Theravance Biopharma, Inc.

Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Fair Advance BioFarmer 3rd 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, press the star key followed by the digit 1, digit 1 on your phone. Again, that's star 1, 1 to ask a question. If listening via webcast, please mute your audio on your webcast device before asking a question over the phone. I'll repeat the instructions after management completes their prepared remarks. Also, today's conference call is being recorded. And now I'd like to turn the conference over to Rick Winningham, Chief Executive Officer. Please go ahead, sir.

Good afternoon, and welcome to Fair Advance BioFarmer's 3rd Quarter 2024 Earnings Results Conference Call. I encourage you to review our forward-looking statements disclaimer on slide 2, which covers certain risk factors, which could cause actual results to differ materially from any forward-looking statements that we might make in today's call, and which are described further in our filings with the SEC. You will find today's agenda on slide 3, along with members of the Fair Advance Leadership Team who will join me in the call today. These are Rhonda Farnham, Chief Business Officer, Aziz Salaf, Chief Financial Officer, and Anya Miller, Head of Development. Now, if you turn to slide 4, I'd like to cover our most recent operational and financial results. Starting on the left, we're pleased to have delivered sequentially improved upeliori quarterly net sales performance in partnership with Beatrice, having driven 7% growth year on year and 14% quarter on quarter to 62.2 million in a new launch today high. Third quarter upeliori demand increased 14% and hospital doses increased 40% versus the same period a year ago. Second, we made solid progress on our pivotal cipher study for ampullocity and remain on target to achieve our updated timelines. Lastly, GSK delivered another good trilogy result, reaching 789 million for the quarter and putting us in a position to achieve the higher 50 million 2024 sales milestone should fourth quarter sales exceed approximately 610 million, which is well below consensus estimate. If achieved, Fair Advance would expect to receive this milestone in the first half of 2025. Turning to slide 5, I'd like to cover two initiatives our board has approved relating to our ongoing efforts to unlock value of TheraVenous biopharmaceuticals. These reflect our willingness to proactively implement measures aligned with the interest of our shareholders while sharpening our operational focus in pursuit of delivering innovation to medicines with, to patients with the highest unmet medical need. First, in keeping with our regular review and updating of governance practices, we announced that the board of directors has separated the role of CEO and chair and that Susanna Gray has been elected chair of the board of TheraVenous biopharma. I'll continue my focus and my efforts on TheraVenous' mission as a director and CEO. Susanna's unique experiences and skill set make her a natural choice to lead the board moving forward as she brings over 30 years of experience in the biopharmaceutical industry, specializing in capital markets and corporate finance. Second, we announced today that the board of directors has formed a strategic review committee consisting of independent directors with the purpose of comprehensively exploring alternatives available to the company involving all of its key assets, including eupillary, amphaloxythene, trilogy and its tax attributes. Lizard will be acting as a financial advisor to assist in this review process. As we've stated consistently, TheraVenous' board regularly considers options to enhance the company's strategic positioning and we believe that forming the strategic review committee highlights our focus on unlocking value and aligns with our shareholders' best interests. Lastly, as we previously communicated, we remain committed to returning excess capital to shareholders. Now I'd like to turn the presentation over to Rhonda to cover eupillary's performance in the quarter. Rhonda.

Thanks, Rick. I will begin with slide seven where we present eupillary's quarterly net sales progression. Beatrice reported 7% -over-year growth in net sales, reaching approximately 62 million, which is an all-time high. This growth was driven by a 14% increase in demand, exceeding expectations. Additionally, this quarter showed sequential improvement in pricing and channel mix relative to Q2. And we have also seen a more recent increase to average selling price or ASP. When we reported second quarter performance, we highlighted net pricing headwinds due to channel mix, specifically increased demand into lower margin channels and one-time charges that impacted quarterly pricing. In collaboration with Beatrice, we are executing on strategies to deliver demand in higher margin, non-retail channels, and we are confident these initiatives will continue to enhance net pricing and overall brand performance. And as a reminder, we are limited in our ability to discuss certain elements of pricing, giving confidentiality considerations. Turning to slide eight, we continue to experience considerable momentum in the hospital setting. During the quarter, we shift approximately 227,000 upelredoses, up 40% compared with Q3 of 2023 and equivalent to our performance in Q2, which was particularly strong. Notably, this pattern is typical of the seasonality we see in our hospital business, where Q3 does not show as much sequential growth as in other quarters. As a reminder, the strategic objective for our focus in the hospital setting is to create the catalyst to drive post-discharge outpatient maintenance use of upelre. Supporting that objective, we continued to broaden our base of formulary winds and implementation of therapeutic interchange protocols to position patients to continue their treatment after leaving the hospital. Based on our historical experience and a better than expected rate of formulary and new account winds in the quarter, we expect a strong finish to the year and continued momentum into 2025. On slide nine, you can see how our hospital performance has contributed to share gains within the hospital long-acting net market on the left-hand side. Based on data through the end of the quarter, we are up to a nearly 19% share, which is a new all-time high. As it relates to our concomitant use messaging and the goal of driving to a -to-one ratio of NebLaba to upelre use over time, we continue to make good progress in end of the quarter at a -to-one ratio. We see further opportunity for improvement in coming quarters, which should help us continue to contribute significantly to upelre's overall growth. On the right-hand side of the slide, you can see upelre's share development in the community setting. As a reminder, we do not have a full data view by the time we report, so the 32% share we are presenting here only represents our performance through August. Given the demand generation we are seeing, compared with trends we see for Nebulized Labas in the community setting, we are optimistic this trend will continue to develop favorably moving forward. Moving on to slide 10, in addition to the substantial opportunity that still remains in the U.S., we also see significant potential to realize value in China, where Beatrice filed an NDA in June. The median time to review an NDA in China is approximately 15 months, and we stand to realize a 7.5 million milestone on approval. Additionally, we have the opportunity to earn up to 37.5 million of sales milestones and upwardly tiered royalties of between 14 and 20%. Finally, I will wrap up my comments on slide 11. First, upelre is a unique medicine offering a substantial and highly differentiated value proposition. It is the only nebulized llama for COPD maintenance treatment in the U.S., and we believe it is underutilized within the patient population to which it is best suited. We see long-term growth potential for the product, driving considerable value to TheraVent shareholders. Second, in addition to our co-promotion economics in the U.S., we potentially stand to achieve milestones and royalties as outlined here, which includes those I referenced in the previous slide associated with the potential new opportunity in China. At this point, I'll turn things over to Aziz for an update on trilogy. Aziz?

Thanks, Rhonda. I'll start on slide 13, where I'll discuss our potential to earn milestones for trilogy. As reported by GSK, trilogy sales increased 17% in the quarter to 789 million. -to-date, this brings sales to 2.6 billion, up 30%. Based on -to-date results, in Q4, we estimate that GSK needs approximately 260 million in sales for us to achieve the 25 million milestones, and approximately 610 million in sales to achieve the 50 million milestones. To put the 610 million requirement into perspective, this is 240 million, or approximately 30% less than the consensus estimate of 850 million. We believe the recent performance for trilogy bodes well not just for the 2024 milestones, but also for the 150 million of additional milestones we could achieve in 2025 and 2026, where consensus estimates are significantly higher than the sales required to achieve the full 150 million of milestones. Given we are in a position to earn a milestone in 2024, I'd like to remind investors that achieving these milestones is tied to Ruralty Farm's receipt of trilogy royalties from GSK. In order to make it easier for investors to track, we have provided an estimate of what net sales would need to be in order for these royalty thresholds to be met. For example, should 2024 net sales exceed 3.2 billion, we estimate that GSK would pay Ruralty Farm at 275 million in royalties, which would trigger the 50 million milestones at Theravans. Turning to slide 14, a reminder that in 2029, high single digit royalties on trilogy will revert back to Theravans, an asset we believe is often overlooked as a component of long-term value to shareholders. Now I'll hand it back to Anya to brief, now I'll hand it to Anya to provide a brief update on Amperloxetine.

Anya? Thanks, Aviv. As again on slide 16, as we discussed at our last earnings call, we've been working with important academic institutions and affiliated MSA sensors of excellence in order to deliver high quality results for our Phase 3 Pivotal Study Cycle. The level of expertise at these sites ensures that the trial experience of these patients is well managed and enables us to both recruit and retain the appropriate number of patients we required to report out the Cycle study. During quarter three, we were able to progress and an open additional site was planned. We have enrolled patients over the quarter at a month over month royalties that keeps us on track to achieve our objective of enrolling the final patients in the open labelled portion of Cypress by the middle of next year and disclosing top line results of the study approximately six months later. Turning to the bottom of the slide, we continue to engage the scientific community with presentations at both the International Parkinson's Disease and Movement Disorder Conference, also referred to as the MDS meeting, which took place in September, and the American Autonomic Society meeting held earlier this month. Our MDS presentation focused on safety and tolerability data observed in the long term extension of Study 170. Amproloxetine was generally well tolerated by patients with NOH, but only 10% of patients experiencing treatment emerges at birth events considered related to amproloxetine and no patients reporting supine hypotension. Just 6% of the 110 patients evaluated in the study dropped out over a mean duration of exposure to amproloxetine over approximately nine months. A second analysis just presented at AAS evaluated data from our 169 study and highlighted the impact of NOH on symptom burden and daily functioning in patients with NOH. This analysis demonstrated greater baseline NOH symptoms in MSA as compared to other synucleinopathies, translating into higher symptom burden, reduced functioning and lower quality of life, despite treatment with available pressure agents. A clear need for improved treatment alternatives remains in symptomatic NOH in MSA that we hope amproloxetine will help address. On slide 17, I'll briefly remind you of where we stand with amproloxetine. We've substantiated the significant on-met need which we believe can be addressed with a targeted commercial effort. Approximately 40,000 patients with MSA in the United States suffer from symptoms of NOH and available therapies have significant efficacy and safety limitations. We validated amproloxetine target profile, which has clear differentiation from available alternatives used to treat NOH and MSA patients. Our work to date on amproloxetine supports its safety and tolerability profile and its ability to raise plasma norepinephrine and prevent symptom worsening. We are aligned with FDA on requirements for a full approval should the CIPER study be positive and we have obtained orphan drug designation in the United States. We believe we are positioned to complete our regulatory filing quickly given we have already given the work we've already completed. Now I'll turn the presentation back to Aziz for our financial results and guidance. Aziz?

Thanks, Anya. Starting off with the results for the quarter, slides 19 and 20 cover the detailed financials. I'll review the highlights on slide 21 where we had a solid quarter with slightly better than expected results across all key financial metrics. Starting with collaboration revenue, we reported 16.9 million above expectations representing an 8% increase compared with last year. This quarter also marked an all time high in product level profitability. Total operating expenses excluding share based comp saw modest year over year increase due to the progression of the CIPER study, but were slightly better than expectations. And while our R&D expenses increased, thanks to cost savings initiatives, G&A expenses decreased by 7% in the quarter and 21% year to date compared with last year, positioning us to achieve our goal of a 20% reduction for the year. We reported 5 million in share based comp for the quarter, another 21% reduction when compared with last year. This again puts us on track with both our G&A and share based comp reduction targets for the year. During the quarter, we incurred a 1.6 million non-cash impairment charge due to the write down in the value of our operating lease assets related to our excess lab space. Given current market conditions, we took a conservative approach and wrote down the full remaining value of the lease related to our excess lab space. We closed the period with 91 million of cash and 49 million shares outstanding. On slide 22, I'll comment on our expected financial performance in the fourth quarter and full year 2024. We are reaffirming guidance made at the beginning of the year and expect R&D expenses in Q4 to be slightly higher than Q3 due to the continued progression of the CIPER study and for SG&A expenses to be similar to Q3. For the full year, this would put us near the midpoint of guidance for both R&D and SG&A. Furthermore, we expect our non-GAAP results in cash burn and Q4 to be consistent with Q3. Finally, as was the case last year, we expect to incur a higher non-cash tax charge sequentially in Q4, primarily due to better than expected results and other non-cash charges from one of our operating entities. Looking ahead to 2025, our minimal cash burn enables us to progress the CIPER study to a major value reflection point without relying on the capital market. Our focus remains on driving growth through disciplined investment and delivering long-term value to shareholders. With that, I'll pass it back to Rick to conclude. Rick?

Thanks, Aziz. I'll conclude on slide 23 by covering the main strategic elements of our plan to maximize the value of TheraVenus biopharma while delivering on our core mission of delivering medicines that make a difference to patients. First, a top priority is always to maximize the number of appropriate patients on UPELLRI who could benefit from its significant loan function improvement delivered via nebulization over a full 24 hours. Based on our market research, we continue to see a considerable opportunity to expand UPELLRI's utilization in the United States and we're optimistic about its growth moving forward. Second, we're progressing well with both Cypress enrollment and our regulatory and early commercialization preparations for AmploxPete and NOH and MSA and are looking forward to delivering important milestones in 2025. Third, we're dedicated to maximizing value for shareholders. We're excited with the trends that we've seen in trilogy and the potential milestones that could accrue to the company. We're managing our expenses carefully and expect the limit cash utilization moving forward. The board has formed a strategic review committee to evaluate all alternatives available to TheraVenus to unlock the significant value of TheraVenus' assets given our view that much of the intrinsic value is not currently reflected in our share price. And finally, we remain committed to returning excess capital to shareholders. We thank you for your continued support and at this time are ready to open the line questions.

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 the audio on your webcast device before asking your question over the phone. If you're using a speakerphone for today's call, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that's star one one if you would like to ask a question and we'll pause for a moment while we assemble our roster. Our first question comes from Julian Harrison with BTIG. Your line is open.

Hi, congrats on the quarter and thank you for taking my questions. First, I'm curious if you're seeing any changes in UPelway prescribing patterns post and suspension launch. You know, either headwinds or tailwinds there and then second, can you remind us where you stand on site activations for the Cypress study? Are you at target now? If not, how far away are you from that?

Yeah, sure, Julian. Thank you. Roger, you want to take the UPelway question and then on? We'll follow.

Great. Thanks for the question, Julian. As I've mentioned before, we're very excited to have other effort and share of voice in the marketplace highlighting the importance of nebulization as an offering for patients. And I think it's a little too early to see kind of the full gamut of what exact patients are getting what relative to encephentrine. But I will say in anecdotal feedback that we're hearing from the field, we are hearing that encephentrine is being added on to you, Pauline, and specifically, a multitude of examples of concomitant use. So, lava plus llama and then encephentrine added on. I think as we get closer, maybe another quarter in, we'll have full visibility into the MedB prescribing and can be able to comment on that more readily.

Good. Hanya.

Hi, Julian. Very pleased to say that we're now in a position where we have the vast majority of our sites now activated. You'll remember last quarter, we talked about our naming number of key sites that we wanted to progress and we've been in a position to progress them over the last quarter and almost all sites over the line at this point.

Excellent. Thank you and congrats again.

One moment for our next question. Our next question comes from Ernie Rodriguez with TD Cowen. Your line is open.

Hi, Tane. Congratulations on your record quarter and thanks for taking our question. I'll start with you, you mentioned the hospital does so increase by 40% year to year and you also are increasing your market share. Could you give us more color on what's driving that and what the expectations are going forward as the year to year becomes harder to come? Rhonda.

Yes, thanks Ernie. What continues to drive that growth, which we are very pleased with, is continuing to build upon the number of formulary approvals we have in the US, as well as when we are able to achieve a formulary that that formulary also includes a therapeutic interchange, which I think you already appreciate that that basically puts in place in the EMR system. The substitution for when a llama is prescribed that you tell her is the choice. So seeing this last quarter that of our focus accounts, we have now moved up to 50% of those accounts have a therapeutic interchange. So where we have therapeutic interchange, we have significantly higher. Market share, so I commented that we're roughly at 19% for total market share where we have therapeutic interchange. We are at 36% market share. So it's getting those wins that are continuing to drive that effort in the hospital channel.

Thank you. That's very useful. And then just another quick question on the committee, the newly formed committee to the strategic alternatives. What prompted the initiative? I guess, why now? And what would be the ideal outcome of options that you consider?

Yeah, already great question. Well, the board's always evaluating the company's strategy against the most short term and long term goals. If you look at where the company is today, and we've covered a number of the key elements of value in the company, namely the continued strength of trilogy, not only the 50 million milestone coming into for 2024 sales coming into frame and what we should be able to earn, but the other milestones in 25 and 26, as these highlighted. So you put trilogy and those milestones and longer term, the royalties coming back to us. You have upeliorate growing in the United States, continuing to grow. We've worked closely, as Rhonda said, with Beatrice over the last quarter, sharpening up our execution sort of across the board. And then the China approval. And then slightly around 12 months or so from data from a very important phase three study with Amphiloxetine in a rare neurological condition in Cyprus. And then you kind of close with the tax attributes. You know, the board determined that now was just an appropriate time to undertake a formal review with the options that are available to the company to unlock the value of those of those assets. And given, you know, we want to take a proactive approach that allows us to make informed decisions that will benefit our benefit our shareholders. So, you know, I think that's the some substance of the action is, you know, we believe that our assets are appropriately valued. The board's got a strategic review committee in place now to work with Wizzard to map out a plan and actions to get better valuation out of those assets, the benefit of our shareholders and the underlying business of their advances is very strong and we're optimistic about it. So we need to pull that value through to our shareholders. Does that help?

Yeah, no, that's very helpful. Thank you for that and congrats again on the quarter.

Thank you again, ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. It appears we have no further questions on the phone. I'd like to turn the conference back over to Mr. Winningham. Please go ahead, sir.

Thank you, operator. Thanks, everyone, for participating and joining us at our third quarter update call and look forward to seeing all of you soon and have a good day.

Pardon me, Mr. Winningham, we did have one person just QF. Did you want to go ahead and take that question?

Yes.

Sorry, one moment. Our next question comes from Douglas Sile with AC Rainwright. Your line is open.

Hi, good afternoon. Thanks for taking the questions. So apologies in advance that this question has already been asked, but just curious, it looked like we sort of started to have a nice rebound with you. I'll read this quarter, certainly coming in ahead of our expectations. Just curious, you know, the extent that you were able to make progress in terms of impacting the ASP and what that might mean for, you know, expectations heading into 2025. Thank you.

Robbie, you want to take that?

Yes, thanks, Doug. I think relative to progress, as you know, we've highlighted in the past, specifically to ASP, you know, that's a two-quarter lag of impact once there are any implications for initiatives that are put in place. I think more of what was able to drive the success in Q3 was really looking at that further supplier diversification and, you know, the output of the channel deployment and execution very specifically across all channels, that being community, hospital, long-term care, etc. What I would say relative to the improvement in price, you know, relative to Q2 and, you know, the expectation that overall price will continue to improve, that's more relative to early 2025. So you combine that with the strong demand growth we have been seeing now for two quarters straight. We're just remaining very optimistic about net sales progression for the brand, you know, into 2025 and certainly beyond.

And I think, Doug, coming out of the second quarter, the collaboration really with Beatrice, you know, on pricing, on, you know, marketing and driving the business forward just has been excellent. So I interrupted you. Go ahead.

No, no, no. I was going to say, Rick, I mean, so obviously, Ron, as you noted, there is a lag in terms of the reported ASP and that obviously affects, you know, what you're able to command in certain channels. But I'm just curious in terms of the sort of receptivity or impact on the customer base as you sort of try to pursue these initiatives and whether you have experienced any resistance or were you able to sort of implement them without any kind of disruption from a volume standpoint? For ruffling feathers, perhaps that's a better way to put it.

Yes, well, it's always the goal to not ruffle feathers. So I would say I would answer to the latter is the situation.

You might just talk, Rhonda, briefly for Doug about the overall value, you know, the value prop really for you, Pelory, you know, in the patients that we're treating in the hospital and the community.

Yes, well, I think we've certainly highlighted in the past of where there continues to be what we feel is under realized opportunity within three different patient segments. And, you know, certainly borrowing off of what I commented on relative to the concomitant use strategy, ensuring that where there is lava use that we want to ensure that along with mirroring gold guidelines that adding that llama or you pelory is certainly in the consideration. So executing on that, improving that ratio. The goal is to get to two to one and continuing to see improvements in both the hospital and the community efforts there. And then for those patients who already prefer nebulized therapy and recognize that concomitant use is certainly an option, there are still those patients that are relying on short acting therapy to support what they feel is their maintenance care. But they are using a nebulizer four to six times a day and still experiencing symptoms. So the goal is to continue to switch those patients from short acting them, get those patients control and ensure that they're recognizing the value of a long acting medication. And then lastly, for those patients that are receiving triple therapy, handheld, often, most often I should say as a dry powder inhaler, we want to ensure that this patient population recognizing that dexterity, cognition difficulties are limiting their ability to use the device properly. So this reference represents a primary reason of why we feel that there is an opportunity to educate on the value of changing device, which is easy to administer and offers a one stay daily option for these patients. We feel like recognizing the value and the number of roughly 1.5 million patients that could stand to benefit from upeliori. In addition to the 400,000 that represents the first two segments I just highlighted, there is significant room to grow this brand.

Okay, great. Thank you.

And that was our last question. I'm not sure if you are finished your concluding comments, Mr. Winningham.

I did, operator. Thank you very much. Thank you for joining us.

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