OSMT Osmotica Pharmaceuticals plc

5.25
+0.3  (+6%)
Previous Close 4.95
Open 4.97
52 Week Low 2.81
52 Week High 9.67
Market Cap $334,862,325
Shares 63,783,300
Float 16,719,822
Enterprise Value $466,939,325
Volume 304,542
Av. Daily Volume 419,760
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Upcoming Catalysts

Drug Stage Catalyst Date
Ontinua ER (arbaclofen)
Spasticity resulting from multiple sclerosis
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
Upneeq (RVL-1201)
Blepharoptosis
Approved
Approved
FDA Approval announced July 9, 2020.

Latest News

  1. 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:

    Primary Logo

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  2. 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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  3. 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:

    Primary Logo

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  4. 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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  5. 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

    E:  

    Primary Logo

    View Full Article Hide Full Article
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