Theravance Biopharma, Inc.
For the period ended Mar 31, 2026. Filed May 7, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 7, 2026
TBPH$17.030.0%Stored close · as of Sep 23, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001104659-25-110382
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001104659-26-056760
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 97 previous paragraphs and 105 current paragraphs.
34 unchanged; 40 reworded; 26 added; 18 removed; 5 previous and 5 current paragraphs rearranged.
Tables are not compared: 19 previous and 18 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (26)
Current report
Significant Developments - First Quarter of 2026
Current report
Ampreloxetine Phase 3 Clinical Study Top-line Results
Current report
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 are in the process of winding down the ampreloxetine program.
Current report
Strategic Review Committee
Current report
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 is acting 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 inform any regulatory engagement in the context of the Committee’s ongoing strategic review. 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 as to the outcome of any regulatory engagement or its impact on the Committee’s evaluation of alternatives.
Current report
Organizational Restructuring
Current report
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 involves winding down our R&D function and significantly reducing our G&A function. The Restructuring is 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.
Current report
Ampreloxetine
Current report
On March 3, 2026, we announced that the CYPRESS study did not meet its primary endpoint in the OHSA composite score. The primary endpoint, the change in OHSA composite score at Week 8 during the double-blind randomized withdrawal period, was not statistically significant. Similar trends were observed in the secondary endpoints at week 8. Changes in blood pressure, heart rate and norepinephrine levels confirmed a consistent pressor effect and reaffirmed ampreloxetine's biological activity. Ampreloxetine was generally well tolerated, with safety findings consistent with prior studies, including no signal of worsening of supine hypertension.
Current report
As a result of the CYPRESS study results, we have decided to wind down the ampreloxetine program. 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 inform any regulatory engagement in the context of the Committee’s ongoing strategic review. This assessment is intended to provide us with additional clarity regarding any remaining value in ampreloxetine for our shareholders. There can be no assurance as to the outcome of any regulatory engagement.
Current report
Economic Interests
Current report
TRELEGY®
Current report
Future Royalty Payment Contingency
Current report
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.
Current report
In periods in which updated estimates of the amount or timing of future royalty payments results in the undiscounted cash flows payable to be less than the current net carrying amount of the debt, we cease the recognition of interest expense on the royalty liability. Consistent with the accounting guidance applicable to debt financings, we do not reduce the net carrying amount of the royalty liability below its initial carrying amount, which represents the original proceeds received.
Current report
As a result of the Restructuring, we expect quarterly R&D expenses to continue to decrease year-over-year into the second half of 2026.
Current report
As a result of the Restructuring, we expect quarterly SG&A expenses to continue to decrease year-over-year into the second half of 2026.
Current report
Restructuring Expenses
Current report
Restructuring expenses, as compared to the prior year comparable period, were as follows:
Current report
NM: Not Meaningful
Current report
Total Restructuring expenses were $3.6 million for the three months ended March 31, 2026 and were primarily comprised of one-time severance costs and other employee-related separation costs.
Current report
We estimate that we will incur total cash expenses of approximately $5.0 million to $7.0 million related to one-time sever ance costs which are expected to be incurred and paid through the third quarter of 2026. We estimate that we will also incur total non-cash Restructuring charges related to the modification of equity-based awards of approximately $3.5 million to $4.5 million through the third quarter of 2026.
Current report
We may also incur additional costs not currently contemplated due to events that may occur because of, or that are associated with, the Restructuring.
Current report
On March 3, 2026, we announced that our ampreloxetine Phase 3 clinical study top-line results did not meet its primary endpoint. As a result of this outcome, we decided to wind down the ampreloxetine program, and in accordance with accounting guidance underASC 470, Debt, we ceased recognizing interest expense on the contingent liability balance beginning in the first quarter of 2026. As a result, there was no interest expense recognized for the three months ended March 31, 2026.
Current report
For the three months ended March 31, 2026, we recognized an income tax benefit of $1.5 million primarily due to the Company’s pre-tax loss for the year-to-date period. For the prior year comparable period, the $0.6 million income tax benefit was primarily related to forecasted pre-tax losses.
Current report
In January 2026, we received a $25.0 million milestone payment from Viatris for the achievement of certain minimum US net sales thresholds in 2025, and in February 2026, we received a $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.
Removed paragraphs (18)
Previous report
To achieve the $25.0 million sales milestone for the year ending December 31, 2025, approximately $54.0 million in US net sales is required in the fourth quarter of 2025. By comparison, YUPELRI US net sales totaled $66.7 million in the fourth quarter of 2024.
Previous report
Ampreloxetine (TD-9855)
Previous report
Economic Interests and Other Assets
Previous report
Mid- and Long-Term Economic Interest in TRELEGY®
Previous report
For the nine months ended September 30, 2025, we also recognized $7.5 million in licensing revenue related to YUPELRI’s regulatory approval by China’s National Medical Products Administration (“NMPA”) in June 2025.
Previous report
R&D expenses increased by $1.9 million for nine months ended September 30, 2025 compared to the prior year period. The $1.9 million increase was primarily attributed to a $1.6 million increase in external-related expenses which was primarily driven by the continued progression of the CYPRESS study and incremental NDA and regulatory-related activities associated with ampreloxetine.
Previous report
The $2.7 million increase in year-to-date G&A expenses (excluding SBC) compared to the prior year period was primarily due to one-time legal costs. Excluding the one-time legal costs, G&A expenses (excluding SBC) were 3% lower compared to the prior year period driven by cost savings initiatives. SM&M expenses (excluding SBC) increased by $2.8 million year-to-date 2025 compared to the prior year period and was primarily due to pre-launch medical affairs and commercialization expenses associated with ampreloxetine and an increase in employee-related expenses.
Previous report
Impairment of Long-Lived Assets
Previous report
Impairment of long-lived assets, as compared to the prior year comparable periods, was as follows:
Previous report
For the three and nine months ended September 30, 2024, we recognized non-cash impairment charges of $1.6 million and $4.5 million, respectively, related to our vacant laboratory spaces and related leasehold improvements in South San Francisco, California, which were on the market for sublease. There was no charge for impairment of long-lived assets recognized for the three and nine months ended September 30, 2025.
Previous report
Net Gain on Realized Contingent Milestone and Royalty Assets
Previous report
Net gain on realized contingent milestone and royalty assets was as follows:
Previous report
For the nine months ended September 30, 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.
Previous report
Although we sold the future royalties related to TRELEGY, we retained the right to receive the potential remaining $150.0 million in Milestone Payments from Royalty Pharma if certain TRELEGY global nets sales thresholds are achieved in 2025 and 2026.
Previous report
Interest expense was $0.6 million and $1.9 million for the three and nine months ended September 30, 2025, respectively, and represented non-cash interest expense associated with the $25.0 million received from Royalty Pharma in July 2022 to partially fund the CYPRESS study. We do not anticipate having any cash interest expense in the foreseeable future.
Previous report
For the nine months ended September 30, 2025, we recognized an income tax expense of $11.3 million which was primarily attributed to the net gain on realized contingent milestone and royalty assets arising from the sale of our TRELEGY royalties in May 2025. For the prior year comparable period, the $5.2 million income tax expense was primarily related to uncertain tax positions, as well as interest expense on our uncertain tax position liability which we began to accrue in the fourth quarter of 2023. For the three months ended September 30, 2025, we recognized an income tax benefit of $6.5 million driven by a favorable true-up related to taxes from the May 2025 TRELEGY royalty sale.
Previous report
In February 2025, we received a $50.0 million milestone from Royalty Pharma, which was the maximum that we could have received related to 2024 TRELEGY global net sales, and in June 2025, we received $225.0 million from GSK related to the Royalty Sales Agreement transaction.
Previous report
Net cash used in financing activities was $2.1 million for the nine months ended September 30, 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, $0.4 million of cash inflows related to the sale of shares through our employee share purchase program (“ESPP”) and $2.1 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.
Reworded paragraphs (40)
Previous wording
You should read the following discussion in conjunction with our condensed consolidated financial statements (unaudited) and related notes included elsewhere in this report. This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements involve risks, uncertainties, and assumptions. All statements in this report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, designs, expectations, and objectives are forward-looking statements. The words “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “designed,” “developed,” “drive,” “estimate,” “expect,” “forecast,” “goal,” “indicate,” “intend,” “may,” “mission,” “opportunities,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “represent,” “seek,” “suggest,” “should,” “target,” “will,” “would,” and similar expressions (including the negatives thereof) are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward-looking statements and the assumptions underlying our forward-looking statements may prove incorrect. Therefore, you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and objectives disclosed in the forward-looking statements that we make. Factors that we believe could cause actual results or events to differ materially from our forward-looking statements include, but are not limited to, those discussed in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and
Current wording
“estimate,” “expect,” “forecast,” “goal,” “indicate,” “intend,” “may,” “mission,” “opportunities,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “represent,” “seek,” “suggest,” “should,” “target,” “will,” “would,” and similar expressions (including the negatives thereof) are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward-looking statements and the assumptions underlying our forward-looking statements may prove incorrect. Therefore, you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and objectives disclosed in the forward-looking statements that we make. Factors that we believe could cause actual results or events to differ materially from our forward-looking statements include, but are not limited to, those discussed in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report and in our Annual Report on Form 10-K for the year ended December 31, 2025. Our forward-looking statements in this report are based on current expectations, and we do not assume any obligation to update any forward-looking statements for any reason, even if new information becomes available in the future. When used in this report, all references to “Theravance Biopharma”, the “Company”, or “we” and other similar pronouns refer to Theravance Biopharma, Inc. collectively with its subsidiaries.
Previous wording
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”). 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.
Current wording
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”).
Previous wording
Under the terms of the Viatris Agreement, as amended, as of September 30, 2025, we were eligible to receive from Viatris potential global sales and regulatory 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. 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:
Current wording
Under the terms of the Viatris Agreement, as amended, we received a $25.0 million milestone payment for the achievement of $250.0 million in net sales in 2025. As of March 31, 2026, we were eligible to receive from Viatris potential global sales and regulatory milestone payments (excluding China and adjacent territories) of up to $180.0 million in the aggregate with $135.0 million associated with YUPELRI monotherapy and $45.0 million associated with future potential combination products. Of the $135.0 million associated with monotherapy, $10.0 million relates to regulatory actions in the European Union (“EU”) and $125.0 million relates to sales milestones based on achieving certain levels of annual aggregate US net sales as follows:
Previous wording
In 2019, we granted Viatris exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territories, which include the Hong Kong SAR, the Macau SAR, and Taiwan (collectively, the “China Region”). In November 2023, we learned that Viatris’ Phase 3 study of YUPELRI in China was positive, and the data were consistent with previous findings of YUPELRI’s strong efficacy. In June 2024, Viatris completed a registrational filing for YUPELRI in China, and on June 26, 2025, we announced that Viatris had secured regulatory approval from China’s National Medical Products Administration (“NMPA”) for YUPELRI. The regulatory approval triggered a one-time $7.5 million milestone payment from Viatris which we received on July 7, 2025. 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.
Current wording
registrational filing for YUPELRI in China, andin June 2025, we announced that Viatris had secured regulatory approval from China’s National Medical Products Administration (“NMPA”) for YUPELRI. The regulatory approval triggered a one-time $7.5 million milestone payment from Viatris which we received in July 2025. 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.
Previous wording
Ampreloxetine is an investigational, once-daily Norepinephrine Reuptake Inhibitor (“NRI”) that we are developing for the treatment of Multiple System Atrophy (“MSA”) patients with symptomatic neurogenic orthostatic hypotension (“nOH”). nOH is caused by primary autonomic failure conditions and the majority of patients with MSA experience symptoms of nOH. Ampreloxetine has high affinity for binding to the norepinephrine (“NE”) transporter. By blocking the action of the NE transporter, ampreloxetine causes an increase in extracellular concentrations of norepinephrine. Ampreloxetine is wholly owned by Theravance Biopharma.
Current wording
Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor (“NRI”) intended for the treatment of multiple system atrophy (“MSA”) patients with symptomatic neurogenic orthostatic hypotension (“nOH”). nOH is caused by primary autonomic failure conditions and the majority of patients with MSA experience symptoms of nOH. Ampreloxetine has high affinity for binding to the norepinephrine (“NE”) transporter. By blocking the action of the NE transporter, ampreloxetine causes an increase in extracellular concentrations of norepinephrine. Ampreloxetine is wholly owned by Theravance Biopharma.
Previous wording
In June 2022, we held a Type C meeting with the FDA. From this meeting, we aligned on a path to a New Drug Application (“NDA”) filing with one additional Phase 3 clinical study (CYPRESS) in MSA patients with symptomatic nOH, using the OHSA composite score as the primary endpoint. This Phase 3 study was initiated in the first quarter of 2023, and the last patient was enrolled in the open label period of the study in late-August 2025. We expect top-line data to be available in the first quarter of 2026. In May 2023, we announced that the FDA granted Orphan Drug Designation status to ampreloxetine for the treatment of symptomatic nOH in patients with MSA.
Current wording
In June 2022, we held a Type C meeting with the FDA. From this meeting, we aligned on a path to a New Drug Application (“NDA”) filing with one additional Phase 3 clinical study (CYPRESS) in MSA patients with symptomatic nOH, using the OHSA composite score as the primary endpoint. This Phase 3 study was initiated in the first quarter of 2023, and the last patient was enrolled in the open label period of the study in late-August 2025. In May 2023, we announced that the FDA granted Orphan Drug Designation status to ampreloxetine for the treatment of symptomatic nOH in patients with MSA.
Previous wording
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. 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. 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.
Current wording
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. 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. 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.
Previous wording
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)”). In February 2025,
Current wording
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)”). 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. Furthermore, in February 2026, we were informed by Royalty Pharma that the 2025
Previous wording
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.
Current wording
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.
Previous wording
With respect to 2026 TRELEGY global net sales, we are eligible to receive either (i) $50.0 million if Royalty Pharma receives $270.0 million or more in royalty payments from GSK, 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, which we would expect to occur in the event TRELEGY global net sales exceed approximately $3.51 billion. To achieve the higher $100.0 million milestone in 2026, TRELEGY global net sales would require less than a 2% increase over its 2024 global net sales.
Current wording
As of March 31, 2026, a total of up to $100.0 million in potential Milestone Payments remain available to us. 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.
Previous wording
Total 2024 TRELEGY global net sales represented a 26% increase compared to 2023, and TRELEGY is currently expected to generate global peak sales of approximately $4.0 billion in 2026 according to consensus estimates. TRELEGY global net sales for the three and nine months ended September 30, 2025 were $979 million and $2.92 billion, respectively, which represented 24% and 13% year-over-year growth, respectively.
Current wording
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. Total 2025 TRELEGY global net sales represented a 13% increase compared to 2024, and TRELEGY is currently expected to generate global sales of $4.2 billion in 2026 according to consensus estimates. TRELEGY global net sales for the three months ended March 31, 2026 were $873 million which represented a 2% year-over-year growth.
Previous wording
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. 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. The TRELEGY royalties that were payable to us by Royalty Pharma are country specific. Total royalty rates were upward tiering from 6.5% to 10% and based on total annual global net sales as follows:
Current wording
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. 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. The TRELEGY royalties that were payable to us by Royalty Pharma are country specific. Total royalty rates were upward tiering from 6.5% to 10% and based on total annual global net sales as follows:
Previous wording
On June 2, 2025, we announced that we had entered into a definitive agreement to sell our remaining royalty interest in the global net sales of TRELEGY (as described above) to GSK for $225.0 million (the “Royalty Sales Agreement”) while retaining our right to receive the remaining potential $150.0 million in Milestone Payments from Royalty Pharma. We received the $225.0 million cash payment from GSK on June 27, 2025.
Current wording
In June 2025, we announced that we had entered into a definitive agreement to sell our remaining royalty interest in the global net sales of TRELEGY (as described above) to GSK for $225.0 million (the “TRELEGY Royalty Sales Agreement”) while retaining our right to receive the remaining potential Milestone Payments related to 2025 and 2026 TRELEGY global net sales from Royalty Pharma. We received the $225.0 million cash payment from GSK in June 2025 and, as noted above, we received a $50.0 million Milestone Payment from Royalty Pharma in February 2026.
Previous wording
The Royalty Sales Agreement transaction represented the first outcome of the ongoing efforts of the Strategic Review Committee (the "Committee") of the board of directors. We announced in November 2024 that the board of directors had formed the Committee, composed entirely of independent directors, to assess all strategic alternatives available to us to unlock shareholder value. We remain focused on disciplined capital allocation and returning
Current wording
The TRELEGY Royalty Sales Agreement transaction represented the first outcome of the ongoing efforts of the Committee to assess all strategic alternatives available to us to unlock shareholder value. We remain focused on disciplined capital allocation and returning excess cash to shareholders, and the Committee is continuing to evaluate a range of alternatives to further enhance shareholder value, though there can be no assurance that additional transactions will occur.
Previous wording
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. TRELEGY is approved for use in the US, European Union (“EU”), and other countries for the long-term, once-daily, maintenance treatment of patients with COPD. Additionally, the FDA approved an sNDA for the use of TRELEGY to treat asthma in adults in September 2020 making TRELEGY the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US. GSK continues to pursue approval for the asthma indication in additional markets.
Current wording
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. TRELEGY is approved for use in the US, EU, and other countries for the long-term, once-daily, maintenance treatment of patients with COPD. Additionally, the FDA approved an sNDA for the use of TRELEGY to treat asthma in adults in September 2020 making TRELEGY the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US. GSK continues to pursue approval for the asthma indication in additional markets.
Previous wording
We believe that the accounting policies and estimates discussed in our Annual Report on Form 10-K for the year ended December 31, 2024 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. There have been no material changes to the critical accounting policies and estimates discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
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.
Previous wording
While Viatris records the total net sales of YUPELRI within its own financial statements, our implied 35% YUPELRI revenue, as compared to the prior year comparable periods, was as follows:
Current wording
While Viatris records the total net sales of YUPELRI within its own financial statements, our implied 35% YUPELRI revenue, as compared to the prior year comparable period, was as follows:
Previous wording
Our recognized revenue, as compared to the prior year comparable periods, was as follows:
Current wording
Our recognized revenue, as compared to the prior year comparable period, was as follows:
Previous wording
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 condensed 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.
Current wording
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 condensed consolidated statements of operations as revenue from “Viatris collaboration agreement”. Any reimbursement from Viatris attributed
Previous wording
For the three and nine months ended September 30, 2025, we recognized revenue of $20.0 million and $54.1 million, respectively, under the Viatris collaboration agreement. These amounts represented increases of 19%, compared to the corresponding periods in the prior year. The increases were primarily attributed to higher net sales of YUPELRI, which grew 15% year-over-year in the third quarter and were driven by customer demand growth of 6% 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.
Current wording
For the three months ended March 31, 2026, we recognized revenue of $17.7 million under the Viatris collaboration agreement. This amount represented an increase of 15%, compared to the corresponding period in the prior year. The increase was primarily attributed to higher net sales of YUPELRI, which grew 7% year-over-year in the first quarter and was driven by customer demand growth of 4% and improved net pricing.
Previous wording
The following table summarizes our R&D expenses incurred, net of any reimbursements from collaboration partners, as compared to the prior year comparable periods:
Current wording
The following table summarizes our R&D expenses incurred, net of any reimbursements from collaboration partners, as compared to the prior year comparable period:
Previous wording
R&D expenses decreased by $1.2 million for the three months ended September 30, 2025 compared to the prior year period. The $1.2 million decrease was primarily attributed to a $1.0 million decrease in external-related expenses which was primarily driven by the completion of the CYPRESS study enrollment in August 2025 and partially offset by incremental NDA and regulatory-related activities associated with ampreloxetine
Current wording
R&D expenses decreased by $5.6 million for the three months ended March 31, 2026 compared to the prior year period. The $5.6 million decrease was primarily attributed to decreases in employee-related and external-related expenses and were related to cost savings associated with the Restructuring announced in March 2026 and the subsequent winding-down of the CYPRESS clinical trial.
Previous wording
SG&A expenses, as compared to the prior year comparable periods, were as follows:
Current wording
SG&A expenses, as compared to the prior year comparable period, were as follows:
Previous wording
Total SG&A expenses were $18.3 million for the three months ended September 30, 2025. Excluding share-based compensation expense (“SBC”), total SG&A expenses were $14.8 million for the third quarter of 2025 and were comprised of $7.5 million of general and administrative (“G&A”) expenses and $7.3 million of selling, marketing & medical affairs (“SM&M”) expenses. Total SG&A expenses (excluding SBC) were $13.0 million for the third quarter of 2024 and were comprised of $6.6 million of G&A expenses and $6.4 million of SM&M expenses.
Current wording
Total SG&A expenses were $17.7 million for the three months ended March 31, 2026. Excluding share-based compensation expense (“SBC”), total SG&A expenses were $14.9 million for the first quarter of 2026 and were comprised of $8.0 million of general and administrative (“G&A”) expenses and $6.9 million of selling, marketing & medical affairs (“SM&M”) expenses. Total SG&A expenses (excluding SBC) were $14.6 million for the first quarter of 2025 and were comprised of $7.3 million of G&A expenses and $7.3 million of SM&M expenses.
Previous wording
Third quarter of 2025 G&A expenses (excluding SBC) increased by $0.9 million compared to the prior year period and were primarily due to one-time legal costs. Excluding the one-time legal costs, G&A expenses (excluding SBC) were relatively flat compared to the prior year period. SM&M expenses (excluding SBC) increased by $0.9 million in the third quarter of 2025 compared to the prior year period and were primarily due to pre-launch medical affairs and commercialization expenses associated with ampreloxetine.
Current wording
First quarter of 2026 G&A expenses (excluding SBC) increased by $0.7 million compared to the prior year period and were primarily due to one-time legal costs. Excluding the one-time legal costs, G&A expenses (excluding SBC) decreased by $1.2 million, or 17%, and was related to cost savings associated with the Restructuring announced in March 2026. SM&M expenses (excluding SBC) decreased by $0.4 million, or 5%, in the first quarter of 2026 compared to the prior year period and was primarily due to lower employee-related costs.
Previous wording
Total SBC related to SG&A expenses were $3.5 million and $10.9 million for the three and nine months ended September 30, 2025, respectively, and $3.9 million and $11.8 million for the three and nine months ended September 30, 2024, respectively.
Current wording
Total SBC related to SG&A expenses was$2.8 million for the three months ended March 31, 2026 and$3.8 million for the three months ended March 31, 2025.
Previous wording
Interest expense, as compared to the prior year comparable periods, was as follows:
Current wording
Interest expense, as compared to the prior year comparable period, was as follows:
Previous wording
Interest and other income, net, as compared to the prior year comparable periods, was as follows:
Current wording
Interest and other income, net, as compared to the prior year comparable period, was as follows:
Previous wording
Interest and other income, net, increased by $2.7 million and $2.6 million for the three and nine months ended September 30, 2025, respectively, compared to the prior year periods. The increases were primarily attributable to an increase in interest income related to an increase in our cash, cash equivalents, and marketable securities balances.
Current wording
Interest and other income, net, increased by $2.1 million for the three months ended March 31, 2026, compared to the prior year period. The increase was primarily attributable to an increase in interest income related to an increase in our cash, cash equivalents, and marketable securities balances. The increase in the balances was primarily driven by (i) proceeds of $225.0 million from the sale of TRELEGY royalties in June 2025; (ii) a $25.0 million milestone payment from Viatris in January 2026 associated with the achievement of certain minimum US net sales thresholds in 2025; and (iii) a $50.0 million milestone payment from Royalty Pharma in February 2026 associated with the achievement of certain minimum royalty payments related to 2025 TRELEGY global net sales.
Previous wording
Provision for Income Tax Benefit (Expense)
Current wording
Provision for Income Tax Benefit
Previous wording
The provision for income tax benefit (expense), as compared to the prior year comparable periods, was as follows:
Current wording
The provision for income tax benefit, as compared to the prior year comparable period, was as follows:
Previous wording
As of September 30, 2025, we had approximately $332.7 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash) and no long-term debt.
Current wording
As of March 31, 2026, we had approximately $394.7 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash) and no long-term debt.
Previous wording
Our strategic business plan is subject to significant uncertainties and risks as a result of, among other factors, the clinical trial outcome for ampreloxetine, expenses being higher than anticipated, the sales levels of YUPELRI, 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.
Current wording
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.
Previous wording
Cash flows, as compared to the prior year comparable periods, were as follows:
Current wording
Cash flows, as compared to the prior year comparable period, were as follows:
Previous wording
Net cash flows provided by (used in) operating activities
Current wording
Net cash flows provided by operating activities
Previous wording
Net cash used in operating activities was $10.6 million for the nine months ended September 30, 2024, consisting of a net loss of $40.9 million, a net increase in cash resulting from adjustments to net loss for non-cash and other reconciling items of $23.8 million and a net increase in cash resulting from cash movements related to changes in operating assets and liabilities of $6.5 million.
Current wording
Net cash provided by operating activities was $73.3 million for the three months ended March 31, 2026, consisting of a net loss of $4.9 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $2.4 million and a net increase in cash resulting from changes in operating assets and liabilities of $75.8 million. The net increase in cash resulting from changes in operating assets and liabilities included $75.0 million in milestone payments from Viatris and Royalty Pharma as noted above.
Previous wording
Net cash provided by operating activities was $244.6 million for the nine months ended September 30, 2025, consisting of net income of $44.9 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $6.9 million and a net increase in cash resulting from changes in operating assets and liabilities of $192.9 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.
Current wording
Net cash provided by operating activities was $43.0 million for the three months ended March 31, 2025, consisting of a net loss of $13.6 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $4.7 million and a net increase in cash resulting from changes in operating assets and liabilities of $51.9 million. The net increase in cash resulting from changes in operating assets and liabilities included the $50.0 million milestone payment from Royalty Pharma.
Previous wording
Net cash used in investing activities was $105.9 million for the nine months ended September 30, 2025, consisting primarily of net cash outflows from the purchase and maturities of marketable securities.
Current wording
Net cash provided by investing activities was $52.6 million for the three months ended March 31, 2026, consisting of cash inflows from the net purchase and maturities of marketable securities.
Previous wording
Net cash used in investing activities was $3.4 million for the nine months ended September 30, 2024, consisting of cash outflows from the net purchase and maturities of marketable securities of $3.3 million and cash outflows from the purchase of property and equipment of $0.1 million.
Current wording
Net cash provided by investing activities was $30.6 million for the three months ended March 31, 2025, consisting of cash inflows from the net purchase and maturities of marketable securities.
Previous wording
Net cash used in financing activities was $1.8 million for the nine months ended September 30, 2025, consisting primarily of $2.1 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations which was partially offset by $0.3 million cash inflows related to the exercise of employee share options.
Current wording
Net cash used in financing activities was $5.6 million for the three months ended March 31, 2026, consisting primarily of $5.8 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
You should read the following discussion in conjunction with our condensed consolidated financial statements (unaudited) and related notes included elsewhere in this report. This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements involve risks, uncertainties, and assumptions. All statements in this report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, designs, expectations, and objectives are forward-looking statements. The words “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “designed,” “developed,” “drive,”
Current report — wording carried from elsewhere
In 2019, we granted Viatris exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territories, which include the Hong Kong SAR, the Macau SAR, and Taiwan (collectively, the “China Region”). In November 2023, we learned that Viatris’ Phase 3 study of YUPELRI in China was positive, and the data were consistent with previous findings of YUPELRI’s strong efficacy. In June 2024, Viatris completed a
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
Net cash flows provided by investing activities
Current report — wording carried from elsewhere
Net cash used in financing activities was $0.9 million for the three months ended March 31, 2025, consisting primarily of $0.9 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
Results of Operations” and elsewhere in this report and in our Annual Report on Form 10-K for the year ended December 31, 2024. Our forward-looking statements in this report are based on current expectations, and we do not assume any obligation to update any forward-looking statements for any reason, even if new information becomes available in the future. When used in this report, all references to “Theravance Biopharma”, the “Company”, or “we” and other similar pronouns refer to Theravance Biopharma, Inc. collectively with its subsidiaries.
Previous report — wording carried elsewhere
As of September 30, 2025, a total of $150.0 million in potential Milestone Payments remain available to us. For the next potential Milestone Payment, we are eligible to receive either (i) $25.0 million if Royalty Pharma receives $260.0 million or more in royalty payments from GSK with respect to 2025 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales are approximately $3.06 billion or (ii) $50.0 million if Royalty Pharma receives $295.0 million or more in royalty payments from GSK with respect to 2025 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales exceed approximately $3.41 billion. Achievement of either the $25.0 million or $50.0 million milestone in 2025 would not require an increase in global net sales compared to 2024, as the $3.46 billion in global net sales achieved in 2024 exceeds the threshold necessary to trigger the higher $50.0 million milestone payment in 2025.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Total SG&A expenses were $55.1 million for the nine months ended September 30, 2025. Excluding SBC, total SG&A expenses were $44.3 million and were comprised of $23.0 million of G&A expenses and $21.3 million of SM&M expenses. Total SG&A expenses (excluding SBC) were $38.8 million for the prior year period and were comprised of $20.3 million of G&A expenses and $18.5 million of SM&M expenses.
Previous report — wording carried elsewhere
Net cash flows used in investing activities