Theravance Biopharma Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 26, 2024

There are 8 speakers on the call.

Operator

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma 4th Quarter 2023 Conference Call. During the presentation, all participants will be in a listen only mode. A question and answer session will follow the company's formal remarks. Also, today's conference call is being recorded.

Operator

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

Speaker 1

Good afternoon, everyone, and thank you for joining the Theravance Biopharma 4th quarter and full year 2023 earnings results conference call. Turning to Slide 2, I remind you that this call will contain forward looking statements that involve risks and uncertainties, including statements about our development pipeline, expected benefits of our product candidates, anticipated timing of clinical trials, regulatory filings and expected financial results, information containing factors that could cause results to differ materially from our forward looking statements as described further in our filings with the SEC. Today, I'm joined by Anya Miller, our Head of Development Rhonda Farnam, Theravance's Chief Business Officer and Aziz Suaf, our Chief Financial Officer. On Slide 4, I'll begin by hitting high points for a very productive 2023 for Theravance. We began the year with the decision to focus on driving YUPELRI growth and maximizing Amploxetine's value, while increasing our capital return program.

Speaker 1

I'm pleased to report that our team delivered on these objectives. For both the Q4 and the full year, we increased YUPELRI's net sales 9% from $61,000,000 $221,000,000 respectively, as is recorded by Viatris. We grew hospital volumes at outstanding 46% for the year and set the business up for continued momentum in 2024. We initiated ampreloxetine Cypress study and began immediately began evaluating and activating sites around the world. In May, we were granted orphan drug status, which can first important financial advantages such as tax credits and user fee exemptions and shields ampreloxetine from price negotiations associated with the Inflation Reduction Act.

Speaker 1

Cypress enrollment remains on track and we look forward to enrolling the last patient in the open label portion of the study in the second half of this year. Turning to our corporate progress, I'm proud we delivered on our promise of reaching non GAAP profitability in the 4th quarter, which involves significant efforts on the part of the entire Theravance team. In addition, we completed our $325,000,000 capital return program within the 1st few days of January, while maintaining a strong financial profile. Now on Slide 5, I'll cover plans and anticipated financial performance for the upcoming year. Beginning with YUPELRI, we expect to grow YUPELRI net sales in partnership with Viatris and build on profit margin improvements experienced in 2023.

Speaker 1

We set ambitious goals for our hospital business in 2024, which we believe will translate into future share gains in the long acting nebulization market. Finally, we look forward to VITRIS submitting a regulatory application for YUPELRI in China by mid year, which will put us on a path towards achieving meaningful economics in that territory. Turning to ampreloxetine, we're focused on completing the Cypress study. In addition, we expect to initiate regulatory and early commercialization preparations as we progress through the year. We're very excited to host a virtual investor event during the Q2, where we will bring MSA experts and senior leadership from Theravance together to discuss the unmet need in MSA patients with symptomatic nOH and the expected benefits of ampreloxetine.

Speaker 1

Turning to our 2024 financial outlook, we expect annual collaboration growth to remain strong and for our quarterly financial results to improve as the year progresses. During the 1st year, we expect to report losses on a non GAAP basis. During the second half of the year, subject to timing of YUPELRI growth and Cypress progress, we plan to approach breakeven on a non GAAP basis. We plan to limit cash utilization and we believe we are in a strong position to achieve the $25,000,000 Trelegy sales milestone in 2024 and possibly the higher $50,000,000 milestone. If you turn to Slide 6, you'll see an updated summary of our compelling value proposition.

Speaker 1

In addition to YUPELRI and ampreloxetine, we're in a strong financial position with over $100,000,000 in cash as well as the potential to accrue significant value through milestones and royalties on YUPELRI and TRELEGY over time. Specifically, in addition to the TRELEGY milestones that I referenced, we stand to receive one time sales milestone of $25,000,000 when the U. S. YUPELRI net sales reached $250,000,000 in any calendar year. Additional information on our milestones and royalties may be found in our SEC filings.

Speaker 1

Moving to Slide 8 to focus on ampreloxetine. We're motivated to make ampreloxetine available to patients as expeditiously as possible should the Cypress results support approval for the tens of thousands of MSA patients around the world who suffer from symptomatic nOH without effective treatment options. Data thus far support ampraloxetine's potential to represent a major advance for these patients. The company retains commercial rights to ampreloxetine worldwide. On Slide 9, I'll start with a considerable unmet need in the United States.

Speaker 1

MSA is a neurodegenerative disease that shares features with other movement disorders, such as Parkinson's disease. It's often misdiagnosed with many patients not confirmed to have MSA for months to years after symptoms begin. Unfortunately, most epidemiology research was conducted decades ago on Parkinsonism, more generally using survey techniques with significant limitations. For example, one off-site study relies on a 25 year old survey of 15 general practices in London. Using this limited sample, some have suggested that there are approximately 14,000 individuals with MSA in the United States given the country's current population.

Speaker 1

In contrast, recent analysis rely on the use of the real world's claims databases and capture important geographic variances and demographic trends, which affect MSA prevalence estimates. These analyses support a much higher estimate of roughly 50,000 individuals, which is consistent with estimates from both the UCSD Department of Neurosciences and MSA Center of Excellence and the National Institutes of Health. Based on this figure, we believe that the addressable U. S. Population for ampreloxetine is approximately 40,000 MSA patients suffering from symptomatic nOH.

Speaker 1

Turning to Slide 10, our goal is to make ampreloxetine available to MSA patients with symptomatic nOH worldwide. In Europe and Asian countries, including the EU5, Japan and China, the number of addressable patients is several fold larger than it is in the U. S. And in some territories, the range of therapeutic options is even more limited than in the U. S.

Speaker 1

At this point, I'd like to turn the call over to our new Head of Development, Anja Miller, to characterize the value that we see in ampreloxetine and provide an update on the progress we are making with Cypress. Anja?

Speaker 2

Thanks, Rick. Let's begin on Slide 11. MSA is an incurable neurodegenerative disorder associated with inappropriate deposits of alpha synuclein in the brain. MSA patients experience a progressive loss of autonomic function as well as challenges with standing, walking, speaking and swallowing. Many also experienced depression and anxiety.

Speaker 2

According to a 20 eighteen-nineteen U. K. Survey of over 10,000 patients with neurological disorders, MSA ranks as having the 2nd most severe impact on quality of life of any neurological disorder studied, ahead of disorders like progressive supranuclear palsy, Huntington's disease and Parkinson's disease among others. Neurogenic or diastatic hypertension, which causes significant and unremitting drops in blood pressure upon standing affects about 4 in 5 patients with MSA. Patients with symptoms of nOH may feel dizzy upon sitting or standing, can become unable to stand or walk for even short periods of time, feel pain associated with a lack of perfusion in their upper extremities and face a higher risk of falls.

Speaker 2

Not surprisingly, a significant majority of patients with symptomatic nOH report that they have a reduced ability to perform daily activities, while many also expressing a loss of independence. As I'll discuss on Slide 12, MSA patients with symptomatic nOH lack a safe, convenient and durable effective treatment option. While non pharmacological therapies are available, they are often insufficient to control symptoms. About 30 years ago, the FDA approved a product called mitadrine on the basis of its ability to increase blood pressure. However, mitidrine is not indicated to improve symptoms of nOH, must be taken 3 times daily and carries a black box warning for its potential to lead to a marked elevation of supine blood pressure.

Speaker 2

Nearly 20 years later, the FDA approved a second drug called droxidopa to treat dizziness in patients with nOH. Based on the still high unmet need for these patients, the FDA granted droxidopa a conditional or accelerated approval. After initially having rejected the sponsor's application and despite droxidopa having failed 2 of the 4 Phase 3 studies included in the application. As with Medidrine, droxidopa is dosed multiple times a day and carries a black box warning for supine hypertension. It has never demonstrated a durable effect on NOH symptoms beyond 2 weeks of treatment in a double blind study.

Speaker 2

And more recently, based on data reported on clinicaltrials.gov, it failed to demonstrate a benefit in the confirmatory study requested by the FDA known as ReStore. Based on third party analysis of claims and prescription data, droxidopa is still only prescribed to a small percentage of MSA patients with nOH. Let's fast forward to the day and it has been more than a decade since MSA patients with symptomatic nOH have been offered a novel treatment alternative. While we still have important work to do to confirm its clinical profile in the Cypress study, we anticipate that ampreloxetine will represent a significant advance for these individuals given the benefits it has demonstrated to date. Ampreloxetine's durable impact on a broad range of nOH symptoms in MSA patients in Study 170, coupled with its safety and tolerability profile and convenient once daily dosing is expected to drive high levels of adherence.

Speaker 2

Moreover, as the first novel therapy in years, we are optimistic we will be able to build a case for a broad access and significant adoption in the population for which it is indicated should ampreloxetine be approved. Now shifting gears to the Cypress study on Slide 13. I'd like to share our approach and the progress that we are making. As many of you know, Theravance is directly managing study conduct for Cypress rather than utilizing the traditional CRO model. By design, we are deeply involved in identifying sites with high standards for clinical conduct, investigators who understand the complexities of managing nOH and MSA and patients who best fit the criteria of the Cypress study.

Speaker 2

We are informed by our experience in studies 169170 and have reinvested many of the same sites and KOLs involved in those studies. Beyond this, we have enriched our network through AI efforts that leverage claims information, the work of data scientists and our own expertise. This has allowed us to identify additional qualified sites in the United States. Finally, we are early adopters of telehealth and have incorporated options for patients and clinical personnel to participate in Cypress even if factors limit patients' ability to undergo evaluations in the clinic. We are pleased with the internal metrics we are monitoring thus far, which are consistent with our expectations on Study 170.

Speaker 2

While we don't comment specifically on enrollment, we continue to make excellent progress activating sites, including many outside of the United States. Shifting now to the right hand side of Slide 13. We have aligned with the FDA on the design of Cypress, including the use of the OHSA composite score, a 6 item assessment of Orto study hypertension symptom severity as the primary endpoint. When using patient reported outcome measures such as OHSA, the FDA recommends anchoring these data in order to determine clinical meaningfulness. In November, at the AAS Annual Meeting, we presented data from our anchor based analysis of studies 169170, which support the use of the OHSA composite score for MSA patients with nOH as well as the threshold for which is considered a clinically meaningful change.

Speaker 2

Our analysis demonstrated that threshold improvements and worsening of approximately one point on the OHSA composite were considered clinically meaningful. This is important as it supports our Cypress study design and compares favorably to the 1.6 point benefit we saw on this measure in MSA patients in Study 170. Finally, in order to minimize the time from Cypress completion to potential commercial availability, we have already completed much of the work required for our NDA submission and are in the progress of ordering the application. At this point, I'll turn the call over to Rhonda to discuss you, Hillary.

Speaker 3

Thanks, Anja. Beginning on Slide 15, I'm pleased to report that the Theravance and Beatrice Commercial Partnership finished the year strong, having driven YUPELRI net sales growth of 9% for the full year of 2023. 4th quarter net sales reached $60,600,000 and full year sales reached $221,000,000 with YUPELRI recording its highest level of profitability since launch. Although quarter to quarter results can vary depending on the timing of shipments and other seasonal factors, we remain optimistic for YUPELRI's continued growth based on the success we are delivering in the hospital channel as well as several key performance indicators we track across the business. While realized sales this quarter closely tracked with demand generation, we have traditionally experienced seasonal dips and reported net sales as we transition from the Q4 to the Q1 of the following year.

Speaker 3

Moving to Slide 16, I'm also very pleased to share with you the exceptional finish to the year our hospital team was able to deliver. Hospital doses shipped in the 4th quarter increased 37% year over year with full growth reaching 46%. This was easily the highest volume quarter for the hospital channel delivered since launch. As you know, our goal continues to be to increase the number of patients exposed to the YUPELRI during hospitalization who are then discharged on YUPELRI as maintenance patients. This is achieved by gaining support for formulary inclusion, implementation of hospital protocols involving all nebulization strategies and therapeutic inter changes and equally important high touch transition of care programs.

Speaker 3

Our market research continues to demonstrate that the vast majority of patients who initiate YUPELRI in the hospital setting receive a prescription for YUPELRI maintenance care at discharge. It is with the execution of this winning strategy that our small but focused commercial organization is able to make a considerable contribution to the overall YUPELRI business both directly and indirectly. Turning to Slide 17, on the left side you can see the impact our efforts have had on our hospital market share. During the quarter, our share of the long acting NIM market in the hospital segment increased to 16.6%, while on the right side of the slide YUPELRI achieved a 31% share in the community, up nearly 4 percentage points year over year. We attribute both segments share growth to the increasing traction of our concomitant therapy messaging.

Speaker 3

This taps into the significant number of COPD patients who remain symptomatic on LABA therapy and could benefit from the addition of a LAMA, which is foundational in the treatment of COPD and references the 2022 changes to the gold report guidelines, which recommend dual lava, llama therapy for category B and E patients. As a basis for speaking to the trends we have achieved in the retail setting, where we have our most real time and current demand view outside of the hospital channel, we felt it might be helpful to share another visual. If you turn to Slide 18, we provide data on the fulfillment growth trends in both the total community and retail segment settings through the Q3 of the year. At the time that we share our quarterly results, we do not have a completed data capture of fulfillment in the DME channel, which accounts for approximately 60% of our total community business. Because retail, which accounts for the other 40% generally correlates with total community fulfillment over time, we have historically offered this view.

Speaker 3

You will find our most up to date performance in the retail channel on Slide 19. Looking at the left side of Slide 19, retail prescriptions grew a robust 7% sequentially during the quarter, which is consistent with recent brand performance trends. Looking to the right side of the slide, we also grew new product starts a sequential 7% in Q4. You may remember from our last update that we had experienced some quarter to quarter seasonality and new starts, which is not atypical for this metric in Q3. As anticipated, however, we were able to drive a sequential return to growth in Q4.

Speaker 3

Finishing on Slide 20, we think it is important to highlight the unique and compelling value proposition we offer patients and caregivers as the only once daily nebulized LAMA for maintenance treatment of COPD. YUPELRI has demonstrated consistently meaningful lung function benefits is typically available at low out of pocket cost and requires only a few minutes to administer once per day. As such, we believe YUPELRI plays a key role in the COPD market where there remains a substantial opportunity to reach patients who could benefit from YUPELRI. Our go to market strategy aligns with this profile, which we believe is why YUPELRI is only one of 3 branded COPD maintenance therapies in the U. S.

Speaker 3

That is delivering consistent growth. Looking ahead, we expect to achieve continued growth and value creation for YUPELRI driven both by continued penetration of the U. S. Maintenance COPD market and the potential launch of YUPELRI in China. Lastly, in the U.

Speaker 3

S, we are eligible to receive a one time sales milestone of $25,000,000 from Beatrice when YUPELRI net sales reach $250,000,000 in any calendar year. In China, where Viatrix is planning to file for regulatory approval by the middle of this year, we are eligible to receive a $7,500,000 milestone upon approval, as well as additional sales milestones and upwardly tiered royalties of between 14% 20%. That brings us to the end of the PELRI update. So I will turn things over to Aziz to cover our financials. Aziz?

Speaker 4

Thanks, Rhonda. Starting off with the results for the quarter, Slide 22 and 23 cover the detailed financials. I'll cover the highlights on Slide 24. Starting with collaboration revenue, we reported an all time high of $17,400,000 representing year over year growth of 19%. Operating expenses were in line with expectations for the quarter, resulting in full year operating expenses, excluding share based comp, to be under the low end of R and D guidance and within the range for SG and A and total OpEx.

Speaker 4

The combination of judicious expense management and increased Trepellerie net sales led to a non GAAP profit of $1,400,000 in the quarter. Please note that our GAAP loss of $8,500,000 was affected by a larger than expected income tax expense in the quarter, primarily due to better than expected results and other non cash charges from one of our operating entities. However, this is a non cash item and we expect to have immaterial if any cash taxes payable for 2023. In Q4, we repurchased approximately $30,000,000 worth of shares, leaving $400,000 on the return of capital program at quarter end, which was completed in early January. This reduced our share count by 3,000,000 shares in the quarter and by 31,000,000 shares from the program's inception, a 37% reduction in share count.

Speaker 4

We closed the period with 102,000,000 in cash and approximately 48,000,000 shares outstanding. On Slide 25, I'll provide an update on our potential to earn milestones from Trelegy, noting that GSK delivered another excellent quarter of growth. Quarterly and year to date sales reached $737,000,000 $2,700,000,000 respectively, up 35% and 28% year over year. As a result, we are well positioned to achieve milestones in 2024 and beyond. Compared with 2023 actuals, we need only 5% growth in annual net sales to achieve the first $25,000,000 milestone and 17% to achieve the second $50,000,000 milestone.

Speaker 4

As a reminder, these milestones are not cumulative. If both milestones were to be achieved, we would receive a total of $50,000,000 not 75,000,000 dollars Lastly, turning to financial guidance on Slide 26, we will continue to provide R and D and SG and A operating expense guidance excluding share based comp in 2024. In addition to enhance our financial disclosure, we will be adding non cash share based compensation to our guidance metrics. For R and D OpEx excluding share based comp, we are expecting between $30,000,000 $36,000,000 which will be exclusively allocated to ampriloxetine. A significant majority of this will be for the Cypress study execution.

Speaker 4

In addition, guidance includes gated spend towards NDA preparation, primarily during the second half of the year. The un gating of this spend will depend on being on track with Cypress enrollment in line with industry best practices. For SG and A OpEx, excluding share based comp, we are expecting between $45,000,000 $55,000,000 While our YUPELRI related spend will be largely flat year over year, guidance includes incremental spend for ampreloxetine pre launch commercial activity, primarily in market research, medical affairs and market access, which will occur mostly in the second half of the year. Given our focus on expected return on invested capital, any incremental spending for pre launch activities will be gated based on Cypress enrollment and will be subject to Board approval. Partially offsetting these increases is a reduction of G and A spend by approximately 20%, driven by ongoing cost cutting initiatives.

Speaker 4

Starting in Q1, we will break out G and A separately from SG and A within our MD and A commentary in our 10 Qs and 10 ks. For share based comp, we are expecting between $18,000,000 $22,000,000 the midpoint reflecting a year over year reduction of approximately 20%. In terms of our non GAAP metric, we expect we will turn from a non GAAP profit in Q4 2023 to a non GAAP loss in early 2024. This is due to an expected decrease in collaboration revenue in Q1 from Q4 of 2023, driven by typical seasonality for YUPELRI net sales as mentioned by Rhonda, combined with a temporary increase in R and D spend due to the expected ramp in patient enrollment and site initiation for the Cypress study. Turning to the second half of twenty twenty four, we expect our non GAAP metric to approach breakeven, which will be dependent on continued net sales growth for YUPELRI as well as the amount of spend on ampreloxetine pre launch commercialization.

Speaker 4

As discussed on prior earnings calls, this non GAAP metric is a proxy for cash flow, and we therefore expect limited cash burn in 2024, most of which will be incurred early in the year. Given multiple potential milestones in 2024 and beyond, such as $25,000,000 or $50,000,000 milestone for TRELEGY, we expect to generate net cash prior to the Cypress top line data readout in 2025. Lastly, we may continue to incur non cash income tax expense of several $1,000,000 each quarter. However, we continue to expect to have immaterial, if any, cash taxes in 2024 from ongoing operations. With that, I'll pass it back to Rick to conclude.

Speaker 4

Rick?

Speaker 1

Thanks Aziz. On Slide 27, we summarize Theravance's compelling vision and value we offer shareholders. Having focused our organization's efforts behind YUPELRI and ampreloxetine, the Theravance team is now unified in pursuit of 3 objectives. First, we'll work to drive U. S.

Speaker 1

YUPELRI net sales growth in the hospital, while collaborating closely with our partners at Beatrice to maximize the brand's overall potential in the hospital and community settings. 2nd, we'll continue to work diligently in pursuit of the Cypress study's successful completion, while making appropriate regulatory preparations and laying the groundwork for its broad access if approved. 3rd, we'll maintain a strong capital structure as we work to deliver value for shareholders. Based on the choices we made regarding YUPELRI, ampreloxetine and Trelegy, we believe we're at the crossroads of Theravance's evolution where we stand poised to deliver significant incremental value through our operational assets as well as near term milestones and royalties, while making limited incremental investments in managing risk. We thank you for your time and attention this afternoon, and we're ready to take your questions.

Speaker 1

Operator? Thank

Operator

And our first question comes from the line of Doug Hsu from H. C. Wainwright. Your question please.

Speaker 5

Hi. Can you hear me?

Speaker 1

Yes. We can hear you.

Speaker 5

Okay. Good afternoon and congrats on the progress. Just a couple of questions. First, maybe starting with YUPELRI. Rhonda, I'm just curious when we think about the share gains that you're seeing, especially those in the hospital, to what extent are those coming from adding new accounts versus gaining share within the existing account base?

Speaker 5

Thank you. And then I've got a follow-up.

Speaker 3

Thanks, Doug. Great question. Actually thinking about that share gain up to 16.6% for the quarter, that is drawn both from the new accounts, but I would say the predominant growth there is from those accounts that continue to build upon their base business where we are converting them to therapeutic interchange. And for those accounts where we do have that all med strategy implementation as well as therapeutic interchange, we see that the market share is even higher in those accounts.

Speaker 5

Typically, maybe just as a follow-up to that, Rhonda, what's the process or how long does it take to get a hospital to sort of move to that therapeutic interchange and all that approach?

Speaker 3

If we are moving from their initial formulary to therapeutic interchange that can range anywhere from 6 months to a year. If we're converting prior existing formulary review approvals, it's usually 6 to 9 months. That's on average.

Speaker 5

Okay. And within your account base, I mean, what percent would you say are at either sort of doing that have achieved therapeutic tender change and an all net approach?

Speaker 3

That varies just based on the growing base, but roughly 2 thirds of our volume already have a therapeutic interchange or I should say 2 thirds of our volume is driven from those therapeutic interchange accounts, if that makes sense.

Speaker 5

Well, but I guess, but then and then as a follow-up to that though, what percentage of accounts are therapeutic interchange? Because obviously, given that 2 thirds, it would seem that there is significant growth by getting accounts to that.

Speaker 3

Yes.

Speaker 1

Yes.

Speaker 3

You've got it, Doug. If we move them to Therapeutic Interchange, that automatic substitution is what converts every existing WAMA, weather handheld from the past experience over. So that is the ultimate of what we are trying to achieve here with these new games.

Speaker 5

No, no, I get it. But what percentage of your overall accounts are there? Have you achieved that? Is it 10%, 20%, 30% just to sort of help understand the magnitude of the opportunity still in front of you?

Speaker 3

Roughly 35% of our COPD focus accounts have a therapeutic interchange. Okay.

Speaker 5

Great. Thank you. Yes, that's really helpful. And then just Rick, as a follow-up, obviously, you have now brought yourself in the company to expense management and some difficult choices to a point where your cash burn is pretty minimal. You are also on the cusp of seemingly restarting to bring into milestones via for TRELEGY as well as it seems like YUPELRI, which could begin to enhance your cash balance.

Speaker 5

When you think about YUPELRI and the success you're achieving in the hospital, does it ever how close are you to the point where it would make sense strategically to gain some leverage with that sales organization and bring in another product. And not necessarily one, even of the same magnitude of opportunity as YUPELRI, but just something that could give you some efficiency or sort of some additional leverage because in theory even a small product could drive some pretty nice incremental margins on that sales force? Thank you.

Speaker 1

Yes. Doug, that's a good question. A couple of points. 1, we see such significant opportunity in ampreloxetine and the execution of the Cypress study and the preparatory work over the next year, both on the regulatory side, as well as some very early commercial preparation work that any distraction from anything else, I think, would be net harmful from where we are right now. I'd say the second point is, as Rhonda mentioned, we have a small sales force and they're doing an outstanding job executing a particular strategy.

Speaker 1

And we are early we are in the early days of the execution of the strategy both at Theravance and I'd say in particular in combination with the efforts of Viatris. So we've got a significant amount of opportunity, I think within the hospital with YUPELRI and we would pay some opportunity costs by shifting our focus to anything else given sort of where we set with those accounts where we're on formulary and we need to move and take the next step towards therapeutic interchange. And those steps that those institutions largely which are multi hospital sort of groups of going from not being on formulary to being on formulary with therapeutic interchange. So we really view as there's just such opportunity behind both YUPELRI and ampreloxetine that we need to keep our focus on those two assets.

Speaker 5

Okay, great. Thank you so much.

Operator

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

Speaker 6

Yes. Thanks very much and thank you for the update. So my first question is, can you talk a little bit about how you're thinking about the introduction of ensifentrine from Verona and what implications that might have for YUPELRI? And then second, if you could just provide a little bit more detail on the execution of the ampreloxetine trial from here, the event path and then

Speaker 4

the likely timing of the

Speaker 6

press release with the results? Thank you.

Speaker 1

Okay. Rhonda, you want to take ensifentrine?

Speaker 3

Absolutely. Thanks, David, for the question. We're very excited about the opportunity for ensifentrine having additional share of voice focused on a nebulized asset in the COPD maintenance space would be tremendous. And thinking about as well how that particular product would enter the market and most likely still meeting the backbone or the foundation of therapy, thinking about that as an add on therapy, it's a great opportunity for us to both ensure that the patients that could benefit from both products have that chance?

Speaker 1

So on the ampreloxetine, obviously, we're we've initiated a lot of sites as Anya hit on her comments high quality sites with physicians who understand MSA patients, understand the care of MSA patients and understand the execution of the clinical trial. We'll continue to activate sites and there is some work that's necessary there. But more and more work obviously is focused on just getting patients into and through the sites for the study. We're making very good progress there. And I think if you split that, we've got this year is really about is a little bit tilted towards patients as opposed to sites.

Speaker 1

And that's where our focus will be. In terms of the where the study is, I think we'll enroll our target. And right now that's what we believe we can do is enroll the last patient into the open label portion in the second half of the year. This would sort of mean data probably sometime in the first half of next year. And that's what we'd be looking forward to, but stay tuned as we progress throughout the year.

Speaker 1

I think the from at least from the science and the medicine part of ampreloxetine and the value that it can provide for patients with MSA and nOH. I think hopefully our investor event that we have in the Q2 will be able to provide good information to investors about the opportunity that we see there.

Speaker 4

Great. Thank you very much.

Speaker 1

Yes. Thanks, David.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Eva Pratyra from Cowen. Your question please.

Speaker 3

Hi, guys. Congrats on the great quarter and thanks for taking our questions. I have a question about the Q2 investor events for ampreloxetine. Will there be any additional analyses that we haven't seen before?

Speaker 1

Yes. Thanks, Eva. I think relative to ampreloxetine, I think the additional analysis will be relatively limited. I think as we mentioned, we will have opinion leaders there that present other analyses, obviously, both nOH and MSA patients as part of their presentations that outline the medical need and the opportunity that ampreloxetine has to meet that medical need through the data that they have and that is currently published, but certainly consolidating it into one particular event.

Speaker 3

Got it. That's helpful. And another one from me. How should we think about ampreloxetine's market opportunity relative to NORTHERA, which I believe achieved $400,000,000 in peak sales, given all of NORTHERA's shortcomings and ampreloxetine differentiation, how much bigger could ampreloxetine be?

Speaker 1

Well, I think we're very we're optimistic on ampreloxetine. That's one of the reasons why we focused on both in my comments as well as Anya's comments on patient populations and the fact that there really is no solution that's adequate out there for patients that have MSA and nOH. But in a population of 40,000 patients with MSA and nOH and given that as Anya presented, this is in fact a debilitating condition that keeps many of them really unable to interact with their environment. I think that being able to show among multiple different parameters as measured by the OHSA composite score that we improve the well-being of these patients, I think should open up a significant opportunity for us. And as a reminder, we did we were granted orphan drug designation.

Speaker 1

This is an orphan drug for a rare disease. So we're quite excited about, obviously continuing to progress with the study, the investor event that we have in quarter 2, which I think will fill in some more information and then continue to provide additional information as we work towards closing the study and data.

Speaker 3

Perfect. Thank you. Congrats again.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Julian Harrison from BTIG. Your question please.

Speaker 7

Hi, congrats on the quarter and thank you for taking my questions. It was great to see a positive outcome from your Phase 3 trial of YUPELRI in China back in November. I'm wondering if you could remind us about how you're thinking about the China market opportunity there and what are the gating steps to filing later this year? And then on Cypress, do you have a good sense now for what the U. S, ex U.

Speaker 7

S. Enrollment split will likely look like? Any big differences there relative to the 170 study? Thank you.

Speaker 1

Ron, do you want to comment on China? And then Anya maybe give just a high level comment on U. S. Non U. S.

Speaker 1

On Cyprus. Rhonda first.

Speaker 3

Yes. Thanks, Julian, for the question and recognizing the positive outcome of that Phase 3 that the interest completed. So they will be continuing to prepare and as they've indicated we'll be striving to make that filing for the application by the midpoint of this year. And thinking about the market for YUPELRI, we haven't made an hourly communication around an absolute market projection and just thinking about certainly it's a very significant financial burden on that healthcare system not too dissimilar from the U. S.

Speaker 3

We can ensure that we continue to evaluate what that opportunity can be for YUPELRI.

Speaker 1

Yes. And I think, yes, just to add to that, Julian, Beatrice will be commercializing the medicine in China. They have a substantial organization in China, which is one of the reasons that we licensed YUPELRI to them in China. I think that they've since it is sort of their commercial responsibility, they have a, a I think their call is coming up and you may get some ask a question of them on opportunity. But obviously, the China market and COPD is very, very large and it's about capturing as much of that opportunity as really makes economic sense.

Speaker 3

Julien, just to give you some fact basis for the China market itself, COPD affects about 100,000,000 patients in that marketplace and a significant roughly 40% of those patients are moderate to very severe patients suffering with COPD. So as you can think about that relative to that being the focus for us here in the U. S, if I can give you some estimates.

Speaker 4

Julian, hey, it's Aziz. Thanks for the question. One additional point in our 10 ks, which we'll file in a couple of days now, we're going to be actually disclosing the YUPELRI economics for both the U. S. Sales milestones and the China milestones and royalty rates in more detail.

Speaker 4

So we'll actually break out the sales milestones and you can see for the first time we broke out the percentage of the royalties 14% to 20%. So a pretty significant royalty in a huge market obviously. So we're really excited about the opportunity and the economics there.

Speaker 1

Anja, do you want to talk about amploxetine? Julien, thanks for

Speaker 2

the question on the Cypress study. As I alluded to earlier, we've already made a lot of great progress activating sites in Europe and the U. S. And we have reengaged a lot of the sites in the U. S.

Speaker 2

And Europe that we had previously engaged in the prior studies. I would expect that we the majority of patients will still come from Europe as it did in the previous program, Although we are making efforts to expand our footprint in the U. S. And identify additional qualified sites and I spoke about how we're going about that in terms of using an AI tool. So overall, I think the more patients will come from Europe, but the actual percentage of the split may differ for a Cyprus study.

Speaker 2

Hopefully, that's helpful.

Speaker 7

Very helpful. Thank you again.

Operator

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

Speaker 1

Yes. Thank you. I'd like to just thank everyone for joining us today. We're pleased with the accomplishments of 2023 and look forward to what we can accomplish in 2024, both through effective financial management of the business as well as the growth of YUPELRI and the execution on the Cypress study in order to bring what we believe will be an important medicine to patients with MSA and nOH. Thank you very much.

Operator

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

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Earnings Conference Call
Theravance Biopharma Q4 2023
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