Investment Group Going All-In Thinking Long Term with Strongbridge Biopharma


 
 
02:00 08/09/2018

Strongbridge Biopharma plc., SBBP  revealed earlier today that 10% Shareholder, CDK Associates, L.L.C., has purchased more stock with the company, bringing its total share value purchases to more than $2.8M.

Yesterday, Strongbridge Biopharma, 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. 

For the three months ended June 30, 2018, basic net loss attributable to ordinary shareholders on a GAAP basis was $2.9 million, or $0.06 per share, compared to a basic net loss attributable to ordinary shareholders of $30.2 million, or $0.86 per share, for the same period in 2017. Net loss for the three months ended June 30, 2018 was lower than the same period in 2017 primarily due to an unrealized gain of $19.0 million on the fair value of warrants recorded in 2018, compared to an unrealized loss of $15.2 million on the fair value of warrants recorded in the same period of 2017, as well as increased net revenues recorded in 2018 from sales of KEVEYIS, offset in part by increased operating expenses associated with the commercialization of KEVEYIS and MACRILEN, higher research and development expenses primarily associated with the continued development of RECORLEV, and higher interest expense.

"We have achieved several value-creating milestones across our rare disease portfolio over the last several months, including the compelling RECORLEV Phase 3 clinical trial results announced earlier today," said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. "In addition to the continued strong performance of KEVEYIS, we are particularly excited about the launch of MACRILEN, which provides Strongbridge with an efficient, synergistic presence in the rare endocrine community ahead of the potential regulatory approval of RECORLEV. Early launch indicators are encouraging, signaling pent-up demand for this novel solution to diagnose adult growth hormone deficiency (AGHD), a serious, rare, under-diagnosed disease.”

The Company recorded net revenues from sales of KEVEYIS of $4.3 million and cost of goods sold of $0.8 million for the three months ended June 30, 2018, compared to net revenues of $1.5 million and cost of goods sold of $0.4 million for the same period in 2017. 

Strongbridge Biopharma (NASDAQ:SBBP) SBBP  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 MACRILEN™ (macimorelin), the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency, 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. MACRILEN has orphan drug exclusivity in the United States, and 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.


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