1. DUBLIN and SOUTH SAN FRANCISCO, Calif., Sept. 15, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today announced strategic actions to focus on leveraging its expertise in developing and commercializing respiratory therapeutics in order to maximize shareholder value. These changes follow a comprehensive scenario planning exercise led by the Board and Management with the assistance of outside advisors. In order to implement this plan, Theravance Biopharma will immediately initiate a significant cost reduction program:

    • Headcount will be reduced by approximately 75%, an estimated 270 positions1, with approximately 75% of the reduction expected to be completed in November 2021 and the remainder to be completed in February 2022
    • Total annualized operating expense2 savings of approximately $165 million in 2022 compared with the Company's updated 2021 Financial Guidance below

    Updated 2021 and Preliminary 2022 Financial Guidance2:

    Expenses

    $ million

    2021 Initial

    Guidance

    2021 Updated

    Guidance

    2022 Preliminary

    Guidance

    R&D

    $195 – 225

    $180 – 190

    $55 – 65

    SG&A

    $80 – 90

    $70 – 80

    $30 – 40

    By implementing these strategic actions, Theravance Biopharma expects to become sustainably cash flow positive beginning in the second half of 2022.

    The go-forward organization will build on the Company's proven track record of innovation leading to several approved medicines for COPD and asthma, including YUPELRI®, launched in 2019, which was discovered and developed by the Company and is now commercialized in partnership with Viatris Inc., and TRELEGY, a respiratory medicine developed by Glaxo Group Limited in collaboration with the Company's predecessor, Theravance, Inc.

    TRELEGY is currently expected to generate global peak sales of approximately $3.0 billion annually3. YUPELRI remains early in its product lifecycle, has demonstrated quarter-over-quarter market share growth, and has the potential to generate US peak sales exceeding $400 million4. Theravance Biopharma believes the strong and growing cash flows of YUPELRI and TRELEGY will generate significant value creation opportunities for the Company's shareholders.

    In addition, the Company intends to significantly narrow its R&D focus on its core respiratory assets, including a clinical study in partnership with Viatris Inc., intended to generate data supporting label expansion for YUPELRI, which would significantly increase YUPELRI's addressable market, and investment in Theravance Biopharma's inhaled Janus kinase inhibitor portfolio, with focus on the most advanced clinical candidate, nezulcitinib, initially targeting acute lung injury. In order to implement this plan, the Company will halt the development of all non-respiratory disease related programs except that it will close-out the izencitinib Phase 2 Crohn's disease Study 0157 (NCT03758443) and the ampreloxetine Phase 3 REDWOOD Study 0170 (NCT03829657).

    Furthermore, management will work to optimize the Company's capital structure as financial flexibility increases in order to maximize total shareholder returns. Management will also prioritize initiatives that seek to realize the value of the Company's non-core assets and partnerships.

    "Given the recent results from our late-stage development programs, we have made the difficult but necessary decision to focus our resources on our most promising respiratory programs and reduce the size of the organization," said Rick E Winningham, Chairman and Chief Executive Officer. "I want to thank all of the patients who participated in our clinical trials and their families, the investigators, as well as the Theravance Biopharma employees who have worked tirelessly on these programs. I am grateful for the team's significant contributions over the years. I am confident these actions will help us to continue making transformational medicines aimed at improving the lives of patients suffering from serious respiratory illnesses while creating value for our shareholders."

    The Company has also decided to reduce the size of its Board, and is announcing the resignations from the Board of two long-term directors: George M. Whitesides, Ph.D., and Robert V. Gunderson, Jr., effective September 14, 2021 and September 11, 2021, respectively. Dr. Whitesides has served on the Board of the Company and its predecessor, Theravance, Inc., since its inception in 1996. Mr. Gunderson has served on the Board of the Company and its predecessor, Theravance, Inc., since September 1999. "George and Bob each have dedicated themselves to the Company and its predecessor for over two decades, providing their valuable expertise to us on a variety of matters. On behalf of my fellow Board members I thank them both for their many contributions to the Company over their years of service," said Winningham.

    Conference Call and Live Webcast Today at 8:00 AM ET (5:00 AM PT)

    Theravance Biopharma will hold a conference call and live webcast today at 8:00 AM ET / 5:00 AM PT. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 6475192. Those interested in listening to the conference call live via the internet may do so by visiting www.theravance.com, under the Investors section, Events and Presentations.

    A replay will be available on www.theravance.com for 30 days through October 15, 2021. An audio replay will also be available through 11:00 AM ET on September 22, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 6475192.

    About Theravance Biopharma 

    Theravance Biopharma, Inc. is a biopharmaceutical company primarily focused on the discovery, development and commercialization of respiratory medicines. Its core purpose is to create medicines that help improve the lives of patients suffering from respiratory illness.

    In pursuit of its purpose, Theravance Biopharma leverages decades of respiratory expertise to discover and develop transformational medicines that make a difference. These efforts have led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its respiratory pipeline of internally discovered programs is targeted to address significant patient respiratory 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 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 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.

    Forward-Looking Statements

    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 goals, designs, strategies, plans and objectives, the impact of the Company's restructuring plan, ability to provide value to shareholders, 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 and the market for products being commercialized, the Company's expectations regarding its allocation of resources, potential regulatory actions and commercialization (including differentiation from other products or potential products and addressable market), 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: disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings could be adverse to the Company, additional future analysis of the data resulting from our clinical trial(s), 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, products or product candidates are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, the feasibility of undertaking future clinical trials 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, ability to retain key personnel, the impact of the Company's restructuring actions on its employees, partners and others. 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 August 5, 2021 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.









    1 Regular and contingent workers.

    Excludes share-based compensation and any one-time costs related to strategic actions.

    3 Source: Bloomberg Consensus September 2021.

    4 Source: TBPH Broker Consensus September 2021.



    Contact: Gail B. Cohen

    Corporate Communications

    917-214-6603

     

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  2. DUBLIN and SOUTH SAN FRANCISCO, Calif., Sept, 15, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today announced top-line results from a Phase 3 randomized, double-blind, placebo-controlled multi-center Phase 3 study assessing the safety and efficacy of ampreloxetine compared to placebo for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). 

    The study did not meet its primary endpoint. The majority of treatment-related adverse events were mild or moderate in severity. Serious adverse events occurred in two patients on placebo and four on ampreloxetine and none were considered related to the study drug; no deaths were reported. There was no signal for supine hypertension. The Company plans to present the results at a future scientific forum.

    "These are not the results we had hoped to achieve, especially given the clear unmet need for patients suffering from symptomatic nOH and the positive top-line four-week results from the Phase 2 study announced in 2018. We will continue to analyze the data to better understand the findings," said Rick E Winningham, Chief Executive Officer, Theravance Biopharma. "We are grateful to all those who dedicated their time and efforts to progress this study, especially during the challenges of the pandemic. We are hopeful that insights from this study may inform future drug development to help those with this debilitating condition."

    In light of these results, the Company will be determining the appropriate next steps for Study 0170 (NCT03829657; more than 75% enrolled) and Study 0171 (NCT04095793); clinical trial sites will be notified accordingly.

    About the Phase 3 Study

    Study 0169 (NCT03750552) was a Phase 3, 4-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ampreloxetine compared to placebo in patients with symptomatic nOH (n=195). Patients from Study 0169 were eligible to enter into Study 0170, a Phase 3, 22-week, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in patients with symptomatic nOH.

    About Symptomatic nOH

    Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a sustained orthostatic fall in systolic blood pressure (SBP) of ≥ 20 mm Hg or diastolic blood pressure (DBP) of ≥ 10 mm Hg within three minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain. nOH is caused by autonomic nervous system malfunction and is associated with several underlying medical conditions including multiple system atrophy (MSA), pure autonomic failure (PAF), and Parkinson's disease (PD).

    About OHSA #1

    OHSA #1 is an endpoint that is part of the Orthostatic Hypotension Questionnaire, a validated scale assessing the presence of a range of hypotension-related symptoms including dizziness, weakness, problems with vision, fatigue, trouble concentrating, and head/neck discomfort. It is based on a scale from 0 (no symptoms) to 10 (worst possible severity of a symptom), with reductions in OHSA points indicating symptom improvement and increases in OHSA score indicating symptom worsening. OHSA #1 specifically measures patients' dizziness, lightheadedness, feeling faint, or feeling like they might black out. OHSA #1 has been accepted as a suitable endpoint in the investigation of neurogenic orthostatic hypotension by regulatory agencies.

    About Ampreloxetine 

    Ampreloxetine (TD-9855) is an investigational, Theravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH).

    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 utilizes 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 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 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.

    Forward-Looking Statements

    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 goals, designs, strategies, plans and objectives, the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, and interpretation of the results of our clinical trials or conclusions drawn therefrom. 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: disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings could be adverse to the Company, and additional future analysis of the data resulting from our clinical trial(s). Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on August 5, 2021 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

     

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  3. DUBLIN and SOUTH SAN FRANCISCO, Calif., Aug. 23, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today announced top-line results from its Phase 2b dose-finding induction study of izencitinib, an orally administered, gut-selective pan-Janus kinase (JAK) inhibitor in development for the treatment of ulcerative colitis. 

    The study did not meet its primary endpoint of change in the total Mayo score or the key secondary endpoint of clinical remission at week 8, relative to placebo. There was a small dose-dependent increase in clinical response measured by the adapted Mayo score, which was driven by a reduction in rectal bleeding. 

    At all doses, izencitinib was well-tolerated when administered orally once daily for 8 weeks; adverse event rates were similar among patients receiving izencitinib and placebo. There were no instances of perforation, opportunistic infection, major cardiovascular or thromboembolic event, complicated zoster, or non-melanoma skin cancer in patients receiving izencitinib. There were no notable changes in lab values including creatine phosphokinase and lipids in patients receiving izencitinib relative to placebo. Plasma exposure of izencitinib was low, consistent with expectations for a gut-selective medicine.

    The Company plans to present study results at a scientific forum.

    "We had high expectations for the Phase 2b study after eight weeks of treatment with izencitinib in ulcerative colitis given the totality and consistency of the broad range of clinical, histologic, and biomarker data we saw in the Phase 1b study with only four weeks of treatment, albeit in a small number of patients. We plan to analyze the data to better understand the findings and the potential for optimization of a gut-selective medicine as a treatment for patients with inflammatory bowel diseases," said Rick E Winningham, Chief Executive Officer, Theravance Biopharma. "We are grateful to all those who participated in this clinical trial and to those who are still participating in the Crohn's Phase 2 study – which we expect to report top-line results in late fourth quarter 2021 or early first quarter 2022." 

    Regarding current plans, the Company will work to understand the complete results and implications for izencitinib. Forthcoming ulcerative colitis data will include results from the 16-week extended induction portion of the study and the 44-week maintenance study. The Company reiterates timing of the top-line results of the Crohn's Phase 2 study in late fourth quarter 2021 or early first quarter 2022. Based on the ulcerative colitis results, the Company will seek to minimize future expenses associated with the izencitinib program.

    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 IST. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 3198387. Those interested in listening to the conference call live via the internet may do so by visiting Theravance.com, under the Investors section, Events and Presentations.

    A replay will be available on Theravance.com under the Investors section for 30 days. An audio replay will be also available through 8:00 p.m. ET on August 30, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 3198387.

    About the Phase 2b Dose-Finding Induction Study

    The study was a randomized, double-blind, placebo-controlled, multi-center Phase 2b dose-finding induction study (NCT03758443) for the treatment of adults with moderately-to-severely active ulcerative colitis with the primary endpoint at Week 8 (n=239). The safety and efficacy data of this Phase 2b study were intended to inform induction and maintenance dose regimens for a confirmatory Phase 3 induction study and the ongoing maintenance study.

    About Theravance Biopharma and Janssen Strategic Collaboration 

    Theravance Biopharma and Janssen Biotech, Inc. have a global co-development and commercialization agreement for izencitinib, also known as TD-1473, and other compounds for inflammatory intestinal diseases. 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. In that scenario, Theravance Biopharma and Janssen will jointly develop and commercialize izencitinib in inflammatory intestinal diseases, with the two companies sharing expenses related to a potential Phase 3 program and profits in the U.S. 

    About 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 immune-mediated diseases such as rheumatoid arthritis, myelofibrosis, and ulcerative colitis. However, these products are known to have adverse effects associated with their systemic exposure. 

    About Izencitinib 

    Izencitinib, also known as TD-1473, is an orally administered, once-daily, investigational, internally discovered, high affinity, reversible pan-JAK inhibitor which was designed to be gut selective. The gut-selective design provides izencitinib the potential to distribute throughout the gastrointestinal tract tissues and target inflammation at the site of gastrointestinal disease while limiting its systemic exposure. Theravance Biopharma is focused on utilizing izencitinib for the potential treatment of a range of inflammatory intestinal diseases including ulcerative colitis and Crohn's disease.

    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 utilizes 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 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 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.

    Forward-Looking Statements

    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 goals, designs, 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: disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings could be adverse to the Company, additional future analysis of the data resulting from our clinical trial(s), 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, ineffective or not differentiated, 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 August 5, 2021 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

     

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  4. DUBLIN, Aug. 3, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the second quarter of 2021.

    "We made strong progress in the second quarter. Our field team is energized and has recently been able to increase its face-to-face engagements with customers, driving continued sales volume and market share growth. As we look to the future for YUPELRI, we and our partner Viatris are initiating a controlled clinical study intended to provide data for a possible label update," said Rick E Winningham, Chief Executive Officer. "We continued to execute across our clinical trials and eagerly anticipate study results this quarter and later this year/early next. 2021 is a pivotal year for Theravance Biopharma, and we are looking forward to the second half of the year furthering our mission of medicines that make a difference."

    Upcoming Clinical Milestones

    • Q3 2021: Izencitinib (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases) Phase 2b in ulcerative colitis (study 0157) – top-line results expected in Q3 2021.
    • Q3 2021: Ampreloxetine (norepinephrine reuptake inhibitor) Phase 3 for symptomatic neurogenic orthostatic hypotension (study 0169) – enrollment complete and top-line results expected in Q3 2021.
    • Q4 2021/Q1 2022: Izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) Phase 2 in Crohn's disease (study 0173) – top-line results expected in late Q4 2021/early Q1 2022.

    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 its share of the long-acting nebulized COPD market, increasing to 21% in April 2021, up from 19% in January 2021, and net sales increased by 38% year-over-year (Q2 2020 vs. Q2 2021).
      • The Company, in collaboration with our partner Viatris, is also initiating a Phase 4 study comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment with either YUPELRI® (revefenacin) delivered via standard jet nebulizer or tiotropium delivered via a dry powder inhaler (Spiriva® HandiHaler®). This study is aimed at helping to better inform decisions when physicians are designing a personalized COPD treatment plan with patients. 
    • Nezulcitinib, an investigational, inhaled, lung-selective, pan-JAK inhibitor in development for hospitalized patients with COVID-19, reported Phase 2 top-line results (read more about the data here). 
    • On June 29, 2021, the Company closed a public offering of ordinary shares at a price to the public of $15.00 per share, with gross proceeds of $115.6 million, before deducting underwriting discounts and commissions and offering expenses.

    Economic Interest

    • TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted second quarter 2021 global net sales of $405 million (up from $241 million, 68%, in the second quarter of 2020); Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3

    Second Quarter Financial Results  

    • Revenue: Total revenue for the second quarter of 2021 was $12.9 million, comprised of non-cash collaboration revenue of $2.0 million primarily attributed to our global collaboration with Janssen and $10.9 million in Viatris collaboration revenue. Total revenue for the second quarter represents a $2.1 million decrease over the same period in 2020.



    • YUPELRI: The Viatris collaboration revenue of $10.9 million for the second quarter of 2021 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 second quarter of 2021 was $14.6 million.



    • Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2021 were $51.1 million, compared to $62.4 million in the same period in 2020. Second quarter R&D expenses included total non-cash share-based compensation of $7.3 million.



    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2021 were $25.9 million, compared to $24.8 million in the same period in 2020. Second quarter SG&A expenses included total non-cash share-based compensation of $7.6 million.



    • Operating Loss: Operating loss for the second quarter of 2021 was $64.1 million compared to $72.2 million in the same period of 2020.



    • Cash Position: Cash, cash equivalents and marketable securities totaled $265.0 million as of June 30, 2021.

    2021 Financial Guidance

    • Operating Expenses (excluding share-based compensation): The Company reiterates that it 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 IST. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 2615108. Those interested in listening to the conference call live via the internet may do so by visiting www.theravance.com, under the Investors section, Presentations and Events.

    A replay will be available on www.theravance.com for 30 days through September 2, 2021. An audio replay will also be available through 8:00 p.m. ET on August 10, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-2406 for international callers, and then entering confirmation code 2615108.

    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 utilizes 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 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 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.

    Forward-Looking Statements

    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 goals, designs, 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: disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings could be adverse to the Company, additional future analysis of the data resulting from our clinical trial(s), 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, ineffective or not differentiated, 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 May 6, 2021 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

    _________________________

    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 and 25% of income from the Company's investment in TRC is retained by the Company.

    3 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 and 25% of income from the Company's investment in TRC is retained by the Company.

     

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

















    June 30,



    December 31,



    2021



    2020

    Assets

    (Unaudited)



    (1)

    Current assets:







    Cash and cash equivalents and short-term marketable securities

    $

    264,953



    $

    292,941

    Receivables from collaborative arrangements



    12,220





    15,868

    Amounts due from TRC, LLC



    27,741





    53,799

    Prepaid clinical and development services



    15,913





    20,374

    Other prepaid and current assets  



    12,353





    10,359

      Total current assets  



    333,180





    393,341

    Property and equipment, net  



    16,583





    16,422

    Operating lease assets



    41,508





    43,260

    Equity in net assets of TRC, LLC



    35,822





    12,750

    Restricted cash  



    833





    833

    Other assets



    1,325





    2,451

     Total assets  

    $

    429,251



    $

    469,057













    Liabilities and Shareholders' Deficit











    Current liabilities

    $

    67,127



    $

    123,571

    Convertible senior notes due 2023, net



    227,499





    226,963

    Non-recourse notes due 2035, net



    375,069





    372,873

    Long-term operating lease liabilities



    57,768





    47,220

    Other long-term liabilities



    2,162





    2,181

    Shareholders' deficit



    (300,374)





    (303,751)

    Total liabilities and shareholders' deficit

    $

    429,251



    $

    469,057













    ________________________________























    (1)  The condensed consolidated balance sheet as of December 31, 2020 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, 2020.

     

     

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

























































    Three Months Ended June 30,



    Six Months Ended June 30,





    2021



    2020



    2021



    2020





    (Unaudited)



    (Unaudited)

    Revenue:

























    Collaboration revenue



    $

    1,980



    $

    5,488



    $

    5,852



    $

    12,120

    Licensing revenue





    -





    -





    -





    1,500

    Viatris collaboration agreement





    10,934





    9,520





    21,319





    21,250

    Total revenue 





    12,914





    15,008





    27,171





    34,870



























    Costs and expenses:

























       Research and development (1)





    51,093





    62,404





    118,692





    128,417

       Selling, general and administrative (1)





    25,931





    24,780





    56,481





    51,105

       Total costs and expenses  





    77,024





    87,184





    175,173





    179,522

    Loss from operations  





    (64,110)





    (72,176)





    (148,002)





    (144,652)

    Income from investment in TRC, LLC





    21,926





    21,381





    38,473





    34,896

    Interest expense





    (11,612)





    (11,391)





    (23,485)





    (21,332)

    Loss on extinguishment of debt





    -





    -





    -





    (15,464)

    Interest and other income (expense), net





    1,171





    (662)





    937





    798

    Loss before income taxes  





    (52,625)





    (62,848)





    (132,077)





    (145,754)

    Provision for income tax benefit (expense)





    220





    (39)





    (7)





    (186)

    Net loss  



    $

    (52,405)



    $

    (62,887)



    $

    (132,084)



    $

    (145,940)



























    Net loss per share:

























    Basic and diluted net loss per share  



    $

    (0.80)



    $

    (1.00)



    $

    (2.03)



    $

    (2.39)

    Shares used to compute basic and diluted net loss per share  





    65,669





    62,861





    65,085





    61,162



























    ________________________________



















































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























































    Three Months Ended June 30,



    Six Months Ended June 30,

    (In thousands)



    2021



    2020



    2021



    2020

    Research and development 



    $

    7,315



    $

    8,098



    $

    15,236



    $

    15,963

    Selling, general and administrative 





    7,626





    8,487





    15,537





    15,898

    Total share-based compensation expense 



    $

    14,941



    $

    16,585



    $

    30,773



    $

    31,861

     

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-second-quarter-2021-financial-results-and-provides-business-update-301347426.html

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  5. DUBLIN, Ireland, July 20, 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 second quarter 2021 financial results and provide a business update after market close on Tuesday, August 3, 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. IST) 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 2615108. 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 Investors section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through September 2, 2021. An audio replay will also be available through 8:00 p.m. ET on August 10, 2021 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 2615108.

    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 utilizes 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 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 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.

    Contact Information:

    Gail Cohen

    Corporate Communications

    917-214-6603

    investor.relations@theravance.com

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  6. DUBLIN, June 24, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma"), 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 6,700,000 ordinary shares at a price to the public of $15.00 per share. The gross proceeds to Theravance Biopharma from the offering are expected to be $100.5 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 1,005,000 ordinary shares at the public offering price, less underwriting…

    DUBLIN, June 24, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma"), 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 6,700,000 ordinary shares at a price to the public of $15.00 per share. The gross proceeds to Theravance Biopharma from the offering are expected to be $100.5 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 1,005,000 ordinary shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 29, 2021, subject to customary closing conditions. 

    SVB Leerink and Evercore ISI acted as joint lead bookrunners. Credit Suisse also acted as a bookrunner for the offering. H.C. Wainwright & Co. acted as lead-manager 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 a final 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 final  prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525 ext. 6105, or by email at syndicate@svbleerink.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474 0200, or by email at ecm.prospectus@evercore.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Raleigh, NC 27560, or by telephone at 1-800-221-1037, or by e-mail at usa.prospectus@credit-suisse.com.

    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 May 6, 2021, 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 June 24, 2021. 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.

    Contact: Gail Cohen

    Corporate Communications

    917-214-6603

    investor.relations@theravance.com

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  7. DUBLIN, June 24, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, announced today that it intends to offer its 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 15% of the number of ordinary shares in the offering.  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.

    DUBLIN, June 24, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) ("Theravance Biopharma"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, announced today that it intends to offer its 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 15% of the number of ordinary shares in the offering.  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 intends to use the net proceeds from this offering for general corporate purposes, including further development of (1) its norepinephrine reuptake inhibitor, ampreloxetine, which is in a Phase 3 clinical program for neurogenic orthostatic hypotension and (2) its gut-selective pan-Janus kinase inhibitor izencitinib, which is in a Phase 2b/3 clinical program for ulcerative colitis and Phase 2 clinical program for Crohn's disease. Any remaining net proceeds will be used for the advancement of its other clinical and preclinical product candidates, working capital, and acquisitions of technology or drug candidates.

    SVB Leerink, Evercore ISI, and Credit Suisse are acting as bookrunners 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 SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525 ext. 6105, or by email at syndicate@svbleerink.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474 0200, or by email at ecm.prospectus@evercore.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Raleigh, NC 27560, or by phone: 1-800-221-1037, or by e-mail at usa.prospectus@credit-suisse.com.

    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 May 6, 2021, 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 June 24, 2021. 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.

    Contact: Gail Cohen

    Corporate Communications

    917-214-6603

    investor.relations@theravance.com

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  8. DUBLIN and SOUTH SAN FRANCISCO, Calif., June 21, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today announced top-line results from its Phase 2 study of 3 mg once-daily nezulcitinib compared to placebo, each in combination with standard of care. Nezulcitinib is an investigational, inhaled, lung-selective, pan-Janus kinase (JAK) inhibitor in development for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation. 

    DUBLIN and SOUTH SAN FRANCISCO, Calif., June 21, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today announced top-line results from its Phase 2 study of 3 mg once-daily nezulcitinib compared to placebo, each in combination with standard of care. Nezulcitinib is an investigational, inhaled, lung-selective, pan-Janus kinase (JAK) inhibitor in development for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation. 

    "Since learning of the extensive respiratory complications in severe COVID-19, we have worked to advance the science behind inhaled lung-selective JAK inhibitors in critical diseases like COVID-19," said Rick E Winningham, Chief Executive Officer, Theravance Biopharma. "Even though this Phase 2 study, enrolling more than 200 patients, did not meet the primary endpoint, we are encouraged by the trend in the pre-specified analysis of the 28-day mortality rate in the intent-to-treat population. We are grateful to the patients and their families, our research partners, the clinical investigators, and our team at Theravance Biopharma for their important contributions."

    "This is the first investigation of an inhaled JAK inhibitor in COVID-19 patients. The classification of a COVID-ALI endotype using a blood biomarker, such as C-reactive protein, may advance the understanding and stratification of a subpopulation of patients with immune characteristics that best responds to a targeted-therapeutic such as nezulcitinib," said John Belperio, MD, professor of medicine in the pulmonary and critical care department at the David Geffen School of Medicine at UCLA and trial investigator.

    The study was a 1:1 randomized, double-blind, placebo-controlled, multi-center Phase 2 trial for the treatment of hospitalized COVID-19 patients (n=210) with impaired oxygenation (NCT04402866). Key endpoints were measured through Day 28. Standard of care in the study included approximately 99% receiving steroids (91% received dexamethasone).

    Key Study Findings

    • Outcomes:
      • Primary: No statistically significant difference in RFDs from randomization through Day 28 between nezulcitinib and placebo in ITT (median: 21 vs. 21 days; p=0.61).
      • Secondary: No difference in change from baseline at Day 7 in SaO2/FiO2 ratio, proportion of patients in each category of the 8-point Clinical Status scale, and proportion of patients alive and respiratory failure-free at Day 28.
      • Nezulcitinib demonstrated a favorable trend in improvement when compared to placebo for 28-day all-cause mortality (total number of deaths: 6 vs. 13, HR: 0.42, p=0.08) and time to recovery (median: 10 vs. 11 days, HR: 1.27, p=0.12).
      • In a post-hoc analysis of patients with baseline CRP (n=201):
        • In patients with CRP <150 mg/L (n=171), there was an improvement in those treated with nezulcitinib when compared to placebo in:
          • 28-day all-cause mortality (total number of deaths: 1 vs 9, HR: 0.097, p=0.009).
          • time to recovery (median: 10 vs. 11 days, HR: 1.48, p=0.02).
        • In patients with CRP >150 mg/L (n=30), there was no difference in time to recovery or 28-day all-cause mortality between those treated with nezulcitinib or placebo.
    • Safety:
      • Nezulcitinib was well-tolerated; adverse events and serious adverse events occurred in 34.0% and 9.7% of patients treated with nezulcitinib, and 41.2% and 15.7% of patients treated with placebo, respectively.
      • Adverse events of liver abnormalities or disease occurred in 9.7% and 7.8% of patients treated with nezulcitinib and placebo, respectively.
      • Serious infections and venous thromboembolism occurred in 1.0% and none of the patients treated with nezulcitinib, and 2.0% and 4.9% in patients treated with placebo, respectively.
    • Plasma exposure of nezulcitinib was low and consistent with expectations for a lung-selective medicine.

    The Company will share these results with FDA and other regulatory agencies to seek input on protocols to further study nezulcitinib in acute hyperinflammation in the lung. A more detailed analysis of the data, including further pharmacokinetic and biomarker results, will be available in the future.

    Conference Call and Live Webcast Today at 8 am ET

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 8 am ET / 5 am PT / 1 pm IST. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 6984147. Those interested in listening to the conference call live via the internet may do so by visiting Theravance.com, under the Investors section, Events and Presentations.

    A replay will be available on Theravance.com for 30 days through July 21, 2021. An audio replay will also be available through 11:00 am ET on June 28, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 6984147.

    About Nezulcitinib

    Nezulcitinib, also known as TD-0903, is an investigational, inhaled, lung-selective, pan-JAK inhibitor that was discovered and developed at Theravance Biopharma. Nezulcitinib has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. The organ selectivity of nezulcitinib is demonstrated preclinically via a high lung: plasma ratio and rapid metabolic clearance resulting in low systemic exposure. As an inhaled JAK inhibitor, nezulcitinib is expected to intervene broadly to interrupt excessive immune activation in the airways. Nezulcitinib, delivered via nebulization, may present a novel therapeutic modality to address the cytokine release syndrome that has been associated with acute lung injury, ventilator use, and increased morbidity and mortality in COVID-19 patients.

    The Company previously reported results from the initial dose-finding portion of this Phase 2 study, in which nezulcitinib was generally well-tolerated and showed numerical improvements in clinical outcome, duration of hospital stay, and fewer deaths compared to placebo. Results of this dose-finding portion of the Phase 2 study informed a decision to progress the 3 mg dose into the larger Phase 2 study reported herein. Read more about the dose-finding portion of the Phase 2 study here.

    Nezulcitinib may also provide a potential treatment for other causes of acute hyperinflammation of the lung and the prevention or delay of lung transplant rejection.

    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 utilizes 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 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 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.

    Forward-Looking Statements

    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 goals, designs, 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: disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings could be adverse to the Company, additional future analysis of the data resulting from our clinical trial(s), 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 May 6, 2021 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

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  9. DUBLIN, May 6, 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 an investor event as follows:

    • Rick E Winningham (Chief Executive Officer) will be presenting at the Bank of America 2021 Healthcare Conference on Thursday, May 13 at 2:45 p.m. ET (11:45 a.m. PT/7:45 p.m. IST)

    Webcast of the event may be accessed by visiting Theravance.com, under the Investors section, Presentations and Events. 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 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.

    Contact Information:

    Gail Cohen

    Corporate Communications

    917-214-6603

    investor.relations@theravance.com

     

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  10. DUBLIN, May 4, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial results for the first quarter of 2021.

    "2021 is on track to be a transformational year as we make significant progress towards our business goals," said Rick E Winningham, Chief Executive Officer. "Our commercial assets provide cash flow to invest in our diversified clinical pipeline. GSK's TRELEGY continues an exceptional, unabated growth trajectory. Our YUPELRI team, with our partner Viatris, continues to drive performance despite pandemic-associated headwinds. While we experienced slightly down sequential quarter-over-quarter net sales results, our January 2021 market share was 19%—its highest level since launch—and we ended the quarter on a strong note with March volume demand demonstrating 28% growth over February."

    "Additionally, we are focused on advancing development of our innovative and differentiated pipeline. We continue to progress nezulcitinib, our wholly-owned nebulized lung-selective pan-JAK inhibitor, our potentially best-in-class ampreloxetine for symptomatic neurogenic orthostatic hypotension and izencitinib, our oral gut-selective pan-JAK inhibitor for inflammatory bowel disease that is partnered with Janssen Pharmaceuticals. Our team is looking forward to four significant clinical readouts between now and Q1 2022: our Phase 2 nezulcitinib trial in Q2, our Phase 3 ampreloxetine and Phase 2b izencitinib Ulcerative Colitis trials each in Q3, and the Phase 2 izencitinib Crohn's disease trial in Q4/Q1 2022. We remain committed to delivering each of these clinical data sets with the highest quality as expeditiously as possible."

    Upcoming Clinical Milestones

    • Q2 2021: Nezulcitinib (nebulized lung-selective pan-Janus kinase (JAK) inhibitor) Phase 2 for acute hyperinflammation of the lung in COVID-19 (study 0188) – enrollment complete and topline results expected in Q2.
    • Q3 2021: Ampreloxetine (norepinephrine reuptake inhibitor) Phase 3 for symptomatic neurogenic orthostatic hypotension (study 0169) – enrollment near complete and topline results expected in Q3.
    • Q3 2021: Izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) Phase 2b in ulcerative colitis (study 0157) – enrollment complete and topline results expected in Q3.
    • Q4 2021/Q1 2022: Izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) due to enrollment challenges, Phase 2 in Crohn's disease (study 0173) – enrollment ongoing and topline results now expected in late Q4 2021/early Q1 2022.

    Quarterly Highlight

    • 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 its share of the long-acting nebulized COPD market, increasing to 19.0% in January 2021, up from 18.6% in December 2020.

    Economic Interest

    • TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted first quarter 2021 global net sales of $341 million (up from $249 million, 36.9%, in the first quarter of 2020); Theravance Biopharma is entitled to tiered royalties of 5.5% to 8.5% of TRELEGY global net sales.3

    First Quarter Financial Results  

    • Revenue: Total revenue for the first quarter of 2021 was $14.3 million, comprised of non-cash collaboration revenue of $3.9 million primarily attributed to our global collaboration with Janssen and $10.4 million in Viatris collaboration revenue. Total revenue for the first quarter represents a $5.6 million decrease over the same period in 2020.
    • YUPELRI: The Viatris collaboration revenue of $10.4 million for the first quarter of 2021 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 first quarter of 2021 was $12.9 million.
    • Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2021 were $67.6 million, compared to $66.0 million in the same period in 2020. First quarter R&D expenses included total non-cash share-based compensation of $7.9 million.
    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2021 were $30.6 million, compared to $26.3 million in the same period in 2020. First quarter SG&A expenses included total non-cash share-based compensation of $7.9 million.
    • Operating Loss: Operating loss for the first quarter of 2021 was $83.9 million compared to $72.5 million in the same period of 2020.
    • Cash Position: Cash, cash equivalents and marketable securities totaled $210.0 million as of March 31, 2021.

    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 IST. To participate, please dial (855) 296-9648 from the U.S. or (920) 663-6266 for international callers, using the confirmation code 1092615. Those interested in listening to the conference call live via the internet may do so by visiting Theravance.com, under the Investors section, Presentations and Events.

    A replay will be available on Theravance.com for 30 days through June 3, 2021. An audio replay will also be available through 8:00 pm ET on May 11, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 1092615.

    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 utilizes 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 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 registered trademark of Mylan Specialty L.P., a Viatris company. 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 goals, designs, 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: disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings 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-K filed with the SEC on February 26, 2021 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

    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 and 25% of income from the Company's investment in TRC is retained by the Company.

    3 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 and 25% of income from the Company's investment in TRC is retained by the Company.

     

    THERAVANCE BIOPHARMA, INC.



    CONDENSED CONSOLIDATED BALANCE SHEETS



    (In thousands)























    March 31,



    December 31,





    2021



    2020

    Assets

    (Unaudited)



    (1)



    Current assets:









    Cash and cash equivalents and short-term marketable securities

    $

    209,968



    $

    292,941



    Receivables from collaborative arrangements



    11,915





    15,868



    Receivables from licensing arrangements



    -





    -



    Amounts due from TRC, LLC



    42,359





    53,799



    Prepaid clinical and development services



    18,792





    20,374



    Other prepaid and current assets  



    10,037





    10,359



      Total current assets  



    293,071





    393,341



    Property and equipment, net  



    16,944





    16,422



    Operating lease assets



    42,517





    43,260



    Equity in net assets of TRC, LLC



    19,439





    12,750



    Restricted cash  



    833





    833



    Other assets



    2,304





    2,451



     Total assets  

    $

    375,108



    $

    469,057

















    Liabilities and Shareholders' Deficit













    Current liabilities

    $

    86,492



    $

    123,571



    Convertible senior notes due 2023, net



    227,230





    226,963



    Non-recourse notes due 2035, net



    375,181





    372,873



    Long-term operating lease liabilities



    57,026





    47,220



    Other long-term liabilities



    2,397





    2,181



    Shareholders' deficit



    (373,218)





    (303,751)



    Total liabilities and shareholders' deficit

    $

    375,108



    $

    469,057

















    ________________________________















    (1)  The condensed consolidated balance sheet as of December 31, 2020 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, 2020.



     



    THERAVANCE BIOPHARMA, INC.



    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS



    (In thousands, except per share data)











































    Three Months Ended March 31,









    2021



    2020









    (Unaudited)





    Revenue:

















    Collaboration revenue



    $

    3,872



    $

    6,632





    Licensing revenue





    -





    1,500





    Viatris collaboration agreement





    10,385





    11,730





    Total revenue 





    14,257





    19,862























    Costs and expenses:

















       Research and development (1)





    67,599





    66,013





       Selling, general and administrative (1)





    30,550





    26,325





       Total costs and expenses  





    98,149





    92,338





    Loss from operations  





    (83,892)





    (72,476)





    Income from investment in TRC, LLC





    16,547





    13,515





    Interest expense





    (11,873)





    (9,941)





    Loss on extinguishment of debt





    -





    (15,464)





    Interest and other income, net





    (234)





    1,460





    Loss before income taxes  





    (79,452)





    (82,906)





    Provision for income tax expense





    (227)





    (147)





    Net loss  



    $

    (79,679)



    $

    (83,053)























    Net loss per share:

















    Basic and diluted net loss per share  



    $

    (1.24)



    $

    (1.40)





    Shares used to compute basic and diluted net loss per share  





    64,493





    59,463























    ________________________________



































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







































    Three Months Ended March 31,





    (In thousands)



    2021



    2020





    Research and development 



    $

    7,921



    $

    7,865





    Selling, general and administrative 





    7,911





    7,411





    Total share-based compensation expense 



    $

    15,832



    $

    15,276





















     

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  11. DUBLIN, April 20, 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 first quarter 2021 financial results and provide a business update after market close on Tuesday, May 4, 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. IST) 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 1092615. 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 Investors section, Presentations and Events.

    A replay of the conference call will be available on Theravance Biopharma's website for 30 days through June 3, 2021. An audio replay will also be available through 8:00 p.m. ET on May 11, 2021 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 1092615.

    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., a Viatris Company. 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

    investor.relations@theravance.com

     

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  12. 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

    investor.relations@theravance.com

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  13. 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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  14. 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

    investor.relations@theravance.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-participate-in-upcoming-investor-conferences-301225449.html

    SOURCE Theravance Biopharma, Inc.

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  15. 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

    investor.relations@theravance.com

    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

    SOURCE Theravance Biopharma, Inc.

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  16. 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

    investor.relations@theravance.com

    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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  17. 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

    investor.relations@theravance.com

    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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  18. 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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  19. 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

    investor.relations@theravance.com

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  20. 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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  21. 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

    investor.relations@theravance.com

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  22. 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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-second-quarter-2020-financial-results-and-provides-business-update-301108085.html

    SOURCE Theravance Biopharma, Inc.

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  23. 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

    investor.relations@theravance.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-to-report-second-quarter-2020-financial-results-on-august-6-2020-301099877.html

    SOURCE Theravance Biopharma, Inc.

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  24. 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

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-appoints-deepika-r-pakianathan-phd-to-board-of-directors-301087380.html

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  25. 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 indica