Theravance Biopharma Inc

NASDAQ:TBPH

Earnings Call Transcript 2024-Q1

[Operator]

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma First Quarter 2024 Conference Call. [Operator Instructions]. Also, today's conference call is being recorded.

And now I would 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 First Quarter 2024 Earnings Results conference call. On Slide 2, you'll find our safe harbor language. And I'd remind everyone that our call today will include forward-looking statements involving risks and uncertainties pertaining to our development pipeline, expected benefits of our product candidate, anticipated timing of clinical trials, regulatory filings and expected financial results. Information concerning factors that could cause results to differ materially from our forward-looking statements is described further in our filings with the SEC.

Now please turn to Slide 3. Because joining me today -- joining me on the call today are Aine Miller, our Head of Development; Rhonda Farnum, Theravance's Chief Business Officer; and Aziz Sawaf, our Chief Financial Officer.

Next, on Slide 4, I'll begin with a recap of our first quarter highlights before turning the call over to the rest of the team. As you can see on the left side of the slide, we've made good commercial progress with YUPELRI during the quarter, achieving $55.2 million in net sales in partnership with Viatris. This translates into 18% year-on-year growth. Our team at Theravance got off to a terrific start this year in the hospital setting, again, achieving another all-time high in terms of hospital doses sold in the quarter, up 31% from the prior year.

In addition, we continue to expect our partners at Viatris to complete a regulatory filing for YUPELRI in China by midyear based on the strong Phase III results announced last November.

Turning to Ampreloxetine. In the middle of the slide, we're very excited to be hosting a dedicated virtual investor event on May 23 and at 10:00 a.m. Eastern. We're 2 thought leaders in the field of autonomic dysfunction as well as our team at Theravance will discuss the compelling science behind ampreloxetine's opportunity to address the unmet need and nOH and MSA patients.

We continue to work diligently to complete the registrational Phase III CYPRESS study with the last patient planned to be enrolled in the second half of this year. as well as put in place the regulatory and commercial framework that will enable Theravance to make ampreloxetine available quickly and broadly should CYPRESS be successful.

Finally, we delivered another strong order of financial performance, driven in equal parts by good YUPELRI growth and expense management. Despite experiencing some seasonal transitioning from quarter 4 to quarter 1, which is typical of the pharmaceutical business, we realized a limited cash burn ending the period with $100 million in cash and no debt. As Aziz will discuss later, TRELEGY turned in a fantastic performance which makes us increasingly optimistic for the value that, that product stands to deliver to Theravance shareholders in the future.

Turning to Slide 5, I'll briefly touch on how our strategic imperatives position Theravance to deliver compelling value to shareholders over both the near and the long term. We have a detailed plan in place to continue YUPELRI's growth for the foreseeable future while still delivering on expanded profitability and cash returns to the company.

Over the past 12 months, U.S. YUPELRI sales have increased 12% to $229 million, while the collaboration revenues we recognized from Viatris have increased 27%. We are expecting top line data for the CYPRESS study in 2025. If successful, we'll act decisively with our regulatory and precommercialization strategies in order to bring about ampreloxetine's successful filing and launch.

As Aziz will also discuss, we will execute this strategy while deploying our capital in a way that maintains the company's strong financial position throughout. We believe we're well positioned to achieve significant milestones in the coming years as well as meaningful royalties on YUPELRI and TRELEGY in the future.

With that, I'd like to turn the call over to our Head of Development, Aine Miller, who will provide some brief comments on ampreloxetine. Aine?

[Aine Miller, executive]

Thanks, Rick. As Rick indicated, I'm going to keep my comments brief this afternoon, recognizing that in a short 10 days, we'll be providing an extensive overview of the ampreloxetine program. Including our ongoing registrational study, CYPRESS and how we are seeking to address the unmet need for MSA patients with symptomatic nOH.

In CYPRESS, we continue to activate sites and progress enrollment. We are closely engaged with these sites in order to enroll the right patients and ensure data quality. We continue to be pleased with our progress and maintain the expectation of completing enrollment of the open-label portion of the study during the second half of the year.

Also, we continue to prepare for our possible NDA filing shortly on the heels of learning the CYPRESS results. As we have discussed in the past, we have generated much of the data required for other elements of the [ submission ] beyond the CYPRESS data and are already in the process of altering the NDA.

Finally, given our decision to work directly with these investigators and sites who treat substantial numbers of MSA patients with symptomatic nOH, we are able to coordinate with our analytics and market access teams in order to begin positioning ampreloxetine for broad availability should CYPRESS be positive.

On Slide 8, you'll see the details of the upcoming investor event on May 23 to discuss the role of [ Duloxetine ] stand to play in addressing the unmet need in MSA patients with nOH. It's a virtual event and it begins at 10 A.M. Eastern. We have prepared remarks for roughly the first 60 minutes before opening it up to a question-and-answer session.

I'm encouraged both listening to sign open to participate in the session and come prepared to ask questions of our key opinion leaders, Dr. Horacio Kaufmann and Dr. Italo Biaggioni, who have agreed to share their insights. We believe this will be an informative session that sets the stage for the content CYPRESS data in 2025.

With that, I'll turn the call over to our Chief Business Officer, Rhonda Farnum, who will cover our over performance during the floor. Rhonda?

[Rhonda Farnum, executive]

Thanks, Aine. Beginning on Slide 10. I'm pleased to report that the Theravance Viatris commercial partnership finished the first quarter of 2024 with net sales reaching $55.2 million. Having driven, you play year-over-year net sales growth of 18% and a continued increase in profitability.

As Rick mentioned earlier, we have traditionally experienced seasonal dips in reported net sales as we transition from the fourth quarter to the first quarter of the following year. Based on the success we are delivering in the hospital channel, and the view of early demand and retail data from April, we remain optimistic for YUPELRI's continued growth in 2024.

Moving to Slide 11. I'm also very pleased to share with you the exceptional finish to the quarter, our hospital team was able to deliver. Hospital doses shipped in the first quarter increased 31% year-over-year. This was yet another launch to date high-volume order for the hospital business. Our goal continues to be to increase the number of patients exposed to Yupelri during hospitalization who are then discharged on YUPELRI as maintenance patients. This is achieved by continuing to gain support for formulary inclusion, implementing hospital protocols involving all nebulization strategies and therapeutic interchanges and equally important our high-touch transition of care programs.

Our market research continues to demonstrate that the vast majority of patients who initiate YUPELRI in the hospital setting also receive a prescription for YUPELRI maintenance care when leaving the hospital. It is with the execution of the strategy that our small, targeted and focused commercial organization is able to make a considerable contribution to the overall YUPELRI business, both directly and indirectly.

Turning to Slide 12. On the left side, you can see our efforts impact on the hospital market share. During the quarter, our share of the long-acting NIM market in the hospital segment was steady at 16.6%. And we are encouraged by the April data, which suggests further growth to roughly 18% share so far in Q --

-- on the right side of the slide, YUPELRI maintained an approximately 31% share in the community. As a reminder, the total community view has a 3-month lag due to the Med adjudication process. So we only have Q1 data through January of this year. We continue to gain traction with our concomitant therapy messaging, which taps into the significant number of COPD patients who remain symptomatic on LABA Therapy and could benefit from the addition of a LAMA. Lama therapy is foundational in the treatment of COPD and current gold report guidelines recommend dual LABA/LAMA treatment for Category B and E patients.

Turning to the retail channel view on Slide 13, where we have our most real-time and current demand view outside of the hospital channel. I will once again remind you that when we share our quarterly results, we do not have a completed data capture of the fulfillment in the DMA channel, which accounts for approximately 55% of our total community business. Because retail, which accounts for the other 45% generally correlates with total community fulfillment over time, we have historically offered this view.

So looking at the left side of the slide, retail prescriptions declined 9% during the quarter. While we're still in the process of evaluating, we believe that the lower retail volume in Q1 was possibly exacerbated by a cyber incident and Change Healthcare, which is a subsidiary of UnitedHealth Group and a processor for nearly 50% of medical claims in the U.S.

Looking to the right side of the slide, we saw a 3% dip in new product starts in Q1. In addition to some expected impact from the Change Healthcare cyber incident. It is not atypical for this metric due to experience quarter-to-quarter variability. Similar for both total prescriptions and new product starts, we expect both metrics to return to growth in Q2.

Finishing on Slide 14. 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 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 replays 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 1 of 3 branded COPD maintenance therapies in the U.S. delivering consistent growth.

Looking ahead, we expect to achieve continued growth and value creation for YUPELRI driven by continued penetration of the U.S. maintenance COPD market and the potential launch of YUPELRI in China.

Lastly, in the U.S., where we are eligible to receive a onetime sales milestone of $25 million from Viatris when YUPELRI net sales reached $250 million in any calendar year. In China, where Viatris is planning to file for regulatory approval by the middle of this year we are eligible to receive a $7.5 million milestone upon approval as well as additional sales milestones and outly tiered royalties of between 14% and 20%.

That brings us to the end of the YUPELRI update. So I will turn things over to Aziz to cover our financials. Aziz?

[Aziz Sawaf, executive]

Thanks, Rhonda. Starting off with the results for the quarter. Slide 16 and 17 cover the detailed financials. I'll briefly cover the highlights on Slide 18. Starting with collaboration revenue. We reported $14.5 million, representing year-over-year growth of 39%, driven by YUPELRI net sales growth and improved operating margins. For the quarter, both our operating expense and non-GAAP loss metrics were in line with expectations, reflecting meaningful improvement compared with Q1 of 2023. .

Moving forward into the year, operating expenses will increase slightly over the next couple of quarters as CYPRESS enrollment continues to accelerate, and we begin to incur ampreloxetine prelaunch commercialization costs in the second half of the year. We closed the period with $100 million of cash and approximately 48.6 million shares outstanding.

On Slide 19, I'll provide an update on our potential to earn milestones from TRELEGY, noting that GSK delivered another excellent quarter of growth, again beating consensus estimates. Quarterly net sales reached $749 million, up 32% year-over-year. This quarter's results reinforce our belief that we are well positioned to achieve at least 1 milestone in 2024.

With run rate now trending above the first $25 million milestone threshold of approximately $2.9 billion of net sales and run rate approaching the second $25 million milestone threshold of approximately $3.2 billion of net sales.

Moving to Slide 20. TRELEGY's performance also strengthens our confidence in achieving milestones in 2025 and 2026. Relative to annual run rate of approximately $3 billion based on Q1 net sales, we need only minimal growth to achieve the lower end of the milestones shown on the slide in orange, and modest growth to achieve the higher end of the milestones shown on the slide in green, growth rates that TRELEGY is currently exceeded. As a reminder, we have $50 million of potential milestones in 2024 and 2025. And which increased to $100 million of potential milestones in 2026 for a total of $200 million of potential milestones.

Lastly, turning to financial guidance on Slide 20. We are reiterating all financial guidance metrics. With that, I'll pass it back to Rick to conclude. Rick?

[Rick Winningham, executive]

Thanks, Aziz. I'll wrap up our comments on Slide 21 and simply remind you of the company's current strategic focus. We continue to identify and capitalize on YUPELRI's growth opportunities in partnership with Viatris while remaining disciplined with our expense base in order to maximize its value.

In the U.S. We look forward to continuing to make a significant contribution through our hospital-based commercial organization while outside the U.S. Our model is to rely on the interest infrastructure, and we are particularly excited for YUPELRI's potential filing and approval in China. At our May 23 investor event as well as in the coming months, we look forward to sharing much more about this investigational therapy, ampreloxetine and its progress.

Finally, we have the resources to deliver. With $100 million in cash, no debt, significant near-term milestones and modest cash demands, we believe Theravance is positioned for success.

With that, I'll thank you for your time. and turn the call back to the operator. Operator?

[Operator]

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

[Douglas Tsao, analyst]

Can you hear me? .

[Rick Winningham, executive]

Yes, Doug, we can hear you. .

[Douglas Tsao, analyst]

So I guess maybe starting, Rhonda, with you in terms of YUPELRI and what you saw in the retail channel, it's not uncommon to see some sort of sequential headwinds. I mean -- now that I think change health is sort of back online or I'm just sort of looking for -- to understand, I mean, from your perspective and YUPELRI is change sort of back online and all the claims being adjudicated and -- do you think there were scripts that were sort of lost permanently? Or do you think that there might be some catch-up at now that change out is sort of back up?

[Rhonda Farnum, executive]

Doug, excellent question and certainly one we've been very focused on trying to understand. I think an aspect of the phenomenon of what was associated with change health is, we are quite aware that some of our specialty pharmacies determined that they needed to make a switch and make it switch quickly from change to relay health as their processor. So we need to allow for more time for the view into those data to give us a better informed answer on your exact question. Did we lose these patients? Or are they there and it's just an artifact of the data capture right now, which could be highly likely.

[Rick Winningham, executive]

I'd also comment, Rhonda, just on April -- sorry, Doug.

[Rhonda Farnum, executive]

Yes. And if you're tracking along with us, which I think is highly likely, knowing you, Doug, if you look at the April numbers, you definitely can see a rebound in the TRx and new starts for YUPELRI. And obviously, we'll continue to monitor that extremely closely.

[Douglas Tsao, analyst]

Okay. And again, so in that rebound, you're not sure or at this point, it's not clear to you whether that is just sort of the underlying momentum that the product has enjoyed or whether there might be some catch-up or maybe it's a little bit of all?

[Rhonda Farnum, executive]

It's just unfortunately a little too early to give that exact answer, which is what we want to be able to give you that confidence in.

[Operator]

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

[Julian Harrison, analyst]

Great to see the year-over-year heavy growth and sequential growth on key metrics. I guess thinking about the rest of the year, if YUPELRI revenue is to continue trending upwards, how soon can we expect operating margins to expand from here?

[Rick Winningham, executive]

Aziz, you want to comment on that just on what we've seen thus far and?

[Aziz Sawaf, executive]

Yes. Julian, thanks for the question. So as we discussed during the last earnings call, as we set the stage with respect to guidance for the year, we are -- we knew that we were going to hit kind of non-GAAP losses in the first half, which is what we saw in Q1. So Q1 was in line with expectations. .

As we think about the rest of the year, what we've guided to is that we would basically approach breakeven in the second half. So get close to breakeven in the second half, and that's going to be driven by a couple of things. On the expense side, as I had talked about on the call, we're going to -- probably going to increase a little bit in the next couple of quarters, driven by the increased enrollment for CYPRESS. And then as we start to spend a little bit, not much, but a little bit in the second half around the ampreloxetine prelaunch commercialization spending. So -- but that will be offset largely by the increase we're expecting for YUPELRI net sales, which will increase our collaboration revenue.

So we do think that the increase in collaboration revenue will offset the increase to the expense so that the non-GAAP loss improves throughout the rest of the year. Is that helpful, Julian?

[Julian Harrison, analyst]

That's very helpful. And then I had a quick question on CYPRESS. I'm wondering if there's any possibility for data disclosure from the open-label segment that could proceed randomized controlled data, or are you waiting for the second phase to disclose data?

[Rick Winningham, executive]

No. Well, this is Rick. We'll wait until we have data from the randomized withdrawal period -- the conclusion of that period to disclose the data because the primary endpoint is data in the OHSA questionnaire at the end of the randomized withdrawal. Thanks for the question. .

[Operator]

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

[David Risinger, analyst]

Yes. Thanks very much, and thank you for the various updates. So maybe sort of ignoring the incremental ampreloxetine spend. I'm hoping that Rick or Aziz, that you could sort of paint a picture for how you see YUPELRI's prospects, right, assuming that it plays out on the trajectory that you're expecting, how you see its prospects for driving operating leverage for the company.

And then if you could just remind us about the big milestones in coming years, the optionality that would be helpful as well. But I'm particularly interested in how much operating leverage YUPELRI can drive? Obviously, you can't quantify it, but I'm just hoping that you can paint that picture.

[Rick Winningham, executive]

Yes. Thanks for the question, Dave. I'll take a brief -- make a brief comment and then turn it over to Aziz. I mean, clearly, with the YUPELRI, we see a significant amount of operating leverage going forward and working with Viatris. There are various aspects of continuing to tighten and sharpen execution sort of across the board to hospital to community, which should drive incremental sales off of off of a similar expense base.

So -- and the fact that, as Rhonda has mentioned, the [indiscernible] therapy message is, in fact, taking hold, and that particular promotion is quite effective relative to resources employed. So we do expect to pick up operating leverage over time. And continue to see YUPELRI grow from where it is. Aziz?

[Aziz Sawaf, executive]

Yes. And you can actually see that in this quarter, David. The collaboration revenue grew 39% when the net sales growth increased 18%. So of -- the collaboration revenue year-over-year was up about $4.1 million $2.9 million of that was due to the net sales growing 8%. And the balance, the $1.2 million was due to efficiencies on the expense line, which improved the overall margin for YUPELRI.

So you're already seeing it I don't know if you'll see this kind of the delta being this high in the future, meaning the 39% collaboration revenue versus the net sales, but we should continue to see some efficiencies on the expense side relative to prior years, so that the overall margin continues to improve, not just from the sales growth expectations, but the expense line a little bit as well.

The second question you had, I think, was related to -- remind you of the near-term milestone. So let's start with YUPELRI. Obviously, we have $25 million for achieving $250 million of net sales. And then we have the $7.5 million milestone for the approval of the China, equivalent of an NDA. So Rick mentioned earlier, Viatris will be submitting the application mid this year, hopefully, pretty soon. And then whenever that gets approved in the next couple of years or so after that, we'll get $7.5 million.

And then I commented on all the TRELEGY milestones over the next 3 years, we have 50 potential for this year ,50 potential for 2025, and then that increases to $100 million in 2026. And as I noted on the call, we had another excellent quarter, close to $3 billion run rate. And -- so really excited about TRELEGY's progress and expectations of achieving those milestones for TRELEGY.

[Operator]

One moment please for our next question. And our next question comes from the line of Marc Frahm with TD Callon.

[Marc Frahm, analyst]

Maybe just following on some of the milestone comments that you just made the -- just one from a housekeeping perspective. Can you remind me just the guidance around approaching non-GAAP breakeven. That excludes all milestones, right, that you might be getting from YUPELRI or TRELEGY?

And then maybe more for Rick. Just how are you approaching kind of capital allocation as potentially some of these milestones start coming in? Should we expect more things like you did in the past to return to cash shareholders -- does that -- can that be made before you have ampreloxetine data? Or do you really need to wait for ampreloxetine data to kind of figure out -- put the whole picture together.

[Aziz Sawaf, executive]

Yes. The answer to your first question is, yes, that's correct. When we talk about the non-GAAP getting -- approaching breakeven, that excludes any impact for potential milestones. So obviously, if we hit those, it would be significantly over, we would be profitable if we hit any of those.

Go ahead, Rick.

[Rick Winningham, executive]

Yes. So the -- we look at the total capital picture of the company. And I think that clearly, we've got -- we're excited about where we are with YUPELRI and continued growth, Excited about the ampreloxetine data from CYPRESS and should the CYPRESS data be positive. Obviously, this is a rare drug to treat a rare neurological condition. We'll talk more about this on the 23rd. But obviously, we think the financial dynamics of ampreloxetine are quite favorable. .

As you -- and the Board continues to look at as we approach these milestones, the capital that we're going to need for the business versus the capital we have, and we made a comment earlier that we would return all excess capital to shareholders, and I think that the business doesn't need. So -- and we've done that before. Obviously, Mark, you remember, we -- at one point, we were at, I think, $250 million in the share repurchase program. we looked at our business, we thought we had an additional $75 million that we could add to the repurchase program, and we did that and ended up doing a total of $325 million in the repurchase program. And the board looks at this both the forecast of where we're going to be from a cash perspective and what the cash demands are going to be and should the excess capital be there, then we'll return that to the shareholders.

[Operator]

One moment please for our next question. Our next question comes from the line of Liisa Bayko with Evercore ISI.

[Jingming Chen, analyst]

This is Jingming on for Liisa. So could you please give us an update on what percentage of your accounts have implemented all that strategy? And what percentage of accounts or therapeutic [ interchange ] accounts?

[Rick Winningham, executive]

Rhonda?

[Rhonda Farnum, executive]

Yes. Well, as we continue to grow our base of accounts purchasing within that larger base. We're still roughly around 35%, have therapeutic interchanges in place for those that do have therapeutic interchanges predominantly, those are all nebulization accounts because that's what they drive their decision-making off of.

[Operator]

Thank you. It appears we have no further questions on the phone. I would now like to turn the conference back to Mr. Winningham. Please go ahead, sir.

[Rick Winningham, executive]

Yes. I'd like to thank everyone for joining us today. We look forward to the ampreloxetine investor event on May 23, I encourage everyone to join us for that event, I think we'll -- it will be an exciting day to review all the data on MSA and nOH and ampreloxetine as well as the idea of really projecting the opportunity that's out there for Theravance and the opportunity for this medicine to make a significant difference in patients' lives.

So until then, thank you for dialing in today, and thank you for sharing in the first quarter update. We look forward to talking to you in the future and hope to see you on for the virtual event on May 23. Thank you.

[Operator]

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