1. DUBLIN, March 2, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will participate in a pre-recorded Fireside Chat at the H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9.

    Webcast of this event may be accessed by visiting the "Investors" section of Theravance Biopharma's website at www.theravance.com under the "Events and Presentations" tab. Replay of the webcast will be archived on the Company's website for at least 30 days.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:



    Gail Cohen

    Corporate Communications

    917-214-6603

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-participate-in-an-upcoming-investor-conference-301238153.html

    SOURCE Theravance Biopharma, Inc.

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  2. DUBLIN, Feb. 23, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the fourth quarter and full year ended December 31, 2020.

    "2020 was a critical year of growth for YUPELRI, with our commercial team persevering during a respiratory pandemic and driving increased market share," said Rick E Winningham, Chief Executive Officer. "This same resilience was seen across our organization, laying the foundation for this year's clinical development milestones for ampreloxetine and izencitinib. Our focus in 2021 is to deliver on these milestones in what could be a transformational year."

    "Importantly, we are also encouraged by the initial clinical data from a TD-0903 study in patients hospitalized with acute lung injury due to COVID-19. The data we are reporting today are from Part 1 of a two-part Phase 2 clinical study. The results show that inhaled administration of nebulized TD-0903, once daily over seven days, was generally well-tolerated and showed a numerical trend towards improved clinical status, reduced hospital stay and fewer deaths compared to placebo during a 28-day observation period. We look forward to reporting data from Part 2 in Q2 2021 and continuing to progress this potential therapy for those hospitalized with COVID-19."

    Quarterly Highlights

    • YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), continued to increase market share and achieved year-over-year sales growth of 159%; its share of the nebulized COPD market increased to 18.6% through November 2020 (up from 17.4% in September 2020).



    • TD-0903, an investigational nebulized lung-selective pan-JAK inhibitor, is in a two-part Phase 2 study (NCT04402866) comparing treatment with TD-0903 versus placebo, on a background of standard of care treatment in hospitalized patients with COVID-19 who required oxygen at the time of enrollment. Part 1 of the study explored three once-daily doses (1 mg, 3 mg, 10 mg) and matched placebo in a double-blind, multiple-ascending dose (MAD) design. Each cohort comprised eight patients (six receiving TD-0903 and two receiving placebo), all treated up to seven days with the majority receiving background standard of care therapy, including oxygen, anticoagulation and dexamethasone.



      • Part 1 Safety:
        • TD-0903 was generally well-tolerated across the three dose levels
        • There were no drug-related serious adverse events
        • One patient in the 10 mg dose cohort discontinued therapy after four days because of an isolated increase in liver alanine aminotransferase (ALT) that met pre-defined stopping criteria



      • Part 1 Exploratory Clinical Observations:
        • TD-0903 showed numerical improvements in clinical outcome and duration of hospital stay and fewer deaths compared to placebo (n=25)


    Placebo

    (n=6)

    1 mg

    (n=6)

    3 mg

    (n=7*)

    10 mg

    (n=6)

    All-Cause Mortality by Day 28

    2 (33%)

    1 (17%)

    0 (0%)

    0 (0%)

    Clinical status worsened during 7-day treatment period#

    3 (50%)

    0 (0%)

    0 (0%)

    0 (0%)

    Alive and Respiratory Failure Free on Day 28##

    4 (67%)

    5 (83%)

    6 (86%)

    6 (100%)

    Mean Time to Hospital Discharge (Days)

    22.5

    18.8

    15.3

    15.2



    * One patient in the 3 mg group received 2 doses of TD-0903 before repeated polymerase chain reaction (PCR) testing confirmed the patient did not have COVID-19. The patient was replaced per the protocol allowances and their data is included for safety but not for efficacy.

    # Worsening defined as a score of 8, 7 or 6 on World Health Organization (WHO) COVID-19 Clinical Status Ordinal Scale

    ## Respiratory Failure Free defined as a score of 1, 2, 3 or 4 on WHO COVID-19 Clinical Status Ordinal Scale

      • Part 1 Biomarkers and Pharmacokinetics (PK): 
        • Evidence of improvement in several relevant inflammatory biomarkers
        • Low systemic exposure at all doses of nebulized TD-0903, in keeping with the lung-selective design features of the molecule

    The 3 mg dose is currently being evaluated in Part 2 of the Phase 2 study, which is a randomized, double-blind, parallel-group study evaluating efficacy and safety of a seven-day course of once-daily nebulized TD-0903 compared to placebo in 198 hospitalized COVID-19 patients. The Company expects to announce data from Part 2 in Q2 2021.

    Upcoming Data Milestones

    • TD-0903 Phase 2 Part 2 expected to report results in Q2 2021
    • Ampreloxetine (norepinephrine reuptake inhibitor (NRI)) for symptomatic neurogenic orthostatic hypertension (nOH) Phase 3 study expected to report results in Q3 2021
    • Izencitinib (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases) Phase 2b/3 study in ulcerative colitis and Phase 2 study in Crohn's disease expected to report results, separately, in Q3 2021

    Economic Interest

    • TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted fourth quarter 2020 net sales of $315 million (up from $224 million in fourth quarter of 2019) and full year 2020 net sales of $1,058 million (up from $663 million in 2019), achieving year-over-year sales growth of 60%; Theravance Biopharma is entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product.2,3

    Fourth Quarter and Full Year Financial Results  

    • Revenue: Total revenue for the fourth quarter of 2020 was $18.7 million, comprised of non-cash collaboration revenue of $7.1 million primarily attributed to our global collaboration with Janssen and $11.6 million in Viatris collaboration revenue. Total revenue for the fourth quarter represents a $10.8 million decrease over the same period in 2019. Full year 2020 revenue was $71.9 million, comprised of non-cash collaboration revenue of $26.5 million primarily attributed to our global collaboration with Janssen, licensing revenue of $1.5 million related to a Viatris clinical trial application milestone and $43.9 million in Viatris collaboration revenue.



    • YUPELRI: The Viatris collaboration revenue of $11.6 million for the fourth quarter represents amounts receivable from Viatris and is comprised of the Company's 35% share of net sales of YUPELRI as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, our implied 35% share of net sales of YUPELRI for the fourth quarter of 2020 was approximately $13.6 million.



    • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2020 were $65.2 million, compared to $67.0 million in the same period in 2019. Fourth quarter R&D expenses included total non-cash share-based compensation of $7.6 million. Full year 2020 R&D expenses were $261.0 million, or $229.7 million excluding non-cash share-based compensation.



    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2020 were $30.1 million, compared to $33.0 million in the same period in 2019. Fourth quarter SG&A expenses included total non-cash share-based compensation of $8.0 million. Full year 2020 SG&A expenses were $108.7 million, or $77.0 million excluding non-cash share-based compensation.



    • Operating Loss: Operating loss for the fourth quarter of 2020 was $76.5 million compared to $70.6 million in the same period of 2019. Full year 2020 operating loss was $297.8 million, or $234.8 million excluding share-based compensation expense compared to $251.9 million, or $191.5 million excluding share-based compensation expense in 2019.



    • Cash Position: Cash, cash equivalents and marketable securities totaled $292.9 million as of December 31, 2020. 

    2021 Financial Guidance

    • Operating Expenses (excluding share-based compensation): The Company expects full year 2021 R&D expense of $195 million to $225 million and SG&A expense of $80 million to $90 million.

    Conference Call and Live Webcast Today at 5 pm ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5 pm ET / 2 pm PT / 10 pm GMT. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 9469708. Those interested in listening to the conference call live via the internet may do so by visiting Theravance.com, under the Investor Relations section, Events and Presentations.

    A replay will be available on Theravance.com for 30 days through March 25, 2021. An audio replay will also be available through 8:00 pm ET on March 2, 2021 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 9469708.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Its purpose is to pioneer a new generation of small molecule drugs designed to better meet patient needs. Its research is focused in the areas of inflammation and immunology.

    In pursuit of its purpose, Theravance Biopharma applies insights and innovation at each stage of its business and utilize its internal capabilities and those of partners around the world. The Company applies organ-selective expertise to target disease biologically, to discover and develop medicines that may expand the therapeutic index with the goal of maximizing efficacy and limiting systemic side effects. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its pipeline of internally discovered programs is targeted to address significant patient needs.

    Theravance Biopharma has an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris Company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that the Company's research programs will progress product candidates into the clinic, the Company's expectations for product candidates through development, the Company's expectations regarding its allocation of resources, potential regulatory approval and commercialization (including their differentiation from other products or potential products), product sales or profit share revenue and the Company's expectations for its expenses, excluding share-based compensation and other financial results. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: current and potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. In addition, while we expect the effects of COVID-19 to continue to adversely impact our business operations and financial results, the extent of the impact on our ability to generate revenue from YUPELRI® (revefenacin), our clinical development programs (including but not limited to our later stage clinical programs for izencitinib and ampreloxetine), and the value of and market for our ordinary shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. These potential future developments include, but are not limited to, the ultimate duration of the COVID-19 pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, other measures taken by us and those we work with to help protect individuals from contracting COVID-19, and the effectiveness of actions taken globally to contain and treat the disease, including vaccine availability, distribution, acceptance and effectiveness. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on November 9, 2020 and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact: Gail B. Cohen

    Corporate Communications

    917-214-6603

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

























































    Three Months Ended December 31,



    Year Ended December 31,





    2020



    2019



    2020



    2019





    (Unaudited)



    (Unaudited)



    (1)

    Revenue:

























    Collaboration revenue



    $

    7,083



    $

    9,584



    $

    26,464



    $

    31,250

    Licensing revenue





    -





    10,000





    1,500





    28,500

    Viatris collaboration agreement





    11,647





    9,915





    43,893





    13,664

    Total revenue 





    18,730





    29,499





    71,857





    73,414



























    Costs and expenses:

























       Research and development (2)





    65,165





    67,025





    260,953





    219,248

       Selling, general and administrative (2)





    30,055





    33,046





    108,661





    106,081

       Total costs and expenses  





    95,220





    100,071





    369,614





    325,329

    Loss from operations  





    (76,490)





    (70,572)





    (297,757)





    (251,915)

    Income from investment in TRC, LLC





    20,139





    11,913





    68,438





    33,705

    Interest expense





    (11,680)





    (8,035)





    (44,585)





    (31,862)

    Loss on extinguishment of debt





    -





    -





    (15,464)





    -

    Interest and other income, net





    798





    1,137





    2,831





    8,395

    Loss before income taxes  





    (67,233)





    (65,557)





    (286,537)





    (241,677)

    Provision for income tax benefit (expense)





    8,799





    (49)





    8,520





    5,222

    Net loss  



    $

    (58,434)



    $

    (65,606)



    $

    (278,017)



    $

    (236,455)



























    Net loss per share:

























    Basic and diluted net loss per share  



    $

    (0.92)



    $

    (1.17)



    $

    (4.46)



    $

    (4.25)

    Shares used to compute basic and diluted net loss per share  





    63,725





    56,102





    62,345





    55,610



    ________________________________



















































    (1) The condensed consolidated statement of operations for the year ended December 31, 2019 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019.



    (2) Amounts include share-based compensation expense as follows:







    Three Months Ended December 31,



    Year Ended December 31,

    (In thousands)



    2020



    2019



    2020



    2019

    Research and development 



    $

    7,570



    $

    10,615



    $

    31,294



    $

    28,953

    Selling, general and administrative 





    7,981





    13,297





    31,682





    31,497

    Total share-based compensation expense 



    $

    15,551



    $

    23,912



    $

    62,976



    $

    60,450

     

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

















    December 31,



    December 31,



    2020



    2019

    Assets

    (Unaudited)



    (1)

    Current assets:







    Cash and cash equivalents and short-term marketable securities

    $

    292,941



    $

    280,831

    Receivables from collaborative arrangements



    15,868





    11,996

    Receivables from licensing arrangements



    -





    10,000

    Amounts due from TRC, LLC



    53,799





    28,574

    Prepaid clinical and development services



    20,374





    2,736

    Other prepaid and current assets  



    10,359





    4,351

      Total current assets  



    393,341





    338,488

    Property and equipment, net  



    16,422





    12,644

    Long-term marketable securities



    -





    4,985

    Operating lease assets



    43,260





    46,604

    Equity in net assets of TRC, LLC



    12,750





    -

    Restricted cash  



    833





    833

    Other assets



    2,451





    5,272

     Total assets  

    $

    469,057



    $

    408,826













    Liabilities and Shareholders' Deficit











    Current liabilities

    $

    123,571



    $

    111,703

    Convertible senior notes due 2023, net



    226,963





    225,890

    Non-recourse notes due 2035, net



    372,873





    -

    Non-recourse notes due 2033, net



    -





    219,300

    Long-term operating lease liabilities



    47,220





    47,725

    Other long-term liabilities



    2,181





    28,048

    Shareholders' deficit



    (303,751)





    (223,840)

    Total liabilities and shareholders' deficit

    $

    469,057



    $

    408,826



    ________________________________























    (1)  The condensed consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019.

    1 While Viatris, Inc. ("Viatris") records the total YUPELRI net sales, the Company is entitled to a 35% share of the profits and losses pursuant to a co-promotion agreement with Viatris.

    2 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles the Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC (TRC) expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). 75% of the income from the Company's investment in TRC is pledged to service outstanding notes, 25% of income from the Company's investment in TRC is retained by the Company.

    3 On June 10, 2020, the Company disclosed in a Form 8-K that it had formally objected to Theravance Respiratory Company, LLC ("TRC") and Innoviva, as the manager of TRC, regarding their proposed plan to use TRELEGY royalties to invest in certain privately-held companies, funds that would otherwise be available for distribution to the Company under the terms of the TRC LLC Agreement. The Company intends to continue to seek to protect its interests in this matter consistent with the dispute resolution procedures of the TRC LLC Agreement. In this regard, the Company initiated an arbitration proceeding against Innoviva and TRC in October 2020 challenging the authority of Innoviva and TRC to pursue such a business plan rather than distribute such funds to the Company in a manner consistent with the LLC Agreement and the Company's 85% economic interest in TRC. The arbitration hearing was held during the week of February 16, 2021, with post-hearing briefing and arguments to take place over the next few weeks. We currently anticipate a decision in those proceedings near the end of the current quarter or early in the second quarter of 2021.

     

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  3. DUBLIN, Feb. 10, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will participate in investor events as follows:

    • Management will be participating in a Fireside Chat at the SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24 at 12:00 p.m. ET (9:00 a.m. PT/5:00 p.m. GMT)
    • Richard A. Graham (Senior Vice President, Development) will be participating in the GI/Microbiome Panel at the Cowen 41st Annual Cowen on Tuesday, March 2 at 11:10 a.m. ET (8:10 a.m. PT/4:10 p.m. GMT)

    Webcast of the events may be accessed by visiting the "Investors" section of Theravance Biopharma's website at www.theravance.com under the "Presentations and Events" tab. Replay of the webcast will be archived on the Company's website for at least 30 days.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:



    Gail Cohen

    Corporate Communications

    917-214-6603

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  4. DUBLIN, Feb. 9, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will report its fourth quarter and full year 2020 financial results and provide a business update after market close on Tuesday, February 23, 2021. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

    Conference Call Information

    To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 9469708. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Events and Presentations.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through March 25, 2021. An audio replay will also be available through 8:00 p.m. ET on March 2, 2021 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 9469708.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).

    YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:



    Gail Cohen

    Corporate Communications

    917-214-6603

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-report-fourth-quarter-and-full-year-2020-financial-results-on-february-23-2021-301224371.html

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  5. DUBLIN, Jan. 5, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, will webcast its presentation at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021, at 2:00 p.m. ET (11:00 a.m. PT/7:00 p.m. GMT). A webcast of the presentation may be accessed by visiting the "Investors" section of the Company's website at https://investor.theravance.com/events-and-presentations, and the replay will be archived for 30 days.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:



    Gail Cohen

    Corporate Communications

    917-214-6603

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-present-at-the-39th-annual-jp-morgan-healthcare-conference-301200465.html

    SOURCE Theravance Biopharma, Inc.

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  6. DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will webcast a presentation as follows:

    • Evercore ISI 3rd Annual HEALTHCONx Conference on Tuesday, December 1 at 2:40 p.m. ET (11:40 a.m. PT/7:40 p.m. GMT)

    Webcast of the presentation may be accessed by visiting the "Investors" section of Theravance Biopharma's website at www.theravance.com under the "Presentations and Events" tab. Replay of the webcast will be archived on the Company's website for at least 30 days.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:



    Gail Cohen

    Corporate Communications

    917-214-6603

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-present-at-the-3rd-annual-evercore-isi-healthconx-conference-301174097.html

    SOURCE Theravance Biopharma, Inc.

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  7. DUBLIN, Nov. 5, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the third quarter ending September 30, 2020. Theravance Biopharma's Total Revenue for the third quarter 2020 was $18.3 million. Operating loss was $76.6 million, or $61.1 million excluding share-based compensation expense. Cash, cash equivalents and marketable securities totaled $358.3 million as of September 30, 2020.

    In connection with the commercialization of YUPELRI®, the Company is entitled to a share of U.S. profits and losses (65% to Mylan; 35% to the Company) pursuant to its agreement with Mylan. While Mylan records the total Net Sales of YUPELRI within its financial statements, Theravance Biopharma's implied 35% share of net sales for YUPELRI during Q3 2020 was $13.0 million (up from $5.8 million in Q3 2019). Going forward, Theravance Biopharma will report its implied 35% of Net Sales for YUPELRI in public communications and in the Company's quarterly SEC filings on Form 10-Q and Form 10-K.

    "YUPELRI gained market share, delivered sales growth versus the second quarter and achieved brand profitability for Theravance Biopharma thanks to the efforts of the Mylan and Theravance Biopharma commercial teams. Based on the constraints posed by the pandemic, the team implemented a hybrid model of virtual selling, utilizing digital resources and in-person meetings when and where permitted," said Rick E Winningham, Chief Executive Officer.

    "Despite ongoing challenges and the uncertain environment created by the global pandemic, we have seen a significant uptick in clinical trial enrollment. We therefore have more confidence in guiding to Phase 3 results for ampreloxetine for symptomatic neurogenic orthostatic hypotension (nOH) and for TD-1473 Phase 2b results in ulcerative colitis and Phase 2 results in Crohn's disease in Q3 2021."

    "We completed the TD-8236 Phase 1 Part C and Phase 2a Lung Allergen Challenge (LAC) study. The LAC study represented the first time an inhaled JAK inhibitor was studied in such a model. We met our primary objectives with the Phase 1 Part C study in moderate-to-severe asthmatics dosing TD-8236 with an inhaled corticosteroid. Decreases in key inflammatory biomarkers were seen in the TD-8236 plus steroid arm versus the steroid alone arm. Gene expression and cytokine data from the Phase 1 Part C is still under analysis. While we are still reviewing the full data set, TD-8236 as a single agent did not meet the primary objective of the Phase 2a LAC study."

    "In regard to TD-0903, we have had a chance to review the Phase 1 data. Results showed favorable safety and tolerability profile across the full range of nebulized doses and low systemic levels of TD-0903 in the systemic circulation, consistent with the lung-selective design. This has given us confidence as we continue to dose patients in the Phase 2 COVID-19 trial, which is being conducted in multiple locations around the world with results expected in Q2 2021."

    Corporate Highlights

    YUPELRI® (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)): 

    • First and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), reimbursed by Part B Medicare program
    • Overall market challenges remain due to COVID-19, yet YUPELRI increased market share and achieved quarter-over-quarter net sales growth of 22%; achieved stand-alone brand profitability in Q3 2020
    • Data as of July 2020 show that YUPELRI achieved 17.4% share (up from 16% in April 2020) of the long-acting nebulized bronchodilator market and 93% share (up from 91.8% in Q2 2020) of the nebulized LAMA market; market data reflects IQVIA Retail Data and the Durable Medical Equipment (DME) market segment

    Key Pipeline Progress

    The COVID-19 pandemic has made it difficult to operate a business in many ways and none more so than in clinical trials. Despite the challenges, Theravance Biopharma has been encouraged by the response to our ongoing clinical trial recruitment efforts. By design, both ampreloxetine and TD-1473 clinical programs employ geographical diversity, which has allowed the Company to continue to work closely with sites to continue enrollment where possible.

    Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):

    • Ongoing registrational program in symptomatic nOH comprised of:
      • Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy expected to read out in Q3 2021  
      • Phase 3 four-month open-label study followed by a six-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response
      • Phase 3 26-week open-label study (OAK), which is a long-term extension study that will be ongoing at the time of registration, to allow subjects completing REDWOOD to have continued access to ampreloxetine for up to 3.5 years and to collect safety and tolerability data over the course of treatment
    • Given the ongoing pandemic and the fragility of the patient population, the Company worked with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to update the protocol for these clinical trials to accommodate a decentralized approach in which patients can participate in the majority of the study from home without needing to attend clinic visits; this infrastructure, leveraging a telemedicine platform and in-home healthcare assessments, is now being rolled out globally.

    TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases): 

    • RHEA (this program consists of 3 separate studies in Ulcerative Colitis):
      • Phase 2b eight-week placebo-controlled dose-finding induction study expected to read out in Q3 2021
      • Phase 3 eight-week placebo-controlled dose-confirming induction study to start after dose selection based on Phase 2b Induction Study results (to be initiated post-Janssen opt-in)
      • Phase 3 44-week placebo-controlled maintenance study in which subjects roll over from either the Phase 2b or Phase 3 Induction Study
    • DIONE:
      • Phase 2 placebo-controlled induction study in Crohn's disease expected to read out in Q3 2021 with patients given the potential to continue to receive ongoing access to TD-1473 as part of a long-term extension study

    TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):

    • TD-5202 was generally well-tolerated as a single oral dose up to 2,000 milligrams and as a twice-daily oral dose up to 2,000 milligrams total per day given for 10 consecutive days in healthy subjects

    TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory lung diseases):

    • The Part C extension portion of the Phase 1 trial assessing additional biomarkers in moderate-to-severe asthmatics demonstrated biomarkers of JAK target engagement (pSTAT1 and pSTAT6) were reduced in cellular fractions of bronchoalveolar lavage fluid after 7 days of once-daily dosing at a dose level of 1500 µg
    • TD-8236 is the first JAK inhibitor to be studied in a Phase 2a Lung Allergen Challenge (LAC) study; TD-8236 had no impact on decrease in lung function (FEV1) following the LAC study after 14 days of once-daily dosing at dose levels of 150 µg and 1500 µg
      • FeNO was reduced at 1500 µg consistent with previous studies; lack of FeNO response at 150 µg and lack of effect on late asthmatic response (LAR) at 150 µg was expected based on previous studies
      • TD-8236 engages the JAK mechanism at a dose of 1500 µg as evidenced by the reductions in FeNO consistent with Phase 1; lack of effect on the LAR at 1500 µg in the LAC study was inconsistent with expectations

    The collective data set (pre-clinical, Phase 1, Phase 2a) demonstrates TD-8236 engages the JAK mechanism at a dose of 1500 µg as evidenced by the reduction in FeNO and reductions in pSTAT. The Company will continue to analyze the data set including the forthcoming gene expression and cytokine data from the Phase 1 Part C study.

    TD-0903 (nebulized lung-selective pan-JAK inhibitor for acute hyperinflammation of the lung in COVID-19 and chronic inflammation for the prevention of lung transplant rejection):

    For treatment of Acute Lung Injury caused by COVID-19

    • Completed Phase 1 study to assess the safety, tolerability and pharmacokinetics (PK) of single- and multiple-ascending doses (SAD/MAD) in healthy volunteers; data provided confidence to continue dosing patients in a Phase 2 study
      • Favorable safety and tolerability profile across the full range of nebulized doses from 1 to 10 mg after once-daily dosing for 7 days
      • Low systemic levels of TD-0903 in the blood, consistent with lung-selective design
      • PK profile supports long duration of exposure in the lung, consistent with pre-clinical models and supporting once-daily dosing
    • Initiated Phase 2 study in June 2020; Part 1 was a multiple dose-ascending study (from 1 to 10 mg doses) conducted in 24 hospitalized COVID-19 patients that has now completed dosing. Part 2 is a randomized, double-blind, parallel-group study evaluating efficacy and safety of one dose of TD-0903 compared with placebo in approximately 200 hospitalized COVID-19 patients; the Company expects to report results of the Phase 2 study in Q2 2021

    The ongoing effects of the COVID-19 pandemic present a substantial public health and economic challenge, affecting our employees, patients, communities, clinical trial sites, suppliers, business partners and business operations. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact our business will depend on future developments that are highly uncertain, including the ongoing spread of the virus globally, and the actions taken to contain or treat it.

    Economic Interest

    TRELEGY (first once-daily single inhaler triple therapy for COPD)1

    • 3Q 2020 net sales of $251.9 million (up from $172.8 million in Q3 2019); Theravance Biopharma is entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
    • GSK received FDA approval to expand the label to include asthma on September 9, 2020; the European Medicines Agency accepted the regulatory submission for the treatment of asthma in adults supported by the Phase III CAPTAIN study
    • GSK received a Complete Response Letter for the addition of the mortality indication

    Notes:1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles the Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC (TRC) expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). 75% of the income from the Company's investment in TRC is pledged to service outstanding notes, 25% of income from the Company's investment in TRC is retained by the Company.

    Innoviva and Theravance Respiratory Company 

    On June 10, 2020, the Company disclosed in a Form 8-K that it had formally objected to Theravance Respiratory Company, LLC ("TRC") and Innoviva, as the manager of TRC, regarding their proposed plan to use TRELEGY royalties to invest in certain privately-held companies, funds that would otherwise be available for distribution to the Company under the terms of the TRC LLC Agreement. The Company intends to continue to seek to protect its interests in this matter consistent with the dispute resolution procedures of the TRC LLC Agreement. In this regard, the Company initiated an arbitration proceeding against Innoviva and TRC in October 2020 challenging the authority of Innoviva and TRC to pursue such a business plan rather than distribute such funds to the Company in a manner consistent with the LLC Agreement and the Company's 85% economic interest in TRC. An arbitration hearing is scheduled for the first quarter of 2021. 

    Third Quarter Financial Results  

    • Revenue: Total revenue for the third quarter of 2020 was $18.3 million, comprised of non-cash collaboration revenue of $7.3 million primarily attributed to the Janssen collaboration agreement for TD-1473 and $11.0 million in Mylan collaboration revenue related to net sales of YUPELRI. Total revenue for the third quarter represents a $5.8 million increase over the same period in 2019. The increase was primarily due to a $7.4 million increase in Mylan collaboration revenue which was partially offset by a $1.6 million decrease in Janssen collaboration revenue. The decrease in Janssen collaboration revenue was due to a smaller portion of revenue recognized in the third quarter 2020 related to the $100.0 million upfront payment from the Janssen collaboration agreement that was entered into in February 2018.



    • YUPELRI: The Mylan collaboration revenue of $11.0 million represents amounts receivable from Mylan and is comprised of the Company's implied 35% share of net sales of YUPELRI as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred by us are recorded within operating expenses. While Mylan records the total net sales of YUPELRI within its financial statements, our implied 35% share of net sales of YUPELRI for the third quarter of 2020 was approximately $13.0 million. Going forward, we will report our implied 35% share of net sales for YUPELRI in future communications.



    • Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2020 were $67.4 million, compared to $52.0 million in the same period in 2019. The $15.4 million increase was primarily due to (i) a $10.2 million increase in external-related expenses related to the advancement of our priority programs, notably the continued progression of TD-1473, ampreloxetine, TD-8236, and the initiation of TD-0903 in COVID-19; (ii) a $3.5 million increase in employee-related expenses primarily due to increases in compensation-related expenses; and (iii) a $1.3 million increase in share-based compensation expense primarily due to an increase in annual grants of share-based awards to employees. Third quarter R&D expenses included total non-cash share-based compensation of $7.8 million.



    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2020 were $27.5 million, compared to $25.6 million in the same period in 2019. The $1.9 million increase was primarily attributed to (i) a $1.2 million increase in employee-related expenses primarily due to increases in compensation-related expenses; (ii) a $1.2 million increase in share-based compensation expense primarily due to an increase in annual grants of share-based awards to employees; and (iii) a $0.6 million increase in facilities and other expenses. These increases were partially offset by a $1.2 million decrease in external-related expenses primarily related to legal and consulting services. Third quarter SG&A expenses included total non-cash share-based compensation of $7.8 million.



    • Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $358.3 million as of September 30, 2020.  

    2020 Financial Guidance

    • Operating Loss (excluding share-based compensation): The Company is changing financial guidance and expects full-year 2020 operating loss, excluding share-based compensation, of $225 million to $235 million. Operating loss guidance does not include:
      • Royalty income for TRELEGY which the Company recognizes in its statement of operations as "income from investment in TRC, LLC;" or
      • Potential future business development collaborations

    Annual Meeting

    The Company will hold its 2021 Annual General Meeting on April 27, 2021.

    Conference Call and Live Webcast Today at 5 pm ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5 pm ET / 2 pm PT / 10 pm GMT. To participate in the live call by telephone, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 1269525. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through December 5, 2020. An audio replay will also be available through 8:00 pm ET on November 12, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 1269525.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that the Company's research programs will progress product candidates into the clinic, the Company's expectations for product candidates through development, potential regulatory approval and commercialization (including their differentiation from other products or potential products), product sales or profit share revenue and the Company's expectations for its 2020 operating loss, excluding share-based compensation. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: current and potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. In addition, while we expect the COVID-19 pandemic to continue to adversely impact our business operations and financial results, the extent of the impact on our ability to generate revenue from YUPELRI, our clinical development programs (in particular our later stage clinical programs for TD-1473 and ampreloxetine) and the value of and market for our common shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. These potential future developments include, but are not limited to, the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. Other risks affecting Theravance Biopharma are in the company's Form 10-Q filed with the SEC on August 10, 2020 and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact:

    Gail B. Cohen

    Corporate Communications and Investor Relations

    917-214-6603













    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

















    September 30,



    December 31,



    2020



    2019

    Assets

    (Unaudited)



    (1)

    Current assets:







    Cash and cash equivalents and short-term marketable securities

    $

    358,347



    $

    280,831

    Receivables from collaborative arrangements



    12,399





    11,996

    Receivables from licensing arrangements



    -





    10,000

    Amounts due from TRC, LLC



    48,909





    28,574

    Prepaid clinical and development services



    20,761





    2,736

    Other prepaid and current assets  



    10,308





    4,351

      Total current assets  



    450,724





    338,488

    Property and equipment, net  



    15,430





    12,644

    Long-term marketable securities



    -





    4,985

    Operating lease assets



    44,391





    46,604

    Restricted cash  



    833





    833

    Other assets



    810





    5,272

     Total assets  

    $

    512,188



    $

    408,826













    Liabilities and Shareholders' Deficit











    Current liabilities

    $

    104,270



    $

    111,703

    Convertible senior notes due 2023, net



    226,695





    225,890

    Non-recourse notes due 2035, net



    384,482





    -

    Non-recourse notes due 2033, net



    -





    219,300

    Long-term operating lease liabilities



    47,823





    47,725

    Other long-term liabilities



    10,454





    28,048

    Shareholders' deficit



    (261,536)





    (223,840)

    Total liabilities and shareholders' deficit

    $

    512,188



    $

    408,826













    ________________________________























    (1)  The condensed consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated financial

    statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019.

     



























    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

























































    Three Months Ended September 30,



    Nine Months Ended September 30,





    2020



    2019



    2020



    2019





    (Unaudited)



    (Unaudited)

    Revenue:

























    Collaboration revenue



    $

    7,261



    $

    8,836



    $

    19,381



    $

    21,666

    Licensing revenue





    -





    -





    1,500





    18,500

    Mylan collaboration agreement





    10,996





    3,591





    32,246





    3,749

    Total revenue 





    18,257





    12,427





    53,127





    43,915



























    Costs and expenses:

























       Research and development (1)





    67,371





    52,006





    195,788





    152,223

       Selling, general and administrative (1)





    27,501





    25,622





    78,606





    73,035

       Total costs and expenses  





    94,872





    77,628





    274,394





    225,258

    Loss from operations  





    (76,615)





    (65,201)





    (221,267)





    (181,343)

    Income from investment in TRC, LLC





    13,403





    7,197





    48,299





    21,792

    Interest expense





    (11,573)





    (8,068)





    (32,905)





    (23,827)

    Loss on extinguishment of debt





    -





    -





    (15,464)





    -

    Interest and other income, net





    1,235





    2,089





    2,033





    7,258

    Loss before income taxes  





    (73,550)





    (63,983)





    (219,304)





    (176,120)

    Provision for income tax (expense) benefit





    (93)





    5,552





    (279)





    5,271

    Net loss  



    $

    (73,643)



    $

    (58,431)



    $

    (219,583)



    $

    (170,849)



























    Net loss per share:

























    Basic and diluted net loss per share  



    $

    (1.16)



    $

    (1.05)



    $

    (3.55)



    $

    (3.08)

    Shares used to compute basic and diluted net loss per share  





    63,303





    55,858





    61,881





    55,445



























    ________________________________



















































    (1)Amounts include share-based compensation expense as follows:



















































    Three Months Ended September 30,



    Nine Months Ended September 30,

    (In thousands)



    2020



    2019



    2020



    2019

    Research and development 



    $

    7,761



    $

    6,458



    $

    23,724



    $

    18,338

    Selling, general and administrative 





    7,803





    6,561





    23,701





    18,200

    Total share-based compensation expense 



    $

    15,564



    $

    13,019



    $

    47,425



    $

    36,538

     

     

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  8. DUBLIN, Oct. 22, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will report its third quarter 2020 financial results and provide a business update after market close on Thursday, November 5, 2020. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

    Conference Call Information

    To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 1269525. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through December 5, 2020. An audio replay will also be available through 8:00 p.m. ET on November 12, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 1269525.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).

    YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Gail Cohen

    Corporate Communications and Investor Relations

    917-214-6603

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  9. Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for people with central nervous system (CNS) disorders, today announced that it has expanded its leadership team as it works to advance its clinical and preclinical-stage portfolio of novel programs for both rare and prevalent conditions. The leadership appointments include Dean J. Mitchell as chairman of the board of directors, Nicole Sweeny as chief commercial officer and Alyssa Wyant as senior vice president, regulatory and quality. Mr. Mitchell replaces former chairman Nicholas Galakatos, Ph.D., global head of Blackstone Life Sciences, who will continue to serve as a director of Praxis.

    "We are thrilled…

    Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for people with central nervous system (CNS) disorders, today announced that it has expanded its leadership team as it works to advance its clinical and preclinical-stage portfolio of novel programs for both rare and prevalent conditions. The leadership appointments include Dean J. Mitchell as chairman of the board of directors, Nicole Sweeny as chief commercial officer and Alyssa Wyant as senior vice president, regulatory and quality. Mr. Mitchell replaces former chairman Nicholas Galakatos, Ph.D., global head of Blackstone Life Sciences, who will continue to serve as a director of Praxis.

    "We are thrilled to welcome this esteemed group of leaders to the team, each of whom brings significant expertise in their respective functions," said Marcio Souza, president and chief executive officer of Praxis. "Praxis is at an exciting stage in its evolution following our recent financing, with multiple potential value creating milestones expected over the next year. Dean's extensive industry track record and wealth of strategy and development insights will be invaluable as we enter the next phase of growth for our company. Nicole's background leading portfolio and product strategy and Alyssa's experience leading regulatory functions will be critical as we navigate the clinical development and potential registration paths for our programs in depression, movement disorders, pain and epilepsy."

    Dean J. Mitchell is a pharmaceutical industry veteran, with extensive expertise building and leading biopharmaceutical companies as chairman or chief executive officer across all stages of growth and product development. Mr. Mitchell is the former chairman of Covid Pharma Holdings and PaxVax Corporation, prior to their respective sales, and currently serves as chairman of the board of directors of Kinnate Biopharma Inc., and as a member of the board of directors at Theravance Biopharma, Inc. (NASDAQ:TBPH), ImmunoGen Inc. (NASDAQ:IMGN) and Precigen Inc. (formerly Intrexon Inc.).

    Nicole Sweeny has nearly 20 years of commercial experience from product strategy to multiple specialty and rare disease launches across more than a dozen approved products. Ms. Sweeny previously served as franchise head/U.S. general manager at Takeda, and earlier, held U.S. and global roles of increasing responsibility at Shire and Genzyme.

    Alyssa Wyant brings more than 20 years of regulatory affairs experience to Praxis, including having led the creation and implementation of global strategies for the development, registration and post-approval activities for numerous approved products across both CNS and rare diseases. Most recently, Ms. Wyant served as senior vice president, regulatory affairs at EryDel S.p.A, and earlier, held senior leadership roles at Edge Therapeutics, Inc. and PTC Therapeutics, Inc.

    "Praxis is making swift progress in the advancement of their portfolio of therapies for the treatment of a range of CNS disorders, and I am pleased to join the board at such a pivotal time in its evolution," said Mr. Mitchell. "The company's approach to restoring excitatory and inhibitory balance to neuronal circuits in the brain has the potential to address prevalent psychiatric diseases and neurologic disorders, as well as severe pediatric epilepsies, and I look forward to working closely with Marcio and the team to advance this exciting and potentially high-impact pipeline."

    About Praxis

    Praxis is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. We are applying insights into genetic mutations that drive excitation-inhibition imbalance to enable us to develop a pipeline addressing prevalent psychiatric and neurologic conditions and rare diseases. We have established a broad portfolio, including five disclosed programs across multiple CNS disorders, including depression, epilepsy, movement disorders and pain syndromes. For more information, please visit www.praxismedicines.com.

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  10. DUBLIN, Sept. 1, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will webcast Management presentations as follows:

    • Morgan Stanley 18th Annual Global Healthcare Conference 2020 on Monday, September 14 at 1:30 p.m. ET (10:30 a.m. PT/5:30 p.m. GMT)
    • H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15 at 9:30 a.m. ET (6:30 a.m. PT/1:30 p.m. GMT)

    Webcasts of the presentations may be accessed by visiting the "Investors" section of Theravance Biopharma's website at www.theravance.com under the "Presentations and Events" tab. Replays of the webcasts will be archived on the Company's website for at least 30 days.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Gail Cohen

    Corporate Communications and Investor Relations

    917-214-6603

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-present-at-upcoming-investor-conferences-301121359.html

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  11. DUBLIN, Aug. 6, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the second quarter ending June 30, 2020. Revenue for the second quarter 2020 was $15.0 million. Operating loss was $72.2 million, or $55.6 million excluding share-based compensation expense. Cash, cash equivalents and marketable securities totaled $438.3 million as of June 30, 2020.

    "This quarter was the first quarter for Theravance Biopharma working completely remotely, with the exception of our essential lab workers, and I could not be more proud and grateful of the work the team has been able to deliver. We will continue to incorporate the key learnings into our processes and will work to ensure that we become an even stronger company post-pandemic," said Rick E Winningham, Chief Executive Officer.

    "Our commercial team continued to find ways to sustain market share momentum with YUPELRI, coordinating meaningful interactions with their accounts by leveraging digital and virtual selling tools. Given the challenges in a market which was and continues to be negatively affected by COVID-19, we were able to improve YUPELRI market share. Moving into the third quarter, we are tailoring our sales model to a hybrid model – in-person and remote call options – that can be modified depending on state and local restrictions, as well as customer preference. This allows our field teams to customize their approach based on what's right for them and their customers, always keeping health and safety the priority. We continue to forecast YUPELRI becoming a cash-flow positive brand in the United States (US) by the end of 2020."

    "We continue to move our clinical programs forward despite ongoing challenges from the global pandemic. These challenges have resulted in delays in our late stage clinical programs for ampreloxetine, a norepinephrine reuptake inhibitor (NRI) under evaluation for the treatment of symptomatic neurogenic orthostatic hypotension (nOH), and TD-1473, a gut-selective oral JAKi in development for inflammatory intestinal disease in Crohn's and ulcerative colitis. We continue to expect both programs to readout in 2021. Regarding TD-8236, our lung-selective dry powder inhaled pan-JAK inhibitor in development for inflammatory lung disease, we expect to report data from the asthma Phase 2 program in fourth quarter 2020."

    "During the second quarter, the team leaned into our organizational expertise in respiratory disease and moved our pre-clinical candidate TD-0903 into the clinic at an accelerated pace in response to the COVID-19 pandemic. We designed TD-0903 to be a lung-selective nebulized JAKi with the intent of addressing lung hyperinflammation in both the acute and chronic setting. In June, we completed Phase 1 and entered a Phase 2 study in the United Kingdom (UK) exploring the potential of TD-0903 to treat hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19 to prevent progression to Acute Respiratory Distress Syndrome (ARDS) and the need for assisted ventilation. We are now opening additional sites in other countries to accelerate TD-0903's progression in the clinic."

    Corporate Highlights

    YUPELRI® (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)): 

    • First and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), reimbursed by Part B Medicare program
    • COVID-19 resulted in decreased overall market demand, yet YUPELRI increased market share; trajectory could continue to be affected by COVID-19 in third quarter
    • Data as of April 2020 show that YUPELRI achieved a 91.8% share (up from 87% in Q1 2020) of the nebulized LAMA market and a 16% share (up from 13.7% in Q1 2020) of the long-acting nebulized market; market data reflects IQVIA Retail Data and the Durable Medical Equipment (DME) market segment

    Key Pipeline Progress

    The COVID-19 pandemic continues to be a threat to public health throughout the world, however Theravance Biopharma is encouraged by the ability to initiate the reopening of clinical sites for new patient screenings for ampreloxetine and TD-1473. The health and safety of the community Theravance Biopharma serves is the Company's utmost priority; therefore, the Company is continuing to work closely with investigator sites and vendors to help ensure their safety and that of the study participants as they contribute to our clinical programs. In mid-March, both programs paused new patient screenings for four weeks to allow sites to focus on supporting patients who were already in screening or already randomized and preserve data collection during this period. Screening of new patients resumed in mid-April, and Theravance Biopharma has seen a significant percentage of sites reopen to new patients globally.

    By design, both ampreloxetine and TD-1473 clinical programs employ geographical diversity, which has allowed the Company to continue assessing where to reopen sites based on where the pandemic is waning. That said, the pandemic shows no signs of stopping, and Theravance Biopharma expects ongoing challenges as new "hot spots" emerge. We continue to expect both programs to readout in 2021.

    Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):

    • Ongoing registrational program in symptomatic neurogenic orthostatic hypertension (nOH) comprised of two studies:
      • Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy, with data expected in 2021
      • Phase 3 four-month open label study followed by a six-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response
    • Given the ongoing pandemic and the fragility of the patient population, the Company, with input from the Food and Drug Administration (FDA) and other regulatory agencies and ethics committees, is working to adjust the protocol for these clinical trials to accommodate a decentralized approach in which patients can participate in the studies from home without needing to attend clinic visits

    TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases): 

    • Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn's disease (DIONE) progressing
    • Enrollment continues in both studies, and data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn's disease studies is expected in 2021

    TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):

    • TD-5202 was generally well tolerated as a single oral dose up to 2000 milligrams and as a twice-daily oral dose up to 2000 milligrams total per day given for 10 consecutive days in healthy subjects

    TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory lung diseases):

    • Part C extension portion of the Phase 1 trial assessing additional biomarkers in moderate to severe asthmatics underway with results expected in 4Q 2020
    • Phase 2 lung allergen challenge study initiated in 4Q 2019; data expected 4Q 2020

    TD-0903 (lung-selective nebulized pan-JAK inhibitor for treatment of Acute Lung Injury caused by COVID-19)

    • Completed Phase 1 study to assess the safety, tolerability and pharmacokinetics of single-and multiple-ascending doses (SAD/MAD) in healthy volunteers; data expected 4Q 2020
    • Phase 2 study was initiated in the UK on June 25, 2020; to expedite enrollment in the study, we are opening additional sites in other regions including Europe and the US, pending approval by the relevant regulatory agencies and ethics committees

    Economic Interest

    TRELEGY (first once-daily single inhaler triple therapy for COPD)1

    • 2Q 2020 net sales of $241 million; Theravance Biopharma is entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
    • GSK sNDA approval for asthma expected 2H 2020; The European Medicines Agency accepted the regulatory submission for the treatment of asthma in adults supported by the Phase III CAPTAIN study
    • GSK sNDA for survival benefit claim over ANORO is under review; FDA postponed the Advisory Committee Meeting originally scheduled to review this sNDA on April 21, 2020; rescheduled Advisory Committee has not been publicly updated by FDA

    Notes:

    1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC (TRC) expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). 75% of the income from Company's investment in TRC is pledged to service outstanding notes, 25% of income from Company's investment in TRC is retained by Company.

    Innoviva and Theravance Respiratory Company

    On June 10, 2020, we disclosed in a Form 8-K our objections to Theravance Respiratory Company, LLC ("TRC") and Innoviva, as the manager of TRC, regarding TRC's proposed use of funds to invest in certain privately-held companies. On July 16, Innoviva and TRC filed a complaint in Delaware Chancery Court seeking an order establishing that the arbitration award from the parties' 2019 dispute conclusively established that (a) Innoviva possesses the authority as Manager of TRC to cause TRC to make such investments and (b) Innoviva possesses the authority as Manager of TRC to cause TRC to reserve cash to make such investments. The Court directed the parties to refer certain relevant questions raised by the complaint to the arbitrator in the 2019 dispute, who in turn determined that the 2019 proceedings did not resolve the issues currently in dispute. On August 5, Innoviva and TRC voluntarily dismissed the complaint, without prejudice.  We are pursuing and intend to continue to pursue the protection of the interests of the Company in this matter consistent with the dispute resolution procedures of the TRC LLC Agreement, including, if necessary, the initiation of a new arbitration proceeding.

    Second Quarter Financial Results

    • Revenue: Total revenue for the second quarter of 2020 was $15.0 million, comprised of collaboration revenue of $5.5 million primarily attributed to the Janssen collaboration agreement for TD-1473 and $9.5 million in Mylan collaboration revenue related to net sales of YUPELRI. Total revenue for the second quarter represents a $11.1 million decrease over the same period in 2019. The decrease was primarily due to a $2.0 million decrease in Janssen collaboration revenue and a $18.5 million decrease in licensing revenue. The decrease in Janssen collaboration revenue was due to a smaller portion of revenue recognized in the second quarter 2020 related to the $100.0 million upfront payment from the Janssen collaboration agreement that was entered into in February 2018. The decrease in licensing revenue was due to an $18.5 million upfront payment received from Mylan associated with an amendment signed in June 2019 for the commercialization and development rights to nebulized revefenacin in China and adjacent territories. The overall decrease in revenue was partially offset by a $9.4 million increase in the Mylan collaboration revenue related to YUPELRI.
    • Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2020 were $62.4 million, compared to $46.4 million in the same period in 2019. The $16.0 million increase was primarily due to a $12.8 million increase in external-related expenses related to the advancement of our priority programs, notably the continued progression of ampreloxetine and TD-8236, and the initiation of TD-0903 for COVID-19 and a $2.4 million increase in share-based compensation expense. Second quarter R&D expenses included non-cash share-based compensation of $8.1 million.
    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2020 were $24.8 million, compared to $22.2 million in the same period in 2019. The $2.6 million increase was primarily attributed to a $2.9 million increase in share-based compensation expense, a $0.3 million increase in employee-related expenses, and a $0.3 million increase in facilities and other expenses. These increases were partially offset by a $0.8 million decrease in external-related expenses related to consulting services. Second quarter SG&A expenses included non-cash share-based compensation of $8.5 million.
    • Cash, Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities totaled $438.3 million as of June 30, 2020.

    2020 Financial Guidance

    • Operating Loss (excluding share-based compensation): The Company is not changing financial guidance and expects full-year 2020 operating loss, excluding share-based compensation, of $205 million to $225 million. Operating loss guidance does not include:
      • Royalty income for TRELEGY which the Company recognizes in its statement of operations as "income from investment in TRC, LLC;" or
      • Potential future business development collaborations

    On June 22, 2020, GlaxoSmithKline plc (GSK) completed an offering of $300 million of exchangeable senior notes due 2023; $280.3 million of which are exchangeable into existing ordinary shares of Theravance Biopharma held by GSK. The notes are guaranteed by GSK and will be exchangeable at the option of noteholders on any business day on or after September 1, 2020, under certain terms and conditions outlined in the offering documents. The Company will not be issuing any new shares in connection with this offering, and the Company did not receive any proceeds from the GSK offering.

    Conference Call and Live Webcast Today at 5 pm ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 2 pm PT / 9 pm GMT. To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 8098314. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through September 5, 2020. An audio replay will also be available through 8:00 pm ET on August 13, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 8098314.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that the Company's research programs will progress product candidates into the clinic, the Company's expectations for product candidates through development, potential regulatory approval and commercialization (including their differentiation from other products or potential products), product sales or profit share revenue and the Company's expectations for its 2020 operating loss, excluding share-based compensation. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: current and potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. In addition, while we expect the COVID-19 pandemic to continue to adversely impact our business operations and financial results, the extent of the impact on our ability to generate revenue from YUPELRI, our clinical development programs (in particular our later stage clinical programs for TD-1473 and Ampreloxetine) and the value of and market for our common shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. These potential future developments include, but are not limited to, the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. Other risks affecting Theravance Biopharma are in the company's Form 10-Q filed with the SEC on May 8, 2020 and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact:

    Gail B. Cohen

    Corporate Communications and Investor Relations

    917-214-6603

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

















    June 30,



    December 31,



    2020



    2019

    Assets

    (Unaudited)



    (1)

    Current assets:







    Cash and cash equivalents and short-term marketable securities

    $

    438,340



    $

    280,831

    Receivables from collaborative arrangements



    11,413





    11,996

    Receivables from licensing arrangements



    -





    10,000

    Amounts due from TRC, LLC



    35,509





    28,574

    Other prepaid and current assets  



    13,124





    7,087

      Total current assets  



    498,386





    338,488

    Property and equipment, net  



    14,433





    12,644

    Long-term marketable securities



    -





    4,985

    Operating lease assets



    45,184





    46,604

    Restricted cash  



    833





    833

    Other assets



    5,494





    5,272

     Total assets  

    $

    564,330



    $

    408,826













    Liabilities and Shareholders' Deficit











    Current liabilities

    $

    106,574



    $

    111,703

    Convertible senior notes due 2023, net



    226,427





    225,890

    Non-recourse notes due 2035, net



    375,266





    -

    Non-recourse notes due 2033, net



    -





    219,300

    Long-term operating lease liabilities



    47,631





    47,725

    Other long-term liabilities



    10,768





    28,048

    Shareholders' deficit



    (202,336)





    (223,840)

    Total liabilities and shareholders' deficit

    $

    564,330



    $

    408,826





    ________________________________























    (1)  The condensed consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019.

     

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

























































    Three Months Ended June 30,



    Six Months Ended June 30,





    2020



    2019



    2020



    2019





    (Unaudited)



    (Unaudited)

    Revenue:

























    Collaboration revenue



    $

    5,488



    $

    7,493



    $

    12,120



    $

    12,831

    Licensing revenue





    -





    18,500





    1,500





    18,500

    Mylan collaboration agreement





    9,520





    157





    21,250





    157

    Total revenue 





    15,008





    26,150





    34,870





    31,488



























    Costs and expenses:

























       Research and development (1)





    62,404





    46,399





    128,417





    100,217

       Selling, general and administrative (1)





    24,780





    22,227





    51,105





    47,413

       Total costs and expenses  





    87,184





    68,626





    179,522





    147,630

    Loss from operations  





    (72,176)





    (42,476)





    (144,652)





    (116,142)

    Income from investment in TRC, LLC





    21,381





    8,366





    34,896





    14,595

    Interest expense





    (11,391)





    (7,901)





    (21,332)





    (15,759)

    Loss on extinguishment of debt





    -





    -





    (15,464)





    -

    Interest and other income (expense), net





    (662)





    2,374





    798





    5,169

    Loss before income taxes  





    (62,848)





    (39,637)





    (145,754)





    (112,137)

    Provision for income tax expense





    (39)





    (201)





    (186)





    (281)

    Net loss  



    $

    (62,887)



    $

    (39,838)



    $

    (145,940)



    $

    (112,418)



























    Net loss per share:

























    Basic and diluted net loss per share  



    $

    (1.00)



    $

    (0.72)



    $

    (2.39)



    $

    (2.04)

    Shares used to compute basic and diluted net loss per share  





    62,861





    55,529





    61,162





    55,235



























    ________________________________



















































    (1)Amounts include share-based compensation expense as follows:





















































    Three Months Ended June 30,



    Six Months Ended June 30,

    (In thousands)



    2020



    2019



    2020



    2019

    Research and development 



    $

    8,098



    $

    5,720



    $

    15,963



    $

    11,880

    Selling, general and administrative 





    8,487





    5,578





    15,898





    11,639

    Total share-based compensation expense 



    $

    16,585



    $

    11,298



    $

    31,861



    $

    23,519

     

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  12. DUBLIN, July 27, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will report its second quarter 2020 financial results and provide a business update after market close on Thursday, August 6, 2020. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/9:00 p.m. GMT) that day.

    Conference Call Information

    To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 8098314. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through September 5, 2020. An audio replay will also be available through 8:00 p.m. ET on August 13, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 8098314.

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies.  YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Gail Cohen

    Corporate Communications and Investor Relations

    917-214-6603

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  13. DUBLIN, July 2, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced the appointment of Deepika R. Pakianathan, Ph.D. to its Board of Directors. Since 2001, Dr. Pakianathan has served as a Managing Member at Delphi Ventures, a venture capital firm focused on biotechnology and medical device investments and leads the firm's biotechnology investment activities.

    "We are honored to welcome Dr. Pakianathan to our board of directors," said Rick E Winningham, Chief Executive Officer. "We believe her vast experience in the biotechnology sector, translating breakthrough science and taking important therapies from pipeline to patients, will further enhance our already talented Board of Directors."   

    "I am excited to join the Theravance Biopharma board, which features a roster of high caliber expertise from within the biotechnology industry. The company is at a critical point in its growth and I look forward to helping the company navigate its catalyst-rich future," said Dr. Pakianathan.

    Prior to joining Delphi, Dr. Pakianathan was a Vice President in the healthcare group at J.P. Morgan where she was involved in several large healthcare M&A transactions and led public offerings for biotechnology companies. Prior to that, she was a biotechnology research analyst at Genesis Merchant Group. She worked as a postdoctoral scientist in the Immunology Department at Genentech Corporation from 1993 to 1997.

    Dr. Pakianathan received her Ph.D. and M.S. from Wake Forest University and her MSc and BSc from the University of Bombay. Dr. Pakianathan also currently serves on the boards of Calithera Biosciences, Inc., Karyopharm Therapeutics, Inc., and Mereo BioPharma Group, PLC.

    To learn more about Theravance Biopharma's Board of Directors, please visit https://www.theravance.com/about-us/board-directors.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Company's product and product candidates, particularly TD-0903, the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies), expectations for the repayment of its notes and the expected future commercial performance of TRELEGY ELLIPTA. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: impacts of the COVID-19 global pandemic on our business, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company.  Other risks affecting Theravance Biopharma are in the company's Form 10-Q filed with the SEC on May 8, 2020, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact Information

    Gail B. Cohen

    Corporate Communications and Investor Relations

    917-214-6603

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  14. DUBLIN and SOUTH SAN FRANCISCO, Calif., June 25, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced that the first COVID-19 patient has been dosed in a Phase 2 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19. The Company believes TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome (ARDS).

    DUBLIN and SOUTH SAN FRANCISCO, Calif., June 25, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced that the first COVID-19 patient has been dosed in a Phase 2 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19. The Company believes TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome (ARDS).

    The initiation of the Phase 2 study in patients in the United Kingdom (UK) follows the successful completion of dosing in the Phase 1 study in healthy volunteers at the same clinical unit in the UK, allowing for a rapid transition to Phase 2.

    The Phase 2 study consists of two parts. The first part will assess the safety, tolerability and clinical response to treatment in sequential ascending dose cohorts of hospitalized COVID-19 patients, with each patient being dosed for 7 days. Patients will be enrolled if they demonstrate hypoxia (lack of oxygen in the blood) as that is believed to be a marker of underlying hyperinflammation (cytokine storm) in the lung. More information can be found on clinicaltrials.gov, identifier number: NCT04402866. The second part will be a larger, multi-center study conducted at hospital-based clinical sites in the UK, as well as other European countries and in the United States, pending appropriate Ethics Committee and regulatory approvals in those territories.

    "A subgroup of hospitalized patients with COVID-19 develops Acute Lung Injury due to a dysfunctional immune response to the virus within the lungs resulting in hypoxia which then requires hospitalization, supplemental oxygen and in some cases even mechanical ventilation in the ICU if patients develop Acute Respiratory Distress Syndrome (ARDS). Delivery of a JAK inhibitor directly to the lung could be an important intervention to treat this hyperinflammation and to prevent patients from deteriorating to the point where they need assisted ventilation or ICU admission," said Professor Ashley Woodcock, Chairman of the Medicines Evaluation Unit (MEU) conducting the Phase 1 and Phase 2 studies, Associate Dean for Clinical Affairs, Professor of Respiratory Medicine, University of Manchester and Consultant Physician, NW Lung Centre, Manchester University NHS Foundation Trust.i "We are pleased to be leading the clinical trial on behalf of Theravance Biopharma to efficiently evaluate the safety and efficacy of TD-0903 in this patient population to inform its potential role in the fight against COVID-19."

    "Working with the Medicines Evaluation Unit over the past few months has once again been an outstanding experience as we mobilized our response to COVID-19. The initiation of the Phase 2 study of TD-0903 is a significant milestone in our ongoing efforts to apply our organ-selective therapies and expertise to treat inflammatory conditions," said Rick E Winningham, Chief Executive Officer at Theravance Biopharma. "Theravance Biopharma has a long history of developing lung-selective medicines to treat respiratory disease, and we are proud to leverage this experience and expertise to respond to the current pandemic."

    About TD-0903

    JAK inhibitors function by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2) that play a key role in cytokine signaling. Inhibiting these JAK enzymes interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. Limiting JAK inhibition to the lung is expected to improve the therapeutic index relative to systemic inhibition. Thus, inhaled JAK inhibitors with lung-restricted exposure are of high interest as potential treatments for respiratory illness.

    TD-0903 is a lung-selective, nebulized pan-JAK inhibitor that was discovered and developed at Theravance Biopharma. TD-0903 has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. By its mechanism, TD-0903 has the potential to block the release of cytokines and chemokines that may be associated with Acute Lung Injury and the initiation of a cytokine storm syndrome. Preclinical studies suggest that TD-0903 has a very high lung:plasma ratio and rapid metabolic clearance resulting in low systemic exposure, compatible with its lung selectivity. TD-0903 is administered via a nebulized inhalation solution, which further enhances its lung selectivity. Preclinical pharmacodynamic studies indicate that TD-0903 has an extended duration of action that should enable once or twice daily dosing in humans.

    As disclosed initially at Theravance Biopharma's December 2018 Research and Development Day, the Company indicated the initial clinical application of TD-0903 would be to explore its utility in preventing/delaying graft rejection among individuals receiving lung transplantation. Although this is still a potential clinical application for TD-0903, in response to the current COVID-19 pandemic, the Company has prioritized activities toward assessing the potential for TD-0903 to treat hospitalized COVID-19 patients who become short of breath and whose blood oxygen levels begin to drop. These patients are at increased risk of respiratory complications including ALI and ARDS. They may also require prolonged hospitalization, continuous oxygen and, in the most severe cases, admission to ICU to assist their breathing with non-invasive and/or mechanical ventilation. Treatment with JAK inhibition is recognized as an important anti-inflammatory mechanism to potentially reduce the hyperinflammation seen in hospitalized COVID-19 patients who develop ALI and ARDS.ii

    For more information please visit: https://investor.theravance.com/events-and-presentations

    About Theravance Biopharma

    Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk.  These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Company's product and product candidates, particularly TD-0903, the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies), expectations for the repayment of its notes and the expected future commercial performance of TRELEGY ELLIPTA. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: impacts of the COVID-19 global pandemic on our business, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company.  Other risks affecting Theravance Biopharma are in the company's Form 10-Q filed with the SEC on May 8, 2020, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact Information

    Gail B. Cohen

    Corporate Communications and Investor Relations

    917-214-6603

    i Professor Woodcock is an independent consultant to Theravance Biopharma and is reimbursed on an hourly basis for his consultancy services

    ii The Lancet, March 13, 2020, "COVID-19: consider cytokine storm syndromes and immunosuppression" Mehta, McAuley, Brown, Sanchez, Tattersall, Manson, et al.

     

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  15. DUBLIN, May 6, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the first quarter ended March 31, 2020. Revenue for the first quarter 2020 was $19.9 million. Operating loss was $72.5 million, or $57.2 million excluding share-based compensation expense. Cash, cash equivalents and marketable securities totaled $492.1 million as of March 31, 2020.

    "As we are each challenged by COVID-19 – personally and professionally, I want to thank our employees who have supported the communities we serve: the most vulnerable with respiratory illness and immune deficiencies, healthcare professionals across the globe and each other in extremely troublesome times. I could not be prouder," said Rick E Winningham, Chief Executive Officer. "Theravance Biopharma moved to remote working conditions in early March 2020 for the vast majority of our workforce. Our past investment in technology infrastructure is enabling us to rapidly shift and service our business. Our geographic diversification of clinical trial sites as well as supply chain  is  minimizing impact on our clinical trial programs.  The commitment of our lab-based personnel to work in our laboratories during this time has been crucial to continued progress of our pipeline programs."

    "Our commercial team remains focused on delivering YUPELRI to the COPD community – always a vulnerable community and especially during this pandemic – to both the people with COPD and the healthcare professionals that treat them; our team has been continuously available to support them with YUPELRI.  As the only once-daily nebulized maintenance therapy for COPD, we believe YUPELRI has made a difference for the community during these challenging times."

    "We are well-capitalized to continue our pipeline momentum.  We have significantly accelerated internal research and development efforts on TD-0903, a lung-selective nebulized JAKi with the potential to treat hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19 to prevent progression to Acute Respiratory Distress Syndrome (ARDS) and the need for assisted ventilation. The learnings from the early clinical experience of TD-0903 will not only benefit the program in its potential for the treatment of COVID-19 lung hyperinflammation but will inform the broader clinical program in other severe inflammatory conditions of the lung.  We are working in close collaboration with our partner, Janssen, on TD-1473, a gut-selective oral JAKi in development for inflammatory intestinal disease and TD-5202, gut-selective irreversible JAK3 inhibitor in development for inflammatory intestinal diseases. TD-8236, our lung-selective dry powder inhaler pan-JAK inhibitor in development for inflammatory lung disease, continues to progress. Ampreloxetine, a norepinephrine reuptake inhibitor (NRI) is under evaluation for treatment of symptomatic neurogenic orthostatic hypotension (nOH), a rare disease, in a Phase 3 clinical program. We continue to move these programs forward despite the significant hurdles imposed by social distancing and government lockdowns around the world."

    "As we look ahead, as a company with a legacy in developing respiratory medicines, we hope our inhaled JAK inhibitor program can help make a meaningful contribution to the COVID-19 story as we continue to progress our other high priority programs of TD-1473 and ampreloxetine."

    Corporate Highlights

    Partnered with Mylan:

    YUPELRI® (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)): 

    • First and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), reimbursed by Part B Medicare program
    • Data as of January 2020 show that YUPELRI achieved an 87% share of the nebulized LAMA market and a 13.7% share of the long-acting nebulized market (including Durable Medical Equipment)
    • YUPELRI is manufactured in the United States and supply chains are monitored regularly; no disruption of supply is currently anticipated
    • In-person field calls on YUPELRI ceased as of mid-March 2020; as with most pharmaceuticals, sales momentum has been affected by COVID-19; the team is leveraging established relationships, digital technology, and non-personal promotion to continue the dialogue with stakeholders to continue sales growth; an "Insight and Innovation Think Tank" has been established to evolve "next practices" during the peri- and post-COVID-19 period

    Key Pipeline Progress

    The COVID-19 pandemic is a significant threat to public health throughout the world and the Company has been diligently monitoring and adapting to the threat. Theravance Biopharma has been evaluating each of its clinical trial programs to determine necessary modifications and working closely with regulators, ethics committees, sites, CROs and data safety monitoring boards. The Company appreciates the pragmatism, collaboration and the ongoing prioritization of the clinical trial participants and all of those caring for them. Given the significant strains on the healthcare system across the globe, Theravance Biopharma took the decision in mid-March to temporarily suspend adding new patients to the screening phase for its TD-1473 and ampreloxetine trials for 4 weeks, in order to prioritize ongoing support for patients who were already in screening and those patients who were already randomized.  As a result, the studies were able to continue randomizing existing screened patients into the studies and the randomized patients were able to continue to receive study medication per the protocol requirements. Screening of new patients is now resuming in some countries in a controlled and measured fashion as individual sites confirm their ability to support the study requirements and new patients are able to be assessed for their eligibility to participate in the studies. The global nature of the TD-1473 and ampreloxetine clinical programs will allow for flexibility as COVID-19 control measures evolve in different countries. The situation is expected to continue to change at different rates in different countries around the world in response to COVID-19 interventions, and as a result it is not possible to provide an accurate re-estimation of expected completion dates for these programs at this time outside of our guidance of shifting data delivery to 2021.

    In light of the COVID-19 pandemic, the Company is implementing mitigation plans to ensure patients in the clinical trials have continued access to drug supply and regular visits with their physicians for study visits per trial protocols. The Company continues to develop strategies to reduce patient needs to travel to sites in hopes of avoiding unnecessary exposure while balancing safety monitoring of investigational products. The Company is working closely with regulators and Ethics Committees and taking steps to ensure protection of patients, site personnel and clinical trial integrity.

    Partnered with Janssen Biotech, Inc.:
    TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases): 

    • Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn's disease (DIONE) progressing
    • Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn's disease studies originally planned for late-2020 and now expected in 2021

    TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):

    • TD-5202 was generally well tolerated as a single oral dose up to 2000 milligrams and as a twice-daily oral dose up to 2000 milligrams total per day given for 10 consecutive days in healthy subjects

    Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):

    • Ongoing registrational program in symptomatic neurogenic orthostatic hypertension (nOH) comprised of two studies:
      • Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy, with data originally planned for late-2020 and now expected in 2021
      • Phase 3 four-month open label study followed by a six-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response

    TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory lung diseases):

    • Part C extension portion of the Phase 1 trial assessing additional biomarkers in more severe asthmatics underway with results expected in 2H 2020
    • Phase 2 lung allergen challenge initiated in 4Q 2019; data expected 2H 2020

    TD-0903 (lung-selective nebulized pan-JAK inhibitor for treatment of Acute Lung Injury caused by COVID-19)

    • Initiated Phase 1 study to assess the safety, tolerability and pharmacokinetics of single- and multiple-ascending doses (SAD/MAD) in healthy volunteers
    • The program will then initially move to a nested Phase 2 study in hospitalized patients with COVID-19 with the first part (an ascending dose study) being conducted in the same clinical setting in the UK as the Phase 1 study; the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom approved the Phase 2 study today
    • The second part of the Phase 2 study will be a larger, multi-center study conducted at hospital-based clinical sites in the UK, and potentially other clinical sites in the European Union and United States; both of the latter territories would join the Phase 2 study program subject to review and approval of the relevant regulatory approvals required by the relevant EU National Competent Authorities and Food and Drug Administration (FDA)

    Economic Interest

    TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1

    • 1Q 2020 net sales of $249 million; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
    • GSK sNDA for asthma expected 2H 2020; The European Medicines Agency accepted the regulatory submission for the treatment of asthma in adults supported by the Phase III CAPTAIN study; FDA postponed Advisory Committee Meeting originally scheduled for April 21, 2020 regarding mortality sNDA and no additional public information available at this time

    Notes:
    1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination of fluticasone furoate, aclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC ("TRC LLC") expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). 75% of the income from Company's investment in TRC is pledged to service outstanding notes, 25% of income from Company's investment in TRC is retained by Company.

    First Quarter Financial Results

    • Revenue: Revenue for the first quarter of 2020 was $19.9 million, comprised of collaboration revenue of $6.6 million primarily attributed to the Janssen collaboration agreement for TD-1473 and $11.7 million in Mylan collaboration revenue related to YUPELRI. Revenue for the first quarter represents a $14.5 million increase over the same period in 2019. The increase was primarily due to an increase in Mylan collaboration revenue related to YUPELRI and a larger portion of recognized revenue related to the $100.0 million upfront payment from the Janssen collaboration agreement that was entered into in February 2018.
    • Research and Development Expenses: Research and Development (R&D) expenses for the first quarter of 2020 were $66.0 million, compared to $53.8 million in the same period in 2019. The $12.2 million increase was primarily due to a $12.4 million increase in external-related expenses related to the advancement of our priority programs, notable TD-1473, ampreloxetine, and TD-8236, a $1.7 million increase in share-based compensation expense, and a $2.2 million decrease in employee-related expenses. First quarter R&D expenses included non-cash share-based compensation of $7.9 million.
    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2020 were $26.3 million, compared to $25.2 million in the same period in 2019. The $1.1 million increase was primarily attributed to a $1.4 million increase in share-based compensation expense, a $0.8 million increase in employee-related expenses, and a $0.6 million increase in external-related expenses. These increases were partially offset by a $1.4 million decrease related to collaboration expenses payable to Mylan in connection with the commercialization of YUPELRI which was formally launched in the first quarter of 2019. First quarter SG&A expenses included non-cash share-based compensation of $7.4 million.
    • Cash, Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities totaled $492.1 million as of March 31, 2020.

    2020 Financial Guidance

    • Operating Loss (excluding share-based compensation): The Company is not changing financial guidance and expects full-year 2020 operating loss, excluding share-based compensation, of $205 million to $225 million. Operating loss guidance does not include:
      • Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in TRC, LLC;" or
      • Potential future business development collaborations

    Additionally, as previously announced, the Company closed its public offering of 5,500,000 ordinary shares at a price to the public of $27.00 per share on February 14, 2020.  The gross proceeds to Theravance Biopharma from the offering are approximately $148.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.

    On March 2, 2020 Theravance Biopharma announced the closing of a private placement of $400 million in aggregate principal amount of non-recourse 9.5% fixed rate term notes.  The notes are secured by a portion of the future payments the Company expects to receive related to royalties due on net sales of TRELEGY ELLIPTA, with 75% of such payments to be used to satisfy the debt obligations until the notes are repaid and the remaining 25% of such payments being directed to benefit the Company on an ongoing basis. The Company used a portion of the net proceeds from this transaction to repay in full the remaining outstanding balance of the $250 million Triple PhaRMASM 9.0% fixed rate term notes due 2033 and intends to use the remainder of the net proceeds to support continued execution of its key development programs.

    Conference Call and Live Webcast Today at 5 pm ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 2 pm PT / 9 pm GMT). To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 8371418. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through June 5, 2020. An audio replay will also be available through 8:00 pm ET on May 13, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 8371418.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that the Company's research programs will progress product candidates into the clinic, the Company's expectations for product candidates through development, potential regulatory approval and commercialization (including their differentiation from other products or potential products), product sales or profit share revenue and the Company's expectations for its 2020 operating loss, excluding share-based compensation. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. In addition, while we expect the COVID-19 pandemic to continue to adversely impact our business operations and financial results, the extent of the impact on our ability to generate revenue from YUPELRI, our clinical development programs (in particular our later stage clinical programs for TD-1473 and Ampreloxetine) and the value of and market for our common shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. These potential future developments include, but are not limited to, the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.  Other risks affecting Theravance Biopharma are in the company's Form 10-K filed with the SEC on February 27, 2020 and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact:
    Gail B. Cohen
    Corporate Communications and Investor Relations
    917-214-6603

     



    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)









    March 31,


    December 31,


    2020


    2019

    Assets

    (Unaudited)


    (1)

    Current assets:




    Cash and cash equivalents and short-term marketable securities

    $

    487,031


    $

    280,831

    Receivables from collaborative arrangements


    14,214



    11,996

    Receivables from licensing arrangements


    1,200



    10,000

    Amounts due from TRC, LLC


    26,282



    28,574

    Other prepaid and current assets  


    5,491



    7,087

      Total current assets  


    534,218



    338,488

    Property and equipment, net  


    13,905



    12,644

    Long-term marketable securities


    5,067



    4,985

    Operating lease assets


    46,106



    46,604

    Restricted cash  


    833



    833

    Other assets


    5,280



    5,272

     Total assets  

    $

    605,409


    $

    408,826







    Liabilities and Shareholders' Deficit






    Current liabilities

    $

    98,040


    $

    111,703

    Convertible senior notes due 2023, net


    226,158



    225,890

    Non-recourse notes due 2035, net


    373,854



    -

    Non-recourse notes due 2033, net


    -



    219,300

    Long-term operating lease liabilities


    47,199



    47,725

    Other long-term liabilities


    18,094



    28,048

    Shareholders' deficit


    (157,936)



    (223,840)

    Total liabilities and shareholders' deficit

    $

    605,409


    $

    408,826




    ________________________________


    (1) 

    The condensed consolidated balance sheet as of December 31, 2019 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019.

     

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

















    Three Months Ended March 31,



    2020


    2019



    (Unaudited)

    Revenue:







    Collaboration revenue


    $

    6,632


    $

    5,338

    Licensing revenue



    1,500



    -

    Mylan collaboration agreement



    11,730



    -

    Total revenue 



    19,862



    5,338








    Costs and expenses:







       Research and development (1)



    66,013



    53,818

       Selling, general and administrative (1)



    26,325



    25,186

       Total costs and expenses  



    92,338



    79,004

    Loss from operations  



    (72,476)



    (73,666)

    Income from investment in TRC, LLC



    13,515



    6,229

    Interest expense



    (9,941)



    (7,858)

    Loss on extinguishment of debt



    (15,464)



    -

    Interest and other income, net



    1,460



    2,795

    Loss before income taxes  



    (82,906)



    (72,500)

    Provision for income tax expense



    (147)



    (80)

    Net loss  


    $

    (83,053)


    $

    (72,580)








    Net loss per share:







    Basic and diluted net loss per share  


    $

    (1.40)


    $

    (1.32)

    Shares used to compute basic and diluted net loss per share  



    59,463



    54,938








    ________________________________














    (1) Amounts include share-based compensation expense as follows:














    Three Months Ended March 31,

    (In thousands)


    2020


    2019

    Research and development 


    $

    7,865


    $

    6,159

    Selling, general and administrative 



    7,411



    6,061

    Total share-based compensation expense 


    $

    15,276


    $

    12,220

     

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    SOURCE Theravance Biopharma, Inc.

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  16. DUBLIN, April 28, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will report its first quarter 2020 financial results and provide a business update after market close on Wednesday, May 6, 2020. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/9:00 p.m. GMT) that day.

    Conference Call Information

    To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 8371418. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through June 5, 2020. An audio replay will also be available through 8:00 p.m. ET on May 13, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 8371418.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies.  YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Gail Cohen
    Corporate Communications and Investor Relations
    917-214-6603

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-report-first-quarter-2020-financial-results-on-may-6-2020-301048045.html

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  17. DUBLIN and SOUTH SAN FRANCISCO, Calif., April 23, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced that the first healthy volunteer has been dosed in a Phase 1 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19.  The Company believes TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome (ARDS).

    DUBLIN and SOUTH SAN FRANCISCO, Calif., April 23, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced that the first healthy volunteer has been dosed in a Phase 1 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19.  The Company believes TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome (ARDS).

    Theravance Biopharma received approval of TD-0903's initial Clinical Trial Application (CTA) in the United Kingdom (UK) for the Phase 1 study. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single- and multiple-ascending doses (SAD/MAD) of TD-0903 in healthy volunteers and will enroll up to 54 volunteers. More information can be found on clinicaltrials.gov, identifier number: NCT04350736. Upon regulatory review and approval, the program will then initially move to a nested Phase 2 study in hospitalized patients with COVID-19 in the same clinical setting in the UK.

    "Theravance Biopharma's efforts to address COVID-19 leverage years of experience in developing lung-selective medicines to treat respiratory disease. We are pleased to have received expedited approval of TD-0903's CTA and are working to progress this potential treatment option through clinical trials as quickly as possible," said Rick E Winningham, Chief Executive Officer. "The clinical site that we are working with has a long history of evaluating our inhaled medicines, and we are proud to be working with them to advance TD-0903 into clinical testing."

    "There is accumulating evidence that a subgroup of patients with COVID-19 develop a dysfunctional immune response resulting in a cytokine storm within the lungs. JAK inhibition could be an important intervention to treat this hyperinflammation," said Brett Haumann, M.D., Chief Medical Officer. "TD-0903 has been shown in preclinical studies to have broad pan-JAK inhibition, reducing the signaling of multiple cytokines that have been associated with cytokine storm syndrome. Additionally, the nebulized formulation and organ-selective properties of TD-0903 have the potential to address hyperinflammation in the lung without suppressing the systemic immune system, leading to potential patient benefit and improved utilization of limited hospital critical care resources."  

    About TD-0903

    TD-0903 is a lung-selective, nebulized pan-JAK inhibitor that was discovered and developed at Theravance Biopharma. TD-0903 has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. By its mechanism, TD-0903 has the potential to block release of cytokines and chemokines that may be associated with acute lung injury and the initiation of a cytokine storm syndrome. Preclinical studies suggest that TD-0903 has a very high lung:plasma ratio and rapid metabolic clearance resulting in low systemic exposure, compatible with its lung selectivity. TD‑0903 is administered via nebulized inhalation solution, which further enhances its lung selectivity. Preclinical pharmacodynamic studies indicate that TD-0903 has an extended duration of action that should enable once or twice daily dosing in humans.

    As disclosed initially at Theravance Biopharma's December 2018 Research and Development Day, the Company indicated the initial clinical application of TD-0903 would be to explore its utility in preventing/delaying graft rejection among individuals receiving lung transplantation. Although this is still a potential clinical application for TD-0903, in response to the current COVID-19 pandemic, the Company has prioritized activities toward assessing the potential for TD-0903 to treat hospitalized COVID-19 patients who become short of breath and whose blood oxygen levels begin to drop. These patients appear to be at increased risk of respiratory complications including ALI and ARDS. They may also require prolonged hospitalization, continuous oxygen and, in the most severe cases, admission to ICU to assist their breathing with non-invasive and/or mechanical ventilation. Treatment with JAK inhibition is recognized as an important anti-inflammatory mechanism to potentially reduce the hyperinflammation seen in hospitalized COVID-19 patients who develop ALI and ARDS.1

    Following the completion of the Phase 1 study, Phase 2 will consist of two parts. The first part will assess the safety, tolerability and clinical response to treatment in sequential ascending dose cohorts of COVID-19 patients in the UK. This part of the study will not be formally powered for efficacy but will inform the selection of dose(s) for the second part. The second part of the Phase 2 study will be a larger, multi-center study conducted at hospital-based clinical sites in the UK, and potentially other clinical sites in the European Union and United States. Both of the latter territories would join the Phase 2 study program following review and approval of the relevant regulatory filings required by the relevant EU National Competent Authorities and Food and Drug Administration (FDA). Further details on the program, including more on the Phase 2 study will be provided once these studies have been approved by the appropriate regulatory and ethics review authorities.

    For more information please visit: https://investor.theravance.com/events-and-presentations

    About the Inhaled JAK Inhibitor Program

    JAK inhibitors function by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2) that play a key role in cytokine signaling. Inhibiting these JAK enzymes interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. Limiting JAK inhibition to the lung is expected to improve therapeutic index relative to systemic inhibition. Thus, inhaled JAK inhibitors with lung-restricted exposure are of high interest as potential treatments for respiratory illness.

    TD-8236 is the Company's most advanced investigational pan-Janus kinase (JAK) inhibitor currently designed for delivery to the lungs using a dry powder inhaler (DPI). Similar to TD-0903, TD-8236 is a lung-selective agent designed to inhibit the JAK family of enzymes in lung tissue with limited systemic exposure. An extensive set of preclinical pharmacological studies and toxicological studies support its current clinical development in the primary indication of moderate to severe asthma. Insights from the ongoing clinical development of TD-8236 DPI are informing the Company's confidence to bring TD-0903 forward for the treatment of COVID-19 acute lung injury.

    In addition, Theravance Biopharma is currently assessing the impact of the COVID-19 pandemic on its operations, including on the commercial operations associated with YUPELRI® (revefenacin inhalation solution) and on the conduct of its clinical development programs for TD-1473, ampreloxetine and TD‑8236. The situation continues to evolve as the pandemic's effects are felt around the world. The Company has implemented a comprehensive business continuity plan to support its performance, and it remains well capitalized to advance the company despite the obstacles presented by the current environment. The Company will provide further program updates during its Q1 financial results and business update call in early May 2020.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk.

    These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Company's product and product candidates, particularly TD-0903, the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies), expectations for the repayment of its notes and the expected future commercial performance of TRELEGY ELLIPTA. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: impacts of the COVID-19 global pandemic on our business, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company.  Other risks affecting Theravance Biopharma are in the company's Form 10-K filed with the SEC on February 27, 2020, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact Information

    Gail B. Cohen
    Corporate Communications and Investor Relations
    917-214-6603

     

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  18. DUBLIN, April 20, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced the publication of a peer-reviewed paper summarizing positive results from completed Phase 1 clinical and preclinical studies of TD-1473, the Company's gut-selective pan-Janus kinase (JAK) inhibitor. The manuscript, which was published in the Journal of Crohn's and Colitis, highlights a broad collection of data demonstrating minimal systemic drug exposure, local target engagement, and trends toward reduced markers of ulcerative colitis disease activity following TD-1473…

    DUBLIN, April 20, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced the publication of a peer-reviewed paper summarizing positive results from completed Phase 1 clinical and preclinical studies of TD-1473, the Company's gut-selective pan-Janus kinase (JAK) inhibitor. The manuscript, which was published in the Journal of Crohn's and Colitis, highlights a broad collection of data demonstrating minimal systemic drug exposure, local target engagement, and trends toward reduced markers of ulcerative colitis disease activity following TD-1473 administration versus placebo.

    TD-1473 is a novel, gut-selective oral pan-JAK inhibitor in clinical development with the potential to treat a range of inflammatory intestinal diseases, including ulcerative colitis and Crohn's disease.  In contrast to other oral JAK inhibitors under development for inflammatory bowel disease, TD-1473 is gut-selective -- specifically designed to act locally at the site of inflammation in the intestinal wall with limited systemic exposure.  TD-1473, which is the focus of a global co-development and commercialization agreement with Janssen Biotech, Inc., is currently being evaluated in a Phase 2b/3 study in ulcerative colitis patients (RHEA) and a Phase 2 study in patients with Crohn's disease (DIONE).

    The published manuscript, authored by William Sandborn, MD, chief of the division of gastroenterology of University of California, San Diego Health, is titled "Development of gut-selective pan-Janus kinase inhibitor TD-1473 for ulcerative colitis: A translational medicine program."  Key study findings featured in the paper, which highlight potential differentiation for TD-1473 as compared to systemically active JAK inhibitors, include:

    Phase 1b Clinical Study Results for TD-1473 (40 patients):

    • Signals of clinical, histologic and biomarker activity following four weeks of treatment versus placebo, suggesting achievement of localized target engagement in patients with moderately-to-severely active ulcerative colitis
    • Minimal systemic exposures and no evidence of systemic immunosuppression or systemic opportunistic infections

    Phase 1 Clinical Study Results for TD-1473 (72 subjects):

    • Generally well tolerated in healthy subjects as a single dose (up to 1000 mg) and as a daily dose (up to 300 mg) given for 14 days
    • Low plasma exposure and high stool concentrations at a range of doses, supporting gut-selective properties

    Preclinical Study Results for TD-1473:

    • Demonstrated potent inhibition of JAK inflammatory activity
    • Gut selectivity, as evidenced by high drug concentrations in colon with minimal plasma drug exposure
    • Efficacy in a colitis mouse model, as evidenced by significantly reduced colitis manifestations

    "This manuscript offers the most comprehensive collection of data from our ongoing TD-1473 program to date, highlighting the potentially transformational nature of our organ-selective JAK inhibition approach in treating inflammatory intestinal diseases such as ulcerative colitis and Crohn's disease.  This compilation of data from preclinical and clinical studies paints a consistent and encouraging picture of TD-1473 in the areas of minimized systemic exposure, localized target engagement and potential to reduce disease activity," said Brett Haumann, MD, chief medical officer at Theravance Biopharma.  "Importantly, the content of this manuscript highlights the critical advantages that TD-1473's gut-selective JAK inhibition may offer as compared to systemically active JAK inhibitors, which continue to be associated with dose-limiting side effects that prevent their use at doses that optimize efficacy.  We continue to explore the therapeutic potential of TD-1473, including the specific benefits of its gut-selective activity, in our ongoing Phase 2 and 3 studies and look forward to the new findings those trials generate."

    The peer-reviewed manuscript in the Journal of Crohn's and Colitis can be accessed at: https://doi.org/10.1093/ecco-jcc/jjaa049 

    About Theravance Biopharma and Janssen Strategic Collaboration

    Theravance Biopharma and Janssen Biotech, Inc. have a global co-development and commercialization agreement for TD-1473 and related back-up compounds for inflammatory intestinal diseases, including ulcerative colitis and Crohn's disease. Under the terms of the agreement, Theravance Biopharma received an upfront payment of $100 million and is eligible to receive up to an additional $900 million in potential payments, if Janssen elects to remain in the collaboration following the completion of certain Phase 2 activities. Theravance Biopharma together with Janssen will jointly develop and commercialize TD-1473 in inflammatory intestinal diseases, with the two companies sharing profits in the US and expenses related to a potential Phase 3 program.

    About Gut-Selective Pan-Janus (JAK) Kinase Inhibition

    JAK inhibitors function by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2) that play a key role in cytokine signaling. Inhibiting these JAK enzymes interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. JAK inhibitors are currently approved for the treatment of diseases such as rheumatoid arthritis, myelofibrosis, and ulcerative colitis. However, these products are known to have side effects associated with their systemic exposure.

    TD-1473 is an internally-discovered JAK inhibitor that has demonstrated a high affinity for each of the JAK family of enzymes. Importantly, TD-1473 is a gut-selective treatment specifically designed to distribute adequately and predominantly to the tissues of the intestinal tract, treating inflammation in those tissues while minimizing its systemic exposure. Theravance Biopharma is focused on utilizing targeted JAK inhibitors for potential treatment of a range of inflammatory intestinal diseases including ulcerative colitis and Crohn's disease, which affect roughly 900,000 and 700,000 patients in the United States, respectively.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines.

    Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk.

    These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, and the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies and their differentiation from other products or potential products). These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: impacts of the COVID-19 global pandemic on our business, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective (including when our product candidates or products are studied in combination with other compounds), risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company. Other risks affecting Theravance Biopharma are described under the heading "Risk Factors" and elsewhere in Theravance Biopharma's Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2020 and Theravance Biopharma's other filings with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact Information:

    Gail B. Cohen
    Corporate Communications and Investor Relations
    917-214-6603

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    SOURCE Theravance Biopharma, Inc.

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  19. DUBLIN and SOUTH SAN FRANCISCO, Calif., April 9, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced that it is advancing TD-0903, a lung-selective nebulized Janus kinase inhibitor (JAKi) into clinical development to assess its utility in preventing the cytokine storm associated with Acute Lung Injury (ALI) in patients hospitalized due to COVID-19, with the ultimate goal of preventing progression to Acute Respiratory Distress Syndrome (ARDS).

    "In response to the unprecedented healthcare challenges presented by the emergence of COVID-19, we have combined our immunology and respiratory medicine expertise to accelerate development of our nebulized lung-selective JAK inhibitor, TD-0903. With great urgency, we have redirected our program to treat the acute lung injury caused by COVID-19," said Rick E Winningham, Chief Executive Officer. "We recognize how critical it is to help those suffering from shortness of breath and low oxygen levels, including those who need intensive care and ventilation, to address the effects of profound lung hyperinflammation. TD-0903 could provide benefit to hospitalized patients by preventing the progression of lung hyperinflammation and reducing the requirement for, or the duration of, assisted ventilation.  As a result, this could improve utilization of limited hospital critical care resources."

    "We are pleased to be able to direct our resources and expertise towards helping to treat COVID-19," said Brett Haumann, M.D. Chief Medical Officer. "Janus kinase inhibitors have the potential to inhibit a broad set of immune-modulatory pathways that could prove to be effective in dampening the abnormal immune response that occurs in the lungs of some patients. The nebulized formulation of our lung-selective inhaled JAK inhibitor will allow TD-0903 to be administered directly to the lung in a number of hospitalized settings, including patients who can breathe unaided in the ward, as well as in the ICU setting in patients who require non-invasive or mechanical ventilation. If our initial CTA submission for this study in healthy volunteers is approved and the study is successful, we intend to study TD-0903 in COVID-19 patients in the very near future.  We are proud of the tremendous efforts of the global team of Theravance Biopharma scientists and physicians that has enabled us to rapidly progress TD-0903, and we are grateful for their collaboration and dedication to continue its advancement."

    About TD-0903

    TD-0903 is a lung-selective, nebulized pan-JAK inhibitor that was discovered and developed at Theravance Biopharma. TD-0903 has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. By its mechanism, TD-0903 has the potential to block release of cytokines and chemokines that may be associated with acute lung injury and the initiation of a cytokine storm syndrome. Preclinical studies suggest that TD-0903 has a very high lung:plasma ratio and rapid metabolic clearance resulting in low systemic exposure, compatible with its lung selectivity. TD‑0903 is administered via nebulized inhalation solution, which further enhances its lung selectivity.  Preclinical pharmacodynamic studies indicate that TD-0903 has an extended duration of action that should enable once or twice daily dosing in humans.

    As disclosed initially at Theravance Biopharma's December 2018 Research and Development Day, the Company indicated the initial clinical application of TD-0903 would be to explore its utility in preventing/delaying graft rejection among individuals receiving lung transplantation. Although this is still a potential clinical application for TD-0903, in response to the current COVID-19 pandemic, the Company has prioritized activities toward assessing the potential for TD-0903 to treat hospitalized COVID-19 patients who become short of breath and whose blood oxygen levels begin to drop. These patients appear to be at increased risk of respiratory complications including Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). They may also require prolonged hospitalization, continuous oxygen and, in the most severe cases, admission to ICU to assist their breathing with non-invasive and/or mechanical ventilation. Treatment with JAK inhibition is recognized as an important anti-inflammatory mechanism to potentially reduce the hyperinflammation seen in hospitalized COVID-19 patients who develop ALI and ARDS.1

    Upon review and approval of the initial CTA, the Company is planning to initiate a Phase 1 study this month in the United Kingdom (UK), starting with single- and multiple-ascending doses in healthy volunteers to assess safety. Upon regulatory review and approval, the program will then move to a nested Phase 2 study in hospitalized patients with COVID-19. The Phase 2 study will consist of two parts. The first part will assess the safety, tolerability and clinical response to treatment in sequential ascending dose cohorts of COVID-19 patients in the UK. This part of the study will not be formally powered for efficacy but will inform the selection of dose(s) for the second part. The second part of the Phase 2 study will be a larger, multi-center study conducted at hospital-based clinical sites in the UK, and potentially other clinical sites in the European Union and United States.  Both of the latter territories would join the Phase 2 study program following review and approval of the relevant regulatory filings required by the European Medicines Authority (EMA) and Food and Drug Administration (FDA). Further details on the program, including more on Phase 1 and Phase 2 studies will be provided once these studies have been approved by the appropriate regulatory and ethics review authorities.

    Theravance Biopharma's efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease.

    About the Inhaled JAK Inhibitor Program

    JAK inhibitors function by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2) that play a key role in cytokine signaling. Inhibiting these JAK enzymes interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines.  Limiting JAK inhibition to the lung is expected to improve therapeutic index relative to systemic inhibition. Thus, inhaled JAK inhibitors with lung-restricted exposure are of high interest as potential treatments for respiratory illness.

    TD-8236 is the Company's most advanced investigational pan-Janus kinase (JAK) inhibitor currently designed for delivery to the lungs using a dry powder inhaler (DPI).   Similar to TD-0903, TD-8236 is a lung-selective agent designed to inhibit the JAK family of enzymes in lung tissue with limited systemic exposure. An extensive set of preclinical pharmacological studies and toxicological studies support its current clinical development in the primary indication of moderate to severe asthma.  Insights from the ongoing clinical development of TD-8236 DPI are informing the Company's confidence to bring TD-0903 forward for the treatment of COVID-19 acute lung injury.

    In addition, Theravance Biopharma is currently assessing the impact of the COVID-19 pandemic on its operations, including on the commercial operations associated with YUPELRI® (revefenacin inhalation solution) and on the conduct of its clinical development programs for TD-1473, ampreloxetine and TD‑8236. The situation continues to evolve as the pandemic's effects are felt around the world.  The Company has implemented a comprehensive business continuity plan to support its performance, and it remains well capitalized to advance the company despite the obstacles presented by the current environment. The Company will provide further program updates during its Q1 financial results and business update call in early May 2020.

    Conference Call and Live Webcast Today at 8:00 a.m. ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 8:00 a.m. ET (5:00 a.m. PT / 1:00 p.m. GMT). To participate in the live call by telephone, please dial (855) 296-9648 from the U.S., or (920) 663-6266 for international callers and use the confirmation code 5076939. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through May 9, 2020. An audio replay will also be available through 11:00 a.m. ET on April 16, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 5076939.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines.

    Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk.

    These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Company's product and product candidates, particularly TD-0903, the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies), expectations for the repayment of its notes and the expected future commercial performance of TRELEGY ELLIPTA. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: impacts of the COVID-19 global pandemic on our business, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company.  Other risks affecting Theravance Biopharma are described under the heading "Risk Factors" and elsewhere in Theravance Biopharma's Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2020, in the Form S-3 filed with the SEC on December 3, 2019 and in the Prospectus Supplement filed with the SEC on February 12, 2020. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact Information

    Gail B. Cohen
    Corporate Communications and Investor Relations
    917-214-6603

    1 The Lancet, March 13, 2020, "COVID-19: consider cytokine storm syndromes and immunosuppression" Mehta, McAuley, Brown, Sanchez, Tattersall, Manson, et al.

     

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  20. DUBLIN, March 2, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" and together with its subsidiaries, the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced the closing of a private placement of $400 million of non-recourse Triple II 9.5% fixed rate term notes. The notes are secured by a portion of the future payments the Company expects to receive related to royalties due on net sales of Trelegy Ellipta. The Company used a portion of the net proceeds from this transaction to repay in full the remaining outstanding balance of the $250 million Triple PhaRMASM 9.0% fixed rate term notes due 2033…

    DUBLIN, March 2, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" and together with its subsidiaries, the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced the closing of a private placement of $400 million of non-recourse Triple II 9.5% fixed rate term notes. The notes are secured by a portion of the future payments the Company expects to receive related to royalties due on net sales of Trelegy Ellipta. The Company used a portion of the net proceeds from this transaction to repay in full the remaining outstanding balance of the $250 million Triple PhaRMASM 9.0% fixed rate term notes due 2033 and intends to use the remainder of the net proceeds to support continued execution of its key development programs.

    About the Financing

    Triple Royalty Sub II LLC (the "Issuer"), a wholly-owned, indirect subsidiary of Theravance Biopharma, issued $400 million in aggregate principal amount of Triple II 9.5% fixed rate term notes due June 5, 2035. The notes are secured by all of the Issuer's right, title and interest in certain membership interests (the "Issuer Class C Units") in Theravance Respiratory Company, LLC, a Delaware limited liability company ("TRC LLC").  TRC LLC holds the right to receive upward-tiering royalties ranging from 6.5% to 10% on worldwide net sales of Trelegy Ellipta, and the Company holds an 85% economic interest in TRC LLC. The Issuer Class C Units represent 75% of the Company's 85% economic interest, which equates to 63.75% of the economic interests in TRC LLC.

    The primary source of funds to make payments on the notes will be the Issuer's 63.75% economic interest (evidenced by the Issuer Class C Units) in any future payments made by Glaxo Group Limited ("GSK") under the Collaboration Agreement, dated as of November 14, 2002, by and between Innoviva, Inc. and GSK, as amended from time to time (net of the amount of cash, if any, expected to be used in TRC LLC pursuant to the TRC LLC Agreement over the next four fiscal quarters) relating to the Trelegy Ellipta program.  The notes are not convertible into Company equity and have no security interest in nor rights under any agreement with GSK.

    The notes may be redeemed at any time after the second year and prior to maturity, in whole or in part, at specified redemption premiums.

    The notes bear an annual interest rate of 9.5%, with interest and principal payable quarterly beginning June 5, 2020. Prior to and including the December 5, 2024 payment date, in the event that the distributions received by the Issuer from TRC LLC in a quarter is less than the interest accrued for that quarter, the principal amount of the notes will increase by the interest shortfall amount for that quarter. Because the principal and interest payments on the notes are ultimately based only on royalties from product sales, which will vary from quarter to quarter, the notes may be repaid prior to the final maturity date in 2035. Following the redemption or repayment of the notes, all Trelegy Ellipta-related pledged cash flows will revert back to the Company.

    In order to comply with Regulation RR — Credit Risk Retention (17 C.F.R. Part 246), 5% of the notes were retained by Theravance Biopharma R&D, Inc., a wholly-owned subsidiary of Theravance Biopharma. Excluding the $20 million of retained notes and other fees related to the transaction, net proceeds of the offering were approximately $380 million. The notes have not been and will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any security.

    Cowen and Company, LLC acted as sole placement agent for the notes.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company with the core purpose of creating medicines that help improve the lives of patients suffering from serious illness.

    In our relentless pursuit of this objective, we strive to apply insight and innovation at each stage of our business, including research, development and commercialization, and utilize both internal capabilities and those of partners around the world. Our research efforts are focused in the areas of inflammation and immunology. Our research goal is to design localized medicines that target diseased tissues, without systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing localized medicines for the lungs to treat respiratory disease. The first potential medicine to emerge from our research focus on immunology and localized treatments is an oral, gut-selective pan-Janus kinase (JAK) inhibitor, currently in development to treat a range of inflammatory intestinal diseases. Our pipeline of internally discovered product candidates will continue to evolve with the goal of creating transformational medicines to address the significant needs of patients.

    In addition, we have an economic interest in future payments that may be made by Glaxo Group or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including Trelegy Ellipta.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to expectations for the repayment of the notes, the expected future commercial performance of Trelegy Ellipta, the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Company's product and product candidates, the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies). These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure.  Other risks affecting Theravance Biopharma are described under the heading "Risk Factors" and elsewhere in Theravance Biopharma's Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2020, in the Form S-3 filed with the SEC on December 3, 2019 and in the Prospectus Supplement filed with the SEC on February 12, 2020. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact Information
    Gail B. Cohen
    Corporate Communications and Investor Relations
    917-214-6603

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  21. DUBLIN, Feb. 24, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the fourth quarter and full year ended December 31, 2019. Revenue for the fourth quarter and full year 2019 was $29.5 million and $73.4 million, respectively. Full-year operating loss was $251.9 million or $191.5 million excluding share-based compensation expense. Cash, cash equivalents and marketable securities totaled $285.8 million as of December 31, 2019.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Rick E Winningham, Chairman and Chief Executive Officer, commented: "2019 was a year of achievement for Theravance Biopharma across our business. We successfully launched YUPELRI with Mylan and advanced our development- and research-stage…

    DUBLIN, Feb. 24, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the fourth quarter and full year ended December 31, 2019. Revenue for the fourth quarter and full year 2019 was $29.5 million and $73.4 million, respectively. Full-year operating loss was $251.9 million or $191.5 million excluding share-based compensation expense. Cash, cash equivalents and marketable securities totaled $285.8 million as of December 31, 2019.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Rick E Winningham, Chairman and Chief Executive Officer, commented: "2019 was a year of achievement for Theravance Biopharma across our business. We successfully launched YUPELRI with Mylan and advanced our development- and research-stage pipeline, further building a diversified portfolio with promising, differentiated programs in every stage of development. Our roster of partnerships continued to strengthen, with ongoing successful collaborations with Mylan for YUPELRI and Janssen for TD-1473 and TD-5202. In addition, we entered into a new agreement with Pfizer to out-license our skin-selective pan-JAK inhibitor program. Our partnerships complement and expand our capabilities and execution and underscore our potential to transform the treatment of serious diseases." 

    "As we look ahead, 2020 will be an important year for our Company. We have established a strong capital position, augmented by our partnerships, as well as TRELEGY ELLIPTA royalties and YUPELRI commercialization. We are optimistic about future data readouts, especially our wholly owned programs -- ampreloxetine in nOH and TD-8236 in asthma -- which could both represent new treatment paradigms for patients with debilitating chronic diseases. The combined strengths of our research engine, pipeline, proven development expertise and commercial infrastructure have set the stage for a data- and catalyst-rich 2020 -- a year that we believe can deliver meaningful value for stakeholders." 

    Corporate Highlights

    Partnered with Mylan:
    YUPELRI® (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)): 

    • First and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
    • One year post-launch -- continued strong customer acceptance across key market metrics; combined Theravance Biopharma/Mylan sales infrastructures covering the hospital, hospital discharge, and home health settings
      • Data as of October 2019 show that YUPELRI achieved an 86% share of the nebulized LAMA market and a 10.7% share of the long-acting nebulized market (including Durable Medical Equipment)

    Partnered with Janssen:
    TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):

    • TD-5202 was generally well tolerated as a single oral dose up to 2000 milligrams and as a twice-daily oral dose up to 2000 milligrams total per day given for 10 consecutive days in healthy subjects

    TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases): 

    • Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn's disease (DIONE) progressing
    • Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn's disease studies planned for late-2020

    Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):

    • Ongoing registrational program in symptomatic neurogenic orthostatic hypertension (nOH) comprised of two studies:
      • Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy, with data expected in late 2020
      • Phase 3 four-month open label study followed by a six-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response

    TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory lung diseases):

    • Part C extension portion of the Phase 1 trial assessing additional biomarkers in more severe asthmatics underway with results expected in mid-2020
    • Phase 2 lung allergen challenge initiated in 4Q 2019; data expected in mid-2020

    TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)2

    • 4Q 2019 net sales of $221.5 million and full-year 2019 net sales of $661.3 million; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
    • Product now launched for COPD in 38 markets, including China
    • GSK filed sNDA 2Q 2019 for mortality benefit compared with ANORO in COPD and sNDA for use in patients with asthma in 3Q 2019

    Notes:
    1 Theravance Biopharma's full-year operating loss, excluding share-based compensation expense, was below the 2019 guidance of $200 million to $210 million operating loss excluding share-based compensation due to the Pfizer upfront payment of $10 million being recognized as revenue in late December.
    2 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination of fluticasone furoate, aclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC ("TRC LLC") expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). 75% of the income from Company's investment in TRC is pledged to service outstanding PhaRMASM notes, 25% of income from Company's investment in TRC is retained by Company.

    Fourth Quarter and Full Year Financial Results

    • Revenue: Revenue for the fourth quarter of 2019 was $29.5 million, comprised of collaboration revenue of $9.6 million primarily attributed to the upfront payment from Janssen for TD-1473, licensing revenue of $10.0 million related to the upfront payment from Pfizer for rights to our skin-selective pan-JAK inhibitor program, and revenue from the Mylan collaboration agreement of $9.9 million. Revenue for the fourth quarter represents a $13.8 million increase over the same period in 2018. The increase was primarily due to licensing revenue associated with the upfront payment from Pfizer and an increase in revenue from the Mylan collaboration agreement, partially offset by a decrease in product sales which resulted from the sale of VIBATIV® to Cumberland Pharmaceuticals in late-2018. Full-year 2019 revenue was $73.4 million, comprised of collaboration revenue of $31.3 million primarily associated with our global collaboration with Janssen, licensing revenue of $28.5 million related to upfronts from Pfizer and Mylan and revenue from the Mylan collaboration of $13.7 million

    • Research and Development Expenses: Research and Development (R&D) expenses for the fourth quarter of 2019 were $67.0 million, compared to $52.3 million in the same period in 2018. The increase was primarily due to an increase in employee-related costs and share-based compensation related to long-term retention and incentive awards, plus external-related costs associated with the progression of our key programs. Full-year 2019 R&D expenses were $219.2 million, or $190.3 million excluding non-cash share-based compensation.

    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2019 were $33.0 million, compared to $25.5 million in the same period in 2018. The increase was primarily due to an increase in share-based compensation related to long-term retention and incentive awards. Full-year 2019 SG&A expenses were $106.1 million, or $74.6 million excluding non-cash share-based compensation.

    • Cash, Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities totaled $285.8 million as of December 31, 2019.  

    2020 Financial Guidance

    • Operating Expenses: The Company expects full-year 2020 operating loss, excluding share-based compensation, of $205 million to $225 million. Operating loss guidance does not include:
      • Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in TRC, LLC;" or
      • Potential future business development collaborations

    Note: timing and cost of clinical studies associated with key programs, among other factors, could impact financial guidance. 

    Additionally, as announced on February 11th, 2020, we closed our public offering of 5,500,000 ordinary shares at a price to the public of $27.00 per share.  The gross proceeds to Theravance Biopharma from the offering are approximately $148.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.

    Conference Call and Live Webcast Today at 5:00 pm ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET (2:00 pm PT / 10:00 pm GMT). To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 5775588. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through March 25, 2020. An audio replay will also be available through 8:00 pm ET on March 2, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 5775588.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA.

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    This press release contains and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that the Company's research programs will progress product candidates into the clinic, the Company's expectations for product candidates through development, potential regulatory approval and commercialization (including their differentiation from other products or potential products), product sales or profit share revenue and the Company's expectations for its 2019 operating loss, excluding share-based compensation. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective, risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. Other risks affecting Theravance Biopharma are in the company's Prospectus Supplement filed with the Securities and Exchange Commission (SEC) on February 12, 2020, Form 10-Q filed with the SEC on November 8, 2019, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Contact:
    Gail B. Cohen
    Corporate Communications and Investor Relations
    917-214-6603

    THERAVANCE BIOPHARMA, INC.


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


    (In thousands, except per share data)


















    Three Months Ended December 31,


    Year Ended December 31,




    2019


    2018


    2019


    2018


    Revenue:


    (Unaudited)


    (Unaudited)


    (1)


       Product sales  


    $

    -


    $

    2,415


    $

    -


    $

    15,304


       Collaboration revenue



    9,584



    10,047



    31,250



    41,791


       Licensing revenue



    10,000



    -



    28,500



    -


       Mylan collaboration agreement



    9,915



    3,275



    13,664



    3,275


         Total revenue 



    29,499



    15,737



    73,414



    60,370
















    Costs and expenses:














       Cost of goods sold



    -



    632



    -



    715


       Research and development (2)



    67,025



    52,269



    219,248



    201,348


       Selling, general and administrative (2)



    33,046



    25,457



    106,081



    97,058


    Total costs and expenses  



    100,071



    78,358



    325,329



    299,121


    Loss from operations  



    (70,572)



    (62,621)



    (251,915)



    (238,751)


    Income from investment in TRC, LLC



    11,913



    5,428



    33,705



    11,182


    Interest expense



    (8,035)



    (4,071)



    (31,862)



    (10,482)


    Interest and other income, net



    1,137



    7,822



    8,395



    11,966


    Loss before income taxes  



    (65,557)



    (53,442)



    (241,677)



    (226,085)


    Provision for income tax benefit (expense)



    (49)



    3,256



    5,222



    10,561


    Net loss  


    $

    (65,606)


    $

    (50,186)


    $

    (236,455)


    $

    (215,524)
















    Net loss per share:














       Basic and diluted net loss per share  


    $

    (1.17)


    $

    (0.92)


    $

    (4.25)


    $

    (3.99)


       Shares used to compute basic and diluted net loss per share  



    56,102



    54,555



    55,610



    53,969
















    ________________________________




























    (1)  The condensed consolidated statement of operations for the year ended December 31, 2018 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018.















    (2) Amounts include share-based compensation expense as follows:





















    Three Months Ended December 31,


    Year Ended December 31,


    (In thousands)


    2019


    2018


    2019


    2018


    Research and development 


    $

    10,615


    $

    5,806


    $

    28,953


    $

    25,563


    Selling, general and administrative 



    13,297



    5,908



    31,497



    25,750


       Total share-based compensation expense 


    $

    23,912


    $

    11,714


    $

    60,450


    $

    51,313


     







    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)









    December 31,


    December 31,


    2019


    2018

    Assets

    (Unaudited)


    (1)

    Current assets:




    Cash and cash equivalents and short-term marketable securities

    $

    280,831


    $

    505,276

    Receivables from collaborative arrangements


    11,996



    10,053

    Receivables from licensing arrangements


    10,000



    -

    Amounts due from TRC, LLC


    28,574



    5,422

    Other prepaid and current assets  


    7,087



    12,072

      Total current assets  


    338,488



    532,823

    Property and equipment, net  


    12,644



    13,176

    Long-term marketable securities


    4,985



    11,869

    Operating lease assets


    46,604



    -

    Restricted cash  


    833



    833

    Other assets


    5,272



    1,534

     Total assets  

    $

    408,826


    $

    560,235







    Liabilities and Shareholders' Deficit






    Current liabilities

    $

    111,703


    $

    98,554

    Convertible senior notes due 2023, net


    225,890



    224,818

    Non-recourse notes due 2033, net


    219,300



    229,535

    Long-term operating lease liabilities


    47,725



    -

    Other long-term liabilities


    28,048



    58,917

    Shareholders' deficit


    (223,840)



    (51,589)

    Total liabilities and shareholders' deficit

    $

    408,826


    $

    560,235












     (1) 

     The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018.

     

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  22. DUBLIN, Feb. 18, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will webcast Management presentations:

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    • SVB Leerink 9th Annual Global Healthcare Conference at 11:30 a.m. ET (8:30 a.m. PT/4:30 p.m. GMT) on Wednesday, February 26, 2020
       
    • Cowen and Company 40th Annual Health Care Conference at 1:30 p.m. ET (10:30 a.m. PT/6:30 p.m. GMT) on Monday, March 2, 2020

    Webcasts of the presentations may be accessed by visiting the Investor Relations section of Theravance Biopharma's website at www.theravance.com, under the Presentations and Events tab. Replays of the webcasts will be archived on the…

    DUBLIN, Feb. 18, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will webcast Management presentations:

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    • SVB Leerink 9th Annual Global Healthcare Conference at 11:30 a.m. ET (8:30 a.m. PT/4:30 p.m. GMT) on Wednesday, February 26, 2020
       
    • Cowen and Company 40th Annual Health Care Conference at 1:30 p.m. ET (10:30 a.m. PT/6:30 p.m. GMT) on Monday, March 2, 2020

    Webcasts of the presentations may be accessed by visiting the Investor Relations section of Theravance Biopharma's website at www.theravance.com, under the Presentations and Events tab. Replays of the webcasts will be archived on the Company's website for at least 30 days.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies.  YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Gail Cohen
    Corporate Communications and Investor Relations
    917-214-6603

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  23. DUBLIN, Feb. 13, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will report its fourth quarter and full year 2019 financial and operating results and provide a business update after market close on Monday, February 24, 2020. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Conference Call Information

    To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 5775588. Those interested in listening to the conference…

    DUBLIN, Feb. 13, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will report its fourth quarter and full year 2019 financial and operating results and provide a business update after market close on Monday, February 24, 2020. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Conference Call Information

    To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 5775588. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investor Relations section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through March 25, 2020. An audio replay will also be available through 8:00 p.m. ET on March 2, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 5775588.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies.  YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Gail Cohen
    Corporate Communications and Investor Relations
    917-214-6603

     

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  24. DUBLIN, Feb. 11, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, announced today the pricing of its underwritten public offering of 5,500,000 ordinary shares at a price to the public of $27.00 per share. The gross proceeds to Theravance Biopharma from the offering are expected to be approximately $148.5 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, Theravance Biopharma has granted the underwriters a 30-day option to purchase up to an additional 825,000 ordinary shares at the public offering…

    DUBLIN, Feb. 11, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, announced today the pricing of its underwritten public offering of 5,500,000 ordinary shares at a price to the public of $27.00 per share. The gross proceeds to Theravance Biopharma from the offering are expected to be approximately $148.5 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, Theravance Biopharma has granted the underwriters a 30-day option to purchase up to an additional 825,000 ordinary shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on February 14, 2020, subject to customary closing conditions. 

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Morgan Stanley, J.P. Morgan and Cowen are acting as the joint book-running managers for the offering. Credit Suisse, Cantor and Needham & Company are acting as co-managers for the offering.

    A shelf registration statement (including a base prospectus) relating to the shares was filed with the SEC and is effective. A preliminary prospectus supplement related to the offering has been filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 2nd Floor, 180 Varick Street, New York, New York 10014, United States of America, J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by calling 1-866-803-9204, or by email at ; or Cowen and Company, LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by calling 1-(833) 297-2926, or by email at .

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

    Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This announcement contains "forward-looking statements" such as those, among others, relating to Theravance Biopharma's expectations regarding the completion of the proposed public offering. These statements are subject to significant risks and uncertainties; actual results could differ materially from those projected and Theravance Biopharma cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to the satisfaction of customary closing conditions related to the proposed public offering. There can be no assurance that Theravance Biopharma will be able to complete the public offering on the anticipated terms, or at all. Risks and uncertainties relating to Theravance Biopharma and its business can be found in the "Risk Factors" section of Theravance Biopharma's Form 10-Q, filed with the SEC on November 8, 2019, in Theravance Biopharma's other filings with the SEC and in the preliminary prospectus supplement relating to the proposed offering filed with the SEC on February 10, 2020. Theravance Biopharma undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Theravance Biopharma's expectations.

    Theravance Biopharma Contact

    Gail Cohen
    Corporate Communications and Investor Relations
    917-214-6603

     

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  25. DUBLIN, Feb. 10, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, announced today that it intends to offer $150.0 million of ordinary shares in an underwritten public offering. Theravance Biopharma also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of additional ordinary shares. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Theravance Biopharma intends to…

    DUBLIN, Feb. 10, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, announced today that it intends to offer $150.0 million of ordinary shares in an underwritten public offering. Theravance Biopharma also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of additional ordinary shares. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Theravance Biopharma intends to use the net proceeds from the offering for general corporate purposes, which may include, among other things, research activities, preclinical and clinical development of product candidates, manufacture of pre-clinical, clinical and commercial drug supplies, selling and marketing expenses, capital expenditures, working capital, general and administrative expenses and acquisitions of technology or drug candidates.

    Morgan Stanley, J.P. Morgan and Cowen are acting as the joint book-running managers for the offering.

    A shelf registration statement relating to the offered shares was filed with the SEC and is effective. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 2nd Floor, 180 Varick Street, New York, New York 10014, United States of America, by calling 1- 866-718-1649, or by email at ; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by calling 1-866-803-9204, or by email at ; or Cowen and Company, LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by calling 1-833-297-2926, or by email at .

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

    Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This announcement contains "forward-looking statements" such as those, among others, relating to Theravance Biopharma's expectations regarding the completion, timing and size of the proposed public offering. These statements are subject to significant risks and uncertainties; actual results could differ materially from those projected and Theravance Biopharma cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to whether or not Theravance Biopharma will be able to raise capital through the offering, the final terms of the proposed public offering, market and other conditions, and the satisfaction of customary closing conditions related to the proposed public offering.  There can be no assurance that Theravance Biopharma will be able to complete the public offering on the anticipated terms, or at all. Risks and uncertainties relating to Theravance Biopharma and its business can be found in the "Risk Factors" section of Theravance Biopharma's Form 10-Q, filed with the SEC on November 8, 2019, in Theravance Biopharma's other filings with the SEC and in the preliminary prospectus supplement relating to the proposed offering to be filed with the SEC on February 10, 2020. Theravance Biopharma undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Theravance Biopharma's expectations.

    Theravance Biopharma Contact

    Gail Cohen
    Corporate Communications and Investor Relations
    917-214-6603

     

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  26. DUBLIN, Jan. 7, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will webcast its presentation at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020. The presentation is scheduled for 8:30 a.m. PT (11:30 a.m. ET/4:30 p.m. GMT) and may be accessed by visiting the Investor Relations section of Theravance Biopharma's website at www.theravance.com, under the Presentations and Events tab.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software. Audio replays…

    DUBLIN, Jan. 7, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, will webcast its presentation at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020. The presentation is scheduled for 8:30 a.m. PT (11:30 a.m. ET/4:30 p.m. GMT) and may be accessed by visiting the Investor Relations section of Theravance Biopharma's website at www.theravance.com, under the Presentations and Events tab.

    Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)

    Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software. Audio replays will be available for 30 days following the presentation.

    About Theravance Biopharma

    Theravance Biopharma, Inc. ("Theravance Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.

    In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including FDA approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.

    We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA. 

    For more information, please visit www.theravance.com.

    THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

    Contact Information:

    Jessica Stitt
    650-808-4045