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What changed in Theravance Biopharma, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Theravance Biopharma, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+377 added−373 removedSource: 10-K (2026-03-23) vs 10-K (2025-03-07)

Top changes in Theravance Biopharma, Inc.'s 2025 10-K

377 paragraphs added · 373 removed · 286 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

85 edited+36 added−34 removed73 unchanged
Biggest changeIn particular, our wholly-owned subsidiary Theravance Biopharma R&D IP, LLC owns the following US patents that are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for YUPELRI (revefenacin) inhalation solution: US Patent No. 7,288,657, expiring on October 31, 2028 (including patent term extension); US Patent No. 7,491,736, expiring March 10, 2025; US Patent No. 7,521,041, expiring March 10, 2025; US Patent No. 7,550,595, expiring March 10, 2025; US Patent No. 7,585,879, expiring March 10, 2025; US Patent No. 7,910,608, expiring March 10, 2025; US Patent No. 8,034,946, expiring March 10, 2025; US Patent No. 8,053,448, expiring March 10, 2025; US Patent No. 8,273,894, expiring March 10, 2025; US Patent No. 8,541,451, expiring August 25, 2031; US Patent No. 9,765,028, expiring July 14, 2030; US Patent No. 10,106,503, expiring March 10, 2025; US Patent No. 10,343,995, expiring March 10, 2025; US Patent No. 10,550,081, expiring July 14, 2030; US Patent No. 11,008,289, expiring July 14, 2030; US Patent No. 11,247,969, expiring March 10, 2025; US Patent No. 11,484,531, expiring October 23, 2039; US Patent No. 11,691,948, expiring July 14, 2030; US Patent No. 11,858,898, expiring July 14, 2030; and US Patent No. 12,048,692, expiring August 29, 2039.
Biggest changeIn particular, our wholly-owned subsidiary Theravance Biopharma R&D IP, LLC owns the following US patents that are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for YUPELRI (revefenacin) inhalation solution: US Patent No. 7,288,657, expiring on October 31, 2028 (including patent term extension); US Patent No. 8,541,451, expiring August 25, 2031; US Patent No. 9,765,028, expiring July 14, 2030; US Patent No. 10,550,081, expiring July 14, 2030; US Patent No. 11,008,289, expiring July 14, 2030; US Patent No. 11,484,531, expiring October 23, 2039; US Patent No. 11,691,948, expiring July 14, 2030; US Patent No. 11,858,898, expiring July 14, 2030; US Patent No. 12,048,692, expiring August 29, 2039; and US Patent No. 12,285,417, expiring August 29, 2039.
Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. ​ Fraud and Abuse Laws Our interactions and arrangements with customers and third-party payors are subject to applicable US federal and state fraud and abuse laws and equivalent third country laws.
Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on investment in product development. ​ Fraud and Abuse Laws Our interactions and arrangements with customers and third-party payors are subject to applicable US federal and state fraud and abuse laws and equivalent third country laws.
The FDA has broad post-market regulatory and enforcement powers, including the ability to require changes to a product’s approved labeling, including the addition of new warnings and contraindications, or the implementation of other risk management measures, including distribution-related restrictions, if there are new safety information developments, suspend or delay issuance of approvals, seize products, withdraw approvals, enjoin violations, and initiate criminal prosecution. ​ If regulatory approval for a medicine is obtained, the clearance to market the product will be limited to those diseases and conditions approved by FDA and for which the medicine was shown to be effective, as demonstrated through clinical studies and specified in the medicine’s labeling.
The FDA has broad post-market regulatory and enforcement powers, including the ability to require changes to a product’s approved labeling, including the addition of new warnings and contraindications, or the implementation of other risk management measures, including distribution-related restrictions, if there are new safety information developments, suspend or delay issuance of approvals, seize products, withdraw approvals, enjoin violations, and initiate criminal prosecution. ​ If regulatory approval for a medicine is obtained, the approval to market the product will be limited to those diseases and conditions approved by the FDA and for which the medicine was shown to be effective, as demonstrated through clinical studies and specified in the medicine’s labeling.
For more information, see the risk factor under the heading “Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor and distributor cost containment initiatives, may negatively impact us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties” of this Annual Report on Form 10-K. ​ Pharmaceutical Pricing We participated in and had certain price reporting obligations under the Medicaid Drug Rebate and other programs and we remain responsible for data reported under those programs in past quarters, as described in greater detail under the risk factor “ If we failed to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects” of this Annual Report on Form 10-K. ​ Our ability, and the ability of our collaboration partners, licensees, or those commercializing products with respect to which we have an economic interest or right to receive royalties to commercialize our products successfully, and our ability to attract commercialization partners for our products, depends in significant part on the availability of adequate financial coverage and reimbursement from third-party payors, including, in the US, governmental payors such as the Medicare and Medicaid programs, managed care organizations, and private health insurers.
For more information, see the risk factor under the heading “Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor and distributor cost containment initiatives, may negatively impact us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties” of this Annual Report on Form 10-K. ​ Pharmaceutical Pricing We participated in and had certain price reporting obligations under the Medicaid Drug Rebate and other programs and we remain responsible for data reported under those programs in past quarters, as described in greater detail under the risk factor “ If we failed to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects” of this Annual Report on Form 10-K. ​ Our ability, and the ability of our collaboration partners, licensees, or those commercializing products with respect to which we have an economic interest or right to receive royalties to commercialize our products successfully depends in significant part on the availability of adequate financial coverage and reimbursement from third-party payors, including, in the US, governmental payors such as the Medicare and Medicaid programs, managed care organizations, and private health insurers.
Note 3. Segment Information,” to our consolidated financial statements in this Annual Report on Form 10-K. ​ Corporation Information Theravance Biopharma was incorporated in the Cayman Islands in July 2013 under the name Theravance Biopharma, Inc. Theravance Biopharma began operating as an independent, publicly-traded company on June 2, 2014 following a spin-off from Innoviva, Inc.
Note 3. Segment Information, to our consolidated financial statements in this Annual Report on Form 10-K. ​ Corporation Information Theravance Biopharma was incorporated in the Cayman Islands in July 2013 under the name Theravance Biopharma, Inc. Theravance Biopharma began operating as an independent, publicly-traded company on June 2, 2014 following a spin-off from Innoviva, Inc.
From January 1, 2024, eligible GB marketing authorization applications can benefit from a new International Recognition Procedure that allows the UK regulatory authority, the MHRA, to conduct targeted assessments by recognizing approvals from trusted reference regulatory agencies in Australia, Canada, the EU, Japan, Singapore, Switzerland and the US.
From January 1, 2024, eligible UK marketing authorization applications can benefit from a new International Recognition Procedure that allows the UK regulatory authority, the MHRA, to conduct targeted assessments by recognizing approvals from trusted reference regulatory agencies in Australia, Canada, the EU, Japan, Singapore, Switzerland and the US.
The FDA may determine that a Risk Evaluation and Management Strategy (“REMS”) is necessary to ensure that the benefits of a product outweigh its risks. At the end of the review period, the FDA communicates either approval of the NDA or issues a complete response letter (“CRL”) listing the application’s deficiencies.
The FDA may determine that a Risk Evaluation and Management Strategy is necessary to ensure that the benefits of a product outweigh its risks. At the end of the review period, the FDA communicates either approval of the NDA or issues a complete response letter (“CRL”) listing the application’s deficiencies.
The NDA also must contain extensive manufacturing information, and under the Pediatric Research Equity Act (“PREA”), certain applications for approval must also include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject drug in relevant pediatric populations.
The NDA also must contain extensive manufacturing information, and under the Pediatric Research Equity Act, certain applications for approval must also include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject drug in relevant pediatric populations.
Post-approval modifications to the drug, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional pre-clinical studies or clinical trials, to be submitted in a new or supplemental NDA, which would require FDA approval. ​ If an application is approved, drug products are subject to continuing regulation by the FDA, and the FDA may withdraw the product approval if compliance with post-marketing regulatory standards is not maintained or if safety or quality issues are identified after the product reaches the marketplace.
Post-approval modifications to the drug, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional preclinical studies or clinical trials, to be submitted in a new or supplemental NDA, which would require FDA approval. ​ If an application is approved, drug products are subject to continuing regulation by the FDA, and the FDA may withdraw the product approval if compliance with post-marketing regulatory standards is not maintained or if safety or quality issues are identified after the product reaches the marketplace.
Nebulized ensifentrine has the potential to be complementary to YUPELRI given that it is another nebulized treatment for COPD maintenance care and is positioned as an add-on to standard of care (“SOC”) therapy which includes LAMA + LABA. ​ Sanofi and Regeneron Pharmaceutical, Inc. received US approval for their first-in-class, IL-4/IL-13 monoclonal antibody (mAb) Dupixent ® (dupilumab) for COPD in September 2024.
Nebulized ensifentrine has the potential to be complementary to YUPELRI given that it is another nebulized treatment for COPD maintenance care and is positioned as an add-on to standard of care (“SOC”) therapy which includes LAMA + LABA. ​ Sanofi and Regeneron Pharmaceuticals, Inc. received US approval for their first-in-class IL-4/IL-13 monoclonal antibody (mAb), Dupixent ® (dupilumab), for COPD in September 2024.
These laws and related risks are described in greater detail under the risk factor “If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or 13 Table of Contents criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and busines s” of this Annual Report on Form 10-K. ​ Patents and Proprietary Rights We will be able to protect our technology from unauthorized use by third parties only to the extent that our technology is covered by valid and enforceable patents or is effectively maintained as trade secrets.
These laws and related risks are described in greater detail under the risk factor “If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and busines s” of this Annual Report on Form 10-K. ​ Patents and Proprietary Rights We will be able to protect our technology from unauthorized use by third parties only to the extent that our technology is covered by valid and enforceable patents or is effectively maintained as trade secrets.
For more information, see the risk factor under the heading “ There is a single source of supply for our product candidate and for YUPELRI, and our business will be harmed if any of these single-source manufacturers are not able to satisfy demand and alternative sources are not available ” of this Annual Report on Form 10-K. ​ Government Regulation The development and commercialization of pharmaceutical products and our product candidates by us, our collaboration partners and licensees, and those commercializing products in which we have an economic interest, such as GSK, are subject to extensive regulation by governmental authorities in the US and other countries.
For more information, see the risk factor under the heading “ There is a single source of supply for YUPELRI, and our business will be harmed if manufacturers are not able to satisfy demand and alternative sources are not available ” of this Annual Report on Form 10-K. ​ Government Regulation The development and commercialization of pharmaceutical products and product candidates by us, our collaboration partners and licensees, and those commercializing products in which we have an economic interest, such as GSK, are subject to extensive regulation by governmental authorities in the US and other countries.
In each of these areas, as above, the FDA and other regulatory authorities have broad regulatory and enforcement powers, including the ability to suspend or delay issuance of approvals, seize products, withdraw approvals, enjoin violations, and initiate criminal prosecution, any one or more of which could have a material adverse effect upon our business, financial condition and results of operations. ​ Outside the US, the ability to market products will also depend on receiving marketing authorizations from the appropriate regulatory authorities.
In each of these areas, as above, the FDA and other regulatory authorities have broad regulatory and enforcement powers, including the ability to suspend or delay issuance of 11 Table of Contents approvals, seize products, withdraw approvals, enjoin violations, and initiate criminal prosecution, any one or more of which could have a material adverse effect upon our business, financial condition and results of operations. ​ Outside the US, the ability to market products will also depend on receiving marketing authorizations from the appropriate regulatory authorities.
Risks similar to those associated with FDA approval described above exist with the regulatory approval processes in other countries. ​ United States Healthcare Reform The Patient Protection and Affordable Care Act, as amended (the “Healthcare Reform Act”), substantially changed the way healthcare is financed by both governmental and private insurers, and impacts pricing and reimbursement of YUPELRI and the marketed drugs with respect to which we are entitled to royalty or similar payments, and related commercial operations.
Risks similar to those associated with FDA approval described above exist with the regulatory approval processes in other countries. ​ United States Healthcare Reform The Patient Protection and Affordable Care Act, as amended (the “ACA”), substantially changed the way healthcare is financed by both governmental and private insurers, and impacts pricing and reimbursement of YUPELRI and the marketed drugs with respect to which we are entitled to royalty or similar payments, and related commercial operations.
The CRL may require additional testing or information, including additional pre-clinical or clinical data, for the FDA to reconsider the application. Even if such additional information and data are submitted, the FDA may decide that the NDA still does not meet the standards for approval.
The CRL may require additional testing or information, including additional preclinical or clinical data, for the FDA to reconsider the application. Even if such additional information and data are submitted, the FDA may decide that the NDA still does not meet the standards for approval.
However, if we are unable to obtain contract manufacturing or obtain such manufacturing on commercially reasonable terms, or if manufacturing is interrupted at one of our suppliers, whether due to regulatory or other reasons, we may not be able to develop or commercialize our products as planned. ​ Any inability to acquire sufficient quantities of API or drug product in a timely manner from current or future sources could disrupt our development programs, the conduct of clinical trials or our commercialization efforts.
However, if we are unable to obtain contract manufacturing or obtain such manufacturing on commercially reasonable terms, or if manufacturing is interrupted at one of our suppliers, whether due to regulatory or other reasons, we may not be able to develop or commercialize products. ​ Any inability to acquire sufficient quantities of API or drug product in a timely manner from current or future sources could disrupt any development programs, clinical trials or commercialization efforts.
Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor. FDA approval of any application may include many delays or never be granted. If FDA grants approval, an approval letter authorizes commercial marketing of the product candidate with specific prescribing information for specific indications.
Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor. FDA 10 Table of Contents approval of any application may include many delays or never be granted. If FDA grants approval, an approval letter authorizes commercial marketing of the product candidate with specific prescribing information for specific indications.
The benefit to MSA patients in the study was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment Scale (“OHSA”) composite, Orthostatic Hypotension Daily Activities Scale (“OHDAS”) composite, Orthostatic Hypotension Questionnaire (“OHQ”) composite 7 Table of Contents and OHSA #1. Throughout the study, there was no indication of worsening of supine hypertension among any of the patient sub-groups.
The benefit to MSA patients in the study was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment Scale (“OHSA”) composite, Orthostatic Hypotension Daily Activities Scale (“OHDAS”) composite, Orthostatic Hypotension Questionnaire (“OHQ”) composite and OHSA #1. Throughout the study, there was no indication of worsening of supine hypertension among any of the patient sub-groups.
We invest in employee learning and development by identifying and providing training and development programs, speakers, tuition reimbursement, and cross-training in areas of interest beyond hired role. ​ We work diligently to attract the best talent from a diverse range of sources to meet the current and future demands of our business.
We invest 17 Table of Contents in employee learning and development by identifying and providing training and development programs, speakers, tuition reimbursement, and cross-training in areas of interest beyond hired role. ​ We work diligently to attract the best talent from a diverse range of sources to meet the current and future demands of our business.
Healthcare providers are permitted to prescribe drugs for “off-label” uses - that is, uses not approved by the FDA and not described in the product’s labeling - because the FDA does not 11 Table of Contents regulate the practice of medicine. However, FDA regulations impose restrictions on manufacturers’ communications regarding off-label uses.
Healthcare providers are permitted to prescribe drugs for “off-label” uses - that is, uses not approved by the FDA and not described in the product’s labeling - because the FDA does not regulate the practice of medicine. However, FDA regulations impose restrictions on manufacturers’ communications regarding off-label uses.
In exchange, Royalty Pharma will receive future unsecured royalties of 2.5% on annual ampreloxetine global net sales up to $500.0 million and 4.5% on annual global net sales over $500.0 million.
In exchange, Royalty Pharma would receive future unsecured royalties of 2.5% on annual ampreloxetine global net sales up to $500.0 million and 4.5% on annual global net sales over $500.0 million.
In addition, we provide a variety of programs and services that meet our employees' needs and encourage work-life balance. These services 18 Table of Contents include competitive and affordable healthcare and additional insurance benefits for both full-time and part-time employees, including eligible dependents.
In addition, we provide a variety of programs and services that meet our employees' needs and encourage work-life balance. These services include competitive and affordable healthcare and additional insurance benefits for both full-time and part-time employees, including eligible dependents.
Before marketing in the US, any medicine must undergo rigorous preclinical studies and clinical studies and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act. ​ Outside the US, the ability to market a product depends upon receiving a marketing authorization from the appropriate regulatory authorities which are subject to equally rigorous regulatory obligations.
Before marketing in 9 Table of Contents the US, any medicine must undergo rigorous preclinical studies and clinical studies and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act. ​ Outside the US, the ability to market a product depends upon receiving a marketing authorization from the appropriate regulatory authorities which are subject to equally rigorous regulatory obligations.
The reimbursement environment is described in greater detail under the risk factor “Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor and distributor cost containment initiatives, may negatively impact us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties” of this Annual Report on Form 10-K. ​ Coverage and Reimbursement Market acceptance and sales of any one or more of our product candidates will depend on reimbursement policies and may be affected by future healthcare reform measures in the US.
The reimbursement environment is described in greater detail under the risk factor “Changes in healthcare law and implementing regulations, including government restrictions on pricing and 12 Table of Contents reimbursement, as well as healthcare policy and other healthcare payor and distributor cost containment initiatives, may negatively impact us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties” of this Annual Report on Form 10-K. ​ Coverage and Reimbursement Market acceptance and sales of any product depend on reimbursement policies and may be affected by future healthcare reform measures in the US.
These clinical trials are intended to establish the overall risk/benefit profile of the product and provide an adequate basis for product labeling. ​ 10 Table of Contents The results of product development, preclinical studies and clinical studies must be submitted to the FDA as part of an NDA.
These clinical trials are intended to establish the overall risk/benefit profile of the product and provide an adequate basis for product labeling. ​ The results of product development, preclinical studies and clinical studies must be submitted to the FDA as part of an NDA.
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. ​ 5 Table of Contents We co-developed YUPELRI with our collaboration partner, Viatris Inc.
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. ​ We co-developed YUPELRI with our collaboration partner, Viatris Inc. (“Viatris”).
The second pivotal study (REDWOOD), a four-month open label study followed by a six-week randomized withdrawal phase was designed to evaluate the durability of the same patient group’s response to ampreloxetine.
The second pivotal study (REDWOOD), a four-month open label study followed by a six-week 6 Table of Contents randomized withdrawal phase was designed to evaluate the durability of the same patient group’s response to ampreloxetine.
During 2023, Sunovion Pharmaceuticals Inc. voluntarily withdrew Lonhala ® Magnair ® (glycopyrrolate) from the US market due to limited utilization, leaving YUPELRI as the only approved nebulized LAMA. ​ Verona Pharma plc’s ensifentrine, a first-in-class, selective inhaled dual inhibitor of PDE3 and PDE4 received FDA approval in June 2024.
During 2023, Sunovion Pharmaceuticals Inc. voluntarily withdrew Lonhala ® Magnair ® (glycopyrrolate) from the US market due to limited utilization, leaving YUPELRI as the only approved nebulized LAMA. ​ Verona Pharma plc’s, now Merck & Co., Inc’s Ohtuvayre ® (ensifentrine), a first-in-class, nebulized selective inhaled dual inhibitor of PDE3 and PDE4 received FDA approval in June 2024.
However, our understanding of whether and when our products are likely to be subject to selection for negotiation could evolve as the Drug Price Negotiation Program is implemented. We further expect continued scrutiny on pricing from Congress, agencies, and other bodies with respect to drug pricing.
Our understanding of whether and when our product is likely to be subject to selection for negotiation could evolve as the Drug Price Negotiation Program is implemented. We further expect continued scrutiny on pricing from Congress, agencies, and other bodies with respect to drug pricing.
District Court for the Middle District of North Carolina. The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of our Orange Book listed patents.
The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of our Orange Book listed patents.
The Inflation Reduction Act of 2022 (the “IRA”) establishes a new manufacturer discount program, Part B and Part D inflation rebates, and a Drug Price Negotiation Program under which the prices for Medicare units of certain high Medicare spend drugs without generic or biosimilar competition will be capped by reference to, among other things, a specified non- 12 Table of Contents federal average manufacturer price, with negotiated prices set to take effect starting in 2026.
The Inflation Reduction Act of 2022 (the “IRA”) established a new manufacturer discount program, Part B and Part D inflation rebates, and a Drug Price Negotiation Program under which the prices for Medicare units of certain high Medicare spend drugs without generic or biosimilar competition are capped by reference to, among other things, a specified non-federal average manufacturer price, with negotiated prices set to take effect starting in 2026.
(collectively, the “generic companies”), that they have each filed with the FDA an ANDA, for a generic version of YUPELRI. The notices from the generic companies each included a paragraph IV certification with respect to five of our patents listed in the FDA’s Orange Book for YUPELRI on the date of our receipt of the notice.
(collectively, the “generic companies”), that they have each filed with the FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI. The notices from the generic companies each included a Paragraph IV certification with respect to five of our patents listed in the FDA’s Orange Book for YUPELRI on the date of our receipt of the notice.
GSK continues to pursue approval for the asthma indication in additional markets. ​ See “Risk Factors—We do not control the commercialization of TRELEGY; accordingly, our receipt of Milestone Payments and receipt of the value we currently anticipate from the Outer Years Royalty will depend on, among other factors, GSK’s ability to further commercialize TRELEGY” for additional information. ​ Our Strategy Our focus is to deliver medicines that make a difference ® in people's lives.
GSK continues to pursue approval for the asthma indication in additional markets. ​ See “Risk Factors—We do not control the commercialization of TRELEGY; accordingly, our receipt of Milestone Payments will depend on, among other factors, GSK’s ability to further commercialize TRELEGY” for additional information. ​ Our Strategy Our focus is to deliver medicines that make a difference ® in people's lives.
Our 2024 survey scores averaged an overall score of 4.4 on a scale of 1 (Strongly Disagree) through 5 (Strongly Agree), and we received 96% participation from employees.
Our 2025 survey scores averaged an overall score of 4.4 on a scale of 1 (Strongly Disagree) through 5 (Strongly Agree), and we received 98% participation from employees.
Total 2024 TRELEGY global net sales represented a 26% increase compared to 2023, and TRELEGY is currently expected to generate global peak sales of $4.0 billion in 2026 according to consensus estimates. ​ In addition to potential Milestone Payments, we will receive from Royalty Pharma 85% of the royalty payments on TRELEGY payable to Royalty Pharma for: (a) sales or other activities occurring on and after January 1, 2031 related to TRELEGY in the US; and (b) sales or other activities occurring on and after July 1, 2029 related to TRELEGY outside of the US.
Total 2025 TRELEGY global net sales represented a 13% increase compared to 2024, and TRELEGY is currently expected to generate global peak sales of $4.3 billion in 2026 according to consensus estimates. ​ In addition to potential Milestone Payments, we were eligible to receive from Royalty Pharma 85% of the royalty payments on TRELEGY payable to Royalty Pharma for: (a) sales or other activities occurring on and after January 1, 2031 related to TRELEGY in the US; and (b) sales or other activities occurring on and after July 1, 2029 related to TRELEGY outside of the US.
In February 2025, we were informed by Royalty Pharma that the 2024 minimum royalty amount for TRELEGY was achieved based on $3.46 billion of 2024 TRELEGY global net sales, and we received the maximum $50.0 million Milestone Payment from Royalty Pharma in February 2025. ​ As of February 28, 2025, a total of $150.0 million in potential Milestone Payments remain available to us.
Furthermore, in February 2026, we were informed by Royalty Pharma that the 2025 minimum royalty amount for TRELEGY was also achieved based on $3.91 billion of 2025 TRELEGY global net sales, and we received the maximum $50.0 million Milestone Payment from Royalty Pharma in February 2026. ​ As of February 28, 2026, a total of $100.0 million in potential Milestone Payments remain available to us.
Certain provisions of the Healthcare Reform Act have been subject to judicial challenges as well as efforts to modify them or to alter their interpretation or implementation.
Certain provisions of the ACA have been subject to judicial challenges as well as efforts to modify them or to alter their interpretation or implementation.
Where it is necessary to share our proprietary information or data with outside parties, our policy is to make available only that information and data required to accomplish the desired purpose and only pursuant to a duty of confidentiality on the part of those parties. ​ As of December 31, 2024, we owned a total of 177 issued US patents and 1,070 granted foreign patents, as well as additional pending US patent applications and foreign patent applications.
Where it is necessary to share our proprietary information or data with outside parties, our policy is to make available only that information and data required to accomplish the desired purpose and only pursuant to a duty of confidentiality on the part of those parties. 13 Table of Contents ​ As of December 31, 2025, we owned a total of 119 issued US patents and 666 granted foreign patents, as well as additional pending US patent applications and foreign patent applications.
Within the EU and the UK, regulatory protections are afforded to medicinal products such as data exclusivity. On April 26, 2023, the European Commission adopted a proposal for a new Directive and a new Regulation. In April 2024, the European Parliament published its amendments to the Commission proposal.
Within the EU and the UK, regulatory protections are afforded to medicinal products such as data exclusivity. On April 26, 2023, the European Commission adopted a proposal for a new Directive and a new Regulation.
Our current Code of Business Conduct, Corporate Governance Guidelines, Articles of Association, Board of Director Committee Charters, and other materials, including amendments thereto, may also be found on our investor relations website under “Corporate Governance.” The information found on our website is not part of this or any other report that we file with or furnish to the SEC.
Our current Code of Business Conduct, Corporate Governance Guidelines, Articles of Association, Board of Director Committee Charters, and other materials, including amendments thereto, may also be found on our investor relations website under “Corporate Governance.” The information found on our website is not part of this or any other report that we file with or furnish to the SEC. 18 Table of Contents Theravance Biopharma and the Theravance Biopharma logo are registered trademarks of the Theravance Biopharma group of companies.
We are committed to creating/driving shareholder value. ​ We follow these core guiding principles in our mission to drive value creation: ​ ● Focus on insight and innovation; ● Outsource non-core activities; ● Create and foster an integrated environment; and ● Aggressively manage uncertainty. We manage our programs with the goal of optimizing value and allocation of resources.
We are committed to creating/driving shareholder value. ​ We follow these core guiding principles in our mission to drive value creation: ​ ● Focus on insight and innovation; ● Outsource non-core activities; ● Create and foster an integrated environment; and ● Aggressively manage uncertainty.
The notice from the subsequent ANDA filer included a paragraph IV certification with respect to certain of our patents listed in FDA’s Orange Book for YUPELRI. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In June 2024, we filed a patent infringement suit against the subsequent ANDA filer in the U.S.
The notice from the subsequent ANDA filer included a Paragraph IV certification with respect to certain of our patents listed in FDA’s Orange Book for YUPELRI. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI.
This suit has been consolidated with the action described above. ​ This litigation and the related risks are described in greater detail under the risk factor “ Litigation to protect or defend our intellectual property or third-party claims of intellectual property infringement will require us to divert resources and may prevent or delay our drug development and commercialization efforts” of this Annual Report on Form 10-K. ​ Competition Our late-stage development program, and the marketed products to which we are entitled to profit share revenue, royalty or similar payments are primarily focused on respiratory and neurological therapeutics.
Method of treatment patents expiring in 2039 remain in the litigation. ​ This litigation and the related risks are described in greater detail under the risk factor “ Litigation to protect or defend our intellectual property or third-party claims of intellectual property infringement will require us to divert resources and may prevent or delay our drug development and commercialization efforts ” of this Annual Report on Form 10-K. ​ Competition The marketed products to which we are entitled to profit share revenue, royalty or similar payments are primarily focused on respiratory therapeutics.
If ampreloxetine regulatory approval is not achieved or if ampreloxetine sales are never recognized, the amounts invested by Royalty Pharma would not be repaid by us. ​ Economic Interests and Other Assets ​ Mid- and Long-Term Economic Interest in TRELEGY ® In July 2022, we completed the sale of all of our equity interests in Theravance Respiratory Company, LLC (“TRC”) representing our 85% economic interest in the sales-based royalty rights on worldwide net sales of GSK plc's (“GSK”) TRELEGY ELLIPTA (“TRELEGY”) to Royalty Pharma for approximately $1.11 billion in upfront cash while retaining future value through the right to receive contingent milestone payments and certain outer year-royalties. ​ From and after January 1, 2023, for any calendar year starting with the year ended December 31, 2023 and ending with the year December 31, 2026, upon certain milestone minimum royalty amounts for TRELEGY being met, Royalty Pharma is obligated to make certain cash payments to us (the “Milestone Payments(s)”).
There can be no assurance that any additional regulatory engagement will occur. ​ Economic Interests and Other Assets ​ Economic Interest in TRELEGY ® In July 2022, we completed the sale of all of our equity interests in Theravance Respiratory Company, LLC (“TRC”) representing our 85% economic interest in the sales-based royalty rights on worldwide net sales of GSK plc's 7 Table of Contents (“GSK”) TRELEGY ELLIPTA (“TRELEGY”) to Royalty Pharma for approximately $1.11 billion in upfront cash while retaining future value through the right to receive contingent milestone payments and certain outer year-royalties. ​ From and after January 1, 2023, for any calendar year starting with the year ended December 31, 2023 and ending with the year ending December 31, 2026, upon certain milestone minimum royalty amounts for TRELEGY being met, Royalty Pharma is obligated to make certain cash payments to us (the “Milestone Payments(s)”).
Whether any of our products are selected for negotiation for a given year will depend on whether they are at least 7 years post-approval/licensure; whether they meet any of the exclusions from eligibility for selection for negotiation, such as the exclusion of certain orphan drugs; their expenditures under Medicare Part B or Part D during a statutorily specified period; and whether a generic of the product has been determined to have come to market.
Whether our product is selected for negotiation for a given year will depend on whether it is at least 7 years post-approval/licensure; whether it meets any of the exclusions from eligibility for selection for negotiation; its expenditures under Medicare Part B or Part D during a statutorily specified period; and whether a generic of the product has been determined to have come to market.
We expect that the Healthcare Reform Act, its implementation, efforts to modify, or invalidate, the Healthcare Reform Act or portions thereof, or its implementation, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on the ability of us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties to maintain or increase sales of our existing products or to successfully commercialize our product candidates, if approved.
We expect that the ACA and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on the ability of us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties to maintain or increase sales of products.
We believe that we and our partners have in-house expertise to manage this network of third-party manufacturers, and we believe that we will be able to continue to negotiate third-party manufacturing arrangements on commercially reasonable terms and that it will not be necessary for 9 Table of Contents us to rely on internal manufacturing capacity in order to develop or, potentially, commercialize our products.
We believe that we and our partners have in-house expertise to manage this network of third-party manufacturers, and we believe that we are able to negotiate third-party manufacturing arrangements on commercially reasonable terms and that it is not necessary for us to rely on internal manufacturing capacity.
The complaint alleges that by filing the ANDA, the subsequent ANDA filer has infringed certain of our Orange Book listed patents. ​ As of February 28, 2025, we have settled all litigation with Accord Healthcare, Inc.; Lupin Pharmaceuticals, Inc.; Orbicular Pharmaceutical Technologies Private Limited; Qilu Pharmaceuticals Co., Ltd.; and Teva Pharmaceuticals, Inc. pursuant to individual agreements in which we granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
These suits have been consolidated with the action described above. ​ As of February 28, 2026, we have settled all litigation with Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Pharmaceuticals, Inc.; Orbicular Pharmaceutical Technologies Private Limited; Qilu Pharmaceuticals Co., Ltd.; and Teva Pharmaceuticals, Inc. pursuant to individual agreements in which we granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
Our commercial infrastructure is focused primarily on the acute care setting. We expect that any medicines that we commercialize with our collaborative partners or on our own will compete with existing and future market-leading medicines. ​ Many of our competitors have substantially greater financial, technical and personnel resources than we have.
Our commercial infrastructure is focused primarily on the acute care setting. The medicine that we commercialize with our collaborative partner competes with existing, and expected future, market-leading medicines. 15 Table of Contents ​ Many of our competitors have substantially greater financial, technical and personnel resources than we have.
In addition, we have an easily accessible hotline available to employees wishing to report complaints anonymously. ​ Diversity, Equity, Inclusion & Belonging As an equal-opportunity employer, we strive to build and maintain a culture of diversity, equity, inclusion and belonging through both our business and human resources practices and policies.
In addition, we have an easily accessible hotline available to employees wishing to report complaints anonymously. ​ Corporate Responsibility We strive to build and maintain a positive workplace culture through both our business and human resources practices and policies.
We are eligible to receive either (i) $50.0 million if Royalty Pharma receives $270.0 million or more in royalty payments from GSK with respect to 2026 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales are approximately $3.16 billion or (ii) $100.0 million if Royalty Pharma receives $305.0 million or more in royalty payments from GSK with respect to 2026 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales exceed approximately $3.51 billion.
For the next potential Milestone Payment, we are eligible to receive either (i) $50.0 million if Royalty Pharma receives $270.0 million or more in royalty payments from GSK with respect to 2026 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales are approximately $3.16 billion or (ii) $100.0 million if Royalty Pharma receives $305.0 million or more in royalty payments from GSK with respect to 2026 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales exceed approximately $3.51 billion. ​ Achievement of either the $50.0 million or $100.0 million milestone in 2026 would not require an increase in global net sales compared to 2025, as the $3.91 billion in global net sales achieved in 2025 exceeds the thresholds necessary to trigger either Milestone Payment in 2026.
For example, the EU has its own procedure for the authorization of eligible medicines, referred to as the centralized procedure, where a single application, evaluation and authorization can result in a single marketing authorization which covers all the EU and also Northern Ireland. A separate product licensing procedure applies in Great Britain (England, Scotland and Wales) (“GB”).
For example, the EU has its own procedure for the authorization of eligible medicines, referred to as the centralized procedure, where a single application, evaluation and authorization can result in a single marketing authorization which covers all the EU Member States and also Iceland, Norway and Liechtenstein. A separate product licensing procedure applies in the United Kingdom (“UK”).
Through the combined commercialization efforts with our partner Viatris Inc. (“Viatris”), total YUPELRI net sales increased by 8% to $238.6 million in 2024 compared to 2023.
Through the combined commercialization efforts with our partner Viatris Inc., total YUPELRI net sales increased by 12% to $266.6 million in 2025 compared to 2024. Customer demand grew 7% in 2025 compared to 2024.
Theravance Biopharma and the Theravance Biopharma logo are registered trademarks of the Theravance Biopharma group of companies. Trademarks, tradenames, or service marks of other companies appearing in this report are the property of their respective owners. ​ ​ 19 Table of Contents
Trademarks, tradenames, or service marks of other companies appearing in this report are the property of their respective owners. ​
Our success in the future will depend in part on obtaining patent protection for our product candidates. Accordingly, patents and other proprietary rights are essential elements of our business. Our policy is to seek patent protection in the US and selected foreign countries for novel technologies, including compositions of matter that are commercially important to the development of our business.
Accordingly, patents and other proprietary rights are essential elements of our business. Our policy is to seek patent protection in the US and selected foreign countries for novel technologies, including compositions of matter that are commercially important to the development of our business. Issued US and foreign patents generally expire 20 years after their filing date.
We strive to build and foster a culture where all employees feel empowered to be their authentic selves. ​ Our Diversity, Equity, Inclusion & Belonging Council and Women’s Leadership Network are Company-sponsored, employee-led groups open to all that aim to improve attraction, retention, development, inclusion, and engagement of a diverse and global workforce.
We strive to build and foster a culture where all employees feel empowered to be their authentic selves. ​ We have employee-led groups, which are open to all employees, that aim to improve attraction, retention, development, inclusion, and engagement of a talented and global workforce. We are committed to creating a workplace culture that values and celebrates our workforce.
A payer’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.
Products may not be considered by payers to be medically necessary or cost-effective for particular diseases or conditions. A payer’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.
On a country-by-country basis, we will be entitled to royalties until the expiration of the longest-lived patent or 15 years after commercial launch, whichever comes later.
On a country-by-country basis, we were entitled to royalties until the expiration of the longest-lived patent or 15 years after commercial launch, whichever comes later. We expect fifteen years after the commercial launch in the US will occur in late 2032 and fifteen years after the first commercial launch in ex-US jurisdictions will start occurring in the mid-2030s.
Our focus is to deliver medicines that make a difference ® in people’s lives. ​ In pursuit of our purpose, we leverage decades of expertise, which has led to the development of the United States (“US”) Food and Drug Administration (the “FDA”) approved YUPELRI ® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”).
Our focus is to deliver medicines that make a difference ® in people’s lives. ​ In pursuit of our purpose, we leverage decades of expertise, which has led to the development of the United States (“US”) Food and Drug Administration (the “FDA”) approved YUPELRI ® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”). ​ Recent Significant Developments Ampreloxetine Phase 3 Clinical Study Top-line Results On March 3, 2026, we announced that our ampreloxetine Phase 3 clinical study (CYPRESS) in development for the treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy did not meet its primary endpoint in the Orthostatic Hypotension Symptom Assessment composite score.
An example of such use includes a LABA/ICS combination, such as AstraZeneca’s Symbicort ® and a LAMA such as Boehringer Ingelheim’s Spiriva ® . ​ Human Capital As of December 31, 2024, we had 97 employees.
An example of such use includes a LABA/ICS combination, such as AstraZeneca’s Symbicort ® and a LAMA such as Boehringer Ingelheim’s Spiriva ® . ​ 16 Table of Contents Human Capital As of December 31, 2025, we had 90 employees. Of these employees, 79 were based in the US, and 11 were based in Dublin, Ireland.
Royalty Pharma’s $40.0 million investment in ampreloxetine included a $25.0 million upfront payment received in July 2022 and an additional $15.0 million payment upon the first regulatory approval of ampreloxetine.
In July 2022, Royalty Pharma Investments (“Royalty Pharma”) agreed to invest up to $40.0 million to advance the development of ampreloxetine in MSA in exchange for unsecured low single-digit royalties. Royalty Pharma’s $40.0 million investment in ampreloxetine included a $25.0 million upfront payment received in July 2022 and an additional $15.0 million payment upon the first regulatory approval of ampreloxetine.
Third-party payers include government health administrative authorities, managed care providers, private health insurers and other organizations. The process for determining whether a payer will provide coverage for a drug product may be separate from the process for setting the price or reimbursement rate that the payer will pay for the drug product.
The process for determining whether a payer will provide coverage for a drug product may be separate from the process for setting the price or reimbursement rate that the payer will pay for the drug product.
Significant uncertainty exists as to the coverage and reimbursement status of any drug products. In the US and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payers.
Significant uncertainty exists as to the coverage and reimbursement status of any drug products. In the US and markets in other countries, sales of any products depend in part on the availability of reimbursement from third-party payers. Third-party payers include government health administrative authorities, managed care providers, private health insurers and other organizations.
The legislative process for this reform is expected to take several years, and adoption of the new legislation is not expected to take place before 2026. ​ Before commencing clinical studies in humans in the US, we must submit to the FDA an investigational new drug application (“IND”) that includes, among other things, the general investigational plan and protocols for specific human studies and the results of preclinical studies.
The final text of the reform proposal is expected to be endorsed and published in the first or second quarter of 2026 and, after a transition period, the new legislation is expected to start to apply from mid-2028. ​ Before commencing clinical studies in humans in the US, we must submit to the FDA an investigational new drug application (“IND”) that includes, among other things, the general investigational plan and protocols for specific human studies and the results of preclinical studies.
We strive to live these values across the Company every day, integrating them into everything from our interview, hiring, and onboarding processes to our PULSE performance process, total rewards, 17 Table of Contents and recognition programs.
We have a strong value proposition anchored in our Core Values— We Think it Through, We Find a Way, We Get it Done, and We Win Together. We strive to live these values across the Company every day, integrating them into everything from our interview, hiring, and onboarding processes to our PULSE performance process, total rewards, and recognition programs.
Additional patents covering YUPELRI, granted on July 4, 2023 15 Table of Contents and January 2, 2024, were subsequently listed in FDA’s Orange Book. We filed additional patent infringement suits in the U.S. District Court for the District of New Jersey during August 2023 and January 2024. These suits have been consolidated with the above action.
We filed additional patent infringement suits in the US District Court for the District of New Jersey during August 2023 and January 2024. These suits have been consolidated with the above action.
The patent portfolio for this development product includes additional pending patent applications and granted patents in a number of jurisdictions. Nevertheless, issued patents can be challenged, narrowed, invalidated, or circumvented, which could limit our ability to stop competitors from marketing similar products and threaten our ability to commercialize our product candidates.
Issued patents can be challenged, narrowed, invalidated, or circumvented, which could limit our ability to stop competitors from marketing similar products and threaten our ability to commercialize products.
The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In February 2023, we filed patent infringement suits against the generic companies in federal district courts, including the United States District Court for the District of New Jersey, the U.S. District Court for the District of Delaware, and the U.S.
In February 2023, we filed patent infringement suits against the generic companies in federal district courts, including the US District Court for the District of New Jersey, the US District Court for the District of Delaware, and the US District Court for the Middle District of North Carolina.
As noted above, Viatris is responsible for all aspects of development and commercialization of nebulized revefenacin in the China Region, including pre- and post-launch activities and product registration and all associated costs. ​ Under the terms of the Viatris Agreement, as amended, as of December 31, 2024, we were eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding the China Region) of up to $205.0 million in the aggregate with $160.0 million associated with YUPELRI monotherapy and $45.0 million associated with future potential combination products.
Viatris is responsible for all aspects of development and commercialization of YUPELRI in the China Region, including pre- and post-launch activities and product registration and all associated costs. ​ With respect to the China Region royalties, we are eligible to receive tiered royalties on net sales of nebulized revefenacin as follows: ​ ​ ​ YUPELRI China Region Net Sales Thresholds Royalty Rate (Annual) Due from Viatris ≤ $75.0 million 14% > $75.0 million to ≤ $150.0 million 17% > $150 million 20% ​ As of December 31, 2025, w e were also eligible to receive additional potential sales and regulatory milestones of up to $45.0 million related to Viatris’ development and commercialization of nebulized revefenacin in the China Region with $37.5 million associated with YUPELRI monotherapy and $7.5 million associated with achieving regulatory milestones related to future potential combination products.
Our ability to compete successfully will depend largely on our ability to leverage our experience in drug development and commercialization to: ​ ● develop medicines that are superior to other products in the market; ● attract and retain qualified scientific, clinical development and commercial personnel; ● obtain patent and/or other proprietary protection for our medicines and technologies; ● obtain required regulatory approvals; ● commercialize approved products; and ● successfully collaborate with pharmaceutical companies in the development and commercialization of new medicines. 16 Table of Contents YUPELRI (revefenacin) inhalation solution YUPELRI competes predominately with short-acting nebulized bronchodilators that are dosed three to four times per day.
Our ability to compete successfully depends largely on our ability to leverage our experience in drug development and commercialization to: ​ ● deliver medicines that are superior to other products in the market; ● attract and retain qualified personnel; ● maintain and enforce patent and/or other proprietary protection for our medicines and technologies; ● maintain required regulatory approvals; ● develop and effectively implement commercialization strategies, with or without collaborative partners; and ● successfully collaborate with pharmaceutical companies in the development and commercialization of medicines.
Also, we do not know whether any of our patent applications will result in any issued patents or, if issued, whether the scope of the issued claims will be sufficient to protect our proprietary position. 14 Table of Contents ​ Patent Term Restoration, Regulatory Exclusivities, and Hatch-Waxman Litigation Depending upon the timing, duration, and specifics of FDA approval of our product candidates, some of our US patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.
Thus, the last to expire patent currently listed in the Orange Book for YUPELRI (revefenacin) inhalation solution expires on October 23, 2039. ​ Patent Term Restoration, Regulatory Exclusivities, and Hatch-Waxman Litigation Depending upon the timing, duration, and specifics of FDA approval of product candidates, some of our US patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.
Current enrollment is in-line with expectations for completion in mid-2025, with data anticipated to be available approximately six months later. ​ Achievement of $50.0 Million TRELEGY ® Royalty Milestone Payment for 2024 In February 2025, we received a $50.0 million maximum milestone payment from Royalty Pharma Investments associated with the achievement of certain minimum royalty payments related to 2024 TRELEGY global net sales.
The sales transaction represented the first outcome of the ongoing efforts of the Committee to assess all strategic alternatives available to us to unlock shareholder value. ​ Achievement of $50.0 Million TRELEGY ® Royalty Milestone Payment for 2025 In February 2026, we received a $50.0 million maximum milestone payment from Royalty Pharma Investments associated with the achievement of certain minimum royalty payments related to 2025 TRELEGY global net sales.
For the benefit of our employees, patients, and community, we must celebrate, encourage, and support similarities and differences to drive innovation. ​ Talent, Development, and Total Rewards We believe that our talent strategy of providing exciting career growth and development opportunities, recognizing, and rewarding performance, providing competitive compensation and benefits assists us in attracting and retaining the best talent.
We believe that different experiences are essential for innovation and growth, and we are committed to creating an inclusive workplace where everyone feels welcomed, valued, and empowered, fueling our ability to collaborate and win together. ​ Talent, Development, and Total Rewards We believe that our talent strategy of providing exciting career growth and development opportunities, recognizing, and rewarding performance, providing competitive compensation and benefits assists us in attracting and retaining the best talent.
Pending confirmation of its clinical profile in the CYPRESS study, it is anticipated that ampreloxetine will represent a differentiated treatment option for MSA patients with symptomatic nOH. ​ Trelegy (the combination of fluticasone furoate/umeclidinium bromide/vilanterol) For treatment of COPD, Trelegy competes in all major markets with AstraZeneca’s Breztri ® Aerosphere ® (budesonide/glycopyrronium/formoterol fumarate, dosed twice per day).
Nucala is also indicated for asthma, chronic rhinosinusitis, eosinophilic granulomatosis with polyangitis, and hyper-eosinophilic syndrome. ​ Trelegy (the combination of fluticasone furoate/umeclidinium bromide/vilanterol) For treatment of COPD, Trelegy competes in all major markets with AstraZeneca’s Breztri ® Aerosphere ® (budesonide/glycopyrronium/formoterol fumarate, dosed twice per day).
District Court for the District of New Jersey during August 2024 against the three remaining generic companies.
We filed additional patent infringement suits in the US District Court for the District of New Jersey during August 2024 and May 2025 against the generic companies remaining at that time.
Of the $160.0 million associated with monotherapy, $10.0 million relates to regulatory actions in the EU and $150.0 million relates to sales milestones based on achieving certain levels of annual aggregate US net sales as follows: ​ ​ ​ YUPELRI US Net Sales Sales Milestones (In a Calendar Year) Due from Viatris $250.0 million $25.0 million $500.0 million $50.0 million $750.0 million $75.0 million ​ As of December 31, 2024, w e were also eligible to receive additional potential development and sales milestones of up to $52.5 million related to Viatris’ development and commercialization of nebulized revefenacin in the China Region with $45.0 million associated with YUPELRI monotherapy and $7.5 million associated with future potential combination products.
Of the $135.0 million associated with monotherapy, $10.0 million relates to regulatory actions in the EU and $125.0 million relates to sales milestones based on achieving certain levels of annual aggregate US net sales as follows: ​ ​ ​ YUPELRI US Net Sales Sales Milestones (In a Calendar Year) Due from Viatris $500.0 million $50.0 million $750.0 million $75.0 million ​ ​ 5 Table of Contents While Viatris records total YUPELRI net sales, we are entitled to a 35% share of the net profit (loss).
Of these employees, 86 were based in the US, and 11 were based in Dublin, Ireland. ​ Culture and Employee Engagement We consider our employee experience to be first-rate and strive to provide a culture of purpose, engagement, and learning.
The restructuring will involve winding down the R&D function and significantly reducing the G&A function. ​ Culture and Employee Engagement We consider our employee experience to be first-rate and strive to provide a culture of purpose, engagement, and learning.
Thus, the last to expire patent currently listed in the Orange Book for YUPELRI (revefenacin) inhalation solution expires on October 23, 2039. ​ The patent rights relating to YUPELRI (revefenacin) inhalation solution currently consist of issued US patents, pending US patent applications and certain counterpart patents and patent applications in a number of jurisdictions, including Europe and China. ​ Additionally, some of our patents and patent applications are directed to products in development.
Our patent position, similar to other companies in our industry, is generally uncertain and involves complex legal and factual questions. ​ The patent rights relating to YUPELRI (revefenacin) inhalation solution currently consist of issued US patents, pending US patent applications and certain counterpart patents and patent applications in a number of jurisdictions, including Europe and China.
As required by law, the settlements are subject to review by the U.S. Department of Justice and the Federal Trade Commission.
As required by law, the settlements are subject to review by the US Department of Justice and the Federal Trade Commission. The patent litigation against the one remaining generic company, Mankind Pharma Ltd., along with certain affiliates, remains pending.
Total royalty rates are upward tiering from 6.5% to 10% and based on total annual global net sales as follows: ​ ​ ​ TRELEGY Global Net Sales Thresholds Royalty Rate (Annual) Due from GSK to Royalty Pharma ≤ $750.0 million 6.5% > $750.0 million to ≤ $1,250.0 million 8.0% > $1,250.0 million to ≤ $2,250.0 million 9.0% > $2,250.0 million 10.0% ​ The following information regarding the TRELEGY program is based solely upon publicly available information and may not reflect the most recent developments under the programs. ​ TRELEGY provides the activity of an inhaled corticosteroid (FF) plus two bronchodilators (UMEC, a LAMA, and VI, a long-acting beta2 agonist, or LABA) in a single delivery device administered once-daily.
We remain focused on disciplined capital allocation and 8 Table of Contents returning excess cash to shareholders, and the Committee will continue to evaluate a range of alternatives to further enhance shareholder value, though there can be no assurance that additional transactions will occur. ​ The following information regarding the TRELEGY program is based solely upon publicly available information and may not reflect the most recent developments under the program. ​ TRELEGY provides the activity of an inhaled corticosteroid (FF) plus two bronchodilators (UMEC, a LAMA, and VI, a long-acting beta2 agonist, or LABA) in a single delivery device administered once-daily.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAdditional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. ​ Summary of Principal Risks Associated with Theravance Biopharma’s Business ​ ● We may never achieve or sustain profitability from our operations; ​ ● If YUPELRI’s acceptance by physicians, patients, third-party payors, or the medical community in general does not continue to grow, we may not receive significant additional revenues from sales of this product; ​ ● In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks; ​ ● Any delay in commencing or completing clinical studies for product candidates or product and any adverse results from clinical or non-clinical studies or regulatory obstacles product candidates or product may face, would harm our business and the price of our securities could fall; ​ ● If our product candidates are not approved by regulatory authorities, including the FDA, we will be unable to commercialize them; ​ ● If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with them, we may not be able to develop or commercialize our partnered product candidates as planned; ​ ● Our ongoing drug development efforts might not generate additional approvable drugs; ​ ● We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products before or more successfully than we do; ​ ● We are subject to extensive and ongoing regulation, oversight and other requirements by the FDA and failure to comply with these regulations and requirements may subject us to penalties that may adversely affect our financial condition or our ability to commercialize any approved products; and ​ ● We and/or our collaboration partners and those commercializing products with respect to which we have an economic interest or right to receive royalties may face competition from companies seeking to market generic versions of any approved products in which we have an interest, such as YUPELRI. ​ RISKS RELATING TO THE COMPANY ​ We may never achieve or sustain profitability from our operations.
Biggest changeAdditional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. ​ Summary of Principal Risks Associated with Theravance Biopharma’s Business ​ ● If YUPELRI’s acceptance by physicians, patients, third-party payors, or the medical community in general does not continue to grow, we may not receive significant additional revenues from sales of this product; ​ ● In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks; ​ ● If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with us, we may not be able to develop or commercialize our partnered products as planned; ​ ● We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products more successfully than we do; ​ ● Our strategic review process may not result in an executed or consummated transaction or other strategic alternative, and the process of reviewing strategic alternatives or its conclusion could adversely affect our business and our shareholders; ​ ● We are subject to extensive and ongoing regulation, oversight and other requirements by the FDA and failure to comply with these regulations and requirements may subject us to penalties that may adversely affect our financial condition or our ability to commercialize products; ​ ● We and/or our collaboration partners and those commercializing products with respect to which we have an economic interest may face competition from companies seeking to market generic versions of any approved products in which we have an interest, such as YUPELRI; and ​ ● We may not sustain profitability from our operations. ​ RISKS RELATING TO THE COMPANY ​ If YUPELRI’s acceptance by physicians, patients, third-party payors, or the medical community in general does not continue to grow, we may not receive significant additional revenues from sales of this product.
In addition, effective collaboration with a partner requires coordination to achieve complex and detail-intensive goals between entities that potentially have different priorities, capabilities and processes and successful navigation of the challenges such coordination entails.
In addition, effective collaboration with a partner requires coordination to achieve complex and detail-intensive goals between entities that potentially have different priorities, capabilities and processes and successful navigation of the challenges such coordination entails.
We depend on third-parties in the conduct of our non-clinical and clinical studies for our product candidates. We depend on independent clinical investigators, contract research and manufacturing organizations and other third-party service providers in the conduct of our non-clinical and clinical studies for our product candidates.
We depend on third parties in the conduct of our non-clinical and clinical studies for product candidates. We depend on independent clinical investigators, contract research and manufacturing organizations and other third-party service providers in the conduct of our non-clinical and clinical studies for product candidates.
Further, if we encounter delays in our clinical trials or in obtaining regulatory approval of our product candidates, the effective patent lives of the related product candidates could be reduced.
Further, if we encounter delays in our clinical trials or in obtaining regulatory approval of product candidates, the effective patent lives of the related product candidates could be reduced.
We also face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials. In addition, changes in laws outside the US are expanding our potential liability for injuries that occur during clinical trials.
We also face an inherent risk of product liability exposure related to the testing of product candidates in human clinical trials. In addition, changes in laws outside the US are expanding our potential liability for injuries that occur during clinical trials.
For example, in February 2023, we filed patent infringement lawsuits against seven companies and certain of their affiliates seeking to market a generic version of YUPELRI, and in December 2023, we amended the lawsuit to include several non-Orange Book listed patents. Additional lawsuits were filed later in 2023 and into 2024 based on newly-issued patents.
For example, in February 2023, we filed patent infringement lawsuits against seven companies and certain of their affiliates seeking to market a generic version of YUPELRI, and in December 2023, we amended the lawsuit to include several non-Orange Book listed patents. Additional lawsuits were filed later in 2023 and into 2024 and 2025 based on newly-issued patents.
A protectionist trade environment in either the US or those foreign countries in which we do business, such as a change in the current tariff structures, including any tariffs imposed by the US presidential administration and any reciprocal tariffs in response thereto , export compliance or other trade policies, may materially and adversely affect our operations.
A protectionist trade environment in either the US or those foreign countries in which we do business, such as a change in the current tariff structures, including any tariffs imposed by the current US administration and any reciprocal tariffs in response thereto , export compliance or other trade policies, may materially and adversely affect our operations.
While we do not intend to engage in unfair or deceptive acts or practices, the FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may be result in FTC enforcement. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.
While we do not intend to engage in unfair or deceptive acts or practices, the FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may result in FTC enforcement. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.
See the Risk Factor entitled “ We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products before or more successfully than we do ” for additional information regarding the competitive landscape in which we operate.
See the Risk Factor entitled “ We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products more successfully than we do ” for additional information regarding the competitive landscape in which we operate.
The completion of clinical studies for our product candidate may be delayed and programs may be terminated due to many factors, including, but not limited to: ● lack of efficacy of product candidate during clinical studies; ​ ● adverse events, safety issues or side effects (or perceived adverse developments or results) relating to the product candidate or its formulation into medicines; ​ ● unfavorable study data or unfavorable interpretations of data among the FDA and foreign regulatory authorities; ​ ● insufficient capital to continue our development program; ​ ● inability to enter into partnering arrangements relating to the development and commercialization of our program and product candidate or partner decisions not to maintain a partnership with us; ​ ● delays in patient enrollment and variability in the number and types of patients available for clinical studies; ​ ● competitive clinical trials; ​ ● our inability or the inability of our collaborators or licensees to manufacture or obtain from third-parties materials sufficient for use in non-clinical and clinical studies; ​ 22 Table of Contents ● governmental or regulatory delays or suspensions of the conduct of the clinical trials and changes in regulatory requirements, policy and guidelines; ​ ● challenges with recruitment and/or progressing patients through studies; ​ ● failure of any partners to advance product candidates through clinical development; ​ ● incomplete data from clinical trials; ​ ● varying regulatory requirements or interpretations of data among the FDA and foreign regulatory authorities; ​ ● new clinical trial regulations in the European Union; and ​ ● a disturbance where we or our collaborative partners are enrolling patients in clinical trials, such as a pandemic, terrorist activities or war, political unrest or a natural disaster. ​ Any adverse developments or results or perceived adverse developments or results with respect to our clinical program including, without limitation, any delays in our development program, any halting of development in our program, any difficulties or delays encountered with regard to the FDA or other third country regulatory authorities with respect to our program, or any indication from clinical or non-clinical studies that the compounds in our program are not safe, efficacious or sufficiently differentiated from those of our competitors, could have a material adverse effect on our business and cause the price of our securities to fall.
Programs may be terminated due to many factors, including, but not limited to: ● lack of efficacy of product candidate during clinical studies; ​ ● adverse events, safety issues or side effects (or perceived adverse developments or results) relating to the product candidate or its formulation into medicines; ​ 32 Table of Contents ● unfavorable study data or unfavorable interpretations of data among the FDA and foreign regulatory authorities; ​ ● insufficient capital to continue our development program; ​ ● inability to enter into partnering arrangements relating to the development and commercialization of our program and product candidate or partner decisions not to maintain a partnership with us; ​ ● delays in patient enrollment and variability in the number and types of patients available for clinical studies; ​ ● competitive clinical trials; ​ ● our inability or the inability of our collaborators or licensees to manufacture or obtain from third parties materials sufficient for use in non-clinical and clinical studies; ​ ● governmental or regulatory delays or suspensions of the conduct of the clinical trials and changes in regulatory requirements, policy and guidelines; ​ ● challenges with recruitment and/or progressing patients through studies; ​ ● failure of any partners to advance product candidates through clinical development; ​ ● incomplete data from clinical trials; ​ ● varying regulatory requirements or interpretations of data among the FDA and foreign regulatory authorities; ​ ● new clinical trial regulations in the European Union; and ​ ● a disturbance where we or our collaborative partners are enrolling patients in clinical trials, such as a pandemic, terrorist activities or war, political unrest or a natural disaster. ​ Any adverse developments or results or perceived adverse developments or results with respect to our clinical program including, without limitation, any delays in our development program, any halting of development in our program, any difficulties or delays encountered with regard to the FDA or other third country regulatory authorities with respect to our program, or any indication from clinical or non-clinical studies that the compounds in our program are not safe, efficacious or sufficiently differentiated from those of our competitors, could have a material adverse effect on our business and cause the price of our securities to fall.
In November 2024, the board of directors announced the formation of a Strategic Review Committee composed entirely of independent directors to assess all strategic alternatives to the Company, including those related to YUPELRI, ampreloxetine, and TRELEGY, with the objective of unlocking shareholder value.
In November 2024, the board of directors announced the formation of a Strategic Review Committee of our Board of Directors (the "Committee") composed entirely of independent directors to assess all strategic alternatives to the Company, including those related to YUPELRI, ampreloxetine, and TRELEGY, with the objective of unlocking shareholder value.
If a disruption of information technology systems or security breach results in a loss of or damage to our data or regulatory applications, unauthorized access, use, or disclosure of, or the prevention of access to, confidential information, or other harm to our business, we could incur liability and reputational harm, we could be required to comply with federal and/or state breach notification laws and foreign law equivalents, we may incur legal expenses to protect our confidential information, the further development of our product candidates could be delayed and the price of our securities could fall.
If a disruption of information technology systems or security breach results in a loss of or damage to our data or regulatory applications, unauthorized access, use, or disclosure of, or the prevention of access to, confidential information, or other harm to our business, we could incur liability and reputational harm, we could be required to comply with federal and/or state breach notification laws and foreign law equivalents, we may incur legal expenses to protect our confidential information, the development of any product candidates could be delayed and the price of our securities could fall.
We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products before or more successfully than we do.
We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products more successfully than we do.
As of February 28, 2025, we have settled litigation with some of the generic applicants, and pursuant to individual agreements, we granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
As of February 28, 2026, we have settled litigation with some of the generic applicants, and pursuant to individual agreements, we granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
Furthermore, there is no assurance that a product will be considered medically reasonable and necessary for a specific indication, will be considered cost-effective by third-party payors, that an adequate level of 44 Table of Contents reimbursement will be established even if coverage is available, or that the third-party payors’ reimbursement policies will not adversely affect the ability of manufacturers to sell products profitably. ​ Our relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion, contractual damages, reputational harm and diminished profits and future earnings.
Furthermore, there is no assurance that a product will be considered medically reasonable and necessary for a specific indication, will be considered cost-effective by third-party payors, that an adequate level of reimbursement will be established even if coverage is available, or that the third-party payors’ reimbursement policies will not adversely affect the ability of manufacturers to sell products profitably. ​ Our relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion, contractual damages, reputational harm and diminished profits and future earnings.
We depend on a number of third-party Active Pharmaceutical Ingredient (“API”) and drug product manufacturers for clinical study purposes, and we depend on third-party suppliers for warehousing and storage of our existing API and drug product.
We also depend on a number of third-party Active Pharmaceutical Ingredient (“API”) and drug product manufacturers for clinical study purposes, and we depend on third-party suppliers for warehousing and storage of our existing API and drug product.
However, based on English authorities, which would in all likelihood be of persuasive authority and be applied by a court in the Cayman Islands, exceptions to the foregoing principle apply in circumstances in which: ● a company is acting, or proposing to act, illegally or beyond the scope of its authority; ​ ● the act complained of, although not beyond the scope of the authority, could be effected if duly authorized by more than the number of votes which have actually been obtained; or ​ ● those who control the company are perpetrating a “fraud on the minority.” ​ A shareholder may have a direct right of action against the company where the individual rights of that shareholder have been infringed or are about to be infringed.
However, based on English authorities, which would in all likelihood be of persuasive authority and be applied by a court in the Cayman Islands, exceptions to the foregoing principle apply in circumstances in which: ● a company is acting, or proposing to act, illegally or beyond the scope of its authority; ​ 48 Table of Contents ● the act complained of, although not beyond the scope of the authority, could be effected if duly authorized by more than the number of votes which have actually been obtained; or ​ ● those who control the company are perpetrating a “fraud on the minority.” ​ A shareholder may have a direct right of action against the company where the individual rights of that shareholder have been infringed or are about to be infringed.
The IRA also creates a Drug Price Negotiation Program under which the prices for Medicare units of certain high Medicare spend drugs and biologics without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price, with negotiated prices set to take effect starting in 2026.
The IRA also created a Drug Price Negotiation Program under which the prices for Medicare units of certain high Medicare spend drugs and biologics without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price, with negotiated prices set to take effect starting in 2026.
At present, we are not aware of any patent infringement claims that would adversely and materially affect our ability to develop our product candidates, but nevertheless the possibility of third-party allegations cannot be ruled out. In addition, third-parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.
At present, we are not aware of any patent infringement claims that would adversely and materially affect our ability to develop any current product, but nevertheless the possibility of third-party allegations cannot be ruled out. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.
The GDPR and Switzerland’s data protection laws impose a broad range of requirements and obligations relating to the processing and protection of personal data, including obligations to having legal bases for processing personal data (which may result in some instances in obtaining the consent of the individuals to whom the personal data relate), providing detailed information about the processing activities to the individuals, ensuring that personal data is deleted or anonymized after they are no longer needed for the purposes for which they are collected, ensuring that personal data are adequately protected, ensuring that security incidents are detected, handled and reported to individuals and competent authorities where required, and allowing individuals to exercise their privacy rights.
The GDPR and Switzerland’s data protection laws impose a broad range of requirements and obligations relating to the processing and 37 Table of Contents protection of personal data, including obligations to having legal bases for processing personal data (which may result in some instances in obtaining the consent of the individuals to whom the personal data relate), providing detailed information about the processing activities to the individuals, ensuring that personal data is deleted or anonymized after they are no longer needed for the purposes for which they are collected, ensuring that personal data are adequately protected, ensuring that security incidents are detected, handled and reported to individuals and competent authorities where required, and allowing individuals to exercise their privacy rights.
Federal enforcement agencies also have showed increased interest in pharmaceutical companies’ product and patient assistance programs and a number of investigations into these programs have resulted in significant civil and criminal settlements. Other companies have faced enforcement actions for causing false claims to be submitted because of the companies’ marketing the product for unapproved, and thus non-reimbursable, uses.
Federal enforcement agencies also have shown increased interest in pharmaceutical companies’ product and patient assistance programs and a number of investigations into these programs have resulted in significant civil and criminal settlements. Other companies have faced enforcement actions for causing false claims to be submitted because of the companies’ marketing the product for unapproved, and thus non-reimbursable, uses.
Any failure to maintain regulatory approval will materially limit the ability to commercialize a product or any future product candidates and if we fail to comply with FDA regulations and requirements, the FDA could potentially 27 Table of Contents take a number of enforcement actions against us, including the issuance of untitled letters, warning letters, preventing the introduction or delivery of the product into interstate commerce in the US, misbranding charges, product seizures, injunctions, and civil monetary penalties, which would materially and adversely affect our business and financial condition and may cause the price of our securities to fall.
Any failure to maintain regulatory approval will materially limit the ability to commercialize a product or any future product candidates and if we fail to comply with FDA regulations and requirements, the FDA could potentially take a number of enforcement actions against us, including the issuance of untitled letters, warning letters, preventing the introduction or delivery of the product into interstate commerce in the US, misbranding charges, product seizures, injunctions, and civil monetary penalties, which would materially and adversely affect our business and financial condition and may cause the price of our securities to fall.
In addition, we have experienced headwinds from an evolved channel mix and a lower realized net price. While we anticipate a more stable pricing environment and continued YUPELRI demand growth in 2025 and beyond, there can be no assurance that our and our partner Viatris’ efforts to improve our current pricing dynamics will be successful.
In addition, we have experienced headwinds from an evolved channel mix and a lower realized net price. While we anticipate a more stable pricing environment and continued YUPELRI demand growth in 2026 and beyond, there can be no assurance that our and our partner Viatris’ efforts to improve our current pricing dynamics will be successful.
Clinical studies involving our product candidate may reveal that it is ineffective, inferior to existing approved medicines, unacceptably toxic, or that they have other unacceptable side effects. In addition, the results of preclinical studies do not necessarily predict clinical success, and larger and later-stage clinical studies may not produce the same results as earlier-stage clinical studies.
Clinical studies involving a product candidate may reveal that it is ineffective, inferior to existing approved medicines, unacceptably toxic, or that they have other unacceptable side effects. In addition, the results of preclinical studies do not necessarily predict clinical success, and larger and later-stage clinical studies may not produce the same results as earlier-stage clinical studies.
Nevertheless, Irenic may continue to make and/or other activist shareholders may make such public communications in the future. ​ 49 Table of Contents In the event of such shareholder activism – particularly with respect to matters which our board of directors, in exercising their fiduciary duties, disagree with or have determined not to pursue – our business could be adversely affected because responding to such actions by activist shareholders can be costly and time-consuming, disruptive to our operations and divert the attention of management, our board of directors and our employees, and our ability to execute our strategic plan could also be impaired as a result.
Nevertheless, Irenic may continue to make and/or other activist shareholders may make such public communications in the future. ​ In the event of such shareholder activism – particularly with respect to matters which our board of directors, in exercising their fiduciary duties, disagree with or have determined not to pursue – our business could be adversely affected because responding to such actions by activist shareholders can be costly and time-consuming, disruptive to our operations and divert the attention of management, our board of directors and our employees, and our ability to execute our strategic plan could also be impaired as a result.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, exclusion from government funded 46 Table of Contents healthcare programs, such as Medicare and Medicaid in the US and similar programs outside the US, contractual damages, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, exclusion from government funded healthcare programs, such as Medicare and Medicaid in the US and similar programs outside the US, contractual damages, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
For example, a US federal government budget cuts, shutdown or budget sequestration, such as ones that occurred during 2013, 2018, and 2019, or actions by the current US presidential administration in 2025 to limit federal agency budgets and/or personnel, may result in significant reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.
For example, a US federal government budget cuts, shutdown or budget sequestration, such as ones that occurred during 2013, 2018, and 2019, or actions by the current US presidential administration in 2026 to limit federal agency budgets and/or personnel, may result in significant reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of any product candidates or obtain regulatory approval for any product candidates.
If we fail to retain our qualified personnel or replace them when they leave, we may be unable to continue our development and commercialization activities, and the price of our securities could fall. ​ Our business and operations would suffer in the event of significant disruptions of information technology systems or security breaches.
If we fail to retain our qualified personnel or replace them when they leave, we may be unable to continue our business activities, and the price of our securities could fall. ​ Our business and operations would suffer in the event of significant disruptions of information technology systems or security breaches.
These programs included the following: ● The Medicaid Drug Rebate program, under which a manufacturer is required to pay a rebate based on reported pricing data to each state Medicaid program for its covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds made available to the states for the manufacturer’s drugs under Medicaid and Medicare Part B. ​ ● The 340B Program, in which manufacturers must participate in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B.
These programs included the following: ● The Medicaid Drug Rebate program, under which a manufacturer is required to pay a rebate based on 40 Table of Contents reported pricing data to each state Medicaid program for its covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds made available to the states for the manufacturer’s drugs under Medicaid and Medicare Part B. ​ ● The 340B Program, in which manufacturers must participate in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B.
Regulatory approval for our product candidates, if any, may include similar or other limitations on the indicated uses for which we can market our medicines or the patient population that may utilize our medicines, which may limit the market for our medicines or put us at a competitive disadvantage relative to alternative therapies.
Regulatory approval for any product candidate, if any, may include similar or other limitations on the indicated uses for which we can market our medicines or the patient population that may utilize our medicines, which may limit the market for our medicines or put us at a competitive disadvantage relative to alternative therapies.
Based upon our assets and income during the course of 2014, we believe that our company and one of our company’s wholly-owned subsidiaries, Theravance Biopharma R&D, Inc. was a PFIC for 2014. Based upon our assets and income from 2015 through 2024, we do not believe that our company is a PFIC since 2015.
Based upon our assets and income during the course of 2014, we believe that our Company and one of our Company’s wholly-owned subsidiaries, Theravance Biopharma R&D, Inc. was a PFIC for 2014. Based upon our assets and income from 2015 through 2025, we do not believe that our Company is a PFIC since 2015.
For as long as we continue to be a smaller reporting company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies that are not smaller reporting companies, including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and only being required to provide two years of audited financial statements in annual reports.
For as long as we continue to be a smaller reporting company, we may choose to take advantage of exemptions from various 49 Table of Contents reporting requirements applicable to other public companies that are not smaller reporting companies, including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and only being required to provide two years of audited financial statements in annual reports.
The following are some of the factors that may have a significant effect on the market price of our ordinary shares: ● any adverse developments or results or perceived adverse developments or results with respect to YUPELRI, including without limitation, lower than expected sales of or revenues from YUPELRI, 47 Table of Contents difficulties or delays encountered with regard to the FDA or other regulatory authorities in this program or any indication from clinical or non-clinical studies that YUPELRI is not safe or efficacious; ​ ● any adverse developments or results or perceived adverse developments or results with respect to TRELEGY, including our Ongoing Economic Interest; ​ ● any adverse developments or results or perceived adverse developments or results with respect to our clinical development programs, including, without limitation, any delays in development in these programs, any halting of development in these programs, any difficulties or delays encountered with regard to the FDA or other regulatory authorities in these programs, or any indication from clinical or non-clinical studies that the compounds in such programs are not safe or efficacious; ​ ● any announcements of developments with, or comments by, the FDA or other regulatory authorities with respect to products we or our partners have under development, are manufacturing or have commercialized; ​ ● any adverse developments or disagreements or perceived adverse developments or disagreements with respect to our relationship with Royalty Pharma, or the relationship of Royalty Pharma and GSK; ​ ● any adverse developments or perceived adverse developments with respect to our relationship with any of our research, development, or commercialization partners, including, without limitation, disagreements that may arise between us and any of those partners; ​ ● any adverse developments or perceived adverse developments in our programs with respect to partnering efforts or otherwise; ​ ● announcements of patent issuances or denials, technological innovations or new commercial products by us or our competitors; ​ ● publicity regarding actual or potential study results or the outcome of regulatory review relating to products under development by us, our partners, or our competitors; ​ ● regulatory developments in the US and foreign countries; ​ ● announcements with respect to governmental or private insurer reimbursement policies; ​ ● announcements of equity or debt financings; ​ ● possible impairment charges on non-marketable equity securities; ​ ● economic and other external factors beyond our control, such as health emergencies, tax regimes, foreign policy, and fluctuations in interest rates; ​ ● loss of key personnel; ​ ● likelihood of our ordinary shares to be more sensitive to changes in sales volume, market fluctuations and events or perceived events with respect to our business due to our small public float; ​ ● low public market trading volumes for our ordinary shares; ​ ● the sale of large concentrations of our shares to third-parties, which may be more likely to occur due to the concentration of ownership of our shares, such as what we experienced when our then-largest shareholder divested its holdings in 2019; ​ 48 Table of Contents ● developments or disputes as to patent or other proprietary rights; ​ ● approval or introduction of competing products and technologies; ​ ● results of clinical trials; ​ ● failures or unexpected delays in timelines for our potential products in development, including the obtaining of regulatory approvals; ​ ● delays in manufacturing adversely affecting clinical or commercial operations; ​ ● fluctuations in our operating results; ​ ● market reaction to announcements by other biotechnology or pharmaceutical companies; ​ ● initiation, termination, or modification of agreements with our collaborators or disputes or disagreements with collaborators; ​ ● litigation or the threat of litigation; ​ ● public concern as to the safety of product candidates or medicines developed by us; and ​ ● comments and expectations of results made by securities analysts or investors. ​ If any of these factors causes us to fail to meet the expectations of securities analysts or investors, or if adverse conditions prevail or are perceived to prevail with respect to our business, the price of the ordinary shares would likely drop significantly.
The following are some of the factors that may have a significant effect on the market price of our ordinary shares: ● any adverse developments or results or perceived adverse developments or results with respect to YUPELRI, including without limitation, lower than expected sales of or revenues from YUPELRI, difficulties or delays encountered with regard to the FDA or other regulatory authorities in this program or any indication from clinical or non-clinical studies that YUPELRI is not safe or efficacious; ​ ● any adverse developments or results or perceived adverse developments or results with respect to TRELEGY, including the Milestone Payments; ​ ● any adverse developments or results or perceived adverse developments or results with respect to any clinical development program, including, without limitation, any delays in development, halting of development, difficulties or delays encountered with regard to the FDA or other regulatory authorities, or any indication from clinical or non-clinical studies that the compounds in such programs are not safe or efficacious; ​ ● any announcements of developments with, or comments by, the FDA or other regulatory authorities with respect to products we or our partners have under development, are manufacturing or have commercialized; ​ 45 Table of Contents ● any adverse developments or disagreements or perceived adverse developments or disagreements with respect to our relationship with Royalty Pharma, or the relationship of Royalty Pharma and GSK; ​ ● any adverse developments or perceived adverse developments with respect to our relationship with any of our development or commercialization partners, including, without limitation, disagreements that may arise between us and any of those partners; ​ ● any adverse developments or perceived adverse developments with respect to the efforts of the Committee; ​ ● announcements of patent issuances or denials, technological innovations or new commercial products by us or our competitors; ​ ● publicity regarding actual or potential study results or the outcome of regulatory review relating to products under development by us, our partners, or our competitors; ​ ● regulatory developments in the US and foreign countries; ​ ● announcements with respect to governmental or private insurer reimbursement policies; ​ ● announcements of equity or debt financings; ​ ● possible impairment charges on non-marketable equity securities; ​ ● economic and other external factors beyond our control, such as health emergencies, tax regimes, foreign policy, and fluctuations in interest rates; ​ ● loss of key personnel; ​ ● likelihood of our ordinary shares to be more sensitive to changes in sales volume, market fluctuations and events or perceived events with respect to our business due to our small public float; ​ ● low public market trading volumes for our ordinary shares; ​ ● the sale of large concentrations of our shares to third parties, which may be more likely to occur due to the concentration of ownership of our shares, such as what we experienced when our then-largest shareholder divested its holdings in 2019; ​ ● developments or disputes as to patent or other proprietary rights; ​ ● approval or introduction of competing products and technologies; ​ ● results of clinical trials; ​ ● failures or unexpected delays in timelines for products in development, including the obtaining of regulatory approvals; ​ ● delays in manufacturing adversely affecting operations; ​ ● fluctuations in our operating results; ​ ● market reaction to announcements by other biotechnology or pharmaceutical companies; ​ 46 Table of Contents ● initiation, termination, or modification of agreements with our collaborators or disputes or disagreements with collaborators; ​ ● litigation or the threat of litigation; ​ ● public concern as to the safety of product candidates or medicines developed by us; and ​ ● comments and expectations of results made by securities analysts or investors. ​ If any of these factors cause us to fail to meet the expectations of securities analysts or investors, or if adverse conditions prevail or are perceived to prevail with respect to our business, the price of the ordinary shares would likely drop significantly.
Any potential strategic alternative would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, regulatory approvals, and the availability of financing for a potential transaction on reasonable terms.
Any potential strategic alternative would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, and the availability of financing for a potential transaction on reasonable terms.
We rely upon a combination of patents, patent applications, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies. Any involuntary disclosure to or misappropriation by third-parties of this proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market.
We rely upon a combination of patents, patent applications, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies. Any involuntary disclosure to or misappropriation by third parties of this proprietary information could enable competitors to quickly duplicate or surpass 34 Table of Contents our technological achievements, thus eroding our competitive position in our market.
These shareholders could control the outcome of actions taken by us that require shareholder approval, including a transaction in which shareholders might receive a premium over the prevailing market price for their shares. Certain provisions in our constitutional and other documents may discourage our acquisition by a third-party, which could limit your opportunity to sell shares at a premium.
These shareholders could control the outcome of actions taken by us that require shareholder approval, including a transaction in which shareholders might receive a premium over the prevailing market price for their shares. 47 Table of Contents Certain provisions in our constitutional and other documents may discourage our acquisition by a third party, which could limit your opportunity to sell shares at a premium.
While our YUPELRI operations have been profitable on a brand basis since the third quarter of 2020, we will continue to incur costs and expenses associated with the commercialization of YUPELRI in the US, including the maintenance of an independent sales and marketing organization with appropriate technical expertise, and a medical affairs presence and consultant support.
While our YUPELRI operations have been profitable on a brand basis since the third quarter of 2020, we will continue to incur costs and expenses associated with the commercialization 22 Table of Contents of YUPELRI in the US, including the maintenance of an independent sales and marketing organization with appropriate technical expertise, and a medical affairs presence and consultant support.
US holders of our ordinary shares may have filed an election with respect to company shares held at any time during 2014 to be treated as owning an interest in a “qualified electing fund” (“QEF”) or to “mark to market” their ordinary shares to avoid the otherwise applicable interest charge consequences of PFIC treatment with respect to our ordinary shares.
US holders of our ordinary shares may have filed an election with respect to Company shares held at any time during 2014 to be treated as owning an interest in a “qualified electing fund” (“QEF”) or to “mark to market” their ordinary shares to avoid the otherwise applicable interest charge consequences of PFIC treatment 30 Table of Contents with respect to our ordinary shares.
Furthermore, parties making claims against us or our partners may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense against these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
Furthermore, parties making claims against us or our partners may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize a product. Defense against these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
Failure by these parties to comply with applicable regulations and practices in conducting studies of our product candidates can result in a delay in our development programs or non-approval of our product candidates by regulatory authorities.
Failure by these parties to comply with applicable regulations and practices in conducting studies of a product candidate can result in a delay in our development programs or non-approval of a product candidate by regulatory authorities.
If YUPELRI’s acceptance and net price does not grow, or declines from previous levels, our business and financial results could be materially harmed. 21 Table of Contents In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks.
If YUPELRI’s acceptance and net price does not grow, or declines from previous levels, our business and financial results could be materially harmed. In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks.
These geopolitical, social, and economic conditions could harm our business. Our US operating subsidiary’s facility is located near known earthquake fault zones, and the occurrence of an earthquake, extremist attack or other catastrophic disaster could cause damage to our facilities and equipment, which could require us to cease or curtail operations.
These geopolitical, social, and economic conditions could harm our business. 28 Table of Contents Our US operating subsidiary’s facility is located near known earthquake fault zones, and the occurrence of an earthquake, extremist attack or other catastrophic disaster could cause damage to our facilities and equipment, which could require us to cease or curtail operations.
Further, in the event of a release of or exposure to hazardous materials, including at the sites we currently or formerly operate or at sites such as landfills where we send wastes for disposal, we could be held liable for cleanup costs or damages or subject to other costs or penalties and such liability could exceed our resources.
Further, in the event of a release of or exposure to hazardous materials, including at the sites we currently or formerly operate or at sites such as landfills where we have sent wastes for disposal, we could be held liable for cleanup costs or damages or subject to other costs or penalties and such liability could exceed our resources.
Third-parties may assert that we or our partners are using their proprietary rights without authorization. There are third-party patents that may cover materials or methods for treatment related to our product candidates.
Third parties may assert that we or our partners are using their proprietary rights without authorization. There are third-party patents that may cover materials or methods for treatment related to a product.
To the extent that low trading volumes for our ordinary shares continues, our stock price may fluctuate significantly more than the stock market as a whole or the stock prices of similar companies.
To the extent that low trading volumes for our ordinary shares continue, our stock price may fluctuate significantly more than the stock market as a whole or the stock prices of similar companies.
Because a generic applicant does not conduct its own clinical studies, but instead relies on the FDA’s finding of safety and effectiveness for the approved drug, it is able to introduce a competing product into the market at a cost significantly below that of the original drug.
Because a generic applicant does not conduct its own clinical studies, but 24 Table of Contents instead relies on the FDA’s finding of safety and effectiveness for the approved drug, it is able to introduce a competing product into the market at a cost significantly below that of the original drug.
Examples of such adverse developments include, but are not limited to: ● disappointing or lower than expected sales of TRELEGY; ​ ● the emergence of new closed triple or other alternative therapies or any developments regarding competitive therapies, including comparative price or efficacy of competitive therapies; ​ ● disputes between any of Royalty Pharma, GSK, Innoviva and us; ​ ● GSK deciding to modify, delay or halt the TRELEGY program; ​ ● any safety, efficacy or other concerns regarding the TRELEGY program; or ​ ● any particular FDA requirements or changes in FDA policy or guidance regarding the TRELEGY program or any particular regulatory requirements in other jurisdictions or changes in the policies or guidance adopted by foreign regulatory authorities. ​ We do not control the commercialization of TRELEGY; accordingly, our receipt of Milestone Payments and receipt of the value we currently anticipate from the Outer Years Royalty will depend on, among other factors, GSK’s ability to further commercialize TRELEGY.
Examples of such adverse developments include, but are not limited to: ● disappointing or lower than expected sales of TRELEGY; ​ ● the emergence of new closed triple or other alternative therapies or any developments regarding competitive therapies, including comparative price or efficacy of competitive therapies; ​ ● disputes between any of Royalty Pharma, GSK, Innoviva and us; ​ ● GSK deciding to modify, delay or halt the TRELEGY program; ​ ● any safety, efficacy or other concerns regarding the TRELEGY program; or ​ ● any particular FDA requirements or changes in FDA policy or guidance regarding the TRELEGY program or any particular regulatory requirements in other jurisdictions or changes in the policies or guidance adopted by foreign regulatory authorities. ​ We do not control the commercialization of TRELEGY; accordingly, our receipt of Milestone Payments will depend on, among other factors, GSK’s ability to further commercialize TRELEGY.
Accordingly, our Ongoing Economic Interest involves a number of risks and uncertainties, including: ● GSK’s ability to have an adequate supply of TRELEGY product; ​ ● ongoing compliance by GSK or its suppliers with the FDA’s current Good Manufacturing Practice; ​ ● compliance with other applicable FDA and other regulatory requirements in the US or other foreign jurisdictions, including those described elsewhere in this report; ​ ● competition, whether from current competitors or new products developed by others in the future; ​ ● claims relating to intellectual property; ​ ● any future disruptions in GSK’s business which would affect its ability to commercialize TRELEGY; 30 Table of Contents ​ ● the ability of TRELEGY to achieve wider acceptance among physicians, patients, third-party payors, or the medical community in general; ​ ● global economic conditions; and ​ ● any of the other risks relating to commercialization of TRELEGY. ​ These risks and uncertainties could materially impact the amount and timing of future Milestone Payments and Outer Years Royalty, which could have a material adverse effect on our future revenues, other financial results and our financial position and cause the price of our securities to fall.
Accordingly, our receipt of Milestone Payments involves a number of risks and uncertainties, including: ● GSK’s ability to have an adequate supply of TRELEGY product; ​ ● ongoing compliance by GSK or its suppliers with the FDA’s current Good Manufacturing Practice; ​ ● compliance with other applicable FDA and other regulatory requirements in the US or other foreign jurisdictions, including those described elsewhere in this report; ​ ● competition, whether from current competitors, generics, or new products developed by others in the future; ​ ● claims relating to intellectual property; ​ ● any future disruptions in GSK’s business which would affect its ability to commercialize TRELEGY; ​ ● the ability of TRELEGY to achieve wider acceptance among physicians, patients, third-party payors, or the 26 Table of Contents medical community in general; ​ ● global economic conditions; and ​ ● any of the other risks relating to commercialization of TRELEGY. ​ These risks and uncertainties could materially impact the amount and timing of future Milestone Payments, which could have a material adverse effect on our future revenues, other financial results and our financial position and cause the price of our securities to fall.
Any challenge to the intellectual property protection of a late-stage development or commercial-stage asset, particularly those of TRELEGY, could harm our business and cause the price of our securities to fall. Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines.
Any challenge to the intellectual property protection of a late-stage development or commercial-stage asset could harm our business and cause the price of our securities to fall. Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines.
For additional discussion of the risk of generic competition to YUPELRI, please see the risk factor below entitled “ If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our current or future markets ” and “ Litigation to protect or defend our intellectual property or third-party claims of intellectual property infringement will require us to divert resources and may prevent or delay our drug development and commercialization efforts .” If we are unable to enter into future collaboration arrangements or if any such collaborations with third-parties are unsuccessful, we may be unable to fully develop and commercialize certain product candidates and our business will be adversely affected.
For additional discussion of the risk of generic competition to YUPELRI, please see the risk factor below entitled “ If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our current or future markets ” and “ Litigation to protect or defend our intellectual property or third-party claims of intellectual property infringement will require us to divert resources and may prevent or delay our drug development and commercialization efforts .” If we are unable to enter into future collaboration arrangements or if any such collaborations are unsuccessful, we may be unable to fully develop and commercialize products and our business will be adversely affected.
Federal, state, and local laws and regulations govern the use, manufacture, management, storage, handling and disposal of hazardous materials and wastes. We may incur significant additional costs or liabilities to comply with, or for violations of, these and other applicable laws in the future.
Federal, state, and local laws and regulations govern the use, manufacture, management, storage, handling and disposal of hazardous materials and wastes. We may incur significant additional costs or liabilities 44 Table of Contents to comply with, or for violations of, these and other applicable laws in the future.
Any inability to acquire sufficient quantities of API and drug product in a timely manner from these third-parties could delay clinical studies or prevent us from developing our product candidates in a cost-effective manner or on a timely basis or adversely impact YUPELRI sales.
Any inability to acquire sufficient quantities of API and drug product in a timely manner from these third parties could delay clinical studies or prevent us from developing any product candidate in a cost-effective manner or on a timely basis or adversely impact YUPELRI sales.
We are subject to new, evolving, or revised tax laws and regulations in such jurisdictions, and the enactment of or increases in taxes, or other changes in the application of existing taxes, in such jurisdictions may have an adverse effect on our business or on our results of operations.
We are subject to new, evolving, or revised tax laws and regulations in such jurisdictions, and the enactment of or increases in taxes, or other changes in the application of existing taxes, in such jurisdictions may have an adverse 29 Table of Contents effect on our business or on our results of operations.
In the US, numerous federal and state laws, and regulations, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the FTC Act and the Health Breach Notification Rule), govern the collection, use, disclosure, and protection of health related and other personal information.
In the US, numerous federal and state laws, and regulations, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act and the Health Breach Notification Rule), govern the collection, use, disclosure, and protection of health related and other personal information.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes 39 Table of Contents notification obligations on companies for breaches of certain health information contained in personal health records. The FTC has brought enforcement actions under both Section 5 of the FTC Act and the Health Breach Notification Rule.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. The FTC has brought enforcement actions under both Section 5 of the FTC Act and the Health Breach Notification Rule.
Under Section 703 of the National Defense 43 Table of Contents Authorization Act for FY 2008, the manufacturer is required to pay quarterly rebates to DoD on utilization of its innovator products that are dispensed through DoD’s Tricare network pharmacies to Tricare beneficiaries.
Under Section 703 of the National Defense Authorization Act for FY 2008, the manufacturer is required to pay quarterly rebates to DoD on utilization of its innovator products that are dispensed through DoD’s Tricare network pharmacies to Tricare beneficiaries.
These risks include, but are not limited to, the inherent difficulty in selecting the right drug and drug target and avoiding unwanted side effects, as well as unanticipated problems relating to product development, 24 Table of Contents testing, enrollment, obtaining regulatory approvals, maintaining regulatory compliance, manufacturing, competition and costs and expenses that may exceed current estimates.
These risks include, but are not limited to, the inherent difficulty in selecting the right drug and drug target and avoiding unwanted side effects, as well as unanticipated problems relating to product development, testing, enrollment, obtaining regulatory approvals, maintaining regulatory compliance, manufacturing, competition and costs and expenses that may exceed current estimates.
For additional discussion of risks related to partnering programs, please see the risk factor entitled “ If we are unable to enter into future collaboration arrangements or if any such collaborations with third-parties are unsuccessful, we may be unable to fully develop and commercialize certain product candidates and our business will be adversely affected .” If we fail to effectively enforce our proprietary rights against others, our business will be harmed, and the price of our securities could fall. ​ If the efforts of our partners or future partners to protect the proprietary nature of the intellectual property related to collaboration assets are not adequate, the future commercialization of any medicines resulting from collaborations could be negatively impacted, which would materially harm our business and could cause the price of our securities to fall.
For additional discussion of risks related to partnering programs, please see the risk factor entitled “ If we are unable to enter into future collaboration arrangements or if any such collaborations are unsuccessful, we may be unable to fully develop and commercialize products and our business will be adversely affected .” If we fail to effectively enforce our proprietary rights against others, our business will be harmed, and the price of our securities could fall. ​ If the efforts of our partners or future partners to protect the proprietary nature of the intellectual property related to collaboration assets are not adequate, the future commercialization of any medicines resulting from collaborations could be negatively impacted, which would materially harm our business and could cause the price of our securities to fall.
In addition, Viatris distributes YUPELRI in the US through durable medical equipment suppliers, specialty pharmacies and pharmaceutical wholesalers, and a security breach that impairs the distribution operations or retail pharmacies could materially and adversely impair our ability to deliver YUPELRI to healthcare providers and patients and therefore result in reduced revenue.
In addition, Viatris distributes YUPELRI in the US through durable medical equipment suppliers, specialty pharmacies and pharmaceutical wholesalers, and a security breach that impairs the distribution 27 Table of Contents operations or retail pharmacies could materially and adversely impair our ability to deliver YUPELRI to healthcare providers and patients and therefore result in reduced revenue.
Our arrangements with third-party payors and customers expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements through which we market, sell and distribute any products for which we have obtained or may obtain marketing approval.
Our arrangements with third-party payors and customers expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements through which we market, sell 42 Table of Contents and distribute any products for which we have obtained or may obtain marketing approval.
If physicians, patients, third-party payors, or the medical community in general believe that YUPELRI is not a preferred treatment option for those with COPD, do not continue to prescribe, fill prescriptions for, cover, or reimburse for YUPELRI, we may see declines, or fail to grow.
If physicians, patients, third-party payors, or the medical community in general believe that YUPELRI is not a 19 Table of Contents preferred treatment option for those with COPD, do not continue to prescribe, fill prescriptions for, cover, or reimburse for YUPELRI, we may see declines, or fail to grow.
Therefore, you may have more 50 Table of Contents difficulty in protecting your interests than would shareholders of a corporation incorporated in a jurisdiction in the US, due to the different nature of Cayman Islands law in this area.
Therefore, you may have more difficulty in protecting your interests than would shareholders of a corporation incorporated in a jurisdiction in the US, due to the different nature of Cayman Islands law in this area.
In addition, in order to market our medicines in foreign jurisdictions, we or our collaborative partners must obtain separate regulatory approvals in each country. The approval procedure varies among countries and can involve 23 Table of Contents additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval.
In addition, in order to market our medicines in foreign jurisdictions, we or our collaborative partners must obtain separate regulatory approvals in each country. The approval procedure varies among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval.
Worldwide economic conditions remain uncertain due to current global economic challenges, war and hostilities in Ukraine and the Middle East, health emergencies, inflation, priorities of the US presidential administration and related changes in laws, regulations and policies, instability in the US banking sector and other disruptions to global and regional economies and markets.
Worldwide economic conditions remain uncertain due to current global economic challenges, war and hostilities in Ukraine and the Middle East, health emergencies, inflation, priorities of the US presidential administration and related changes in laws, regulations and policies, instability in the US banking and private credit sectors and other disruptions to global and regional economies and markets.
A decision by a third-party payor not to cover a product could reduce physician ordering and patient demand for any of our future products. ​ Outside the US, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.
A decision by a third-party payor not to cover a product could reduce physician ordering and patient demand for a product. ​ Outside the US, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.
If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with us, we may not be able to develop or commercialize our partnered product candidates as planned.
If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with us, we may not be able to develop or commercialize our partnered products as planned.
Our ability to succeed in the future depends on our ability to demonstrate and maintain a competitive advantage with respect to our approach to the development and commercialization of medicines. Our objective is to develop and commercialize new small molecule medicines with superior efficacy, convenience, tolerability and/or safety.
Our ability to succeed in the future depends on our ability to demonstrate and maintain a competitive advantage with respect to our approach to the development and commercialization of medicines. Our objective has been to develop and commercialize small molecule medicines with superior efficacy, convenience, tolerability and/or safety.
Our ability to compete successfully will depend largely on our ability to leverage our experience in drug development and commercialization to: ● develop medicines that are superior to other products in the market; ​ ● attract and retain qualified personnel; ​ ● obtain and enforce patent and/or other proprietary protection for our medicines and technologies; ​ ● conduct effective clinical trials and obtain required regulatory approvals; ​ ● develop and effectively implement commercialization strategies, with or without collaborative partners; and ​ ● successfully collaborate with pharmaceutical companies in the development and commercialization of new medicines. ​ Pharmaceutical companies, including companies with which we collaborate, may invest heavily to quickly discover and develop or in-license novel compounds that could make our product or product candidate obsolete.
Our ability to compete successfully will depend largely on our ability to leverage our experience in drug development and commercialization to: ● deliver medicines that are superior to other products in the market; ​ ● attract and retain qualified personnel; ​ ● maintain and enforce patent and/or other proprietary protection for our medicines and technologies; ​ ● maintain required regulatory approvals; ​ ● develop and effectively implement commercialization strategies, with or without collaborative partners; and ​ ● successfully collaborate with pharmaceutical companies in the development and commercialization of new medicines. ​ Pharmaceutical companies, including companies with which we collaborate, may invest heavily to quickly discover and develop or in-license novel compounds that could make our product obsolete.
The efforts of the government, including as a result of shifting policy priorities of the US presidential administration, insurance companies, managed care organizations and other payors of health care costs, and distributors to contain or reduce costs that they or patients are charged may adversely affect us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties in regard to one or more of the following: ● the ability to set and collect a price believed to be reasonable for products; ​ ● the ability to generate revenues and achieve profitability; and ​ ● the availability of capital. ​ The pricing and reimbursement environment for products may change in the future and become more challenging due to, among other reasons, policies advanced by the presidential administration, federal agencies, new healthcare legislation passed by Congress or fiscal challenges faced by all levels of government health administration authorities.
The efforts of federal and state governments, insurance companies, managed care organizations and other payors of health care costs, and distributors to contain or reduce costs that they or patients are charged may adversely affect us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties in regard to one or more of the following: ● the ability to set and collect a price believed to be reasonable for products; ​ ● the ability to generate revenues and achieve profitability; and ​ ● the availability of capital. ​ The pricing and reimbursement environment for products may change in the future and become more challenging due to, among other reasons, policies advanced by federal agencies, new healthcare legislation passed by Congress or fiscal challenges faced by all levels of government .
As of June 30, 2024, we qualified as a “smaller reporting company,” as defined in the Exchange Act.
As of June 30, 2025, we qualified as a “smaller reporting company,” as defined in the Exchange Act.
The Patient Protection and Affordable Care Act, as amended (the “Healthcare Reform Act”), contains a number of provisions that impact our business and operations, including those governing enrollment in federal healthcare programs, reimbursement changes, benefits for patients within a coverage gap in the Medicare Part D prescription drug program (commonly known as the “donut hole”; the coverage gap was eliminated effective 2025 under the Inflation Reduction Act of 2022 (the “IRA”) and was replaced with a new manufacturer discount program), rules regarding prescription drug benefits under the health insurance exchanges, changes to the Medicare Drug Rebate program, expansion of the Public Health Service Act’s 340B drug pricing program, fraud and abuse and enforcement.
The ACA contains a number of provisions that impact our business and operations, including those governing enrollment in federal healthcare programs, reimbursement changes, benefits for patients within a coverage gap in the Medicare Part D prescription drug program (commonly known as the “donut hole”; the coverage gap was eliminated effective 2025 under the Inflation Reduction Act of 2022 (the “IRA”) and was replaced with a new manufacturer discount program), rules regarding prescription drug benefits under the health insurance exchanges, changes to the Medicare Drug Rebate program, expansion of the Public Health Service Act’s 340B drug pricing program, fraud and abuse and enforcement.
Government authorities and third-party payers, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for any commercialized products. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, our products.
Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for any commercialized product. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, a product.
Any delay in commencing or completing clinical studies for product candidates or product and any adverse results from clinical or non-clinical studies or regulatory obstacles product candidates or product may face, would harm our business and the price of our securities could fall. Product candidates must undergo extensive non-clinical and clinical studies as a condition to regulatory approval.
Any adverse results from clinical or non-clinical studies or regulatory obstacles any product candidates or product may face would harm our business and the price of our securities could fall. Product candidates must undergo extensive non-clinical and clinical studies as a condition to regulatory approval.
However, if there are any adverse developments or perceived adverse developments with respect to TRELEGY, we may not realize the value we currently anticipate from the Ongoing Economic Interest, which would harm our business and may cause the price of our securities to fall.
However, if there are any adverse developments or perceived adverse developments with respect to TRELEGY, we may not realize the value we currently anticipate from the Milestone Payments, which would harm our business and may cause the price of our securities to fall.
Our business and operations, including the use of hazardous and biological materials may result in liabilities with respect to environmental, health and safety matters. Our drug development activities involve the controlled use of potentially hazardous substances, including chemical, biological, and radioactive materials. In addition, our operations produce hazardous waste products, including hazardous waste.
Our business and operations, including prior use of hazardous and biological materials, may result in liabilities with respect to environmental, health and safety matters. Our drug development activities involved the controlled use of potentially hazardous substances, including chemical, biological, and radioactive materials. In addition, our operations produced hazardous waste products, including hazardous waste.
Similar to the federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. ​ ● The federal Physician Payment Sunshine Act, implemented as the Open Payments Program, requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the US Department of Health and Human Services, Centers for Medicare and Medicaid Services, information related to payments and other transfers of value, directly or indirectly, to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Similar to the federal healthcare Anti-Kickback Statute, 43 Table of Contents a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. ​ ● The federal Physician Payment Sunshine Act, implemented as the Open Payments Program, requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the US Department of Health and Human Services, Centers for Medicare and Medicaid Services, information related to payments and other transfers of value, directly or indirectly, to physicians , certain advanced practice professionals, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
In addition, we may have to make additional reductions in our workforce and may be prevented from continuing our development and commercialization efforts and exploiting other corporate opportunities. This would likely harm our business, prospects and financial condition, and cause the price of our securities to fall.
In addition, we may have to make additional reductions in our workforce and may be prevented from continuing our development and commercialization efforts and exploiting other corporate opportunities. This would likely harm our business, prospects and financial condition, and cause the price of our securities to fall. Our drug development efforts might not generate additional approvable drugs.
Until the process is concluded, perceived uncertainties related to our future may result in the loss of potential business opportunities and volatility in the market price of our common stock and may make it more difficult for us to attract and retain qualified personnel and business partners.
Until the process is concluded, perceived uncertainties related to our future may result in the loss of potential business opportunities and volatility in the market price of our common stock and may make it more difficult for us to attract and retain qualified personnel and business partners. We may not sustain profitability from our operations.
Further, development of our product candidates and/or regulatory approval may be delayed for other political events beyond our control.
Further, development of any product candidate and/or regulatory approval may be delayed for other political events beyond our control.
A further lawsuit was filed during 2024 in response to a subsequent company seeking to market a generic version of YUPELRI.
A further lawsuit was filed during 2024 in response to a 35 Table of Contents subsequent company seeking to market a generic version of YUPELRI.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeIn general, we seek to address cybersecurity risks through a comprehensive cross-functional approach that is focused on preserving the confidentiality, security, and availability of the information that we collect and store by identifying, preventing, and mitigating cybersecurity threats and effectively responding to cybersecurity incidents when they occur. ​ 52 Table of Contents Our cybersecurity program includes the following key elements: ​ ● Collaborative Approach We have implemented a comprehensive cross-functional approach to identifying, preventing, and mitigating cybersecurity threats and incidents, while also implementing controls and procedures that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by management in a timely manner. ​ ● Technical Safeguards We deploy technical safeguards that are designed to protect our information systems from cybersecurity threats, including firewalls, intrusion prevention and detection systems, anti-malware functionality, and access controls, which are evaluated and improved through vulnerability assessments and cybersecurity threat intelligence. ​ ● Incident Response and Recovery Planning We have established and maintain comprehensive incident response and recovery plans that address our response to a cybersecurity incident, and such plans are tested and evaluated on a regular basis. ​ ● Third-Party Risk Management We maintain a comprehensive risk-based approach to identifying and overseeing cybersecurity risks presented by third-parties, including vendors, service providers, and other external users of our systems, as well as the systems of third-parties that could adversely impact our business in the event of a cybersecurity incident affecting those third-party systems. ​ ● Education and Awareness We provide regular mandatory training for employees regarding cybersecurity threats as a means to equip our employees with effective tools and education to address cybersecurity threats and to communicate our evolving information security policies, standards, processes, and practices . ​ Governance One of the key functions of our board of directors is informed oversight of our ERM, including risks from cybersecurity threats.
Biggest changeIn general, we seek to address cybersecurity risks through a comprehensive cross-functional approach that is focused on preserving the confidentiality, security, and availability of the information that we collect and store by identifying, preventing, and mitigating cybersecurity threats and effectively responding to cybersecurity incidents when they occur. ​ Our cybersecurity program includes the following key elements: ​ ● Collaborative Approach We have implemented a comprehensive cross-functional approach to identifying, preventing, and mitigating cybersecurity threats and incidents, while also implementing controls and procedures that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by management in a timely manner. ​ ● Technical Safeguards We deploy technical safeguards that are designed to protect our information systems from cybersecurity threats, including firewalls, intrusion prevention and detection systems, anti-malware functionality, and access controls, which are evaluated and improved through vulnerability assessments and cybersecurity threat intelligence. ​ ● Incident Response and Recovery Planning We have established and maintain comprehensive incident response and recovery plans that address our response to a cybersecurity incident, and such plans are tested and evaluated on a regular basis. ​ ● Third-Party Risk Management 50 Table of Contents We maintain a comprehensive risk-based approach to identifying and overseeing cybersecurity risks presented by third-parties, including vendors, service providers, and other external users of our systems, as well as the systems of third-parties that could adversely impact our business in the event of a cybersecurity incident affecting those third-party systems. ​ ● Education and Awareness We provide regular mandatory training for employees regarding cybersecurity threats as a means to equip our employees with effective tools and education to address cybersecurity threats and to communicate our evolving information security policies, standards, processes, and practices . ​ Governance One of the key functions of our board of directors is informed oversight of our ERM, including risks from cybersecurity threats.
Working collaboratively across our Company, the IOS Team implements and maintains a program designed to protect our information systems from cybersecurity threats and to promptly respond to any cybersecurity incidents in accordance with our incident response and recovery plans. 53 Table of Contents
Working collaboratively across our Company, the IOS Team implements and maintains a program designed to protect our information systems from cybersecurity threats and to promptly respond to any cybersecurity incidents in accordance with our incident response and recovery plans.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeITEM 2. PROPERTIES Our principal physical properties in the US consist of approximately 162,000 square feet of office and laboratory space leased in two buildings in South San Francisco, California. Of this office and laboratory space, approximately 118,000 square feet was subleased to subtenants as of December 31, 2024.
Biggest changeITEM 2. PROPERTIES Our principal physical properties in the US consist of approximately 162,000 square feet of office and laboratory space leased in two buildings in South San Francisco, California. Of this office and laboratory space, approximately 130,000 square feet was subleased to subtenants as of December 31, 2025.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe complaint alleges that by filing the ANDA, the subsequent ANDA filer has infringed certain of our Orange Book listed patents. ​ As of February 28, 2025, we have settled all litigation with Accord Healthcare, Inc.; Lupin Pharmaceuticals, Inc.; Orbicular Pharmaceutical Technologies Private Limited; Qilu Pharmaceuticals Co., Ltd.; and Teva Pharmaceuticals, Inc. pursuant to individual agreements in which we granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the U.S. on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
Biggest changeThese suits have been consolidated with the action described above. ​ As of February 28, 2026, the Company has settled all litigation with Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Pharmaceuticals, Inc.; Orbicular Pharmaceutical Technologies Private Limited; Qilu Pharmaceuticals Co., Ltd.; and Teva Pharmaceuticals, Inc. pursuant to individual agreements in which the Company granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
Further, the original complaint was amended during December 2023 to include certain patents not listed in the Orange Book. ​ In May 2024, we received notice from Qilu Pharmaceuticals Co., Ltd. (“subsequent ANDA filer”), that it had filed with the FDA an ANDA for a generic version of YUPELRI.
Further, the original complaint was amended during December 2023 to include certain patents not listed in the Orange Book. ​ In May 2024, the Company received notice from Qilu Pharmaceuticals Co., Ltd. (“subsequent ANDA filer”), that it had filed with the FDA an ANDA for a generic version of YUPELRI.
ITEM 3. LEGAL PROCEEDINGS During January 2023, we received notice from Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Inc.; Mankind Pharma Ltd.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc.
ITEM 3. LEGAL PROCEEDINGS During January 2023, the Company received notice from Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Inc.; Mankind Pharma Ltd.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc.
District Court for the Middle District of North Carolina. The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of our Orange Book listed patents.
The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of the Company’s Orange Book listed patents.
MINE SAFETY DISCLOSURES Not applicable. ​ ​ ​ 55 Table of Contents PART II ​
MINE SAFETY DISCLOSURES Not applicable. ​ ​ ​ 52 Table of Contents PART II ​
The notice from the subsequent ANDA filer included a paragraph IV certification with respect to certain of our patents listed in FDA’s Orange Book for YUPELRI. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In June 2024, we filed a patent infringement suit against the subsequent ANDA filer in the U.S.
The notice from the subsequent ANDA filer included a Paragraph IV certification with respect to certain of the Company’s patents listed in FDA’s Orange Book for YUPELRI. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI.
Additional patents covering YUPELRI, granted on July 4, 2023 and January 2, 2024, were subsequently listed in FDA’s Orange Book. We filed additional patent infringement suits in the U.S. District Court for the District of New Jersey during August 2023 and January 2024. These suits have been consolidated with the above action.
The Company filed additional patent infringement suits in the US District Court for the District of New Jersey during August 2023 and January 2024. These suits have been consolidated with the above action.
(collectively, the “generic companies”), that they have each filed with the FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI. The notices from the generic companies each included a paragraph IV certification with respect to five of our patents listed in the FDA’s Orange Book for YUPELRI on the date of our receipt of the notice.
(collectively, the “generic companies”), that they have each filed with the FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI.
The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In February 2023, we filed patent infringement suits against the generic companies in federal district courts, including the United States District Court for the District of New Jersey, the U.S. District Court for the District of Delaware, and the U.S.
In February 2023, the Company filed patent infringement suits against the generic companies in federal district courts, including the US District Court for the District of New Jersey, the US District Court for the District of Delaware, and the US District Court for the Middle District of North Carolina.
As required by law, the settlements are subject to review by the U.S. Department of Justice and the Federal Trade Commission.
As required by law, the settlements are subject to review by the US Department of Justice and the Federal Trade Commission. The patent litigation against the one remaining generic company, Mankind Pharma Ltd., along with certain affiliates, remains pending.
District Court for the District of New Jersey during August 2024 against the three remaining generic companies. This suit has been consolidated with the action described above. 54 Table of Contents ​ Please also see “Item 1. Business – Patents and Proprietary Rights -- Patent Term Restoration, Regulatory Exclusivities, and Hatch-Waxman Litigation” for additional information.
Method of treatment patents expiring in 2039 remain in the litigation. ​ Please also see “Item 1. Business – Patents and Proprietary Rights -- Patent Term Restoration, Regulatory Exclusivities, and Hatch-Waxman Litigation” for additional information.
Removed
We are seeking a permanent injunction to prevent the generic companies from introducing a generic version of YUPELRI that would infringe our patents. As a result of this lawsuit, a stay of approval through May 2026 has been imposed by the FDA on the generic companies’ ANDAs pending any adverse court decision.
Added
The notices from the generic companies each included a Paragraph IV certification with respect to five of the Company’s patents listed in the FDA’s Orange Book for YUPELRI on the date of the Company’s receipt of the notice. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI.
Removed
District Court for the Eastern District of Pennsylvania.
Added
The Company is seeking a permanent injunction to prevent the generic companies from introducing a generic version of YUPELRI that would infringe the Company’s patents. Additional patents covering YUPELRI, granted on July 4, 2023 and January 2, 2024, were subsequently listed in FDA’s 51 Table of Contents Orange Book.
Removed
The patent litigation against the three remaining generic companies, along with certain affiliates, remains pending. ​ A further method of treatment patent, with an expiration date of August 2039, was granted on July 30, 2024 and was listed in the Orange Book. We filed an additional patent infringement suit in the U.S.
Added
In June 2024, the Company filed a patent infringement suit against the subsequent ANDA filer in the US District Court for the Eastern District of Pennsylvania.
Added
The complaint alleges that by filing the ANDA, the subsequent ANDA filer has infringed certain of the Company’s Orange Book listed patents. ​ Further method of treatment patents, with expiration dates of August 2039, were granted on July 30, 2024 and April 29, 2025 and were listed in the Orange Book.
Added
The Company filed additional patent infringement suits in the US District Court for the District of New Jersey during August 2024 and May 2025 against the generic companies remaining at the time.
Added
Pursuant to a stipulation filed with the court on December 18, 2025, patents related to polymorphs have been dismissed from the case and Mankind has accordingly agreed not to enter the market until after August 25, 2031 regardless of the outcome of the litigation.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

5 edited+0 added−0 removed12 unchanged
Biggest changeOur board of directors will determine the form of any future return of excess capital to shareholders. ​ Equity Compensation Plans The following table provides certain information with respect to all of our equity compensation plans as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of Securities ​ ​ ​ ​ ​ ​ ​ Remaining Available ​ ​ Number of Securities ​ ​ ​ ​ for Future Issuance ​ ​ to be Issued Upon ​ Weighted-Average ​ Under Equity ​ ​ Exercise of ​ Exercise Price of ​ Compensation Plans ​ ​ Outstanding Options, ​ Outstanding Options, ​ (excluding securities Plan Category Warrants and Rights (a) Warrants and Rights reflected in column (a)) Options 1,829,168 ​ $ 15.53 4,426,322 Restricted share units 3,955,487 ​ n/a n/a Employee share purchase plan (suspended as of December 31, 2024) n/a ​ n/a 3,447,685 Equity compensation plans approved by security holders 5,784,655 ​ $ 15.53 7,874,007 ​ ​ ​ ​ ​ ​ ​ ​ Options 67,740 ​ $ 15.52 — Equity compensation plans not approved by security holders 67,740 ​ $ 15.52 — Total 5,852,395 ​ $ 15.53 7,874,007 ​ During 2024, we had three equity compensation plans — our 2013 Equity Incentive Plan (the “2013 EIP”), as amended, our 2013 Employee Share Purchase Plan (the “2013 ESPP”), and our 2014 New Employee Equity Incentive Plan (the “2014 NEEIP”).
Biggest changeOur board of directors will determine the form of any future return of excess capital to shareholders. ​ Equity Compensation Plans The following table provides certain information with respect to all of our equity compensation plans as of December 31, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of Securities ​ ​ ​ ​ ​ ​ ​ Remaining Available ​ ​ Number of Securities ​ ​ ​ ​ for Future Issuance ​ ​ to be Issued Upon ​ Weighted-Average ​ Under Equity ​ ​ Exercise of ​ Exercise Price of ​ Compensation Plans ​ ​ Outstanding Options, ​ Outstanding Options, ​ (excluding securities Plan Category ​ ​ ​ Warrants and Rights (a) ​ ​ ​ Warrants and Rights ​ ​ ​ reflected in column (a)) Options 1,905,707 ​ $ 14.95 3,579,880 Restricted share units 3,202,492 ​ n/a n/a Employee share purchase plan (suspended as of December 31, 2024) n/a ​ n/a 3,447,685 Equity compensation plans approved by security holders 5,108,199 ​ $ 14.95 7,027,565 ​ ​ ​ ​ ​ ​ ​ ​ Options 21,740 ​ $ 23.20 — Equity compensation plans not approved by security holders 21,740 ​ $ 23.20 — Total 5,129,939 ​ $ 15.05 7,027,565 ​ In 2025, we had three equity compensation plans — our 2013 Equity Incentive Plan (the “2013 EIP”), as amended, our 2013 Employee Share Purchase Plan (the “2013 ESPP”), and our 2014 New Employee Equity Incentive Plan (the “2014 NEEIP”).
Unless an employee’s termination of service is due to disability or death, upon termination of service, any unexercised vested options will generally be forfeited at the end of three months or the expiration of the option, whichever is earlier. ​ At the our Annual General Meeting of Shareholders on May 2, 2023, shareholders approved an amendment and restatement of the 2013 EIP to effect the following material changes to the existing plan (i) extend the term of the 2013 EIP by an additional ten years to February 14, 2033; (ii) eliminate the provision that provided for automatic annual 56 Table of Contents increases in the number of shares available for issuance under the 2013 EIP; (iii) reduce the number of shares reserved for issuance by 3,808,287 shares; (iv) eliminate our ability to reprice options and share appreciation rights without first obtaining shareholder approval; and (v) remove certain provisions no longer necessary since the repeal of the exemption from the annual deduction limitation imposed by Section 162(m) of the Internal Revenue Code for performance-based compensation. ​ Under the 2013 ESPP, our officers and employees may purchase ordinary shares through payroll deductions at a price equal to 85% of the lower of the fair market value of the ordinary share at the beginning of the offering period or at the end of each applicable purchase period.
Unless an employee’s termination of service is due to disability or death, upon termination of service, any unexercised vested options will generally be forfeited at the end of three months or the expiration of the option, whichever is earlier. ​ At the our Annual General Meeting of Shareholders on May 2, 2023, shareholders approved an amendment and restatement of the 2013 EIP to effect the following material changes to the existing plan (i) extend the term of the 2013 EIP by an additional ten years to February 14, 2033; (ii) eliminate the provision that provided for automatic annual 53 Table of Contents increases in the number of shares available for issuance under the 2013 EIP; (iii) reduce the number of shares reserved for issuance by 3,808,287 shares; (iv) eliminate our ability to reprice options and share appreciation rights without first obtaining shareholder approval; and (v) remove certain provisions no longer necessary since the repeal of the exemption from the annual deduction limitation imposed by Section 162(m) of the Internal Revenue Code for performance-based compensation. ​ Under the 2013 ESPP, our officers and employees may purchase ordinary shares through payroll deductions at a price equal to 85% of the lower of the fair market value of the ordinary share at the beginning of the offering period or at the end of each applicable purchase period.
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our ordinary shares have traded on The Nasdaq Global Market under the symbol “TBPH” since June 3, 2014. As of February 26, 2025, there were 39 shareholders of record of our ordinary shares.
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our ordinary shares have traded on The Nasdaq Global Market under the symbol “TBPH” since June 3, 2014. As of February 28, 2026, there were 37 shareholders of record of our ordinary shares.
Note 1. Organization and Summary of Significant Accounting Policies,” and “Item 8. Note 11. Share-Based Compensation,” to the consolidated financial statements appearing in this Annual Report on Form 10- K. ​ ITEM 6. [RESERVED ] ​ ​ ​ 57 Table of Contents
Note 1. Organization and Summary of Significant Accounting Policies” and “Item 8. Note 11. Share-Based Compensation” to the consolidated financial statements appearing in this Annual Report on Form 10- K. ​ ITEM 6. [RESERVED ] ​ ​ ​ 54 Table of Contents
Effective as of December 31, 2024, the 2013 ESPP has been suspended.
Effective as of December 31, 2024, the 2013 ESPP was suspended.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

24 edited+21 added−14 removed13 unchanged
Biggest changeThis milestone was associated with certain royalty thresholds that were achieved by Royalty Pharma related to 2024 TRELEGY global net sales. ​ Our strategic business plan is subject to significant uncertainties and risks as a result of, among other factors, clinical program outcomes, expenses being higher than anticipated, the sales levels of YUPERLI, whether, when and on what terms we are able to enter into new collaboration arrangements, and the need to satisfy contingent liabilities, including tax, litigation matters and indemnification obligations. ​ Adequacy of cash resources to meet future needs We expect our cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next twelve months from the issuance date of our consolidated financial statements based on current operating plans and financial forecasts. ​ Cash Flows Cash flows, as compared to the prior year period, were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ (In thousands) 2024 2023 Change Net cash used in operating activities ​ $ (11,535) ​ $ (26,997) ​ $ 15,462 Net cash provided by (used in) investing activities ​ 12,284 ​ (32,697) ​ 44,981 Net cash used in financing activities ​ (2,497) ​ (198,933) ​ 196,436 ​ Net cash flows used in operating activities Net cash used in operating activities was $11.5 million in 2024, consisting of a net loss of $56.4 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items (e.g., share-based compensation expense) of $24.5 million, and a net increase in cash resulting from changes in operating assets and liabilities of $20.4 million. ​ 63 Table of Contents Net cash used in operating activities was $27.0 million in 2023, consisting of a net loss of $55.2 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items (e.g., share-based compensation expense) of $36.5 million, and a net decrease in cash resulting from changes in operating assets and liabilities of $8.3 million. ​ Net cash flows provided by (used in) investing activities Net cash provided by investing activities was $12.3 million in 2024, consisting primarily of cash inflows from the net purchase and maturities of marketable securities of $14.9 million. ​ Net cash used in investing activities was $32.7 million in 2023, consisting primarily of cash outflows from the net purchase and maturities of marketable securities of $31.7 million and cash outflows from the net purchase and sale of property and equipment of $1.0 million. ​ Net cash flows used in financing activities Net cash used in financing activities was $2.5 million in 2024, consisting primarily of $0.4 million of cash outflows related to the repurchase of ordinary shares as part of completion of our capital return program, $0.5 million of cash inflows related to the sale of shares through our employee share purchase program (“ESPP”) and $2.7 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations. ​ Net cash used in financing activities was $198.9 million in 2023, consisting primarily of $197.1 million of cash outflows related to the repurchase of ordinary shares as part of our capital return program. ​ Contractual Obligations The table below represents our contractual obligations, including agreements that, while cancelable as of December 31, 2024, we are likely to continue.
Biggest changeAs a result of these recent cash receipts, we expect to have approximately $400 million in cash, cash equivalents, and marketable securities at the end of the first quarter of 2026. ​ Our strategic business plan is subject to significant uncertainties and risks as a result of, among other factors, expenses being higher than anticipated, the sales levels of YUPELRI, and the need to satisfy contingent liabilities, including tax, litigation matters, and indemnification obligations. ​ Adequacy of cash resources to meet future needs We expect our cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next twelve months from the issuance date of our consolidated financial statements based on current operating plans and financial forecasts. ​ 60 Table of Contents Cash Flows Cash flows, as compared to the prior year period, were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ (In thousands) ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Change Net cash provided by (used in) operating activities ​ $ 238,541 ​ $ (11,535) ​ $ 250,076 Net cash (used in) provided by investing activities ​ (105,284) ​ 12,284 ​ (117,568) Net cash used in financing activities ​ (3,248) ​ (2,497) ​ (751) ​ Net cash flows provided by (used in) operating activities Net cash provided by operating activities was $238.5 million in 2025, consisting of net income of $105.9 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $12.1 million (e.g., share-based compensation expense) and a net increase in cash resulting from changes in operating assets and liabilities of $120.5 million.
W e maintain insurance policies that may limit our exposure, and therefore, we believe the fair value of these indemnification agreements is minimal. Accordingly, we have not recognized any liabilities relating to these agreements as of December 31, 2024.
W e maintain insurance policies that may limit our exposure, and therefore, we believe the fair value of these indemnification agreements is minimal. Accordingly, we have not recognized any liabilities relating to these agreements as of December 31, 2025.
Organization and Summary of Significant Accounting Policies,” in our consolidated financial statements included in this Annual Report on Form 10-K. 64 Table of Contents ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK As a “smaller reporting company,” as defined by Item 10 of Regulation S-K, we are not required to provide this information. ​
Organization and Summary of Significant Accounting Policies,” in our consolidated financial statements included in this Annual Report on Form 10-K. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK As a “smaller reporting company,” as defined by Item 10 of Regulation S-K, we are not required to provide this information. ​
Any reimbursement from Viatris attributed to the 65% cost-sharing of our R&D expenses is characterized as a reduction of R&D expense, as we do not consider performing R&D services for reimbursement to be a part of our ordinary operations. ​ In 2024 and 2023, we recognized $64.4 million and $57.2 million, respectively, in revenue from the Viatris collaboration agreement, which represented an increase of 13%.
Any reimbursement from Viatris attributed to the 65% cost-sharing of our R&D expenses is characterized as a reduction of R&D expense, as we do not consider performing R&D services for reimbursement to be a part of our ordinary operations. ​ In 2025 and 2024, we recognized $75.0 million and $64.4 million, respectively, in revenue from the Viatris collaboration agreement, which represented an increase of 16%.
The increase in interest expense was primarily due to the compounding of non-cash interest due to Royalty Pharma.
The increase in interest expense was primarily 59 Table of Contents due to the compounding of non-cash interest due to Royalty Pharma.
SM&M expenses (excluding SBC) increased by $4.5 million in 2024 compared to the prior year period and was primarily due pre-launch medical affairs and commercialization expenses associated with ampreloxetine and an increase in employee-related expenses. ​ Total SBC related to SG&A expenses was $16.3 million in 2024 compared to $17.0 million in the prior year. ​ 61 Table of Contents Impairment of Long-Lived Assets Impairment of long-lived assets , as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % Impairment of long-lived assets (non-cash) ​ ​ $ 4,513 ​ $ — ​ $ 4,513 ​ NM % NM: Not Meaningful ​ In 2024, we recognized non-cash impairment charges of $4.5 million to impair the carrying value of our operating lease assets associated with our laboratory space and related leasehold improvements located in South San Francisco, California.
SM&M expenses (excluding SBC) increased by $4.1 million compared to 2024 and was primarily due to pre-launch medical affairs and commercialization expenses associated with ampreloxetine. ​ Total SBC related to SG&A expenses was $ 14.4 million in 2025 compared to $16.3 million in 2024. ​ As a result of the Restructuring announced on March 3, 2026, we expect SG&A expenses to decrease beginning in the second quarter of 2026. ​ 58 Table of Contents Impairment of Long-Lived Assets Impairment of long-lived assets , as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ ​ ​ $ ​ % ​ ​ ​ Impairment of long-lived assets (non-cash) ​ $ — ​ $ 4,513 ​ $ (4,513) ​ NM % NM: Not Meaningful ​ In 2024, we recognized non-cash impairment charges of $4.5 million to impair the carrying value of our operating lease assets associated with our laboratory space and related leasehold improvements located in South San Francisco, California.
Excluding share-based compensation expense (“SBC”), total SG&A expenses were $52.9 million and were comprised of $27.2 million of general and administrative (“G&A”) expenses and $25.7 million of selling, marketing & medical affairs (“SM&M”) expenses.
Excluding share-based compensation expense (“SBC”), total SG&A expenses were $59.2 million and were comprised of $29.4 million of general and administrative (“G&A”) expenses and $29.8 million of selling, marketing & medical affairs (“SM&M”) expenses.
We budget total R&D expenses on an internal department level basis, and we manage and report our R&D activities across the following four cost categories: ​ 1) Employee-related costs, which include salaries, wages, and benefits; ​ 2) Share-based compensation, which includes expenses associated with our equity plans; ​ 3) External-related costs, which include clinical trial related expenses, other contract research fees, consulting fees, and contract manufacturing fees; and ​ 4) Facilities and other, which include depreciation and other allocated expenses, such as general and administrative support functions, office rent, and insurance. ​ 60 Table of Contents The following table summarizes our R&D expenses incurred, net of any reimbursements from collaboration partners, as compared to the prior year period: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % Employee-related ​ $ 12,212 ​ $ 12,699 ​ $ (487) ​ (4) % Share-based compensation ​ 5,104 ​ 8,048 ​ ​ (2,944) ​ (37) ​ External-related ​ 17,112 ​ 14,473 ​ ​ 2,639 ​ 18 ​ Facilities, depreciation, and other allocated expenses ​ 3,215 ​ 5,401 ​ ​ (2,186) ​ (40) ​ Total research & development ​ $ 37,643 ​ $ 40,621 ​ $ (2,978) ​ (7) % ​ Total R&D expenses decreased by $3.0 million in 2024, or 7%, compared to 2023.
We budget total R&D expenses on an internal department level basis, and we manage and report our R&D activities across the following four cost categories: ​ 1) Employee-related costs, which include salaries, bonuses, and benefits; ​ 2) Share-based compensation, which includes expenses associated with our equity plans; ​ 3) External-related costs, which include clinical trial related expenses, other contract research fees, consulting fees, and contract manufacturing fees; and ​ 57 Table of Contents 4) Facilities and other allocated expenses, such as general and administrative support functions, office rent, software subscriptions, and insurance. ​ The following table summarizes our R&D expenses incurred, net of any reimbursements from collaboration partners, as compared to the prior year period: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ Employee-related ​ $ 13,742 ​ $ 12,212 ​ $ 1,530 ​ 13 % Share-based compensation ​ 4,081 ​ 5,104 ​ ​ (1,023) ​ (20) ​ External-related ​ 16,228 ​ 17,112 ​ ​ (884) ​ (5) ​ Facilities and other allocated expenses ​ 3,363 ​ 3,215 ​ ​ 148 ​ 5 ​ Total research & development ​ $ 37,414 ​ $ 37,643 ​ $ (229) ​ (1) % ​ Total R&D expenses decreased slightly by $0.2 million in 2025, or 1%, compared to 2024.
We do not anticipate having any cash interest expense in the foreseeable future. ​ Interest Income and Other Income, net Interest and other income, net, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % Interest and other income, net ​ $ 4,881 ​ $ 9,116 ​ $ (4,235) ​ (46) % ​ Interest and other income, net, decreased by $4.2 million in 2024 compared to 2023.
We do not anticipate having any cash interest expense in the foreseeable future. ​ Interest Income and Other Income, net Interest and other income, net, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ Interest and other income, net ​ $ 10,173 ​ $ 4,881 ​ $ 5,292 ​ 108 % ​ Interest and other income, net, increased by $5.3 million in 2025 compared to 2024.
We periodically reassess the amount and timing of estimated royalty payments based on internal sales projections and external information from market data sources, which are considered Level 3 inputs.
The contingent liabilities related to sale of future royalties and the debt amortization are based on current estimates of the amount and timing of future royalty payments. We periodically reassess the amount and timing of probability-adjusted estimated royalty payments based on internal sales projections and external information from market data sources, which are considered Level 3 inputs.
Through the combined commercialization efforts with our partner Viatris Inc. (“Viatris”), total YUPELRI net sales increased by 8% to $238.6 million in 2024 compared to 2023.
Through the combined commercialization efforts with our partner Viatris Inc., total YUPELRI net sales increased by 12% to $266.6 million in 2025 compared to 2024. Customer demand grew 7% in 2025 compared to 2024.
(“Viatris”) records the total net sales of YUPELRI within its own financial statements, our implied 35% YUPELRI revenue, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % YUPELRI net sales (100% recorded by Viatris) ​ $ 238,626 ​ $ 220,962 ​ $ 17,664 ​ 8 % YUPELRI net sales (Theravance Biopharma implied 35%) ​ ​ 83,519 ​ ​ 77,337 ​ ​ 6,182 ​ 8 ​ ​ Our recognized revenue, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 ​ $ % Viatris collaboration agreement ​ $ 64,381 ​ $ 57,201 ​ $ 7,180 ​ 13 % Viatris royalties (Non-US) ​ ​ — ​ ​ 7 ​ ​ (7) ​ NM ​ Collaboration revenue ​ ​ — ​ ​ 216 ​ ​ (216) ​ NM ​ Total revenues ​ $ 64,381 ​ $ 57,424 ​ $ 6,957 ​ 12 % NM: Not Meaningful We are entitled to a share of US profits and losses (65% to Viatris; 35% to Theravance Biopharma) received in connection with YUPELRI net sales.
(“Viatris”) records the total net sales of YUPELRI within its own financial statements, our implied 35% YUPELRI revenue, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ YUPELRI net sales (100% recorded by Viatris) ​ $ 266,600 ​ $ 238,626 ​ $ 27,974 ​ 12 % YUPELRI net sales (Theravance Biopharma implied 35%) ​ ​ 93,310 ​ ​ 83,519 ​ ​ 9,791 ​ 12 ​ ​ Our recognized revenue, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ Viatris collaboration agreement ​ $ 74,964 ​ $ 64,381 ​ $ 10,583 ​ 16 % Licensing and milestone revenue ​ ​ 32,500 ​ ​ — ​ ​ 32,500 ​ NM ​ Total revenues ​ $ 107,464 ​ $ 64,381 ​ $ 43,083 ​ 67 % NM: Not Meaningful We are entitled to a share of US profits and losses (65% to Viatris; 35% to Theravance Biopharma) received in connection with YUPELRI net sales.
Our focus is to create medicines that make a difference ® in people’s lives. ​ In pursuit of our purpose, we leverage decades of expertise, which has led to the development of the United States (“US”) Food and Drug Administration (the “FDA”) approved YUPELRI ® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”).
Our focus is to deliver medicines that make a difference ® in people’s lives. ​ In pursuit of our purpose, we leverage decades of expertise, which has led to the development of the United States (“US”) Food and Drug Administration (the “FDA”) approved YUPELRI ® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”). ​ Recent Significant Developments ​ Ampreloxetine Phase 3 Clinical Study Top-line Results On March 3, 2026, we announced that our ampreloxetine Phase 3 clinical study (CYPRESS) in development for the treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy did not meet its primary endpoint in the Orthostatic Hypotension Symptom Assessment composite score.
As our estimates and assumptions are inherently subjective, the amount of the obligations that we will pay in future periods may differ from the amounts reflected in the table. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years (In thousands) Total Within 1 1 to 3 3 to 5 After 5 Facility operating leases ​ $ 62,890 ​ $ 11,218 ​ $ 23,096 ​ $ 23,578 ​ $ 4,998 Purchase obligations (1) ​ 30,559 ​ 20,919 ​ ​ 9,640 ​ ​ — ​ ​ — Total ​ $ 93,449 ​ $ 32,137 ​ $ 32,736 ​ $ 23,578 ​ $ 4,998 ​ (1) This amount does not represent any minimum contract termination liabilities related to our open purchase obligations. ​ Commitments and Contingencies We indemnify our officers and directors for certain events or occurrences, subject to certain limits.
As our estimates and assumptions are inherently subjective, the amount of the obligations that we will pay in future periods may differ from the amounts reflected in the table. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years (In thousands) ​ ​ ​ Total ​ ​ ​ Within 1 ​ ​ ​ 1 to 3 ​ ​ ​ 3 to 5 ​ ​ ​ After 5 Facility operating leases ​ $ 51,594 ​ $ 11,444 ​ $ 23,314 ​ $ 16,836 ​ $ — Purchase obligations (1) ​ 20,317 ​ 17,612 ​ ​ 2,705 ​ ​ — ​ ​ — Total ​ $ 71,911 ​ $ 29,056 ​ $ 26,019 ​ $ 16,836 ​ $ — ​ (1) This amount (i) does not represent any minimum contract termination liabilities related to our open purchase obligations and (ii) does not reflect expected reductions resulting from our Restructuring announced on March 3, 2026. 61 Table of Contents ​ Commitments and Contingencies We indemnify our officers and directors for certain events or occurrences, subject to certain limits.
The increase in external-related expenses was primarily driven by the continued progression of the ampreloxetine Phase 3 clinical study (CYPRESS) for MSA patients with symptomatic nOH and was partially offset by decreases in expenses related to the previously announced close-out of our research programs. ​ Under certain of our collaborative arrangements, we receive partial reimbursement of external costs, which have been reflected as a reduction of R&D expenses of $0.4 million and $5.7 million for 2024 and 2023, respectively. ​ Selling, General and Administrative Selling, general and administrative (“SG&A”) expenses consist primarily of salaries and benefits, facilities and overhead costs, and other costs related to areas such as legal, finance, information technology, sales and marketing, and medical affairs. ​ SG&A expenses, as compared to the prior year period, were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % Selling, general and administrative ​ ​ $ 69,174 ​ $ 70,095 ​ $ (921) ​ (1) % ​ Total SG&A expenses were $69.2 million in 2024.
The decreases in share-based compensation and external-related expenses were partially offset by an $1.5 million increase in employee-related expenses. ​ As a result of the Restructuring announced on March 3, 2026, we expect R&D expenses to decrease beginning in the second quarter of 2026. ​ Selling, General and Administrative Selling, general and administrative (“SG&A”) expenses consist primarily of salaries and benefits, facilities and overhead costs, and other costs related to areas such as legal, finance, information technology, sales and marketing, and medical affairs. ​ SG&A expenses, as compared to the prior year period, were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ Selling, general and administrative ​ $ 73,652 ​ $ 69,174 ​ $ 4,478 ​ 6 % ​ Total SG&A expenses were $73.7 million in 2025.
Current enrollment is in-line with expectations for completion in mid-2025, with data anticipated to be available approximately six months later. ​ Achievement of $50.0 Million TRELEGY ® Royalty Milestone Payment for 2024 In February 2025, we received a $50.0 million maximum milestone payment from Royalty Pharma Investments associated with the achievement of certain minimum royalty payments related to 2024 TRELEGY global net sales.
The sales transaction represented the first outcome of the ongoing efforts of the Committee to assess all strategic alternatives available to us to unlock shareholder value. ​ Achievement of $50.0 Million TRELEGY ® Royalty Milestone Payment for 2025 In February 2026, we received a $50.0 million maximum milestone payment from Royalty Pharma Investments associated with the achievement of certain minimum royalty payments related to 2025 TRELEGY global net sales.
Cash-related expenses and non-cash related expenses associated with the 2023 strategic actions were $1.2 million and $1.5 million in 2023, respectively. ​ Interest Expense Interest expense, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2024 2023 $ % Ampreloxetine royalty contingency (non-cash) ​ $ (2,546) ​ $ (2,350) ​ $ (196) ​ 8 % ​ Interest expense in 2024 and 2023 represented non-cash interest expense associated with $25.0 million received from Royalty Pharma Investments (“Royalty Pharma”) in July 2022 to partially fund our CYPRESS study.
Although we achieved a similar $50.0 million milestone for TRELEGY global net sales in 2024, the 2024 milestone was previously recognized as income during the sale of our equity interests in Theravance Respiratory Company, LLC (“TRC”) to Royalty Pharma in July 2022. ​ Interest Expense Interest expense, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ ​ ​ $ ​ % ​ ​ ​ Ampreloxetine royalty contingency (non-cash) ​ $ (2,461) ​ $ (2,546) ​ $ 85 ​ (3) % ​ Interest expense in 2025 and 2024 represented non-cash interest expense associated with $25.0 million received from Royalty Pharma in July 2022 to partially fund our CYPRESS study.
The decrease was primarily driven by a reduction in share-based compensation of $2.9 million and facilities & other expenses of $2.2 million.
The decrease was primarily driven by a $1.0 million reduction in share-based compensation and a $0.9 million decline in external-related expenses. The decrease in share-based compensation expense was primarily driven by fewer awards granted in 2025 compared to the prior year.
Total SG&A expenses (excluding SBC) was $53.1 million for the prior year period and were comprised of $31.9 million of G&A expenses and $21.2 million of SM&M expenses. The $4.7 million decrease in G&A expenses (excluding SBC) compared to the prior year period represented a 15% reduction and was primarily due to company-wide cost savings initiatives.
Total SG&A expenses (excluding SBC) were $52.9 million in 2024 and were comprised of $27.2 million of G&A expenses and $25.7 million of SM&M expenses. ​ The $2.3 million increase in G&A expenses (excluding SBC) compared to 2024 was primarily due to one-time legal costs.
To the extent our estimates of the amount and timing of future royalty payments are materially greater or less than previous estimates, we will prospectively adjust the amortization of the contingent liability and effective interest rate. ​ Impairment of Long-Lived Assets We regularly review our long-lived assets, including operating lease assets, to determine whether indicators of impairment may exist.
To the extent our estimates of the amount and timing of future royalty payments are materially greater or less than previous estimates, we will prospectively adjust the amortization of the contingent liability and effective interest rate. ​ 56 Table of Contents Results of Operations The following tables set forth our results of operations and management’s commentary for the 2025 period compared to the 2024 period. ​ Revenue While Viatris Inc.
There can be no assurance that the Company’s strategic review process will result in any transaction. We have not set a timetable for completion of this process, and we do not intend to disclose further developments unless and until we determine that such disclosure is appropriate or necessary. ​ See “ Item 1.
We do not intend to disclose further developments on this review process unless and until it determines that such disclosure is appropriate or necessary.
There were no impairment charges related to our long-lived assets in the prior year period. ​ Restructuring and Related Expenses Restructuring and related expenses, as compared to the prior year period, were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % Restructuring and related expenses ​ $ — ​ $ 2,386 ​ $ (2,386) ​ NM % Share-based compensation expense (non-cash) ​ ​ — ​ ​ 357 ​ ​ (357) ​ NM ​ Total restructuring and related expenses ​ $ — ​ $ 2,743 ​ $ (2,743) ​ NM % NM: Not Meaningful There were no restructuring and related expenses recognized in 2024.
There were no impairment charges related to our long-lived assets in 2025. ​ Net Gain on Realized Contingent Milestone and Royalty Assets Net gain on realized contingent milestone and royalty assets was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ Net gain on realized contingent milestone and royalty assets ​ $ 75,137 ​ $ — ​ $ 75,137 ​ NM % NM: Not Meaningful In 2025, we recognized a $75.1 million net gain on contingent milestone and royalty assets resulting from the sale of our TRELEGY royalties to GSK.
The decrease was primarily due to a reduction in interest income earned on our cash, cash equivalents, and marketable securities driven by 62 Table of Contents a significant reduction in such balances over the past year.
The increase was primarily attributable to an increase in interest income related to an increase in our cash, cash equivalents, and marketable securities balances in 2025.
Our income tax for 2024 was primarily attributed to our uncertain tax positions, including interest on historical positions which we began to accrue in the fourth quarter of 2023, and offset by the realization of tax credits. ​ Liquidity and Capital Resources As of December 31, 2024, we had approximately $88.4 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash) and no long-term debt. ​ In January 2024, we completed our capital return program by repurchasing $0.4 million of our shares.
As a result, the TRELEGY milestone in 2024 did not have an impact our income tax expense in 2024. ​ Liquidity and Capital Resources As of December 31, 2025, we had approximately $326.5 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash), and we had no outstanding long-term debt. ​ In February 2025, we received a $50.0 million milestone payment from Royalty Pharma, which was the maximum amount permitted.
Removed
Ampreloxetine, our late-stage investigational once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (“nOH”) in patients with Multiple System Atrophy (“MSA”) has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. ​ Recent Significant Developments ​ YUPELRI Net Sales Growth In 2024, YUPELRI experienced net sales growth and reached launch-to-date highs in annual net sales and brand profitability.
Added
As a result of this outcome, we have decided to wind down the ampreloxetine program. ​ Strategic Review Committee In connection with the CYPRESS study results, the Strategic Review Committee of our Board of Directors (the "Committee") is accelerating its ongoing review of alternatives to maximize value for shareholders.
Removed
Hospital volumes, which we are directly responsible for, grew 41% in 2024 compared to 2023 and continued to be a meaningful contributor to YUPELRI’s overall net sales growth for the year. ​ Continued Enrollment in Ampreloxetine Phase 3 Clinical Study We continued to make steady progress with the open-label enrollment of our ampreloxetine Phase 3 clinical study (CYPRESS) in MSA patients with symptomatic nOH, using the Orthostatic Hypotension Symptom Assessment Scale (“OHSA”) composite score as the primary endpoint.
Added
Since its formation in 2024, the Committee has been working on an ongoing basis with Lazard, its independent financial advisor, to evaluate opportunities available to the Company, including under multiple potential outcomes for the CYPRESS study.
Removed
TRELEGY’s 2024 global net sales of $3.46 billion would exceed the threshold required to achieve $50.0 million of milestones in 2025 (based on $3.41 billion of global net sales) with only 2% growth required to achieve $100.0 million of milestones in 2026 (based on $3.51 billion of global net sales). ​ 58 Table of Contents Formation of Strategic Review Committee In November 2024, the board of directors announced the formation of a Strategic Review Committee composed entirely of independent directors to assess all strategic alternatives to the Company, including those related to YUPELRI, ampreloxetine, and TRELEGY, with the objective of unlocking shareholder value.
Added
Building upon this work, the Committee will act with urgency to evaluate a broad range of value maximizing and tax efficient alternatives, including but not limited to a sale of the Company. There can be no assurance that the Committee's strategic review process will result in any transaction.
Removed
The contingent liabilities related to sale of future royalties and the debt amortization are based on current estimates of the amount and timing of future royalty payments, including the potential for any future funding milestones.
Added
As we proceed with the orderly wind down of the ampreloxetine program, we will complete additional analyses of the CYPRESS dataset and Phase 3 program, in consultation with external experts, to assess whether the data merits further regulatory discussion. This assessment is intended to provide the Committee with additional clarity regarding any remaining value in ampreloxetine for our shareholders.
Removed
If indicators of impairment exist, we perform a test of recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset over its useful life to the carrying value of the long-lived asset.
Added
There can be no assurance that any additional regulatory engagement will occur. ​ Organizational Restructure While the Committee accelerates its review, we are implementing an organizational restructuring (the “Restructuring”) to streamline costs and align our resources with our commercial focus on YUPELRI. The Restructuring will involve winding down our R&D function and significantly reducing our G&A function.
Removed
If the carrying value of the long-lived asset exceeds such estimated undiscounted cash flows, we would determine the fair value of the long-lived assets using the estimated discounted future cash flow approach. We will recognize an impairment loss for the amount in which the carrying value exceeds the estimated fair value of the long-lived asset.
Added
The Restructuring is 55 Table of Contents expected to reduce operating expenses by approximately 60%, relative to 2025 operating expenses of $111.1 million.
Removed
For year ended December 31, 2024, we recognized a non-cash impairment charge of $4.5 million related to our long-lived assets consisting of operating lease assets and leasehold improvements. ​ 59 Table of Contents Results of Operations The following tables set forth our results of operations and management’s commentary for the 2024 period compared to the 2023 period. ​ Revenue While Viatris Inc.
Added
The full run-rate cost savings of approximately $70 million are expected to be realized beginning in the third quarter of 2026. ​ YUPELRI Net Sales Growth In 2025, YUPELRI experienced net sales growth and reached launch-to-date highs in annual net sales and brand profitability.
Removed
The increase was primarily driven by (i) an increase in net sales as YUPELRI continued to increase its share of the long-acting nebulized COPD market in both the hospital and outpatient settings and (ii) lower costs incurred by Viatris.
Added
In addition, in January 2026, we received a $25.0 million milestone payment for the achievement of $250.0 million in US net sales in 2025. ​ Sale of TRELEGY ® Royalties In June 2025, we sold our remaining royalty interest in the global net sales of TRELEGY to GSK plc for $225.0 million while retaining our right to receive up to $150.0 million in remaining potential milestone payments from Royalty Pharma Investments.
Removed
YUPELRI continued to be profitable for us on a brand basis, and total YUPELRI net sales recorded by Viatris reached another all-time high for 2024 and for the most recent fourth quarter of $238.6 million and $66.7 million, respectively. ​ Research and Development Our R&D expenses consist primarily of employee-related costs, external costs, and various allocable expenses.
Added
As of December 31, 2025, we are eligible to receive up to $100.0 million in remaining milestone payments related to TRELEGY’s 2026 global net sales. TRELEGY’s 2025 global net sales of $3.91 billion would exceed the thresholds required to achieve the $100.0 million milestone in 2026 (based on $3.51 billion of global net sales). ​ See “ Item 1.
Removed
These reductions were primarily attributed to (i) our previously announced 2023 strategic actions which included the discontinuation of investment in our research activities resulting in employee departures and (ii) allocated company-wide cost savings initiatives. ​ The R&D expense decreases discussed above were partially offset by a $2.6 million increase in external-related expenses.
Added
The increase was primarily attributed to higher net sales of YUPELRI, which grew 12% and was driven by customer demand growth of 7% and improved net pricing due to favorable channel mix.
Removed
The restructuring and related expenses of $2.7 million in 2023 were driven by our 2023 strategic actions that included the discontinuation of our research activities, resulting in a 17% reduction in headcount in March 2023 .
Added
We view customer demand as the primary driver for the brand and believe improvements to net pricing will likely moderate in the future. ​ In 2025, we also recognized $32.5 million in licensing and milestone revenue comprised of (i) $25.0 million related to the achievement of a YUPELRI US net sales milestone and (ii) $7.5 million related to YUPELRI’s regulatory approval by China’s National Medical Products Administration (“NMPA”). ​ Research and Development Our R&D expenses consist primarily of employee-related costs, external costs, and various allocable expenses.
Removed
The restructuring and related expenses were primarily related to one-time severance payments, employee-related separation costs, and the loss on sale of property and equipment .
Added
The decline in external-related expenses was primarily attributed to the completion of the CYPRESS study enrollment in August 2025 which was partially offset by incremental new drug application (“NDA”) and regulatory-related activities for ampreloxetine.
Removed
Our cash, cash equivalents, and marketable securities balances were lower in 2024, compared to the prior year, due to the completion of our previously announced $325.3 million capital return program that began in September 2022 and was completed in early January 2024. ​ Provision for Income Tax Expense The provision for income tax expense, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) 2024 2023 $ % Provision for income tax expense ​ $ (11,804) ​ $ (5,924) ​ $ (5,880) ​ 99 % ​ In 2024, we recognized income tax expense of $11.8 million compared to $5.9 million in 2023.
Added
Excluding the one-time legal costs, G&A expenses (excluding SBC) were 3% lower compared to 2024 driven by cost savings initiatives.
Removed
Since the inception of the capital return program in September 2022 through its completion in January 2024, we successfully returned $325.3 million to our shareholders. ​ In February 2025, we received a $50.0 million milestone from Royalty Pharma Investments (“Royalty Pharma”), which was the maximum we could have received.
Added
This net gain reflects total cash proceeds of $225.0 million from GSK, less (i) the contingent milestone and royalty assets carrying value of $144.2 million and (ii) transaction costs of $5.7 million.
Added
We received the $225.0 million from GSK in June 2025. ​ Although we sold the future royalties related to TRELEGY, we retained the right to receive up to the remaining $100.0 million in potential Milestone Payments from Royalty Pharma Investments (“Royalty Pharma”) if certain TRELEGY global nets sales thresholds are achieved in 2026. ​ TRELEGY Milestone Income ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ TRELEGY milestone income ​ $ 50,000 ​ $ — ​ $ 50,000 ​ NM % NM: Not Meaningful In December 2025, we recognized $50.0 million in milestone income for the achievement of certain minimum royalty payments related to 2025 TRELEGY global net sales.
Added
The increase in the balances was primarily driven by (i) proceeds of $225.0 million from the sale of TRELEGY royalties in June 2025 and (ii) a $50.0 million milestone payment from Royalty Pharma in February 2025 associated with the achievement of certain minimum royalty payments related to 2024 TRELEGY global net sales. ​ Provision for Income Tax Expense The provision for income tax expense, as compared to the prior year period, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ (In thousands) ​ 2025 ​ 2024 ​ $ ​ % ​ ​ ​ Provision for income tax expense ​ $ (23,352) ​ $ (11,804) ​ $ (11,548) ​ 98 % ​ In 2025, we recognized income tax expense of $23.4 million compared to $11.8 million in 2024.
Added
Income tax for 2025 was primarily attributed to US federal tax on the sale of our royalty interest in TRELEGY in 2025 and the TRELEGY milestone that we earned in 2025, as well as our uncertain tax positions, including interest on historical positions.
Added
Although we achieved a TRELEGY milestone in 2024, the associated tax expense was already recognized in connection with the sale of our equity interests in TRC to Royalty Pharma in 2022.
Added
This milestone was associated with certain royalty thresholds that were achieved by Royalty Pharma related to 2024 TRELEGY global net sales.
Added
In June 2025, we also received $225.0 million from GSK related to the sale of our TRELEGY royalty interests. ​ In January 2026, we received a $25.0 million milestone payment from Viatris for the achievement of a sales threshold related to 2025 YUPELRI US net sales, and in February 2026, we received another $50.0 million milestone payment from Royalty Pharma associated with certain royalty thresholds that were achieved by Royalty Pharma related to 2025 TRELEGY global net sales.
Added
The net increase in cash resulting from changes in operating assets and liabilities included a $50.0 million TRELEGY milestone payment from Royalty Pharma in February 2025 and cash proceeds of $225.0 million from GSK in June 2025 resulting from the sale of our TRELEGY royalties. ​ Net cash used in operating activities was $11.5 million in 2024, consisting of a net loss of $56.4 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $24.5 million, and a net increase in cash resulting from changes in operating assets and liabilities of $20.4 million. ​ Net cash flows (used in) provided by investing activities Net cash used in investing activities was $105.3 million in 2025, consisting primarily of net cash outflows from the purchase and maturities of marketable securities. ​ Net cash provided by investing activities was $12.3 million in 2024, consisting primarily of cash inflows from the net purchase and maturities of marketable securities of $14.9 million. ​ Net cash flows used in financing activities Net cash used in financing activities was $3.2 million in 2025, consisting primarily of $4.0 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations which was partially offset by $0.8 million cash inflows related to the exercise of employee share options. ​ Net cash used in financing activities was $2.5 million in 2024, consisting primarily of $0.4 million of cash outflows related to the repurchase of ordinary shares as part of completion of our capital return program, $0.5 million of cash inflows related to the sale of shares through our employee share purchase program (“ESPP”) and $2.7 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations. ​ Contractual Obligations The table below represents our contractual obligations, including agreements that are cancelable as of December 31, 2025.

Other TBPH 10-K year-over-year comparisons