Theravance Biopharma, Inc.

Hello, ladies and gentlemen. Good afternoon. I'd like to welcome everyone to the TheraVans BioPharm first quarter 2025 conference call. During the presentation, all participants will be in a listen-only mode. A question in this session will follow company's formal remarks. To ask a question, press the star key followed by the digit 1 on your phone. Again, that is star 1 to ask a question. 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 is being recorded. And now, I would like to turn the call over to Rick Winningham, Chief Executive Officer. Please go ahead, sir.

Good afternoon, and welcome to TheraVance Biopharma's first quarter 2025 earnings results conference call. On slide two, you will 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 Fardham, Chief Business Officer, Anya Miller, Head of Development, and Aziz Sawaf, Chief Financial Officer. Moving to slide four and beginning on the left-hand side, UPelry delivered solid results in the first quarter with net sales increasing 6% to just over $58 million. This performance was driven by a similar increase in demand as well as favorable pricing and channel mix. Building on the strong momentum we experienced in 2024, hospital doses increased 48% year on year. We are steadily advancing the Cypress trial consistent with our objective of enrolling the right patients at high performing sites and are pleased to be nearing the completion of the planned enrollment into the open label portion of the study. Shifting to the randomized withdrawal portion of the study, we are laser-focused on ensuring that we optimize those factors that are within our control, including study power and patient experience. Based on our current projections, we anticipate enrolling the final patient into the open-label portion of the study by late summer with top-line data available approximately six months later. Our overarching objective remains to deliver the highest quality result possible in order to bring this once-daily selective norepinephrine reuptake inhibitor to a rare disease population of roughly 40,000 U.S. patients with MSA who desperately need new options to address their symptoms of NOH, as well as thousands more around the world. And finally, Our positive outlook for Trilogy and our strong financial position remain unchanged. On April 30th, GSK reported another strong quarter for Trilogy, with global net sales at 14%, placing us comfortably on pace to achieve the higher $50 million milestone from Royalty Pharma in 2025. We ended the quarter with $131 million in cash and remain committed to to returning excess capital to shareholders. I'll now turn the presentation over to Rhonda to cover UPelry's performance in the quarter. Rhonda?

Thanks, Rick. If you turn to slide six, you'll see that the Farrah Vance and Beatrice Commercial Partnership turned in another strong quarter of UPelry performance. Overall net sales increased 6%, which was driven primarily by demand growth, as well as pricing and channel mix improvements since the first half of 2024. As we've communicated, the first quarter has historically been impacted by seasonality, not only for UPelry, but across other maintenance COPD products that demand an overall net sales to continue to improve throughout the year. On slide seven, in addition to the importance of the community channel efforts and volume, our hospital performance continues to be a key strategic differentiator and contributor to UPelry's growth. We achieved record high volume in the quarter with approximately 316,000 units pulled through the hospital channel, which was up 48% year over year. This was our strongest quarter launched to date in the hospital setting, and demonstrates the impact of our focus and continued success in securing formulary wins and therapeutic interchange protocols. The strong hospital performance remains critical to the overall brand strategy, specifically in transitioning our growing number of UPelRI hospital patients to community maintenance care. Moving to slide eight, there continues to be significant future potential with UPelRI. Recent market research conducted with Vietris supports additional demand growth along with the sizable remaining addressable patient population. Our joint brand strategies continue to increase both the adoption of concomitant use with LAMA-LABA therapies, as well as switches to upelre from handheld-only regimens, where patients may have difficulty receiving the full benefit of those medications and could be better served with once-daily nebulizations. We're also encouraged by our success in improving fulfillment and are confident that we can expect continued progress across adherence, persistency, and overall claim approvals. UPelry remains a foundational, durable, and highly profitable asset. It continues to demonstrate strong brand momentum across both the hospital and community channels, with sales up 6% in the most recent quarter and expanding margins. With the potential for a $25 million near-term milestone, extended IP protection through 2039 in the U.S., and future royalties and milestones from China, we believe Upelri is well-positioned to deliver long-term, sustainable value to Theravance and our shareholders. At this point, I'll turn things over to Aziz for a quick update on Trilogy. Aziz?