly,
inflamed skin, fragile hair, and are more likely to develop skin
infections, allergies, asthma and eczema. Netherton syndrome can be
life threatening, especially during infancy when patients are
vulnerable to dehydration and recurrent infections. Currently,
there is no approved treatment for Netherton syndrome.
- In 2025, the company plans to advance avoralstat, a plasma
kallikrein inhibitor, into a clinical trial of patients with
diabetic macular edema (DME).
- DME is an important cause of vision
loss in diabetes and is due to leakage from the blood vessels in
the retina. While current treatments focus on VEGF inhibition, DME
can develop from other mechanisms, such as the
kallikrein-bradykinin pathway. This is supported by observations
that many DME patients have an incomplete response to intravitreal
anti-VEGF therapies that are administered every four to eight
weeks. Avoralstat targets the kallikrein-bradykinin system on the
retinal vascular endothelial cells and may result in less vascular
leakage and less edema. Avoralstat, delivered to the suprachoroidal
space as a depot formulation, is designed to provide high dose
levels to the retinal vessels with long-lasting exposure, which
could result in less frequent injections and a reduced burden on
patients and the healthcare system.
Second Quarter 2024 Financial
Results
For the three months ended June 30, 2024, total
revenues were $109.3 million, compared to $82.5 million in the
second quarter of 2023 (+32.5 percent year-over-year (y-o-y)). The
increase was primarily due to $108.3 million in ORLADEYO net
revenue in the second quarter of 2024, compared to $81.0 million in
ORLADEYO net revenue in the second quarter of 2023 (+33.7 percent
y-o-y).
R&D expenses for the second quarter of 2024
decreased to $37.6 million from $51.2 million in the second quarter
of 2023 (-26.6 percent y-o-y), primarily due to decreased spending
on BCX10013 and the discontinuation of the BCX9930 program. These
reductions were partially offset by increased investment in
BCX17725, avoralstat and other discovery programs, and our ongoing
ORLADEYO pediatric trial.
Selling, general and administrative expenses for
the second quarter of 2024 increased to $61.2 million, compared to
$51.0 million in the second quarter of 2023 (+20.0 percent y-o-y),
primarily due to an increase in commercial expenses to support
growing revenue, newly launched regions and expanded international
operations. In addition, there was an increase in general and
administrative expenses, primarily related to an increase in
resourcing to support our accounting and IT functions.
Total operating expenses were $100.6 million for
the second quarter of 2024, compared to $103.2 million in the
second quarter of 2023 (-2.5 percent y-o-y). Non-cash stock
compensation was $13.2 million for the second quarter of 2024.
Total operating expenses, not including non-cash stock compensation
for the second quarter of 2024 were $87.4 million, compared to
$90.4 million in the second quarter of 2023 (-3.3 percent
y-o-y).
The company generated a GAAP operating profit of
$8.8 million in the second quarter of 2024. This compares to a GAAP
operating loss of $20.7 million in the second quarter of 2023.
Adjusted for non-cash stock compensation, the non-GAAP operating
profit was $21.9 million in the second quarter of 2024, compared to
a non-GAAP operating loss of $7.9 million in the second quarter of
2023.
Interest expense was $24.7 million in the second
quarter of 2024, compared to $28.9 million in the second quarter of
2023 (-14.5 percent y-o-y). The decrease was primarily due to a
decrease in the amortization of interest associated with our
royalty financing obligations.
Net loss for the second quarter of 2024 was
$12.7 million, or $0.06 per share, compared to a net loss of $75.3
million, or $0.40 per share, for the second quarter of 2023. In the
second quarter of 2023, there was a $29.0 million one-time debt
extinguishment fee related to the close-out of the Athyrium debt
facility. Excluding this one-time event, non-GAAP net loss for the
second quarter of 2023 was $0.24 per share.
Cash, cash equivalents, restricted cash and
investments totaled $338.1 million at June 30, 2024, compared to
$415.7 million at June 30, 2023. Operating cash use for the second
quarter of 2024 was $0.2 million.
Non-GAAP Pro forma Financial
Measures
The information furnished in this release
includes non-GAAP pro forma financial measures that differ from
measures calculated in accordance with generally accepted
accounting principles in the United States of America (GAAP),
including financial measures labeled as “non-GAAP” or
“adjusted.”
We believe providing these non-GAAP measures,
which show our pro forma results with these items adjusted, is
valuable and useful since they allow the company and investors to
better understand the company’s financial performance in the
absence of these one-time events and allow investors to more
accurately understand our second quarter 2023 and second quarter
2024 results and more easily compare them to future results. These
non-GAAP pro forma measures also correspond with the way we
expected Wall Street analysts to compare our results. Our non-GAAP
pro forma measures should be considered only as supplements to, and
not as substitutes for or in isolation from, our other measures of
financial information prepared in accordance with GAAP, such as
GAAP revenue, operating income, net income, operating profit and
earnings per share.
Our references to our second quarter 2023 and
first six months 2023 “non-GAAP pro forma” financial measures of
adjusted net loss and adjusted earnings per share constitute
non-GAAP financial measures. They refer to our GAAP results,
adjusted to show the results without the one-time loss on the
extinguishment of the Athyrium term loans. Our reference to our
second quarter 2024 and first six months 2024 “non-GAAP pro forma”
financial measure of non-GAAP operating profit constitutes a
non-GAAP financial measure. It refers to our GAAP results, adjusted
to show the results without including non-cash stock compensation
expense.
Financial Outlook for 2024
Based on the operational improvements and strong
patient and physician demand for ORLADEYO seen in the first half of
2024, the company is raising its outlook for full year 2024 global
net ORLADEYO revenue to be between $420 million and $435 million
(previously $390 million to $400 million).
The company maintains its prior operating
expense outlook, and expects full year 2024 operating expenses to
be between $365 million and $375 million, flat to full year 2023
operating expenses.
This operating expense outlook does not reflect
non-cash stock compensation expense, or one-time expenses related
to the previously announced workforce reduction implemented in the
first quarter of 2024.
Based on the company’s disciplined approach to
capital allocation, and the increased revenue guidance for
ORLADEYO, the company is confident that it will achieve a full-year
operating profit in 2024 (not including non-cash stock
compensation), be approaching quarterly positive earnings per share
(EPS) and positive cash flow in the second half of 2025 (not
including non-cash stock compensation) and be profitable on an EPS
basis, with positive cash flow, for full year 2026. The company
expects it can achieve these financial milestones without raising
additional funds and does not intend to draw the additional $150
million of debt available to it from Pharmakon.
Conference Call and
WebcastBioCryst 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 1-844-481-2942 for domestic callers and 1-412-317-1866 for
international callers. A live webcast and replay of the call will
be available online in the investors section of the company website
at www.biocryst.com.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals is a global biotechnology company with a
deep commitment to improving the lives of people living with
complement-mediated and other rare diseases. BioCryst leverages its
expertise in structure-guided drug design to develop first-in-class
or best-in-class oral small-molecule and protein therapeutics to
target difficult-to-treat diseases. BioCryst has commercialized
ORLADEYO® (berotralstat), the first oral, once-daily plasma
kallikrein inhibitor, and is advancing a pipeline of small-molecule
and protein therapies. For more information, please visit
www.biocryst.com or follow us on LinkedIn.
Forward-Looking StatementsThis
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: BioCryst’s
ability to successfully implement or maintain its commercialization
plans for ORLADEYO; risks related to the planned discontinuation of
the development of BCX10013; BioCryst’s ability to successfully
progress its pipeline development plans as described herein; risks
related to the reduction in size of BioCryst’s R&D
organization; 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
sustained market acceptance; ongoing and future preclinical and
clinical development of product candidates may take longer than
expected and may not have positive results; 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; BioCryst’s ability to successfully
manage its growth and compete effectively; risks related to the
international expansion of BioCryst’s business; timing for
achieving profitability and positive cash flow may not meet
management’s expectations; statements and projections regarding
financial guidance and goals and the attainment of such goals may
differ from actual results based on market factors and BioCryst’s
ability to execute its operational and budget plans; 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, which identify important factors that could
cause 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 June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| Revenues: |
|
|
|
|
|
|
|
|
|
ORLADEYO |
|
$ |
108,288 |
|
|
$ |
81,009 |
|
|
$ |
197,155 |
|
|
$ |
149,423 |
|
|
Other |
|
|
1,044 |
|
|
|
1,482 |
|
|
|
4,938 |
|
|
|
1,846 |
|
|
Total revenues |
|
|
109,332 |
|
|
|
82,491 |
|
|
|
202,093 |
|
|
|
151,269 |
|
| |
|
|
|
|
|
|
|
|
| Expenses: |
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
1,699 |
|
|
|
894 |
|
|
|
2,964 |
|
|
|
1,825 |
|
|
Research and development |
|
|
37,623 |
|
|
|
51,247 |
|
|
|
84,116 |
|
|
|
99,635 |
|
|
Selling, general and administrative |
|
|
61,214 |
|
|
|
50,997 |
|
|
|
120,578 |
|
|
|
98,864 |
|
|
Royalty |
|
|
35 |
|
|
|
56 |
|
|
|
162 |
|
|
|
63 |
|
|
Total operating expenses |
|
|
100,571 |
|
|
|
103,194 |
|
|
|
207,820 |
|
|
|
200,387 |
|
| |
|
|
|
|
|
|
|
|
| Income (loss) from
operations |
|
|
8,761 |
|
|
|
(20,703 |
) |
|
|
(5,727 |
) |
|
|
(49,118 |
) |
| |
|
|
|
|
|
|
|
|
| Interest income |
|
|
3,554 |
|
|
|
3,750 |
|
|
|
7,585 |
|
|
|
7,128 |
|
| Interest expense |
|
|
(24,733 |
) |
|
|
(28,915 |
) |
|
|
(49,239 |
) |
|
|
(56,311 |
) |
| Foreign currency (losses)
gains, net |
|
|
(84 |
) |
|
|
301 |
|
|
|
(135 |
) |
|
|
72 |
|
| Loss on extinguishment of
debt |
|
|
— |
|
|
|
(29,019 |
) |
|
|
— |
|
|
|
(29,019 |
) |
| Loss before income taxes |
|
$ |
(12,502 |
) |
|
$ |
(74,586 |
) |
|
$ |
(47,516 |
) |
|
$ |
(127,248 |
) |
| Income tax expense |
|
|
172 |
|
|
|
740 |
|
|
|
537 |
|
|
|
1,411 |
|
| Net loss |
|
$ |
(12,674 |
) |
|
$ |
(75,326 |
) |
|
$ |
(48,053 |
) |
|
$ |
(128,659 |
) |
| |
|
|
|
|
|
|
|
|
| Basic and diluted net loss per
common share |
|
$ |
(0.06 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.68 |
) |
| |
|
|
|
|
|
|
|
|
| Weighted average shares
outstanding |
|
|
206,425 |
|
|
|
189,118 |
|
|
|
206,244 |
|
|
|
188,815 |
|
| |
| Balance
Sheet Data (in thousands) |
| |
| |
|
June 30, 2024 |
|
December 31, 2023 |
| |
|
(unaudited) |
|
(Note 1) |
|
Cash, cash equivalents and investments |
|
$ |
336,344 |
|
|
$ |
388,987 |
|
| Restricted cash |
|
|
1,795 |
|
|
|
1,804 |
|
| Receivables |
|
|
68,759 |
|
|
|
56,950 |
|
| Total assets |
|
|
472,419 |
|
|
|
516,960 |
|
| Secured term loan |
|
|
313,822 |
|
|
|
303,231 |
|
| Royalty financing
obligation |
|
|
523,633 |
|
|
|
531,599 |
|
| Accumulated deficit |
|
|
(1,729,212 |
) |
|
|
(1,681,159 |
) |
| Stockholders’ deficit |
|
|
(475,606 |
) |
|
|
(455,528 |
) |
| Shares of common stock
outstanding |
|
|
206,629 |
|
|
|
205,771 |
|
Note 1: Derived from audited financial statements.
|
|
|
Reconciliation of Adjusted Net Loss and Adjusted Diluted
Earnings Per Share (in thousands) |
|
|
| |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| GAAP net loss |
|
$ |
(12,674 |
) |
|
$ |
(75,326 |
) |
|
$ |
(48,053 |
) |
|
$ |
(128,659 |
) |
| Less: One-time R&D
restructuring expense |
|
|
— |
|
|
|
— |
|
|
|
(1,264 |
) |
|
|
— |
|
| Less: One-time loss on
extinguishment of Athyrium term loans |
|
|
— |
|
|
|
(29,019 |
) |
|
|
— |
|
|
|
(29,019 |
) |
| Adjusted net loss |
|
$ |
(12,674 |
) |
|
$ |
(46,307 |
) |
|
$ |
(46,789 |
) |
|
$ |
(99,640 |
) |
| |
|
|
|
|
|
|
|
|
| GAAP basic and diluted net
loss per common share |
|
$ |
(0.06 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.68 |
) |
| |
|
|
|
|
|
|
|
|
| Adjusted basic and diluted net
loss per common share |
|
$ |
(0.06 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.53 |
) |
|
|
|
Reconciliation of Adjusted Income (Loss) from
Operations (in thousands) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| GAAP income (loss) from
operations |
|
$ |
8,761 |
|
|
$ |
(20,703 |
) |
|
$ |
(5,727 |
) |
|
$ |
(49,118 |
) |
| Less: Stock-based compensation
expense |
|
|
(13,173 |
) |
|
|
(12,841 |
) |
|
|
(26,825 |
) |
|
|
(26,848 |
) |
| Adjusted income (loss) from
operations |
|
$ |
21,934 |
|
|
$ |
(7,862 |
) |
|
$ |
21,098 |
|
|
$ |
(22,270 |
) |
BioCryst Pharmaceuticals (NASDAQ:BCRX)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
BioCryst Pharmaceuticals (NASDAQ:BCRX)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
