Theravance Biopharma at H.C. Wainwright: Strategic Focus on YUPELRI and Ampreloxetine

On Tuesday, 20 May 2025, Theravance Biopharma (NASDAQ:TBPH) presented at the H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025. The discussion, led by CEO Rick Winningham, highlighted the company’s strategic focus on YUPELRI and ampreloxetine, emphasizing growth opportunities and commercialization strategies while maintaining a strong financial position.

Key Takeaways

• YUPELRI shows strong growth, particularly in the hospital channel, supported by formulary wins.
• Ampreloxetine, a Phase III asset, is generating excitement for its potential in treating neurogenic orthostatic hypertension.
• Trelegy remains a significant source of capital, with long-term potential in asthma and COPD.
• Theravance Biopharma plans to return excess capital to shareholders, prioritizing YUPELRI and ampreloxetine development.
• The company is well-capitalized with a strong balance sheet and expected milestone payments.

Financial Results

Theravance Biopharma reported a solid financial standing, with $130 million on its balance sheet. The company anticipates potential milestone payments, including $150 million from Trelegy and $25 million if YUPELRI achieves $250 million in sales this year. This financial strength supports their strategic initiatives and commitment to shareholder returns.

Operational Updates

YUPELRI, a treatment for COPD, has shown robust growth, particularly in the hospital channel, with approximately 80% of patients leaving the hospital with a prescription. The company is collaborating with Viatris to enhance patient transition to outpatient care, aiming to improve first fill and refill rates. Additionally, channel optimization efforts are underway to improve net pricing.

Future Outlook

Ampreloxetine, targeting neurogenic orthostatic hypertension, is in Phase III development. Clinicians are optimistic about its precision medicine approach, which aims to increase norepinephrine in peripheral nerves. The company is focused on an efficient commercialization strategy, leveraging its understanding of patient locations and integrated team structures.

Q&A Highlights

During the Q&A session, CEO Rick Winningham emphasized the importance of the ampreloxetine program for future growth and shareholder value. He reiterated the company’s commitment to returning excess capital to shareholders if available. Winningham also highlighted the bright future for Trelegy, given its complexity and lack of direct competitors in the market.

In conclusion, for a comprehensive understanding of Theravance Biopharma’s strategic direction and financial outlook, readers are encouraged to refer to the full transcript below.

Full transcript - H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025:

Doug Sav, Senior Analyst, H. C. Wainwright: Okay. I think we’ll get started with our next presentation. Okay. I think we’ll get Okay. I think we’ll get started with our next presentation.

So I’m Doug Sav, senior analyst at H. C. Wainwright. We are thrilled to have us with us, Theravance Biopharma, represented by the company’s CEO, Rick Winningham. So, a lot to ground to cover.

And so maybe we’ll start with YUPELRI, which is your approved on market treatment for COPD. And, you know, this is a product that has had sort of what I would characterize as really strong, consistent growth over the last few years, recovered very nicely coming out of the the the the COVID pandemic. Where we’ve seen incredibly strong performance recently, and execution on your part of your team is in the hospital channel, which you as a company are responsible for. But I think part of you know, and obviously, I think sort of really unlocking the value for the product is on the outpatient side, which your partner, Viatris, is responsible for. But obviously, you both work closely.

And so how does improving that execution around transition of care and capturing, the long term value of the patient? You know, and how can this be accomplished? What’s underway? What are you thinking about? And ultimately, what do you think it would mean if you were successful?

Rick Winningham, CEO, Theravance Biopharma: Yeah. It’s a great it’s a great question. And I think, you know, the last, several quarters, the hospital, hospital business has been quite strong. The total YUPELRI business has also grown. But the hospital business has been growing unit volume at a faster rate, really driven by something that Ron DeFarnum highlighted in the second quarter is that we second quarter of last year is that we were picking up more and more formulary wins.

And that those formulary wins with therapeutic interchange interchange really translated into strong volume growth, in particular, the third quarter, fourth quarter and then the first quarter points of the hospital growth is just the overall scale and volume of the hospital growth. There are more Viatra sales representatives, than Theravance sales representatives. So now with the you can sort of take the unit volume of the of the hospital to the business, divide it by four or five, and you get the an approximate number of of patients really coming out of the hospital with about eighty percent of those coming out of the hospital with prescription for YUPELRI. Well now, the number of patients coming out of the hospital are getting larger and larger that really feed more directly into the Viatris commercial organization, such that the sales reps of the Viatris organization are realizing that they can grow their business by picking up these patients and making sure that the pulmonologists in that area where we have achieved a level of success with major hospitals, pulmonologists are aware of the significant number of patients that are coming out of the hospital with prescriptions for YUPELRI, and we could transition them better.

Now, the other thing that’s working better, honestly, is the sales rep to sales rep work between Theravance and the Viatris reps, even though there’s a lot more Viatris reps than there are Theravance reps. But our business, our representatives understand that their job is not only to be successful in the hospital, but it’s to be successful in transition to care because that’s what drives the overall business long term. And the data on YUPELRI in terms of its level of bronchodilation is really it’s just excellent. I mean, patients really can breathe better, whether it’s in the first thirty minutes, whether it’s over the day, in peak, as measured by peak, whether it’s measured by trough, or whether it’s measured by area under the curve. Regardless of the measure that you look at, you’re looking at YUPELRI either as a single agent or being added to a LABA, that for the nebulized LABA for these patients, the patients being able to breathe better.

And that’s what the message that’s coming across in the hospital. And that’s the message that’s coming across, that’s gotta come across in a stronger way in the community.

Doug Sav, Senior Analyst, H. C. Wainwright: And Rick, you mentioned, I think you said eighty percent of patients leave the hospital with a script. And so are you losing that patient, for lack of a better word, on getting that initial script filled, or is it the refill? Meaning that they’re maybe getting that first script filled, but then at some point that continuity of care

Rick Winningham, CEO, Theravance Biopharma: Yeah, think that, I think we, I think honestly we lose both. We lose some of them at first fill, and then while they might get their first fill at the hospital pharmacy as they’re being discharged, The follow-up through regional pulmonologists, lose some patients there. But again, I think the two organizations are working better together in the field, such that because opportunity. One in ten COPD patients use nebulized care. And that’s the way it’s been for the last twenty or thirty years.

Those patients can’t use a handheld. They need a level of bronchodilation. Lama therapy is foundational. It’s just being able to get those patients on therapy, keep them on therapy, provide the offices the necessary reimbursement support services that they need. Because this product has got a long way to grow.

I still think we’re in the early innings of growth, and we can continue working with our partner to capitalize on the opportunity.

Doug Sav, Senior Analyst, H. C. Wainwright: And I’m just curious, when you see that breakdown, you know, what are patients ultimately getting treated? Because it’s not as if they leave the hospital and their COPD goes away. Most of these patients are symptomatic. And so are they going on products like TIDORZA? And I’m just curious what have you seen from ensifentrine entry into the market and has that had sort of any impact on the COPD landscape for you?

Rick Winningham, CEO, Theravance Biopharma: Yeah, I’ll take ensifentrine first. And the answer is really no. We don’t see in general switches from YUPELRI to ensifentrine, because ensifentrine is largely being added to existing therapy for patients that really don’t, they don’t think they have anything else to go after triple therapy. I think, what do you see patients from YUPELRI, if we’re losing the prescription, what are they going on? Well, they’re probably going back on triple therapy, they’re probably not being able to use the handheld therapy, and they’re likely being round tripped back to the hospital.

And I think the hospital is becoming more and more sensitive to it. Clearly, that’s one of the reasons we’ve been successful with discharges on YUPELRI, is they’re trying to eliminate the round trippers. If you’re a COPD patient and you end up in the hospital because you’ve got a COPD exacerbation, you’ve likely had some sort of insult. Or many times, not only did you an insult like a viral insult, you’re just not using your inhaler properly, and some of these patients just won’t ever use a handheld inhaler properly, and that’s the benefit of a nebulizer that shows up in market research, is that physicians and patients are confident that the patient is getting the medicine that’s prescribed, you know, not only from the pharmacy, but all the way through into their lungs.

Doug Sav, Senior Analyst, H. C. Wainwright: You know, one of the things that you’ve talked about is sort of channel optimization and sort of how that would affect net pricing. Because that was something that was disruptive probably in the the second and third quarters of last year. And and maybe how much progress have you made there, and what do you think ultimately how long it will take to to get to your end game?

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think that we’ve slowly been working on optimizing the channel. I think our partner gets a great deal of credit for that, as well as the collaboration of the two companies working to optimize price overall. And I think, is there still work to do? Can we still improve the general fulfillment process? And by improving the fulfillment process, potentially capture a greater price, obviously capture greater volume, but capture on the margin greater price?

Yes, I think there’s more work to do there. But I think what you’ve seen coming out of the second quarter of last year is that we have been able to move price up a little bit. Not going to continue to go up, but at least it’ll stabilize to move up slightly. And I think that’s very encouraging and is the result of both the work of the interest as well as the collaboration of Viatris and Theravance.

Doug Sav, Senior Analyst, H. C. Wainwright: And Rick, given the effectiveness of your, of the Theravance sales force in the hospital, does there come a point when you think that they’re perhaps underutilized and there’d be value to have another product in their bag?

Rick Winningham, CEO, Theravance Biopharma: Yeah, that’s a great question, Doug. And we think about that all the time. I think right now, the opportunity cost of taking the focus away from YUPELRI, given opportunity that we have, is so significant. We haven’t chosen to exercise that option. And we still see a terrific opportunity for YUPELRI going forward in the hospital, because we’re really even though we’ve been working at this for some time, we’re we’re still lowly penetrated in the hospital.

And we can continue to grow the hospital business, which in turn will continue to drive the outpatient business. So right now, the opportunity cost is too great for us to turn away from YUPELRI, when we’re having the success that we’re having and when we have the opportunity ahead of us that we have. Perhaps sometime in the future it may be, but that isn’t today.

Doug Sav, Senior Analyst, H. C. Wainwright: Okay. And I did want to turn to ampreloxetine, right, which is your lead developmental stage asset, which is in phase three for treating, neurogenic orthostatic hypertension in MSA patients. You had a number of presentations at the AAN meeting and the IMSA meeting. You know how does this maybe provide your perspective on sort of what were the most significant updates and you know feedback that you got from clinicians in terms of how this might advance the treatment of MSA patients?

Rick Winningham, CEO, Theravance Biopharma: Yeah I think a great question. And the development of Ampreloxetine obviously is important. You know, to the future of Theravance. And what we’ve seen at both, you know, the American Academy presentations as well as, as well as the International MSA. Symposium of of last week is is just an incredible level of.

Of excitement and interest in in in a therapy to treat neurogenic or static hypertension MSA patients. Because nothing really works. Think the opinion leaders really view Ampreloxetine as a precision medicine. A medicine that’s really engineered to work in the peripheral nerves right where the problem is to increase norepinephrine in the peripheral nerves, post ganglionic nerves, and to apply pressure, use that to apply pressure and increase pressure on the blood vessels to drive blood perfusion into the organ systems and improve the symptoms of nOH. Because for these patients, nothing really works now.

And I think that’s the most exciting thing is that if we can show an improvement in the composite score with Ampreloxetine, we’re going to be in a market in MSA where there is no product today. And there’s forty thousand patients, it’s a rare disease, there’s not a product that treats these patients well today. And the opportunity to prescribe Ampreloxetine to these patients, and make a dramatic difference in their quality of life, is just terrifically exciting. And I think that’s what we’ve heard and that’s what we’ve seen coming out of these presentations. Were the most important presentations?

I think, namely that in the American Academy presentation, is that we didn’t see an increase overall of treatment emergent supine hypertension. That makes sense. Now these patients at baseline have supine hypertension. They have dysautonomia. But the treatment of ampreloxetine didn’t make that supine hypertension worse.

We didn’t see a shift, as presented at the American Academy meeting. And that makes biological sense, because if the patients are laying down, there isn’t that drive, neurogenic drive, to increase norepinephrine levels in the synapse. It’s just once they set up or stand, that they get that drive and they require that pressure on the blood vessels to drive perfusion into the organ system. So, I think, clearly, reconfirm that in the ongoing Cypher study will be important, but it’s certainly encouraging. We haven’t seen it in the earlier 01/1970 study.

Doug Sav, Senior Analyst, H. C. Wainwright: And this lack of supine hypertension is something that distinguishes Ampreloxetine from some of the therapies that are often used off label.

Rick Winningham, CEO, Theravance Biopharma: That’s correct. And that the challenge with the existing therapies is that effectively you’re treating them that adds endogenous norepinephrine into the system. And that endogenous norepinephrine doesn’t go away when the patient lays down. Or exogenous norepinephrine doesn’t go away, it’s there. So that exogenous norepinephrine that’s been added has no place to go, and it increases the supine efficacy as demonstrated by the composite score.

We do that, we do something that no other drug has done and provide a benefit that no other drug has provided to these MSA patients.

Doug Sav, Senior Analyst, H. C. Wainwright: And with the Phase III program, I think with the update you’re sort of getting close to the finish line on completing enrollment. You know maybe provide some perspective on how enrollment has gone, and what I mean by that in terms of patient enrichment as as well as power for the study.

Rick Winningham, CEO, Theravance Biopharma: Yeah. It’s it’s a great great question, and and it’s a it’s a rare disease. MSA, with patients with n o h, about forty thousand in the in The US, similar numbers in Europe. And what is particularly important for us in the execution of this study is that we, we in fact, select the patients and the sites that can care for these patients all the way through the study. You know, through the, not only the open label portion of the study, but also the randomized withdrawal.

Because these patients are, you know, they have multiple system atrophy, they’re not well. So, we’ve gotta get the right patients treated by the right clinicians to care for them all the way through the study such that we retain them as many as we can through the open label, but in particular, by the time they get to the randomized withdrawal. Because it’s coming out of the randomized withdrawal period, that in fact is where the measure of the primary endpoint is made. And so, I’d say, at least I’ve been developing medicines for a long time. We’ve paid more attention to the quality and the care of the investigators and the patients in this study than we have in any study I’ve ever been involved with, because it’s a rare and because that it’s a serious underlying condition that causes all sorts of medical issues for these patients.

And, you know, to the point that you’re making, you know, we’ve continued to refine the quality of the patients entering the study, such that we can get them through the open label. There’s an enrichment period at the fourth office visit, where they need to show a two point improvement in dizziness to retain in the study. And that enrichment design is what you see with randomized withdrawal studies. Because it’s not just that you wanna see a patient improve, it’s you wanna make sure in this particular disease that they’ve got the, you know, effectively the consciousness to identify the improvement. They may be improving, their caregivers may see them improving, but the patient by themselves may not pick it up because of an underlying condition.

So that’s the critical element of the enrichment. We get a lot of pay, obviously, most of the patients go through enrichment and then into the randomized withdrawal.

Doug Sav, Senior Analyst, H. C. Wainwright: And I guess, you know, you’ve sort of significantly reduced your cash burn, right, which has been accomplished through sort of, some some some restructurings engaged by the company as well as, you know, YUPELRI growing. How should we think about the launch of what the I get

Rick Winningham, CEO, Theravance Biopharma: benefits of the commercialization of rare disease products, and in particular, in a condition MSA with NOH, is we know today, based on analysis of claims data, where the patients are for commercialization. We know how to design and structure the integrated team of sales, medical reimbursement support. And we will be able to do this in a very efficient way. We’ve got the cash flow today from YUPELRI, that is right now funding the ampreloxetine phase three program. We’ve got $130,000,000 on the balance sheet.

We’ve got a potential for another 150,000,000 of Trelegy milestones coming in, as well as a potential for a $25,000,000 milestone if we hit $250,000,000 on YUPELRI this year. So we’re very well capitalized, but at the same time, we’re very, very focused on designing a commercialization plan for Ampreloxetine that is highly efficient, that makes the most use out of every dollar that we have. And right now, we’re spending a minimal amount of money on pre commercial activities. Obviously, once we have data, will begin to go up a little bit. And then obviously, once we get approval, you know, we’ll go from there.

But I think if I had to underscore one point about the launch of Ampreloxetine, it would be efficiency, because we know where the patients are.

Doug Sav, Senior Analyst, H. C. Wainwright: And I did wanna touch on Trelegy because, you know, it has become a a great source of capital to you, given the fact that the product has just continued to exceed expectations. You know, how should we think about the sort of long term potential and your perspectives and how you’re thinking about when royalties sort of revert back to the company and how should we think about the tail just because I think oftentimes investors are sort of quick to sort of think about a product LOE and sort of its rapid decline. But I think there’s reason to be skeptical whether that will occur with a triple combination like Trelegy.

Rick Winningham, CEO, Theravance Biopharma: Yeah. I think it’ll be very difficult to recreate Trelegy as a multi source product, because the Ellipta device itself is complex, the ability to design a device and commercialize it at scale is just an incredible order. And the fact of what you’re seeing now with Trelegy, the product has just performed incredibly well, in both asthma and COPD. I think what was largely, probably underappreciated is how well this product could do in asthma. It’s been continuing to grow.

The royalties, as you say, come back to us, Doug, in 2029 outside The United States in the middle of ’twenty nine and the beginning of ’2 thousand and ’30 ’1 in The U. S. Product is pretty heavily discounted now, so the impact of any further discounts from the IRA certainly could be they may be there, but they could be modest given the level of discounting. So we continue to see a pretty bright future for YUPELRI for long time sorry, for YUPELRI, yes, but Trelegy, for a long period of time, because there just doesn’t look like there’s gonna be anything that really comes in and replaces the Trelegy product as a product of both asthma and COPD.

Doug Sav, Senior Analyst, H. C. Wainwright: And just one final one, the company between Ampreloxetine, Trelegy as well as YUPELRI sort of have the potential for bringing in significant cash flows. And I’m just curious how you’re thinking about returning excess cash to shareholders. You’ve done some you’ve done share buybacks versus perhaps starting to reinvest in the pipeline again just because you are a biotech company and so people often evaluate you through sort of your ability to innovate.

Rick Winningham, CEO, Theravance Biopharma: Yeah, I think another good question. I think our focus today is on the Ampreloxetine program for future growth. Because quite that changes the entire perspective of the company. And I think the ability to get the product approved, to execute, successfully a commercial strategy with Ampreloxetine, can drive the value of the company. And then we’re in a position where we have more opportunity for choices than we do today.

We’ve said today that we’re going to return excess capital to shareholders if we have it, and we intend to do that. So to the extent right now, our focus is on the success of YUPELRI continuing to drive the partnership with Viatris and the successful development of ampreloxetine. And that’s where our focus, that’s where our resources are going. And with success with ampreloxetine, that creates a lot of opportunity for us.

Doug Sav, Senior Analyst, H. C. Wainwright: K. Great. Well, Rick, I think that is it. We’re out of time, so we’ll wrap it there. And so thank you very much.

Rick Winningham, CEO, Theravance Biopharma: Thanks so much, Doug, and thank you, HC Wainwright, for inviting us to the conference. Appreciate it.

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