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11/10/2025
Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVance Biopharma third quarter 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 star 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. And now I'd like to turn the call over to Rick Winningham, Chief Executive Officer. Please go ahead, sir.
Good afternoon, and welcome to Theravance Biopharma's third quarter 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 Farnham, Chief Business Officer, Anya 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 upelry net sales growth and record brand profitability, leading to the achievement of non-gap break-evens. 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 Amproloxatine 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, UPelry, our durable cash-generating asset continues to the 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 Beatrice. With Amproloxatine, 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 Cypher 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 amproloxetine 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 the 8th to highlight the significant unmet medical need of these patients and how Amproloxatine aims to address it. We ended the quarter with approximately $333 million in cash and no debt. And importantly, we remain on track to achieve near-term milestones totaling $75 million in the fourth quarter. $50 million for Trilogy and $25 million for Eucalyptus. In addition, the strong growth trends for Trilogy 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 UPelbry, 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?
Thanks, Rick. If you turn to slide six, you'll see that the TheraVance-Theatris Commercial Partnership delivered a record quarter for UPelRI. Third quarter 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. And second, continued net price improvement due to a more favorable channel mix, which is the result of a close collaboration with our partners at Beatrice 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 Vietris. Turning to slide seven, in addition to our solid net sales growth, UPelry 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, UPelRe'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, UPelry is positioned for continued expansion with a sizable, addressable population remaining in the U.S. Our aligned strategies with Beatrice 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 three safety study showing that patients treated with upelry experienced a lower incidence and severity of moderate to severe exacerbations compared to those taking teatropium. The second presentation was a new retrospective cohort study of claims data. which demonstrated that following hospital discharge, patients adherent to upelry experienced significantly fewer and less severe exacerbations and lower health system costs than non-adherent patients. These findings reinforce upelry'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 upelry. 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 Anya to provide an update on the Amprolox team development program. Anya? Thanks, Rhonda.
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