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?

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 one-to-one to receive either revifenazine via nebulization or teatropium delivered via dry powder inhaler, and the primary endpoint is change from baseline in troth 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 Beatrice 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 PIPR-2 study design. Our previously conducted PIPR-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 would be predicted. In PIFR1, revifenazine treatment did not demonstrate a statistically significant advantage over teatropium, although there was a numerical trend favoring ribofenicin, driven by GOLD 3 and 4 patients with baseline FEV1 of less than 50% of predicted. Importantly, a pre-specified analysis of GOLD 3 and 4 patients shown on the right-hand figure demonstrated a clear and clinically relevant treatment benefit of ribofenicin over teatropin. We therefore designed the PIPR-2 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 PIPR-2 would provide the commercial organization a catalyst to help drive UCAL reuptake in a portion of the maintenance COPD market whose symptoms are inadequately controlled despite treatment with handheld LAMA-containing regimens. Turning to ampryloxetine. Slide 15 outlines the design of our Registrational Study 197, also known as CYPRS, for the treatment of symptomatic NOH in MSA patients. Based on the strength of the prior phase three study results and alignment with the FDA on the primary endpoint and study design, we believe the CYPRS study has a high probability of technical and regulatory success. The study consists of a 12-week open-label period, followed by an eight-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 CYPRS 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 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. As shown on slide 16, we estimate that the addressable patient population for Amproloxatine is between 35 and 45,000 individuals in the United States. Despite two approved therapies indicated to treat symptoms of orthostatic hypotension, there remains a significant unmet need, which we believe Amproloxatine could address. First, Based on data generated to date, we believe ampryloxetine 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, ampryloxetine 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 with NOH are also at risk for supine hypertension, a dangerous increase 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 options, Amproloxetine has the potential to decrease the risk of supine hypertension. At night, Amproloxetine remains in the system, resulting from its relatively long half-life. But because the natural norepinephrine levels are reduced during sleep, Amproloxetine 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 Amproloxetine treatment. As we enter a new era in treating MSA symptoms, we believe amproloxetine offers hope to MSA patients with symptomatic NOH. On slide 17, we summarize how the current treatment landscape translates into opportunity for amproloxetine. Owing in part to only two therapies being FDA approved, coupled with their 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 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 amproloxetine 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. Amfiloxetine 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.

Thanks, Rick. On slides 19 and 20, you can find our financial results for the quarter, which came in in line with our expectations. Skipping ahead to the highlights on slide 21, our collaboration revenue recognized through our Vietris partnership grew 26% in the quarter to $13.7 million. As a reminder, while this figure incorporates 35% of upelry net sales as recorded by Vietris, it may fluctuate from quarter to quarter due to the shared expenses we and Vietris 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 million, down from $27 million 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, 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 non-cash, non-recurring 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 programs. 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&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 upelry. 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 Trilogy 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 Trilogy's performance. In the second quarter, Trilogy sales reached $760 million, up 29%, and year-to-date sales reached approximately $1.3 billion, up 27%. While it's still unclear whether we will achieve the first of the milestones in 2023, we are increasingly optimistic based on Trilogy'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 Farming. With that, I'll turn the call back to Rick for closing remarks.

Rick?

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. Upelry 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. Finally, it's heartening to see Trilogy 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 in 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.

Certainly. As a reminder, if you have a question at this time, simply press star 1-1 on your telephone. One moment for our first question. And our first question comes from the line of David Reisinger from Lee Rink. Your question, please.

Yes, 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&A spending That was $30 million in the first half of 23, excluding stock-based comp. The guidance is for 45 to 55 for the year. So at the midpoint of that guidance, at $50 million, that would reflect a meaningful step down in SG&A spending in the second half versus that $30 million in the first half. If you could comment on that and help us think about how we should think about prospects for SG&A spending both in the third quarter and the fourth quarter, i.e., is one going to be higher than another for some reason? Thank you very much.

Aziz, you want to take the revenue and then bridge over to SG&A? Yeah, 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 or $6 million, 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. In other words, 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 by 35% and add it to the collaboration revenue, and that'll 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 one. The second question is a good question about the SG&A. As I mentioned during the call, I do expect the SG&A spend to go down in Q3 and Q4. For overall spend, we are very much in line with our guidance. It's kind of $90 million at the midpoint. We're trending a little bit lighter on the R&D side and a little bit higher on the SG&A side. Part of that for SG&A relates to this, an allocation issue between R&D and SG&A. After the research restructuring in Q1, as a proportion of the overall company, R&D is smaller and therefore just gets allocated lesser amounts of the kind of overhead costs, which gets shifted over to SG&A because it becomes a greater proportion of the overall company, even though the actual overhead costs don't change at all. So it's just kind of some shifting of the dollars between R&D and SG&A artificially as a result of the research structuring. So that's one reason, but if you think about the SG&A and Q3 and Q4, it should be pretty 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 for total expense perspective related to guidance. We're slightly below for R&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.

Yeah. To add just a bit more on, you know, drivers of sales growth. And Rhonda talked about this during her section. If you really look at, you know, the sales right now of nebulized long-acting beta agonists, which are generic, and current goal guidelines, and then the fact that, you know, nearly 50% of our phase three program had concomitant use of either a beta agonist or beta agonist plus an inhaled corticosteroid. the use of upelry with a nebulized long-acting beta agonist. You know, that patient adhering to gold guidelines and physicians adhering to gold guidelines can serve as a significant driver of revenue growth for us going forward with upelry. And that's setting aside the opportunity Rhonda spoke about with short-acting nebulized medications that are currently inappropriately being used as maintenance therapy. And then any lift that we can get from the PEMFOR-2 study should be positive.

Got it. Thank you, Rick. Yep. Next question, operator?

Yes, sorry. Our next question comes from the line of Douglas South from HC Wainwright. Your question, please.

Hi, good afternoon. Thanks for taking the questions. 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 know, you said that it's been about $5 to $6 million on a quarterly basis. Should we think about in terms of absolute dollars, 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?

Yeah. Thanks, Doug. So I would, as I mentioned to David a second ago, it's from an absolute basis. So that five or six million should stay consistent. In other words, if you tolerate sales, you know, go up $100 million, making up an extreme example, the gap between 35% of the sales and the collaboration revenue will still be $5 million. Now, the percentage from a relative basis, it'll be very minor, but the nominal absolute number will still be 5%. So when upelry starts to grow more materially in the future, this gap will be less relevant, right? It'll be, from a percentage standpoint, a relative standpoint, be somewhat unmeaningful. Does that help, Doug?

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

Yeah, Ron? Yeah, I think that... Go ahead, Aziz.

T. yeah so we can't and i'll pass it on to Rhonda for additional commentary here, but. T. We don't comment on gross to net that's something that Beatrice manages. T. But I think in terms of ASP I think it's safe to say that Beatrice is a nice job has done a nice job keeping a ASP relatively stable over time. T. And we have not seen any material changes to the gross to net over the last you know 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 very happy with the way in which Beatrice has managed ASP. So, Rhonda, do you have any additional comments there?

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

And then just one more final question. I mean, now that the PIT for two readout is really sort of getting close, how should we think, you know, if we get the outcome that we expect to get, how should we think about that, or what's the sort of the roadmap for getting the full benefit of that commercially? Thank you.

Rhonda, do you want to take that?

Yeah, I'll start with, you know, the obvious that you've already stated, Doug, and 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 would be the optimized outcome, which would transpire over the course of the subsequent quarters for 2024. Would there be any other?

Yeah, I think if you look at, go ahead, Doug. I was going to say, Rick, is there any thought to trying to get that added to the label formally?

Well, I think the, you know, we have a, you know, our label is very broad with upelry. 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, you know, what we've done here is just narrowed down on a segment of Pfeffer patients based on, as Rick outlined, FEV1 predicted in a particular gold stage, gold three and four, where we might be able to further highlight the benefits versus handheld product teatropium. So I think it really can be positive data here can be quite meaningful to us without putting it in a 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 teatropium.

Okay, great. That's really helpful.

Thank you. And as a reminder, ladies and gentlemen, if you do have a question at this time, please press star 1-1 on your telephone. And one moment for our next question. And our next question comes from the line of Eva Privatera from Cowan. Your question, please.

Hi. Congrats on the quarter, and thanks for taking our questions. For you, Pelri, 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?

Sure, Eva. I appreciate the question. think just to still kind of level set that slight decline was coming off of the largest and 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 NEB. It's just a bit of a small blip in thinking about the impact of some short-acting nebulized shortages that basically informed some some buying patterns within the hospital segment. 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 the significant proportion of patients that are leaving the hospital with a post-discharge script for upelry, 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 start, seeing those significant growth factors contributing to the larger kind of transition of care.

Thanks, Rhonda. That's very helpful.

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

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

So I'll start with, and then I'll hand it over to Rick. I think relative to the disclosure and what, you know, what a release might look like, you know, we're still working through that obviously with our partner. you know, being able to show, you know, a difference, a clinically meaningful difference, you know, in FEV1 along the range that we saw in earlier GOLD3, GOLD4 patients that Rick highlighted, that would be quite substantial. And, you know, Rick can talk about the other secondaries, but we're still working through, talking about secondaries, we're still working through what the disclosure would be in a relief. Rick?

Yeah, not much more to add. But, Eva, I think, you know, as Rick said, the primary endpoint, change from baseline and trough FEV1 at day 85. The key secondary endpoint, trough overall treatment effect on FEV1. I think that's probably reasonable to include. And then key focus on, you know, the key safety events. And then, as we usually do after top line, we'll present the follow-up data in some format, perhaps in upcoming medical meetings.

Perfect. Thank you so much.

Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Rick Winham for any further remarks.

Yeah, I'd just like to thank you for joining us today for a discussion on the second quarter results. We look forward to keeping 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.

Thank you, ladies and gentlemen, for your participation in today's conference. This does include the program. You may now disconnect. Good day.