Strongbridge Biopharma plc Announces Preliminary Fourth Quarter and Full-Year 2019 Financial Results and Provides Update on C...
09 January 2020 - 11:30PM
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 announced preliminary and
unaudited financial results for the fourth quarter and full-year
2019 and provided an update on key corporate priorities for
2020.
“Based on our preliminary fourth quarter and
full-year 2019 results, coupled with recent actions taken to
strengthen the Company's overall financial position, we have
extended our cash runway through the third quarter of 2021, which
is at least one year beyond our anticipated timeframe for reporting
top-line LOGICS results,” said John H. Johnson, executive
chairman of Strongbridge Biopharma. “We remain confident in
our long-term growth prospects and believe that 2020 will provide
several opportunities to deliver shareholder value. As we enter
this next phase of growth, our priorities remain focused on
completing the Phase 3 LOGICS trial, submitting a quality new drug
application for RECORLEV™ (levoketoconazole), pursuing life cycle
opportunities for KEVEYIS® (dichlorphenamide), continuing to grow
the primary periodic paralysis market, and identifying a new chief
executive officer.”
Preliminary and Unaudited Fourth Quarter
and Full-Year 2019 Financial Results and 2020 KEVEYIS Revenue
Guidance
- The Company anticipates that it
will achieve KEVEYIS net product sales of approximately $5.6
million for the fourth quarter ended December 31, 2019
and approximately $21.7 million for the full-year ended
December 31, 2019, exceeding its previous $18 to $20 million
guidance range, and representing a 29 percent increase over 2018
revenue of $16.8 million.
- The Company projects that the
full-year 2020 revenue guidance for KEVEYIS will be approximately
$26 to $27 million; based upon current assumptions, the Company
anticipates a continued positive and growing contribution
margin.
- Strongbridge expects to report
approximately $78 million of cash and cash equivalents and no
outstanding debt as of December 31, 2019.
- The Company has further extended
its cash runway guidance by an additional three months, and now
believes it can fund operations as currently planned through the
third quarter of 2021, at least one-year following anticipated
receipt of LOGICS top-line results.
Key Corporate Priorities for
2020
- Complete enrollment in the Phase 3
LOGICS study of RECORLEV in endogenous Cushing’s syndrome. To date,
the trial is more than 70 percent enrolled. The Company projects
that all of the remaining patients required to complete enrollment
are currently in the titration and maintenance phase.
- Report top-line results for the
Phase 3 LOGICS study in the second or third quarter of 2020 and
submit a New Drug Application (NDA) for RECORLEV to the U.S. Food
and Drug Administration approximately six months after reporting
top-line LOGICS results.
- Continue our efforts to pursue life
cycle extension opportunities for KEVEYIS and grow the primary
periodic paralysis market.
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), a cortisol
synthesis inhibitor currently being studied in Phase 3
clinical studies for the treatment of endogenous Cushing’s
syndrome, and veldoreotide extended-release, a pre-clinical
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
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.
About RECORLEV
RECORLEV™ (levoketoconazole) is an
investigational cortisol synthesis 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
is believed to significantly suppress serum cortisol in healthy
subjects and has the potential to be a next-generation cortisol
inhibitor. The Phase 3 program for RECORLEV consists of 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 ongoing LOGICS study
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. RECORLEV has received
orphan drug designation from the FDA and
the European Medicines Agency for the treatment of
endogenous Cushing's syndrome.
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 the Company’s anticipated fourth quarter and full
year 2019 financial results, 2020 revenue guidance and expected
cash runway, future cash balances, the potential advantages of
RECORLEV, the anticipated timing for the release of top-line
data from the LOGICS study and the submission of an NDA for
RECORLEV to the FDA, Strongbridge’s strategy, plans, status
and results of clinical trials, 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, 2018 and subsequent
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 and Investor Relations Strongbridge
Biopharma plc Marcy Nanus +1 484-312-3744
m.nanus@strongbridgebio.com
Media Relations Elixir Health Public Relations
Lindsay Rocco +1 862-596-1304
lrocco@elixirhealthpr.com
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