Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVance Biopharma first quarter 2022 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 on your phone. Again, that's 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 call is being recorded. And now I would like to turn the call over to Gail Cohen, Vice President, Corporate Communications. Please go ahead.

Good afternoon, and thank you for joining the Theravance BioPharm, our first quarter 2022 conference call to discuss our business. As always, I remind you that this call will contain forward-looking statements that involve risks and uncertainties, including statements about our development pipeline, expected benefits of our products, anticipated timing of clinical trials, regulatory filings, and expected financial results. Information concerning factors that could cause results to differ materially from our forward-looking statements is described further in our filings with the SEC. I would direct your attention to slide three. Joining us are Rick Winningham, Chief Executive Officer, followed by Rhonda Farnham, Senior Vice President, Chief Business Officer, Rick Graham, Senior Vice President, Research and Development, and Andrew Hyman, Chief Financial Officer. Now, I will hand the call to Rick Winningham for opening remarks.

Thanks, Gail. I'm turning to slide four. Last September, we announced the restructuring of the company to optimize our business. Since then, we've rapidly transitioned to a focused and streamlined TheraVance Biopharma. We're focused on leveraging our expertise in developing and commercializing respiratory therapeutics. We've streamlined our R&D investments to concentrate on highest value opportunities, and we're exploring strategic partnerships for our pipeline assets to unlock additional value. All of these actions drive towards our goal to maximize shareholder value. There are three key pillars of value creation as highlighted on slide five for the go-forward plan that builds on our proven record of respiratory innovation supporting several approved medicines for COPD and asthma. These pillars include Upelri, which was discovered and developed by TheraVets Biopharma as commercialized in partnership with Beatrice. Upelri has continued quarter-over-quarter market share growth despite the respiratory pandemic. Bellside analysts covering Theravance Biopharma estimate Upelri has the potential to generate U.S. peak sales of approximately $400 million annually. We announced in early January the enrollment of the first patient in the Upelri Phase 4 PIFR2 study. The study's successful, or an addressable U.S. market could potentially include all patients with low peak inspiratory flow, which is estimated to be one in five patients with COPD. The impact of this study, obviously, is not included in current analyst peak sales estimates. Rhonda will speak to UPelry's successes from this most recent quarter. Second, our pipeline, our second pillar of value creation, includes our most advanced respiratory candidate, Nezalcetinib, our dry powder inhaled JAK inhibitor program, which we have said before, we'd advance a drug candidate into the clinic with a strategic partner. It also includes amproloxetine, an investigational Theravance Biopharma discovered once daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension, or NOH. Results from a phase three study of amproloxetine we reported last month showed a benefit in patients with multiple systems atrophy. Rick Graham will walk through the data and the next steps for that program. And the third pillar is our economic interest in Trilogy, a respiratory medicine developed by GlaxoSmithKline, also known as GSK, in collaboration with the company's predecessor, Theravance Inc., now known as InnoViva. Trilogy is the first and only once-daily single inhaler triple combination therapy approved for the treatment of COPD and asthma and is owned, controlled, and marketed globally by GSK. Given the strength of the clinical data underlying Trilogy and its indicated uses, coupled with GSK's commercial excellence, Trilogy continues to experience exceptional revenue growth trends, even in the face of the global respiratory pandemic. At present, GSK sell-side analysts project that Trilogy could generate global peak sales of $3.5 billion annually. Andrew will review Trilogy's first quarter performance of 2022, as well as review Theravance financials. We continue to believe in the strong and growing cash flows of UPelri and Trilogy, and the expected future robust revenue performance for both, coupled with several sources of potential upside in our development pipeline, can generate significant value creation opportunities for our shareholders. I'll now turn the call over to Rhonda to review UPelri.