Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVance Biopharma first 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 star key followed by the digit 11 on your phone. Again, that's star 11 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 the instructions after the management completes their prepared remarks. Also, today's conference call 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 TheraVest Podcast. first quarter 2024 earnings results conference call. On slide two, you'll find our safe harbor language. And I'd remind everyone that are called today, we'll include forward-looking statements involving risks and uncertainties pertaining to our development pipeline, expected benefits of our product candidate, anticipated timing of clinical trials, regulatory filings, and expected financial results. information concerning factors that could cause results and differ materially from our forward-looking statements is described further in our filings with the sec now please turn to slide three because joining me today on today joining me on the call today or audio miller our head of development uh rod de farnham theravance's chief business officer and aziz saw off our chief financial officer Next, on slide four, I'll begin with a recap of our first quarter highlights before turning the call over to the rest of the team. As you can see on the left side of the slide, we made good commercial progress with UPelry during the quarter, achieving $55.2 million in net sales in partnership with Vietris. This translates into 18% year-on-year growth. Our team at Theravance got off to a terrific start this year in the hospital setting. again achieving another all-time high in terms of hospital doses sold in the quarter, up 31% from the prior year. In addition, we continue to expect our partners at Vietris to complete a regulatory filing for Eupelri in China by mid-year, based on the strong Phase III results announced last November. Turning to ampryloxetine, in the middle of the slide, We're very excited to be hosting a dedicated virtual investor event on May 23rd at 10 a.m. Eastern. We're two thought leaders in the field of autonomic dysfunction. As well as our team at Theravance, we'll discuss the compelling science behind Amperlochstein's opportunity to address the unmet need in NOH and MSA patients. We continue to work diligently to complete the registrational phase three Cypress study, with the last patient planned to be enrolled in the second half of this year, as well as put in place the regulatory and commercial framework that will enable TheraVans to make ampryloxidine available quickly and broadly should Cypress be successful. Finally, we delivered another strong order of financial performance, driven in equal parts by good upel regrowth and expense management. Despite experiencing some seasonal transitioning from quarter four to quarter one, which is typical of the pharmaceutical business, we realized a limited cash burn, ending the period with $100 million in cash and no debt. As Aziz will discuss later, Trilogy turned in a fantastic performance, which makes us increasingly optimistic for the value that that product stands to deliver to TheraVan shareholders in the future. Turning to slide five, I'll briefly touch on how our strategic imperatives position Theravance to deliver compelling value to shareholders over both the near and the long term. We have a detailed plan in place to continue upelry's growth for the foreseeable future while still delivering on expanded profitability and cash returns to the company. Over the past 12 months, U.S. upelry sales have increased 12%. 229 million while the collaboration revenues we recognize from viatris have increased 27 percent we are expecting top line data from the cipher study in 2025 if successful we'll act decisively with our regulatory and pre-commercialization strategies in order to bring about amperlockstein successful filing and launch as disease will also discuss we will execute this strategy while deploying our capital in a way that maintains the company's strong financial position throughout. We believe we're well-positioned to achieve significant milestones in the coming years, as well as meaningful royalties on Upelry and Trilogy in the future. With that, I'd like to turn the call over to our head of development, Anya Miller, who will provide some brief comments on Amproloxatine. Anya?

Thanks, Rick. As Rick indicated, I'm going to keep my comments brief this afternoon, recognizing that in a short 10 days, we'll be providing an extensive overview of the amperloxidine program, including our ongoing registration of study Cypress and how we are seeking to address the unmet need for MSA patients with symptomatic NOH. In Cypress, we continue to activate sites and progress enrollment. We are closely engaged with these sites in order to enroll the right patients and ensure data quality. We continue to be pleased with our progress and maintain the expectation of completing enrollment of the open label portion of the study during the second half of the year. Also, we continue to prepare for our possible NDA filing shortly on the heels of learning the CIPRS results. As we have discussed in the past, we have generated much of the data required for other elements of the submission beyond the CIPRS data and are already in the process of authoring the NDA. Finally, given our decision to work directly with these investigators and sites who treat substantial numbers of MSA patients with symptomatic NOH, we are able to coordinate with our analytics and market access teams in order to begin positioning Amproloxidine for broad availability should Cypress be positive. On slide eight, you'll see the details of the upcoming investor event on May 23rd to discuss the role Amproloxidine stands to play in addressing the unmet need in MSA patients with NOH. It's a virtual event and it begins at 10 a.m. Eastern. We have prepared remarks for roughly the first 60 minutes before opening it up to a question and answer session. I'd encourage those listening to sign up and to participate in the session and come prepared to ask questions of our key opinion leaders, Dr. Horacio Kauffman and Dr. Italo Biagio, who have agreed to share their insights. We believe this will be an informative session that sets the stage for the countdown to Cyprus data in 2025. With that, I'll turn the call over to our Chief Business Officer, Rhonda Farnham, who will cover our upellery performance during the course. Rhonda?