Theravance Biopharma Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 7, 2023

There are 8 speakers on the call.

Operator

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to Theravance Biopharma 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. Also, today's conference call is being recorded.

Operator

And now I'd like to turn the call over to Rick Whittingham, Chief Executive Officer. Please go ahead, sir.

Speaker 1

Good afternoon and thank you for joining the Theravance Biopharma's 2nd quarter 2023 Conference Call. On Slide 2, 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 as described further in our filings with the SEC. Turning your attention to Slide 3, I'm joined today by Rhonda Fardim, Chief Business Officer Rick Graham, Head of Research and Development and Zvi Swoff, Chief Financial Officer. Beginning today's presentation with Slide 4, we set out earlier this year with 3 clear strategic objectives in mind to continue to grow YUPELRI by executing on our in hospital strategy, while closely collaborating with Viatris.

Speaker 1

To launch and build momentum behind our 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 1st 6 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 II study for YUPELRI to begin early regulatory and commercial planning for ampreloxetine and attain non GAAP profitability subject to YUPELRI's continued growth. Moving to Slide 5, I'd like to highlight our 2023 progress to date.

Speaker 1

During the quarter, our commercial team worked closely with our Beatrice 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 PIFR2 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.

Speaker 1

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.

Speaker 1

These are of potential importance in helping establish ampreloxetine's differentiated clinical profile as we approach Cypress' conclusion and potential commercialization. 3rd, 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 $264,000,000 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.

Speaker 1

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?

Speaker 2

Thanks, Rick. Moving to Slide 7, we are pleased to share the latest performance for YUPELRI. During the quarter, total net sales of YUPELRI reached $55,000,000 up 12% year over year. Theravance has implied 35% share of net sales for YUPELRI during the Q1 of 2023 was 19,300,000 dollars As a reminder, Theravance and Beatrice co promote YUPELRI in the U. S.

Speaker 2

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 YUPELRI 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 a goal of making YUPELRI available to COPD patients who may benefit from the only long acting nebulized LAMA.

Speaker 2

Looking at Theravance's hospital results on the right side of Slide 7, 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 8, YUPELRI's share of the long acting nebulized market in the hospital setting reached an all time high of 15 point 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 1st llama 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 team, data continue 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.

Speaker 2

On Slide 9, we provide a snapshot of YUPELRI 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 Q2. 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.

Speaker 2

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 YUPELRI. 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 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 4 to 6 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.

Speaker 2

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 PIPR2 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 sized the addressable patient population at approximately 2,000,000 potential patients for whom YUPELRI may be appropriate, suggesting we've only started to scratch the surface.

Speaker 2

Given the significant remaining opportunity, we expect to be able to continue, if not accelerate the pace of YUPELRI's adoption moving forward. With that, I will turn the presentation over to Rick Graham. Rick?

Speaker 3

Thanks, Rhonda. As we've covered in the past, Slide 12 illustrates the design of the ongoing Phase 4 PIFR2 study in patients with severe or very severe COPD and suboptimal peak inspiratory flow rates. Patients are randomized 1 to 1 to receive either revafenacin via nebulization or tiotroprium 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 Q4 of the year. We're continuing to work with our partners at Beatrice regarding the exact timing of disclosure, but currently intend to disclose results in January of 2024.

Speaker 3

On Slide 13, I'd like to remind our audience briefly of the rationale behind the PIPR2 study design. Our previously conducted PIPR1 study published in 2019 included 206 patients, GOLD2, 3 and 4 status and a peak inspiratory flow of less than 60 liters per minute. GLD-two-four patients have moderate to severe moderate to very severe COPD and baseline FEV1 of less than 80% of what would be predicted. In PIFR1, revafenacin treatment did not demonstrate a statistically significant advantage over tatropium, although there was a numerical trend favoring revafenacin, driven by GOLD34 patients with baseline FEV1 of less than 50% of predicted. Importantly, a pre specified analysis of GOL-three and 4 patients shown on the right hand figure demonstrated a clear and clinically relevant treatment benefit of rivafenasan over tatropion.

Speaker 3

We therefore designed the PIPR2 study in this population of responders. COPD patients with suboptimal peak inspiratory flow and baseline FEV1 values of less than 50% of predicted. As Rhonda covered in her comments, a positive result from PIFR2 would provide the commercial organization a catalyst to help drive YUPELRI update in a portion of the maintenance COPD market whose symptoms are inadequately controlled despite treatment with handheld LAMA containing regimens. Turning to ampreloxetine. Slide 15 outlines the design of our registrational Study 197, also known as Cypress for the treatment of symptomatic nOH in MSA patients.

Speaker 3

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 Cyprus 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 1, an endpoint that has been used in other programs.

Speaker 3

As announced last quarter, the Phase 3 Cyprus study is open and actively recruiting patients and we project enrollment to be completed in the second half of twenty twenty four. 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 more 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.

Speaker 3

As shown on Slide 16, we estimate that the addressable patient population for ampreloxetine is between 35,045,000 individuals in the United States. Despite 2 approved therapies indicated to treat symptoms of orthostatic hypotension, 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. 2nd, ampreloxetine is dosed as a single 10 milligram tablet administered once daily.

Speaker 3

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. 3rd, patients with nOH are also at risk for supine hypertension, a dangerous increase in blood pressure while lying down. The 2 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 options, ampreloxetine has the potential to decrease the risk of supine hypertension.

Speaker 3

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 and 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 2 therapies being FDA approved, coupled with their limited effectiveness as well as safety and tolerability issues, treatment tends to be highly individualized in nOH.

Speaker 3

Issues such as inconsistent response to therapy and the risk of supine hypertension complicate 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.

Speaker 4

Thanks, Rick. On slides 1920, 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 13,700,000 dollars As a reminder, while this figure incorporates 35 percent of YUPELRI net sales as recorded by Beatrice, it may fluctuate from quarter to quarter due to the shared expenses we and Beatrice reimburse each other under the terms of our collaboration. During the quarter, our operating expenses excluding stock based comp and non recurring items were approximately $22,000,000 down from $27,000,000 in Q1 2023, 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.

Speaker 4

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 $1,200,000 non recurring charge related to the sale of lab equipment in the quarter. While generating an accounting loss, the sale actually brought in approximately $1,500,000 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 $7,400,000 and excluding the aforementioned non cash non recurring accounting charge, our non GAAP loss would have been 6,200,000 dollars We ended Q2 with $157,000,000 of cash and equivalents, no debt and 53,700,000 shares outstanding, reflecting a 30% reduction in share count year over year due to the continued progress of our share buyback program.

Speaker 4

Looking ahead, we are maintaining our operating expense guidance for the year, excluding share based comp and one time items. As we have previously mentioned, R and D expense should be steady in the Q3 before beginning to build into year end. We expect SG and 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.

Speaker 4

We bought back over 80,000,000 worth of shares in the quarter, leaving us with $61,000,000 left on our authorization and bringing the total capital return since inception to $264,000,000 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 $250,000,000 in sales milestones depending on TRELEGY's performance. In the Q2, Trelegy sales reached $760,000,000 up 29% and year to date sales reached approximately $1,300,000,000 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.

Speaker 4

With that, I'll turn the call back to Rick for closing remarks. Rick?

Speaker 1

Thanks, Aziz. I'm happy to share that the Q2 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 lavas. 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, but 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.

Speaker 1

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 $260,000,000 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.

Operator

Certainly. And our first question comes from the line of David Risinger from Leerink. Your question please.

Speaker 5

Yes. Thanks very much and thank you for the update. So I have a few questions please. First, with respect to the revenue prospects for the business, could you talk about how we should think about year over year revenue growth potential in coming quarters relative to the rate of growth that you booked in revenue in the second quarter? And then second, with respect to the SG and A spending, that was $30,000,000 in the first half of twenty twenty three excluding stock based comp.

Speaker 5

The guidance is for $45,000,000 to $55,000,000 for the year. So at the midpoint of that guidance at $50,000,000 that would reflect a meaningful step down in SG and A spending in the second half versus that $30,000,000 in the first half. If you could comment on that and help us think about how we should think about prospects for SG and A spending, both in the Q3 and the Q4, I. E, is one going to be higher than another for some reason? Thank you very

Speaker 1

much. Aziz, you want to take the revenue and then bridge over to SG and A?

Speaker 4

Yes, sure. I can comment on the collaboration revenue and the net sales. So, David, as we've talked about before, I think there's the gap between the 35% of the net sales and our collaboration revenue has been around $5,000,000 or $6,000,000 and that's been consistent over the past year or so. That gap will probably remain pretty consistent going forward into the outer years. So the way in which you would model the collaboration revenue going forward is just whatever incremental dollar of net sales, 35% of that gets added to the collaboration revenue.

Speaker 4

In other words, that gap the gap between the 35% and the collaboration revenue should remain steady. So if you want to model in next year, just take the incremental sales amount times it by 35% and add it to the collaboration revenue and that will get your model out to next year and beyond for collaboration revenue. Now we're still in the process of going through the budget with Beatrice, the shared budget that does affect that gap between the 35% of the sales and the collaboration revenue, but I don't expect to be a meaningful change to the underlying shared expenses related to the collaboration. So that's question 1. The second question is a good question about the SG and A.

Speaker 4

As I mentioned during the call, I do expect SG and A spend to go down in Q3 and Q4. For overall spend, we are very much in line with our guidance of kind of $90,000,000 at the midpoint. We're trending a little bit lighter on the R and D side and a little bit higher on the SG and A side. Part of that for SG and A relates to this an allocation issue between R and D and SG and A. After the research restructuring in Q1, as a proportion of the overall company, R and D is smaller and therefore just gets allocated, lesser amounts of the kind of overhead costs, which gets shifted over to SG and A because it becomes a greater proportion of the overall company, even though the actual overhead costs don't change at all.

Speaker 4

So it's just kind of some shifting of the dollars between R and D and SG and A artificially as a result of the research restructuring. So that's one reason. But if you think about the SG and A in Q3 and Q4, it should be pretty similar in Q3 and Q4. It's going to go down from Q2. But again, the big picture is we're right in line from a total expense perspective related to guidance.

Speaker 4

We're slightly below for R and D and slightly above, but all within the ranges that we've provided before. So hopefully that provides a bit of color for you, David. Great. Thank you very much. And David, just to

Speaker 1

Yes, to add just a bit more on drivers of sales growth and Rhonda talked about this during her section. If you really look at the sales right now of nebulized long acting beta agonist, which are generic and current goal guidelines and then the fact that nearly 50% of our Phase 3 program had concomitant use of either a beta agonist or beta agonist plus inhaled corticosteroid. The use of YUPELRI with nebulized long acting beta agonist that patients adhering to gold guidelines and physicians adhering to gold guidelines can serve as a significant driver of revenue growth for us going forward with YUPELRI. And that's setting aside the opportunity Rhonda spoke about with short acting nebulized medications that are currently and appropriately being used as maintenance therapy. And then any lift that we can get from the PIFR2 study should be positive.

Speaker 5

Got it. Thank you,

Speaker 4

Rick. Yes.

Speaker 1

Next question, operator?

Operator

Yes, sorry. Our next question comes from the line of Douglas Tsao from H. C. Wainwright. Your question please.

Speaker 6

Hi, good afternoon. Thanks for taking my question. Just maybe starting with, as a follow-up to the last one in terms of how we should think about your share of the collaboration revenue versus your sort of the implied revenue share. I think you said that it's been about $5,000,000 to $6,000,000 on a quarterly basis. Should we think about it in terms of absolute dollars?

Speaker 6

Or does it come a point where we should just think about it as a certain percent change? And over time, should that sort of narrow as we get increased profitability in that business through economies of scale or leverage in the business?

Speaker 4

Yes. Thanks, Doug. So I would as I mentioned to David a second ago, it's from an absolute basis. So that $5,000,000 or $6,000,000 should stay consistent. In other words, if YUPELRI sales go up $100,000,000 making up an extreme example, the gap between 35% of the sales and the collaboration revenue will still be $5,000,000 Now the percentage from a relative basis, it will be very minor, but the nominal absolute number will still be 5%.

Speaker 4

So when YUPELRI starts to grow more materially in the future, this gap will be less relevant, right? It will be from a percentage standpoint or relative standpoint be somewhat unmeaningful. Does that help, Doug?

Speaker 6

Yes, that does. And could you provide just a comment in terms of how YUPELRI is doing from a gross to net standpoint right now?

Speaker 4

Yes, Rhonda. Yes.

Speaker 1

I think that go ahead Aziz.

Speaker 4

Yes. So we can't and I'll pass it on to Rhonda for additional commentary here. But we don't comment on gross to net. That's something that Beatrice manages. But I think in terms of ASP, I think it's safe to say that Beatrice has done a nice job keeping ASP relatively stable over time.

Speaker 4

And we have not seen any material changes to the gross to net over the last you have typical things, small things here and there. But overall, the gross to net has been pretty steady quarter over quarter. And we've been pretty we've been very happy with the way in which Beatrice has managed ASP. So, Ron, did you have any additional comments there?

Speaker 2

No, I think well said. ASP is very healthy for this product.

Speaker 6

And then just one more final question. Now that the PIFR II readout is very sort of getting close, how should we think if we get the outcome that we expect to get, how should we think about that? Or how what's the sort of the roadmap for getting the full benefit of that commercially? Thank you.

Speaker 1

Rhonda, do you want to take that?

Speaker 2

Yes. I'll start with the obvious that you've already stated, Doug, in that being a positive study and then ensuring that we get that publication in peer review very quickly, which would be the plan. And then having the ability to communicate these data more broadly with our partner with the optimized outcome, which would transpire over the course of the subsequent quarters for 2024.

Speaker 4

Would there be a I think if you look

Speaker 1

at go ahead.

Speaker 4

I was

Speaker 6

going to say, Rick, is there any thought to trying to get that added to the label formally?

Speaker 1

Well, I think the we have a our label is very broad with YUPELRI, it's the maintenance treatment of COPD. There are as you can see from the publications that we've had historically, there are a lot of PIFR patients within the label today. And what we've done here is just narrowed down on a segment of PIFRA patients based on this as Rick outlined FEV1 predicted in a particular gold stage, gold 34, where we might be able to further highlight the benefit versus handheld product, tiotropium. So I think it really can be positive data here can be quite meaningful to us without putting it in label, given we have such a broad label right now. And that we're talking about showing in a fairly sizable patient population of COPD patients that the medicine could outperform the largest product in the category, which is the Atropium.

Speaker 6

Okay, great. That's really helpful.

Operator

Thank you. And our next question comes from the line of Eva Privekarra from Cowen. Your question please.

Speaker 7

Hi, congrats on the quarter and thanks for taking our questions. For YUPELRI, can you talk about the slight decrease of 2% this quarter in the hospital doses despite the share increasing? Maybe discuss this decline in the hospital market and what was the reason for that?

Speaker 2

Sure, Eva. Appreciate the question. I think just to still kind of level set that slight decline was coming off of the largest in a significant large quarter in Q1. Also trying to reconcile that relative to seeing that continued market share and some decline overall in the long acting nebb. It's just a bit of a small blip in thinking about the impact of some short acting nebulized shortages that basically inform some buying patterns within the hospital segment.

Speaker 2

However, that drawdown has already occurred. And looking at the current trends already in Q3, we've already exceeded that gap. So I think I would kind of classify that as a small dip and then take that in consideration relative to all of the other KPIs that continue to increase. We have a significant proportion of patients that are leaving the hospital with a post discharge script for YUPELRI. So thinking about that translating to the outpatient persistency as well as the increases in the retail view with both total prescriptions as well as the new patient starts seeing those significant growth factors contributing to the larger kind of transition of care.

Speaker 2

Thanks Rhonda. That's very helpful.

Speaker 1

So in short, Eva, our view is Q2 was really a blip in terms of the market. And as Ron said, the market is already back on track here in Q3.

Speaker 7

Perfect. Thank you. And for the PIFR2 trial, can you level set about what we can expect from the top line disclosure, which secondary endpoints are going to be disclosed and how much safety? And in terms of the secondary endpoints, which ones do you think are particularly important to drive adoption?

Speaker 1

So I'll start with it and then I'll hand it over to Rick. I think relative to the disclosure and what a release might look like, we're still working through that obviously with our partner, being able to show a difference clinically meaningful difference in FEV1 along the range that we saw in earlier, GOL3, GOL4 patients that Rick highlighted, that would be quite substantial. And we can talk about the other secondaries, but we're still working through talking about secondary. I'll keep you updated through the remainder of the year and we're very excited about 2023 and what it means for the company, what it means for our execution in driving our mission to medicines that make a difference for patients and driving long term shareholder value. So with that, thank you very much and have a good day.

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Earnings Conference Call
Theravance Biopharma Q2 2023
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