Strongbridge Biopharma plc, (Nasdaq: SBBP), a global
commercial-stage biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases
with significant unmet needs, today reported financial results for
the first quarter of 2021 and provided a corporate update.
“We delivered strong financial results in the
first quarter with 25 percent quarter-over-quarter revenue growth
achieved with KEVEYIS® (dichlorphenamide) versus the first
quarter last year, providing a strong foundation as we enter the
second quarter. Looking ahead, Strongbridge remains focused on
driving continued revenue growth for KEVEYIS and leveraging our
operational and commercial expertise to further accelerate the
growth of Strongbridge’s rare disease portfolio,” said John H.
Johnson, chief executive officer of Strongbridge Biopharma.
Johnson added, “Strongbridge is currently
awaiting notification from the U.S. Food and Drug Administration
(FDA) regarding filing of the Company’s New Drug Application (NDA)
for RECORLEV® (levoketoconazole) for the treatment of endogenous
Cushing’s syndrome. We look forward to receiving the official Day
74 letter shortly and sharing an update thereafter, as well as the
potential opportunity to bring a new therapeutic option to the
Cushing's syndrome community.”
Corporate & Financial
Highlights
Rare Neuromuscular Franchise:
KEVEYIS® (dichlorphenamide)
- The Company achieved KEVEYIS net
product sales of $8.4 million for the first quarter
ended March 31, 2021, representing a 25 percent increase over
first quarter 2020 revenue of $6.7 million. Sales momentum
continued in April with KEVEYIS delivering the highest month of net
product sales since its launch by the Company in 2017.
- First quarter performance is
attributed to the growth in patients on drug, resulting from new
patient starts combined with improved discontinuation rates for
existing patients on therapy.
- In April, a case report concerning
a patient with Andersen-Tawil Syndrome switching from acetazolamide
to KEVEYIS was presented at the American Academy of Neurology (AAN)
virtual meeting. This case report was also recently published in
the peer-reviewed journal Neuromuscular Disorders.
Rare Endocrine Franchise: RECORLEV®
(levoketoconazole)
- Strongbridge is currently awaiting
filing notification via the Day 74 letter from the FDA regarding
the Company’s NDA submission for RECORLEV for the treatment of
endogenous Cushing’s syndrome.
- The United States Patent and
Trademark Office (USPTO) has entered a Notice of Allowance for U.S.
Patent Application 17/010,387 covering a method of treating
Cushing’s syndrome patients with RECORLEV who also take metformin
for Type 2 diabetes.
- This Notice of Allowance concludes
the substantive examination of the patent application and is
expected to result in the issuance of a U.S. patent after
administrative processes are completed.
- The term of the U.S. patent
scheduled to issue from this application will expire in September
2040.
- Strongbridge continues to prepare
for the potential commercial launch of RECORLEV in the first
quarter of 2022.
- In April, a diabetes subgroup analysis from the Phase 3 SONICS
study of RECORLEV was published in the peer-reviewed
journal, Frontiers in Endocrinology.
- In March, interim safety and efficacy results, including new
data analyses from the Phase 3 LOGICS study, were presented via
poster at the Endocrine Society’s (ENDO) 2021 virtual annual
meeting.
Corporate Updates
- Strongbridge reports approximately $73.9 million of
cash and cash equivalents as of March 31, 2021.
- Assuming the availability and full
draw-down of the remaining $10 million from its debt
facility, the Company believes that it can fund operations as
currently planned
into, and potentially beyond, the first quarter
of 2023.
- Strongbridge has been recognized as
a 2021 Great Place to Work®-Certified company. Great Place to Work®
is a global authority on workplace culture, employee experience and
the leadership behaviors proven to deliver market-leading revenue
and increased innovation.
First Quarter 2021 Financial
ResultsThe Company’s net revenues from sales of KEVEYIS
increased $1.7 million, or 25 percent, to $8.4 million for the
three months ended March 31, 2021 compared to $6.7 million for the
three months ended March 31, 2020. The Company recorded cost
of sales of $0.4 million for the three months ended March 31, 2021,
compared to cost of sales of $1.0 million for the same period in
2020. Cost of sales decreased due to changes in the assumptions
underlying the allocation between the purchase price of our
inventory and our supply agreement. Gross margins were 95 percent
for three months ended March 31, 2021, compared to gross margins of
85 percent for the same period in 2020.
Selling, general and administrative expenses
were $10.9 million for the three months ended March 31, 2021,
compared to $10.4 million for the same period in 2020. The increase
during the current period was primarily due to an increase in our
non-cash stock compensation expense.
Research and development expenses were $5.8
million for the three months ended March 31, 2021, compared to $7.6
million for the same period in 2020. The decrease was primarily due
to decreases in costs associated with our LOGICS and OPTICS trials,
offset by increases in regulatory costs associated with our NDA
submission.
For the three months ended March 31, 2021, basic
net loss attributable to ordinary shareholders on a GAAP basis was
($11.8 million), or ($0.18) per share, compared to a basic net loss
attributable to ordinary shareholders of ($12.7) million, or
($0.23) per share, for the same period in 2020. Net loss for the
three months ended March 31, 2021 was lower than the same period in
2020 due to the increase in KEVEYIS revenue of $1.7 million, the
improvement in gross margin and the reduction in research and
development expenses. Those decreases were offset by $0.8 million
of interest expense recorded in the three months ended March 31,
2021, and a $1.4 million change in the revaluation of the fair
value of our liability classified warrants due to the increase in
the Company’s stock price in 2021 compared to 2020.
For the three months ended March 31, 2021,
non-GAAP basic net loss attributable to ordinary shareholders was
($7.2 million), or ($0.11) per share, compared to a non-GAAP basic
net loss attributable to ordinary shareholders of ($10.3 million),
or ($0.19) per share, for the same period in 2020. The decrease in
non-GAAP net loss during the three months ended March 31, 2021 was
primarily due to an increase in KEVEYIS revenue of $1.7 million and
improvement in gross margin. In addition, research and development
expenses decreased during the three months ended March 31, 2021
compared to the same period in 2020 offset by cash interest expense
in the three months ended March 31, 2021.
STRONGBRIDGE BIOPHARMA plc |
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Select Consolidated Balance Sheet Information
(unaudited) |
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(in thousands, except share and per share
data) |
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March 31, |
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December 31, |
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2021 |
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2020 |
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Consolidated Balance Sheet Data: |
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Cash and cash equivalents |
$ |
73,898 |
|
$ |
87,522 |
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Total assets |
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108,050 |
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121,100 |
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Long-term debt, net |
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17,399 |
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17,114 |
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Total liabilities |
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52,203 |
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55,495 |
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Total shareholders’ equity |
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55,847 |
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|
65,605 |
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STRONGBRIDGE BIOPHARMA plc |
Consolidated Statements of Operations and Comprehensive
Loss (unaudited) |
(in thousands, except share and per share
data) |
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Three Months Ended March 31, |
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2021 |
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2020 |
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Total revenues |
$ |
8,382 |
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$ |
6,674 |
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Cost and expenses: |
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Cost of sales (excluding amortization of intangible asset) |
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411 |
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|
969 |
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Selling, general and administrative |
|
10,946 |
|
|
|
10,403 |
|
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Research and development |
|
5,839 |
|
|
|
7,552 |
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Amortization of intangible asset |
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1,256 |
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|
|
1,256 |
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Total cost and expenses |
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18,452 |
|
|
|
20,180 |
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Operating loss |
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(10,070 |
) |
|
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(13,506 |
) |
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Other (expense) income, net: |
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|
|
|
|
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Interest expense |
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(782 |
) |
|
|
— |
|
|
Unrealized (loss) gain on fair value of warrants |
|
(774 |
) |
|
|
580 |
|
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Other (expense) income, net |
|
(188 |
) |
|
|
228 |
|
|
Total other (expense) income, net |
|
(1,744 |
) |
|
|
808 |
|
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Loss before income taxes |
|
(11,814 |
) |
|
|
(12,698 |
) |
|
Income tax expense |
|
— |
|
|
|
— |
|
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Net loss |
$ |
(11,814 |
) |
|
$ |
(12,698 |
) |
|
Other comprehensive loss: |
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|
|
|
|
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Unrealized loss on marketable securities |
|
— |
|
|
|
3 |
|
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Comprehensive loss |
$ |
(11,814 |
) |
|
$ |
(12,695 |
) |
|
|
|
|
|
|
|
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Net loss attributable to ordinary shareholders: |
|
|
|
|
|
|
Basic |
$ |
(11,814 |
) |
|
$ |
(12,698 |
) |
|
Diluted |
$ |
(11,814 |
) |
|
$ |
(13,278 |
) |
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Net loss per share attributable to ordinary shareholders: |
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|
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Basic |
$ |
(0.18 |
) |
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$ |
(0.23 |
) |
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Diluted |
$ |
(0.18 |
) |
|
$ |
(0.24 |
) |
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Weighted-average shares used in computing net loss per
shareattributable to ordinary shareholders: |
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Basic |
|
67,375,383 |
|
|
|
54,231,024 |
|
|
Diluted |
|
67,375,383 |
|
|
|
54,444,681 |
|
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STRONGBRIDGE BIOPHARMA plc |
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Reconciliation of Non-GAAP Financial Measures
(unaudited) |
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(in thousands, except share and per share
data) |
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Three Months Ended March 31, 2021 |
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Operatingloss |
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Loss beforeincome taxes |
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Net lossattributable toordinaryshareholders |
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Net loss pershareattributable toordinaryshareholders |
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GAAP |
|
|
|
|
$ |
(10,070 |
) |
|
$ |
(11,814 |
) |
|
$ |
(11,814 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
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|
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|
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Non-GAAP Adjustments: |
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|
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|
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Amortization of intangible asset (a) |
|
$ |
1,256 |
|
|
$ |
1,256 |
|
|
$ |
1,256 |
|
|
|
|
|
|
Stock-based compensation - Selling, General & Admin. (b) |
$ |
1,719 |
|
|
$ |
1,719 |
|
|
$ |
1,719 |
|
|
|
|
|
|
Stock-based compensation - Research & Development (b) |
$ |
558 |
|
|
$ |
558 |
|
|
$ |
558 |
|
|
|
|
|
|
Unrealized loss on fair value of warrants (c) |
|
- |
|
|
$ |
774 |
|
|
$ |
774 |
|
|
|
|
|
|
Non-cash interest expense (d) |
|
|
|
- |
|
|
$ |
286 |
|
|
$ |
286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Adjusted |
|
|
|
|
$ |
(6,537 |
) |
|
$ |
(7,221 |
) |
|
$ |
(7,221 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
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Three Months Ended March 31, 2020 |
|
|
|
|
|
|
|
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Operatingloss |
|
|
Loss beforeincome taxes |
|
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Net lossattributable toordinaryshareholders |
|
|
Net loss pershareattributable toordinaryshareholders |
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|
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|
|
|
|
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|
|
|
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|
GAAP |
|
|
|
|
$ |
(13,506 |
) |
|
$ |
(12,698 |
) |
|
$ |
(12,698 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Adjustments: |
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|
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|
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|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible asset (a) |
|
$ |
1,256 |
|
|
$ |
1,256 |
|
|
$ |
1,256 |
|
|
|
|
|
|
Stock-based compensation - Selling, General & Admin. (b) |
$ |
1,270 |
|
|
$ |
1,270 |
|
|
$ |
1,270 |
|
|
|
|
|
|
Stock-based compensation - Research & Development (b) |
$ |
481 |
|
|
$ |
481 |
|
|
$ |
481 |
|
|
|
|
|
|
Unrealized gain on fair value of warrants (c) |
|
- |
|
|
$ |
(580 |
) |
|
$ |
(580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
$ |
(10,499 |
) |
|
$ |
(10,271 |
) |
|
$ |
(10,271 |
) |
|
$ |
(0.19 |
) |
|
|
|
|
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(a) The effects of amortization of the intangible asset are
excluded because these charges are non-cash, and we believe such
exclusion facilitates investors’ ability to more accurately compare
our operating results to those of our peer companies. |
|
(b) The effects of non-cash employee stock-based compensation are
excluded because of varying available valuation methodologies and
subjective assumptions. We believe this is a useful measure
for investors because such exclusion facilitates comparison to peer
companies who also provide similar non-GAAP disclosures and is
reflective of how management internally manages the business. |
|
(c) The unrealized gain on fair value of warrants is excluded due
to the nature of this charge, which is non-cash and related
primarily to the effect of changes in the company’s stock price at
a point in time. We believe such exclusion facilitates investors’
ability to more accurately compare our operating results to those
of our peer companies. |
|
(d) The effects of non-cash interest charges are excluded. We
believe such exclusion facilitates an understanding of the effects
of the debt service obligations on the Company’s liquidity and
comparisons to peer group companies and is reflective of how
management internally manages the business. |
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Conference Call
DetailsStrongbridge will host a conference call
on Wednesday, May 12, 2021 at 8:30 a.m. ET. To
access the live call, dial (844) 285-7153 (domestic) or (478)
219-0180 (international) with conference ID 9478726. The conference
call will also be webcast from the Company’s website
at www.strongbridgebio.com under the “Investor/Webcasts
and Presentations” section. A replay of the call will be made
available for one week following the conference call. To hear a
replay of the call, dial (855) 859-2056 (domestic) or (404)
537-3406 (international) with conference ID 9478726.
About Strongbridge
BiopharmaStrongbridge Biopharma is a global
commercial-stage biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases
with significant unmet needs. Strongbridge’s rare endocrine
franchise includes RECORLEV® (levoketoconazole), an adrenal
steroidogenesis inhibitor, currently being studied in Phase 3
clinical studies for the treatment of endogenous Cushing’s
syndrome, and veldoreotide extended release, a preclinical
next-generation somatostatin analog being investigated for the
treatment of acromegaly and potential additional applications in
other conditions amenable to somatostatin receptor activation. Both
RECORLEV and veldoreotide have received orphan drug designation
from the FDA and the European Medicines Agency. The Company’s
rare neuromuscular franchise includes KEVEYIS® (dichlorphenamide),
the first and only FDA-approved treatment for hyperkalemic,
hypokalemic, and related variants of primary periodic paralysis.
KEVEYIS has orphan drug exclusivity in the United
States.
About RECORLEVRECORLEV®
(levoketoconazole) is an investigational adrenal steroidogenesis
inhibitor in development for the treatment of patients with
endogenous Cushing’s syndrome, a rare but serious and potentially
lethal endocrine disease caused by chronic elevated cortisol
exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a
steroidogenesis inhibitor. RECORLEV has demonstrated in two
successful Phase 3 studies to significantly suppress serum cortisol
and has the potential to be a next-generation cortisol
inhibitor.
The Phase 3 program for RECORLEV includes SONICS
and LOGICS: two multinational studies designed to evaluate the
safety and efficacy of RECORLEV when used to treat endogenous
Cushing’s syndrome. The SONICS study met its primary and secondary
endpoints, demonstrating a statistically significant normalization
rate of urinary free cortisol at six months. The LOGICS study,
which met its primary endpoint and key secondary endpoint, is a
double-blind, placebo-controlled randomized-withdrawal study of
RECORLEV that is designed to supplement the long-term efficacy and
safety information supplied by SONICS. The ongoing long-term open
label OPTICS study will gather further useful information related
to the long-term use of RECORLEV.
RECORLEV has received orphan drug designation
from the FDA and the European Medicines Agency for the
treatment of endogenous Cushing's syndrome.
About KEVEYISKEVEYIS®
(dichlorphenamide) is indicated for the treatment of primary
hyperkalemic periodic paralysis, primary hypokalemic periodic
paralysis, and related variants. In clinical studies, the most
common side effects of KEVEYIS were a numbness or tingling,
difficulty thinking and paying attention, changes in taste, and
confusion. These are not all of the possible side effects that you
may experience with KEVEYIS. Talk to your doctor if you have any
symptoms that bother you or do not go away. You are encouraged to
report side effects to Strongbridge Biopharma at
1-855-324-8912, or to the FDA at 1-800-FDA-1088 or
visit www.fda.gov/medwatch. For additional KEVEYIS important
safety information and the full prescribing information
visit www.keveyis.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the federal securities laws. The words “anticipate,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“project,” “target,” “will,” “would,” or the negative of these
terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. All statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements, including statements
related to 2021 KEVEYIS revenue guidance, expected cash
balances and cash runway, potential advantages of RECORLEV, the
anticipated timing for the review of the NDA for RECORLEV and the
potential launch of RECORLEV (if approved), Strongbridge’s
strategy, plans, intellectual property portfolio, outcomes of
product development efforts and objectives of management for future
operations. Forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from those expressed in such statement, including risks and
uncertainties associated with clinical development and the
regulatory approval process, the reproducibility of any reported
results showing the benefits of RECORLEV, the adoption of RECORLEV
by physicians, if approved, as treatment for any disease and the
emergence of unexpected adverse events following regulatory
approval and use of the product by patients. Additional risks and
uncertainties relating to Strongbridge and its business can be
found under the heading “Risk Factors” in Strongbridge’s Annual
Report on Form 10-K for the year ended December 31,
2020 and its subsequent Quarterly Reports on Form 10-Q, as
well as its other filings with the SEC. These forward-looking
statements are based on current expectations, estimates, forecasts
and projections and are not guarantees of future performance or
development and involve known and unknown risks, uncertainties and
other factors. The forward-looking statements contained in this
press release are made as of the date of this press release,
and Strongbridge Biopharma does not assume any obligation
to update any forward-looking statements except as required by
applicable law.
Contacts:
Corporate & Media RelationsElixir Health
Public RelationsLindsay Rocco+1
862-596-1304lrocco@elixirhealthpr.com
Investor RelationsSolebury TroutMike Biega+1
617-221-9660mbiega@soleburytrout.com
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