~ Strongbridge Commercial Introduction of
KEVEYIS® (dichlorphenamide) in Mid-April Shows Encouraging Initial
Demand ~
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 provided a corporate update and
reported first quarter 2017 financial results.
“We recently initiated our commercial
introduction of KEVEYIS® (dichlorphenamide), the first and only FDA
approved treatment for Primary Periodic Paralysis (PPP), an
ultra-rare, genetic, debilitating neuromuscular disease. We are
focused on meeting the needs of patients and the broader PPP
community by enabling access to treatment and providing
comprehensive patient and physician support services.
Although it is still early in our launch rollout, it is clear that
the unmet need in the PPP market is significant, and we are pleased
with the interest in, and demand for, KEVEYIS,” said Matthew Pauls,
president and chief executive officer of Strongbridge Biopharma.
“Simultaneously, we have maintained our strong focus on driving the
clinical development of RECORLEV™ (levoketoconazole), our Phase 3
product candidate for the treatment of endogenous Cushing’s
syndrome (CS). Enrollment in the Phase 3 SONICS study is on track
for completion in the second quarter, and enrollment in the LOGICS
study will begin on schedule by mid-year. The need for a safe and
effective, next-generation cortisol inhibitor in the treatment of
CS is substantial, and we are excited about the potential to become
a leader in the growing CS market in the near term,” Pauls
added.
“Primary Periodic Paralysis (PPP) is an
ultra-rare and complex neuromuscular condition, which is often
misunderstood and can take a significant toll on a patient's
ability to participate in everyday life activities. For the
five-to-six thousand people in the U.S. living with this physically
debilitating genetic condition, the time from disease onset to
confirmed diagnosis can sometimes take up to 20 years,” said Jacob
Levitt, M.D., F.A.A.D., president and medical director of the
Periodic Paralysis Association. “The PPP community is pleased by
Strongbridge’s commitment and early efforts to further educate
physicians and improve upon the time it takes to diagnose this
treatable condition.”
Recent Corporate
Highlights
- Strongbridge Commercial Introduction of KEVEYIS
in Mid-April Shows Encouraging Initial Demand, Successful
Transition of Existing Patients to Commercial
Supply. Strongbridge launched KEVEYIS
(www.keveyis.com) in the U.S. market in mid-April after acquiring
the U.S. marketing rights to it from Taro Pharmaceutical Industries
Ltd. in December 2016. KEVEYIS is the first and only
FDA-approved treatment indicated for hyperkalemic, hypokalemic, and
related variants of primary periodic paralysis (PPP), which is a
group of rare hereditary disorders that causes potentially severe
episodes of muscle weakness and/or paralysis.The Company has
partnered with PANTHERx® Specialty Pharmacy to build a customized
support and product distribution program, Strongbridge
CareConnection, for members of the KEVEYIS ecosystem, including
patients, caregivers, physicians and payers. During the month of
April, a phased reimbursement transition process was implemented,
resulting in the Company successfully transitioning, thus far, more
than 70 percent of the 80 existing KEVEYIS patients to
Strongbridge’s commercial supply, and continues to make progress
transitioning remaining patients. The Company’s highly specialized
12 person rare disease sales team, with nearly 80 years of
collective rare disease sales experience and a combined 20 orphan
product launches, has generated a number of new patient start forms
just three weeks into the recent KEVEYIS launch. The Company has
also built out key functions across the enterprise to support the
KEVEYIS efforts, including patient support services, medical
science liaisons, market access, and marketing personnel.
- RECORLEV Phase 3 clinical development program timeline
on track. The Phase 3 SONICS study evaluating RECORLEV for
the treatment of endogenous Cushing’s syndrome has a sufficient
number of patients dosed and potential subjects in the enrollment
queue to achieve full enrollment by the end of the second quarter
of 2017, with top-line data supporting the primary efficacy
analysis available in the first quarter of 2018. The SONICS
Data and Safety Monitoring Board (DSMB) recently completed its
semi-annual comprehensive data review, and determined that the
study was progressing well and that there were no safety concerns
warranting changes to the study of any kind. Patient enrollment in
the Phase 3 LOGICS study, which will supplement the long-term
efficacy and safety data from SONICS, is anticipated to begin
enrolling in mid-2017 with top-line data anticipated in the third
quarter of 2018.
- Financial position consistent with prior
guidance. Strongbridge had cash and cash equivalents of
$49.9 million and $20.0 million in outstanding debt as of March 31,
2017, compared to cash and cash equivalents of $66.8 million and
$20.0 million in outstanding debt as of December 31, 2016. Net cash
used in operating activities was $9.3 million for both the three
months ended March 31, 2017 and 2016. In addition, during the three
months ended March 31, 2017, the Company paid the remaining $7.5
million of the upfront payment owed in connection with the
acquisition of the U.S. marketing rights of KEVEYIS. The Company
continues to believe its existing financial resources are
sufficient to fund planned operations into 2019.
Year-to-Date March 2017
Results
For the three months ended March 31, 2017, basic
and diluted net loss attributable to ordinary shareholders was
$29.5 million, or $0.83 per share. Basic and diluted net loss
during the three months ended March 31, 2017 included a $14.9
million non-cash charge related to an increase in the fair value of
the Company’s warrant liability resulting from the increase in the
Company’s stock price during the quarter, and non-cash charges of
$1.6 million for income taxes and $1.3 million for intangible asset
amortization. The basic and diluted net loss attributable to
ordinary shareholders for the three months ended March 31, 2016 was
$12.2 million, or $0.57 per share.
Research and development expenses were $3.5
million for the three months ended March 31, 2017, compared to $6.8
million for the same period in the prior year. The decrease
during the 2017 period was primarily due to decreased development
spend related to programs discontinued during 2016, a planned
decrease in development activity for veldoreotide, and a
timing-related decrease in expenses relating to the ongoing
clinical trials for RECORLEV.
Selling, general and administrative expenses
were $7.4 million for the three months ended March 31, 2017,
compared to $4.1 million for the same period in the prior
year. The increase during the 2017 period was primarily
due to costs incurred in preparing for the launch of KEVEYIS.
STRONGBRIDGE BIOPHARMA plc |
|
Select Consolidated Balance Sheet
Information |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
( in thousands) |
|
Consolidated
Balance Sheet Data: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
49,898 |
|
$ |
66,837 |
|
Total
assets |
|
|
117,933 |
|
|
137,531 |
|
Total
liabilities |
|
|
79,277 |
|
|
70,559 |
|
Total
shareholders’ equity |
|
|
38,656 |
|
|
66,972 |
|
STRONGBRIDGE BIOPHARMA plc |
Consolidated Statement of Operations and
Comprehensive Loss |
(Unaudited, in thousands, except share and per
share data) |
|
|
Three Months Ended March 31, |
|
2017 |
|
|
2016 |
|
|
|
|
|
Consolidated
Statement of Operations Data: |
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
$ |
3,481 |
|
|
$ |
6,794 |
|
Selling, general and administrative |
|
7,442 |
|
|
|
4,129 |
|
Amortization of intangible asset |
|
1,256 |
|
|
|
— |
|
Total
operating expenses |
|
12,179 |
|
|
|
10,923 |
|
Operating loss |
|
(12,179 |
) |
|
|
(10,923 |
) |
Other expense,
net: |
|
|
|
|
|
Unrealized loss on fair value of warrants |
|
(14,928 |
) |
|
|
— |
|
Interest expense |
|
(737 |
) |
|
|
— |
|
Foreign exchange loss |
|
(12 |
) |
|
|
(47 |
) |
Other expense, net |
|
(35 |
) |
|
|
(1,290 |
) |
Total
other expense, net |
|
(15,712 |
) |
|
|
(1,337 |
) |
Loss before income
taxes |
|
(27,891 |
) |
|
|
(12,260 |
) |
Income tax (expense)
benefit |
|
(1,594 |
) |
|
|
55 |
|
Net loss |
|
(29,485 |
) |
|
|
(12,205 |
) |
Net loss attributable
to non‑controlling interest |
|
— |
|
|
|
51 |
|
Net loss attributable
to Strongbridge Biopharma |
$ |
(29,485 |
) |
|
$ |
(12,154 |
) |
|
|
|
|
|
|
Net loss attributable
to ordinary shareholders: |
|
|
|
|
|
Basic and diluted |
$ |
(29,485 |
) |
|
$ |
(12,154 |
) |
Net loss per share
attributable to ordinary shareholders: |
|
|
|
|
|
Basic and diluted |
$ |
(0.83 |
) |
|
$ |
(0.57 |
) |
Weighted-average shares
used in computing net loss per share attributable to ordinary
shareholders: |
|
|
|
|
|
Basic and diluted |
|
35,335,026 |
|
|
|
21,205,382 |
|
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 first commercial product is KEVEYIS®
(dichlorphenamide), the first and only FDA-approved treatment for
hyperkalemic, hypokalemic, and related variants of Primary Periodic
Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S.
through August 7, 2022. In addition to establishing this
neuromuscular disease franchise, the Company has a clinical-stage
pipeline of therapies for rare endocrine diseases. Strongbridge's
lead compounds include RECORLEV™
(levoketoconazole), a cortisol synthesis inhibitor currently being
studied for the treatment of endogenous Cushing's syndrome, and
veldoreotide, a next-generation somatostatin analog being
investigated for the treatment of acromegaly, with potential
additional applications in Cushing's syndrome and neuroendocrine
tumors. Both RECORLEV and veldoreotide have received orphan
designation from the U.S. Food and Drug Administration and the
European Medicines Agency. For more information, visit
www.strongbridgebio.com.
About KEVEYIS
KEVEYIS®
IndicationKEVEYIS® (dichlorphenamide) is indicated
for the treatment of primary hyperkalemic periodic paralysis,
primary hypokalemic periodic paralysis, and related variants.
KEVEYIS Important Safety
InformationIn 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.
KEVEYIS is not for everyone. Do not take KEVEYIS
if you:
- Are on a high-dose aspirin regimen
- Are allergic to sulfa-based drugs
- Have liver, kidney, or certain lung conditions
- Are pregnant, planning to become pregnant, or nursing
- Are under 18 years old
Taking KEVEYIS may cause a drop in the amount of
potassium (an electrolyte) in your body, which can lead to heart
problems. Ask your doctor if you need to eat foods that contain
high amounts of potassium while taking KEVEYIS.
Your body may produce too much acid or may not
be able to remove enough acid from body fluids while taking
KEVEYIS. Your doctor will run tests on a regular basis to check for
signs of acid buildup and may reduce your dose or stop your
treatment with KEVEYIS.
KEVEYIS may also increase the risk of falls,
especially in elderly patients and patients taking high doses of
KEVEYIS. Use caution when driving, operating machinery, or
performing any other hazardous activities while taking KEVEYIS, as
this medication may cause drowsiness.
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 more
information, go to www.keveyis.com.
For additional KEVEYIS important safety
information, please see full prescribing information at
www.keveyis.com.
STRONGBRIDGE BIOPHARMA™ is a trademark of
Strongbridge Biopharma plc.
KEVEYIS® is a registered trademark licensed
exclusively in the U.S. to Strongbridge Biopharma plc.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements. These statements relate to
future events and involve known and unknown risks, including,
without limitation, uncertainties regarding Strongbridge's
strategy, plans, future financial position, anticipated
investments, costs and results, outcomes of product development
efforts, status and results of clinical trials and objectives of
management for future operations. 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. 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.
Corporate and Media Relations
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
lrocco@elixirhealthpr.com
Investor Relations
U.S.:
The Trout Group
Marcy Nanus
+1 646-378-2927
mnanus@troutgroup.com
Europe:
First House
Mitra Hagen Negård
+47 21 04 62 19
strongbridgebio@firsthouse.no
USA
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Tel. +1 610-254-9200
Fax. +1 215-355-7389
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