What the changes say
- Theravance Biopharma is heavily focused on the commercial performance and royalty streams of TRELEGY and YUPELRI.
- The company disclosed a strategic review process accelerated after its Phase 3 CYPRESS study failed its primary endpoint.
- Financial results improved temporarily due to a one-time gain from selling TRELEGY royalties and achieving sales milestones.
What changed since the prior 10-K
New
- NewRISKS RELATING TO THE COMPANY
The Milestone Payments are ultimately based on the amount of sales of TRELEGY by GSK. Whether we receive Milestone Payments will depend on GSK’s ability to commercialize the product, and the future payments, if any, made by GSK to Royalty Pharma
Our receipt of milestone payments depends on GSK's ability to successfully commercialize TRELEGY, maintain product supply, and comply with manufacturing and regulatory rules.
- NewRISKS RELATING TO THE COMPANY
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
Information technology disruptions, security breaches, or loss of clinical trial data could delay regulatory approvals, incur penalties, and lead to reputational harm.
- NewRISKS RELATING TO THE COMPANY
If sufficient capital is not available, we may have to further curtail operations or we could be forced to sell or license assets on terms that may not be favorable to us
We held approximately $326.5 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which we expect to fund operations for twelve months.
- NewRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
respect to which we have an economic interest or right to receive royalties to maintain or increase sales of existing products or to successfully commercialize product candidates, if approved
Medicare sequestration cuts and the Inflation Reduction Act require new manufacturer discounts and inflation rebates that could reduce reimbursement for our products.
- NewRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
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
We must accurately report pricing data for outpatient drugs to state Medicaid programs, the 340B Program, and CMS to maintain federal funding eligibility.
- NewRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
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
Failure to comply with the federal Physician Payment Sunshine Act or state anti-kickback and false claims laws can result in civil monetary penalties and investigations.
Dropped
- DroppedRISKS RELATING TO THE COMPANY
testing, enrollment, obtaining regulatory approvals, maintaining regulatory compliance, manufacturing, competition and costs and expenses that may exceed current estimates
- DroppedRISKS RELATING TO THE COMPANY
regulations and similar foreign standards and we do not have control over compliance with these regulations by our manufacturers
- DroppedRISKS RELATING TO THE COMPANY
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
- DroppedRISKS RELATING TO THE COMPANY
administration, including the potential use and effects of tariffs to address the administration’s policy goals, could materially impact the macroeconomic framework in which we operate
- DroppedRISKS RELATING TO THE COMPANY
If sufficient capital is not available, we may have to further curtail operations or we could be forced to share our rights to commercialize our product candidates with third-parties on terms that may not be favorable to us
- DroppedRISKS RELATING TO THE COMPANY
We may seek to obtain future financing through the issuance of debt or equity, which may have an adverse effect on our shareholders or may otherwise adversely affect our business
- DroppedRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercial production and sale of our products, which could adversely affect our business
- DroppedRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
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
- DroppedRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
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
Clinical studies may reveal ineffectiveness, toxicity, or side effects.
- DroppedRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
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
- DroppedRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
companies to ensure compliance. Criminal penalties, including imprisonment and criminal fines, are also possible for making or presenting a false, fictitious or fraudulent claim to the federal government
- DroppedRISKS RELATING TO OUR ORDINARY SHARES
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
Reworded
- 89% rewrittenRISKS RELATING TO THE COMPANY
Our drug development efforts might not generate additional approvable drugs
Added specific references to the inherent risks and potential failures of clinical trials, including testing, enrollment, and regulatory compliance issues.
Was: Our ongoing drug development efforts might not generate additional approvable drugs
- 83% rewrittenRISKS RELATING TO OUR ORDINARY SHARES
Our shareholders may face difficulties in protecting their interests because we are incorporated under Cayman Islands law
Expanded on specific Cayman Islands legal limitations regarding shareholder rights to inspect corporate records and accounts.
- 74% rewrittenRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
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 business
Updated citations for federal consumer protection laws, changing FTC references to the Federal Trade Commission Act.
- 66% rewrittenRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
The coverage and reimbursement status of products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for products could limit our ability to market those products and decrease our ability to generate revenue
Refined language regarding reimbursement uncertainty from applying specifically to product candidates to covering products broadly.
Was: The coverage and reimbursement status of new or current products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
- 55% rewritten
Summary of Principal Risks Associated with Theravance Biopharma’s Business
Updated principal risk summaries to include partnership dependency, heavy market competition, and the strategic review process.
- 52% rewrittenRISKS RELATING TO THE COMPANY
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
Added that the Phase 3 CYPRESS study failed its primary endpoint in March 2026, accelerating the strategic review.
- 50% rewrittenRISKS RELATING TO THE COMPANY
Our business and operations would suffer in the event of significant disruptions of information technology systems or security breaches
Minor grammatical and punctuation adjustments regarding IT systems and confidential information reliance.
- 49% rewrittenRISKS RELATING TO THE COMPANY
We may not sustain profitability from our operations
Updated financial figures to show net income of $105.9 million in 2025 driven by TRELEGY royalty sales and milestones.
Was: We may never achieve or sustain profitability from our operations
- 43% rewrittenRISKS RELATING TO THE COMPANY
Global economic, political, and social conditions may harm our ability to do business, increase our costs and negatively affect our stock price
- 42% rewrittenRISKS RELATING TO THE COMPANY
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
Was: 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
- 40% rewrittenRISKS RELATING TO THE COMPANY
If there are any adverse developments or perceived adverse developments with respect to TRELEGY, we may not receive Milestone Payments, which would harm our business and could cause the price of our securities to fall
Was: If there are any adverse developments or perceived adverse developments with respect to TRELEGY, we may not receive Milestone Payments or the revenue we expect from the Outer Years Royalty, which would harm our business and could cause the price of our securities to fall
- 39% rewrittenRISKS RELATING TO THE COMPANY
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
Was: 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
- 38% rewrittenRISKS RELATING TO THE COMPANY
If we lose key management, sales, or other personnel, or if we fail to attract and retain key employees, our ability to develop product candidates, commercialize our products and maximize shareholder value will be impaired
Was: If we lose key management, sales, clinical development or scientific personnel, or if we fail to attract and retain key employees, our ability to discover and develop our product candidates and commercialize our products will be impaired
- 34% rewrittenRISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines
- 34% rewrittenRISKS RELATING TO THE COMPANY
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
Was: 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
- 33% rewrittenRISKS RELATING TO THE COMPANY
Future tax reform, including changes in tax rates and imposition of new taxes, could impact our results of operations and financial condition
- 33% rewrittenRISKS RELATING TO OUR ORDINARY SHARES
Concentration of ownership will limit your ability to influence corporate matters
- 33% rewrittenRISKS RELATING TO THE COMPANY
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
Was: 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
- 23% rewrittenRISKS RELATING TO THE COMPANY
Taxing authorities may challenge our structure and transfer pricing arrangements
- 21% rewrittenRISKS RELATING TO THE COMPANY
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
All 47 risk factors
Headings as the filing states them, in filing order.
Other
- 01Summary of Principal Risks Associated with Theravance Biopharma’s Business55% rewritten
RISKS RELATING TO THE COMPANY
- 02If 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
- 03In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks
- 04If 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
- 05We 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 do34% rewritten
- 06Our 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 shareholders52% rewritten
- 07We may not sustain profitability from our operations49% rewritten
- 08There 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 available42% rewritten
- 09We 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
- 10We 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
- 11If 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 affected39% rewritten
- 12If there are any adverse developments or perceived adverse developments with respect to TRELEGY, we may not receive Milestone Payments, which would harm our business and could cause the price of our securities to fall40% rewritten
- 13The Milestone Payments are ultimately based on the amount of sales of TRELEGY by GSK. Whether we receive Milestone Payments will depend on GSK’s ability to commercialize the product, and the future payments, if any, made by GSK to Royalty PharmaNew
- 14If we lose key management, sales, or other personnel, or if we fail to attract and retain key employees, our ability to develop product candidates, commercialize our products and maximize shareholder value will be impaired38% rewritten
- 15Our business and operations would suffer in the event of significant disruptions of information technology systems or security breaches50% rewritten
- 16operations or retail pharmacies could materially and adversely impair our ability to deliver YUPELRI to healthcare providers and patients and therefore result in reduced revenueNew
- 17Global economic, political, and social conditions may harm our ability to do business, increase our costs and negatively affect our stock price43% rewritten
- 18Our 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 operations21% rewritten
- 19We may be treated as a US corporation for US federal income tax purposes
- 20Future tax reform, including changes in tax rates and imposition of new taxes, could impact our results of operations and financial condition33% rewritten
- 21Taxing authorities may challenge our structure and transfer pricing arrangements23% rewritten
- 22We were a passive foreign investment company, or “PFIC,” for 2014, but we were not a PFIC from 2015 through 2025, and we do not expect to be a PFIC for the foreseeable future
- 23If we are unable to maintain effective internal controls, our business, financial position, and results of operations could be adversely affected
- 24If sufficient capital is not available, we may have to further curtail operations or we could be forced to sell or license assets on terms that may not be favorable to usNew
- 25Our drug development efforts might not generate additional approvable drugs89% rewritten
- 26Any 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 fall33% rewritten
- 27If any product candidate is not approved by regulatory authorities, including the FDA, we will be unable to commercialize it
- 28We depend on third parties in the conduct of our non-clinical and clinical studies for product candidates
RISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
- 29If 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
- 30Litigation 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
- 31Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines34% rewritten
- 32If 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 business74% rewritten
- 33respect to which we have an economic interest or right to receive royalties to maintain or increase sales of existing products or to successfully commercialize product candidates, if approvedNew
- 34reported 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 BNew
- 35The coverage and reimbursement status of products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for products could limit our ability to market those products and decrease our ability to generate revenue66% rewritten
- 36a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violationNew
- 37Our business and operations, including prior use of hazardous and biological materials, may result in liabilities with respect to environmental, health and safety matters
RISKS RELATING TO OUR ORDINARY SHARES
- 38The market price for our shares has and may continue to fluctuate widely and may result in substantial losses for purchasers of our ordinary shares
- 39Activist shareholders could negatively impact our business and cause disruptions
- 40Concentration of ownership will limit your ability to influence corporate matters33% rewritten
- 41Certain 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
- 42In addition, in May 2018, our shareholders approved a resolution authorizing our board of directors to adopt a shareholder rights plan in the future intended to deter any person from acquiring more than 19.9% of our outstanding ordinary shares without the approval of our board of directors
- 43Our shareholders may face difficulties in protecting their interests because we are incorporated under Cayman Islands law83% rewritten
- 44There is uncertainty as to shareholders’ ability to enforce certain foreign civil liabilities in the Cayman Islands
- 45If securities or industry analysts cease coverage of us or do not publish research, or publish inaccurate or unfavorable research, about our business, the price of our ordinary shares and trading volume could decline
- 46Capital appreciation, if any, of our ordinary shares may be your sole source of gain for the foreseeable future
- 47We are a smaller reporting company, and any decision on our part to comply only with reduced reporting and disclosure requirements applicable to such companies could make our ordinary shares less attractive to investors
Other Theravance Biopharma 10-Ks
- FY2024 10-K risk factors53 risks
Theravance Biopharma faces concentrated revenue risk tied to YUPELRI sales and partnership performance with Viatris and Royalty Pharma. The company relies on continuous clinical development, single-source manufacturing, and navigating extensive regulatory and healthcare pricing frameworks. A Strategic Review Committee was formed in November 2024 to unlock shareholder value.
Filed Mar 07, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.