Theravance Biopharma Inc

NASDAQ:TBPH

Earnings Call Analysis

Earnings Call Transcript 2024-Q2

[Operator]

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma Second Quarter 2024 Conference Call. [Operator Instructions]. 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.

[Rick Winningham, executive]

Good afternoon, and welcome to Theravance Biopharma's Second Quarter 2024 Earnings Results Conference Call. Slide 2 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 3, most of the Theravance's leadership team joining me on today's call including Rhonda Farnum, Theravance's Chief Business Officer; Aine Miller, Theravance as Head of Development; and Aziz Sawaf, our Chief Financial Officer.

Turning to Slide 4. We have a number of updates to cover, which either impacted our quarterly results or tied to future financial and operational guidance. Beginning on the left-hand side of the slide, we reported $54.5 million in net sales for YUPELRI. 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 2-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 YUPELRI demand growth across all patient fulfillment channels.

In line with our prior guidance, Viatris filed an NDA for YUPELRI 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 YUPELRI method of use patent with a 2039 expiration date, and this new patent has been listed in the FDA Orange Book. Moving to Ampreloxetine. We're today updating when we expect to achieve key milestones in the pivotal CYPRESS study. Aine 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. 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 for a 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 time line. We expect to report top line results from CYPRESS approximately 6 months after we enrolled 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 used in the quarter, finishing the period with $96 million in cash and no debt. While our second half financial performance will depend partly on YUPELRI's performance, we no longer expect to approach non-GAAP breakeven and instead expect to report losses in the second half of 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 Trelegy, GSK reported another outstanding performance this quarter with the reported sales of 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 YUPELRI's performance in the quarter and our strategy to deliver future growth. Rhonda?

[Rhonda Farnum, executive]

Thanks, Rick. Let's begin the YUPELRI overview on Slide 6. with a snapshot of the product's net sales performance. As Rick highlighted in his opening comments, we reported total YUPELRI 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 our strategy with YUPELRI has been to present patients and health care providers with flexibility of choice and fulfillment options that best meet their individual needs. Although we are limited in terms of the detail we can provide today, Viatris has taken proactive steps during the quarter to reposition YUPELRI for crude 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 YUPELRI is reimbursed under Medicare Part B, where ASP is updated with the 2-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 in our ability to position YUPELRI 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 YUPELRI's bright future based on its highly differentiated profile and the strategies we are implementing to drive increased awareness and adoption.

On Slide 7, 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 approvals 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 YUPELRI in the hospital setting but also contributing to establishing discharge processes that best support patients for continued use on YUPELRI 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 NIM 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 sets. We are temporarily pausing the provision of our retail script and [ new to ] product view given that the prescriptions for a large specialty pharmacy in the mail-order channel of the broader retail data have been underreported for the last 2 quarters.

Subsequent to the February change health care cyber incident. In fact, we have simply remove -- 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 YUPELRI. On Slide 9, I think it's important to revisit the road map from 2023 and the substantial long-term growth opportunity that remains for YUPELRI. As we've previously discussed, we estimate that there are approximately 200,000 patients receiving LABA 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 --YUPELRI in the hospital setting.

Since initiating the strategy, we have seen the ratio of LABA to LAMA use improved from 5:1 now to 3:1 as of Q2 2024, with the goal of getting this close to 2:1 or 50% of NAVLABA volume as possible. This metric, in addition to our growing long-acting NEM market share in both the hospital and community suggest that our strategy is working to continue increasing the YUPELRI patient population. Beyond this, we continue to design and implement topics 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 4 to 6 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 YUPELRI within this population as well. Moving to Slide 10. I'll share some information relevant to the significant commercial opportunity that exists for YUPELRI in China which is an important market for respiratory medications and pharmaceuticals overall.

According to IQVIA data, China is the second largest market globally with spending approaching 1/4 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 6 months to over 24 months with a median of approximately 15 months. We are fortunate to have a strong partner in Viatris 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 YUPELRI'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, YUPELRI 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. would 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 Aine to address further details on the progress of the ampreloxetine program. Aine?m

[Aine Miller, executive]

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. Amidst the FDA's requirement for a full approval. Randomized withdrawal designs are well-established methods for demonstrating durable efficacy without exposing patients to undue time on placebo and are often used when the endpoint is a patient-reported outcome as is the case with the OHSA consolidate 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, we're making the differential diagnosis and addressing patient needs can be challenging, identifying experts and training study personnel is about most important.

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 positions CYPRESS for success. We also made a strategic decision to manage the CYPRESS study ourselves, given our substantial experience working with this autonomy specialist, 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 the patients and caregivers.

While we have encountered longer time lines 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 CYPRESS 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 CYPRESS 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 flight activations, primarily due to longer-than-anticipated contract completion time line at the larger academic centers for which we anticipate a significant contribution to patient recruitment. We also knew that we would work -- we'll be working with a new centralized EU clinical trial application process which allowed for a substantial number of countries to secure regulatory and [indiscernible] approval in parallel for 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 one, however, with over 80% of our planned sites now activated, we are experiencing strong enrollment metrics. The majority of activated sites subscreen 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 liquated in areas of high numbers with 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 likely occur in mid-2025. We believe we'll be in a position to report top line data approximately 6 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 empowered 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 4 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 design and consistent with Study 170 and potential discontinuations given the severity of the disease.

Our firm plan is to enroll just over 100 patients into the open-label portion of fibers, but the actual number will be driven by our ongoing study experience. Our updated forecast also accounts to 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 ampreloxetine from pharmacological treatments currently offered to MSA patients suffering from symptomatic nOH, if successful. First, CYPRESS should highlight the broad symptom benefits of ampreloxetine in MSA. Clinical experts developed the OHSA composite as a measure of global symptom burden, capturing the most frequent, debilitating aspects of organ hypoperfusion across the broader patient population.

At last year's American Autonomic Society Conference, we presented data supporting a 1 point change on the OHSA composite of clinically meaningful location, which is something that the currently approved therapies have not demonstrated. By comparison, our MSA data from Study 170 supports ampreloxetine's potential to deliver such a benefit and CYPRESS is designed to provide confirmation. Second, the PIPER study is designed to demonstrate ampreloxetine's ability to deliver durable clinical bet. 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 ampreloxetine 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 ampreloxetine 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 overlain 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?

[Aziz Sawaf, executive]

Thanks, Aine. 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 YUPELRI pricing 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 reported operating expenses and cash burn metrics in line with our expectation, reflecting slight improvement compared with Q2 of 2023 net of onetime items.

During the quarter, we did incur a $3 million noncash 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 onetime unless there are further changes to the leasing market 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 million 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 CYPRESS 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 million 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 YUPELRI pricing dynamics described earlier and incremental spend to support the CYPRESS study. As a result, we now expect to approach breakeven 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 Trelegy 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 particular [indiscernible] milestones for Trelegy. Q2 net sales grew 40% year-over-year and reached nearly $1.1 billion, beating consensus by approximately 20%. Year-to-date, this brings Trelegy sales to $1.8 billion. In 2024, we stand to earn a $25 million milestone payment as sales reached approximately $2.9 billion and a total of $50 million of sales reach approximately $3.2 billion.

Based on year-to-date results, we are increasingly optimistic we will achieve at least the lower end milestone in 2024, if not the full 20 to achieve -- excuse me, if not the full $50 million. To achieve the $50 million, 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 trend. Further in 2025 and 2026, we stand to receive a total of up to another $150 million of milestones. As depicted here, Trelegy's sales trajectory and consensus estimates point to an improving picture with Bloomberg consensus for the first time ever, exceeding the higher end milestone threshold in 2024, 2025 and 2026. With that, I'll pass it back to Rick to conclude. Rick?

[Rick Winningham, executive]

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 YUPELRI 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 our 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 ampreloxetine 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 on new 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]

[Operator Instructions]. And our first question comes from the line of Douglas Tsao from H.C. Wainright.

[Douglas Tsao, analyst]

Just maybe starting with YUPELRI. I guess, Rick Rhonda, I'm just curious how it seems that they came on sort of so unexpectedly. Was this due to sort of competitive dynamics? And 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 Viatris to correct these over time. Rhonda?

[Rhonda Farnum, executive]

Thanks, Doug. Really appreciate the question. First, just to reiterate, the interest 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 2 quarters of the year. So speaking specifically to Q2 of 2024, some factors led to what we believe were onetime 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, Viatris 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 sales in the second half relative to the Q2 actual. So I hope that helps with your question.

[Douglas Tsao, analyst]

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

[Rhonda Farnum, executive]

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.

[Douglas Tsao, analyst]

And so Rhonda, I guess just to clarify, 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?

[Rhonda Farnum, executive]

There are other channels, whether it's a matter of varied elements within retail, long-term care hospital, which 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.

[Rick Winningham, executive]

So I'll say, Doug, just obviously, a majority of the volume flows through the different community channels the hospital channel is a smaller amount in total of the entire brand. And it's 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 YUPELRI going into the community.

[Operator]

And our next question comes from the line of Julian Harrison from BTIG.

[Unknown Analyst]

This is [ Ray Ann ] on for Julian. We were just wondering if you could give us an update on the Paragraph IV litigations for YUPELRI.

[Rick Winningham, executive]

Yes, sure. Well, I can -- I just give you a very brief update given that we've got -- we're in the middle of litigation. And as we noted in the press release, we settled with four of the litigants that were originally there. We have a total of in the existing litigation, a total of 8 litigant, 7 in New Jersey, 1 in Pennsylvania. And then importantly, I think today, what we what we announced is that we did add another patent on YUPELRI into the orange book. And that's sort of where, overall, the IP -- the IP portfolio sets with Theravance and YUPELRI.

[Unknown Analyst]

Got it. 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 U.S.

[Rick Winningham, executive]

Yes. I think Viatris will probably, as we 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.

[Operator]

And our next question comes from the line of David Risinger from Leerink Partners.

[David Risinger, analyst]

Yes. Thanks very much. So in terms of the channel mix shift for YUPELRI, could you just help us understand whether the trust drove that channel mix shift through promotional activities and is now reversing it or whether Viatris was taken advantage of by some channel participants or just how negative channel mix shift occurred and then how you -- or how Viatris 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?

[Rick Winningham, executive]

Yes. Let me just take CYPRESS. And CYPRESS, the guidance will be for the data is about 6 months after we finish enrollment into the open label. So I think when we finish enrollment into the open label, then we will start the clock effectively for the data. And so I think we'll just have to see where we finished the open label in sort of the mid -- the range of mid-25% as we've given today. So Rhonda, do you want to cover the YUPELRI channel.

[Rhonda Farnum, executive]

Yes, David, as much as I want to get into 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 compliantly diversifying those fulfillment options is what contributes to the mix of where brand is fulfilled.

[Operator]

And our next question comes from the line of Ernie Rodriguez from TD Cowen.

[Unknown Analyst]

Just one for us. So we've seen YUPELRI has reported sales of around $55 million per quarter over the last 8 quarters. And this has been despite some volume gains. So guidance seems to imply that sales of similar levels for the remainder of 2024. So what gives you confidence that the revenue can grow in 2025? Is it -- is it going to be just the pricing issues that we disclosed? Or is there some more to it.

[Rhonda Farnum, executive]

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.

[Rick Winningham, executive]

And we've -- and as Rhonda mentioned in her remarks, Viatris 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 and to get the overall net sales growing

[Operator]

[Operator Instructions]. Our next question comes from the line of Liisa Bayko from Evercore ISI.

[Liisa Bayko, analyst]

You mentioned completing enrollment of the CYPRESS study at the end of this year and that was at the time line 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?

[Rick Winningham, executive]

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

[Aine Miller, executive]

Yes. 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 report top line data 6 months, approximately 6 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 8-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 evaluable patients at the end of the randomized withdrawal period.

[Operator]

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.

[Rick Winningham, executive]

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

[Operator]

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