Strongbridge Biopharma plc Provides Corporate Update and Reports Full-Year 2016 Financial Results
“We believe that Strongbridge is well positioned for success in 2017. With the planned launch of KEVEYIS® in April, our interactions with patients, advocacy organizations and healthcare providers continue to reinforce our view that significant unmet needs remain in the diagnosis and treatment of primary periodic paralysis, and Strongbridge is passionate and enthusiastic about making KEVEYIS available to the community. Strongbridge is committed to ensuring that primary periodic paralysis patients have access to KEVEYIS and will also be making investments in disease education and awareness initiatives and patient support services,” said
Recent Corporate Highlights
- Preparing for the launch of KEVEYIS® (dichlorphenamide) in
April 2017. In December 2016, Strongbridge acquired the U.S. rights to KEVEYIS for the treatment of 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. In January, the Company announced the hiring of Dave Bonnelland Scott Wilhoitto focus on building out sales, marketing, market access and patient support service capabilities. Since then, the Company has continued to expand its commercial infrastructure with the hiring of 12 highly-experienced, rare disease field force personnel along with two individuals focusing on patient services and market access. The Company is also actively engaged with the PPP community, including patients, advocacy organizations and healthcare practitioners to develop disease education and awareness initiatives aimed at increasing awareness and diagnosis of PPP.
- COR-003 Phase 3 clinical development program remains on track, and the
U.S. Food and Drug Administrationconditionally accepted the proprietary name RECORLEV™ for the brand. The Phase 3 SONICS study evaluating RECORLEV (levoketoconazole, and formerly known as COR-003) for the treatment of endogenous Cushing’s syndrome is on track to be fully enrolled in the second quarter of 2017, with top-line data for the primary efficacy analysis available in the first quarter of 2018. Patient enrollment in the Phase 3 LOGICS study, which will supplement the long-term efficacy and safety data from SONICS, is anticipated to begin in mid-2017 and top-line data are expected in the third quarter of 2018.
- Veldoreotide (formerly known as COR-005) formulation and process optimization activities are ongoing. Strongbridge is continuing to optimize a long-acting release formulation based on PLGA microspheres and has initiated scale-up and technology transfer to the selected cGMP contract manufacturing site that will be used for clinical supplies. PLGA is a well-known polymer that has been widely applied in long-acting formulations due to its biocompatibility, biodegradability, and favorable release kinetics.
- Strengthened financial position. In
December 2016, Strongbridge secured $35million in equity financing and a $40million credit facility, of which $20 millionhas been initially borrowed. The Company had $66.8 millionof cash and cash equivalents as of December 31, 2016. The Company believes it has sufficient financial resources, excluding any additional borrowings under the credit facility, to fund planned operations into 2019.
For the twelve months ended
Research and development expenses were
General and administrative expenses were
During the twelve months ended
Strongbridge had cash and cash equivalents of
|STRONGBRIDGE BIOPHARMA plc
|Select Consolidated Balance Sheet Information
|(in thousands, except share and per share data)
|December 31,||December 31,|
|( in thousands)|
|Consolidated Balance Sheet Data:|
|Cash and cash equivalents||$||66,837||$||51,623|
|Total shareholders’ equity||66,972||90,927|
|STRONGBRIDGE BIOPHARMA plc
|Consolidated Statement of Operations and Comprehensive Loss
|(In thousands, except share and per share data)|
|Year ended December 31,
|Consolidated Statement of Operations Data:|
|Research and development||$||20,023||$||20,135|
|General and administrative||14,875||22,719|
|Intangible asset impairment charges||15,828||—|
|Total operating expenses||50,726||42,854|
|Other income (expense), net:|
|Foreign exchange loss||(69||)||(124||)|
|Unrealized gain on fair value of warrants||638|
|Other income (expense), net||(1,180||)||(1,105||)|
|Total other income (expense), net||(631||)||(1,229||)|
|Loss before income taxes||(51,357||)||(44,083||)|
|Income tax benefit||2,638||450|
|Net loss attributable to non-controlling interest||122||53|
|Net loss attributable to Strongbridge Biopharma||$||(48,597||)||$||(43,580||)|
|Net loss attributable to ordinary shareholders:|
|Net loss per share attributable to ordinary shareholders:|
|Weighted-average shares used in computing net loss per share attributable to ordinary shareholders:|
About Strongbridge Biopharma
Strongbridge 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
KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
KEVEYIS Important Safety Information
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.
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.
For additional KEVEYIS important safety information, please see full prescribing information at www.keveyis.com.
STRONGBRIDGE BIOPHARMA™ is a trademark of
KEVEYIS® is a registered trademark licensed exclusively in the U.S. to
This 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.
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