Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma second quarter 2024 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, please press star followed by the digit 11 on your telephone. Again, that's star 11 to ask a question. If listening via webcast, please mute audio on your webcast device before asking a question over the phone. I will repeat these instructions after management completes their prepared remarks. Also, today's conference 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 welcome to TheraVance BioPharm's second quarter 2024 earnings results conference call. Slide two is our forward-looking statement slide, which I would encourage you to read. Our call today will include forward-looking statements involving risks and uncertainties, information concerning factors that could cause results to differ materially from these forward-looking statements as described further in our filings with the SEC. As you can see on slide three, members of the TheraVans leadership team joining me on today's call include Rhonda Farnham, Theravance's Chief Business Officer, Anya Miller, Theravance's Head of Development, and Aziz Swaf, our Chief Financial Officer. Turning to slide four, we have a number of updates to cover, which either impacted our quarterly results or tie to future financial and operational guidance. Beginning on the left-hand side of the slide, we reported 54.5 million in net sales for UPelri. This reflects another strong quarter of volume growth and demand generation with hospital doses up 43% and overall customer demand up 13% versus the prior year, offset by a reduction in net realized price, resulting in net sales decreasing 1% year over year. Given the current mix and resulting ASP coupled with the nature of Medicare Part B, where reimbursement limits are set with a two-quarter lag, we are only expecting the lower net price in Q2 to improve slightly during the second half of the year. For 2025 and beyond, we anticipate a more stable pricing environment with continued upelry demand growth across all patient fulfillment channels. In line with our prior guidance, Beatrice filed an NDA for upelry in China in June. which puts us on the path to achieve meaningful economics in that territory. And finally, in July, we were granted a new upelry method of use patent with a 2039 expiration date, and this new patent has been listed in the FDA Orange Book. Moving to ampryloxetine, we're today updating when we expect to achieve key milestones in the pivotal Cypress study. Anya will provide more details in her portion of today's presentation, but we now expect to enroll the last patient into the open-label portion of the study sometime in mid-2025, where we had previously been guiding the second half of 2024. One of the main reasons for this is longer lead times between initial site engagement and activation, particularly at large U.S. Centers of Excellence, which are core to our strategy of delivering a high quality result. We have recently brought on a number of larger sites and our enrollment rate per active site are now at or above our internal projections, which give us confidence in our updated timeline. We expect to report top line results from Cypress approximately six months after we enroll the final patient in the open label portion of the study. Turning to the right-hand side of the slide, we were able to limit cash use in the quarter, finishing the period with $96 million in cash and no debt. While our second half financial performance will depend partly on UPelry's performance, we no longer expect to approach non-GAAP breakeven and instead expect to report losses in the second half of 2024 similar to what we experienced during the first half of the year. We expect cash utilization in the second half of the year to be similar to or slightly above first half levels. Finally, moving to Trilogy, GSK reported another outstanding performance this quarter, with a reported sales of up 40%. This achievement brings year-to-date sales to $1.8 billion, up 37%, and increases our confidence in achieving the higher $50 million sales milestone for 2024, as well as additional potential milestones in 2025 and 2026. With that, I'll turn it over to Rhonda to cover upelry's performance in the quarter and our strategy to deliver future growth. Rhonda?

Thanks, Rick. Let's begin the upelry overview on slide six with a snapshot of the product's net sales performance. As Rick highlighted in his opening comments, we reported total upelry net sales of 54.5 million in the quarter, which represents a 1% decline quarter on quarter and year on year. This result was driven by a lower than anticipated realized net price in the quarter reflective of the brand's evolved channel mix. As you know, our strategy with upelry has been to present patients and healthcare providers with flexibility of choice in fulfillment options that best meet their individual needs. Although we are limited in terms of the detail we can provide today, Beatrice has taken proactive steps during the quarter to reposition upelry for improved performance across a range of distribution channels over the longer term. While we do not expect to realize the full effect of these improvements on net price for a couple of quarters, given that upelry is reimbursed under Medicare Part B, where ASP is updated with a two-quarter lag, We may see modest sequential improvements in price during the remainder of the year. While the second quarter net sales performance is disappointing, we believe that the effect of one factor should not overshadow our continuous success in demand generation and our ability to position UPelry for sustained long-term growth. This quarter, our combined team was able to drive a 13% year-on-year increase in customer demand volume, and we remain confident in UPelry's bright future based on its highly differentiated profile and the strategies we are implementing to drive increased awareness and adoption. On slide seven, you can see our strong hospital performance in the quarter. We are quite pleased with not only the growth we delivered, but also with the KPIs that tie this performance to potential future growth in our ability to drive outpatient community utilization. Doses shipped during the quarter increased 43% year-on-year and again reached a new all-time high. We made continued progress in terms of new formulary approval with our year-to-date performance essentially already on par with the entirety of 2023. In addition, the team continues to focus on the implementation of therapeutic interchanges. As you know, therapeutic interchange adoption is core to our commercial strategy and is fundamental not only to increase adoption and volume growth of upelry in the hospital setting, but also contributing to establishing discharge processes that best support patients for continuing use on upelry as they return to the community care setting. Shifting to our market share trends on slide 8, I'm pleased to report that our share of the long-acting NED market once again increased during the quarter in both the hospital and community segments. with our hospital share surpassing 18% and our community share reaching 32%, both new launch-to-date highs. This performance is consistent with our expectations given the strong momentum we've generated in terms of formulary wins, therapeutic interchange in the hospital setting, coupled with the success of our concomitant therapy messaging strategy in both the hospital and community settings. We are temporarily pausing the provision of our retail script and new to product view given that the prescriptions for a large specialty pharmacy and the mail order channel of the broader retail data have been underreported for the last two quarters, subsequent to the February change healthcare cyber incident. In fact, we have simply removed, if we simply remove the underreported mail order volume from the retail view, We did see another launch-to-date high in Q2. We do have access to the individual pharmacy stream that was impacted, which confirms the strong demand trends and the volume growth we are experiencing with upelry. On slide nine, I think it's important to revisit the roadmap from 2023 and the substantial long-term growth opportunity that remains for upelry. As we've previously discussed, We estimate that there are approximately 200,000 patients receiving LABAs as maintenance therapy and that this population is central to our concomitant therapy messaging strategy. Our internal metrics demonstrate that we are improving the ratio of LABA use to UPEL reuse in the hospital setting. Since initiating this strategy, we have seen the ratio of LABA to LAMA use improve from five to one now to three to one. as of Q2 2024, with the goal of getting as close to 2 to 1 or 50% of NEB lava volume as possible. This metric, in addition to our growing long-acting NEB market share in both the hospital and community, suggests that our strategy is working to continue increasing the UPelry patient population. Beyond this, we continue to design and implement tactics that can tap into the next 200,000 patients inappropriately using short-acting nebulized bronchodilators as maintenance treatment. These are patients who are accustomed to nebulized delivery, but nevertheless choose to administer a short-acting nebulized agent four to six times daily in the absence of clinical evidence supporting their use as maintenance. As a once daily nebulized LAMA with strong bronchodilation effects over a full 24-hour dosing interval, we expect to be able to make significant inroads into this additional patient segment opportunity. As we've highlighted before, there remains a large opportunity among patients who struggle with handheld devices. Over time, and with education particularly associated with the ease and benefits of a nebulized therapy administration, We expect to be able to continue to grow upelry within this population as well. Moving to slide 10, I'll share some information relevant to the significant commercial opportunity that exists for upelry in China, which is an important market for respiratory medications and pharmaceuticals overall. According to Acuvia data, China is the second largest market globally with spending approaching one quarter that of the U.S. COPD represents a significant health problem in the territory, affecting nearly 100 million individuals, with nearly half of those experiencing moderate to severe disease. China has been modernizing its regulatory framework. From the end of 2022 through May 2024, the review time for NDAs and BLAs in China ranged from six months to over 24 months, with a median of approximately 15 months. We are fortunate to have a strong partner in Vietris in China, which ranks as the country's eighth largest multinational pharmaceutical company with strong government and regulatory affairs capabilities, as well as a field force of over 4,000 sales representatives. We are very excited for UPelry's potential introduction and note that the economics to TheraVance are substantial with up to 45 million in regulatory and sales milestones plus Upwardly tiered royalties ranging from 14% to 20% of net sales. Finally, I'll wrap my comments on slide 11. First, Upelri is a unique medicine offering a substantial and highly differentiated value proposition. It is the only nebulized LAMA for COPD maintenance treatment in the U.S., and we believe it is underutilized within the patient population to which it is best suited. We see long-term growth potential for the product. driving considerable value for Theravance shareholders. Second, in addition to our co-promotion economics in the U.S., we potentially stand to achieve milestones and royalties as outlined here, which include those I referenced in the previous slides associated with the potential new opportunity in China. With that, I will hand it over to Anya to address further details on the progress of the Amphiloxetine program. Anya?

Thanks, Rhonda. I'll begin on slide 13 with a quick recap of our approach to Cypress. As many of you know, we met with the FDA in June 2022 and aligned with the agency around conducting a small randomized withdrawal study in MSA patients in order to confirm the durable benefits we saw in study 170 and meet the FDA's requirement for a full approval. Randomized withdrawal designs are a well-established method for demonstrating durable efficacy without exposing patient to undue time on placebo, and are often used when the endpoint is a patient reported outcome, as is the case with the OHSA composite score. We knew that identifying the right sites in order to recruit the right patients would be crucial to Cypress' potential success. For a rare and clinically complex disease like MSA, where making a differential diagnosis and addressing patient needs can be challenging, identifying experts and training study personnel is of utmost importance. We therefore are prioritizing working with academic institutions and MSA centers of excellence to deliver a high-quality result. These sites are best equipped not only to identify the most appropriate patients for the study, but also to manage their experience in a way that has positioned Cypress for success. We also made a strategic decision to manage the Cypress study ourselves, given our substantial experience working with dysautonomia specialists, advocacy groups, and other members of the broader MSA community. In doing so, we have strengthened relationships with decision makers, deepened our understanding of the unmet need, and informed our go-to market model with direct insights regarding how best to reach and engage patients and caregivers. While we have encountered longer timelines to site activations, as I'll cover shortly, we remain confident that our decision positions us for a high-quality study outcome and a differentiated message to support strong market access should Cyprus read out as we hope and anticipate. Next on slide 14, I'd like to walk through the updated timing for achieving important milestones in the Cyprus study and some of the factors that have led us to adjust the date at which we now expect to enroll the last patient into the open label portion of the study to mid 2025. As we first reported in our Q1 2023 earnings call, Cypress recruitment officially opened at the end of March 2023, with the first patient enrolled in June of last year. While we opened a number of centers early on, we encountered difficulty ramping site activations, primarily due to longer than anticipated contract completion timelines at the larger academic centers, for which we anticipate a significant contribution to patient recruitment. We also knew that we would be working with a new centralized EU clinical trial application process which allowed for a substantial number of countries to secure regulatory and ethics approval in parallel, but which demanded a greater investment in time and resources approach. As highlighted on the left-hand side of this slide, these factors impacted our ability to achieve a significant number of planned site activations. We have been responding real-time to the evolving site activation and enrollment dynamics of the study, and while these measures have been positive, we are no longer confident that they are sufficient to return us to our original enrollment forecast. which is why we are updating our projections today. In recent months, however, with over 80% of our planned sites now activated, we are experiencing strong enrollment metrics. The majority of activated sites have screened patients, many have already enrolled patients, and our monthly cadence of patients enrolled into Cypress is robust. We also have a small number of remaining academic centers that will activate in the coming months, which are located in areas of high numbers of MSA referrals. Overall, where we had previously expected to enroll the last patient into the open-label portion of the study in the second half of this year, we now believe that this milestone will most likely occur in mid-2025. We believe we'll be in a position to report top-line data approximately six months after having enrolled the last patient into the open-label portion of the study. Finally, turning to slide 15, I'll add a few comments on the importance of the Cypress study design. Beginning with the primary endpoint, we designed and powered Cypress to demonstrate a durable, clinically important benefit with high probability. In doing so, we held many of the design elements constant from Study 170, where we achieved a clinically meaningful 1.6-point benefit on the OHSA composite score in MSA patients. We also sized Cypress appropriately. As a reminder, we achieved nominal significance on the OHSA composite with only 38 evaluable patients in Study 170, and are planning to enroll enough patients in Cypress to evaluate approximately 60 patients using the same composite score as our primary endpoint. In order to do so, we need to account for both study design and factors that will impact the number of patients completing all 20 weeks of the study. These include both the enrichment criteria in the 12-week open-label period, which are typical of randomized withdrawal designs and consistent with Study 170, and potential discontinuations given the severity of the disease. Our current plan is to enroll just over 100 patients into the open-label portion of Cypress, but the actual number will be driven by our ongoing study experience. Our updated forecast also accounts for the need to ensure we have sufficient patients progressing to the randomized withdrawal portion of the study. Overall, we believe we have designed a study that will support full approval by the FDA and differentiate Amproloxidine from pharmacological treatments currently offered to MSA patients suffering from symptomatic NOH if successful. First, Cypress should highlight the broad symptom benefits of amprylacidine in MSA patients. Clinical experts developed the OHSA composite as a measure of global symptom burden, capturing the most frequent debilitating aspects of organ hyperperfusion across the broader patient population. At last year's American Autonomic Society Conference, we presented data supporting a one-point change on the OHSA composite as clinically meaningful to patients, which is something that the currently approved therapies have not demonstrated. By comparison, our MSA data from Study 170 support ampryloxidine's potential to deliver such a benefit, and Cypress is designed to provide confirmation. Second, the Cypress study is designed to demonstrate ampryloxidine's ability to deliver durable clinical benefits. We believe this is supported by its mechanism of action, selectivity for norepinephrine at 10 milligrams, attractive tolerability profile, and convenient once-daily dosing. Third, along with the results from Study 170, a positive Cypress outcome would position amperloxidine to be the first therapy with a full approval specifically indicated for NOH patients with MSA. Taken collectively, we believe these attributes would make a strong case for amperloxidine's differentiated efficacy when contrasted to the clinical track record and real-world experience of commonly used therapies in this underserved patient population. Unfortunately, none of the drugs currently available for NOH work well in MSA, with 65 remaining symptomatic despite treatment. So there is an urgent need for an effective treatment that can help these patients, and we believe that ampriloxidine is specifically tailored to address NOH in patients with MSA. At this point, I'd like to turn the call over to Aziz to cover our financial results. Aziz?

Thanks, Sonia. Starting off with the results for the quarter, slide 17 and 18 cover the detailed financials. I'll cover the highlights on slide 19. Beginning with collaboration revenue, we reported $14.3 million, representing year-over-year growth of 4%. This was below our internal expectations due to the UPOL repricing dynamics described earlier, which impacted net sales. However, while sales decreased versus the prior year, we were still able to deliver collaboration revenue growth by managing expenses to achieve improved profitability. Turning to the rest of the P&L, we've reported operating expenses and cash burn metrics in line with our expectations, reflecting slight improvement compared with Q2 of 2023 net of one-time items. During the quarter, we did incur a $3 million non-cash impairment charge due to the write-down in the value of our operating lease assets related to our excess lab space, which we are currently attempting to sublease. The impairment charge is expected to be one time unless there are further changes to the leasing marketing condition. We closed the period with $96 million of cash and approximately 49 million shares outstanding. We remain debt-free. Turning to our updated financial guidance on slide 20, I'll cover three areas. First, for R&D, we are trending towards the higher end of our guided range of between 30 and 36 million and expect R&D spend to increase in the second half of the year. This is driven by incremental spending associated with the CIPRS study, including support for additional high-quality sites to be activated in the second half. We expect that these sites will help contribute towards the completion of enrollment by mid-2025. For SG&A, we expect to be within our guided range of $45 to $55 million. For non-GAAP earnings and cash burn, we are updating our guidance to reflect the combination of lower-than-expected collaboration revenue due to the near-term upelary pricing dynamics described earlier and incremental spend to support the CYPRT study. As a result, we no longer expect to approach break-even in the second half, and now expect non-GAAP losses and cash burn in the second half to be similar to first half actuals, with cash burn potentially being slightly higher than the first half of the year. Importantly, this guidance excludes any potential milestone payments that may be earned in 2024 and received in early 2025, for example, the Trilogy milestone. Despite the revision to our near-term financial goals, we remain confident in our capital allocation strategy. With no debt, limited near-term cash needs, and the potential to achieve several significant milestones in the near term, we are well positioned to continue executing on our plan to maximize shareholder value. Finally, on slide 21, I'll discuss our potential to earn milestones for Trilogy. G2 net sales grew 40% year-over-year and reached nearly $1.1 billion, beating consensus by approximately 20%. Year-to-date, this brings Trilogy sales to $1.8 billion. In 2024, we stand to earn a 25 million milestone payment if sales reach approximately 2.9 billion and a total of 50 million if sales reach approximately 3.2 billion. Based on year-to-date results, we are increasingly optimistic we will achieve at least a lower end milestone in 2024, if not the full 20, to achieve, excuse me, if not the full 50. To achieve the 50, we estimate that net sales in the second half of the year would need to be around 1.4 billion, a target which looks increasingly attainable given the current trends. Further, in 2025 and 2026, we stand to receive a total of up to another 150 million of milestones. As depicted here, Trilogy's sales trajectory and consensus estimates point to an improving picture, with Bloomberg Consensus for the first time ever exceeding the higher-end milestone thresholds in 2024, 2025, and 2026. With that, I'll pass it back to Rick to conclude. Rick?

Thanks, Aziz. I'll keep my closing comments brief in order to preserve as much time as possible for Q&A. On slide 22, you can see the elements of our company's strategic focus, which remains unchanged. We plan to grow upelry in the U.S. and see a clear path forward for doing so. Our hospital strategy is an undeniable success, and we see strong support for a concomitant messaging strategy, both in the hospital and in the community. We believe our efforts will translate into considerable value creation over time, potentially including several milestones and important economics in China, which represents another meaningful near-term opportunity. We are executing a well-designed development regulatory strategy in support of Amproloxidine and look forward to sharing the results of Cypress. While we now expect it to take slightly longer to do so, we do believe that it's imperative to manage the study with high quality in order to maximize its potential for success. We will continue to adapt our regulatory and commercial preparations in a fashion that utilizes resources judiciously in order to maximize potential returns to our shareholders while minimizing undue financial risk. Finally, we continue to evaluate novel ways in which we can deliver value to shareholders as we've done historically. With that, we're ready for questions. Operator?

Thank you, sir. Once again, if you'd like to ask a question, you may do so by pressing star 1-1 on your title phone. If listening via webcast, please mute your audio on your webcast device before asking a question over the phone. If you're using a speakerphone for today's call, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that's star 1-1 if you'd like to ask a question. And we'll pause for a moment to assemble our roster. And our first question comes from the line of Douglas Howe from HC Wainwright. Your question, please.

Hi, good afternoon. Thanks for taking your questions. Just maybe starting with you, Pelri, I guess, you know, Rick, Rhonda, I'm just curious how it seems that they came on sort of so unexpectedly. You know, was this due to sort of competitive dynamics or

and you know i think you noted that it will sort of take i guess i'm curious what sort of specific actions are being taken by you or the address to you know correct these over time thank you rhonda thanks doug really appreciate the question um first just to reiterate beatrice manages the pricing and contracting for the brand so i'm going to be limited in how much detail i can provide And as we've mentioned, that the channel mix for the brand has shifted, which has put some pressure on gross to net through the first two quarters of the year. So speaking specifically to Q2 of 2024, some factors led to what we believe were one-time gross to net adjustments. As for the second half, we would anticipate some slight increase in that price over Q2, depending on the evolving channel mix. And then if I'm looking to the medium and longer term, Beatrice has taken corrective measures to hopefully change that trajectory of the brand's realized net price. We expect to see more significant pricing improvement in 2025 and beyond. Lastly, I just want to flag that given the continued demand growth and slight improvement expected to pricing in the second half, We believe that we would still see an increase to net cells in the second half relative to the Q2 actual. So I hope that helps with your question.

Yes, Rhonda, that is helpful. And I guess I'm just curious in terms, if you could provide some details, exactly how the channel mix affects things.

So again, limited commentary I can provide, but if you think about the channel mix, there is a varied discounting range across the various channels, and that's about all I can say to that.

And so, Rhonda, I guess just to clarify, so as sort of the hospital channel grows versus the retail channel, I mean, I guess is that how we should think about it, just sort of the balance between those two? Or are there other channels that we're missing?

There are other channels, whether it's a matter of varied elements within retail, long-term care, hospital, which I'll also comment to hospital not only being a discounted channel, there is full WAC pricing purchasing within hospital, and then where the DME distribution occurs. So it's the element of where fulfillment occurs for these patients.

Okay, thank you. Just obviously, a majority of the volume flows through, you know, the different community channels. The hospital, you know, the hospital channel is a smaller amount in total of the entire brand and is really the key to the hospital is us achieving penetration in the hospital, use in the hospital, such that we can maintain a high level of discharge rate of patients on upelry going into the community.

Thank you. One moment for our next question.

And our next question comes from the line of Julian Harrison from PTIG. Your question, please.

Hi, good afternoon. This is Rayon for Julian. Thanks for taking our questions. We were just wondering if you could give us an update on the paragraph for litigations for upelry.

Yeah, sure. Well, I can just give you a very brief update, given that we're in the middle of litigation. And as we note in the press release, we've settled with four of the litigants that were originally there. We have a total of, in the existing litigation, a total of eight litigants, seven in New Jersey, one in Pennsylvania. And then, importantly, I think today what we announced is that we did add another patent on UPelri into the Orange Book. And, you know, that's sort of where, you know, overall the IP, you know, the IP portfolio sets with, you know, sets with Theravance and UPelri. Okay.

Got it. Thank you. Very helpful. We did have a follow up on the pricing dynamics in China. Do you have a sense of what that looks like? How should we be thinking about pricing or pricing parity or discount versus the US?

Yeah, I think Vietris will probably as we approach, you know, approach approval. in China and finish the regulatory process there, I would expect them to comment on that. We don't have any comments on that today.

Got it. Thank you.

Thank you. And our next question comes from the line of David Reisinger from Lee Ring Partners. Your question, please.

Yes, thanks very much. So in terms of the channel mix shift for you, Pelri, could you just help us understand whether Vietris drove that channel mix shift through promotional activities and is now reversing it, or whether Vietris was taken advantage of by some channel participants or just, you know, how negative channel mix shift occurred and then how you or how Beatrice could reverse it. And then separately, regarding the top line for Cypress, it seems like you're suggesting that Wall Street should expect a top line press release in early 26. Is that correct? Thank you.

Yeah, let me just take Cypress. And Cypress, you know, the guidance will be for the data is about six months after we, you know, finish enrollment into the open label. So I think, you know, when we finish enrollment into the open label, then we'll, you know, it'll start the, you know, start the clock effectively for the data. And so I think we'll just have to see where, you know, where we finish the open label and sort of the mid you know, the range of mid-25 as we've given today. So, Rhonda, you want to cover the upelry channel?

Yeah. David, as much as I want to get into, you know, granular detail of the dynamics of fulfillment, that's just not an area we can with our partnership agreement. We try to ensure our patients have the best access possible. and trying to ensure we're appropriately and compliantly diversifying those fulfillment options is what contributes to the mix of where brand is fulfilled.

Okay, thank you.

Thank you. And our next question comes from the line of Ernie Rodriguez from TD Cowen. Your question, please.

Hi. Thank you for taking my question. Just one for us. So we've seen Yield Parity has reported sales of around $55 million per quarter over the last eight quarters, and this has been despite some volume gains. Guidance seems to imply that sales of similar levels for the remainder of 2024. So what gives you confidence that the revenues can grow in 2025? Is it going to be just the pricing issues that we discussed, or is there more to it?

No, I would say there's more to it, Ernie. It's certainly all dependent on that continued demand growth, which we are seeing quarter on quarter.

And as Rhonda mentioned in her remarks, Vietris has taken certain action to improve the pricing dynamic. We think that while there might be a minor amount of it occur in the second half of this year, It will occur in 2025. And I think the brand, in terms of volume, is growing. So we've got to match that overall with stability and improvement in price to get the overall net sales growing.

That's helpful. Thank you.

Thank you. And as a reminder, if you have a question at this time, please press star 1-1 on your telephone. And our next question comes from the line of Lisa Baker from Evercore ISI. Your question, please.

Hi. You mentioned completing enrollment of the Cypress study at the end of this year, and that was at the timeline for data mid-next year, but it's predicated on... I think patient number. Can you maybe elaborate a little bit on that and what goes into feeding that patient number? Thanks.

Sure.

Anya, you want to take that and just with the revised guidance on the last patient in and the open label?

Yeah. So just to start with reiterating the revised guidance. So we now hope to complete enrollment in the open label portion of the study. mid-2025 and then reports offline data six months, approximately six months later. And then in terms of the patient flow through the study, remember we have a 12-week open label period that then leads into the eight-week randomized withdrawal portion. So we need to ensure that we've got sufficient patients progressing through the open label period into the randomized withdrawal so that we end up with 60 available patients at the end of the randomized withdrawal period.

Okay, understood. Thank you.

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

Thank you, Operator, and I'd like to thank everyone for joining us today on the 2Q update, and we look forward to updating you as the business evolves in the second half of the year. Thank you.

This concludes today's conference call. We thank you for your participation. You may now disconnect.