Theravance Biopharma - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 delivered record YUPELRI net sales of $71.4M (+15% YoY) and non-GAAP breakeven, with cash of $332.7M and no debt; GAAP EPS was $0.07 and non-GAAP net income was $2.3M.
• Revenue of $20.0M grew 19% YoY, entirely from the Viatris collaboration; GAAP net income of $3.6M benefited from a $6.5M tax true-up tied to the Q2 TRELEGY royalty sale.
• Guidance maintained for FY25 OpEx, but tone improved: management achieved non-GAAP breakeven in Q3 and expects similar breakeven in Q4 (ex one-time items), vs prior guidance for non-GAAP losses similar to 2024; milestone accounting reiterated for potential $25M YUPELRI (license revenue) and $50M TRELEGY (other income) in Q4.
• Near-term catalysts: triggering $25M YUPELRI milestone if Q4 net sales ≥ ~$54M, and $50M TRELEGY milestone if Q4 global sales ≥ ~$471M; medium-term transformational catalyst is CYPRESS Phase 3 ampreloxetine topline in Q1 2026.

What Went Well and What Went Wrong

What Went Well

• Record YUPELRI net sales and brand profitability: “Theravance delivered strong results…record YUPELRI net sales and the achievement of non-GAAP breakeven,” CEO Rick Winningham noted.
• Hospital channel strength: doses up 29% YoY with hospital market share ~21%, reinforcing inpatient initiation and outpatient transition strategy.
• TRELEGY momentum improves milestone visibility: Q3 global sales ~$1.0B and YTD ~$2.9B put FY25 $50M milestone within reach; only ~$471M needed in Q4.

What Went Wrong

• GAAP profit aided by one-time tax benefit: income tax benefit of $6.5M boosted GAAP net income; excluding it, Q3 would have been a $2.9M GAAP net loss.
• SG&A up YoY: SG&A rose to $18.3M vs $16.9M prior year, reflecting pre-launch and commercial activities; share-based comp though declined YoY.
• Revenue declined sequentially vs Q2 due to absence of Q2’s $7.5M licensing milestone (China approval), highlighting mix sensitivity to one-time items.

Transcript

Operator (participant)

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma Q3 2025 conference call. During the presentation, all participants will be in a listen-only mode. A question-and-answer session will follow the company's formal remarks. To ask a question, press *11 on your telephone. If listening via webcast, please mute audio on your webcast device before asking a question over the phone. I will repeat these instructions after management completes their prepared remarks. Also, today's conference call is being recorded. Now I'd like to turn the call over to Rick Winningham, Chief Executive Officer. Please go ahead, sir.

Rick Winningham (CEO)

Good afternoon, and welcome to Theravance Biopharma's Q3 2025 earnings results conference call. On slide two, you'll find our forward-looking statements disclaimer, which covers certain risk factors which could cause actual results to differ materially from any forward-looking statements we might make in today's call and which are described further in our filings with the SEC. Moving to slide three, I'm joined today by Rhonda Farnum, Chief Business Officer; Aine Miller, Head of Development; and Aziz Sawaf, Chief Financial Officer. Turning to slide four, Theravance delivered strong results in the third quarter, reflecting continued execution across the business and notable progress toward our strategic objectives. We achieved several key accomplishments, including solid UPELRI net sales growth and record brand profitability, leading to the achievement of non-GAAP break-even, underscoring the strength of our business model and commitment to financial discipline.

In parallel, we continue to advance the pivotal phase III Cypress trial of ampraloxetine towards a data readout in early 2026, a milestone we believe could represent a material value inflection point for the company. Starting with our commercial business, UPELRI, our durable cash-generating asset continues to deliver strong results. Net sales and, importantly, profitability for the quarter reached all-time highs, driven by continued demand growth and favorable net pricing. This performance puts UPELRI year-to-date sales on track to trigger a $25 million milestone from Viatris. With ampraloxetine, we are excited as we approach a critical moment for Theravance. We remain on track to deliver top-line results from the pivotal phase III Cypress study in the first quarter of 2026.

We believe this readout has the potential to be transformational for both patients and the company, as we hope ampraloxetine will become the first precision therapy for symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy, a rare debilitating disease. In preparation for the data, we will host a KOL event for investors on December 8 to highlight the significant unmet medical need of these patients and how ampraloxetine aims to address it. We ended the quarter with approximately $333 million in cash and no debt. Importantly, we remain on track to achieve near-term milestones totaling $75 million in the fourth quarter, $50 million for Trelegy and $25 million for UPELRI. In addition, the strong growth trends for Trelegy bode well for the achievement of the $100 million milestone in 2026.

Lastly, in October, we launched a new disease education campaign for healthcare professionals to raise awareness and deepen scientific understanding of NOH associated with MSA. This initiative reflects our continued commitment to the MSA community and to advancing education on the complex mechanisms underlying NOH and MSA. Theravance today stands on a foundation of financial strength with significant upside opportunity, anchored by a robust balance sheet, continued cash generation from UPELRI, and highly probable near-term milestone payments. We enter the final quarter of 2025 with confidence and growing excitement for the rapidly approaching transformational potential of the Cypress data readout. With that, I'll turn the call over to Rhonda to provide additional detail on UPELRI's performance. Rhonda?

Rhonda Farnum (Chief Business Officer)

Thanks, Rick. If you turn to slide six, you'll see that the Theravance Biopharma Viatris commercial partnership delivered a record quarter for UPELRI. Q3 net sales increased 15% year-over-year to $71.4 million. This was driven by two main factors. First, strong demand growth, up 6% year-over-year versus Q3 of 2024. Second, continued net price improvement due to a more favorable channel mix, which is the result of a close collaboration with our partners at Viatris, as exemplified by effective field sales execution with a focus on fulfillment optimization efforts. Importantly, following these results, only $54 million of net sales are required in the fourth quarter for us to achieve the $250 million calendar year sales threshold required to trigger a $25 million milestone payment from Viatris.

Turning to slide seven, in addition to our solid net sales growth, UPELRI continued to experience expanding profit margins, reaching record levels and positive momentum across both hospital and community outpatient channels. The hospital channel continues to be a key driver of prescribing, with hospital volume increasing 29% versus Q3 of 2024, illustrating our team's sustained success in securing formulary wins and implementing therapeutic interchange protocols. This quarter, UPELRI's share in the long-acting nebulized hospital market reached a new launch-to-date high of approximately 21%. Moving forward, our goal is to continue to secure institutional access and further expand the hospital channel as a foundational component of our brand strategy, functioning as a critical entry point for transitioning patients to community outpatient maintenance therapy.

Beyond the encouraging growth trends in Q3 with net sales demand and hospital volume, UPELRI is positioned for continued expansion with a sizable, addressable population remaining in the U.S. Our aligned strategies with Viatris continue to deliver strong results, specifically the adoption of concomitant use with LABA therapies and switches from handheld-only regimens, as well as further diversification of product fulfillment. We were also excited to share two analyses presented at the recent 2025 CHEST meeting. First, we presented new post-hoc analyses from a phase III safety study showing that patients treated with UPELRI experienced a lower incidence and severity of moderate to severe exacerbations compared to those taking tiotropium. The second presentation was a new retrospective cohort study of claims data, which demonstrated that following hospital discharge, patients adherent to UPELRI experienced significantly fewer and less severe exacerbations and lower health system costs than non-adherent patients.

These findings reinforce UPELRI's differentiated clinical profile and highlight its potential to improve both clinical and economic outcomes for appropriate COPD patients, further reinforcing the scientific foundation of UPELRI. In summary, UPELRI's profit margin continues to expand, supported by disciplined execution and patent protection in the U.S. into 2039. As a result, we are confident that UPELRI will continue to deliver long-term sustainable value for Theravance and its shareholders. With that, I'll turn the call over to Aine to provide an update on the ampraloxetine development program. Aine?

Aine Miller (Head of Development)

Thanks, Rhonda. Turning to slide nine, before providing an update on the Cypress study, I'd like to highlight some recent ampraloxetine publications and presentations. First, we submitted a manuscript detailing the results of the prior phase III Redwood study in the MSA subgroup, where ampraloxetine demonstrated durable improvement in symptoms of NOH. I will take the opportunity to provide a quick recap of this data shortly, as it reinforces our confidence in ampraloxetine's mechanism of action and its potential to deliver meaningful benefit to patients with MSA, a community that remains underserved by current treatment options. A preprint version of this manuscript has been posted online to MedArchive. Second, a publication establishing the minimally clinically important difference for the orthostatic hypotension questionnaire was published in a peer-reviewed journal, Clinical Autonomic Research, an important tool to support interpretation of clinical benefit as we head into the phase III Cypress readout.

Additionally, we had a strong presence at the recent International Symposium of Autonomic Nervous System organized by the American Autonomic Society, or AAS, where we had one platform presentation and three posters. The platform presentation highlighted the results from the prior phase III Redwood study in the MSA subgroup analysis, along with a poster reviewing the impact of ampraloxetine on supine hypertension in the phase III Sequoia study, which showed no worsening of supine hypertension, an important potential differentiator for the product. The two other poster presentations detailed the rigorous recruitment and retention methodologies used to address challenges in conducting a trial in a rare disease with severely ill patients. By applying these insights in the Cypress study, we were well positioned to successfully address the executional challenges associated with clinical studies in rare and severe neurodegenerative diseases.

As I mentioned earlier, I'd like to recap the results from the subgroup analysis of patients with MSA from the Redwood study shown here on slide 10. The top graph shows the standing systolic blood pressure throughout the Redwood trial, where a pressure effect was observed in the open-label phase of the trial, with blood pressure at three minutes of standing increasing compared to baseline. At the end of the randomized withdrawal, compared to the open label, blood pressure at three minutes of standing dropped in the group withdrawn to placebo while remaining stable in patients that stayed on ampraloxetine. This increase in standing blood pressure observed with ampraloxetine translated to a meaningful impact on patient symptoms and daily activities.

However, the benefits seen in symptoms and short-term daily living activities shown in the two bottom graphs were only maintained in patients who remained on ampraloxetine in the randomized withdrawal portion, but worsened in those withdrawn to placebo. Moving to slide 11, we continue to make strong progress towards our pivotal phase III Cypress readout. At this stage, the open-label portion of the study is now complete, and a small subset of patients are now completing the randomized withdrawal portion, an important step towards completion of the trial. The team continues to demonstrate excellent operational execution, and we are highly encouraged by the level of engagement across our study sites and the broader MSA community.

We remain on track to deliver top-line results in the first quarter of 2026, and we view this as a significant milestone for Theravance Biopharma as we advance our efforts to bring ampraloxetine to patients with MSA-related NOH. We've also made substantial progress on NDA preparation, particularly across the non-clinical, CMC, and clinical pharmacology components of the application. Much of this work has already been completed, positioning us to incorporate the Cypress data quickly once available and move efficiently towards an expedited NDA submission should the results be positive. We also intend to request priority review if the data are supportive. Lastly, in preparation for the upcoming readout, we will host a virtual KOL event for our investors on December 8, which will feature Dr. Horatio Kaufman, Professor and Director of the Dysautonomia Center at New York University, one of the world's leading experts in autonomic disorders. During this event, Dr.

Kaufman will provide an overview of the unmet need for patients with MSA-related NOH and will highlight why we believe ampraloxetine is uniquely positioned to address this rare and debilitating condition. In addition, we will review the ongoing Cypress study and outline the commercial opportunity for ampraloxetine as a potential new treatment option. We are excited and well prepared as we approach the Cypress data readout in the first quarter of 2026. With that, I'll turn the call over to Aziz to walk us through the financials. Aziz?

Aziz Sawaf (CFO)

Thanks, Aine. Turning to slide 13, I'll start with an update on our Trelegy milestones. GSK reported $1 billion in sales for the quarter ahead of consensus and $2.9 billion year-to-date. Given the $3.4 billion threshold required to trigger the $50 million milestone in 2025, we need only $470 million in Q4 sales to hit this milestone, which is roughly 50% below the current run rate. Looking ahead, the $100 million milestone in 2026 is also well within reach, with a $3.5 billion sales requirement, a level that both current run rate and consensus comfortably exceed. With Trelegy continuing to post strong, above-expectation performance, we have clear visibility into achieving these milestones, which together represent $150 million in expected cash inflow over the next 15 months, further strengthening our financial position. Turning to slide 17, I'll summarize our Q3 financial performance, where we delivered another strong quarter.

Collaboration revenue increased to $20 million, up 19% year-over-year, reflecting UPELRI's strong operating leverage, which drove record brand-level profitability. Operating expenses, excluding share-based comp, were $22 million, as R&D costs began to decline, following completion of Cypress enrollment, while we progressed towards data readout in the first quarter of next year. Share-based comp decreased 8% year-over-year, reflecting continued cost discipline. Our GAAP net income was positive in the quarter, aided by a non-recurring benefit due to a favorable true-up related to taxes from the Trelegy royalty sale in Q2. However, driven by UPELRI's profit contribution and continued expense discipline, we also achieved non-GAAP profit break-even in the quarter. Given that this metric excludes one-time items, such as the income tax benefit, it more accurately reflects the underlying performance of our operations. We ended the quarter with $333 million of cash and no debt.

Lastly, turning to slide 18, I'll cover our 2025 financial guidance. First, we are reiterating all expense guidance ranges. Second, given that we achieved break-even on a non-GAAP basis in Q3, again excluding one-time items, we now expect results to remain broadly consistent in Q4, though there can always be normal quarterly variability. This guidance reflects our continued focus on operating leverage and cost discipline. Importantly, this outlook excludes the $75 million of milestones expected to be earned in Q4, $25 million for UPELRI, which will be recognized as revenue, and $50 million for Trelegy, which will be recognized as other income, not revenue. Note that while we expect these milestones will be earned in Q4, we will receive the cash in Q1 of 2026. In summary, Q3 was another step forward for Theravance Biopharma.

We delivered record UPELRI performance, achieved break-even on a non-GAAP basis, and further strengthened our balance sheet, setting the stage for a potentially transformational 2026 with continued financial discipline and a clear focus on value creation. With that, I'll turn it back to Rick to conclude. Rick?

Rick Winningham (CEO)

Thanks, Aziz. To summarize on slide 19, Theravance enters the final stretch of 2025 with strong momentum, driven by a profitable commercial business, a robust balance sheet, and clear visibility into near-term milestones that will further strengthen our financial profile. UPELRI continues to be a key driver of that performance, with sustained growth and increased profitability highlighting the durability and long-term value of the franchise. We remain confident in the execution of the Cypress study and in ampraloxetine's potential to become the first precision therapy for patients with MSA who suffer from NOH. With Cypress results expected in the first quarter of 2026, we are now approaching a significant moment for the company. This readout represents a transformational catalyst with meaningful upside potential while our profitable UPELRI franchise and strong financial position provide downside protection, creating a compelling risk-reward profile as we approach the data.

As we move into 2026, we do so with focus, financial strength, and confidence in the opportunities ahead. With that, we'll open the line for questions. Operator?

Operator (participant)

Thank you, sir. Once again, ladies and gentlemen, if you do have a question at this time, please press star 11 on your telephone. Our first question for today comes from the line of Douglas South from HC Wainwright. Your question, please.

Douglas Tsao (MD Equity Research)

Hi, good afternoon. Thanks for taking the question. I guess, Rick, just given sort of the continued outperformance we've seen from Trelegy and the likelihood of some additional cash coming in, how are you thinking about right now? You've talked about the special committee being committed to returning capital to shareholders, but how much do you potentially need to sort of keep in-house for the potential launch of ampraloxetine?

Rick Winningham (CEO)

Yeah, it's a good question, Doug. I think, obviously, the financial strength of the company is one of its key elements of value. We continue to view the cash on the balance sheet, and the Strategic Review Committee looks at the timing and the optimum amount of returning capital, and if we do return capital again, how much and when. Obviously, ampraloxetine's launch will be a fairly efficient launch in a rare disease, not creating a substantial burden on the P&L, but nonetheless triggering up expenses.

I think for the company and the board, what we're focused on right now, because we are so close, is, in fact, the execution of the Cypress study through the top-line results and getting those top-line results and then making future decisions for the company on capital and capital return, etc., because of the, as was stressed in this call, the very important nature of that data. Importantly, we're in a position of financial strength, giving us terrific opportunities going forward to return capital to shareholders if that's what the board desires to do.

Douglas Tsao (MD Equity Research)

I guess as a follow-up, when we think about the company over the last several years, you've obviously sort of narrowed your focus. Obviously, we're sort of almost sort of dual goals of maximizing the opportunity with UPELRI as well as executing on the ampraloxetine study. I guess when we think about the company over the long term, are there pipeline assets? I mean, there were several assets which I think some people were interested in, but sort of were put on pause. I guess, has that ever sort of come back into the equation? Just given you noted the sort of operational effort, sort of the efficiency in launching ampraloxetine, I mean, that could just bring significant capital into the company and sort of change your position.

Rick Winningham (CEO)

Yeah, I think that's again, kind of go back to my central theme, and I think the central theme for the management and the board, which is the focus on Cypress and the focus on ampraloxetine clinical success that sets up a successful launch of the product. At that point in time, once we get post-ampraloxetine and post-success, we'll evaluate options. I think we not only need ampraloxetine success clinically, but a pathway which we believe we have as long as we hit a clinically meaningful result in the Cypress study to approval. I think as we're going through that, we'll obviously look at the options and the alternatives to maximize shareholder value.

Again, I'd say right now, given the relatively small organization that we've got, 110% of our focus, as you rightly point out, is on growing UPELRI, growing UPELRI in an effective way to drive additional profitability and finishing ampraloxetine clinical study and setting it up for commercial success. I think once we achieve those objectives, we have time or intellectual space to work on other things that may increase shareholder value, because I do believe you're right in that ampraloxetine being a rare targeting a rare disease that has the opportunity for a significant value inflection for the company.

Douglas Tsao (MD Equity Research)

Okay, great. Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Julian Harrison from BTIG. Your question, please.

Julian Harrison (MD)

Hi, congrats on the quarter, and thank you for taking the questions. First, I'm curious to what extent that recently published manuscript detailing the MCID for the OHSA composite score informs your expectations for top-line Cypress data first quarter of next year. Any other comments on what you think a win on data would be helpful as well? The UPELRI data at CHEST looked fantastic. Thinking about that some more, I'm wondering if you could talk more about how these results are supportive of UPELRI new patient starts at the hospital call point.

Rick Winningham (CEO)

Hey, Rhonda, do you want to take the CHEST presentations, and then we'll come back to Aine and myself for ampraloxetine?

Rhonda Farnum (Chief Business Officer)

Absolutely. Thanks, Julian, for the question, and thanks for recognizing the data that were recently presented. Certainly, having data of this nature relative to both highlighting a clinical outcome, which is quite meaningful, as well as reduction in healthcare and health system costs, are crucial knowledge points for the brand. I would say the team is first focused on ensuring we get those new data into manuscript form, and then we'll be able to think about other communications and educational efforts around these data. They certainly help further substantiate what is already an element of how and why we sell into the hospital space. They are very nicely kind of putting a bow on top of the package we already use promotionally. We will see in the future if these are used in kind of more expanded fashion, if that makes sense.

Rick Winningham (CEO)

That is the exacerbation data. Yeah, very important. Again, versus tiotropium to add to really the medical education efforts that we have ongoing with UPELRI in both the community and the hospital. Now on ampraloxetine, the minimally clinically important difference, and yeah, this publication is important to us because effectively a one-point difference for us will be in the composite score, will be this kind of the minimally important difference that we need to see in Cypress. We obviously saw that in 170, and Aine can touch on the steps we have taken to make sure 170 is replicated by Cypress. Aine?

Aine Miller (Head of Development)

Yeah, so thanks, Julian. I would encourage you to take a look at the publication. It is available online. There's open access to the article. The article was based on the data that we had previously seen in 170 and 169, looking at changes in the OHSA questionnaire, which is central, obviously, also to the Cypress study. It was based on an anchoring analysis between changes on the scale to how patients actually felt using other scales that we'd included in the study, PGIG and PGIS. We've proactively built this analysis into the Cypress study. From what we have seen in our previous analysis, and you'll see in this publication, as Rick said, a one-point change on the scale is considered clinically meaningful.

Our objective with the Cypress study is obviously to replicate the previous benefit that we had seen in the 170 study, where we did see that level of change. I believe that's clinically significant. Obviously, this information is important to the overall outcome of the study and will be part of the regulatory submission. We've also had FDA review our analysis plan around the study and this anchoring analysis, and feel like we're in a really good position as we move into the Cypress readout in the first quarter of next year.

Julian Harrison (MD)

Very helpful. Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Ellen Horst from TD Cowen. Your question, please.

Ellen Horste (Equity Research Associate)

Hi guys. Thanks for taking the question, and congrats on the exciting quarter and the progress in the Cypress study. My question is about Cypress. With the open label portion complete, can you share how many patients have ultimately enrolled in the randomized withdrawal portion? If not, can you confirm that this number is sufficient for the powering according to the original trial design? Thank you.

Rick Winningham (CEO)

Aine.

Aine Miller (Head of Development)

As I said in my remarks, we're really encouraged with how the study has progressed and where we've landed in terms of overall enrollment numbers. While we're not sharing specific enrollment numbers today, I will say that we remain very confident in the operational execution and pleased with where we have landed in terms of accrual, but most importantly, also progression into the randomized withdrawal portion of the study. We do believe that we have randomized a sufficient number of patients for us to be able to detect a treatment difference between the two arms. Just as a reminder, the study design and the analysis plan for the Cypress study has been aligned with FDA, and we believe that we have an adequately powered study.

We will be disclosing all the specific numbers and the contents of our data readout, which is coming really soon, and we are excited about what's to come in quarter one 2026.

Rick Winningham (CEO)

Ellen, just the schematics that we've outlined as a part of our ongoing investor presentation on the study remains accurate relative to what we need to achieve and what we are achieving with the study design and execution.

Ellen Horste (Equity Research Associate)

Thank you. That's really helpful.

Rick Winningham (CEO)

Okay, operator, do we have any further questions? It appears that we do not have any further questions coming in from the operator, so I will just take this opportunity to thank you for joining on our call, third quarter call. We're very pleased with the results this year to date. We look forward to a very good fourth quarter and then the exciting first quarter in 2026 headlined by the Cypress data. Thank you again very much for joining, and please have a good day.