Theravance Biopharma, Inc. (NASDAQ:TBPH) Q2 2023 Earnings Call Transcript
Theravance Biopharma, Inc. (NASDAQ:TBPH) Q2 2023 Earnings Call Transcript August 7, 2023
Operator: Ladies and gentlemen, good afternoon. I'd like to welcome everyone to Theravance 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. [Operator Instructions] 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.
Rick Winningham: Good afternoon, and thank you for joining the Theravance Biopharma's 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 and the 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 Farnum, Chief Business Officer; Rick Graham, Head of Research and Development; and Aziz Sawaf, 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 YUPELRI executing on our in-hospital strategy, while closely collaborating with Viatris, to launch and build momentum behind our Drive Phase 3 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 4 PIFR-2 study for YUPELRI to begin early regulatory and commercial planning for ampreloxetine and obtain non-GAAP profitability subject to YUPELRI's continued growth.
Moving to slide five. I'd like to highlight our 2023 progress today. During the quarter, our commercial team worked closely with our Viatris partners to post solid results for YUPELRI 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 YUPELRI 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 PIFR-2 study, the results of which we expect to communicate early next year.
In addition to having received orphan drug designation for ampreloxetine 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 ampreloxetine's differentiated clinical profile as we approach CYPRESS’ 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 30, 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 YUPELRI's performance and significant opportunity that we see to continue its growth for the foreseeable future.
Rhonda?
Rhonda Farnum: Thanks, Rick. Moving to slide seven. We are pleased to share the latest performance for YUPELRI. During the quarter, total net sales of YUPELRI reached $55 million, up 12% year-over-year. Theravance's implied 35% share of net sales for YUPELRI during the first quarter of 2023 was $19.3 million. As a reminder, Theravance and Viatris copromote YUPELRI in the U.S. with Theravance's commercial and medical teams covering the hospital segment and Viatris being responsible for outpatient-based community health care 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 YUPELRI growth in the hospital setting. We focus our efforts on a number of areas, including formulary wins, clinical pathways and discharge planning protocols, all with the goal of making YUPELRI available to COPD patients, who may benefit from the only long-acting nebulized LAMA. 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. YUPELRI'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 YUPELRI will be the first LAMA of choice in many hospitals due to the growing recognition and acceptance of YUPELRI's clinical benefits and once-daily value proposition. As a key component of the joint strategy between the Theravance and Viatris teams, data continued to show that the large majority of patients receiving YUPELRI in the hospital setting are discharged with a prescription to continue their treatment in the outpatient setting, allowing for continuity of YUPELRI maintenance therapy post hospitalization. Reflecting further on the community setting, which includes both the retail and DME channel, YUPELRI's market share increased to 29% through May of 2023 based on our latest available data.
On slide nine, we provide a snapshot of YUPELRI retail script performance, which serves as a reliable proxy and a more real-time view of community demand. Those 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 channel, and continued focus on fulfillment support.
Looking beyond this quarter's success, there still exists significant long-term growth opportunities for YUPELRI. 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 education. As we have previously noted, updated 2023 gold guidelines now recommend initial combo LAMA plus LABA therapy for both Group 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 YUPELRI. There are also many patients inappropriately using short-acting nebulized treatment for maintenance who may benefit from switching to a once-a-day long-acting therapy such as YUPELRI, 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, further 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 YUPELRI as the only once-daily nebulized LAMA indicated for COPD maintenance treatment. In particular, we are looking forward to learning the results of the PIFR-2 study, which compares YUPELRI directly to tiotropium administered via a dry powder handheld device in patients with suboptimal peak inspiratory flow. As many of you know, tiotropium is one of the most prescribed LAMA therapies for COPD. At present, we estimate that approximately 60,000 patients are receiving YUPELRI 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 YUPELRI 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 YUPELRI adoption moving forward. With that, I will turn the presentation over to Rick Graham. Rick?
Rick Graham: Thanks, Rhonda. As we've covered in the past, slide 12 illustrates the design of the ongoing Phase 4 PIFR-2 study in patients with severe or very severe COPD and suboptimal peak inspiratory flow rates. Patients are randomized 1:1 to receive either revefenacin via nebulization or tiotropium delivered via dry powder inhaler and the primary endpoint is change from baseline in trough FEV1 at day 85. Enrollment is nearly complete, and we expect to have top line results late in the fourth quarter of the year. We're continuing to work with our partners at Viatris regarding the exact timing of disclosure, but currently intend to disclose results in January of 2024. On slide 13, I'd like to remind our audience briefly of the rationale behind the PIFR-2 study design.
Copyright: jezper / 123RF Stock Photo
Our previously conducted PIFR-1 study published in 2019 included 206 patients, GOLD 2, 3 and 4 status and a peak inspiratory flow of less than 60 liters per minute. GOLD 2 through 4 patients have moderate to very severe COPD and baseline FEV1 of less than 80% of what will be predicted. In PIFR-1 revefenacin treatment did not demonstrate a statistically significant advantage over tiotropium, although there was a numerical trend favoring revefenacin, driven by GOLD 3 and 4 patients with baseline FEV1 of less than 50% are predicted. Importantly, a prespecified analysis of GOLD 3 and 4 patients shown on the right hand figure, demonstrated a clear and clinically relevant treatment benefit of revefenacin over tiotropium. We, therefore, designed the PIFR-2 study in this population of responders.
COPD patients with suboptimal peak inspiratory flow and baseline FEV1 values of less than 50% are predicted. As Rhonda covered in her comments, the positive result from PIFR-2 would provide the commercial organization, a catalyst to help drive YUPELRI uptake in a portion of the maintenance COPD market whose symptoms are inadequately controlled despite treatment with handheld LAMA containing regimen. Turning to ampreloxetine. Slide 15 outlines the design of our registrational study, 197, also known as CYPRESS, for the treatment of symptomatic nOH and MSA patients. Based on the strength of the prior Phase 3 study results and alignment with the FDA on the primary endpoint and study design, we believe the CYPRESS study has a high probability of technical and regulatory success.
The study consists of a 12-week open-label period, followed by an 8-week double-blind placebo-controlled randomized withdrawal phase. The duration of the open-label and randomized withdrawal periods were optimized based on the results from our prior 170 study. Given strong results from the 170 study, the primary efficacy endpoint in CYPRESS is the change in OHSA composite score. The composite score captures a broad set of symptoms and is expected to reduce variability relative to an individual symptom score such as OHSA number one, an endpoint that has been used in other programs. As announced last quarter, the Phase 3 CYPRESS study is open and actively recruiting patients, and we project enrollment to be completed in the second-half of 2024.
I'm proud of the team's accomplishments as they've made good progress in activating multiple clinical trial sites in the U.S. with several are coming online in the near future. We have also made substantial progress with the new centralized EU clinical trial application process and expect to be in a position to activate a large number of EU sites throughout the second-half of this year. As shown on slide 16, we estimate that the addressable patient population for ampreloxetine is between 35,000 and 45,000 individuals in the United States. Despite two approved therapies indicated to treat symptoms of orthostatic hypertension, there remains a significant unmet need, which we believe ampreloxetine could address. First, based on data generated to date, we believe ampreloxetine has the potential to impact multiple symptoms of nOH durably with a favorable safety profile.
Neither approved OH therapy has demonstrated broad and durable symptom relief in patients with nOH, including those with MSA. Second, ampreloxetine is dosed as a single 10-milligram tablet administered once daily. This is especially beneficial for MSA patients with dysphagia, which is a frequent and disabling symptom of the disease. Current therapies typically require patients to take multiple tablets several times a day. Third, patients within nOH are also at risk for supine hypertension, a dangerous decrease in blood pressure while lying down. The two FDA-approved therapies that are used for the treatment of orthostatic hypertension have black box warnings in the label, highlighting the risk and recommending both frequent monitoring and management thereof.
Relative to the current treatment option, ampreloxetine has the potential to decrease the risk of in hypertension. At night, ampreloxetine remains in the system, resulting from its relatively long half-life. But because the natural norepinephrine levels are reduced during sleep, ampreloxetine does not cause overstimulation and as a result, reduces the risk of hypertension. In fact, in a safety database of more than 800 patients in healthy subjects, no signal for supine hypertension has been observed with ampreloxetine treatment. As we enter a new era in treating MSA symptoms, we believe ampreloxetine offers hope to MSA patients with symptomatic nOH. On slide 17, we summarize how the current treatment landscape translates into opportunity for ampreloxetine owing in parts only two therapies being FDA-approved, coupled with our limited effectiveness as well as safety and tolerability issues, treatment tends to be highly individualized in nOH.
Issues such as inconsistent response to therapy and the risk of supine hypertension, complicated medical management and lead to high administrative burden. Depending on their experiences, patients may remain on therapy for only a short duration. Based on our clinical experience with ampreloxetine to-date, we believe that it offers significant potential to improve both the number of symptomatic MSA patients treated with pharmacotherapy for nOH and both compliance and persistence rates amongst those treated. Ampreloxetine appears to be safe and well tolerated, and given its differentiated efficacy and safety profile, we are optimistic that it will yield clinically relevant and durable benefit for patients. I'll now turn the call over to Aziz to review the financials.
Aziz Sawaf: Thanks, Rick. On slides 19 and 20, you can find our financial results for the quarter, which came in line with our expectations. Skipping ahead to the highlights on slide 21, our collaboration revenue recognized through our Viatris partnership grew 26% in the quarter to $13.7 million. As a reminder, while this figure incorporates 35% of YUPELRI net sales as recorded by Viatris, it may fluctuate from quarter-to-quarter due to the shared expenses we and Viatris reimbursed each other under the terms of our collaboration. During the quarter, our operating expenses, excluding stock-based comp and non-recurring items were approximately $22 million, down from $27 million in Q1 2023 and landing us in line with internal expectations and on track to meet our 2023 guidance.
Stock-based comp, excluding restructuring expenses declined 21% year-over-year and including restructuring expenses which were incurred in 2022 and not in 2023, our stock-based comp declined 35% year-over-year. One item to call out that was not in our previous guidance is a $1.2 million non-recurring charge related to the sale of lab equipment in the quarter. While generating an accounting loss, the sale actually brought in approximately $1.5 million of net cash proceeds. As mentioned on previous calls, we do not anticipate incurring any additional cash related restructuring costs in the future. Our non-GAAP loss in the quarter was $7.4 million, and excluding the aforementioned noncash nonrecurring accounting charge, our non-GAAP loss would have been $6.2 million.
We ended Q2 with $167 million of cash and equivalents, no debt and 53.7 million shares outstanding, reflecting a 30% reduction in share count year-over-year due to the continued progress of our share buyback program. Looking ahead, we are maintaining our operating expense guidance for the year, excluding share-based comp and onetime items. As we have previously mentioned, R&D expense should be steady in the third quarter before beginning to build into year-end. We expect SG&A to slightly decline in Q3 and Q4 and remain relatively steady throughout the remainder of the year. As Rick mentioned earlier, we continue to expect to generate non-GAAP profitability in the second half of the year, which will be primarily driven by the expectation of increased net sales growth from YUPELRI.
Turning to slide 23 for a brief update on our capital return program. We bought back over 80 million worth of shares in the quarter leaving us with $61 million left on our authorization and bringing the total capital return since inception to $264 million. We continue to expect to complete the program by year-end. Finally, on slide 24, I'd remind everyone of our potential to earn milestones and royalties on global net sales of TRELEGY realized by GSK. Beginning this year and extending through 2026, we have the potential to earn up to $250 million in sales milestones depending on TRELEGY's performance. In the second quarter, TRELEGY's sales reached $760 million, up 29%, and year-to-date sales reached approximately $1.3 billion, up 27%. While it is still unclear whether we will achieve the first of the milestones in 2023, we are increasingly optimistic based on TRELEGY's continued strong growth that we should achieve at least some of the sales milestones between now and 2026 available to us through our arrangement with Royalty Pharma.
With that, I'll turn the call back to Rick for closing remarks. Rick?
Rick Winningham: Thanks, Aziz. I'm happy to share that the second quarter of 2023 represented a strong example of how Theravance's focused strategy positions the company and its shareholders to benefit from balanced value creation. YUPELRI enjoyed good growth this quarter, owing to solid execution by our commercial partnership and continued messaging around concomitant use with nebulized LAMAs. On top of this, we also see a substantial opportunity to replace inappropriate use of short-acting therapies as maintenance and handheld devices where nebulized therapy may offer clinical advantages. We continue to work hard to advance the CYPRESS study, such that we might make this important therapy available more broadly, and we look forward to sharing further details on the program in the coming months.
Finally, it's heartening to see TRELEGY growing so strongly with several important financial milestones right around the corner. We're delivering all this from a position of solid -- from a solid financial position and having returned over $260 million of cash to our shareholders through our capital returns program, while reducing our ongoing expense base significantly. We appreciate both your interest and support as we continue on Theravance's new growth trajectory. Thank you all for joining us today, and I'll now hand the call back to the operator for questions.
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