1. -- Phase 3 trials showed UPNEEQ was associated with positive outcomes after instillation on days 1 and 14 and was well-tolerated, demonstrating its potential promise for the treatment of acquired ptosis --

    BRIDGEWATER, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (NASDAQ:OSMT) (Osmotica), today announced that JAMA Ophthalmology has published pooled analysis of data from two Phase 3 clinical trials of Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for treatment of acquired blepharoptosis (ptosis) in adults. Upneeq, a novel pharmacologic agent, is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment…

    -- Phase 3 trials showed UPNEEQ was associated with positive outcomes after instillation on days 1 and 14 and was well-tolerated, demonstrating its potential promise for the treatment of acquired ptosis --

    BRIDGEWATER, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (NASDAQ:OSMT) (Osmotica), today announced that JAMA Ophthalmology has published pooled analysis of data from two Phase 3 clinical trials of Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for treatment of acquired blepharoptosis (ptosis) in adults. Upneeq, a novel pharmacologic agent, is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of ptosis. Upneeq is a preservative-free eye drop administered once daily to the ptotic eye(s).  

    In two Phase 3 studies comprising of 304 patients, the treatment was associated with positive outcomes after instillation on days 1 and 14 and was well tolerated.  

    Ptosis is an abnormal drooping of the upper eyelid margin with the eye in primary gaze1. In addition to the characteristic asymmetric or sleepy appearance caused by ptosis, obstruction of the pupil by the upper eyelid can lead to superior visual field deficits.2 Ptosis is a common eyelid disorder that is often associated with aging3 4 5.

    "Upneeq contains oxymetazoline, a potent, direct-acting alpha-adrenergic receptor agonist, which when administered to the eye, is believed to stimulate Müller muscle causing contraction resulting in elevation of the upper eyelid," said Tina deVries, PhD, Executive Vice President, Research & Development, Osmotica. "These trials represent a meaningful step in our evolution to an innovation-focused specialty pharmaceutical company."  

    "Acquired blepharoptosis is a common, but often overlooked and under-treated, ophthalmic condition, leaving many patients frustrated until they become candidates for surgery," said Charles Slonim, M.D., Chief Medical Officer, Oculos Development Services and lead medical monitor for the Phase 3 trials. "In these clinical trials, we saw statistically significant improvements in the ptosis-induced superior visual field defects and drooping upper eyelid positions. These improvements were observed from the first patient assessment on Day 1 and maintained over the 14-day treatment period. Upneeq, which was just recently approved by the FDA, has the potential to significantly change the treatment paradigm in a condition where patients and clinicians have had only surgical treatment options."

    The pooled analysis combined data from 2 randomized, double-masked, placebo-controlled, multicenter Phase 3 clinical trials (Study RVL-1201-201 and Study RVL-1201-202) totaling 304 participants including 203 receiving Upneeq and 101 receiving vehicle once daily as a single drop per eye for 42 days. Overall, 97.5% of participants receiving oxymetazoline 0.1% and 97.0% of participants receiving vehicle completed the studies.

    The primary efficacy endpoint was change from baseline in the number of points seen on the Leicester Peripheral Field Test (LPFT), a test to detect superior visual field deficits due to ptosis, on days 1 (6 hours post-instillation) and 14 (2 hours post-instillation). The secondary endpoint, change from baseline in Marginal Reflex Distance 1 (MRD-1), was assessed at the same time points.

    Key trial findings published in JAMA Ophthalmology include the following (Click HERE for the full text reprint):

    • Increase from baseline in mean number of points seen on superior visual field (LPFT):
      • Day 1: 5.9 ± 6.4 (oxymetazoline 0.1%) versus 1.8 ± 4.1 (vehicle),
        • mean difference: 4.07 (95% CI: 2.74, 5.39), p<0.001
      • Day 14: 7.1 ± 5.9 (oxymetazoline 0.1%) versus 2.4 ± 5.5 (vehicle),
        • mean difference: 4.74 (95% CI: 3.43, 6.04), p<0.001

    • Increase from baseline in upper eyelid elevation (MRD-1):
      • Day 1: 0.96 ± 0.89 mm (oxymetazoline, 0.1%) vs 0.50 ± 0.81 mm (vehicle),
        • mean difference: 0.47 mm (95% CI: 0.27, 0.67), p<0.001
      • Day 14: 1.16 ± 0.87 mm (oxymetazoline, 0.1%) vs 0.50 ± 0.80 mm (vehicle),
        • mean difference: 0.67 mm (95% CI: 0.46, 0.88), p<0.001

    Treatment emergent adverse events (TEAEs) were observed in 31.0% of patients receiving Upneeq and 35.6% of patients receiving vehicle. Among participants receiving Upneeq and reporting a TEAE, 81% had a maximum TEAE intensity of mild. No serious TEAE was suspected of being treatment-related, and all were resolved.

    There were no mean shifts from baseline in vital signs, or intraocular pressure, Snellen, visual acuity, pupil diameter, slit-lamp or ophthalmoscopy/fundus results in either eye judged to be clinical relevant.

    In addition to 6-week efficacy trials, a randomized, double-masked, placebo-controlled, multicenter Phase 3 clinical trial was conducted to evaluate the safety of Upneeq over 12 weeks of once daily treatment. The results of this study will be reported separately.

    IMPORTANT SAFETY INFORMATION

    UPNEEQ™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

    WARNINGS AND PRECAUTIONS

    • Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
    • Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren's syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
    • UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
    • Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

    ADVERSE REACTIONS

    Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

    DRUG INTERACTIONS

    • Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as betablockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
    • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

    About Acquired Blepharoptosis

    Acquired blepharoptosis, also known as ptosis, or droopy eyelid, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid.  It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis. The current standard of care is surgery, which is often reserved only for severe cases.

    About Upneeq

    Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller muscle and elevate the upper eyelid. Upneeq is the first and only FDA-approved pharmacologic treatment indicated for the treatment of acquired blepharoptosis (ptosis, or droopy eyelid) in adults.

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc (NASDAQ:OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of four promoted products and approximately 30 non-promoted products, several of which incorporate Osmotica's proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company's ophthalmic subsidiary supporting Upneeq. Vertical Pharmaceuticals, LLC represents the Company's diversified branded portfolio and Trigen Laboratories, LLC represents the Company's non-promoted products, including complex generic formulations.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E: 

    1 Fausett BV, Nerad JA. Upper eyelid ptosis and retraction. In: Fay A, Dolman PJ, eds. Diseases and Disorders of the Orbit and Ocular Adnexa: Expert Consult. 1st ed. St Louis, United States: Elsevier; 2016.

    2 Cahill KV, Burns JA, Weber PA. The effect of blepharoptosis on the field of vision. Ophthal Plast Reconstr Surg. 1987;3:121-125.

    3 Forman WM, Leatherbarrow B, Sridharan GV, Tallis RC. A community survey of ptosis of the eyelid and pupil size of elderly people. Age Ageing. 1995;24:21-24.

    4 Hashemi H, Khabazkhoob M, Emamian MH, et al. The prevalence of ptosis in an Iranian adult population. J Curr Ophthalmol. 2016;28:142-145.

    5 Kim MH, Cho J, Zhao D, et al. Prevalence and associated factors of blepharoptosis in Korean adult population: the Korea National Health and Nutrition Examination Survey. Eye (Lond). 2017;31:940-946.

     

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  2. BRIDGEWATER, N.J., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and James "JD" Schaub, Chief Operating Officer, will present at the 2020 Wells Fargo Virtual Healthcare Conference as follows:

    Date:Thursday, September 10, 2020
    Time:11:20 a.m. Eastern Time
    Webcast:https://metroconnections.zoom.us/webinar/register/WN_G-jTjqTlQjK1okCOjFJgDQ

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    About Osmotica Pharmaceuticals plc
    Osmotica Pharmaceuticals…

    BRIDGEWATER, N.J., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and James "JD" Schaub, Chief Operating Officer, will present at the 2020 Wells Fargo Virtual Healthcare Conference as follows:

    Date:Thursday, September 10, 2020
    Time:11:20 a.m. Eastern Time
    Webcast:https://metroconnections.zoom.us/webinar/register/WN_G-jTjqTlQjK1okCOjFJgDQ

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    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™ (oxymetazoline hydrochloride ophthalmic solution), 0.1%.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E:

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  3. Second quarter 2020 total revenue of $37.5 million

    Received U.S Food and Drug Administration ("FDA") approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for acquired blepharoptosis (ptosis or droopy eyelid) in adults

    Entered into exclusive license agreement with Santen Pharmaceutical Co. Ltd. in Japan, Asia and EMEA for RVL-1201 (Upneeq)

    User fee goal date of December 29, 2020 set by FDA for arbaclofen extended release ("ER") tablets for spasticity in Multiple Sclerosis patients

    BRIDGEWATER, 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…

    Second quarter 2020 total revenue of $37.5 million

    Received U.S Food and Drug Administration ("FDA") approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for acquired blepharoptosis (ptosis or droopy eyelid) in adults

    Entered into exclusive license agreement with Santen Pharmaceutical Co. Ltd. in Japan, Asia and EMEA for RVL-1201 (Upneeq)

    User fee goal date of December 29, 2020 set by FDA for arbaclofen extended release ("ER") tablets for spasticity in Multiple Sclerosis patients

    BRIDGEWATER, 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 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.

    Presentation of Non-GAAP Measures

    In 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 Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our business may be adversely affected by the ongoing coronavirus outbreak; our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2019 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Conference Call

    As previously announced, Osmotica management will host its second quarter 2020 conference call and provide a business update as follows:

    Date

    Time

    Toll free (U.S.)

    International

    Webcast (live and replay)

    Conference call ID
    Tuesday, August 11, 2020

    4:30 p.m. ET

    (866) 672-5029

    (409) 217-8312

    www.osmotica.com, under the "Investor & News" section

    5287688

    The webcast will be archived for 30 days at the aforementioned URL.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E:

    -Financial tables follow-

    Osmotica Pharmaceuticals plc      
    Condensed Consolidated Balance Sheets      
    (in thousands)      
           
      June 30, 2020 December 31, 2019
      (Unaudited)  
           
    Assets      
    Current assets:      
      Cash and cash equivalents $140,376  $95,865 
      Trade accounts receivable, net  17,024   43,914 
      Inventories, net  20,301   21,305 
      Prepaid expenses and other current assets  9,091   11,546 
        Total current assets  186,792   172,630 
    Property, plant and equipment, net  29,281   30,238 
    Operating lease assets  3,658   4,983 
    Intangibles, net  141,643   153,986 
    Goodwill  100,855   100,855 
    Other non-current assets  468   563 
      Total assets $462,697  $463,255 
           
    Liabilities and Shareholders' Equity      
    Current liabilities:      
      Trade accounts payable $8,798  $8,495 
      Accrued liabilities  48,353   65,253 
      Current portion of obligation under finance leases  89   127 
      Current portion of lease liability  1,650   2,062 
        Total current liabilities  58,890   75,937 
    Long-term debt, net of non-current deferred financing costs  268,522   267,950 
    Long-term portion of obligation under finance leases  17   44 
    Long-term portion of lease liability  2,175   3,116 
    Deferred taxes  2,182   1,500 
      Total liabilities  331,786   348,547 
      Commitments and contingencies      
    Shareholders' equity      
      Ordinary shares  588   518 
      Additional paid in capital  521,655   489,440 
      Accumulated deficit  (389,103)  (373,021)
      Accumulated other comprehensive loss  (2,229)  (2,229)
      Total shareholders' equity  130,911   114,708 
      Total liabilities and shareholders' equity $462,697  $463,255 
           



     

    Osmotica Pharmaceuticals plc            
    Condensed Consolidated Statements of Operations         
    (Unaudited)            
    (in thousands, except share and per share data)           
                 
                 
      Three Months Ended June 30,  Six Months Ended June 30,
       2020   2019   2020   2019 
                 
    Net product sales $35,300  $56,215  $82,608  $112,615 
    Royalty revenue  1,574   780   2,443   1,501 
    Licensing and contract revenue  658   537   1,130   543 
      Total revenues  37,532   57,532   86,181   114,659 
    Cost of goods sold (inclusive of amortization of intangibles)  19,995   32,644   40,585   61,847 
      Gross profit  17,537   24,888   45,596   52,812 
    Selling, general and administrative expenses 16,555   25,511   37,731   47,168 
    Research and development expenses  5,771   5,360   11,459   15,125 
    Impairment of intangibles  3,618   125,766   3,618   125,766 
      Total operating expenses  25,944   156,637   52,808   188,059 
    Operating loss  (8,407)  (131,749)  (7,212)  (135,247)
    Interest expense and amortization of debt discount  3,740   4,552   7,804   9,052 
    Other non-operating (gain) loss  659   15   (87)  (542)
      Total other non-operating expense  4,399   4,567   7,717   8,510 
    Loss before income taxes  (12,806)  (136,316)  (14,929)  (143,757)
    Income tax benefit (expense)  (193)  11,447   (1,152)  12,201 
    Net and other comprehensive loss $(12,999) $(124,869) $(16,081) $(131,556)
    Loss per share attributable to shareholders            
      Basic and Diluted $(0.22) $(2.38) $(0.27)$ (2.50)
    Weighted average shares basic and diluted            
      Basic and Diluted  58,863,508   52,518,924   58,560,842   52,518,924 

     

    Osmotica Pharmaceuticals plc       
    Condensed Consolidated Statements of Cash Flows       
    (Unaudited)       
    (in thousands)       
            
      Six Months Ended June 30, 
      2020  2019  
    CASH FLOWS FROM OPERATING ACTIVITIES       
    Net loss $(16,081) $(131,556) 
    Adjustments to reconcile net loss to net cash provided by (used in) operating activities:       
      Depreciation and amortization  11,150   35,991  
      Share compensation  2,328   2,496  
      Loss on sale of fixed and leased assets  212   53  
      Impairment of intangibles  3,618   125,766  
      Deferred income tax benefit  682   (11,460) 
      Bad debt provision  10   (157) 
      Amortization of deferred financing and loan origination fees  667   656  
    Change in operating assets and liabilities:       
      Trade accounts receivable, net  26,880   (11,561) 
      Inventories, net  1,004   (3,492) 
      Prepaid expenses and other current assets  2,454   6,816  
      Trade accounts payable  304   (5,953) 
      Accrued and other current liabilities  (16,927)  (11,758) 
        Net cash provided by (used in) operating activities  16,301   (4,159) 
    CASH FLOWS FROM INVESTING ACTIVITIES:       
      Proceeds from sale of fixed and leased assets  49   -  
      Payments on disposal of leased assets  (138)  -  
      Purchase of property, plant and equipment  (1,591)  (2,091) 
        Net cash used in investing activities  (1,680)  (2,091) 
    CASH FLOWS FROM FINANCING ACTIVITIES:       
      Payments on finance lease obligations  (66)  (64) 
      Proceeds from public offering, net of issuance costs  31,791   -  
      Repurchases of ordinary shares  (1,086)  -  
      Payments for taxes related to net share settlement of equity awards  (749)  -  
      Proceeds from insurance financing loan  -   1,314  
      Repayment of insurance financing loan  -   (2,097) 
      Net cash provided by (used in) financing activities  29,890   (847) 
    Net change in cash and cash equivalents  44,511   (7,097) 
    Cash and cash equivalents, beginning of period  95,865   70,834  
    Cash and cash equivalents, end of period $140,376  $63,737  
            



                         
    Osmotica Pharmaceuticals plc                 
    GAAP to Non-GAAP Reconciliations                 
    Adjusted EBITDA (Unaudited)                 
    (in thousands)                   
                         
          Three Months Ended    Six Months Ended   
          June 30,    June 30,   
          2020   2019     2020   2019    
                         
    Net loss    $(12,999) $(124,869)   $(16,081) $(131,556)   
    Interest expense and amortization of debt discount 3,740   4,552     7,804   9,052    
    Income tax benefit   193   (11,447)    1,152   (12,201)   
    Depreciation and amortization expense  5,587   17,999     11,150   35,991    
                         
    EBITDA    (3,479)  (113,765)    4,025   (98,714)   
                         
    Impairment of intangibles   3,618   125,766     3,618   125,766    
    Management fees    -   -     -   (43)   
    Severance expenses   114   181     2,079   363    
    FX translation    63   (11)    122   211    
    Legal expenses    -   1,003     -   1,003    
    Public offering expenses   18   -     546   -    
    Share compensation expense   1,222   1,327     2,238   2,496    
    Other     733   -     733   -    
                         
    Adjusted EBITDA   $2,289  $14,501    $13,361  $31,082    
                         

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  4. BRIDGEWATER, N.J., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced that the Company will release its 2020 second quarter financial results on Tuesday, August 11, 2020, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call as follows:  

    Date  Tuesday, August 11, 2020
    Time  4:30 p.m. ET
    Toll free (U.S.)  (866) 672-5029
    International  (409) 217-8312
    Conference ID  5287688
    Webcast (live and replay)   www.osmotica.com under the "Investor & News" section

    About Osmotica Pharmaceuticals

    BRIDGEWATER, N.J., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced that the Company will release its 2020 second quarter financial results on Tuesday, August 11, 2020, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call as follows:  

    Date  Tuesday, August 11, 2020
    Time  4:30 p.m. ET
    Toll free (U.S.)  (866) 672-5029
    International  (409) 217-8312
    Conference ID  5287688
    Webcast (live and replay)   www.osmotica.com under the "Investor & News" section

    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. The company has a diverse portfolio consisting of four promoted products and approximately 30 non-promoted products, several of which incorporate Osmotica's proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company's ophthalmic subsidiary supporting UPNEEQ. Vertical Pharmaceuticals, LLC represents the Company's diversified branded portfolio and Trigen Laboratories, LLC represents the Company's non-promoted products, including complex generic formulations.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E:

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  5. OSAKA, Japan and BRIDGEWATER, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Santen Pharmaceutical Co., Ltd (hereinafter, Santen) and RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (NASDAQ:OSMT) (hereinafter, Osmotica), announced today an exclusive license agreement covering the development, registration, and commercialization rights in Japan, China, and other Asian countries as well as EMEA countries to RVL-1201, oxymetazoline hydrochloride ophthalmic solution 0.1%, which is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of acquired blepharoptosis or ptosis in adults. Santen will be responsible for further development of RVL-1201 and regulatory approvals…

    OSAKA, Japan and BRIDGEWATER, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Santen Pharmaceutical Co., Ltd (hereinafter, Santen) and RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (NASDAQ:OSMT) (hereinafter, Osmotica), announced today an exclusive license agreement covering the development, registration, and commercialization rights in Japan, China, and other Asian countries as well as EMEA countries to RVL-1201, oxymetazoline hydrochloride ophthalmic solution 0.1%, which is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of acquired blepharoptosis or ptosis in adults. Santen will be responsible for further development of RVL-1201 and regulatory approvals as well as commercialization in its licensed territories under the agreement.

    RVL-1201 is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller's muscle and elevate the upper eyelid. RVL-1201, was approved on July 8, 2020 under the brand name UPNEEQ™ in the United States.

    Acquired blepharoptosis, also known as ptosis or droopy eyelid, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. It can lead to loss of visual field and cosmetic concerns for patients. While precise prevalence of the condition is unknown, tens of millions of adults are believed to suffer from ptosis globally¹⋅². The companies believe that there are no approved pharmacologic treatments for acquired ptosis anywhere outside the United States.

    Shigeo Taniuchi, Santen President and CEO said, "Our mission is to try our hand at resolving eye health-related social challenges that patients worldwide are facing and, in turn, contributing to improving eye health. As a specialized ophthalmic company, we are very pleased to be entering into this license agreement with Osmotica. Ptosis is said to cause conditions such as tight shoulders, cephalalgia, and asthenopia, and is a disease that lowers the Quality of Life (QoL). To better the QoL of patients across the world through eye health and wellness, thus to achieve our WORLD VISION, "Happiness with VISION" that we have set in the new long-term vision, Santen proactively engages in collaborative and open innovation endeavors with various external institutions. We hope that our agreement with Osmotica enables us to serve to people's eyecare."

    "We are delighted to have formed a partnership with Santen, a leading multi-national ophthalmology company, to develop and commercialize RVL-1201 across Japan, China, and other Asian countries as well as EMEA. RVL-1201 is the first-in-class, non-invasive therapy for ptosis in the US, and if successfully approved in other countries, it will similarly address a significant unmet need for patients and providers across the world," stated Brian Markison, Osmotica's Chief Executive Officer. "With its preeminent position in eye care and its established sales organization, Santen is an ideal partner to address the large treatment gap in ptosis and ensure that patients across its broad global footprint will have access to this therapeutic. This is a meaningful advancement and value-driver for our organization," concluded Markison.

    Under the terms of the licensing agreement, Osmotica will receive up to $89 million in upfront and milestone payments, not including future royalties on sales in Santen's territories. Osmotica will receive an upfront cash payment of $25 million and up to an additional $64 million in cash milestone payments based on regulatory and sales achievements in Santen's territories. Osmotica is also entitled to royalty payments on sales of RVL-1201 in Japan, China, and other Asian countries as well as EMEA.

    ¹ Source: A Community Survey of Ptosis of the Eyelid and Pupil Size of Elderly People. G. V. SRIDHARAN, R. C. TALLIS, B. LEATHERBARROW, W. M. FORMAN.

    ² Source: Eye The Scientific Journal of The Royal College of Ophthalmologists. 2017 Jun; 31(6): 940–946. Prevalence and associated factors of blepharoptosis in Korean adult population: The Korea National Health and Nutrition Examination Survey 2008–2011 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5518839/

    About RVL-1201

    In U.S. clinical studies, RVL-1201 demonstrated statistically significant improvements compared to placebo in both superior visual field, as measured by the Leicester Peripheral Field Test (LPFT), and eyelid lift, as measured by the Marginal Reflex Distance Test (MRD-1) in two pivotal double-masked efficacy studies. A third pivotal safety study successfully showed that RVL-1201 was well tolerated when administered once daily in the morning (to both eyes) over a 12-week period. The majority of adverse events were mild and self-limited. Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

    About Santen

    As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen's website (www.santen.com).

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc (NASDAQ:OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of four promoted products and approximately 30 non-promoted products, several of which incorporate Osmotica's proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company's ophthalmic subsidiary supporting UPNEEQ. Vertical Pharmaceuticals, LLC represents the Company's diversified branded portfolio and Trigen Laboratories, LLC represents the Company's non-promoted products, including complex generic formulations. Osmotica has operations in the United States, Argentina, and Hungary.

    IMPORTANT SAFETY INFORMATION

    UPNEEQ™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% was approved for treatment of acquired blepharoptosis in adults by the US FDA on July 8, 2020. As of July 28, 2020, the product is not approved for use in any other countries.

    WARNINGS AND PRECAUTIONS

    • Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
    • Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren's syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
    • UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
    • Patients should not to touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

    ADVERSE REACTIONS

    Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

    DRUG INTERACTIONS

    • Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta‑blockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
    • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

    Santen Forward-looking Statements

    Information provided in this press release contains forward-looking statements. The achievement of these forecasts is subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial conditions are subject to the effects of changes in regulations made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.

    Osmotica Forward-looking Statements

    This press release includes statements that express Osmotica's 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." Osmotica's 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. They include statements regarding Osmotica's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2019 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    CONTACT

    Akiko Yoshikawa

    Corporate Communications Group

    Santen Pharmaceutical Co., Ltd.

    E-mail: communication@santen.com   Tel : +81-6-4802-9360

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E:

     

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  6. BRIDGEWATER, N.J., July 20, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) through its subsidiary Osmotica Pharmaceutical US LLC ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) considers the Company's resubmission to its new drug application (NDA) for arbaclofen extended release (ER) tablets a complete, class 2 response to the July 9, 2016, action letter; the user fee goal date is December 29, 2020.

    About Arbaclofen ER

    Osmotica Pharmaceuticals plc is developing arbaclofen ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets…

    BRIDGEWATER, N.J., July 20, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) through its subsidiary Osmotica Pharmaceutical US LLC ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) considers the Company's resubmission to its new drug application (NDA) for arbaclofen extended release (ER) tablets a complete, class 2 response to the July 9, 2016, action letter; the user fee goal date is December 29, 2020.

    About Arbaclofen ER

    Osmotica Pharmaceuticals plc is developing arbaclofen ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets in patients with spasticity due to MS.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Forward Looking Statements

    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2019 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

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  7. BRIDGEWATER, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the pricing of its previously announced public offering of 5,000,000 ordinary shares at a price to the public of $6.55 per share. All of the shares are being offered by Osmotica. Osmotica also is granting the underwriters a 30-day option to purchase up to an additional 750,000 ordinary shares. The offering is expected to close on July 16, 2020, subject to satisfaction of customary closing conditions.

    Credit Suisse Securities (USA) LLC is acting as sole bookrunner for the offering.

    The ordinary shares are being offered and sold pursuant to the Company's…

    BRIDGEWATER, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the pricing of its previously announced public offering of 5,000,000 ordinary shares at a price to the public of $6.55 per share. All of the shares are being offered by Osmotica. Osmotica also is granting the underwriters a 30-day option to purchase up to an additional 750,000 ordinary shares. The offering is expected to close on July 16, 2020, subject to satisfaction of customary closing conditions.

    Credit Suisse Securities (USA) LLC is acting as sole bookrunner for the offering.

    The ordinary shares are being offered and sold pursuant to the Company's effective registration statement on Form S-3 (File No. 333-236193) filed with the U.S. Securities and Exchange Commission (the "SEC") on January 31, 2020 and declared effective on February 12, 2020. The offering is being made only by means of a written prospectus, including a prospectus supplement, that forms part of the registration statement. A prospectus supplement relating to the Company's ordinary shares to be sold in the offering will be filed with the SEC. You may obtain these documents for free by visiting EDGAR on the SEC's website at www.sec.gov. A copy of the prospectus supplement and accompanying prospectus may be obtained, once available, from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, United States, by telephone at (800) 221-1037, or by email at 

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc (NASDAQ:OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of four promoted products and approximately 30 non-promoted products, several of which incorporate Osmotica's proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company's ophthalmic subsidiary supporting UpneeqTM. Vertical Pharmaceuticals, LLC represents the Company's diversified branded portfolio and Trigen Laboratories, LLC represents the Company's non-promoted products, including complex generic formulations.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Forward-Looking Statements

    This press release includes statements that express the Company's 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 Company's 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, such as statements regarding the anticipated closing of the offering. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The Company may not achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place significant reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the risks and uncertainties described in the "Risk Factors" sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission on March 19, 2020, and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as filed with the Securities and Exchange Commission on May 12, 2020, under the heading "Risk Factors" included in the preliminary prospectus related to the public offering filed with the Securities and Exchange Commission and the other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and the Company does not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E:

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  8. BRIDGEWATER, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the commencement of a proposed public offering of 5,000,000 ordinary shares. All of the shares will be offered by Osmotica. Osmotica also expects to grant the underwriters a 30-day option to purchase up to an additional 750,000 ordinary shares.

    Credit Suisse Securities (USA) LLC will act as sole bookrunner for the proposed offering.

    The ordinary shares will be offered and sold pursuant to the Company's effective registration statement on Form S-3 (File No. 333-236193) filed with the U.S. Securities and Exchange Commission (the "SEC") on January 31…

    BRIDGEWATER, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the commencement of a proposed public offering of 5,000,000 ordinary shares. All of the shares will be offered by Osmotica. Osmotica also expects to grant the underwriters a 30-day option to purchase up to an additional 750,000 ordinary shares.

    Credit Suisse Securities (USA) LLC will act as sole bookrunner for the proposed offering.

    The ordinary shares will be offered and sold pursuant to the Company's effective registration statement on Form S-3 (File No. 333-236193) filed with the U.S. Securities and Exchange Commission (the "SEC") on January 31, 2020 and declared effective on February 12, 2020. The offering will be made only by means of a written prospectus, including a prospectus supplement, that forms part of the registration statement.  A prospectus supplement relating to the Company's ordinary shares to be sold in the offering will be filed with the SEC. You may obtain these documents for free by visiting EDGAR on the SEC's website at www.sec.gov. A copy of the prospectus supplement and accompanying prospectus may be obtained, once available, from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, United States, by telephone at (800) 221-1037, or by email at 

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc (NASDAQ:OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of four promoted products and approximately 30 non-promoted products, several of which incorporate Osmotica's proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company's ophthalmic subsidiary supporting Upneeq™. Vertical Pharmaceuticals, LLC represents the Company's diversified branded portfolio and Trigen Laboratories, LLC represents the Company's non-promoted products, including complex generic formulations.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Forward-Looking Statements

    This press release includes statements that express the Company's 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 Company's 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, such as statements regarding the terms of the proposed offering.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The Company may not achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place significant reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the risks and uncertainties described in the "Risk Factors" sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission on March 19, 2020, and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as filed with the Securities and Exchange Commission on May 12, 2020, under the heading "Risk Factors" included in the preliminary prospectus related to the proposed public offering filed with the Securities and Exchange Commission and the other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and the Company does not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

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  9. -- First and only FDA-approved pharmacologic treatment for acquired blepharoptosis --

    -- Company to host Investor Call at 10:00 a.m. ET today to discuss approval, key elements of the clinical data and commercial plans --

    BRIDGEWATER, N.J, July 09, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. Upneeq becomes the…

    -- First and only FDA-approved pharmacologic treatment for acquired blepharoptosis --

    -- Company to host Investor Call at 10:00 a.m. ET today to discuss approval, key elements of the clinical data and commercial plans --

    BRIDGEWATER, N.J, July 09, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. Upneeq becomes the only FDA-approved medical treatment for ptosis.

    The Company believes that millions of people have ptosis in the United States alone, and an even larger population may be affected in Europe, Japan and China. One study comprising adults over the age of 50 indicates prevalence of ptosis is ~11.5% of adult patients over the age of 501. Upneeq is a safe and effective, first-in-class treatment for acquired ptosis, which often results from a partial or complete dysfunction of Müller's muscle, which in conjunction with the Levator superioris, elevates the eyelid. Upneeq demonstrated statistically significant improvements compared to placebo in both superior visual field, as measured by the Leicester Peripheral Field Test (LPFT), and eyelid lift, as measured by the Marginal Reflex Distance Test (MRD-1) in two pivotal double-masked efficacy studies. A third pivotal safety study successfully showed that Upneeq was well tolerated when administered once daily in the morning (to both eyes) over a 12-week period. The majority of adverse events were mild and self-limited.

    "With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis. Upneeq has garnered a great deal of interest from ophthalmic physicians and key opinion leaders, or KOLs, and we are prepared to commercialize Upneeq and engage providers through our medical education outreach. We look forward to launching Upneeq through our subsidiary, RVL Pharmaceuticals, Inc., and ensuring its widespread availability through the Company's pharmacy," stated Brian Markison, Chief Executive Officer.

    "Upneeq's safety and efficacy profile and its once-a-day dosing provides a significant ophthalmic therapeutic innovation. Given the previous absence of any approved medical treatment options, ptosis has been often under-diagnosed or overlooked. Upneeq has the potential to address a significant unmet need in ptosis therapy," stated Tina deVries, Ph.D., Executive Vice President, Research and Development.

    "This approval marks a critical milestone for Osmotica, as we continue to execute our corporate strategy. Looking ahead, we see Upneeq as a significant growth catalyst and an important opportunity to bring value to our shareholders while addressing a significant unmet medical need with a first-in-class product," concluded Markison.

    Osmotica plans to make Upneeq commercially available next month to a selected group of ophthalmologists and optometrists through an early experience program.

    The Company remains actively engaged in discussions with ex-U.S. partners to commercialize Upneeq in markets beyond the U.S.

    Clinical Studies

    Results from Upneeq's initial Phase III efficacy clinical trial showed that the formulation met its primary efficacy endpoints, which were a change in baseline visual field as measured by the LPFT, on Hour 6, Day 1 (p=0.0003) and Hour 2, Day 14 (p< 0.0001). Patients who received Upneeq once daily experienced a statistically significant improvement in visual field when compared to the placebo group. The 2:1 randomized, double-masked, placebo-controlled study was comprised of 140 patients with acquired blepharoptosis split into two treatment groups for 42 days.

    Upneeq was well tolerated by patients in this clinical trial when administered once daily over a six-week period. There were no serious adverse events identified from treatment with Upneeq in this Phase III clinical trial.

    The second Phase III efficacy trial was a six-week randomized, multicenter, double-masked, placebo-controlled study to evaluate the safety and efficacy of once-daily treatment of Upneeq compared with placebo for the treatment of acquired blepharoptosis. The primary endpoint for both trials was a measurement of the mean change from baseline of the number of points seen out of a total of 35 in the top four rows of the LPFT as measured in two time points: Hour 6, Day 1 and Hour 2, day 14. The secondary endpoint was a measurement of the distance between the center of the pupillary light reflex and the upper eyelid margin, or MRD-1. Topline results from the second Phase III efficacy trial showed that the trial met both the primary and secondary endpoints. The mean change from baseline on the LPFT on Hour 6, Day 1 was 6.3 for Upneeq versus 2.1 for vehicle (p < 0.0001) and on Hour 2, Day 14 was 7.7 for Upneeq versus 2.4 for vehicle (p < 0.0001). The results also showed a statistically significant improvement in MRD-1 at 5 and 15 minutes, and 2 and 6 hours post dose on days 1 and 14. The Company also completed a 12-week randomized, multicenter, double-masked, placebo controlled safety study to evaluate the safety of Upneeq compared with vehicle for the treatment of acquired blepharoptosis.

    The Company will host a conference call as follows: 

    DateThursday, July 9, 2020
    Time10:00 a.m. ET
    Toll free (U.S.)(866) 672-5029
    International(409) 217-8312
    Conference ID7335925
    Webcast (live and replay)www.osmotica.com under the "Investor & News" section

    IMPORTANT SAFETY INFORMATION

    UPNEEQ™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

    WARNINGS AND PRECAUTIONS

    • Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
    • Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren's syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
    • UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
    • Patients should not to touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

    ADVERSE REACTIONS

    Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

    DRUG INTERACTIONS

    • Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta‑blockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
    • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

    About Acquired Blepharoptosis

    Acquired blepharoptosis, also known as ptosis, or droopy eyelid, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid.  It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis. The current standard of care is surgery, which is often reserved only for severe cases.

    About Upneeq

    Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller's muscle and elevate the upper eyelid. Upneeq is the first and only FDA-approved pharmacologic treatment indicated for the treatment of acquired blepharoptosis (ptosis, or droopy eyelid).

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc (NASDAQ:OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of four promoted products and approximately 30 non-promoted products, several of which incorporate Osmotica's proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company's ophthalmic subsidiary supporting Upneeq. Vertical Pharmaceuticals, LLC represents the Company's diversified branded portfolio and Trigen Laboratories, LLC represents the Company's non-promoted products, including complex generic formulations.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

    E:

    1 A Community Survey of Ptosis of the Eyelid and Pupil Size of Elderly People. G. V. SRIDHARAN, R. C. TALLIS, B. LEATHERBARROW, W. M. FORMAN.

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  10. -- Submission based on world's largest database of patients treated for spasticity associated with Multiple Sclerosis --

    -- Demonstrated efficacy, tolerability and one-year safety results on 80 mg/day --

    BRIDGEWATER, N.J., June 30, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) through its subsidiary Osmotica Pharmaceutical US LLC ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that the Company has resubmitted its New Drug Application ("NDA") for arbaclofen extended release ("ER") tablets for the alleviation of spasticity in Multiple Sclerosis ("MS") patients to the U.S. Food and Drug Administration ("FDA").

    "We are excited to have resubmitted our NDA for arbaclofen ER, our…

    -- Submission based on world's largest database of patients treated for spasticity associated with Multiple Sclerosis --

    -- Demonstrated efficacy, tolerability and one-year safety results on 80 mg/day --

    BRIDGEWATER, N.J., June 30, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) through its subsidiary Osmotica Pharmaceutical US LLC ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that the Company has resubmitted its New Drug Application ("NDA") for arbaclofen extended release ("ER") tablets for the alleviation of spasticity in Multiple Sclerosis ("MS") patients to the U.S. Food and Drug Administration ("FDA").

    "We are excited to have resubmitted our NDA for arbaclofen ER, our novel treatment, using the Osmodex technology, for MS spasticity. With the recent completion of our 12-month open-label study – assessing the long-term safety and tolerability of arbaclofen ER 80 mg/day - this resubmission also includes the full results of our second Phase 3 efficacy study ("OS440-3004"). The safety and efficacy results from these studies, together with the entire data package from our clinical development program, supports the clinical significance of arbaclofen ER as a potential treatment for MS spasticity. We look forward to working with the FDA during the course of its review," stated Brian Markison, Chief Executive Officer of Osmotica Pharmaceuticals plc.

    The arbaclofen ER clinical development program represents one of the largest clinical databases of placebo-controlled and open-label studies conducted in MS spasticity patients. The key primary efficacy assessment of spasticity for the pivotal studies was the generally accepted gold standard measure, Total Numeric modified Ashworth Scale TNmAS most affected limb ("TNmAS-MAL").  In addition, a co-primary measure, the Clinician Global Assessment of Change ("CGIC") was examined to provide an assessment of patient's general well-being. The compelling evidence provided by these studies clearly demonstrated clinically improved MS spasticity in patients administered arbaclofen ER in two, large three-month, placebo-controlled studies, and in two one-year, open-label safety studies.

    Results of Study OS440-3004 revealed a statistically significant improvement from baseline to Day 84 in TNmAS-MAL scores in the arbaclofen ER tablet target dose of 40 mg/day (20 mg given twice a day) group compared to the placebo group. Subjects dosed with 80 mg/day (40 mg given twice a day) also derived significant clinical benefit. Though the mean Clinical Global Impression of Change score for arbaclofen ER was not significantly better than placebo, subjects treated with arbaclofen ER tablets did not show a mean worsening of CGIC scores after treatment.

    The long-term open-label study OS440-3005 dosed subjects for up to one year on arbaclofen ER. The majority of subjects enrolled completed the study on the arbaclofen 80 mg/day dose. Of particular note, subjects dosed with arbaclofen ER up to 80 mg daily showed an overall improvement from baseline scores in the TNmAS measure up to one year demonstrating the durability of arbaclofen ERs efficacy. The drug was safe and generally well tolerated throughout the study.

    "We are currently unaware of any MS spasticity program that has the breadth and scope in terms of long-term safety and tolerability assessments while demonstrating efficacy," stated David Jacobs, MD MBA VP Clinical Development and Medical Affairs.

    Spasticity is one of the more common and disabling symptoms of MS. Spasticity in MS is a result of demyelination along the nerves of the brain and spinal cord that control movement. Certain muscles are continuously contracted, which causes stiffness and tightness of the muscles and/or a wide range of involuntary muscle spasms. The main feature of spasticity is stiffness or increased resistance when attempting to move a limb or joint. Often, spasticity can worsen at night with tight muscles and pain from symptoms making it difficult for patients to sleep. Current anti-spastic treatment options, such as baclofen and tizanidine, as well as others, offer limited clinical benefit due to tolerability concerns.

    About Arbaclofen ER

    Osmotica Pharmaceutical plc is developing arbaclofen ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets in patients with spasticity due to MS.

    Baclofen is a racemate (rac-baclofen) consisting of an equal mixture of two enantiomers: the

    l- or R-enantiomer (arbaclofen) and the d- or S-enantiomer. Arbaclofen is the active R-enantiomer of baclofen, and the literature reveals convincing evidence that the efficacy of baclofen is primarily due to the R-enantiomer whereas the S-enantiomer may be inactive and may contribute to adverse events. In a pharmacokinetic/ pharmacodynamic study in healthy volunteers, R-baclofen plasma and cerebral spinal fluid concentrations following administration of immediate-release arbaclofen and baclofen were comparable. The observed increased propensity for drowsiness to occur after baclofen administration was attributed to the S-enantiomer of baclofen.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Forward Looking Statements

    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2019 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

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  11. BRIDGEWATER, N.J., June 16, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and James "JD" Schaub, Chief Operating Officer, will present at the Jefferies Virtual Optical Health Summit as follows:

    Date:Wednesday, June 17, 2020
    Time:2:30 p.m. Eastern Time
    Webcast:http://wsw.com/webcast/jeff131/osmt/

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical…

    BRIDGEWATER, N.J., June 16, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and James "JD" Schaub, Chief Operating Officer, will present at the Jefferies Virtual Optical Health Summit as follows:

    Date:Wednesday, June 17, 2020
    Time:2:30 p.m. Eastern Time
    Webcast:http://wsw.com/webcast/jeff131/osmt/

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson

    In-Site Communications, Inc.

    T: 212-452-2793

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  12. BRIDGEWATER, N.J., May 27, 2020 /PRNewswire/ -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced results of the Company's Annual General Meeting.  

    At the Annual General Meeting of the Company held on May 20, 2020, the resolution placed before the meeting in respect of the approval of the waiver under Rule 37 of the Irish Takeover Rules ("the Rules") taken by independent shareholders of the Company on a poll was not approved. The result of the poll was 2,867,646 votes for; and 3,050,625 votes against.

    Shareholders should note that, as previously announced on September 4, 2019, the independent shareholders of Osmotica approved a waiver proposal under Rule 37 of the Rules at an Extraordinary General Meeting of the Company held on August 29, 2019, whereby as a result of potential future repurchases by the Company of up to 5,251,892 ordinary shares of US$0.01 each in the capital of the Company, the aggregate percentage shareholding in the capital of the Company held by the Affected Parties (being Avista Capital Partners, Altchem Limited and the Management Individuals) may increase up to an aggregate of 94.92%. In such circumstances, the Affected Parties will not incur an obligation under Rule 37 of the Rules to make a general offer to the Company's other shareholders.

    This prior authorization is unaffected by the 2020 Annual General Meeting voting result and does not expire until November 28, 2020, being 15 months from the date of its passing.  

    The full text of the resolution is set of in the Notice of Annual Meeting of Shareholders, which is available at https://www.osmotica.com/.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
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    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/osmotica-pharmaceuticals-plc-announces-result-of-proposal-3-at-annual-general-meeting-301066459.html

    SOURCE Osmotica Pharmaceuticals plc

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  13. BRIDGEWATER, N.J., May 26, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the 2020 Jefferies Virtual Healthcare Conference as follows:

    Date: Wednesday, June 3, 2020
    Time: 2:30 p.m. Eastern Time
    Webcast: http://wsw.com/webcast/jeff126/osmt/

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical…

    BRIDGEWATER, N.J., May 26, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the 2020 Jefferies Virtual Healthcare Conference as follows:

    Date: Wednesday, June 3, 2020
    Time: 2:30 p.m. Eastern Time
    Webcast: http://wsw.com/webcast/jeff126/osmt/

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  14. BRIDGEWATER, N.J., May 13, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the RBC Capital Markets Global Healthcare Virtual Conference as follows:

    Date: Tuesday, May 19, 2020
    Time: 9:10 a.m. Eastern Time
    Webcast:    https://www.veracast.com/webcasts/rbc/healthcare2020/18103270999.cfm

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    About Osmotica Pharmaceuticals plc

    Osmotica Pharmaceuticals…

    BRIDGEWATER, N.J., May 13, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the RBC Capital Markets Global Healthcare Virtual Conference as follows:

    Date: Tuesday, May 19, 2020
    Time: 9:10 a.m. Eastern Time
    Webcast:    https://www.veracast.com/webcasts/rbc/healthcare2020/18103270999.cfm

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:  

     

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  15. First quarter 2020 total revenue of $48.6 million

    On track to achieve major 2020 milestones

    BRIDGEWATER, N.J., May 12, 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 March 31, 2020.

    "Despite the ongoing COVID-19 pandemic, we have not experienced any impact to our manufacturing and supply chain operations to date, and 2020 is shaping up to be an exciting year for us. Our July 16 user fee goal date remains on track for our innovative product, RVL-1201 ("RVL"), for the treatment of acquired blepharoptosis, or droopy eyelid. As there are currently no non-surgical…

    First quarter 2020 total revenue of $48.6 million

    On track to achieve major 2020 milestones

    BRIDGEWATER, N.J., May 12, 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 March 31, 2020.

    "Despite the ongoing COVID-19 pandemic, we have not experienced any impact to our manufacturing and supply chain operations to date, and 2020 is shaping up to be an exciting year for us. Our July 16 user fee goal date remains on track for our innovative product, RVL-1201 ("RVL"), for the treatment of acquired blepharoptosis, or droopy eyelid. As there are currently no non-surgical options or pharmacological treatments for this condition, RVL has garnered a great deal of interest and enthusiasm among eye care professionals and KOLs, who are encouraged both by the results of our clinical development program and by the convenience of this novel treatment option. As we focus on preparing for commercial launch, we are also progressing our RVL strategic partnership discussions," said Brian Markison, Chief Executive Officer.

    "We also remain on track to submit an amended New Drug Application ("NDA") for arbaclofen ER for spasticity associated with Multiple Sclerosis in the second quarter of this year. Having completed the long-term safety study, we are now preparing the amended NDA for submission. With these important catalysts in play, we look forward to a productive year as we execute on our strategic objectives," continued Markison.

    First Quarter 2020 Financial Highlights

    • Total revenues were $48.6 million, compared to $57.1 million in the first quarter of 2019;
    • Net loss was $3.1 million, compared to a net loss of $6.7 million in the first quarter of 2019;
    • Adjusted EBITDA1 was $11.1 million, compared to Adjusted EBITDA of $16.6 million in the first quarter of 2019; and
    • Cash and cash equivalents were $125.8 million, and debt (net of deferred financing costs) was $268.2 million as of March 31, 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."

    First Quarter 2020 Financial Results

    Total revenues for the three months ended March 31, 2020 were $48.6 million, compared to $57.1 million for the three months ended March 31, 2019. Net product sales decreased by $9.1 million to $47.3 million for the three months ended March 31, 2020, as compared to $56.4 million for the three months ended March 31, 2019. Net sales of methylphenidate ER (including M-72) decreased 60% during the quarter due to existing competitors in the market resulting in significantly lower net selling prices and volumes. Net sales of venlafaxine ER tablets ("VERT") decreased 35% reflecting lower volumes and realized net pricing due to the launch of two additional generic forms of VERT, which had been approved in 2019, but not launched. We expect 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 our sales of these products during the remainder of 2020 and in future years. VERT sales were favorably impacted by $6.5 million in the aggregate primarily related to product returns and other adjustments during the three months ended March 31, 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 in 2020 and in future periods.

    Selling, general and administrative expenses decreased $0.5 million during the three months ended March 31, 2020 to $21.2 million as compared to $21.7 million in the three months ended March 31, 2019. The decrease in selling, general and administrative expenses reflects expense reductions associated with a salesforce realignment in the third quarter of 2019, which was partially offset by increases in marketing costs associated with the expected launch of RVL, and severance costs associated with the salesforce reduction during the first quarter of 2020.

    Research and development expenses decreased by $4.1 million in the three months ended March 31, 2020 to $5.7 million as compared to $9.8 million in the three months ended March 31, 2019. The decrease reflects the completion of the second Phase III clinical trial of arbaclofen ER during the first quarter of 2019, lower clinical trial costs related to RVL and the cost of manufacturing development batches of Osmolex in the three month period ended March 31, 2019, which costs were not present in 2020.

    Net loss for the first quarter of 2020 was $3.1 million, compared to a net loss of $6.7 million in the first quarter of 2019.

    Adjusted EBITDA for the first quarter of 2020 was $11.1 million, compared to Adjusted EBITDA of $16.6 million for the first 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 March 31, 2020, the Company had cash and cash equivalents of $125.8 million and borrowing capacity under our revolving credit facility of $50.0 million. During the quarter the Company raised approximately $31.8 million in a public offering of its ordinary shares. As of March 31, 2020, the Company also had $271.4 million aggregate principal amount borrowed under our term loans.

    Presentation of Non-GAAP Measures

    In 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 Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our business may be adversely affected by the ongoing coronavirus outbreak; our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2019 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Conference Call

    As previously announced, Osmotica management will host its first quarter 2020 conference call as follows:

      Date  Tuesday, May 12, 2020 
      Time  4:30 p.m. ET
      Toll free (U.S.)  (866) 672-5029
      International  (409) 217-8312
      Webcast (live and replay) www.osmotica.com, under the "Investor & News" section
      Conference call ID  5646947

    The webcast will be archived for 30 days at the aforementioned URL.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

    -Financial tables follow-

    Osmotica Pharmaceuticals plc          
    Condensed Consolidated Balance Sheets          
    (in thousands)          
               
      March 31, 2020   December 31, 2019
      (Unaudited)    
               
    Assets          
    Current assets:          
    Cash and cash equivalents $ 125,830     $ 95,865  
    Trade accounts receivable, net   32,644       43,914  
    Inventories, net   20,536       21,305  
    Prepaid expenses and other current assets   10,654       11,546  
    Total current assets   189,664       172,630  
    Property, plant and equipment, net   29,987       30,238  
    Operating lease assets   4,471       4,983  
    Intangibles, net   149,624       153,986  
    Goodwill   100,855       100,855  
    Other non-current assets   533       563  
    Total assets $ 475,134     $ 463,255  
               
    Liabilities and Shareholders' Equity          
    Current liabilities:          
    Trade accounts payable $ 8,784     $ 8,495  
    Accrued liabilities   47,256       65,253  
    Current portion of lease liability   110       127  
    Current portion of obligation under finance leases   2,004       2,062  
    Total current liabilities   58,154       75,937  
    Long-term debt, net of non-current deferred financing costs   268,236       267,950  
    Long-term portion of obligation under finance leases   29       44  
    Long-term portion of lease liability   2,646       3,116  
    Deferred taxes   2,329       1,500  
    Total liabilities   331,394       348,547  
    Commitments and contingencies          
    Shareholders' equity          
    Ordinary shares   589       518  
    Additional paid in capital   521,484       489,440  
    Accumulated deficit   (376,104 )     (373,021 )
    Accumulated other comprehensive loss   (2,229 )     (2,229 )
    Total shareholders' equity   143,740       114,708  
    Total liabilities and shareholders' equity $ 475,134     $ 463,255  
               


               
    Osmotica Pharmaceuticals plc          
    Condensed Consolidated Statements of Operations      
    (Unaudited)          
    (in thousands, except share and per share data)          
               
               
      Three Months Ended March 31,
        2020      2019 
               
    Net product sales $ 47,308     $ 56,400  
    Royalty revenue   869       721  
    Licensing and contract revenue   472       5  
    Total revenues   48,649       57,126  
    Cost of goods sold (inclusive of amortization of intangibles)   20,590       29,203  
    Gross profit   28,059       27,923  
    Selling, general and administrative expenses   21,176       21,656  
    Research and development expenses   5,688       9,764  
    Total operating expenses   26,864       31,420  
    Operating income (loss)   1,195       (3,497 )
    Interest expense and amortization of debt discount   4,064       4,501  
    Other non-operating gain   (746 )     (557 )
    Total other non-operating expense   3,318       3,944  
    Loss before income taxes   (2,123 )     (7,441 )
    Income tax benefit (expense)   (960 )     754  
    Net and comprehensive loss $ (3,083 )   $ (6,687 )
    Loss per share attributable to shareholders          
    Basic and Diluted $ (0.05 )   $ (0.13 )
    Weighted average shares basic and diluted          
    Basic and Diluted   58,257,191       52,518,924  
                   



               
    Osmotica Pharmaceuticals plc          
    Condensed Consolidated Statements of Cash Flows          
    (Unaudited)          
    (in thousands)          
               
      Three Months Ended March 31,
      2020   2019
    CASH FLOWS FROM OPERATING ACTIVITIES          
    Net loss $ (3,083 )   $ (6,687 )
    Adjustments to reconcile net loss to net cash used in operating activities:          
    Depreciation and amortization   5,562       17,993  
    Share compensation   1,107       1,169  
    Loss on sale of fixed and leased assets   (3 )     53  
    Deferred income tax benefit   829       (1,060 )
    Bad debt provision   29       (84 )
    Amortization of deferred financing and loan origination fees   333       323  
    Change in operating assets and liabilities:          
    Trade accounts receivable, net   11,242       (378 )
    Inventories, net   769       (3,432 )
    Prepaid expenses and other current assets   891       4,691  
    Other non-current assets   (18 )     -  
    Trade accounts payable   289       (4,279 )
    Accrued and other current liabilities   (18,011 )     (14,436 )
    Net cash used in operating activities   (64 )     (6,127 )
    CASH FLOWS FROM INVESTING ACTIVITIES:          
    Proceeds from sale of fixed and leased assets   4       -  
    Payments on disposal of leased assets   (1 )     -  
    Purchase of property, plant and equipment   (949 )     (635 )
    Net cash used in investing activities   (946 )     (635 )
    CASH FLOWS FROM FINANCING ACTIVITIES:          
    Payments on finance lease obligations   (33 )     (31 )
    Proceeds from public offering, net of issuance costs   31,791       -  
    Repurchases of ordinary shares   (167 )     -  
    Payments for taxes related to net share settlement of equity awards   (616 )     -  
    Proceeds from insurance financing loan   -       (979 )
    Net cash provided by (used in) financing activities   30,975       (1,010 )
    Net change in cash and cash equivalents   29,965       (7,772 )
    Cash and cash equivalents, beginning of period   95,865       70,834  
    Cash and cash equivalents, end of period $ 125,830     $ 63,062  
               

     

               
    Osmotica Pharmaceuticals plc          
    GAAP to Non-GAAP Reconciliations          
    Adjusted EBITDA (Unaudited)          
    (in thousands)          
               
        Three Months Ended
        March 31,
        2020     2019
               
    Net loss $ (3,083 )   $ (6,687 )
    Interest expense and amortization of debt discount   4,064       4,501  
    Income tax benefit   960       (754 )
    Depreciation and amortization expense   5,562       17,993  
               
    EBITDA   7,503       15,053  
               
    Management fees   -       (43 )
    Severance expenses   1,965       182  
    FX translation   59       222  
    Public offering expenses   528       -  
    Share compensation expense   1,016       1,169  
               
    Adjusted EBITDA $ 11,071     $ 16,583  

     

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  16. BRIDGEWATER, N.J., May 08, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced that the Company will release its 2020 first quarter financial results on Tuesday, May 12, 2020, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call as follows:

    Date
    Time
    Toll free (U.S.)
    International
    Conference ID
    Webcast (live and replay)
            Tuesday, May 12, 2020  
    4:30 p.m. ET
    (866) 672-5029
    (409) 217-8312
    5646947
    www.osmotica.com under the "Investor & News" section
         

    About Osmotica Pharmaceuticals plc

    BRIDGEWATER, N.J., May 08, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced that the Company will release its 2020 first quarter financial results on Tuesday, May 12, 2020, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call as follows:

    Date
    Time
    Toll free (U.S.)
    International
    Conference ID
    Webcast (live and replay)
            Tuesday, May 12, 2020  
    4:30 p.m. ET
    (866) 672-5029
    (409) 217-8312
    5646947
    www.osmotica.com under the "Investor & News" section
         

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  17. Fourth quarter and full year 2019 total revenue of $59.9 million and $240.0 million, respectively

    New Drug Application accepted by FDA for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for acquired blepharoptosis, or droopy eyelid; user fee goal date of July 16, 2020

    Completed a public offering of 6.9 million common shares at a price of $5 per share

    BRIDGEWATER, N.J., March 18, 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 and full year ended December 31, 2019.

    "With the completion of our two Phase III trial programs, we continue transitioning our…

    Fourth quarter and full year 2019 total revenue of $59.9 million and $240.0 million, respectively

    New Drug Application accepted by FDA for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for acquired blepharoptosis, or droopy eyelid; user fee goal date of July 16, 2020

    Completed a public offering of 6.9 million common shares at a price of $5 per share

    BRIDGEWATER, N.J., March 18, 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 and full year ended December 31, 2019.

    "With the completion of our two Phase III trial programs, we continue transitioning our business to a branded specialty pharmaceutical company. Last November, the U.S. Food and Drug Administration (FDA) accepted our new drug application (NDA) for RVL-1201 (RVL), our innovative, once-daily ophthalmic product designed to treat acquired blepharoptosis, or droopy eyelid. We believe RVL represents a significant opportunity to address a sizable unmet need. In the months leading up to our July 16 user fee goal date, we are focused on launch preparation and raising awareness among eye care professionals for a potential first pharmacologic treatment for patients with ptosis," said Brian Markison, Chief Executive Officer.

    "Looking ahead, we have a number of exciting milestones in 2020: During the second quarter, we intend to file an amended NDA for arbaclofen ER, a potential treatment for spasticity in patients with Multiple Sclerosis. This summer, we look forward to FDA approval of RVL. Additionally, we expect to provide an update on our RVL partner discussions during the second quarter. If approved, both RVL and arbaclofen ER tablets represent potential significant near-term growth assets, and we look forward to advancing these innovative therapeutics," continued Markison.

    Fourth Quarter and Full Year 2019 Financial Highlights

    • Total revenues:
      • Fourth quarter 2019 total revenues were $59.9 million, compared to $65.7 million in the fourth quarter of 2018;
      • Full year 2019 total revenues were $240.0 million, compared to $263.7 million in 2018;
    • Net loss:
      • Fourth quarter 2019 net loss was $26.6 million, compared to a net loss of $107.0 million in the fourth quarter of 2018. The net losses for the fourth quarters of 2019 and 2018 included $29.9 million and $98 million, respectively, of intangible asset impairment charges;
      • Full year 2019 net loss was $270.9 million, compared to net loss of $109.7 million in 2018. The net losses during 2019 and 2018 included intangible assets impairment charges of $283.7 million and $104.2 million, respectively;
    • Adjusted EBITDA¹
      • Fourth quarter 2019 Adjusted EBITDA was $14.9 million, compared to Adjusted EBITDA of $14.2 million in the fourth quarter of 2018;
      • Full year 2019 Adjusted EBITDA was $68.8 million, compared to Adjusted EBITDA of $95.1 million in 2018; and,
    • Cash and cash equivalents were $95.9 million, and debt (net of deferred financing costs) was $268.0 million as of December 31, 2019.

    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."

    Fourth Quarter 2019 Financial Results

    Total revenues for the three months ended December 31, 2019 were $59.9 million, compared to $65.7 million for the three months ended December 31, 2018. The decrease in total revenue in 2019 reflects lower net pricing on sales of methylphenidate hydrochloride ("HCI") extended-release ("ER") tablets, venlafaxine ER tablets ("VERT") and Lorzone (chlorzoxazone scored tablets), partially offset by higher revenues from other non-promoted products. Net sales of methylphenidate ER (including M-72) and VERT decreased 40% and 16%, respectively during the quarter due to additional competitors entering the market resulting in lower net selling prices and volumes partially offset by lower than estimated product returns. Methylphenidate ER and VERT net sales were favorably impacted by approximately $6.8 million in the aggregate, primarily related to adjustments of product returns reserves during the quarter based on actual product return experience.

    Selling, general and administrative expenses decreased to $21.1 million in the fourth quarter of 2019, compared to $23.0 million in the fourth quarter of 2018. The decrease was primarily due to the realignment of our field force in the third quarter of 2019, offset by higher general and administrative expenses associated with being a public company.

    Research and development expenses decreased to $7.1 million in the fourth quarter of 2019, compared to $14.6 million in the fourth quarter of 2018 primarily due to the completion of the Phase III clinical trials of RVL-1201 and arbaclofen ER.

    During the fourth quarter of 2019, we recognized intangible asset impairment charges of $29.9 million, reflecting write downs of developed technology assets and distribution rights, as compared to $98.0 million for the fourth quarter of 2018, reflecting write downs of goodwill and in-process research and development assets.

    Other non-operating expenses decreased to $4.5 million in the fourth quarter of 2019, compared to $5.6 million in the fourth quarter of 2018. The decrease resulted from lower interest expense due to the prepayment of $50 million of debt during the fourth quarter of 2018.

    Net loss for the fourth quarter of 2019 was $26.6 million, compared to a net loss of $107.0 million in the fourth quarter of 2018 primarily due to lower impairment charges during the quarter.

    Adjusted EBITDA for the fourth quarter of 2019 was $14.9 million, compared to Adjusted EBITDA of $14.2 million for the fourth quarter of 2018.

    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.

    Full Year 2019 Financial Results

    Total revenues decreased by $23.7 million to $240.0 million in 2019, compared to $263.7 million in 2018.

    Net product sales decreased by $25.9 million to $235.5 million for the year ended December 31, 2019, as compared to $261.4 million for the year ended December 31, 2018. Net product sales of methylphenidate ER (including M-72, which was launched in the second quarter of 2018) decreased 43% due to additional competitors entering the market, resulting in significantly lower net selling prices, partially offset by lower than estimated product returns. Product sales from VERT increased by 14% for the year ended December 31, 2019. During 2019 a competing dosage strength was launched which negatively affected sales volumes, however volume decreases were more than offset by lower than estimated product returns and government rebates resulting in higher realized net selling prices in the period. Additionally, during the third and fourth quarter of 2019, two additional generic forms of VERT from competitors were approved but not launched. We expect that the additional competition for both methylphenidate ER and VERT from these competitors, as well as additional generic product approvals and launches in the future, if any, will continue to negatively affect our sales of these products in 2020 and future years. Methylphenidate ER and VERT net sales were favorably impacted by adjustments of approximately $25.3 million in the aggregate primarily related to product returns reserves during the year ended December 31, 2019 based on actual product returns experience. There can be no assurance that actual product returns experience and other adjustments will continue to favorably impact net sales in 2020 and in future years.

    Selling, general and administrative expenses increased by $18.8 million in 2019 to $93.0 million as compared to $74.2 million in 2018. The increase reflects additions to salesforce headcount and marketing costs associated with the launch of Osmolex ER in the first quarter of 2019, severance expenses associated with a salesforce realignment during the third quarter of 2019 and increased share compensation expense and higher costs associated with being a public company.

    Research and development expenses decreased by $11.4 million in 2019 to $32.3 million as compared to $43.7 million in 2018. The decrease primarily reflects the completion of the Phase III clinical trials of arbaclofen ER during the first quarter of 2019, partially offset by increased share compensation expense during 2019 and the cost of manufacturing development batches of Osmolex ER during 2018, which were costs not present in 2019.

    The Company incurred an impairment of intangible assets charge of $283.7 million during the twelve months ended December 31, 2019, primarily related to the write down to fair value of methylphenidate ER, venlafaxine ER tablets due to price and volume decreases resulting from competing generic products. 

    Net loss in 2019 was $270.9 million, compared to net loss of $109.7 million in 2018.

    Adjusted EBITDA in 2019 was $68.8 million, compared to Adjusted EBITDA of $95.1 million in 2018.

    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 December 31, 2019, we had cash and cash equivalents of $95.9 million and borrowing availability under our revolving credit facility of $50.0 million. The Company also had debt of $268.0 million (net of deferred financing costs).

    Presentation of Non-GAAP Measures

    In addition to the results provided in accordance with GAAP throughout this press release, the Company has presented Adjusted EBITDA, which is a non-GAAP measurement. 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: impairment of intangible assets and fixed assets, impairment of goodwill, share compensation expense, loss on debt extinguishment, management fees, IPO 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 Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, our ability to operate our business under our new capital and operating structure, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Conference Call

    As previously announced, Osmotica management will host its fourth quarter 2019 conference call as follows:

      Date Wednesday, March 18, 2020
      Time 4:30 p.m. ET
      Toll free (U.S.) (866) 672-5029
      International (409) 217-8312
      Webcast (live and replay) www.osmotica.com, under the "Investor & News" section
      Conference call ID 8189498

    The webcast will be archived for 30 days at the aforementioned URL.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

    -Financial tables follow-

     
    Osmotica Pharmaceuticals plc
    Consolidated Balance Sheets
    (in thousands)
                 
        December 31, 2019   December 31, 2018
             
                 
    Assets            
    Current assets:            
    Cash and cash equivalents   $ 95,865     $ 70,834  
    Trade accounts receivable, net     43,914       56,424  
    Inventories, net     21,305       24,383  
    Prepaid expenses and other current assets     11,546       20,723  
    Total current assets     172,630       172,364  
    Property, plant and equipment, net     30,238       31,263  
    Operating lease assets     4,983       -  
    Intangibles, net     153,986       490,390  
    Goodwill     100,855       100,855  
    Other non-current assets     2,246       752  
    Total assets   $ 463,255     $ 795,624  
                 
    Liabilities and Shareholders' Equity/Partners' Capital            
    Current liabilities:            
    Trade accounts payable   $ 8,495     $ 24,871  
    Accrued liabilities     65,253       87,237  
    Current portion of long-term debt, net of deferred financing costs     -       1,774  
    Current portion of obligation under finance leases     127       119  
    Current portion of lease liability     2,062       -  
    Total current liabilities     75,937       114,001  
    Long-term debt, net of non-current deferred financing costs     267,950       266,803  
    Long-term portion of obligation under finance leases     44       138  
    Long-term portion of lease liability     3,116       -  
    Income taxes payable - long term portion     -       2,541  
    Deferred taxes     1,500       28,294  
    Total liabilities     348,547       411,777  
    Commitments and contingencies            
                 
    Shareholders' equity:            
    Ordinary shares     518       525  
    Additional paid in capital     489,440       487,288  
    Accumulated deficit     (373,021 )     (102,120 )
    Accumulated other comprehensive loss     (2,229 )     (1,846 )
    Total shareholders' equity     114,708       383,847  
    Total liabilities and shareholders' equity   $ 463,255     $ 795,624  


    Osmotica Pharmaceuticals plc
    Consolidated Statements of Operations
    (in thousands, except share and per share data)
                             
        Year Ended December 31,     Three Months Ended December 31,
          2019       2018       2019       2018  
                             
    Net product sales   $ 235,472     $ 261,398     $ 58,815     $ 65,134  
    Royalty revenue     3,641       1,959       815       303  
    Licensing and contract revenue     918       344       281       259  
    Total revenues     240,031       263,701       59,911       65,696  
    Cost of good sold (inclusive of amortization of intangibles)     111,630       140,082       24,241       37,587  
    Gross profit     128,401       123,619       35,670       28,109  
    Selling, general and administrative expenses     93,030       74,243       21,111       22,954  
    Research and development expenses     32,319       43,693       7,138       14,588  
    Impairment of intangibles and fixed assets     283,747       17,903       29,868       11,730  
    Impairment of goodwill     -       86,318       -       86,318  
    Total operating expenses     409,096       222,157       58,117       135,590  
    Operating loss     (280,695 )     (98,538 )     (22,447 )     (107,481 )
    Interest expense and amortization of debt discount     18,211       20,790       4,655       5,394  
    Other non-operating (income) loss, net     (884 )     (664 )     (165 )     217  
    Total other non-operating expense, net     17,327       20,126       4,490       5,611  
    Loss before income taxes     (298,022 )     (118,664 )     (26,937 )     (113,092 )
    Income tax benefit     27,121       8,983       297       6,085  
    Net loss   $ (270,901 )   $ (109,681 )   $ (26,640 )   $ (107,007 )
                             
    Loss per share attributable to shareholders                        
    Basic   $ (5.17 )   $ (2.42 )   $ (0.51 )   $ (2.36 )
    Diluted   $ (5.17 )   $ (2.42 )   $ (0.51 )   $ (2.36 )
    Weighted average share basic and diluted                        
    Basic and diluted     52,367,444       45,276,268       51,960,082       45,276,268  


    Osmotica Pharmaceuticals plc
    Consolidated Statements of Cash Flows
    (in thousands)
                 
        Year Ended December 31,
        2019
      2018
    CASH FLOWS FROM OPERATING ACTIVITIES            
    Net loss   $ (270,901 )   $ (109,681 )
    Adjustments to reconcile net loss to cash provided by operating activities            
    Depreciation and amortization     57,015       81,573  
    Share compensation     4,932       1,965  
    Impairment of goodwill     -       86,318  
    Impairment of intangibles     283,747       17,903  
    Deferred income tax benefit     (26,794 )     (15,513 )
    Loss on sale of fixed and leased assets     173       93  
    Bad debt provision     (164 )     (1,771 )
    Non-cash interest expenses and amortization of deferred financing and loan origination fees     1,337       1,652  
    Write off of deferred financing fees in connection with loan prepayment     -       876  
    Change in operating assets and liabilities            
    Trade accounts receivable, net     12,674       (17,041 )
    Inventories, net     3,078       (7,436 )
    Prepaid expenses and other current assets     9,177       4,549  
    Trade accounts payable     (16,375 )     (11,326 )
    Accrued and other current liabilities     (24,332 )     5,397  
    Net cash provided by operating activities     33,567       37,558  
    CASH FLOWS FROM INVESTING ACTIVITIES:            
    Proceeds from sale of fixed and leased assets     17       10  
    Payment on disposal of leased assets     (74 )     -  
    Purchase of property, plant and equipment     (3,963 )     (4,144 )
    Net cash used in investing activities     (4,020 )     (4,134 )
    CASH FLOWS FROM FINANCING ACTIVITIES:            
    Payments to affiliates     -       (2 )
    Payments on finance lease obligations     (130 )     (112 )
    Proceeds from insurance financing loan     1,314       2,745  
    Repayment of insurance financing loan     (3,088 )     (971 )
    Proceeds from initial public offering and private placement, net of issuance costs     -       58,084  
    Debt repayment     -       (56,140 )
    Repurchase of ordinary shares     (2,787 )     -  
    Net cash provided by (used in) financing activities     (4,691 )     3,604  
    Net change in cash and cash equivalents     24,856       37,028  
    Effect on cash of change in exchange rate     175       (938 )
    Cash and cash equivalents, beginning of period     70,834       34,744  
    Cash and cash equivalents, end of period   $ 95,865     $ 70,834  


        Osmotica Pharmaceuticals plc
        GAAP to Non-GAAP Reconciliations
        Adjusted EBITDA (Unaudited)
        (in thousands)
                             
          Year Ended     Three Months Ended
          December 31,     December 31,
          2019       2018       2019       2018  
                             
    Net Loss   $ (270,901 )   $ (109,681 )   $ (26,640 )   $ (107,007 )
    Interest expense and amortization of debt discount     18,211       20,790       4,655       5,394  
    Income tax benefit     (27,121 )     (8,983 )     (297 )     (6,085 )
    Depreciation and Amortization Expense     57,015       81,573       6,410       20,249  
                             
    EBITDA     (222,796 )     (16,301 )     (15,872 )     (87,449 )
                             
    Impairment of intangible and fixed assets     283,747       17,903       29,868       11,730  
    Impairment of goodwill     -       86,318       -       86,318  
    Share compensation expense     4,932       1,965       1,101       1,965  
    Loss on debt extinguishment     -       876       -       876  
    Management Fees     (42 )     921       -       151  
    IPO expenses     -       2,442       -       460  
    FX Translation     655       -       80       -  
    Severance expenses     1,802       679       164       195  
    Legal and contractual settlements and litigation reserves     526       332       (477 )     -  
                             
    Adjusted EBITDA   $ 68,824     $ 95,135     $ 14,864     $ 14,246  
                                     

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  18. BRIDGEWATER, N.J., March 12, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced that the Company will release its 2019 fourth quarter and full year financial results on Wednesday, March 18, 2020, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call as follows:

    Date    Wednesday, March 18, 2020  
    Time    4:30 p.m. ET
    Toll free (U.S.)    (866) 672-5029
    International    (409) 217-8312
    Webcast (live and replay)    www.osmotica.com under the "Investor & News" section

    The webcast will be…

    BRIDGEWATER, N.J., March 12, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, today announced that the Company will release its 2019 fourth quarter and full year financial results on Wednesday, March 18, 2020, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call as follows:

    Date    Wednesday, March 18, 2020  
    Time    4:30 p.m. ET
    Toll free (U.S.)    (866) 672-5029
    International    (409) 217-8312
    Webcast (live and replay)    www.osmotica.com under the "Investor & News" section

    The webcast will be archived for 30 days at the aforementioned URL.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  19. BRIDGEWATER, N.J., March 03, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the Barclays Global Healthcare Conference 2020 as follows:

    Date: Tuesday, March 10, 2020
    Time: 11:00 a.m. Eastern Time
    Location: Loews Miami Beach Hotel, Miami Beach, FL
    Webcast: https://cc.talkpoint.com/barc002/031020a_js/?entity=89_651TH2U

    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…

    BRIDGEWATER, N.J., March 03, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the Barclays Global Healthcare Conference 2020 as follows:

    Date: Tuesday, March 10, 2020
    Time: 11:00 a.m. Eastern Time
    Location: Loews Miami Beach Hotel, Miami Beach, FL
    Webcast: https://cc.talkpoint.com/barc002/031020a_js/?entity=89_651TH2U

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  20. BRIDGEWATER, N.J., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the 9th Annual SVB Leerink Global Healthcare Conference as follows:

    Date: Thursday, February 27, 2020
    Time: 10:00 a.m. Eastern Time
    Location: Lotte New York Palace, New York, NY
    Webcast: http://wsw.com/webcast/svbleerink34/osmt/

    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…

    BRIDGEWATER, N.J., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the 9th Annual SVB Leerink Global Healthcare Conference as follows:

    Date: Thursday, February 27, 2020
    Time: 10:00 a.m. Eastern Time
    Location: Lotte New York Palace, New York, NY
    Webcast: http://wsw.com/webcast/svbleerink34/osmt/

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  21. BRIDGEWATER, N.J., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the pricing of its public offering of 6,000,000 ordinary shares at a price to the public of $5.00 per share. All of the shares will be offered by Osmotica. In addition, Osmotica has granted the underwriters a 30-day option to purchase up to an additional 900,000 ordinary shares at the public offering price less underwriting discounts and commissions. The offering is expected to close on January 13, 2020, subject to customary closing conditions.

    Jefferies LLC, SVB Leerink LLC, RBC Capital Markets, LLC and SunTrust Robinson Humphrey, Inc. are acting as joint…

    BRIDGEWATER, N.J., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the pricing of its public offering of 6,000,000 ordinary shares at a price to the public of $5.00 per share. All of the shares will be offered by Osmotica. In addition, Osmotica has granted the underwriters a 30-day option to purchase up to an additional 900,000 ordinary shares at the public offering price less underwriting discounts and commissions. The offering is expected to close on January 13, 2020, subject to customary closing conditions.

    Jefferies LLC, SVB Leerink LLC, RBC Capital Markets, LLC and SunTrust Robinson Humphrey, Inc. are acting as joint book-running managers for the offering. 

    The offering is being made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Telephone: 877-547-6340, Email: ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at or by telephone at (800) 808-7525, ext. 6132.

    A registration statement relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on January 8, 2020. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Forward-Looking Statements

    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the consummation of the offering.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The Company may not achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place significant reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission on March 28, 2019, under the heading "Risk Factors" included in the preliminary prospectus related to the public offering filed with the Securities and Exchange Commission and the other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and the Company does not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  22. BRIDGEWATER, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the commencement of a proposed public offering of 6,000,000 ordinary shares. All of the shares will be offered by Osmotica. Osmotica also expects to grant the underwriters a 30-day option to purchase up to an additional 900,000 ordinary shares.

    Jefferies LLC, SVB Leerink LLC, RBC Capital Markets, LLC and SunTrust Robinson Humphrey, Inc. are acting as joint book-running managers for the proposed offering. 

    The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to the offering may be obtained from Jefferies LLC…

    BRIDGEWATER, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (NASDAQ:OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company, announced today the commencement of a proposed public offering of 6,000,000 ordinary shares. All of the shares will be offered by Osmotica. Osmotica also expects to grant the underwriters a 30-day option to purchase up to an additional 900,000 ordinary shares.

    Jefferies LLC, SVB Leerink LLC, RBC Capital Markets, LLC and SunTrust Robinson Humphrey, Inc. are acting as joint book-running managers for the proposed offering. 

    The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Telephone: 877-547-6340, Email: ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at or by telephone at (800) 808-7525, ext. 6132.

    A registration statement relating to the securities being sold in this offering has been filed with the Securities and Exchange Commission, but has not yet been declared effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Osmotica has operations in the United States, Argentina, and Hungary.

    Forward-Looking Statements

    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the terms of the proposed offering.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The Company may not achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place significant reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission on March 28, 2019, under the heading "Risk Factors" included in the preliminary prospectus related to the proposed public offering filed with the Securities and Exchange Commission and the other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and the Company does not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  23. BRIDGEWATER, N.J., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company) today announced that the Company received notification that the New Drug Application ("NDA") for RVL-1201 ("RVL") for Acquired Blepharoptosis (droopy eyelid or ptosis) has been filed by the U.S. Food and Drug Administration ("FDA") with a Prescription Drug User Fee Act (PDUFA) goal date of July 16, 2020.

    "We are delighted that our NDA has been accepted for filing. Today, there are no pharmacologic options approved for treatment of droopy eyelid.  If approved, RVL would offer physicians and patients a therapeutic option for…

    BRIDGEWATER, N.J., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) ("Osmotica" or the "Company"), a fully integrated biopharmaceutical company) today announced that the Company received notification that the New Drug Application ("NDA") for RVL-1201 ("RVL") for Acquired Blepharoptosis (droopy eyelid or ptosis) has been filed by the U.S. Food and Drug Administration ("FDA") with a Prescription Drug User Fee Act (PDUFA) goal date of July 16, 2020.

    "We are delighted that our NDA has been accepted for filing. Today, there are no pharmacologic options approved for treatment of droopy eyelid.  If approved, RVL would offer physicians and patients a therapeutic option for the treatment of ptosis supported by compelling safety and efficacy data from three well-controlled pivotal studies. With the simplicity of using a once-daily eye drop, RVL has the potential to transform the clinical treatment of acquired blepharoptosis," said Brian Markison, Osmotica's Chief Executive Officer.

    "We look forward to continuing to engage with key opinion leaders and the medical community to build awareness of this novel therapeutic option for the treatment of droopy eyelid. As we build out our commercial and educational strategy for RVL, we are focused on messaging and pre-launch preparation activities that target both ophthalmologists and optometrists," concluded Markison.

    About Acquired Blepharoptosis

    Acquired blepharoptosis is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid.  It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis. The current standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry.

    About RVL-1201
    RVL-1201 is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller's muscle and elevate the upper eyelid.  If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelid.

    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. 

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Forward Looking Statements
    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E: 

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  24. Third quarter 2019 total revenue of $65.5 million

    Submitted NDA for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for acquired blepharoptosis, or droopy eyelid, to FDA

    BRIDGEWATER, N.J, Nov. 14, 2019 (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 quarter ended September 30, 2019.

    "We are pleased with the progress we made on many fronts during the third quarter, beginning with the submission of our new drug application (NDA) for RVL-1201 (RVL) in September. We are currently engaged in productive follow-up discussions with the U.S. Food and Drug Administration (FDA…

    Third quarter 2019 total revenue of $65.5 million

    Submitted NDA for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for acquired blepharoptosis, or droopy eyelid, to FDA

    BRIDGEWATER, N.J, Nov. 14, 2019 (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 quarter ended September 30, 2019.

    "We are pleased with the progress we made on many fronts during the third quarter, beginning with the submission of our new drug application (NDA) for RVL-1201 (RVL) in September. We are currently engaged in productive follow-up discussions with the U.S. Food and Drug Administration (FDA) and believe we are on track for an acceptance to file during the fourth quarter. RVL, with its once-a-day ophthalmic formulation, has the potential to be a first-in-class pharmacologic treatment for acquired blepharoptosis, and a meaningful solution to patients with mild-to-moderate ptosis. In recent weeks, we presented Phase III efficacy and safety trial data for RVL at several global eye care conferences, where we received positive feedback from key opinion leaders. As we build out our medical education strategy for RVL, we are also turning our focus to messaging and pre-launch activities," stated Brian Markison, Chief Executive Officer.

    "We are also in communication with the FDA regarding arbaclofen ER, a treatment for spasticity in Multiple Sclerosis patients, with a potential NDA amendment submission in the first half of 2020. These advancements in our late-stage pipeline are encouraging as we continue to transition our business to a branded specialty pharmaceuticals company," added Markison.  

    Third Quarter 2019 Financial Highlights

    • Total revenues were $65.5 million, compared to $66.3 million in the third quarter of 2018;
    • Net loss was $112.7 million, reflecting an impairment charge of $128.1 million, compared to net loss of $3.6 million in the third quarter of 2018;
    • Adjusted EBITDA1 was $22.9 million, compared to Adjusted EBITDA of $25.8 million in the third quarter of 2018; and
    • Cash and cash equivalents were $98.0 million and debt (net of deferred financing costs) was $268.1 million as of September 30, 2019.

    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."

    Third Quarter 2019 Financial Results

    Total revenues decreased by $0.9 million to $65.5 million for the three months ended September 30, 2019, as compared to $66.3 million for the three months ended September 30, 2018 primarily due to a decrease in net product sales.

    Net product sales decreased by $1.4 million to $64.0 million for the three months ended September 30, 2019, as compared to $65.4 million for the three months ended September 30, 2018.  Net sales of methylphenidate ER (including M-72) decreased 46% during the quarter due to additional competitors entering the market resulting in significantly lower net selling prices and volumes, partially offset by lower than estimated product returns.  Net sales of venlafaxine extended release tablets (VERT) increased 41% during the quarter compared to the prior year period as a result of higher realized net selling prices due to lower than estimated product returns combined with higher volumes. We expect 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 our sales of these products during the remainder of 2019 and in future years.  Methylphenidate and VERT net sales were favorably impacted by adjustments of approximately $11.6 million in the aggregate, primarily related to product returns reserves during the quarter based on actual product returns experience.  There can be no assurance that actual product returns experience and other adjustments will continue to favorably impact net sales in the remainder of 2019 and future years.

    Selling, general and administrative expenses increased $7.3 million during the three months ended September 30, 2019 to $24.8 million as compared to $17.5 million in the three months ended September 30, 2018. The increase in our selling, general and administrative expenses reflects additions to salesforce headcount and marketing costs following the launch of Osmolex ER in the first quarter of 2019, severance costs associated with the salesforce realignment during the third quarter of 2019, and increased share compensation expense and higher costs associated with being a public company.

    Research and development expenses decreased by $3.7 million in the three months ended September 30, 2019 to $8.3 million as compared to $12.0 million in the three months ended September 30, 2018. The decrease reflects the completion of the Phase III clinical trial for arbaclofen ER during the first quarter of 2019, partially offset by increased share compensation expense, and the cost of manufacturing development batches of Osmolex ER in the three month period ended September 30, 2018, which costs did not reoccur in 2019.

    The Company incurred an impairment of intangible assets charge of $128.1 during the three months ended September 30, 2019, primarily related to the write down to fair value of methylphenidate due to price and volume decreases resulting from competing generic products. 

    Net loss for the third quarter of 2019 was $112.7 million, compared to net loss of $3.6 million in the third quarter of 2018.

    Adjusted EBITDA for the third quarter of 2019 was $22.9 million, compared to Adjusted EBITDA of $25.8 million in the third quarter of 2018.

    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 September 30, 2019, we had cash and cash equivalents of $98.0 million and borrowing availability under our revolving credit facility of $50.0 million. The Company also had debt of $268.1 million (net of deferred financing costs).

    Presentation of Non-GAAP Measures

    In addition to the results provided in accordance with GAAP throughout this press release, the Company has presented Adjusted EBITDA, which is a non-GAAP measurement.  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:  impairment of intangible assets, management fees, IPO expenses, severance expenses, foreign currency translation, legal settlements and share-based compensation expense. 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 Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, our ability to operate our business under our new capital and operating structure, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Conference Call

    As previously announced, Osmotica management will host its third quarter 2019 conference call as follows:

    Date Friday, November 15, 2019
       
    Time 8:30 a.m. EST
       
    Toll free (U.S.) (866) 672-5029
       
    International (409) 217-8312
       
    Webcast (live and replay) www.osmotica.com, under the "Investor & News" section
       
    Conference call ID 8189498

    The webcast will be archived for 30 days at the aforementioned URL.

    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. Our diversified product portfolio in the specialty neurology and women's health therapeutic areas, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients' lives. 

    Osmotica has a late‑stage development pipeline highlighted by two NDA candidates that recently completed Phase III clinical trials: arbaclofen ER for spasticity in multiple sclerosis patients and RVL‑1201 for the treatment of acquired blepharoptosis, or droopy eyelid.

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:  

    -Financial tables follow-

    Osmotica Pharmaceuticals plc                          
    GAAP to Non-GAAP Reconciliations                          
    Adjusted EBITDA (Unaudited)                          
    (in thousands)                          
                               
        Three Months Ended         Nine Months Ended
        September 30,         September 30,
        2019       2018           2019       2018  
                               
    Net loss $ (112,704 )   $ (3,606 )       $ (244,260 )   $ (2,675 )
    Interest expense and amortization of debt discount   4,504       5,311           13,555       15,396  
    Income tax benefit   (14,623 )     (3,872 )         (26,824 )     (2,898 )
    Depreciation and amortization expense   14,614       20,457           50,605       61,323  
                               
    EBITDA   (108,209 )     18,290           (206,924 )     71,146  
                               
    Impairment of intangibles   128,113       6,173           253,879       6,173  
    Management fees   -       250           (43 )     770  
    IPO expenses   -       1,038           -       1,982  
    Consulting Fees                         -  
    Severance expenses   1,275       -           1,638       484  
    FX translation   363       -           575       -  
    Legal settlements   -       -           1,002       333  
    Share compensation expense   1,335       -           3,831       -  
                               
    Adjusted EBITDA $ 22,877     $ 25,751         $ 53,958     $ 80,888  
                               


    Osmotica Pharmaceuticals plc            
    Condensed Consolidated Balance Sheets            
    (in thousands)            
                 
        September 30, 2019   December 31, 2018
        (Unaudited)    
                 
    Assets            
    Current assets:            
      Cash and cash equivalents   $ 98,014     $ 70,834  
      Trade accounts receivable, net     33,862       56,424  
      Inventories, net     27,240       24,383  
      Prepaid expenses and other current assets     8,186       20,723  
        Total current assets     167,302       172,364  
    Property, plant and equipment, net     30,325       31,263  
    Operating lease assets     5,558       -  
    Intangibles, net     189,324       490,390  
    Goodwill     100,855       100,855  
    Deferred taxes     198       -  
    Other non-current assets     611       752  
        Total assets   $ 494,173     $ 795,624  
                 
    Liabilities and Shareholders' Equity            
    Current liabilities:            
      Trade accounts payable   $ 9,905     $ 24,870  
      Accrued liabilities     66,076       87,238  
      Current portion of long-term debt, net of deferred financing costs   398       1,774  
      Current portion of lease liability     2,082       -  
      Current portion of obligation under finance leases     130       119  
        Total current liabilities     78,591       114,001  
    Long-term debt, net of non-current deferred financing costs     267,661       266,803  
    Long-term portion of obligation under finance leases     68       138  
    Long-term portion of lease liability     3,677       -  
    Income taxes payable-long term portion     2,479       2,541  
    Deferred taxes     -       28,294  
        Total liabilities     352,476       411,777  
        Commitments and contingencies            
    Shareholders' equity            
      Ordinary shares     522       525  
      Additional paid in capital     489,784       487,288  
      Accumulated deficit     (346,380 )     (102,120 )
      Accumulated other comprehensive loss     (2,229 )     (1,846 )
        Total shareholders' equity     141,697       383,847  
        Total liabilities and shareholders' equity   $ 494,173     $ 795,624  
                 



    Osmotica Pharmaceuticals plc                        
    Condensed Consolidated Statements of Operations                  
    (Unaudited)                        
    (in thousands, except share and per share data)                      
                             
                             
        Three Months Ended September 30,     Nine Months Ended September 30,
          2019       2018       2019       2018  
                             
    Net product sales   $ 64,041     $ 65,444     $ 176,657     $ 196,264  
    Royalty revenue     1,325       903       2,826       1,656  
    Licensing and contract revenue     95       (2 )     637       85  
      Total revenues     65,461       66,345       180,120       198,005  
    Cost of goods sold (inclusive of amortization of intangibles)     27,312       33,356       89,160       102,495  
      Gross profit     38,149       32,989       90,960       95,510  
    Selling, general and administrative expenses   24,751       17,452       71,919       51,290  
    Research and development expenses     8,285       11,965       23,410       29,105  
    Impairment of intangibles     128,113       6,173       253,879       6,173  
      Total operating expenses     161,149       35,590       349,208       86,568  
      Operating income (loss)     (123,000 )     (2,601 )     (258,248 )     8,942  
    Interest expense and amortization of debt discount     4,504       5,311       13,555       15,396  
    Other non-operating gain     (177 )     (434 )     (719 )     (881 )
      Total other non-operating expense     4,327       4,877       12,836       14,515  
    Loss before income taxes     (127,327 )     (7,478 )     (271,084 )     (5,573 )
    Income tax benefit     14,623       3,872       26,824       2,898  
    Net loss   $ (112,704 )   $ (3,606 )   $ (244,260 )   $ (2,675 )
    Other comprehensive loss, net                        
      Change in foreign currency translation                        
      adjustments     (383 )     (148 )     (383 )     (1,239 )
    Comprehensive loss   $ (113,087 )   $ (3,754 )   $ (244,643 )   $ (3,914 )
    Loss per share attributable to shareholders                        
      Basic and Diluted   $ (2.15 )   $ (0.08 )   $ (4.65 ) $   (0.06 )
    Weighted average shares basic and diluted                        
      Basic and Diluted     52,477       42,862       52,505       42,862  



    Osmotica Pharmaceuticals plc            
    Condensed Consolidated Statements of Cash Flows            
    (Unaudited)            
    (in thousands)            
                 
        Nine Months Ended September 30,
        2019     2018  
    CASH FLOWS FROM OPERATING ACTIVITIES            
    Net loss   $ (244,260 )   $ (2,675 )
    Adjustments to reconcile net loss to net cash used in operating activities:            
      Depreciation and amortization     50,605       61,323  
      Share compensation     3,831       -  
      Loss on sale of fixed and leased assets     75       13  
      Impairment of intangibles     253,879       6,173  
      Deferred income tax benefit     (28,493 )     (7,508 )
      Bad debt provision     (160 )     (1,293 )
      Amortization of deferred financing and loan origination fees     1,000       1,261  
    Change in operating assets and liabilities:            
      Trade accounts receivable, net     22,722       (33,821 )
      Inventories, net     (2,857 )     (8,647 )
      Prepaid expenses and other current assets     12,536       811  
      Trade accounts payable     (14,964 )     (9,063 )
      Accrued and other current liabilities     (21,022 )     600  
      Net cash provided by operating activities     32,892       7,174  
    CASH FLOWS FROM INVESTING ACTIVITIES:            
      Proceeds from sale of fixed and leased assets     12       10  
      Payments on disposal of leased assets     (34 )     -  
      Purchase of property, plant and equipment     (3,042 )     (2,998 )
      Net cash used in investing activities     (3,064 )     (2,988 )
    CASH FLOWS FROM FINANCING ACTIVITIES:            
      Payments to affiliates     -       (2 )
      Repurchases of ordinary shares     (1,338 )     -  
      Payments on finance lease obligations     (97 )     (82 )
      Proceeds from insurance financing loan     1,314       975  
      Repayment of insurance financing loan     (2,691 )     (484 )
      Repayment of debt     -       (6,140 )
      Net cash used in financing activities     (2,812 )     (5,733 )
    Net change in cash and cash equivalents     27,016       (1,547 )
    Effect on cash of changes in exchange rate     164       (993 )
    Cash and cash equivalents, beginning of period     70,834       34,743  
    Cash and cash equivalents, end of period   $ 98,014     $ 32,203  
                 

     

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  25. BRIDGEWATER, N.J., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced that the Company will release its 2019 third quarter financial results on Thursday, November 14, 2019, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Friday, November 15, 2019
    Time 8:30 a.m. EST
    Toll free (U.S.) (866) 672-5029
    International (409) 217-8312
    Webcast (live and replay) www.osmotica.com under the "Investor & News" section

    The webcast will be archived…

    BRIDGEWATER, N.J., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced that the Company will release its 2019 third quarter financial results on Thursday, November 14, 2019, after the close of the U.S. financial markets.

    Brian Markison, Chief Executive Officer, James "JD" Schaub, Chief Operating Officer, and Andrew Einhorn, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Friday, November 15, 2019
    Time 8:30 a.m. EST
    Toll free (U.S.) (866) 672-5029
    International (409) 217-8312
    Webcast (live and replay) www.osmotica.com under the "Investor & News" section

    The webcast will be archived for 30 days at the aforementioned URL.

    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. 

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:  

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  26. BRIDGEWATER, N.J., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced the appointment of Michael J. DeBiasi to the Company's Board of Directors, effective as of October 1, 2019.

    "We are pleased to welcome Mike to our Board of Directors. Mike has a proven track record as a successful business leader and has extensive experience building effective commercial teams and implementing appropriate Governance, Compliance, and Quality systems and processes. We look forward to his insights and guidance as we advance our key pipeline assets and make the transition to a specialty branded pharmaceuticals company," stated Brian Markison…

    BRIDGEWATER, N.J., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced the appointment of Michael J. DeBiasi to the Company's Board of Directors, effective as of October 1, 2019.

    "We are pleased to welcome Mike to our Board of Directors. Mike has a proven track record as a successful business leader and has extensive experience building effective commercial teams and implementing appropriate Governance, Compliance, and Quality systems and processes. We look forward to his insights and guidance as we advance our key pipeline assets and make the transition to a specialty branded pharmaceuticals company," stated Brian Markison, Chief Executive Officer.

    Since December 2018, Mr. DeBiasi has held the position of CEO – Kramer Consumer Healthcare, a company focused on growing market-leading consumer healthcare brands in their respective segments. From October 2014 to November 2018, Mr. DeBiasi held positions of increasing responsibility at Bayer US, where he was Vice President and General Manager – US Nutritionals and Digestive Health. Prior to that, Mr. DeBiasi held senior positions at Merck & Co, Inc., where he was the Executive Director – US Allergy. From February 2008 to October 2011, Mr. DeBiasi served as Marketing Director for Welch Foods.

    Mr. DeBiasi earned a BS in Chemical Engineering from the University of Notre Dame and an MBA in Finance and Marketing from Northwestern University, Kellogg School of Business.

    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. 

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Forward Looking Statements
    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  27. BRIDGEWATER, N.J., Sept. 18, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company) today announced that Phase III clinical trial results for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) will be presented at multiple global congresses in October and November. 

    "With the New Drug Application (NDA) now submitted for RVL-1201, we are excited to have the opportunity to present these data and build upon the scientific and medical awareness of RVL-1201 and acquired blepharoptosis," said Brian Markison, Osmotica's Chief Executive Officer.

    Phase III clinical trial data for RVL-1201 will be presented…

    BRIDGEWATER, N.J., Sept. 18, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company) today announced that Phase III clinical trial results for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) will be presented at multiple global congresses in October and November. 

    "With the New Drug Application (NDA) now submitted for RVL-1201, we are excited to have the opportunity to present these data and build upon the scientific and medical awareness of RVL-1201 and acquired blepharoptosis," said Brian Markison, Osmotica's Chief Executive Officer.

    Phase III clinical trial data for RVL-1201 will be presented at the following meetings:

    • Ophthalmology Innovation Summit ( 2019), October 10, 2019, San Francisco, California
      • Innovation Showcase podium presentation, October 10, 2019
         
    • American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium, Oct 10-11, 2019, San Francisco, California
      • Digital presentation, Oct 10-11, 2019
         
    • American Academy of Optometry (AAOptom) Academy Conference 2019, Oct 23-27, 2019, Orlando, Florida
      • Poster presentation, Oct 24, 4:30-6:30 pm
      • Vision Theater (podium) presentation, Oct 25, 11:00-11:30 am
         
    • Academy of Managed Care Pharmacy (AMCP) Nexus 2019, Oct 29-Nov 1, 2019, National Harbor, Maryland
      • Poster presentation, Oct 31, 12:30-2:00 pm
         
    • 16th annual American Academy of Aesthetic Medicine (AAAM) Congress, Nov 8-11, 2019, Las Vegas, Nevada
      • Podium presentation, Nov 9, 5:40-5:55 pm

    "We are excited to present results from the Phase III RVL-1201 studies to all of our eye care colleagues this fall. This product has the potential to revolutionize the clinical treatment of acquired blepharoptosis. The study results, combined with the simplicity of using a once-daily eye drop, would make RVL-1201 a very welcome addition to our treatment armamentarium if approved by the FDA, where the only current option is surgery," said Michael Korenfeld, MD, founder of Comprehensive Eye Care in Washington, Missouri.

    "Since optometrists are the first line of care for ptosis patients and there are no pharmacologic options approved for treatment, if approved, RVL-1201 would be an exciting therapeutic option. As a safe, effective, and simple pharmaceutical treatment for acquired blepharoptosis, RVL-1201 may provide optometrists with an opportunity to build their practices and also retain their patients who currently must be referred for surgical treatment," said Shane Foster OD, owner of Athens Eye Care in Athens, Ohio.

    Phase III Trials Assessing Efficacy and Safety of RVL-1201

    Two clinical trials in the U.S., Study RVL-1201-201 and Study RVL-1201-202 were conducted to demonstrate the efficacy of RVL-1201. Both were multicenter, double-masked, placebo-controlled clinical trials of 6 weeks' duration. The studies compared once-daily RVL-1201 with placebo (vehicle) in subjects with acquired blepharoptosis. The primary efficacy endpoint was the mean change from baseline in the number of points seen on the Leicester Peripheral Field Test, which measures the superior (upper) field of vision. Secondary efficacy endpoints included change from baseline in marginal reflex distance (MRD1), which measures the distance from the center pupillary light reflex to the central margin of the upper eyelid. Safety assessments included adverse event monitoring and reporting, vital sign monitoring, and ophthalmic examination.

    A third clinical trial conducted in the U.S., Study RVL-1201-203, assessed the long-term safety of RVL-1201. The study was a multicenter, double‑masked, placebo‑controlled trial conducted over 84 days. The primary endpoint was safety as assessed by adverse event monitoring and reporting throughout the study. Additional assessments included tolerability and ophthalmic examination (pupil diameter, Snellen visual acuity, corneal fluorescein staining, and intraocular pressure).

    About Acquired Blepharoptosis

    Acquired blepharoptosis is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis.

    About RVL-1201
    RVL-1201 is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller's muscle and elevate the upper eyelid. The standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry. If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelids.

    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. 

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Forward Looking Statements
    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  28. BRIDGEWATER, N.J., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of RVL-1201 (RVL) for the treatment of acquired blepharoptosis (droopy eyelid). 

    RVL is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller's muscle and elevate the upper eyelid.  The standard of care is surgery, which is often reserved only for severe cases and may carry…

    BRIDGEWATER, N.J., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of RVL-1201 (RVL) for the treatment of acquired blepharoptosis (droopy eyelid). 

    RVL is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller's muscle and elevate the upper eyelid.  The standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry. If approved, RVL will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelids.

    The NDA submission is supported by a robust development program with compelling safety and efficacy data from three well-controlled pivotal studies – two efficacy and one extended-duration safety trial. 

    "We are pleased to submit our NDA to the FDA.  As a potential first-in-class pharmacologic treatment, we believe RVL will provide meaningful benefits to patients around the world," said Brian Markison, Chief Executive Officer of Osmotica Pharmaceuticals.  "Our commercial planning and readiness activities are on track for a potential launch in the second half of 2020.  We are excited to enter the ophthalmic therapeutic area and look forward to exploring broader global partnership opportunities to help RVL reach its true potential," concluded Markison.

    About Acquired Blepharoptosis
    Acquired blepharoptosis is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid.  It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis.

    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. 

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Forward Looking Statements

    This press release includes statements that express the Company's 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 Company's 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. They include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:  

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  29. BRIDGEWATER, N.J., Sept. 4, 2019 /PRNewswire/ -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced results of the Company's Extraordinary General Meeting.

    At the Extraordinary General Meeting of the Company held on 29 August 2019, the resolution placed before the meeting in respect of the approval of the waiver under Rule 37 of the Irish Takeover Rules (the Rules) taken by independent shareholders of the Company on a poll was approved. The result of the poll was 3,373,340 votes for; and 1,036,232 votes against.

    Accordingly, as a result of potential future repurchases by the Company of up to 5,251,892 ordinary shares of US$0.01 each in the capital of the Company…

    BRIDGEWATER, N.J., Sept. 4, 2019 /PRNewswire/ -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced results of the Company's Extraordinary General Meeting.

    At the Extraordinary General Meeting of the Company held on 29 August 2019, the resolution placed before the meeting in respect of the approval of the waiver under Rule 37 of the Irish Takeover Rules (the Rules) taken by independent shareholders of the Company on a poll was approved. The result of the poll was 3,373,340 votes for; and 1,036,232 votes against.

    Accordingly, as a result of potential future repurchases by the Company of up to 5,251,892 ordinary shares of US$0.01 each in the capital of the Company, the aggregate percentage shareholding in the capital of the Company held by the parties specified in the table below (and persons deemed to be acting in concert with them under the Rules) (together, the Affected Parties) may proportionally increase up to the maximum percentage specified below (assuming that the Affected Parties do not participate in such repurchases). In such circumstances, the Affected Parties will not incur an obligation under Rule 37 of the Rules to make a general offer to the Company's other shareholders.


    Current Shareholding
    (Number)

    Current Shareholding
    (%)

    Potential Shareholding
    following Share
    Repurchases (%)

    Avista Capital
    Partners

    20,450,785 ordinary shares

    38.94%

    43.27%

    Altchem Limited

    22,417,540 ordinary shares

    42.68%

    47.42%

    Management
    Individuals

    2,003,099 ordinary shares

    3.81%

    4.23%

    The full text of the resolution is set of in the Notice of Extraordinary Meeting of Shareholders which is available at https://www.osmotica.com/.

    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. Our diversified product portfolio in the specialty neurology and women's health therapeutic areas, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients' lives. 

    Osmotica has a late‑stage development pipeline highlighted by two NDA candidates that recently completed Phase III clinical trials: arbaclofen ER for spasticity in multiple sclerosis patients and RVL‑1201 for the treatment of acquired blepharoptosis, or droopy eyelid.

    Osmotica has operations in the United States, Argentina, and Hungary. 

    For further information:

    Investor and Media Relations for Osmotica Pharmaceuticals plc

    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

    Cision View original content:http://www.prnewswire.com/news-releases/osmotica-pharmaceuticals-plc-announces-results-of-extraordinary-general-meeting-300910069.html

    SOURCE Osmotica Pharmaceuticals plc

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  30. BRIDGEWATER, N.J., Aug. 28, 2019 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced that Andrew Einhorn, Chief Financial Officer, will present at the 2019 Wells Fargo Healthcare Conference as follows:

    Date: Thursday, September 5, 2019
    Time: 11:30 a.m. Eastern Daylight Time
    Location: Westin Copley Place, Boston, MA
    Webcast: https://cc.talkpoint.com/well001/090419a_js/?entity=80_53C4D55

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    About Osmotica Pharmaceuticals plc
    Osmotica Pharmaceuticals plc is a fully…

    BRIDGEWATER, N.J., Aug. 28, 2019 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc ("Osmotica" or the "Company") (NASDAQ:OSMT), a fully integrated biopharmaceutical company, today announced that Andrew Einhorn, Chief Financial Officer, will present at the 2019 Wells Fargo Healthcare Conference as follows:

    Date: Thursday, September 5, 2019
    Time: 11:30 a.m. Eastern Daylight Time
    Location: Westin Copley Place, Boston, MA
    Webcast: https://cc.talkpoint.com/well001/090419a_js/?entity=80_53C4D55

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.osmotica.com under the "Investor & News" section.

    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. Our diversified product portfolio in the specialty neurology and women's health therapeutic areas, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients' lives. 

    Osmotica has a late‑stage development pipeline highlighted by two NDA candidates that recently completed Phase III clinical trials: arbaclofen ER for spasticity in multiple sclerosis patients and RVL‑1201 for the treatment of acquired blepharoptosis, or droopy eyelid.

    Osmotica has operations in the United States, Argentina, and Hungary. 

    Investor and Media Relations for Osmotica Pharmaceuticals plc
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E:

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