Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma fourth quarter and full year 2024 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 1-1 on your phone. Again, that's star 1-1 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 call is being recorded. And now I'd like to turn the call over to Rick Winningham, Chief Executive Officer. Please go ahead, sir.

Yeah, good afternoon, and welcome to Theravance Biopharma's fourth quarter 2024 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 further described 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 Swaf, Chief Financial Officer. On slide four, I'll begin by highlighting our fourth quarter results, which represent a strong close to the year. Fourth quarter upelry net sales increased 10% over the fourth quarter of 2023, reaching 66.7 million, an all-time high. And our hospital performance was excellent, with doses up 49% year over year. With Amproloxatine, we achieved solid enrollment in Cyprus throughout the quarter and remain on track with our development timelines. In December, we had a positive exchange with the FDA, which reaffirmed our expectations around filing, should Cyprus be positive. We learned that two abstracts had been accepted for oral presentations at the upcoming American Academy of Neurology meeting in April. and we completed market research underscoring the potential for ampryloxetine to address significant unmet needs of patients with MSA and symptomatic NOH. Finally, based on 2024 Trilogy Net Sales reported by GSK, we've earned a $50 million milestone payment from Royalty Pharma. We continue to manage our expenses carefully and delivered full-year results, which fell within our guidance ranges. I'll cover our strategic priorities on slide five. For upelry, we continue to focus on growing revenue while increasing brand profitability. In addition, there's a potential for a near-term $25 million sales milestone in the U.S., as well as milestone in royalty income from China once approved. With Amproloxatine, we're moving towards completing enrollment in the open-label portion of the Cypress study while simultaneously preparing for an expedited NDA filing. We plan to request priority review in order to bring this much-needed potential treatment to patients as quickly as possible, and we'll continue to build awareness of NOH within the MSA community. Turning to Trilogy, where there's a potential of an additional $150 million of milestones in the coming 24 months, plus the considerable value of our retained interest in Trilogy Royalties. We remain dedicated to maximizing the value of Trilogy and are committed to returning excess capital to our shareholders. We'll continue to build on our recent track record of strong expense management and capital discipline to deliver sustainable value to our investors. I'll now turn the Presentation over to Rhonda to cover UPelry's performance in the quarter. Rhonda?

Thanks, Rick. Beginning on slide seven, I'm pleased to report that the Theravance-Viatris Commercial Partnership delivered a strong finish to 2024, having driven UPelry net sales growth of 10% in the quarter, reaching approximately $67 million and full-year sales of $239 million, with UPel re-recording its highest level of profitability since launch. The growth in Q4 was primarily driven by a 9% increase in demand. Additionally, pricing continued to be favorable compared to the first half of 2024, which is a reflection of Vietris' efforts in demonstrating effective pricing strategy execution as well as an improved channel mix, meaning stronger demand in the higher margin channels aligning with our brand objectives. While the record high net sales this quarter closely tracked with demand generation, I will remind you that we traditionally experience seasonal dips in reported net sales as we transition from the fourth quarter to the first quarter of the following year. Turning to slide eight, We continue to experience considerable momentum in the hospital setting, which exemplifies the strength and effectiveness of the TheraVans hospital selling capability. During the quarter, there were 285,000 ukulele doses pulled through to hospital customers, up 49% year over year. In addition, we continue to broaden our base of formulary wins and therapeutic interchange protocols. achieving the highest annual gain since pre-COVID, and resulting in an increased long-acting NIM market share of nearly 20% by the end of the fourth quarter. Strong hospital performance remains critical to our overall brand strategy, specifically in transitioning patients from the hospital to the community setting, where UPelRe's long-acting NIM market share maintained roughly 32% through the end of the year. To summarize on slide nine, UPAL rate delivered another strong year of net sales growth of 8% in 2024 and driven by an impressive full year 11% growth in demand. Additionally, we're encouraged by the potential sales milestones in the U.S. along with the extended IP protection to 2039 and the opportunity for future milestones in royalties in China. At this point, I'll turn things over to Aziz for an update on Trilogy. Aziz?