Right. Terrific. Let's go right into our next session. I am very pleased to have Pavel Raifeld, CEO of Innoviva. Pavel, thank you so much for being with us for the afternoon session. Maybe, Pavel, just for investors listening on the webcast and those online and maybe for those not really familiar with the story, let's just start to level set with a little bit of a brief evolution of the company, its core pillars, and what in your view makes Innoviva different.
Perfect. Asif, thank you very much. It's a pleasure to be here, and I appreciate an opportunity to attend the conference. I think that Innoviva is a somewhat unusual company. Our roots are that a number of years ago, we invented the technology that's being used in some of the most commonly used asthma and COPD treatments, which are being commercialized by GSK. We are receiving royalties on those revenues. When I joined Innoviva a few years ago, we, in many ways, looked like a pure play royalty company. Over time, in our efforts to create value for shareholders, we have built a much more diversified business. Which right now has three pillars, and I believe that each pillar contributes very meaningfully to the value creation opportunity for Innoviva. The first one is royalties.
Over years, we have found those to be remarkably resilient, and we believe them to be very durable. The second pillar is our operating business, Innoviva Specialty Therapeutics, which is a commercial stage hospital business focused on infectious disease and critical care that has been growing at 40% or 50% a year and we think is a wonderful platform for continued capital deployment. Then last but not the least is our portfolio of strategic healthcare assets that was valued at over $700 million as of March. This portfolio is a collection of high potential opportunities that we believe can generate a lot of upside for our shareholders.
I think that the combination of these assets provides us with a unique opportunity which has fairly meaningful downside protection through cash and royalties that we are receiving and at the same time provides multiple opportunities for growth and value creation through our operating business and then through our strategic healthcare portfolio. All in, I think this is a business that is designed to do well across a range of market environments, including the high volatility environment which we're in right now.
Maybe before we get into some of the specifics of each of these, Pavel, which one of those three pillars are you personally right now spending more of your time on? Where's the sort of like, whether it's from a resource allocation perspective or whether it's as it relates to your own time, maybe just give us a cadence of how those businesses are evolving, just high level.
Sure. That's a great question. I think I probably spend the bulk of my time on the latter two businesses.
I think that IST is our fastest-growing business, and there is a lot of opportunity for value creation there, both organic and inorganic, that we are trying to capitalize on. Then, of course, continued capital deployment is very important to us. The portfolio of businesses within our strategic healthcare assets also has tremendous opportunities for value creation. Because of that, I try to spend my time where I think it would benefit our shareholders the most.
Yep. Okay. All right. Let's start unpacking maybe each of those, Pavel, if I may, starting with the royalty business.
How are you thinking about the durability of the royalty in light of ongoing pricing and policy developments? Maybe just high level on how these revenue streams have been holding up.
Sure. That's a great question. We've been incredibly pleased with the performance of our royalties for a number of years. I believe them to be both resilient and durable. Over the last few years, since I joined Innoviva, we've seen their performance across a wide range of market environments, including some as disruptive as COVID, we've been continually impressed with how stable these royalties have been. I also believe the royalties to be very durable. There is a very strong patent estate against these royalties. Because they are drug device combinations, there is a lot of regulatory and manufacturing complexity associated with them that I feel further builds out a moat against any potential competition. Importantly, these are extremely well-known, well-characterized therapies, which are large-domainant therapies.
For these disease states, patients and physicians are, generally speaking, unwilling to change things if patients are well-controlled on whatever therapies they are. This embeds an extra layer of stickiness into the royalties. Last but not the least, right now we're generating about 1/3 of revenue from the U.S. and then 2/3 from ex-U.S. markets. While people have spoken about policy changes and some of the pricing pressures in the U.S., the dynamics in ex-U.S. markets are quite different, and it's a much more diverse collection of markets. So we think that this diversification provides us with further stability across the revenue portfolio. All in, we have high hopes for. If you look at consensus estimates, people generally believe that we would get about $1 billion of royalty revenues over the course of the next five years.
We view that as a significant source of value for our business.
Who do you see as sort of your main competitors in the field to that business specifically? Maybe talk a little bit about how the arc of competition has been evolving to that business model for both in the U.S. as well as in EU.
Even for these asthma and COPD treatments? This is a market that has had a number of existing players. It's been fairly stable, and I think that the arc of competition actually hasn't changed it meaningfully for us. We are, generally speaking, addressing mild to moderate patient populations, and a lot of innovation has centered on much more advanced patients. We think that, in some ways, we have been insulated from some of the competitive pressures which affect the other products in the asthma or COPD space.
Got it. Okay. Maybe let's move on to the IST business. What is driving the growth algorithm across that portfolio today, and how should investors be thinking about its scaling potential?
Another great question. We designed IST business to be a commercial stage roll-up in the hospital and infectious disease space, and so far it has panned out in line with or a bit ahead of our expectations. We've built it over the last several years through acquisitions and integration of a couple different companies. Right now we have a portfolio of four marketed products. We have another product that's been approved but hasn't been launched yet. We think that our ability to resource the portfolio appropriately, that the strengths of clinical evidence against our products and generally strong commercial execution have been the key growth drivers. I would also say that we've designed this I don't think of IST as a single product entity having multiple products.
I think of it as a platform. It's a platform that has been designed to commercialize products. We see multiple opportunities for organic growth in the space. We would be excited to put additional products onto our platform.
Anything that sort of you're scanning as you look across the horizon that sort of makes sense for that business as you think about other products?
Yes. I mean, we've been looking at a number of products. I mean, generally speaking, it's a commercial stage platform. Synergies are likely maximized that stage. We've also been looking for development stage opportunities. While right now we have presence in critical care infectious disease, hospital channel has multiple other therapeutic areas there. We've also looked at opportunities in other areas as well. All in, we are looking for differentiated assets where we think that our capabilities would make a difference.
Let's talk a little bit, let's stay with that for a second on that business, just in terms of, I guess, near term, just the overall business trends. You provided 2026 U.S. revenue guidance of $150 million for the IST business. Maybe just level set us on how you're tracking towards those targets.
Yes. We provided that guidance, and we still have significant confidence in our ability to achieve that. The business has continued performing very strongly. For reference, we generated a Q1 revenue of approximately $34 million in the U.S., which represents very meaningful growth over past year and importantly, growth over Q4, which generally speaking, tends to be the strongest quarter of the year for a hospital business such as ours. We feel quite comfortable with both our 2026 commercial performance, importantly, the longer term trajectory of our business.
Let's talk a little bit, Pavel, about the hospital market broadly. Before diving into products, talk to us about the dynamics in the hospital space right now. What are those like?
Well, I think that the hospital space in general is fairly disciplined and selective. I think hospitals are very focused on products that can deliver meaningful clinical and perhaps economic value to key stakeholders. I think we, in many ways, are lucky that our product portfolio delivers just that. I know that some people view hospital channel as a somewhat challenging space, we think that given our growth rates of 40% or 50% in the U.S. year-over-year, we've managed to successfully sort of navigate the channel.
I guess when you think about what the most important levers are in advancing product adoption within the hospital setting, what would those be?
That's another great question. Ultimately, there are multiple stakeholders involved. There are formularies and stewardship and kind of physician communications and everything else. I think what it really comes down to for me is clinical differentiation, because ultimately, it's important to have products that deserve a place in the treatment paradigm from both clinical and economic perspectives. We are likely to have these products, A lot of what we do is engage in medical education, commercial and other activities to really explain the value proposition to hospitals and in some ways to let our products shine.
Let's talk a little bit about those products, Pavel, XACDURO and GIAPREZA. Those are both significant products for you. Maybe just start by reminding the audience what the key addressable markets are for those and what the key treatment and use settings are.
Sure. That's a great question and always excited about an opportunity to talk about our products. XACDURO is used in adults for hospital-acquired and ventilator-associated pneumonia driven by susceptible Acinetobacter infections. These are very serious infections and an area of very significant unmet medical need. There are about 40,000 patients of that sort in the U.S. a year, and about 40% of them are carbapenem-resistant, with the resistance rates rising. This is an area of strong unmet need. Importantly, XACDURO was the first product that was specifically designed for and approved in Acinetobacter. It has a very clear use case in this infection, which allows it to address some of the stewardship and other concerns that might have affected more broad-use antibiotics. GIAPREZA is a critical care product.
It's used to stabilize blood pressure in septic and other distributive shock. It has a very important place after first and second-line treatment. There are approximately 140,000 patients for whom it could be applicable, and there are significant mortality rates associated with septic shock. We are very happy to be able to offer this alternative to physicians.
How have the launches been progressing?
I think that for XACDURO, the launch has been one of the most successful launches in the antibacterial space of the last decade. I think that has been driven by the very specific use case of XACDURO, which helps navigate the stewardship and other concerns and just general compelling nature of the data in a situation or in a disease state where the health burden is just high. GIAPREZA is a more established product, but in our hands, following the acquisition of La Jolla Pharmaceutical, which developed the drug, we've been able to generate very significant revenue growth rates. I think that's driven by adoption and our ability to appropriately resource the drug and tell the story.
Where are you in terms of market penetration for both products?
I think with the XACDURO, we are in our third year, I think we're just scratching the surface of the market. Our sales more than doubled last year, and we expect very robust continuing growth on a going-forward basis. It's a drug that physicians have been asking us for this drug, which is somewhat unusual. GIAPREZA is a more established product, but it has a very specific and important use case. We've been able to both facilitate greater adoption in hospitals that use it as well to broaden its use to new hospitals, given some of the strong data that has been generated to date and our ability to continue generating data through investigator-initiated and other relevant trials.
Those are the levers that you have in terms of driving the growth for these products.
Yes, that's right. It comes down to data, medical education, and strong commercial execution. Both of them, but especially XACDURO, are relatively young products which are early in their launch phase. We expect very meaningful sort of continuing growth from them.
Maybe before we move to the next topic, any questions from the room?
That's a good question. I think that the general opportunity for us is fairly broad. Ultimately, if you think about it, we have presence in the hospital channel across multiple areas. There are some physician communications, pharmacist communications, administrative communications, health system communications, et cetera. Depending on the specific product and specific use case, we might be able to rely more or less on our existing infrastructure. All in, we look at all products where we think that our capabilities lend themselves to whatever products. Above all, we look for differentiation. One successful hospital launch is making sure that we work with products that deserve proper space in the treatment paradigm.
Let's talk a little bit about the strategic healthcare assets. Pavel, explain to us how those assets fit into your broader value creation and your capital deployment framework.
That's a great question. If we go back thinking about sort of the other two pillars of the business. Royalties provide us with positive cash flows and significant downside protection. Our operating business, IST, provides us with meaningful growth that we hope will accelerate over time with some inorganic moves. Strategic healthcare assets provide us with further opportunities to generate value for our shareholders. These are assets which we believe have asymmetric risk-reward profiles and which could really drive significant value. We spend meaningful time thinking about these assets and providing capital to these assets. I think a good example of an asset in that space is a company called Armata, which is a very innovative company that's a bacteriophage specialist. We've known the company for a few years and have been a very meaningful supporter of theirs.
Over the course of the last several months, they have had very impressive phase II data in Staph aureus bacteremia, whereas they achieved 100% clinical cure rate in a very challenging patient population. On the back of that data, they've experienced very meaningful share price growth. To us, that's a good example of the opportunities that we're looking for, having a chance to find companies to support them through longer-term value creation, then hopefully to see the value crystallize for the benefit of our shareholders.
Besides Armata, any other assets that you'd want to highlight?
We have a few other assets in the space. There is a neuroscience platform called Syndeio that is running phase II trials in depression, but also has some interesting early-stage assets. Last year, we acquired a very interesting drug delivery platform called Linx that we'll provide more color on in the coming weeks and months. All in, we think this is a very strong collection of assets and a meaningful part of our value proposition.
Let's talk a little bit about capital allocation and overall corporate strategy. You've got a very sizable cash balance. Talk to us about how you think about capital allocation broadly speaking and then afterwards.
Of course. I think, broadly speaking, there are probably three different areas of capital allocation that we think about. The first one is related to IST, supporting inorganic growth there. We think that IST as a platform has proven itself and that we could create value by putting other assets onto the platform. We spend some time thinking about what would be great assets there, as we just discussed. The second part is supporting both our existing investments looking at new investments within the strategic healthcare asset bucket. We're looking for opportunities where our financial resources, also other capabilities might help create long-term value. Last but not the least, we're also focused on capital structure optimization. In particular, we believe that a cash flow positive company should consider returning capital to shareholders.
We recently initiated a share repurchase program.
That's $125 million authorization.
That's right.
How much of that has been completed?
As of the end of last quarter, we completed $25 million of that.
Okay.
Of the $125 million authorization. I think that the program is both a way for us to return capital to shareholders, but I think it also conveys our high conviction in the prospects of our business. While we don't have any specific commitments in terms of how quickly we'll execute on the program, we still believe that we are undervalued.
I guess, in terms of other new capital allocation levers, what sort of BD interest do you have? What kind of external opportunities are you most
We've considered a wide range of things. We've continued supporting Armata over the course of this year. We also remain believers in Syndeio and their neuroscience platform. We've also looked at a number of opportunities which included sort of rare orphan diseases in certain other areas. We try to be both strategic and opportunistic in terms of how we assess opportunities.
How should investors think about the scaling potential of the Innoviva platform?
I think ability to scale the platform is a significant part of the thesis for me. We designed the platform to provide scale. I think that over the last couple of years, we've put the right bones in place. I think that right now the platform is ready to continue scaling. There is very significant operating leverage embedded there. I think that if you look at our revenues, at our kind of various operation performance indicators, it's a very strong platform. I would anticipate that we would accelerate revenue and profitability delivery with an organic growth over the coming quarters. Specific size and timing, it would depend on a host of things.
I guess when you think about strategically over longer period of time, Pavel, maybe five years, 10 years, right? What do you see as the sort of future of Innoviva? Explain to us sort of what the vision is maybe in five years.
Sure. I think that's great. My hope is that over the next five years, we'll continue generating significant revenues from our royalty portfolio. I would anticipate that we would generate significant organic growth from IST, we would complement that with also very significant inorganic growth. I would anticipate that we would get a sort of significant value accretion from some of the companies in the strategic healthcare portfolio bucket, that perhaps we would build another vertical of Innoviva based on one of the assets in that bucket.
Like a fourth pillar or something?
Potentially.
What could that look like?
If you think about IST started with our investment into Entasis. Over time, we took Entasis private, and then we combined it with La Jolla to build out IST. One thing to say is we tend to be very disciplined in terms of our capital allocation, and we're very mindful of sort of correlating risks with potential rewards.
Prudent capital allocation.
Prudent capital allocation and trying to be very disciplined.
Maybe going from long-term to shorter term, Pavel, what are the most important value drivers or milestones for Innoviva that investors should be paying attention to over the, call it, next 12 - 18 months?
Leaving aside the I think that continued revenue delivery, especially given the XACDURO launch and GIAPREZA at IST, would be very interesting to watch. I would also anticipate the launch of NUZOLVENCE in the second half of this year. That would also be sort of a meaningful value driver. We have multiple things within our strategic healthcare asset portfolio. I think that Armata anticipates initiating a phase III trial in the second half of this year. We also expect readouts from Syndeio over the course of the next 12 - 18 months. Of course, last but not least, there could also be updates on things strategic over the course of this time.
Okay.
All in, I think it's going to be sort of a very busy calendar for us with significant growth and multiple catalysts.
Okay. Any questions? Nick.
On the [NUZOLVENCE], what sort of launch prep activities are going into that?
Well, we have started to conduct activities related to potential launch prep, kind of all the customary stuff. I think in general, the way we think about NUZOLVENCE is that there might be two time horizons for the product. Initially, right now there's a standard of care which is fairly efficacious. We know that resistance rates in some markets outside of the U.S. are extremely high. There are markets where it's like 30%-40% and perhaps more than that. All the experts believe that there are some early signs of that happening. I think that initially, the market, the use case for NUZOLVENCE is going to center around its oral availability as a replacement for a very painful sort of intramuscular injection administered in an office.
I think over time, the whole market for gonorrhea is going to open up, and I think that based on the product profile of NUZOLVENCE, we could actually capture a very meaningful market share. Just as a reminder, the gonorrhea market in the U.S. is about 1 million - 1.5 million patients, depending on sort of how you look at it. I think that the opportunity for us will ultimately be very sizable and we'll make sure to the extent we launch it ourselves, we'll make sure to resource things commensurately with the marketability.
Pavel, maybe just to close in the couple of minutes we have left, leave us with how should we think about how you balance downside protection from the royalty base with the upside from IST and strategic assets?
That's a great question. I think that Innoviva has a very unique business model, and in some ways it's an all-weather business model in that we can actually, given the diversity of our business, we can actually thrive in multiple market environments. I think that's especially relevant in high volatility environments like right now. I think that in risk-off environments, the cash flows, the downside protection, the cash on hand that we have actually allows us to perform well. Importantly, it also creates more opportunities for us to deploy capital. When we have risk-on environments, hopefully some of our investments pan out and we can actually continue generating value for our shareholders.
Yeah.
I think that the combination of the three different pieces, so the royalties which are stable, resilient, well-characterized, the high growth that's embedded within the IST business, and then the disruptive potential that I believe is embedded within our strategic healthcare assets. All of these things come together to create an opportunity for growth, but at the same time also in a way that meaningfully protects downside. I think it's a very unique opportunity, and I'm very excited about what the future might hold for us over the course of this year and then, of course, beyond.
Well, I think that's a great place to close. Pavel, thank you very much for the very candid thoughts and the conversation, and really appreciate you being with us.
Thank you very much. I really appreciate it.