TBPH Theravance Biopharma Inc.

8.39
+0.02  (+0%)
Previous Close 8.37
Open 8.27
52 Week Low 6.1
52 Week High 22.74
Market Cap $618,329,475
Shares 73,698,388
Float 42,041,242
Enterprise Value $1,073,352,475
Volume 2,176,550
Av. Daily Volume 1,375,541
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Upcoming Catalysts

Drug Stage Catalyst Date
Ampreloxetine
Neurogenic Orthostatic Hypotension (nOH)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Izencitinib
Ulcerative Colitis
Phase 2b
Phase 2b
Phase 2b data did not meet primary endpoint - August 23, 2021.
Izencitinib
Crohn's Disease
Phase 2
Phase 2
Phase 2 trial voluntarily discontinued, noted November 17, 2021
Nezulcitinib
Acute Lung Injury (ALI) caused by COVID-19
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - June 21, 2021.
YUPELRI (revefenacin)
COPD
Approved
Approved
FDA Approval announced November 9, 2018.
TRELEGY ELLIPTA
Asthma
Approved
Approved
FDA approval announced September 9, 2020.
TD-8236
Asthma
Phase 2
Phase 2
Phase 2a trial did not meet primary endpoint - November 5, 2020.
Telavancin
Bacteremia
Phase 3
Phase 3
Phase 3 trial discontinued following recent interim analysis.
Velusetrag (TD-5108)
Gastroparesis
Phase 2b
Phase 2b
Phase 2b data released August 2, 2017. Primary endpoint not met.
VIBATIV (telavancin hydrochloride) for injection
Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
Approved
Approved
Approved June 21, 2013.
BREO ELLIPTA
Asthma
Approved
Approved
Approved April 30, 2015.

Latest News

  1. DUBLIN, Jan. 10, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today announced enrollment of the first patient in a Phase 4 study of YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Success in this study is intended to capture more of YUPELRI's addressable market and further strengthen its competitive advantage.

    "YUPELRI, discovered and developed by Theravance, is one of the key pillars of value creation for the go-forward organization. We, and our partner Viatris, believe we have just scratched the surface of YUPELRI's contribution to the COPD community," said Rick E Winningham, Chief Executive Officer. "The enrollment of the first patient in the Phase 4 PIFR-2 study demonstrates, through continued investment in controlled clinical studies, our commitment to provide healthcare professionals with the evidence needed to design personalized treatment plans in order to make better informed decisions for their COPD patients."

    About the PIFR-2 Study

    This study (NCT05165485) is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard jet nebulizer or SPIRIVA® (tiotropium) delivered via a dry powder inhaler (Spiriva® HandiHaler®) (n=366).

    The Company expects to report top-line results in first quarter 2023.

    About Theravance Biopharma / Viatris Collaboration

    Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Theravance Biopharma and Viatris co-promote YUPELRI® (revefenacin) in the US, with their combined sales infrastructure targeting healthcare professionals who treat COPD patients suitable for YUPELRI.  The Company is entitled to a share of US profits and losses (65% to Viatris; 35% to Theravance Biopharma) received in connection with commercialization of YUPELRI® (revefenacin), and the Company is entitled to low double-digit tiered royalties on ex-US net sales. 

    About YUPELRI®

    YUPELRI® (revefenacin) inhalation solution is a once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the US. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD, regardless of severity of disease. Our market research indicates there is an enduring population of COPD patients in the US that either need or prefer nebulized delivery for maintenance therapy. The stability of revefenacin in both metered dose inhaler and dry powder inhaler ("MDI/DPI") formulations suggests that revefenacin could also serve as a foundation for novel handheld combination products.

    Important Safety Information

    What is YUPELRI®?

    • YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
    • It is an anticholinergic medicine which helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.
    • It is used long-term as 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer to improve symptoms of COPD for better breathing.

    Who should not use YUPELRI?

    • Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you.
    • Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate).
    • Do not use in children. It is not known if YUPELRI is safe and effective in children.

    Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you:

    • have eye problems such as glaucoma. YUPELRI may make your glaucoma worse.
    • have prostate or bladder problems, or problems passing urine. YUPELRI may make these problems worse.
    • have liver problems.
    • are allergic to any of the ingredients in YUPELRI, or any other medicines.
    • are pregnant or planning to become pregnant. It is not known if YUPELRI may harm your unborn baby.
    • are breastfeeding. It is not known if the medicine in YUPELRI passes into your breast milk and if it can harm your baby.

    Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects.

    Especially tell your healthcare provider if you take:

    • Other anticholinergics (including tiotropium, ipratropium, aclidinium, umeclidinium, glycopyrrolate)
    • Atropine

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

    What are the possible side effects with YUPELRI?

    YUPELRI can cause serious side effects, including:

    • Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away.
    • New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include:
      • Red eyes
      • Blurred vision
      • Seeing halos or bright colors around lights
      • Eye pain or discomfort
      • Nausea or vomiting
    • Urinary retention. People who take YUPELRI may develop new or worse urinary retention. Symptoms of urinary retention may include:
      • difficulty urinating
      • urinating frequently
      • urination in a weak stream or drips
      • painful urination

    If you have any of these symptoms, call your healthcare provider right away before taking another dose.

    • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
      • rash
      • hives
      • severe itching
      • swelling of your face, mouth, and tongue
      • difficulty breathing or swallowing

    If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose.

    Common side effects of YUPELRI include:

    • Cough
    • Runny nose
    • Upper respiratory tract infection
    • Headache
    • Back pain

    Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I use YUPELRI?

    Read the step by step instructions for using YUPELRI at the end of this Patient Information Leaflet

    • YUPELRI is only for use with a nebulizer.
    • Do not use YUPELRI more often than prescribed.
    • Do not mix YUPELRI with other medicines in your nebulizer.
    • Do not use other medicines that contain an anticholinergic for any reason.
    • Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse.
    • Call your healthcare provider or get emergency medical care right away if
      • your breathing problems get worse.
      • you need to use your rescue inhaler medicine more often than usual.
      • your rescue inhaler medicine does not relieve your symptoms.

    This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment.

    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 US 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, 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 market for products being commercialized, potential regulatory actions and commercialization (including differentiation from other products or potential products and addressable market), and product sales or profit share revenue. 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: 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, 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 8, 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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  2. DUBLIN, Jan. 5, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a biopharmaceutical company primarily focused on the discovery, development and commercialization of respiratory medicines, will present as follows: 

    • J.P. Morgan 40th Annual Healthcare Conference on Thursday, January 13, at 12:00 pm ET (9:00 am PT/5:00 pm GMT)

    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 30 days.

    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 US 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:

    Contact: Gail B. Cohen

    Corporate Communications / 917-214-6603

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-to-present-at-the-40th-annual-jp-morgan-healthcare-conference-301454139.html

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  3. DUBLIN, Nov. 18, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), a biopharmaceutical company primarily focused on the discovery, development and commercialization of respiratory medicines, will participate in a fireside chat as follows: 

    • Evercore ISI 4th Annual HEALTHCONx Virtual Conference on Tuesday, November 30, at 11:20 am ET (8:20 am PT/4:20 pm GMT)

    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 30 days.

    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 US 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:

    Contact: Gail B. Cohen

    Corporate Communications / 917-214-6603

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-to-participate-in-an-upcoming-investor-conference-301427456.html

    SOURCE Theravance Biopharma, Inc.

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

    "This last month has been about executing on our strategy to create a new Theravance Biopharma, focused on leveraging expertise in developing and commercializing respiratory therapeutics. We are executing against the strategic plan we announced in mid-September to become cash-flow positive by the second-half of 2022," said Rick E Winningham, Chief Executive Officer. "We are on track to reduce headcount by approximately 75% with the large majority of staff departing by the end of November and the remainder by the end of February. Our focus is driving growth of YUPELRI, streamlining R&D investment and optimizing our asset portfolio to maximize shareholder value."

    Quarterly Highlights

    • YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US 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 22% in July 2021, up from 21% in April 2021, and net sales increased by 7% year-over-year (Q3 2021 vs. Q3 2020).
      • The Company, in collaboration with its 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. Success in this study would capture more of YUPELRI's addressable market and further strengthen its competitive advantage.
    • On September 15, 2021, the Company announced strategic actions to focus on its respiratory disease portfolio (read more about the actions here).
    • Ampreloxetine, an investigational, Theravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH), reported Phase 3 top-line results (Study 0169 - read more about the data here).
    • Izencitinib, an orally administered, once-daily, investigational, internally discovered, high affinity, reversible pan-JAK inhibitor which was designed to be gut-selective, reported Phase 2B top-line results (Study 0157 - read more about the data here).

    Economic Interest

    • TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted third quarter 2021 global net sales of $449 million (up from $253 million, 77%, in the third quarter of 2020); Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3

    Upcoming Clinical Milestones

    • Izencitinib and ampreloxetine study close out activities to be completed by end of Q1 2022.
    • 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 Q1 2022.
    • Q1 2022: Ampreloxetine (norepinephrine reuptake inhibitor) Phase 3 for symptomatic neurogenic orthostatic hypotension (Study 0170) – top-line results expected in Q1 2022.

    Third Quarter Financial Results  

    • Revenue: Total revenue for the third quarter of 2021 was $13.2 million, comprised of non-cash collaboration revenue of $2.8 million primarily attributed to the global collaboration with Janssen and $10.4 million in Viatris collaboration revenue. Total revenue for the third quarter represents a $5.1 million decrease over the same period in 2020 driven by the reduction of non-cash collaboration revenue related to the Janssen collaboration due to the wind down of the izencitinib clinical program.
    • YUPELRI: The Viatris collaboration revenue of $10.4 million for the third 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, the implied 35% share of net sales of YUPELRI for the third quarter of 2021 was $13.8 million, up 7% from Q3 2020.
    • Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $43.7 million, compared to $67.4 million in the same period in 2020. Third quarter R&D expenses included total non-cash share-based compensation of $7.0 million.
    • Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2021 were $21.3 million, compared to $27.5 million in the same period in 2020. Third quarter SG&A expenses included total non-cash share-based compensation of $7.4 million.
    • Restructuring and Related Expenses: Restructuring expenses for the third quarter of 2021 were $1.8 million and primarily comprised of severance costs, termination-related benefits, and one-time retention costs.
    • Operating Loss: Operating loss for the third quarter of 2021 was $53.6 million compared to $76.6 million in the same period of 2020.
    • Cash Position: Cash, cash equivalents and marketable securities totaled $216.2 million as of September 30, 2021.

    2021 Financial Guidance

    • Operating Expenses (excluding share-based compensation): The Company reiterates that it expects full year 2021 R&D expense of $180 million to $190 million, and SG&A expense of $70 million to $80 million.

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

    Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 9:00 pm GMT. To participate, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, using the confirmation code 9772385. 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 December 3, 2021. An audio replay will also be available through 7:00 pm ET on November 10, 2021, by dialing (855) 859-2056 from the US, or (404) 537-2406 for international callers, and then entering confirmation code 9772385.

    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 US 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, 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 

    THERAVANCE BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

















    September 30,



    December 31,



    2021



    2020

    Assets

    (Unaudited)



    (1)

    Current assets:







    Cash and cash equivalents and short-term marketable securities

    $

    216,213



    $

    292,941

    Receivables from collaborative arrangements



    14,001





    15,868

    Amounts due from TRC, LLC



    43,773





    53,799

    Prepaid clinical and development services



    13,242





    20,374

    Other prepaid and current assets  



    9,943





    10,359

      Total current assets  



    297,172





    393,341

    Property and equipment, net  



    16,003





    16,422

    Operating lease assets



    40,718





    43,260

    Equity in net assets of TRC, LLC



    45,086





    12,750

    Restricted cash  



    833





    833

    Other assets



    3,297





    2,451

     Total assets  

    $

    403,109



    $

    469,057













    Liabilities and Shareholders' Deficit











    Current liabilities

    $

    66,082



    $

    123,571

    Convertible senior notes due 2023, net



    227,767





    226,963

    Non-recourse notes due 2035, net



    375,570





    372,873

    Long-term operating lease liabilities



    54,353





    47,220

    Other long-term liabilities



    2,929





    2,181

    Shareholders' deficit



    (323,592)





    (303,751)

    Total liabilities and shareholders' deficit

    $

    403,109



    $

    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 September 30,



    Nine Months Ended September 30,





    2021



    2020



    2021



    2020





    (Unaudited)



    (Unaudited)

    Revenue:

























    Collaboration revenue



    $

    2,797



    $

    7,261



    $

    8,649



    $

    19,381

    Licensing revenue





    -





    -





    -





    1,500

    Viatris collaboration agreement





    10,397





    10,996





    31,716





    32,246

    Total revenue 





    13,194





    18,257





    40,365





    53,127



























    Costs and expenses:

























       Research and development (1)





    43,739





    67,371





    162,431





    195,788

       Selling, general and administrative (1)





    21,299





    27,501





    77,780





    78,606

       Restructuring and related expenses





    1,771





    -





    1,771





    -

       Total costs and expenses  





    66,809





    94,872





    241,982





    274,394

    Loss from operations  





    (53,615)





    (76,615)





    (201,617)





    (221,267)

    Income from investment in TRC, LLC





    30,208





    13,403





    68,681





    48,299

    Interest expense





    (11,742)





    (11,573)





    (35,227)





    (32,905)

    Loss on extinguishment of debt





    -





    -





    -





    (15,464)

    Interest and other income (expense), net





    (166)





    1,235





    771





    2,033

    Loss before income taxes  





    (35,315)





    (73,550)





    (167,392)





    (219,304)

    Provision for income tax benefit (expense)





    7





    (93)





    -





    (279)

    Net loss  



    $

    (35,308)



    $

    (73,643)



    $

    (167,392)



    $

    (219,583)



























    Net loss per share:

























    Basic and diluted net loss per share  



    $

    (0.48)



    $

    (1.16)



    $

    (2.46)



    $

    (3.55)

    Shares used to compute basic and diluted net loss per share  





    73,574





    63,303





    67,945





    61,881



























    ________________________________



















































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























































    Three Months Ended September 30,



    Nine Months Ended September 30,

    (In thousands)



    2021



    2020



    2021



    2020

    Research and development 



    $

    6,956



    $

    7,761



    $

    22,192



    $

    23,724

    Selling, general and administrative 





    7,414





    7,803





    22,951





    23,701

    Total share-based compensation expense 



    $

    14,370



    $

    15,564



    $

    45,143



    $

    47,425

    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.

    3As 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 by 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.

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-third-quarter-2021-financial-results-and-provides-business-update-301415608.html

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  5. DUBLIN, Oct. 20, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH), will report its third quarter 2021 financial results and provide a business update after market close on Wednesday, November 3, 2021. An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm ET (2:00 pm PT/9:00 pm 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 9772385. 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 December 3, 2021. An audio replay will also be available through 7:00 pm ET on November 10, 2021 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 9772385.

    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.

    Contact Information:

    Gail Cohen, Corporate Communications

    917-214-6603 /

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-to-report-third-quarter-2021-financial-results-november-3-2021-301404106.html

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