 Second quarter 2020 total revenue of 37.5 million Received U.S Food and Drug Administration FDA approval for UpneeqTM oxymetazoline hydrochloride ophthalmic solution, 0.1 for acquired blepharoptosis ptosis or droopy eyelid in adultsEntered into exclusive license agreement with Santen Pharmaceutical Co. Ltd. in Japan, Asia and EMEA for RVL-1201 UpneeqUser fee goal date of December 29, 2020 set by FDA for arbaclofen extended release ER tablets for spasticity in Multiple Sclerosis patientsBRIDGEWATER, N.J., Aug. 11, 2020 GLOBE NEWSWIRE -- Osmotica Pharmaceuticals plc Nasdaq: OSMT Osmotica or the Company, 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 ResultsTotal 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.LiquidityAs 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.Presentation of Non-GAAP MeasuresIn addition to the results provided in accordance with GAAP throughout this press release, the Company has presented Adjusted EBITDA, which is a non-GAAP measure. Adjusted EBITDA represents earnings before interest, taxes, depreciation and amortization EBITDA adjusted for i non-operating income or expense, and ii the impact of certain non-cash, nonrecurring or other items that are included in net loss and EBITDA that we do not consider indicative of our ongoing operating performance. In particular, Adjusted EBITDA excludes the following from EBITDA, as applicable: impairment of intangible assets and fixed assets, impairment of goodwill, share compensation expense, loss on debt extinguishment, management fees, public offering expenses, foreign currency translation, severance expenses and legal and contractual settlements and litigation reserves. We use Adjusted EBITDA for business planning purposes, in assessing our performance and determining the compensation of substantially all of our employees, including our executive officers, and in measuring our performance relative to that of our competitors. We also believe that Adjusted EBITDA provides investors with useful information to understand our operating results and analyze financial and business trends on a period-to-period basis. Adjusted EBITDA has important limitations as an analytical tool, however, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Adjusted EBITDA is not intended to replace, and should not be considered superior to, the presentation of our financial results in accordance with GAAP. Our definition of Adjusted EBITDA may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. Adjusted EBITDA is reconciled from the net loss as determined under GAAP in the attached table Osmotica Pharmaceuticals plc GAAP to Non-GAAP Reconciliations. Forward Looking Statements This press release includes statements that express the Companys opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, forward-looking statements. The Companys actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms believes, expects, may, will, should, seeks, projects, approximately, intends, plans, estimates or anticipates, or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. 