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

~ Expects to Report KEVEYIS (dichlorphenamide) Fourth Quarter 2020 Revenue of Approximately $8.2 Million and Full-Year 2020 Revenue of Approximately $30.7 Million, a 41.5 Percent Increase over 2019 Revenue of $ $21.7 Million ~

~ Targets Full-Year 2021 KEVEYIS (dichlorphenamide) Revenue Guidance of Approximately $34 Million to $36 Million ~

~ Company on Track to Submit New Drug Application (NDA) for RECORLEV (levoketoconazole) to the FDA in the First Quarter of 2021 ~

~ Company Exercised its Option to Draw-Down an Additional $10 Million Under its Existing Debt Facility in the Fourth Quarter of 2020; Approximately $87.5 Million in Cash on Hand is Expected to Fund Operations Into and Potentially Beyond the First Quarter of 2023 ~

DUBLIN, Ireland and TREVOSE, Pa., Jan. 06, 2021 (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 announced preliminary and unaudited financial results for the fourth quarter and full-year 2020 and provided an update on select corporate priorities for 2021.  

“Our preliminary fourth quarter and full-year 2020 financial results, along with the previously-announced achievement of positive and statistically significant top-line results from the pivotal Phase 3 LOGICS study of RECORLEV (levoketoconazole), demonstrate the passion and commitment of the entire Strongbridge team to successfully execute against the Company’s strategic plans despite the many challenges associated with the ongoing COVID-19 pandemic,” said John H. Johnson, chief executive officer of Strongbridge Biopharma. “We are confident in the long-term growth prospects for Strongbridge and believe that our progress this past year provides a compelling foundation for continued success in 2021. We are on track to submit a New Drug Application to the U.S. Food and Drug Administration for RECORLEV for the treatment of Endogenous Cushing’s Syndrome in the first quarter of 2021 and are preparing for the potential launch in the first quarter of 2022. In parallel, we remain focused on further growing KEVEYIS (dichlorphenamide) revenue and pursuing patent protection for KEVEYIS based upon clinical pharmacology studies that we conducted.”