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Osmotica Pharmaceuticals plc (Nasdaq: OSMT) issued an announcement confirming its share capital as of January 27, 2021, comprising 62,716,982 ordinary shares. Additionally, there are 2,527,522 restricted stock units and 2,893,115 stock options outstanding. Each restricted stock unit and option allows holders to acquire ordinary shares upon vesting or exercise. The directors accept responsibility for the announcement's accuracy. Further information is available on the company's website.
Osmotica Pharmaceuticals (Nasdaq: OSMT) announced the FDA has issued a Complete Response Letter for its New Drug Application for arbaclofen ER tablets aimed at treating spasticity from multiple sclerosis. The FDA stated that the company did not sufficiently justify the statistical analysis in its NDA amendment for a co-primary endpoint. The FDA recommended Osmotica conduct a new study to provide significant efficacy evidence. Despite this setback, CEO Brian Markison expressed confidence in the safety and efficacy data supporting arbaclofen.
Osmotica Pharmaceuticals announced a $7.5 million deal in which Adamas Pharmaceuticals will acquire global rights to OSMOLEX ER, effective early 2021. This settlement resolves ongoing patent litigation, with both parties dropping their claims. As part of the agreement, Osmotica will continue manufacturing OSMOLEX ER, while Adamas receives existing inventory. The transaction aligns with Osmotica's strategy to focus on its core products, including Upneeq. The company aims to enhance shareholder value through strategic asset management and resource allocation.
Osmotica Pharmaceuticals has appointed Dr. Raymond Douglas, M.D., PhD, as the Global Head of Scientific Affairs for its subsidiary RVL Pharmaceuticals, enhancing the clinical strategy for Upneeq. Dr. Douglas brings extensive experience in ophthalmology and aesthetic procedures, having achieved recognition for his work on Thyroid Eye Disease. CEO Brian Markison expressed confidence that Dr. Douglas's expertise will support Upneeq's launch success. Upneeq is the first FDA-approved treatment for acquired blepharoptosis, or droopy eyelid, emphasizing its innovative approach in ophthalmic solutions.
Osmotica Pharmaceuticals plc (Nasdaq: OSMT) announced that CEO Brian Markison and CFO Andrew Einhorn will present at the 2020 Jefferies Virtual London Healthcare Conference on November 18, 2020, at 11:25 a.m. Eastern Time. The presentation will be accessible via a live webcast, which will be archived for 30 days afterward. Osmotica is a biopharmaceutical company focused on developing specialty products for underserved markets, with a portfolio that includes various proprietary drug delivery systems and subsidiaries such as RVL Pharmaceuticals.
Osmotica Pharmaceuticals reported Q3 2020 revenues of $57.2 million, a decline from $65.5 million in Q3 2019. The company had a net loss of $8.6 million, significantly improved from a net loss of $112.7 million the previous year, which included large impairment charges. Upneeq™, approved by the FDA for treating droopy eyelids, has seen strong early adoption. The company initiated a strategic review for maximizing shareholder value, including potential sale processes for its assets. As of September 30, 2020, cash reserves stood at $126.1 million.
Osmotica Pharmaceuticals (Nasdaq: OSMT) will announce its 2020 third quarter financial results on November 10, 2020, after the U.S. financial markets close. A conference call will be held at 4:30 p.m. ET on the same day, featuring CEO Brian Markison, COO JD Schaub, and CFO Andrew Einhorn. Investors can join via toll-free number (866) 672-5029 for U.S. callers or (409) 217-8312 for international participants, using Conference ID: 4356477. A live webcast will also be available on the Osmotica website.
