Strongbridge Biopharma plc Announces Preliminary Fourth Quarter and Full-Year 2020 Financial Results and Provides Corporate Update - Seite 2

Preliminary and Unaudited Fourth Quarter and Full-Year 2020 Financial Results, Cash Position, and 2021 KEVEYIS(dichlorphenamide) Revenue Guidance

• The Company anticipates that it will report KEVEYIS net product sales of approximately $8.2 million for the fourth quarter ended, December 31, 2020, and approximately $30.7 million for the full-year ended December 31, 2020, exceeding its projected $28 million to $29 million guidance range, and representing a 41.5 percent increase over 2019 revenue of $21.7 million.
• The Company is targeting full-year 2021 revenue guidance of approximately $34 million to $36 million for KEVEYIS.
• Following completion in September 2020 of a $25 million equity raise and a recent year-end borrowing of an additional $10 million under the Company’s existing debt facility, Strongbridge expects to report approximately $87.5 million of cash and cash equivalents as of December 31, 2020.
• The Company believes it can fund operations as currently planned into and potentially beyond the first quarter of 2023.

Select Corporate Priorities for 2021

• The Company is on-track to submit a New Drug Application (NDA) for RECORLEV to the U.S. Food and Drug Administration in the first quarter of 2021; if approved, the launch of RECORLEV is anticipated in the first quarter of 2022, assuming a projected 10-month review cycle.
• Additionally, Strongbridge is executing against its extensive pre-commercialization plans for RECORLEV.
• Based upon clinical pharmacology studies that we conducted, the Company continues its efforts to pursue life cycle extension opportunities for KEVEYIS through prosecution of the patent estate.
  

Upcoming Activities

• Strongbridge management plans to present at two upcoming virtual investor healthcare conferences:
  • The Solebury Trout Virtual Management Access Event being held January 6 – 15, 2021. The Company’s presentation will be available on January 7, 2021 at 7:00 a.m. ET.
  • H.C. Wainwright Virtual BioConnect 2021 Conference, which will be available on-demand from January 11 – 14, 2021.
  • Both of these upcoming presentations will be accessible on the Company’s website: https://investors.strongbridgebio.com/upcoming-events.

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 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 preclinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. 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.