Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVance BioPharma third quarter 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 the star key followed by the digit 1, digit 1 on your phone. Again, that's star 1, 1 to ask a question. If listening via webcast, please mute your audio on your webcast device before asking a question. over the phone. I'll repeat the instructions after management completes their prepared remarks. Also, today's conference call is being recorded. And now I'd like to turn the conference over to Rick Whittingham, Chief Executive Officer. Please go ahead, sir.

Good afternoon, and welcome to Theravance Myocardia's third quarter 2024 earnings results conference call. I encourage you to review our forward-looking statements disclaimer on slide two, which covers certain risk factors which could cause actual results to differ materially from any forward-looking statements that we might make in today's call, and which are described further in our filings with the SEC. You will find today's agenda on slide three, along with members of the TheraVance leadership team who will join me in the call today. These are Rhonda Farnham, Chief Business Officer, Aziz Swaf, Chief Financial Officer, and Anya Miller, Head of Development. Now, if you turn to slide four, I'd like to cover our most recent operational and financial results. Starting on the left, we're pleased to have delivered sequentially improved Upelry quarterly net sales performance in partnership with Beatrice, having driven 7% growth year on year and 14% quarter on quarter to 62.2 million and a new launch today high. Third quarter, upillary demand increased 14% and hospital doses increased 40% versus the same period a year ago. Second, we made solid progress on our pivotal cipher study for ampryloxetine and remain on target to achieve our updated timelines. Lastly, GSK delivered another good trilogy result, reaching $789 million for the quarter and putting us in a position to achieve the higher 50 million 2024 sales milestone should fourth quarter sales exceed approximately 610 million, which is well below consensus estimate. If achieved, TheraVans would expect to receive this milestone in the first half of 2025. Turning to slide five, I'd like to cover two initiatives our board has approved relating to our ongoing efforts to unlock value of TheraVans file format. These reflect our willingness to proactively implement measures aligned with the interests of our shareholders while sharpening our operational focus in pursuit of delivering innovation to medicines with patients with the highest unmet medical need. First, in keeping with our regular review and updating of governance practices, we announced that the Board of Directors has separated the role of CEO and chair and that Susanna Gray has been elected chair of the board of TheraVance Biopharma. I'll continue my focus and my efforts on TheraVance's mission as a director and CEO. Susanna's unique experiences and skillset make her a natural choice to lead the board moving forward as she brings over 30 years of experience in the biopharmaceutical industry, specializing in capital markets and corporate finance. Second, we announced today that the Board of Directors has formed a strategic review committee consisting of independent directors with the purpose of comprehensively exploring alternatives available to the company involving all of its key assets, including upelry, ampryloxetine, Trilogy, and its tax attributes. Lazard will be acting as a financial advisor to assist in this review process. As we've stated consistently, Fair Events' board regularly considers options to enhance the company's strategic positioning, and we believe that forming the Strategic Review Committee highlights our focus on unlocking value and aligns with our shareholders' best interests. Lastly, as we've previously communicated, we remain committed to returning excess capital to shareholders. Now I'd like to turn the presentation over to Rhonda to cover UPelry's performance in the quarter. Rhonda?

Thanks, Rick. I will begin with slide seven, where we present you Hillary's quarterly net sales progression. Beatrice reported 7% year-over-year growth in net sales, reaching approximately 62 million, which is an all-time high. This growth was driven by a 14% increase in demand, exceeding expectations. Additionally, this quarter showed sequential improvement in pricing and channel mix relative to Q2, And we have also seen a more recent increase to average selling price, or ASP. When we reported second quarter performance, we highlighted net pricing headwinds due to channel mix, specifically increased demand into lower margin channels and one-time charges that impacted quarterly pricing. In collaboration with Beatrice, we are executing on strategies to deliver demand in higher margin, non-retail channels, and we are confident these initiatives will continue to enhance net pricing and overall brand performance. And as a reminder, we are limited in our ability to discuss certain elements of pricing, giving confidentiality considerations. Turning to slide eight, we continue to experience considerable momentum in the hospital setting. During the quarter, we shift approximately 227,000 up 40% compared with Q3 of 2023 an equivalent to our performance in Q2, which was particularly strong. Notably, this pattern is typical of the seasonality we see in our hospital business, where Q3 does not show as much sequential growth as in other quarters. As a reminder, the strategic objective for our focus in the hospital setting is to create the catalyst to drive post-discharge outpatient maintenance use of Upelri. Supporting that objective, we continued to broaden our base of formulary wins and implementation of therapeutic interchange protocols to position patients to continue their treatment after leaving the hospital. Based on our historical experience and a better than expected rate of formulary and new account wins in the quarter, we expect a strong finish to the year and continued momentum into 2025. On slide nine, you can see how our hospital performance has contributed to share gains within the hospital long-acting NEB market on the left-hand side. Based on data through the end of the quarter, we are up to a nearly 19% share, which is a new all-time high. As it relates to our concomitant use messaging and the goal of driving to a two-to-one ratio of NEB LABA to UPOA use over time, We continue to make good progress and ended the quarter at a three to one ratio. We see further opportunity for improvement in coming quarters, which should help us continue to contribute significantly to UPelry's overall growth. On the right-hand side of the slide, you can see UPelry's share development in the community setting. As a reminder, we do not have a full data view by the time we report. So the 32% share we are presenting here only represents our performance through August. Given the demand generation we are seeing, compared with trends we see for nebulized LABAs in the community setting, we are optimistic this trend will continue to develop favorably moving forward. Moving on to slide 10, in addition to the substantial opportunity that still remains in the U.S., We also see significant potential to realize value in China, where Beatrice filed an NDA in June. The median time to review an NDA in China is approximately 15 months, and we stand to realize a 7.5 million milestone on approval. Additionally, we have the opportunity to earn up to 37.5 million of sales, milestones, and upwardly tiered royalties of between 14 and 20%. Finally, I will wrap up my comments on slide 11. First, upelri is a unique medicine offering a substantial and highly differentiated value proposition. It is the only nebulized llama for COPD maintenance treatment in the U.S., and we believe it is underutilized within the patient populations to which it is best suited. We see long-term growth potential for the product, driving considerable value to TheraVans shareholders. Second, in addition to our co-promotion economics in the US, we potentially stand to achieve milestones and royalties as outlined here, which includes those I referenced in the previous slide associated with the potential new opportunity in China. At this point, I'll turn things over to Aziz for an update on Trilogy. Aziz?