Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVance Biopharma first quarter 2003 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 digits 1-1 on your telephone. 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.

Good afternoon, and thank you for joining the Theravance Biopharma First Quarter 2023 Earnings Conference Call. On slide two, I'd like to 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. Turning your attention to slide three, I'm joined today by Rhonda Farnham, Chief Business Officer, Rick Graham, Senior Vice President of Research and Development, and Aziz Sawaf, Chief Financial Officer. On slide four, I'd like to begin my presentation by focusing your attention on Theravance's immediate future. Those of you who are familiar with the company recognize the tremendous work that our team and partners have done to bring the organization to this point. Through a combination of perseverance and resilience, we're now in a position to focus our energies behind two key initiatives, capitalizing on the tremendous opportunity we have to grow upelry and executing on an unambiguous regulatory pathway for ampriloxetine in multiple systems atrophy patients with symptomatic NOH. These are reflected in the 2023 targets we outlined in our last quarterly call, and I'm pleased to share with you the progress that we've achieved to date. On slide five, beginning with upelry, our team in collaboration with Beatrice turned in a solid quarter with sales up 8% year over year. As we've previously discussed, there are many COPD patients not well controlled on their existing therapy who could benefit from either the addition of or switching to upelry. We bring a coordinated approach to reducing the barriers that prevent patients from receiving upelry and are working diligently to translate this into tangible results. Importantly, we know our hospital customers comprehensively, and we meet them with solutions that fit their individual needs. This quarter, we were successful at driving growth in both the hospital and the community settings, with hospital volumes up 62% and retail patient new starts up 61% year over year. We reached new highs in market share in both the hospital and community settings. Rhonda will go into greater detail regarding upelry's performance and new growth opportunities later in the presentation. However, I'd remind listeners that upelry demand currently doesn't reflect any upside that we may enjoy should our PIFR 2 study be successful. Rick Graham will provide an update on PIFR 2 later in the presentation. On slide six, while we're excited about UPelry's continued performance, we're just as excited for the potential of ampryloxetine success in Cyprus. We worked extremely hard to optimize a phase three design in consultation with the FDA and believe the results from this study could support a full approval for MSA patients suffering from symptomatic NOH. We're pleased with the progress we've made, having now opened the study and plan to continue to add a number of important recruitment sites in the coming weeks. We've also submitted a request for an orphan drug designation and expect to hear back from the FDA sometime this quarter. As Rick Graham will discuss, amproloxetine has the potential to offer significant efficacy, safety, and dosing advantages over existing therapies. and could represent a life-changing therapy for MSA patients with symptomatic NOH. We project that enrollment in Cypress will be complete by the second half of 2024 and look forward to providing additional guidance around regulatory milestones and commercial plans as we move forward. Now, turning to slide seven, I'd like to offer a brief update on our capital allocation strategy and financial condition. Year-to-date, through the end of April, we've returned approximately $215 million to shareholders through our share repurchase program. We remain on track to return the $110 million that remains outstanding by the end of the year. Importantly, we are doing this from a position of financial strength. We have positioned ourselves by reducing our expense base and remain on track to reach non-gap profitability on an ongoing basis sometime in the second half of the year. Finally, I'd like to publicly welcome Jim Kelly of Weiss Asset Management to our board and express my enthusiasm for the contributions that we expect from Jim, Susanna Gray, and our other board members that continue to make. Jim brings a unique skill set and shareholder perspective to the board, as well as remarkable energy. With that, I'll now hand the call over to Rhonda to review UPelry's first quarter 2023 performance and the opportunities we see to deliver robust growth for the remainder of the year and beyond. Rhonda?

Thanks, Rick. Moving to slide nine, we are pleased to share the latest performance for UPelry. During the quarter, total net sales of UPelry reached 47 million, up 8% year-over-year. TheraVance's implied 35% share of net sales for Upelri during the first quarter of 2023 was $16.4 billion. As a reminder, TheraVance and Vietris co-promote Upelri in the United States. TheraVance's commercial and medical teams covering the hospital segment, and Vietris is responsible for outpatient-based community healthcare needs and promotion for the product. This quarter, as we expected and previously communicated, seasonal factors impacted reported upelary net sales. Changes in ordering patterns, which are typical of the pharmaceutical business and often more pronounced during the first quarter, had a larger than normal effect this period. However, we remain confident that our team will deliver strong upelary performance for the year based on a number of positive key performance indicators. To this end, commercial, I'm sorry, customer demand, once again increased quarter over quarter, and as well, we'll show later in the presentation, patient fulfillment continues to reach new highs. As Rick mentioned in his opening comments, we have formulated a winning strategy for driving upillary growth in the hospital setting. We focus our efforts in a number of areas, including formulary wins, clinical pathways, and discharge planning protocols, all with a goal of making upillary available to COPD patients who may benefit from the only once-a-day long-acting nebulized LAMA. Looking at Theravance's hospital results on the right side of slide nine, and doses sold exclusively in the hospital setting represented an increase of 15% from the previous quarter and 62% compared to the same period a year ago, therein reaching the highest quarterly total launched to date. We have driven significant growth in UPelry's hospital business every quarter since the third quarter of 2020, the point at which our team was able to re-engage more fully following the initial impact of COVID. Launched to date, Theravance has secured 616 hospital formulary wins, leading to approximately 1,350 hospital outlets purchasing UPelry. By comparison, We reported 580 formulary wins and approximately 1,200 purchasing hospital outlets at the end of 2022. Turning to slide 10, UPelry's share of the long-acting nebulized market in the hospital setting once again reached a new record high of 15% in Q1 of 2023. We believe these account wins and forthcoming system additions will yield continued growth through 2023 as UPelry will be the first llama of choice in many hospitals due to the growing recognition and acceptance of upelry's clinical benefits and once daily value proposition. As a key component of the joint strategy between the Theravance and Viatras team, data continue to show that approximately 90% of patients receiving upelry in the hospital setting are discharged with a prescription to continue their treatment in the outpatient setting. allowing for continuity of upelry maintenance therapy post-hospitalization. Reflecting further on the outpatient care setting, upelry's market share in the overall community setting increased to 27.7% through January of 2023, which is our latest data point. We have also been encouraged by the growth trend seen specifically in the retail channel as Q1 total prescriptions grew quarter over quarter, while historically, script volumes have decreased in the first quarter due to seasonal factors. On slide 11, we provide a snapshot of UPelRe retail new patient starts, which during the first quarter increased a robust 61% year-over-year and 23% quarter-over-quarter. New patient starts are key to future performance, and the recent exceptional growth can be attributed to the realization of new commercial initiatives, which include concomitant use education, expansion into additional site of care channels, and additional focus on fulfillment support. Looking beyond this quarter's success, there still exists significant long-term growth opportunities for UPLRE. Starting with the current long-acting nebulized patient population, we expect our market share to continue to grow both from switches as well as an add-on therapy with further deployment of concomitant use education. There are also many patients inappropriately using short-acting nebulized treatments for maintenance who may benefit from switching to a once-a-day long-acting therapy such as Eupolri. Lastly, there are even more patients on handheld maintenance regimens that remain uncontrolled due to a number of reasons, including dexterity challenges, cognitive impairment, and or low peak inspiratory flow. In total, these patient segments represent a sizable niche opportunity for UPelry, and we've only started to scratch the surface. Given this significant remaining opportunity, we expect to be able to continue, if not accelerate, the pace of UPelry's adoption moving forward. One of the ways in which we plan to do so is by making available and communicating data from our phase four PIP for two study, results of which we expect later this year. With that, I will turn the presentation over to Rick Graham.