Theravance Biopharma, Inc. (TBPH) FY 2025 MD&A
This page reproduces the company's own Item 7 MD&A text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Our Management’s Discussion and Analysis (“MD&A”) is intended to facilitate an understanding of our results of operations, as well as our liquidity and capital resources. Additionally, it describes accounting policies and estimates that management has deemed as “critical accounting policies and estimates.” This MD&A should be read in conjunction with our consolidated financial statements and notes included in this Annual Report on Form 10-K. The information contained in this MD&A or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, our operating expenses, and future payments under our collaboration agreements, includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). Such statements are based upon current expectations that involve risks and uncertainties. You should review the section entitled “Risk Factors” in Item 1A of Part I above for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. See the section entitled “Special Note regarding Forward-Looking Statements” on page 3 for more information.
Management Overview
Theravance Biopharma, Inc. (“we,” “our,” “Theravance Biopharma” or the “Company”) is a biopharmaceutical company primarily focused on the development and commercialization of medicines. 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 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. 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. 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. We do not intend to disclose further developments on this review process unless and until it determines that such disclosure is appropriate or necessary. 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. 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. The Restructuring is
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expected to reduce operating expenses by approximately 60%, relative to 2025 operating expenses of $111.1 million. 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. 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. 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. 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. 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. Business” starting on page 4 for a more complete discussion of our business.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US Generally Accepted Accounting Principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities, and other related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies and estimates discussed below are essential to understanding our operating results and financial condition, as these policies and estimates relate to the more significant areas involving management’s judgments.
Future Royalty Payment Contingency
We treat contingent liabilities related to sale of future royalties as debt financings, amortized under the effective interest method over the estimated life of the related expected royalty stream. 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. 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.
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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. (“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. In accordance with the applicable accounting guidance, amounts receivable from Viatris in connection with the commercialization of YUPELRI are recorded within the consolidated statements of operations as revenue from “Viatris collaboration agreement”. 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 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. 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. 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:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| 1) | Employee-related costs, which include salaries, bonuses, and benefits; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| 2) | Share-based compensation, which includes expenses associated with our equity plans; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| 3) | External-related costs, which include clinical trial related expenses, other contract research fees, consulting fees, and contract manufacturing fees; and |
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| Column 1 | Column 2 | Column 3 |
|---|---|---|
| 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. 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. 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. 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. 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. 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. Excluding the one-time legal costs, G&A expenses (excluding SBC) were 3% lower compared to 2024 driven by cost savings initiatives. 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.
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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. The laboratory space had been on the sublease market since March 2023. 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. 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. 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. 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 increase in interest expense was primarily
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due to the compounding of non-cash interest due to Royalty Pharma. 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. 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. 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. 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. 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. 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. This milestone was associated with certain royalty thresholds that were achieved by Royalty Pharma related to 2024 TRELEGY global net sales. 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. As 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.
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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. 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. Some of the amounts are based on management’s estimates and assumptions regarding these obligations, including their duration. 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 | | $ | — |
| Column 1 | Column 2 |
|---|---|
| (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. |
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Commitments and Contingencies
We indemnify our officers and directors for certain events or occurrences, subject to certain limits. We 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. However, no assurances can be given regarding the amounts that may ultimately be covered by the insurers, and we may incur substantial liabilities because of these indemnification obligations.
Recent Accounting Pronouncements
The information required by this item is included in “Item 8. Note 1. Organization and Summary of Significant Accounting Policies,” in our consolidated financial statements included in this Annual Report on Form 10-K.