Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the TheraVance Biopharma first quarter 2024 conference call. During the presentation, all participants will be in a listen-only mode. A question and answer session will follow the company's formal remarks. To ask a question, press star key followed by the digit 11 on your phone. Again, that's star 11 to ask a question. If listening via webcast, please mute audio on your webcast device before asking a question over the phone. I will repeat the instructions after the management completes their prepared remarks. 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.

Good afternoon, and welcome to TheraVest Podcast. first quarter 2024 earnings results conference call. On slide two, you'll find our safe harbor language. And I'd remind everyone that are called today, we'll 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 and differ materially from our forward-looking statements is described further in our filings with the sec now please turn to slide three because joining me today on today joining me on the call today or audio miller our head of development uh rod de farnham theravance's chief business officer and aziz saw off our chief financial officer Next, on slide four, 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 made good commercial progress with UPelry during the quarter, achieving $55.2 million in net sales in partnership with Vietris. 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 Vietris to complete a regulatory filing for Eupelri in China by mid-year, based on the strong Phase III results announced last November. Turning to ampryloxetine, in the middle of the slide, We're very excited to be hosting a dedicated virtual investor event on May 23rd at 10 a.m. Eastern. We're two thought leaders in the field of autonomic dysfunction. As well as our team at Theravance, we'll discuss the compelling science behind Amperlochstein's opportunity to address the unmet need in NOH and MSA patients. We continue to work diligently to complete the registrational phase three 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 TheraVans to make ampryloxidine available quickly and broadly should Cypress be successful. Finally, we delivered another strong order of financial performance, driven in equal parts by good upel regrowth and expense management. Despite experiencing some seasonal transitioning from quarter four to quarter one, 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, Trilogy turned in a fantastic performance, which makes us increasingly optimistic for the value that that product stands to deliver to TheraVan shareholders in the future. Turning to slide five, 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 upelry'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. upelry sales have increased 12%. 229 million while the collaboration revenues we recognize from viatris have increased 27 percent we are expecting top line data from the cipher study in 2025 if successful we'll act decisively with our regulatory and pre-commercialization strategies in order to bring about amperlockstein successful filing and launch as disease 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 Upelry and Trilogy in the future. With that, I'd like to turn the call over to our head of development, Anya Miller, who will provide some brief comments on Amproloxatine. Anya?

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 amperloxidine program, including our ongoing registration of 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 CIPRS results. As we have discussed in the past, we have generated much of the data required for other elements of the submission beyond the CIPRS data and are already in the process of authoring 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 Amproloxidine for broad availability should Cypress be positive. On slide eight, you'll see the details of the upcoming investor event on May 23rd to discuss the role Amproloxidine stands 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'd encourage those listening to sign up and to participate in the session and come prepared to ask questions of our key opinion leaders, Dr. Horacio Kauffman and Dr. Italo Biagio, who have agreed to share their insights. We believe this will be an informative session that sets the stage for the countdown to Cyprus data in 2025. With that, I'll turn the call over to our Chief Business Officer, Rhonda Farnham, who will cover our upellery performance during the course. Rhonda?

Thanks, Anya. Beginning on slide 10, I'm pleased to report that the Theravance-Theatres Commercial Partnership finished the first quarter of 2024 with net sales reaching 55.2 million, having driven upellery 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 UPelRE'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 quarter for the hospital business. Our goal continues to be to increase the number of patients exposed to upelry during hospitalization who are then discharged on upelry 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 upelry in the hospital setting also receive a prescription for upelry maintenance care when leaving the hospital. It is with the execution of this strategy that our small, targeted, and focused commercial organization is able to make a considerable contribution to the overall capillary 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 NEM 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 Q2. On the right side of the slide, UPEL maintained an approximately 31% share in the community. As a reminder, the total community view has a three-month lag due to the MedB 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 at Change Healthcare, which is a subsidiary of United Health 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 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 llama for maintenance treatment of COPD. Upelri has demonstrated consistently meaningful lung function benefits, is typically available at low out-of-pocket costs, and requires only a few minutes to administer once per day. As such, we believe Upelri plays a key role in the COPD market, where there remains a substantial opportunity to reach patients who could benefit from Upelri. Our go-to-market strategy aligns with this profile, which we believe is why UPelry is only one of three branded COPD maintenance therapies in the U.S. delivering consistent growth. Looking ahead, we expect to achieve continued growth and value creation for UPelry, driven by continued penetration of the U.S. maintenance COPD market and the potential launch of UPelry in China. Lastly, in the U.S., where we are eligible to receive a one-time sales milestone of $25 million from Viatris, one-year Pell Re-Net sales reach $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 upwardly-tiered royalties of between 14 and 20 percent. That brings us to the end of the UPelRI update, so I will turn things over to Aziz to cover our financials. Aziz?

Thanks, Rhonda. Starting off with the results for the quarter, slides 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 percent. driven by upelry net sales growth and improved operating margins. For the quarter, both our operating expense and non-gap 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 quarters as Cypress enrollment continues to accelerate and we begin to incur Amperloxkeen 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 Trilogy, 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 one 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, Trilogy'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 the trilogy is currently exceeding. As a reminder, we have 50 million of potential milestones in 2024 and 2025, 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?

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 UPelri's growth opportunities in partnership with Vietris 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's infrastructure, and we are particularly excited for UPelry's potential filing and approval in China. At our May 23rd investor event, as well as in the coming months, we look forward to sharing much more about this investigational therapy amperloxidine 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?

Thank you, sir. Once again, if you would like to ask a question, you may do so by pressing the star key followed by the digit one, digit one on your touchtone phone. If listening via webcast, please mute audio on your webcast device before asking a question over the phone. If you're using a speakerphone for today's call, please make sure you mute your function is turned off to allow your signal to reach our equipment. Again, that's star one one if you'd like to ask a question. and we'll pause for a moment to assemble our roster.

And our first question comes from the line of Douglas Sao with H.C.

Wainwright.

Hi, good afternoon. Can you hear me?

Yes, Doug, we can hear you.

So I guess maybe starting, Rhonda – with you in terms of upelry and what you saw in the retail channel. You know, 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 to understand, I mean, from your perspective and upelry, is Change Health 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 Health is sort of back up?

Thanks, 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 a 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 those patients or are they there? And it's just an artifact of the data capture right now, which could be highly likely.

You might also comment, Rhonda, just on April. Sorry, Doug.

Yeah. And if you're tracking along with this, 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 UPel REIT. And obviously, we'll continue to monitor that extremely closely.

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 balls.

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.

Okay. Great. Thank you very much. I think that's it for me right now.

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

Hi. Good afternoon. Congrats on the progress, and thank you for taking my questions. And great to see the year-over-year UPEL regrowth and sequential growth on key metrics. I guess thinking about the rest of the year, you know, if upelary revenue is, you know, to continue trending upwards, you know, how soon can we expect operating margins to expand from here? Thank you.

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

Yeah. Hey, 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 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. break even 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 amperloxetine prelaunch commercialization spending. So but that will be offset largely by the increase we're expecting for UPelri 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 Tatevossianis That's very helpful. Thank you. 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 precede randomized controlled data, or are you waiting for the second phase to disclose data? Thank you very much.

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. Thank you. One moment, please, for our next question. And our next question comes from the line of David Riesinger with Lyric Partners.

Yes, thanks very much, and thank you for the various updates. So, maybe sort of ignoring the incremental ampryloxetine spend, I'm hoping that Rick or Aziz, that you could sort of paint a picture for, you know, how you see upelre'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 UPelri can drive. Obviously, you can't quantify it, but I'm just hoping that you can paint that picture. Thank you.

Yeah, thanks for the question, Dave. I'll make a brief comment and then turn it over to Aziz. I mean, clearly, you know, with UPelri, we see a significant amount of operating leverage going forward. working with the interest you know there are various aspects of continuing to tighten and sharpen execution sort of across the board to hospital the community which should drive which should drive incremental sales at off of a you know off of a similar expense base so and the fact that as Rhonda's mentioned you know, the therapy message is, in fact, taking hold. And that particular promotion is quite effective relative to resources employed. So, you know, we do expect to pick up operating leverage over time and continue to see upel regrow from where it is. Aziz? Yeah.

You can actually see that in this quarter, David. The collaboration revenue grew 39% when the net sales growth increased 18%. So 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, was due to efficiencies on the expense line, which improved the overall margin for upelary. So you're already seeing it. I don't know if you'll see 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 milestones. So let's start with upelary. 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, Vietris will be submitting the application mid this year, hopefully pretty soon. And then whenever that gets approved in the next couple years or so after that, we'll get $7.5 million. And then I commented on all the trilogy milestones. Over the next three years, we have 50 potential for this year, 50 potential for 2025. And then that increases to $100 million in 2026. As I noted on the call, we had another excellent quarter, close to $3 billion run rates. And so we're really excited about Trilogy's progress and expectations of achieving those milestones for Trilogy. Great. Thank you very much.

Thank you. One moment, please, for our next question. And our next question comes from the line of Mark Fram with TD Callen.

Thanks for taking my questions. Following on some of those milestone comments that you just made, 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 UPelry or Trilogy. And then maybe more for Rick, how are you approaching capital allocation as potentially some of these milestones start coming in? you know, should we expect, you know, more things like you did in the past to return cash shareholders? Does that, can that be made before you have amproloxacin data, or do you really need to wait for amproloxacin data to kind of figure out, put the whole picture together?

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

Go ahead, Rick. Yeah, so the, you know, we look at, you know, look at the total, you know, total capital picture of the company. And I think that, you know, clearly we've got, we're excited about, you know, where we are with upelry and continued growth, excited about, you know, the ampryloxatine uh data from cyprus and should should the cyprus data be positive obviously this is a rare uh drug to treat a rare neurological condition and we'll talk more about this uh you know on the on the 23rd but obviously we think the financial dynamics uh you know of ampryloxetine are quite favorable uh as you and the board continues to look at uh you know as we approach these milestones you know, 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. And we've done that before. Obviously, Mark, you remember, you know, at one point we were at, I think, 250 in the share repurchase program. we looked at our business we thought we had an additional 75 million that we could uh add to the repurchase program and we did that and ended up uh doing a total of 325 million in the repurchase program and the board looks at this you know both the forecasts of where we're going to be from a cash perspective uh and what the cash demands are going to be and and should you know should the excess capital be there then we'll return that to the shareholders

Okay, thanks. Very helpful. Thank you. One moment, please, for our next question. And our next question comes from the line of Lisa Baco with Evercore ISI.

Hi, this is Jamie. I'm for Lisa. Thanks for taking our questions. So could you please give us an update on what percentage of your account have implemented all NAB strategy and what percentage of accounts are therapeutic interchange accounts? Thank you.

Rhonda?

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.

Got it. Thanks.

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

Yeah, I'd like to thank everyone for joining us today. We look forward to the Amproloxatine Investor Event on May 23rd. Encourage everyone to join us for that event. I think it'll be an exciting day to review all the data on MSA and NOH and Amproloxatine as well as the idea of really projecting the opportunity that's out there for TheraVans 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 for the virtual event on May 23rd. Thank you.

This concludes today's conference call. We thank you for your participation.