Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to TheraVans Biopharma's second quarter 2023 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, simply press star 11 on your telephone. Again, that's star 11 to ask a question. If you'd like to remove yourself from the queue, simply press star 11 again. And if you're listening via webcast, please mute the audio on your webcast device before asking a question over the phone. I will repeat these instructions after management completes the 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, sir.

Good afternoon, and thank you for joining the Theravance Biopharma second quarter 2023 conference call. On slide two, I'd 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 Fardham, Chief Business Officer, Rick Graham, Head of Research and Development, and Aziz Swaf, Chief Financial Officer. Beginning today's presentation with slide four, we set out earlier this year with three clear strategic objectives in mind to continue to grow UPelry by executing on our in-hospital strategy while closely collaborating with Vietris. to launch and build momentum behind our Phase III Cypress study in MSA patients with neurogenic orthostatic hypotension, and to deliver on our capital returns commitment while managing our expense base. Through the first six months of the year, we've made good progress and remain on track to accomplish these objectives. As we move into the second half of the year, we're also preparing for an exciting new chapter in TheraVance's evolution. In the coming months, we expect to learn the results of our Phase IV PIFR II study for upelry, to begin early regulatory and commercial planning for ampryloxetine, and attain non-gap profitability subject to upelry's continued growth. Moving to slide five, I'd like to highlight our 2023 progress to date. During the quarter, our commercial team worked closely with our V-interest partners to post solid results for upelry, with the brand achieving record performance on a number of key metrics. Net sales increased 12% while delivering strong retail demand growth and achieving new highs in market share within the long-acting nebulization segment. We continue to drive upelry brand awareness for the maintenance treatment of COPD, including its concomitant use with long-acting beta agonist therapy and its adoption amongst patients who have difficulty with handheld devices. Part of this latter population is the subject of our PIFR2 study, the results of which we expect to communicate early next year. In addition to having received orphan drug designation for ampryloctetine in May, we made significant progress with Cypress, opening sites in the U.S. and working with our outside the U.S. regulators to achieve key milestones towards meeting our enrollment objectives. Our teams also submitted abstracts for presentation at medical meetings scheduled for the second half of this year. These are of potential importance in helping establish Amproloxatine's differentiated clinical profile as we approach Cypress's conclusion and potential commercialization. Third, we made good progress on both our capital returns program and on our goal of reaching non-GAAP profitability. As of June 30th, Theravance had returned nearly $264 million through this program. The company remains debt-free and stands to benefit financially from important milestones and royalties derived from assets and territories for which the company's partners carry commercial responsibility. In summary, Our team is working hard and executing well against the priorities we laid out for the year. We remain enthusiastic about the potential catalysts we have before us. As always, we approach these challenges and opportunities with a core mission of delivering medicines which truly make a difference, thereby maximizing the organization's long-term value on behalf of our shareholders. At this point, I'd like to turn the call over to Rhonda to cover UPelri's performance and significant opportunity that we see to continue its growth for the foreseeable future. Rhonda?

Thanks, Rick. Moving to slide seven, we are pleased to share the latest performance for UPelri. During the quarter, total net sales of UPelri reached 55 million, up 12% year over year. Their advances implied 35% share of net sales for UPelri during the first quarter of 2023, with 19.3 million. As a reminder, Theravance and Beatrice co-promote upelry in the U.S. with Theravance's commercial and medical teams covering the hospital segment and Beatrice being responsible for outpatient-based community healthcare needs and promotion for the product. With the return to net sales growth in Q2, we remain confident that our team will deliver strong performance for the year based on a number of positive key performance indicators. To this end, retail patient demand continues to reach new highs. As Rick mentioned in his opening comments, we have formulated and are executing a winning strategy for driving upelry growth in the hospital setting. We focus our efforts on a number of areas, including formulary wins, clinical pathways, and discharge planning protocol, all with the goal of making upelry available to COPD patients who may benefit from the only long-acting nebulized llama. Looking at Theravance's hospital results on the right side of slide seven, Q2 doses sold exclusively in the hospital setting represented a slight 2% decrease from the previous quarter, but increased 45% compared to the same period a year ago. Turning to slide eight, Upelri's share of the long-acting nebulized market in the hospital setting reached an all-time high of 15.2% in Q2 of 2023. We believe a number of new account wins and forthcoming system formulary additions will yield continued growth through 2023 as Upelri will be the first llama of choice in many hospitals due to the growing recognition and acceptance of Upelri's clinical benefits and once-daily value proposition. As a key component of the joint strategy between the TheraVans and Viatris team, data continue to show that the large majority of patients receiving upelri in the hospital setting are discharged with a prescription to continue their treatment in the outpatient setting, allowing for continuity of upelri maintenance therapy post-hospitalization. Reflecting further on the community setting, which includes both the retail and DME channels, upelri's market share increased to 29% through May of 2023 based on our latest available data. On slide nine, we provide a snapshot of UPelRi retail script performance, which serves as a reliable proxy and a more real-time view of community demand. Both total prescriptions and new patient starts continue to reach new quarterly highs during the second quarter. Total scripts increased 7.8% quarter over quarter and 25.9% year over year. while new patient starts increased 5.6% quarter-over-quarter and 53% year-over-year. New patient starts are key to future performance, and the recent exceptional growth in both new patient starts and total prescriptions can be attributed to the realization of new commercial initiatives, which include concomitant use education, expansion into additional site of care channels, and continued focus on fulfillment support. Looking beyond this quarter's success, there still exists significant long-term growth opportunities for UPel REIT. On slide 10, starting with the current long-acting nebulized patient population in the upper left corner, 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. As we have previously noted, Updated 2023 gold guidelines now recommend initial combo LAMA plus LABA therapy for both groups B and E, yet a substantial number of patients in these groups remain symptomatic on nebulized LABA monotherapy and could receive additional benefit from adding new pillory. 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 upelre. These are patients who are obviously familiar with nebulized therapy and have a reason to be using a nebulizer, but choose to rely on short-acting therapies, which typically require four to six administrations daily versus transitioning to a once-a-day maintenance therapy. Lastly, there are even more patients on handheld-only maintenance regimens that remain symptomatic due to a number of reasons, including dexterity challenges, cognitive impairment, and or suboptimal peak inspiratory flow. We believe that this population could benefit by switching to nebulized therapy involving upelria as the only once-daily nebulized LAMA indicated for COPD maintenance treatment. In particular, we are looking forward to learning the results of the PIPR-2 study, which compares upelary directly to teatropium administered via a dry powder handheld device in patients with suboptimal peak inspiratory flow. As many of you know, teatropium is one of the most prescribed LAMA therapies for COPD. At present, we estimate that approximately 60,000 patients are receiving upelary therapy, representing only a small fraction of the sizable niche opportunity these patient segments represent. In aggregate, we size the addressable patient population at approximately 2 million potential patients for whom upelarine may be appropriate, suggesting we've only started to scratch the surface. Given the significant remaining opportunity, we expect to be able to continue, if not accelerate, the pace of upelarine adoption moving forward. With that, I will turn the presentation over to Rick Graham. Rick?