Theravance Biopharma Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 5, 2024

There are 11 speakers on the call.

Operator

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. Also, today's conference is being recorded.

Operator

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

Speaker 1

Good afternoon, and welcome to Theravance Biopharma's Q2 2024 Earnings Results Conference Call. Slide 2 is our forward looking statements 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 is described further in our filings with the SEC. As you can see on Slide 3, members of the Theravance leadership team joining me on today's call include Rhonda Farnam, Theravance's Chief Business Officer Anya Miller, Theravance's Head of Development and Aziz Swaf, our Chief Financial Officer.

Speaker 1

Turning to Slide 4, 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 $54,500,000 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.

Speaker 1

In line with our prior guidance, Beatrice 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 2,039 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. Anya will provide more details 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-twenty 25, where we had previously been guiding the second half of twenty twenty four. One of the main reasons for this is longer lead times between initial site engagement and activation, particularly at large U.

Speaker 1

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 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 $96,000,000 in cash and no debt.

Speaker 1

While our second half financial performance will depend partly on YUPELRI's performance, we no longer expect to approach non GAAP breakeven instead expect to report losses in the second half of twenty twenty four 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 a reported sales up 40%. This achievement brings year to date sales to $1,800,000,000 dollars up 37% and increases our confidence in achieving the higher 50,000,000 dollars 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.

Speaker 1

Rhonda?

Speaker 2

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 $54,500,000 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 brands evolved channel mix. As you know, our strategy with YUPELRI has been to present patients and healthcare providers with flexibility of choice and fulfillment options that best meet their individual needs.

Speaker 2

Although we are limited in terms of the detail we can provide today, Beatrice has taken proactive steps during the quarter to reposition YUPELRI 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 YUPELRI is reimbursed under Medicare Part B where ASP is updated with a 2 quarter lag, we may see modest sequential improvements in price during the remainder of the year. While the Q2 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 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.

Speaker 2

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. Dosage 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.

Speaker 2

Shifting to our market share trends on Slide 8, I'm pleased to report that our share of the long acting NEM 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 in 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 under reported 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.

Speaker 2

On Slide 9, I think it's important to revisit the roadmap 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 lavas 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 used to YUPELRI use in the hospital setting. Since initiating the strategy, we have seen the ratio of lava to llama use improved from 5:one now to 3:one as of Q2 2024, with the goal of getting as close to 2 to 1 or 50 percent of nevlava volume as possible. This metric in addition to our growing long acting nev market share in both the hospital and community suggests that our strategy is working to continue increasing the YUPELRI patient population.

Speaker 2

Beyond this, we continue to design and implement tactics that can tap into the next 200,000 patients inappropriately using short acting nebulized bronchodilators a 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 was 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 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.

Speaker 2

According to IQVIA data, China is the 2nd largest market globally with spending approaching 1 quarter that of the U. S. COPD represents a significant health problem in the territory affecting nearly 100,000,000 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 Beatrice in China, which ranks as the country's 8th largest multinational pharmaceutical company with strong government and regulatory affairs capabilities as well as a field force of over 4,000 sales representatives.

Speaker 2

We are very excited for YUPELRI's potential introduction and note that the economics to Theravance are substantial with up to $45,000,000 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.

Speaker 2

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. 2nd, 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 ampreloxetine program.

Speaker 2

Anja?

Speaker 3

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.

Speaker 3

For a rare and clinically complex disease like NSA, we're making a differential diagnosis and addressing patient needs can be challenging, identifying experts and training study personnel is above most important. We therefore are prioritizing working with academic institutions and MSA centers of excellence to deliver a high quality results. 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.

Speaker 3

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 Cypress readout 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-twenty 25. 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 activation, 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 work we'll be working with a new centralized EU clinical trial application process, which allows for a substantial number of countries to secure regulatory and ethics approval in parallel, but which demanded a greater investment in time and resources upfront.

Speaker 3

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 Cyprus is robust.

Speaker 3

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-twenty 25. 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 and powered Cypress to demonstrate a durable clinically important benefit with high probability.

Speaker 3

In doing so, we held many of the design elements constant from Study 170 where we achieved a clinically meaningful 1.6. 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.

Speaker 3

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, a potential discontinuation given the severity of the disease. Our current plan is to enroll just over 100 patients into the open label portion of Cyprus, 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 ampreloxetine from pharmacological treatments currently offered to MSA patients suffering from symptomatic nOH if successful. First, Cypress has highlights Cypress should highlight the broad symptom benefits of ampreloxetine in MSA patients.

Speaker 3

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 OHFA composite as clinically meaningful to patients, which is something that is that the currently approved therapies have not demonstrated. By comparison, our MSA data from Study 170 support ampreloxetine's potential to deliver such a benefit and Cypress is designed to provide confirmation. 2nd, the FIPER study is designed to demonstrate ambreloxetine's ability to deliver durable clinical best. We believe this is supported by its mechanism of action, selectivity for norepinephrine at 10 milligrams, attractive tolerability profile and convenient once daily dosing.

Speaker 3

3rd, 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 ampreloxetine is specifically tailored to address nOH in patients with At this point, I'd like to turn the call over to Aziz to cover our financial results. Aziz?

Speaker 4

Thanks, Sonya. Starting off with the results for the quarter, Slide 1718 cover the detailed financials. I'll cover the highlights on Slide 19. Beginning with collaboration revenue, we reported 14,300,000 dollars 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.

Speaker 4

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 and L, we've reported operating expenses and cash burn metrics in line with our expectation, reflecting slight improvement compared with Q2 of 2023 net of one time items. During the quarter, we did incur a $3,000,000 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 $96,000,000 of cash and approximately 49,000,000 shares outstanding.

Speaker 4

We remain debt free. Turning to our updated financial guidance on Slide 20, I'll cover 3 areas. First, for R and D, we are trending towards the higher end of our guided range of between $30,000,000 $36,000,000 and expect R and 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-twenty 25.

Speaker 4

For SG and A, we expect to be within our guided range of $45,000,000 to $55,000,000 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 no longer 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 potential third milestones for Trelegy.

Speaker 4

Q2 net sales grew 40% year over year and reached nearly 1,100,000,000 dollars beating consensus by approximately 20%. Year to date, this brings Trelegy sales to 1,800,000,000 dollars In 2024, we stand to earn a $25,000,000 milestone payment if sales reach approximately $2,900,000,000 and a total of $50,000,000 if sales reach approximately $3,200,000,000 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

Speaker 5

20.

Speaker 4

To achieve the 50, we estimate that net sales in the second half of the year would need to be around $1,400,000,000 a target which looks increasingly attainable given the current trends. Further in 20252026, we stand to receive a total of up to another $150,000,000 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 thresholds in 2024, 2025 and 2026. With that, I'll pass it back to Rick to conclude. Rick?

Speaker 1

Thanks Aziz. I'll keep my closing comments brief in order to preserve as much time as possible for Q and 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.

Speaker 1

And see a clear path forward for doing so. Our hospital strategy is an undeniable success and we see strong support for our CONCOMMENT 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 in 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.

Speaker 1

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?

Operator

Thank you, And our first question comes from the line of Douglas Tsao from H. C. Wainwright. Your question please.

Speaker 6

Hi, good afternoon. Thanks for taking the questions. 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 some curious what sort of specific actions are being taken by you or Viatris to correct these over time?

Speaker 6

Thank you.

Speaker 1

Rhonda?

Speaker 2

Thanks, Doug. Really appreciate the question. 1st, 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 1st two quarters of the year.

Speaker 2

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 net 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 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.

Speaker 2

So I hope that helps with your question.

Speaker 6

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

Speaker 2

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.

Speaker 6

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 2 or are there other channels that we're missing?

Speaker 2

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

Speaker 5

Okay. So I'll

Speaker 1

let Doug just obviously, yes, 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. Your question please.

Speaker 7

Hi, good afternoon. This is Rae on for Julien. Thanks for taking our questions. We were just wondering if you could give us an update on the Paragraph for litigations for YUPELRI?

Speaker 1

Yes, sure. Well, I can I just gave 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've settled with 4 of the litigants that were originally there. We have a total of an existing litigation, a total of 8 litigants, 7 in New Jersey, 1 in Pennsylvania. And then importantly, I think today what we announced is that we did add another patent on YUPELRI into the orange book.

Speaker 1

And that's sort of where overall the IP portfolio sets with Theravance and YUPELRI.

Speaker 7

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?

Speaker 7

How should we be thinking about pricing or pricing parity or discount versus the U. S?

Speaker 1

Yes. I think Viatrix 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.

Speaker 7

Got it. Thank you.

Operator

Thank you. And our next question comes from the line of David Risinger from Leerink Partners. Your question please.

Speaker 8

Yes, thanks very much. So in terms of the channel mix shift for YUPELRI, could you just help us understand whether Viatris 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 Cyprus, it seems like you're suggesting that Wall Street should expect a top line press release in early 'twenty six. Is that correct? Thank you.

Speaker 1

Yes. Let me just take Cypress. 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'll it'll start the start the clock effectively for the data. And so I think we'll just have to see where we finish the open label in sort of the mid the range of mid-twenty 5 as we've given today.

Speaker 1

So, Rhonda, you want to cover the YUPELRI channel?

Speaker 2

Yes. David, as much as I want to get into granular detail We 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.

Speaker 4

Okay. Thank you.

Operator

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

Speaker 5

Hi, thank you for taking my question. Just one for us. So we've seen yield parity has reported sales of around $55,000,000 per quarter over the last eight quarters. And this has been despite some volume gains. So guidance seems to imply that sales of similar levels for the remainder of 2024.

Speaker 5

So what gives you confidence that the revenues can grow in 2025? Is it going

Speaker 9

to be just the pricing issues that

Speaker 5

we discussed or is there more to it?

Speaker 2

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.

Speaker 1

And we and as Rhonda mentioned in her remarks, Viatrist 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

And our next question comes from the line of Lisa Faheygov from Evercore ISI. Your question please.

Speaker 2

Hi. You mentioned completing enrollment of the Cypress study at the end of this year, and that

Speaker 10

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?

Speaker 1

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

Speaker 3

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-twenty 25 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.

Speaker 2

Okay, understood. Thank you.

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.

Speaker 1

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.

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Earnings Conference Call
Theravance Biopharma Q2 2024
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