Exhibit 99.1

 

 

Strongbridge Biopharma plc Reports Second Quarter 2018 Financial Results and Provides Corporate Update

 

~ Statistically Significant Positive Top-line Clinical Results Reported from SONICS Phase 3 Study of RECORLEV™ (levoketoconazole) in Endogenous Cushing’s Syndrome ~

 

~ Rare Endocrine Franchise Expands with the U.S. Launch of MACRILENÔ (macimorelin) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) ~

 

~ Patent Issued in United States for Extended-release veldoreotide Formulation, Providing Patent Protection Until 2037 ~

 

~ KEVEYIS® (dichlorphenamide) Achieves $4.3 Million in Second Quarter 2018 Revenue, a 187 Percent Increase from Second Quarter 2017 ~

 

Dublin, Ireland and Trevose, Pa., August 8, 2018

— 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 second quarter 2018 financial results.

 

Second Quarter 2018 And Recent Highlights:

 

Rare Endocrine Franchise:

 

·                            Earlier today, Strongbridge reported statistically significant positive top-line clinical results from the SONICS Phase 3 study of RECORLEV™ (levoketoconazole) in endogenous Cushing’s syndrome.

·                            Launched MACRILENÔ (macimorelin) in the United States at the end of July. MACRILEN is the Company’s second rare disease commercial product and the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD), a condition often treated by the same endocrinologists who diagnose and treat Cushing’s syndrome.

·                           Patent issued for veldoreotide, a next-generation somatostatin analog (SSA), with claims covering an extended-release formulation and a method of manufacturing the formulation, strengthening the Company’s intellectual property portfolio. The patent is scheduled to expire in February 2037.

 

Rare Neuromuscular Franchise:

 

·                            Achieved KEVEYIS net product sales of $4.3 million in the second quarter of 2018, a 187 percent increase compared to $1.5 million in the second quarter of 2017.

·                            Full-year 2018 KEVEYIS revenue guidance remains $18 — $20 million.

 


The following information was filed by Strongbridge Biopharma Plc (SBBP) on Wednesday, August 8, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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