Theravance Biopharma at H.C. Wainwright Conference: Strategic Focus on Growth

On Tuesday, 09 September 2025, Theravance Biopharma (NASDAQ:TBPH) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company highlighted its financial robustness and strategic initiatives, emphasizing both the promising potential of its drug pipeline and the competitive challenges it faces in the market. Theravance Biopharma is leveraging its financial strength to drive innovation and expansion, maintaining a balanced view of risks and opportunities.

Key Takeaways

• Theravance Biopharma has over $300 million in cash and no debt, with $175 million in anticipated near-term milestones.
• The company is nearing cash flow break-even, supported by the strong performance of YUPELRI, which is expected to generate $40 to $50 million in free cash annually.
• The Phase 3 study for ampreloxetine, targeting neurogenic orthostatic hypotension in MSA patients, is complete, with data expected in the first quarter of next year.
• YUPELRI has been approved in China, with a launch anticipated next year through Viatris, offering an attractive royalty for Theravance Biopharma.
• Ampreloxetine aims to address significant unmet needs in the treatment of NOH, with a focus on a rare disease launch model.

Financial Results

• Theravance Biopharma reported a strong financial position with over $300 million in cash and no debt.
• The company anticipates receiving $175 million in near-term milestones.
• YUPELRI’s sales grew 22% year-over-year in Q2 2024, with a 15% adjusted growth rate excluding a one-time adjustment.
• The company is operating near cash flow break-even and expects to maintain this position until the ampreloxetine data readout.

Operational Updates

• The Phase 3 CYPRESS study for ampreloxetine is complete, with results expected in early next year.
• Theravance Biopharma estimates a total addressable market of 40,000 to 50,000 MSA patients in the U.S. for ampreloxetine.
• YUPELRI has been approved in China, with Viatris planning a launch next year, focusing on transitioning care from hospital to home.

Future Outlook

• The commercial strategy for ampreloxetine will focus on a rare disease model, with plans to build a commercial organization post-data results.
• Theravance Biopharma is preparing for a deliberate and measured commercial investment following successful trial outcomes.
• YUPELRI’s expansion into China is expected to provide significant growth opportunities for the company.

Q&A Highlights

• Ampreloxetine offers a once-daily dosing advantage without a black box warning for supine hypertension, differentiating it from existing treatments like droxidopa.
• The company plans to hire a management team for the MSA NOH segment, using a targeted approach similar to YUPELRI’s launch strategy.

In conclusion, Theravance Biopharma remains committed to leveraging its financial strength and strategic initiatives to drive growth and address unmet medical needs. Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Doug, Interviewer, H.C. Wainwright: Welcome, everybody. We are thrilled to have with us Theravance Biopharma, up next, represented by the company’s CEO, Rick Winningham, and the CFO, Aziz Sawaf. Maybe as a starting point, Rick, maybe just provide an overview for people who aren’t familiar with Theravance’s story, about the company, including your pivotal readout for the ampreloxetine, which is now, with completion of enrollment in the Phase 3 study, expected in the first quarter.

Rick Winningham, CEO, Theravance Biopharma: Thanks, Doug, and thanks to H.C. Wainwright for inviting us to present at the conference. Theravance Biopharma, you look at us today, really, foundation of financial strength, $300 million plus worth of cash on the balance sheet, no debt, near-term, $175 million of milestones with a high probability of receipt, a commercial product, currently cash-flowing, YUPELRI, to us at, say, $45 million positive cash flow every year, revenue continuing to grow, and we see it continuing to grow for the next several years with exclusivity, likely out until 2039. Ampreloxetine, rare disease, medicine targeted at a rare neurological condition, multiple system atrophy, and those patients with neurogenic orthostatic hypotension, about 40,000 patients in the U.S., nothing really to treat them today. As you said, Phase 3 study, last patient in to the study announced that last month, and we should have data in the first quarter of next year.

We’re very, very excited about ampreloxetine.

Doug, Interviewer, H.C. Wainwright: Maybe before we jump in with some more questions about ampreloxetine, I think it might be helpful to just characterize what NOH is and the clinical significance of it and how it affects these patients.

Rick Winningham, CEO, Theravance Biopharma: Yeah, that’s a great question. You know, NOH, neurogenic orthostatic hypotension, is really a marker of autonomic failure for these patients, which is caused by the disease itself, multiple system atrophy. The autonomic failure causes the inability of the patient to regulate their own blood pressure. This dysregulation is really the cornerstone of it, is the lack of production of norepinephrine in the synapse of the nerves, post-ganglionic synapse of the nerves. What that prevents really is the patient from blood pressure adjusting when they go from a sitting to a standing position or laying down to a sitting position. This lack of blood pressure adjustment causes weakness, dizziness, visual problems, et cetera, that really stops the ambulation of the patient. The patient is restricted because of this condition, really restricted to sitting in a chair, on a couch, et cetera.

What we aim to do by treating the neurogenic orthostatic hypotension is to get the patients up and ambulating, really to resolve the core symptom of autonomic failure by addressing blood pressure.

Doug, Interviewer, H.C. Wainwright: Help us, when you were enrolling the study, what did you learn from investigators about both the clinical significance and the potential effect of ampreloxetine?

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think early on, dating back to the Phase 2 work, what we learned was that in MSA patients, ampreloxetine has a positive effect. In the earlier study in 2017 where we looked at Parkinson’s disease patients, found that the drug didn’t work in Parkinson’s disease patients. MSA patients where it did work, what we saw was a resolution of significant improvement, really, of the various symptoms that are associated with autonomic failure. By resolving these symptoms, what investigators fed back to us were that patients were up. They were moving. They weren’t restricted to a couch or, you know, a chair, a comfortable chair in their home.

This ambulation, the ability to be up and moving, obviously is sort of the opposite of what would happen, which is a deconditioning of these patients, of sitting down, not getting up, and the muscle atrophy beginning to set in, which weakens everything about the really the disease and the patient.

Doug, Interviewer, H.C. Wainwright: When you frame it that way, you know, ampreloxetine is not necessarily your traditional disease-modifying therapy, but the benefits should go beyond just the symptomatic treatment of NOH.

Rick Winningham, CEO, Theravance Biopharma: Yeah, because I think what you’re treating here is the core driver of harm in multiple system atrophy being autonomic failure. You’re not reducing the alpha synuclein aggregation in the brain that is leading to the disease, but what you are doing is you’re enabling these patients to live their life more fully and, in fact, to participate in life more fully when they have the disease. I think the resolution of these symptoms or improvement in these symptoms in these patients does, in fact, change their life.

Doug, Interviewer, H.C. Wainwright: Maybe if you could talk a little bit about your pre-launch activities and what you’ve learned about the market during enrollment of the CYPRESS study.

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think one of the things that’s important to understand is that in the execution of the CYPRESS study, we have not used a global CRO. Theravance Biopharma has managed this study by itself, and we’ve hired it both with employees as well as consultants, but it’s been Theravance Biopharma that’s been in the clinical centers. It’s been Theravance Biopharma people building relationships with the investigators, with the treaters, which just so happened to be those treaters that are going to be treating the patient, assuming positive outcome with CYPRESS and that we get the drug approved by the FDA. We’ve been working and building a relationship with the physicians who are going to be treating the physicians, obviously learning about the issues that they have broadly in their practice.

We will use all of this information as well as the strong relationships that we’ve built to enable, hopefully, a successful launch.

Doug, Interviewer, H.C. Wainwright: When you think about the market opportunity, because I think one thing some investors have struggled with is sort of the number of patients that might have multiple system atrophy (MSA), right? We see some varying estimates out there. As you’ve sort of prepped for launch or built the commercial organization, have you been able to better size the market opportunity here?

Rick Winningham, CEO, Theravance Biopharma: I think really from looking at doing fairly sophisticated claims analysis that in the U.S., we feel very confident about about 40,000 patients in the U.S. have multiple system atrophy (MSA) and suffer from neurogenic orthostatic hypotension (NOH), with about two-thirds to 75% of them really continuing to have significant symptoms regardless of interventions that are used. I think what our work to date in marketing research primarily has enabled us to do is to be fairly convinced of the opportunity that’s there and that, in fact, we’re talking about a total addressable market of 40,000 patients. Aziz, anything to add?

Aziz Sawaf, CFO, Theravance Biopharma: Yeah, the claims analysis that we’ve done recently does substantiate about 50,000 MSA patients, of which 80%, almost all of them, have NOH. That is also substantiated by University of California, San Diego, a center of excellence up around the same epidemiology. Other sources substantiate that number. Some of the older, 10, 15 years ago, if you look at that data, it substantiates a lower number, but anything more recent, and again, if you’re doing a claims analysis, 50,000 is the number we’re going with.

Doug, Interviewer, H.C. Wainwright: Droxidopa is approved, although it has a lot of clinical limitations in terms of efficacy and duration of treatment. I’m just curious how many of those patients are currently undergoing some kind of treatment, or is there some amount of work needed to bring patients into the treatment pool because there really is nothing for MSA patients and certainly MSA patients with NOH?

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think really with regard to the launch of ampreloxetine, it’s going to be sort of a classic rare disease effort where you’ve got a medical component of it. There is a sales component. There’s an access component, really tailor-made for the individual offices and treatment centers and the patients that are, in fact, there. I think the beautiful thing about rare disease is that you can get very close to the offices and address the needs that they have, making sure that the patients are, in fact, getting the support that they need and, in fact, getting not only the medical support that they need and the pharmacologic support that they need, but also the access support that they need. I think we’re comfortable about our sort of growth and knowledge on the MSA NOH market, but we’re continuing to build on that knowledge.

I think what it will allow us to do is have a very, very efficient path to market and a very targeted rare disease launch because, as Aziz mentioned, the claims analysis tells us where the patients are. We can become very refined with regard to allocation of our resources.

Aziz Sawaf, CFO, Theravance Biopharma: I think maybe just to build upon the competitive landscape, really, droxidopa, midodrine, fludrocortisone, none of them have shown durability beyond three to four weeks. We’re studying it in 20 weeks. Dosing, ours is once a day. Theirs is three to four times a day, titrating, and safety, but all of them will have black box for supine hypertension. Ours does not. I think that really shows the unmet need that’s there and what ampreloxetine can do if it does get approved.

Doug, Interviewer, H.C. Wainwright: Your other market product, YUPELRI, your commercial effort is based in the hospital. This is now going to be a hospital product. Given the fact we’re now looking at data early next year, you’ve indicated that you are doing the work to file fairly quickly. I think you have an expectation of getting priority review, and we’re not necessarily that far away from commercialization. Where are you in terms of building out your commercial organization?

Rick Winningham, CEO, Theravance Biopharma: I think what we’re going through right now is the planning and the resource modeling of a commercial organization in the future and understanding what the time and event schedule is to, in fact, build it. Obviously, we want to hold off with any sort of capital commitment until we unblind the data and we’re successful. Once we unblind the data and assuming success, then we want to know where to put that first resource, where it’s going to do the best, the most good. I think obviously what we’ll do is hire the management team for the neurogenic orthostatic hypotension multiple system atrophy segment of the business.

This won’t be a hospital business, but I think what we’ve learned from our execution around the hospital with YUPELRI is we’ve learned how to be very, very focused with a relatively small number of people in order to move the needle in the hospital. We’ll apply that same sort of targeting, that same sort of refinement with regard to the multiple system atrophy and the capital, hopefully the capital wisdom that we’ve used in growing YUPELRI. We’ll apply that same approach to, in fact, both the building and the execution of ampreloxetine.

Doug, Interviewer, H.C. Wainwright: As a business, you’ve gotten yourself almost cash flow break even or essentially cash flow break even. I’m just curious, do you anticipate this being a big commercial investment upfront or do you think it will be able to scale fairly quickly?

Rick Winningham, CEO, Theravance Biopharma: I think you look at rare disease launches. They’re not significant capital investments. What you do see with ampreloxetine is, as I said, our ability to understand what commercial organization is needed and, in fact, to build it at the appropriate time. We’re laying out the capital only when we’re confident, in fact, that we’re going to have a successful drug from a regulatory perspective, and we know exactly where to put those resources. It’s going to be, you know, any build will be very deliberate, very focused, and measured because I don’t think it will be a large capital commitment, but it will be a commitment of capital to launch this product. Fortunately, it’s, again, a rare disease, rare neurological disease. Pricing has been pretty good, and as Aziz has pointed out, there really isn’t anything for these patients today.

Even droxidopa, while it was approved under an accelerated mechanism, the RESTORE study did not confirm its efficacy, and it has supine hypertension. As we published and as part of a presentation at the American Academy of Neurology earlier this year, we have not seen a shift in supine hypertension during the studies of ampreloxetine.

Doug, Interviewer, H.C. Wainwright: Now, maybe shifting gears a little bit to YUPELRI, which has continued to grow very nicely, even after being on the market for a number of years. I think you would both note that it’s still worth investing just given the additional runway you have from an IP standpoint with YUPELRI, sort of a long commercial life ahead of it. There was a lot of focus in 2024 on getting the right channel mix, and you had a lot of success, and that’s what led to a real nice rebound in terms of performance. What is the commercial focus right now for that product?

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think it’s really continuing to refine the strategy, the tactics, and working towards flawless execution with both companies. Clearly, the transition of care work from the hospital to the home is a significant focus for both companies because while we’re capturing the patients in the hospital, and 80+% of those patients walk out of the hospital with a prescription, we still have further work to do through the partnership of maximizing the number of patients that are, in fact, eventually not only have a first-time fill, but actually have consistent fill, you know, out beyond five, six, seven months. That’s a terrific opportunity for the brand and an opportunity for brand growth.

I think the other aspect is just capitalizing, again, just execution with our partner in the community and maximizing the community impact of YUPELRI because, again, one in nine patients use a nebulizer for their COPD product, and we are just scratching the surface of that opportunity. Aziz?

Aziz Sawaf, CFO, Theravance Biopharma: No, we had an excellent quarter in Q2. The brand grew 22% net sales versus prior year. We did have about 7% of that 22% was a one-time gross to net adjustment, but even backing that up, 15% growth is excellent. Of that 15%, about 4% was demand. The balance, 11% net pricing. We’re kind of firing on all cylinders with respect to YUPELRI, and that’s generating, you know, as Rick mentioned at the beginning of the call, $40 to $50 million of free cash each year. That’s really funding the ampreloxetine CYPRESS study plus our G&A costs. At the bottom line, we’re basically break even, and we expect to be break even through the data readout.

Doug, Interviewer, H.C. Wainwright: You sort of pointed out, right, part of a big value proposition or value can be derived not just from getting that first script filled when the patient leaves the hospital, but those subsequent scripts. Is there anything that you can do to influence that, or is that something that you’re really relying on Viatris to take care of?

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think we work very, you know, very closely with our partner, Viatris. I mean, there’s, you know, we work really from the beginning of the identification of the patient through achieving persistence, improving the persistence of the product in the community. It’s both companies working together really to make that happen. I think it’s, you know, it’s a relatively seamless approach to working together in order to achieve things like persistence because we not only have to obviously have that in the community, but many of the pulmonologists that are, in fact, the opinion leaders, they’re coming out of the hospital, and they can have an influence on not just the hospital business, but have an influence on the community.

Doug, Interviewer, H.C. Wainwright: You know, YUPELRI recently received approval in China, and if you could maybe provide a framework for, you know, the market opportunity and what that, you know, success there could mean for you at Theravance.

Rick Winningham, CEO, Theravance Biopharma: Our interest in YUPELRI in China is really a passive interest. We have a royalty, an attractive royalty, but I think it’s unlikely that the China launch is this year. I think it’s probably into at least next year. I think Viatris is primarily working through the strategy to bring YUPELRI to the China market. I really don’t have a lot to add versus what we’ve said earlier because I think Viatris is still in the relatively early stages of planning the launch of YUPELRI in China. I do think they believe that it is a significant opportunity for the company.

Doug, Interviewer, H.C. Wainwright: We’re almost out of time, but you recently monetized the Trilogy royalties.

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