Strongbridge Biopharma Reports Q2 2018 Financial Results and Provides Corporate Update

8/8/18

DUBLIN, Ireland and TREVOSE, Pa., Aug. 08, 2018 (GLOBE NEWSWIRE) -- 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 MACRILEN™ (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.

“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.”

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.

For the three months ended June 30, 2018, non-GAAP basic net loss attributable to ordinary shareholders was $16.7 million, or $0.36 per share, compared to a non-GAAP basic net loss attributable to ordinary shareholders of $12.2 million, or $0.34 per share, for the same period in 2017. The increase in non-GAAP net loss was primarily due to 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, offset in part by net revenues recorded from KEVEYIS product sales.

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.

Research and development expenses were $5.5 million for the three months ended June 30, 2018, compared to $4.1 million for the same period in 2017. The increase during the 2018 period was primarily due to expenses related to the RECORLEV LOGICS and OPTICS clinical trials.

Selling, general and administrative expenses were $15.2 million for the three months ended June 30, 2018, compared to $10.1 million for the same period in 2017. The increase during the 2018 period was primarily due to costs incurred to establish the commercial and corporate infrastructure necessary to support the commercialization of KEVEYIS and MACRILEN.

Year-to-Date June 2018 Financial Results
For the six months ended June 30, 2018, basic net loss attributable to ordinary shareholders on a GAAP basis was $31.6 million, or $0.69 per share, compared to a basic net loss attributable to ordinary shareholders of $59.7 million, or $1.69 per share, for the same period in 2017. Net loss for the six months ended June 30, 2018 was lower than the same period in 2017 primarily due to an unrealized gain of $9.3 million on the fair value of warrants recorded in 2018, compared to an unrealized loss of $30.1 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.

For the six months ended June 30, 2018, non-GAAP basic net loss attributable to ordinary shareholders was $31.0 million, or $0.67 per share, compared to a non-GAAP basic net loss attributable to ordinary shareholders of $22.5 million, or $0.64 per share, for the same period in 2017. The increase in non-GAAP net loss was primarily due to 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, offset in part by net revenues recorded from KEVEYIS product sales.

The Company recorded net revenues from sales of KEVEYIS, which was launched in April 2017, of $8.2 million and cost of goods sold of $1.4 million for the six 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.

Research and development expenses were $10.3 million for the three months ended June 30, 2018, compared to $7.6 million for the same period in 2017. The increase during the 2018 period was primarily due to expenses related to the RECORLEV LOGICS and OPTICS clinical trials.

Selling, general and administrative expenses were $27.6 million for the six months ended June 30, 2018, compared to $17.6 million for the same period in 2017. The increase during the 2018 period was primarily due to costs incurred to establish the commercial and corporate infrastructure necessary to support the commercialization of KEVEYIS and MACRILEN.

Strongbridge had $85.5 million of cash and cash equivalents and $87.4 million in outstanding debt as of June 30, 2018, compared to $57.5 million of cash and cash equivalents and $40.8 million in outstanding debt as of December 31, 2017. The Company believes the combination of existing cash resources and potential additional borrowings available under its credit facility will provide sufficient cash resources under its current operating plan, which includes the potential U.S. regulatory approval and launch of RECORLEV, to achieve consistent positive cash flows from operating activities.

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 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.

About KEVEYIS
KEVEYIS® (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 MACRILEN

MACRILEN® (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD). In clinical studies, the most common side effects of MACRILEN were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate. These are not all of the possible side effects that you may experience with MACRILEN. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects to Strongbridge at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.strongbridgebio.com/products/macrilen/. Please see Full Prescribing Information for additional important MACRILEN safety information.

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