BRIDGEWATER, N.J., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT), a fully integrated biopharmaceutical company, today announced business highlights and financial results for the three months ended June 30, 2020.

“The past several months have been extremely productive, achieving several critical milestones. In July, we received FDA approval for Upneeq, our first-in-class pharmacologic treatment for acquired ptosis in adults. This is truly an exciting opportunity for patients who have never had a non-surgical solution available to treat what is more commonly known as 'droopy eyelid.' This accomplishment is the culmination of our rigorous clinical program that demonstrated the safety, efficacy and tolerability of this once-a-day eye drop. We are now ready to introduce Upneeq to doctors and their patients and look forward to making the product commercially available after Labor Day,” said Brian Markison, Chief Executive Officer of Osmotica Pharmaceuticals.

“We are delighted to have entered into an exclusive license agreement with Santen Pharmaceutical Co., Ltd., a premier global ophthalmology focused company with an extensive international footprint and stellar reputation. This transaction allows us to address the large worldwide unmet need for patients with acquired blepharoptosis, and we are pleased to give eyecare professionals in Japan, Asia and EMEA access to this new therapeutic option,” continued Markison.

“As planned, we completed our clinical development program for arbaclofen ER for spasticity in Multiple Sclerosis patients and resubmitted our New Drug Application (“NDA”). The FDA has accepted the application and set a user fee goal date of December 29, 2020. These accomplishments set the stage for an exciting period of growth for our company as we continue to execute our strategic vision,” concluded Markison.

Second Quarter 2020 Financial Highlights

• Total revenues were $37.5 million, compared to $57.5 million in the second quarter of 2019;
• Net loss was $13.0 million, compared to a net loss of $124.9 million in the second quarter of 2019;
• Adjusted EBITDA¹ was $2.3 million, compared to Adjusted EBITDA of $14.5 million in the second quarter of 2019; and
• Cash and cash equivalents were $140.4 million, and debt (net of deferred financing costs) was $268.5 million as of June 30, 2020.

¹Adjusted EBITDA is a non-GAAP measure. Adjusted EBITDA is more fully described and reconciled from net loss determined under U.S. generally accepted accounting principles (“GAAP”) in “Presentation of Non-GAAP Measures” and the attached table “Osmotica Pharmaceuticals plc GAAP to Non-GAAP Reconciliations.”

Second Quarter 2020 Financial Results

Total revenues for the three months ended June 30, 2020 were $37.5 million, compared to $57.5 million for the three months ended June 30, 2019. Net product sales decreased by $20.9 million to $35.3 million for the three months ended June 30, 2020, as compared to $56.2 million for the three months ended June 30, 2019. Net sales of methylphenidate ER (including M-72) decreased 47% during the quarter due to price erosion from generic competitors resulting in significantly lower net selling prices and volumes. Net sales of venlafaxine extended-release tablets (VERT) decreased 76% reflecting additional generic competition resulting in lower volumes and net realized selling prices. The Company expects that additional competition for both methylphenidate ER and VERT from current competitors, as well as additional generic product approvals and launches in the future, if any, will continue to negatively affect sales of these products during the remainder of 2020 and in future years. VERT sales were favorably impacted by $1.3 million in the aggregate related to product returns during the three months ended June 30, 2020 based on actual experience. There can be no assurance that actual product returns experience and other adjustments will continue to favorably impact net sales for the remainder of 2020 or in future periods.

Selling, general and administrative expenses decreased $8.9 million during the three months ended June 30, 2020 to $16.6 million as compared to $25.5 million in the three months ended June 30, 2019. The decrease in our selling, general and administrative expenses reflects lower expenses associated with a salesforce reduction in the first quarter of 2020, combined with lower spending on marketing and general and administrative expenses during the second quarter of 2020.

Research and development expenses increased by $0.4 million in the three months ended June 30, 2020 to $5.8 million as compared to $5.4 million in the three months ended June 30, 2019. The increase reflects costs associated with the preparation of the filing of the amended NDA for arbaclofen ER and increased costs associated with medical education programs partially offset by the cost of manufacturing development batches of Osmolex in the three month period ended June 30, 2019, which costs were not present in 2020.

Net loss for the second quarter of 2020 was $13.0 million, compared to a net loss of $124.9 million in the second quarter of 2019.

During the second quarter of 2020, we recognized an intangible asset impairment charge of $3.6 million, reflecting the write-off of a developed technology asset, as compared with intangible asset impairment charges of $125.8 million in the second quarter of 2019.

Adjusted EBITDA for the second quarter of 2020 was $2.3 million, compared to Adjusted EBITDA of $14.5 million for the second quarter of 2019.

For a reconciliation of Adjusted EBITDA to net loss (income), the most comparable GAAP financial measure, please see the “Osmotica Pharmaceuticals plc GAAP to Non-GAAP Reconciliations” table at the end of this press release.

Liquidity

As of June 30, 2020, we had cash and cash equivalents of $140.4 million and borrowing capacity under our revolving credit facility of $50.0 million. In July 2020, we completed an equity offering generating net proceeds of $30.4 million. Additionally, on July 28, 2020, we announced a licensing transaction with Santen Pharmaceutical Co., Ltd. pursuant to which we received an upfront cash payment of $25 million. As of June 30, 2020, we also had $271.3 million aggregate principal amount borrowed under our term loans. The Company is prepaying $25 million of term loans as part of its strategy to reduce financial leverage.

About Osmotica Pharmaceuticals plc

Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. Vertical Pharmaceuticals, LLC represents the Company’s diversified branded portfolio and Trigen Laboratories, LLC represents the non-promoted products including complex generic formulations. RVL Pharmaceuticals, Inc. is the Company’s ophthalmic subsidiary supporting Upneeq.