Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVans Biopharma First Quarter 2021 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 Biopharma First Quarter 2021 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 can cause results to differ materially from our forward-looking statements is described further in our filings with the FDC. Now, I would direct your attention to slide three. Joining us are Rick Winningham, Chief Executive Officer, followed by Rick Bram, Senior Vice President Development, Frank Pascalone, Chief Business Officer, and Andrew Hyman, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. Now, I will hand the call to Rick Winningham for opening remarks.

Thanks, Gail. 2021 is a pivotal year as we progress on the strategy of approaching drug development differently. We're pioneering a new generation of small molecule medicines designed to better meet patients' needs, and this year, driving several clinical study readouts over the next several months. We believe we can deliver medicines that can make a difference because of how we approach the drug design process, as highlighted on slide four. By harnessing our deep understanding of chemical design and the intersection of that design with disease biology, our novel compounds are first delivered to an area in which the disease is active. Thinner molecules are uniquely designed to optimize the activity exposure relationship in the organ of interest while simultaneously minimizing activity outside the targeted disease area. This precise approach aims to expand the therapeutic index of a treatment, which is typically a narrow window for systemic drugs to potentially result in better efficacy and fewer side effects. As I said, the process starts with an understanding of the underlying disease, constructing a molecule in anti-inflammatory space to modify inflammation in specific tissue, whether targeting tissues of the lung, the gut, the eye, or the skin, We rely on our in-house proven translational science and development expertise, complemented by strategic partnerships to create proprietary medicines of unique value to patients, healthcare professionals, payers, and hence investors. We will have three important clinical studies reporting data beginning in the second quarter and throughout the balance of the year. Moving to slide five, you can see all of our key programs. First, let me address the delay in the Crohn's program. Like many working to deliver better treatments to the Crohn's community, we've experienced recruitment challenges. We're working as expeditiously as possible to complete enrollment in order to deliver top-line results for the Isoncetinib program in Crohn's in late 2021 or early first quarter 2022. Outside the Crohn's program, we're delivering on our strategic priorities and remain focused on creating significant value for our shareholders in three ways. As noted on slide six, first, commercial performance, even during a respiratory pandemic for a COPD treatment like upelry, as we shared in the third quarter of 2020, has been contributing to the change of TheraVance Biopharma's financial complexion. As we started 2021, the upelry market share in retail and durable medical equipment segment moved to its highest level in January, 19% since the launch of the brand. As pulmonologists begin to see more moderate to severe COPD patients again and refocus their practice, Upelri is positioned to provide benefit to patients who require the medicine, whether it's through increased hospital admissions or office visits. Second, will deliver on key inflection points for programs that have been a major focus of the company. Amproloxatine, a wholly-owned transformational product in rare disease and symptomatic NOH, with Phase III data in Study 169. Delivering on the promise of unique organ-selective medicine for IBD, complemented by a partnership with a market leader, Janssen, for Isoncetinib and ulcerative colitis, And the immediate future, phase two data on Nezalcetinib, an inhaled novel JAK inhibitor targeted at stopping pulmonary hyperinflation of the lung. And third, Trilogy, driven by the launch of asthma, continues to grow, providing a source of capital for our business. Given the importance of the development pipeline delivering on the key data readouts throughout the remainder of 2021, I'll turn the call over to Rick Graham, Senior Vice President of Development. Rick will begin by highlighting the key timelines and reasons why TVPH is excited about the readouts. Following Rick, Frank will review the UPelry first quarter commercial results. And finally, Andrew will review our financial results and guidance. Rick.