Hello, everyone. Thank you for joining us today. I'm Trevor Allred, an analyst on the life sciences team here at Oppenheimer. Today, I have with us Pavel Raifeld, CEO at Innoviva. Thanks for joining us, Pavel. Can you start off by giving us a quick overview of where Innoviva is, and where it's been, and what's going on today?
Perfect. Thank you, Trevor, for having me at the conference and the opportunity to discuss our progress at Innoviva. Just for context, it might be helpful to briefly talk about the history of the company. Innoviva was originally formed to manage royalty revenues from products that we developed with and licensed to GSK. As these revenues have become more meaningful, we built out other areas of the business to create and drive shareholder value. Today, Innoviva is made up of three main components. The first one is our royalty business from two respiratory assets, Breo and ANORO, which are marketed by GSK.
This royalty portfolio provides a durable and resilient source of cash flow to the company, you know, generating $250 million in gross royalty revenue last year. The second one is our specialty therapeutics business, known as Innoviva Specialty Therapeutics, or IST. This is a commercial stage critical care infectious disease platform made up of highly differentiated assets. This business delivered almost $120 million in U.S. sales last year, and we have shared that we expect it to generate at least $150 million this year. Which actually would be more than three times, you know, what it was when we first formed the business in 2023.
Last but not the least, we have a diversified portfolio of strategic healthcare assets with high growth potential, which is currently valued at over $600 million. Innoviva is a profitable, well-capitalized company with a resilient all-weather business model and a diversified business structure, that I think puts us in a very favorable and differentiated position across multiple market environments. Actually, yesterday, we, as you saw, we announced our Q4 earnings, which I think showcased the strengths of our business. You know, in particular, you know, all parts of our business have performed quite well and demonstrated strong momentum going into 2026.
Our IST business delivered its best quarter ever with $34 million in U.S. sales, you know, which is, you know, which is effectively the third year in a row of 50% annual growth. Our royalty business has continued to, you know, to be resilient, as, you know, these products have outperformed expectations for the year, again, beating analyst consensus. Finally, we've had some major advances in our strategic healthcare assets, highlighted by breakthrough clinical results at one of our portfolio companies, Armata, which had excellent data, and then also very significant valuation increase last quarter, which continues into this year.
Overall, I think that, you know, we are as well positioned as we've ever been, for growth across our business and, you know, to realize the promise of some of the investments we've made over the past few years.
Great. Yeah, thanks for that overview. Can you tell us a little bit about your expectations for 2026? How do you plan to deploy capital, and what are you looking forward to most?
Sure. As we think about our capital allocation strategy, we are in a very fortunate position, where we have a comfortable cash position of over half a billion, and we are actually seeing a lot of attractive opportunities for value creation through capital deployment. you know, we think about these, you know, in terms of opportunities within our investment, our current portfolio, new investment opportunities, also capital return to shareholders. Internally, I believe that we've built a platform and a portfolio that provides a very good return on investment for incremental capital. First, our IST business is getting to profitability and growing very rapidly. I think it still provides us with opportunities to invest in accelerating organic growth, as well as through acquisitions.
This platform has significant synergies for many additional assets in the hospital channel that could be added to the business. We're actively evaluating those possibilities. The second point is that our strategic healthcare assets continue to perform very well, as evidenced by progress at Armata that I just mentioned, as well as Syndeio and our neuroscience investment. We expect to continue supporting these, in addition to others that we will be talking more about throughout the year. We think that this portfolio really has a pretty asymmetric upside value creation potential. If we look externally, we continue evaluating new investments for long-term value creation, as always, with a very disciplined and strategic approach.
We tend to be patient, but when we see an opportunity that's a good fit for us, you know, we have the flexibility and the firepower to move very quickly. Last but not the least, you know, I think we've consistently demonstrated over years that capital return to shareholders is important to us. We, again, sort of, you know, showed this at the end of last year by announcing a $125 million share buyback program, which underscores both our commitment to shareholders, but also our confidence in the growth prospects of our business.
Great. Yeah, and you mentioned Armata there. Can you give us, you know, more of your thoughts on the direction of Armata, and what are your internal valuation expectations for that company?
Of course. We've been very consistent supporters of Armata over the past few years and are very excited about the company's potential. I think they, you know, they've proven themselves to be the clear market leader in the very innovative field of bacteriophage therapeutics. Last year, they announced groundbreaking positive phase II data in Staph aureus bacteremia, showcasing 100% clinical cure rate in an area where best available treatments are in the 70%, you know, of success, and still have very high mortality levels. This is something that, if validated in a phase III trial, you know, could be among biggest paradigm changes in anti-infectives in the last decades.
In the wake of their strong clinical data, the market has started to internalize the potential of Armata, which has been reflected in their, you know, very meaningful share price appreciation. You know, they are an independent public company, so we're limited in terms of the guidance that we can give, but I think that their plans to initiate a phase III study for their lead asset in the second half of this year are sensible. You know, we remain supportive and, you know, very excited about the recent recognition that they have been getting.
Great. Yeah, I guess you've given a lot of discussions around what's going on and what we're seeing, but what areas do you see as the greatest opportunities for growth for Innoviva?
I think we can break that down by each part of our business. I think that for the therapeutic business, you know, we're in the middle of a very high growth period for our products. Really, we just want to keep doing what we've been doing and, you know, hopefully, you know, continue generating very strong growth rates from our current portfolio. Additionally, we are at a point where the business, you know, can start producing profits that can be strategically reinvested in, you know, in various areas to accelerate the commercial revenue delivery, we're quite excited about that. We think that there is a lot of room left for inorganic growth.
I believe that, you know, we might have the best performing hospital-focused commercial platform in the industry, and I think that there is a very meaningful value that could be unlocked with placing new assets onto this platform. That's also an area of very active evaluation for us. In the other part of our business, for the strategic healthcare assets, we think that our portfolio here has a strong potential asymmetric payoffs with very beneficial risk-reward profile. Armata is a good example of our investments in this space, which is a very wide-ranging platform that also has a high potential lead asset.
You know, and we've made other investments in neuroscience and other areas where, you know, we think that there has been a lot of operational progress, and we're hopeful that, you know, this is also going to translate, in, sort of, you know, more financial recognition for these programs. Then, you know, as, you know, as I said a couple of minutes earlier, we also see a lot of attractive de novo capital deployment opportunities, and so we will continue making disciplined investments in areas where we have a differentiated perspective and can generate strong returns. So to me, there are multiple different opportunities for growth across all of our business.
Yeah, absolutely. Let's talk a little bit about some of the recent updates across the pipeline. We know getting through hospital P&T committees can be a bit of a slow process. Can you update us on the progress there for ZEVTERA? Do you have any expectation for when revenues might begin to inflect for that product?
Yes, of course. We are, we continue being excited about ZEVTERA, which, as you know, you know, is approved to treat three types of bacterial infections. As a reminder, we acquired the U.S. commercial rights for ZEVTERA from Basilea, a year, about a year ago, then we began the U.S. launch in the third quarter of last year. You know, the launch process for hospital therapeutics in general and anti-infectives and bacteria in particular can be a bit slow. Since ZEVTERA has only had two quarters of sales, we're still in the front half of the process of getting through the committees and getting on the formularies. To date, we've had, you know, good success in those and remain confident in the long-term potential of the product.
One metric to think about is that, you know, now that we've been on the market for two quarters, you know, we still have significantly more formulary reviews on the schedule ahead of us than we've had since launch. You know, this is just one of those things that, you know, we would need to be patient with, because, you know, it takes time. We've been very encouraged by positive initial feedback from the medical community and also have had a few good commercial updates recently. You know, for instance, you know, we received the J-code designation from the CMS in the fourth quarter, you know, which helps customers with outpatient reimbursement.
On top of that, we also received a New Technology Add-on Payment status, you know, which increased the reimbursement to hospitals for ZEVTERA. I think that all of that bodes well, for, you know, for the long-term opportunity, for ZEVTERA.
Yeah, great. Also we have zoliflodacin now approved. Can you provide any expectations for that launch, and how does this product differ from those within the other IST portfolio?
Sure. That's a great question. The FDA approved zoliflodacin, or NUZOLVENCE, in December of last year, you know, which was a very exciting milestone for Innoviva, and for patients, as NUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades. We're planning to commercialize NUZOLVENCE in the second half of this year, and we are currently evaluating options on whether to launch by ourselves or with a partner. You know, frankly, you know, what we're very focused on is making sure that, you know, we're going to get this product to patients in a way that's, you know, that's going to be most effective.
It's a little different, you know, from a number of other products in the IST portfolio. You know, while NUZOLVENCE has, you know, some quite strong commercial synergies with IST capabilities and products, it also has a different commercial call point in that, you know, the rest of the IST portfolio is focused on the hospital channel, whereas, you know, NUZOLVENCE is more focused on outpatient providers. It's also unique in that a very significant portion of the commercial opportunity will likely be unlocked, you know, a bit later, when resistance to the current standard of care, cefixone, is going to grow in the U.S.
I think that both of these factors point to a commercial strategy that early on, you know, would be focused on a, you know, more targeted promotion to specific patient populations, that have an unmet medical need and, you know, value a convenient oral option, while at the same time preparing, the platform to scale up as resistance grows and, you know, and, you know, we would be able to capture the larger opportunity that's going to come with that.
Great. In terms of the IST, the broader IST portfolio, can you speak to some of the peak sales expectations for each of those products? What sort of expectations are baked into those peak sales expectations?
Sure. As I mentioned earlier, you know, we anticipate, uh, a hundred and fifty million or more of U.S. net product sales, uh, in 2026 , uh, you know, as compared to, you know, just under a hundred and 20 million , in 2025 . And I think this speaks to our confidence in the growth potential of the IST platform. Um, while we don't really- we don't generally provide peak sales guidance on a product level base, uh, basis, I'd actually be very happy to walk through recent trends and anticipated growth drivers for each of our market products. And so perhaps starting with our largest product, GIAPREZA.
GIAPREZA is approved for the treatment of septic shock, you know, and it delivered $72 million in 2025 U.S. net sales, a growth of about 34% relative to the prior year. It's maintained a very impressive trajectory since we acquired it as a part of the La Jolla acquisition in 2022. Driven by commercial effectiveness and also recently by expansion in the new patient segments based on data generation efforts through, you know, very cost-effective investigator-initiated trials. Looking ahead, I think the big item to potentially watch for are sepsis guideline updates. You know, once we see how, you know, GIAPREZA is positioned there, that might actually provide sort of, you know, meaningful levels of support for access and awareness of the product.
You know, we think there is, you know, still, you know, very significant headroom for GIAPREZA, and it could easily be an over $100 million product in the near future. If we think about our kind of, you know, our second most important product, it's XACDURO. XACDURO is the only therapy, you know, which was indicated specifically for resistant Acinetobacter infections. It's filling a large unmet need, and the growth rate that we've been seeing confirms that to be the case. Right after it launched, it was included in the guidelines as the first-line option for any suspected resistant cases, which will continue to support future growth.
It's been performing ahead of expectations and brought in $33 million in U.S. net sales in 2025, which is a year-over-year increase of over 100%. I think that anywhere, you know, where we're going to see, you know, problems with this bacteria, we would expect high utilization rates, as I think we really are the only option available for these very sick patients. You know, so, you know, so I think that, you know, there is a great deal of opportunity out there for this product and, you know, we think it's, you know, fairly early in the growth curve.
I know that analysts expect this, you know, this drug to be in the range of $150 million-$200 million, you know, we think that, you know, those numbers will be quite achievable. XERAVA, you know, which is another product that we acquired with La Jolla, is an antibacterial for the treatment of complicated intra-abdominal infections. It's more of a stable revenue source in our portfolio as opposed to a big growth story. We expect to see steady, you know, lower growth rates as certain types of resistance and overuse of carbapenems, create more opportunity for this profile. Perhaps there are fewer sort of, you know, major catalysts on the horizon here.
I think with ZEVTERA, you know, which I've just spoken about, you know, it's the first cephalosporin approved for SAB, including MRSA strains. You know, it became commercially available in the U.S. mid-year, and, you know, we expect it to go through formulary process this year. Are hoping to show a good sort of revenue launch trajectory closer to the second half of the year. Of course, with NUZOLVENCE, you know, we've just spoken about that. To reiterate, I think that, you know, the total commercial opportunity will be dependent on the rate of resistance to existing treatments.
You know, if this, if this hit the levels that we expect to see, I think that the total addressable market, you know, could be as large as, you know, say, half a billion dollars. You know, we think that we could be well positioned, to capture much of that.
Yeah, great. Thanks for that overview. Okay, with all of that, what do you see as the most underappreciated aspect of Innoviva, and what do you think investors should be paying more attention to?
That's a great question, and I think I'd highlight a couple of areas which I think people might underappreciate. The first one, I think that, you know, we really are an all-weather company, from my perspective, in terms of our ability to succeed in multiple economic and market environments. You know, of course, you know, we're likely to do well when the markets and the industry are doing well. I think that we could also succeed in down markets, because we have, you know, strong cash flows, you know, good downside protection stemming from our royalty revenues, while risk-off environments actually present, you know, present us with multiple opportunities to deploy capital, like what we have done with Entasis, La Jolla, Armata, and a number of our other assets.
To me, that's, you know, that's an interesting and, you know, perhaps unique feature of Innoviva and our diversified business. I think the second one, the second area that people might not fully appreciate is the growth potential that's embedded in our strategic healthcare assets. I think this is, you know, playing out, you know, with Armata right now, you know, where, you know, they've had, you know, very strong share price performance on the back of, you know, truly, you know, remarkable clinical data.
We also have other assets, you know, that we've discussed, you know, which have significant growth potential and also multiple catalysts, that, you know, might not really be getting the attention they warrant, because, you know, they are currently, you know, individually, a small part of our overall value. You know, I think that, you know, we're very excited to speak about a few of these opportunities, you know, a bit more over the course of the coming year.
Great. Yeah, is there anything else you think investors should be paying attention to into the year ahead as Innoviva heads into 2026?
Yeah. I think that 2026 is going to be a very exciting year for us. I think that, you know, we'd be happy with a sort of, you know, continuation of some of the momentum from 2025, which I believe was an excellent year. We're going to anticipate us having multiple catalysts across our business. You know, Armata is likely to start their phase III trial, which, you know, I think a number of people in the industry are going to be watching carefully. Our neuroscience company, Syndeio, you know, could have a phase II readout in the next year in major depressive disorder, which would also be a meaningful, you know, value catalyst.
We announced last fall, that we acquired assets of a company formerly known as Lyndra Therapeutics, you know, which was an, you know, which was an MIT spin-out from Bob Langer's lab. you know, that's something that we are optimistic about and, you know, perhaps going to be talking more in the spring. then, of course, you know, at IST, you know, we have a lot of focus on, you know, making sure that we continue, you know, growing our portfolio. you know, we look forward to the first full year of ZEVTERA sales and then, of course, to the NUZOLVENCE's launch. you know, we expect to be quite busy in that business.
While it's important, it's very challenging to predict these things ahead of time, you know, we are active in BD evaluations, and, you know, perhaps there will be opportunities for us to further bring in some new assets into our portfolio. All in, I think that, you know, we're, you know, we're very well positioned for, you know, for what the future might hold, and I'm very excited about, you know, the progress that I hope we're going to make over the course of this year.
Yeah, absolutely. Looking forward to it. All right, we're coming up on time now. Thank you all for joining us, and thank you, Pavel, for joining us for that great presentation.
Perfect. Thank you very much, Trevor. Really appreciate it.