Good afternoon, everyone. I'm Trevor Allred, one of the biotech analysts here at Oppenheimer. We have Pavel Raifeld, CEO at Innoviva here with us today to tell us about the company. As always, feel free to submit questions. We'll have a few minutes at the end of the presentation for questions. Pavel, over to you.
Perfect. Thank you very much. It's a great pleasure to be here. Thank you for the opportunity to present and talk about Innoviva. My name is Pavel Raifeld, and I'm the CEO of Innoviva. I would like to start today by giving a bit of background on Innoviva and then also talk about why we're so excited about the direction and momentum in our business. To note, this presentation may contain forward-looking statements, which are subject to risks and uncertainties. Innoviva was originally formed to maximize the value of the royalties coming from respective products we developed with and licensed to GSK to commercialize. These products have been very successful, and resulting royalties have turned Innoviva into a highly profitable company with significant cash flows that we expect to continue for years to come.
As these cash flows have grown, Innoviva began to focus more on capital allocation strategy to thoughtfully deploy our capital in the areas of high unmet medical need with strong growth potential in order to create long-term value for our shareholders. Our largest strategic investment to date was the creation of a critical care and infectious disease therapeutics platform that's now an industry leader. So let me talk about sort of the core parts of Innoviva. Today, we have three main assets. The first asset is our royalty portfolio from the respiratory drugs marketed by GSK. And these have been projected to provide us with over $1.2 billion of revenue over the next five years.
The second part of the portfolio is our high-growth critical care and infectious disease therapeutics platform called Innoviva Specialty Therapeutics, or IST, which had over $100 million in revenue over the last 12 months ending in September, and it has more than doubled year on year. And finally, we also have a diversified portfolio of strategic healthcare investments that was last valued at over $500 million and I believe has a very attractive risk-reward profile. So I'd like to go into a little more detail on our royalty business and the therapeutics platform and show why we're so excited about the prospects of these businesses and Innoviva at large. So our royalty portfolio is the foundation of Innoviva.
We get sizable revenues from two best-in-class respiratory therapies commercialized by GSK that provide us with a dependable source of cash flows that also allowed us to create the other parts of our business. Our portfolio generated $250 million of revenue over the last 12 months, and based on five-year analyst consensus projections, it's expected to deliver over $200 million a year into the future. We're very excited about the prospects of this royalty portfolio because it has proven to be so differentiated and resilient across the range of market environments, including as disruptive a time as the pandemic. Breo and Anoro are some of the best-selling respiratory drugs in the world, proven and trusted.
Although these are more mature drugs in the U.S., the majority of revenues right now actually comes from ex-U.S. territories where the competition is often not as strong, allowing for continued strong growth in multiple geographies. All of this has combined to help this portfolio significantly outperform expectations over the past years and to continue to thrive across the world despite competitive pressures. And we anticipate great things from this portfolio given the strong momentum we have seen coming into 2024. Finally, both of these royalty streams have meaningful additional longevity with strong IP protection and additional buffer provided by the manufacturing complexity that serves as a moat for competitive entrance, as we have seen with other similar drugs in the past. So all in, we think that this is a very important and valuable part of Innoviva.
So maybe I could talk a bit about our operating hospital platform, IST. It's a robust and growing business in infectious disease and critical care. And we think that it has a tremendous growth potential ahead. The IST business was designed as a result of a specific investment thesis that we developed over years when we saw the challenges that were faced by infectious disease companies resulting in depressed valuations across the board. And we believe that with thoughtful asset selection, intelligent capital allocation, and a focus on scale and efficiency, we could create a profitable business via a roll-up strategy. And IST is just that. It was specifically designed to be a profitable, sustainable platform in the infectious disease and hospital space. And so far, it has exceeded my expectations. The business is built on a portfolio of truly differentiated products that have strong synergies with each other.
We have products with novel mechanisms of action and significant ability to affect health outcomes and save lives in patients with septic shock, complicated intra-abdominal infections, carbapenem-resistant Acinetobacter, and Staph aureus bacteremia. In addition, we have an upcoming NDA submission for a drug candidate that could address significant medical needs in the sexually transmitted infection space and the growing threat of resistant gonorrhea. So this portfolio is commercialized with an efficient, targeted operational platform with an experienced team that, from my perspective, has some of the best concentration of therapeutic area expertise in the industry across sales and marketing, medical, regulatory, and CMC. We are in a very strong financial position, whereas we have a robust, rapidly growing revenue base and a long remaining growth runway. Our two most established products, Giapreza and Xerava, have solid utilization and market positions with growth drivers that are unlocking significant additional value.
We have a recent drug launch in Xacduro that's in a high growth mode in the market with huge unmet need and very few treatment options. In addition, we recently announced the acquisition of our fourth approved product, Zevtera, which we expect to further boost our growth profile. And then, of course, as I mentioned, we have a pre-NDA product in zoliflodacin that, if approved, will tap into what's likely to be the biggest market of all, both in the U.S. and the rest of the world. Each of our products has patent protection into the 2030s with options for further extension and exclusivity. And so we're quite confident in the durability of these revenues. Finally, we believe that the current platform is just the beginning, and it will serve as a foundation for further investment to drive both organic and inorganic growth. We're very excited about it.
Maybe I could provide a bit of detail on the specific products. Let me start with the largest one, Giapreza. Giapreza was developed to treat shock patients using a version of the body's own angiotensin II peptide, which has a different mechanism of action compared to the existing treatment options. In its pivotal trial, Giapreza was tested on patients already on high doses of first and second-line therapies who still had low blood pressure. It was shown to restore therapeutic blood pressure levels in as little as five minutes. This is critical because there are more than 140,000 shock patients each year in the U.S. who fail first and second-line vasopressin therapies. These are extremely sick patients who often expire if not treated successfully, leading to very significant unmet medical need.
The most significant growth drivers for Giapreza are potential inclusion in the next guidelines update and new data generation, which we have been doing in partnership with some of the top research in the therapeutic area. Each of these drivers is expected to have a major impact on access and awareness for this lifesaving therapy, and we're very excited about what the future might hold, both near-term and longer-term. Next, I would like to talk about our newest drug launch, Xacduro. It was the first anti-infective drug designed and approved to target Acinetobacter, which represents a critical unmet need in the U.S. and around the world. This pathogen is one of the top priority threats from both the CDC and the WHO.
I think that prior to Xacduro's launch, there really were no good treatment options for carbapenem-resistant organisms, which make up the majority of worldwide cases and have mortality rates of around 40% in the U.S. Physicians were effectively forced to try a range of drugs in these patients and hope that something would work. Xacduro was the first to be approved for this disease specifically in the label. Another key value driver for Xacduro is our targeted approach. Unlike other branded antibiotics, it's not positioned for broad empiric use, but rather for specific identifiable cases. This means that systems don't need to have as many concerns about outsized budget impact. Also, it doesn't create the same stewardship concerns as other antibiotics might.
We believe that this has potential to dramatically improve access and have already seen indication of that in the early launch phase, where we have been quite pleased with how Xacduro's launch has been progressing. Our last currently marketed drug, Xerava, is a novel tetracycline antibiotic that was designed as a powerful broad-spectrum empiric option with coverage of multiple resistant organisms. With rising rates of ESBL-mediated resistance and over-reliance on carbapenems, the unmet need for Xerava continues to increase in the U.S. In addition to its value as an effective carbapenem-sparing empiric therapy, Xerava is also better than comparable treatments in preventing C. diff infections and is more tolerable and potent than prior-generation tetracyclines, both of which are expected to drive Xerava utilization as a substitute for certain patients and institutions.
We're optimistic about Xerava's future and think that these tailwinds will continue to drive growth for this product for years to come. The newest addition to our portfolio is Zevtera, an advanced generation cephalosporin indicated for the treatment of adults with Staph aureus bacteremia, in addition to skin and pneumonia indications. It's the first and only cephalosporin specifically approved for Staph bacteremia, which is a critical area due to the rise of resistant MRSA strains and now increasingly vancomycin-resistant strains. It's also safe and tolerable with no monitoring requirements, which is a key differentiator given the safety burdens of other treatments for this indication. We licensed this drug for the U.S. in December from Basilea and expect to launch it mid-year, and we're very excited to bring this much-needed and long-awaited therapy to patients, addressing a larger unmet need.
It's also a great example of inorganic growth opportunities that we see around us. Finally, I'd like to discuss the next potential addition to our portfolio, zoliflodacin. zoliflodacin is in development for the treatment of gonorrhea, including strains resistant to the current standard of care, injectable ceftriaxone. In its registrational Phase 3 trial, zoliflodacin met the primary efficacy endpoint of non-inferiority to ceftriaxone and azithromycin, the current global standard of care. Furthermore, zoliflodacin was safe and well tolerated. The importance of zoliflodacin in this market is illustrated by two key differentiators. The most critical differentiator is that zoliflodacin is expected to be efficacious against gonorrhea strains that are resistant to injectable ceftriaxone. Around the world, this is a significant and growing concern. In fact, in some countries, injectable ceftriaxone resistance is as high as 30%, and the rate of growth around the world is alarming.
The U.S. is expected to follow the same trend over time, and we're already seeing the early signs of this. Therefore, there is a critical need for a new alternative treatment option once resistance to the standard of care becomes meaningful. Moreover, even before injectable ceftriaxone resistance develops, there is an unmet need for an efficacious and convenient oral therapy as an alternative to the current treatment that requires one or more painful injections administered by a healthcare official in an office. Availability of this new option would also better serve unique populations such as telehealth and those requesting expedited partner therapy, which is a fairly common practice with sexually transmitted infections. All of these points to the fact that zoliflodacin is well positioned to be a standard of care for over a million patients in the U.S. and over 80 million patients around the world.
So we're very excited about our portfolio and the progress we've made and expect to make in the very near term. Perhaps as a brief recap of our earnings for third quarter, which I believe illustrate the strengths of our business across the portfolio. 2024 was really a milestone year at Innoviva. We have shown consistent quarterly growth of our market portfolio, more than doubling our Q3 revenue compared to the same quarter last year. A big portion of that growth was driven by our launch of Xacduro, which, as I mentioned, exceeded our first-year expectation and is on a very strong trajectory. In addition to the substantial growth of our market portfolio of products over the past year, our core royalties business has also significantly outperformed analyst expectations, which we believe signals continued resilience and durability of this asset.
In addition to the top-line delivery, we also had exciting achievements across the business, including updated guidelines that resulted in preferred placement for both Xacduro and Xerava in their respective therapeutic areas, accelerated international expansion with approval in China for Xacduro, the addition of Zevtera to our U.S. commercial portfolio, nomination of Xacduro as a finalist in the prestigious Prix Galien Awards, presentations at numerous scientific conferences, and continued progress toward the filing of an NDA for zoliflodacin in the near term. It's a very exciting time for Innoviva, and we're proud to be delivering innovation to patients in areas of critical unmet need, as well as creating shareholder value. To summarize, we're very confident in the prospects of our business. We feel that we are very well positioned in the current environment, given our profitability, strong cash position, attractive assets, and excellent team.
All of these, I believe, will enable us to take advantage of exciting near-term opportunities ahead of us, and we see tremendous potential for both organic and inorganic growth in our business. On the organic side, we still have untapped growth for each of our market drugs and additional global opportunities to create more value and get our products to more patients who need them. This year has demonstrated the potential of our portfolio, especially with the successful launch of Xacduro that has validated, to a significant extent, our critical care and infectious disease strategy. Building on that, we're very excited about the upcoming year, including continued growth in our marketed product portfolio, the launch of Zevtera, and the potential approval of zoliflodacin, which can further accelerate revenue delivery and value creation within our IST business.
Looking at inorganic growth opportunities as well as other capital deployment priorities, there are a wealth of options available to us. Supported by strong operational execution, I believe we're seen as a partner of choice in the hospital and critical care space and believe that we now have a best-in-class platform that could be leveraged to create value across a range of assets in this space. The Zevtera transaction gave us a differentiated, high-potential product with a great fit with our portfolio and illustrated our ability to execute on the inorganic prong of our strategy. We expect this year to continue to be a good time to potentially license new assets as there are multiple differentiated programs available at attractive valuations in this space. This is also an important year for the strategic healthcare assets part of Innoviva.
We expect to see multiple value-driving catalysts across many companies in our portfolio, including new clinical data at Armata and exciting pipeline and platform advancements at Gate. We have seen meaningful progress across our investees as they innovate in areas of high unmet medical need. In summary, I think that we're very fortunate to be in the position we're in, and we're very excited about what we can accomplish in 2025 across all areas of our business. So thank you very much. And with the last few minutes, I'd like to, I'd be very happy to address any additional questions that you might have.
Yeah, thanks, Pavel. Yeah, I guess I think you touched on it a bit in the presentation, but can you give us a sense of what gives you comfort around the durability of the royalty portfolio that you guys have?
Sure. Our royalty portfolio is protected by a number of different primary and secondary patents. We provide some information in our corporate presentation, but I think the combination of these patents extends to the end of this decade and beyond. Historically, generic entrants have found it very challenging to enter the market because these drug-device combinations are very difficult both to produce, to get approved, and then to manufacture at scale. We think that these challenges provide an additional moat around our portfolio. Also, one thing to note is that we get the majority of our royalty revenues from ex-U.S. markets, where obviously each market has sort of differentiated IP protection dates, but in general, those extend for a couple of years beyond the U.S. dates. We feel very good about the durability of our royalties.
Great. Can you touch on the unmet need that's infectious disease beyond what you're currently treating? What other opportunities are out there, and how do you kind of see this unfolding?
We think that this is a great space. There actually is a fair amount of innovation going on across antibacterials, antifungals, and beyond. We have one of the most credible commercial platforms in the space. For instance, when we were at a different conference at the beginning of the year, there had been multiple meetings we have had with companies who had very interesting differentiated products in their pipeline. We think that we're likely to be one of the better partners for these companies.
I think what Xacduro launch and other things have taught us is that clinical differentiation is critical, and we're very pleased to see that there are multiple assets on the market which really have an opportunity to impact patient outcomes in areas of significant unmet medical needs, and these are available at what I would view as very attractive prices.
Yeah, yeah, definitely. Can you give us some insight how you expect 2025 to unfold for the company? I mean, what things might we be able to look forward to throughout this year?
Sure. There is a tremendous amount of activity at Innoviva over the course of this year. If you look, I mean, we expect continued strong performance from our royalty business. I think I would hope for excellent commercial execution across the market portfolio within IST.
I think that Zevtera launch is going to be a very meaningful catalyst for us, and on top of that, we expect to file the NDA for zoliflodacin in the near term, and we hope that it's going to be approved by the regulators, and so I think that that is going to be very important. In addition to that, there are multiple companies in the strategic healthcare assets part of our business that are going to have clinical and other milestones, and given our economic exposure to those assets, we expect to be a meaningful beneficiary there, and then there are also multiple opportunities for us to drive shareholder value through capital allocation.
Great. Okay. Well, yeah, it looks like that's all the questions we have. Thank you all for joining us, and we will see you in the next one.
Perfect. Trevor, thank you very much. I really appreciate an opportunity to be here.