Innoviva, Inc. (INVA)
NASDAQ: INVA · Real-Time Price · USD
23.69
+0.33 (1.41%)
At close: Apr 28, 2026, 4:00 PM EDT
23.70
+0.01 (0.04%)
After-hours: Apr 28, 2026, 7:42 PM EDT
← View all transcripts

H.C. Wainwright 26th Annual Global Investment Conference 2024

Sep 10, 2024

Li Chen
Managing Director and Equity Research Analyst, H.C. Wainwright

Good morning, everyone, and welcome to the Annual Global Investment Conference at H.C. Wainwright. My name is Li Chen. I'm an Equity Research Associate. I would like to welcome our next speaker, Steve Basso, CFO of Innoviva. Steve, please go ahead.

Steve Basso
CFO, Innoviva

Thank you, Li. And thank you very much for the introduction. It's obviously great to be here at the conference and great to see so much, you know, continued innovation and exciting activity in the industry. As Li mentioned, my name is Steve Basso. I'm the CFO for Innoviva. I'd like to spend some time today giving you a bit of a background on who we are as a company, as, like, we're somewhat unique in this industry. And then also talk a little bit about what we've been doing lately and why we are so excited about the direction of our business. And so Innoviva was originally formed to maximize the value of the royalty streams coming from respiratory products that we had developed and licensed to GSK to commercialize.

These royalty streams have done very well and have turned Innoviva into a highly profitable company with significant cash flows that will continue for years to come, and as these cash flows have grown, Innoviva began to focus more on capital allocation looking at areas to invest in high unmet medical need with strong growth potential in order to provide long-term value for our shareholders. Our largest investment was the creation of a critical care and infectious disease therapeutic platform that is now an industry leader, and so, as a result, today Innoviva is comprised of three main assets. The first asset is our royalty portfolio from the respiratory drugs, which are again marketed by GSK, that is expected to deliver over $1 billion in revenue over the next five years.

The second is our high-growth critical care and infectious disease therapeutics area platform that we call Innoviva Specialty Therapeutics, or IST. This had approximately $90 million in sales over the last year, growing 50%, year-over-year. And finally, we have a diversified portfolio of strategic healthcare assets that is currently valued at over $500 million, which has a, I would say, a very attractive risk-reward profile. So altogether, these assets really form a compelling business. Our royalties ensure strong cash flow generation in order, excuse me, in addition to significant downside protection and sustainable funding for other parts of the business, which together, in turn, provide profitability growth, as well as asymmetric payoffs with significant upside.

I'd now like to go into a little bit more detail on the royalties, as well as our therapeutics area platform, and show why we are so excited about the prospects of the business. And so our royalties, Innoviva's royalties, is really the foundation of who we are. We receive sizable revenues from two best-in-class respiratory therapies, which are again commercialized by GSK, that provide a dependable source of cash flow that has allowed us to create the other parts of the business. This portfolio paid over $250 million in revenue last year, and based on five-year analyst consensus projections, these will continue to deliver over $200 million a year. We're very excited about the prospects of this portfolio because the products are both very differentiated, as well as resilient.

These drugs are some of the best-selling respiratory drugs in the world, excuse me. They're well-characterized and trusted, and although they are somewhat mature drugs in the U.S., it's important to note that the majority of the revenue today comes from territories outside of the U.S., where the competition is often not as strong, allowing for continued strong growth in many regions around the world. All of this has helped to combine to help this portfolio significantly outperform expectations over the years, despite competitive pressures, and we would expect this to continue, especially given the strong momentum that we've had coming into 2024.

And then finally, both of these royalty streams have meaningful additional longevity, backed by strong intellectual property patent protection, as well as manufacturing complexity, which serves as a moat for potential competitive entrants, as we've seen with other drug device combinations in the past. Moving on to address IST. IST, again, our specialty therapeutics platform, is a robust and growing business in the infectious disease and critical care space, and we think it has tremendous growth potential ahead. The IST business was designed as a result of a specific investment thesis that was developed over the years. We saw the challenges that other companies in the infectious disease faced, which resulted in depressed valuations across the board.

We felt strongly that with thoughtful asset selection, intelligent capital allocation, and a focus on scale and efficiency, we could create a profitable business based on a roll-up strategy, and that's just what IST is. It was really specifically designed to serve as a profitable platform in the critical care and infectious disease space and has so far exceeded our expectations. The business is built on a portfolio of truly differentiated products that have strong synergies with each other, as well as novel mechanisms of action in providing life-saving effects in areas such as septic shock, complicated intra-abdominal infections, as well as deadly Acinetobacter infections. We also had a recent Phase III readout that could address significant unmet needs in STIs and the growing threat, excuse me, of resistant gonorrhea.

This portfolio is commercialized by an efficient, targeted operational platform with an experienced team that has some of the best concentration of therapeutic area expertise in the industry, spanning commercial, medical, regulatory, and CMC. And the business itself is in a very strong financial position, where we have a solid base of revenue and long-remaining growth runway for our products. Our two most established products, GIAPREZA and XERAVA, have a solid base today of utilization, along with near-term growth drivers that are unlocking significant additional value. We've had a recent drug launch in XACDURO that is in a high-growth mode in a market with a very few treatment options. And then, as mentioned, we have a pre-NDA product in zoliflodacin that, if approved, what is likely to be the largest market of all, both in the U.S. as well as the rest of the world.

This portfolio has strong IP protection well into twenty-thirties, and so we are also confident in the durability of these revenues, and I will say, since its formation, this platform has been extraordinarily, extraordinarily productive, with a very lean team. In just a year and a half, we've been able to re-energize our marketed portfolio. We've had a successful drug launch in XACDURO that is so far exceeding our expectations, as well as managed a compelling Phase III readout for our portfolio drug, zoliflodacin, and we believe that really this is just the beginning and will serve as the foundation for further investments and drive both organic as well as inorganic growth.

And so now I'd like to spend a minute or two on each of our product portfolios in a bit more detail, highlighting some of the near-term growth drivers that we would expect in each of these over the next year or so. And so to start, GIAPREZA, which was developed to treat shock patients using a synthetic version of the body's own angiotensin II peptide, which has a different mechanism compared to existing treatment options. In its pivotal trial, GIAPREZA was tested on patients already on high doses of both first and second-line therapies, who still had low blood pressure, and it demonstrated its ability to restore therapeutic blood pressure levels in as little as five minutes.

This is critical because there are more than 140,000 shock patients in the U.S. each year who fail first- and second-line vasopressor therapies, and these are extremely sick patients who often expire if not treated successfully, leading to significant unmet medical need. The most significant near-term growth drivers for GIAPREZA are both the inclusion in the next guidelines updates, as well as additional and new data generation, which has been a major priority in partnership with some of the top researchers in the therapeutic area, both of which we expect to have a major impact on access and awareness for this life-saving therapy. XERAVA is a novel synthetic tetracycline antibiotic that was designed as a powerful, broad-spectrum and 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. difficile infections and is more tolerable and potent than previous-generation tetracyclines, both of which are expected to drive XERAVA utilization as a substitute for certain patients and institutions. We are optimistic about XERAVA's future, that these macro trends will continue to drive growth for this product for years to come. XACDURO, which was the first anti-infective drug developed, designed, and approved to target Acinetobacter baumannii, which represents a critical unmet need in the U.S. as well as around the world. This pathogen is one of the top priority threats for both the CDC and the WHO.

Prior to XACDURO's launch, there were really no good treatment options for carbapenem-resistant organisms, which make up the vast majority of worldwide cases and has a majority, excuse me, a mortality rate of approximately 40% in the U.S. Up to this point, physicians were basically thrown, asked to, or forced to throw, excuse me, anything at these patients and hope that something would work. Today, XACDURO is the first to be approved for this disease, specifically in this label. In addition, another key value driver is the targeted approach for XACDURO, which, unlike other branded antibiotics, excuse me, it is not positioned for broad empiric use, but rather specific identifiable cases. This means systems do not need to have as many concerns about budget impacts, and also does not create the same stewardship concerns as with other antibiotics.

We believe this will dramatically improve access, and we have already seen indications of that early in its launch phase. Then finally, to discuss briefly the next potential addition to our portfolio, this is zoliflodacin or ZOLI. Zolifodacin is in the development for the treatment of gonorrhea, including strains resistant to the current standard of care, injectable ceftriaxone. We recently announced the positive results of a registrational Phase III trial, where zoliflodacin met the primary efficacy endpoints of non-inferiority to ceftriaxone, as well as azithromycin, which is the current global standard of care. It also demonstrated that it was both safe and well-tolerated. The importance of zoliflodacin in this market is illustrated by two key differentiators.

The most critical differentiator is that zolifodacin, as mentioned, is expected to be efficacious against gonorrhea strains that are already resistant to injectable ceftriaxone. Around the world, there's a significant and growing concern of rising resistance. In some countries already, injectable ceftriaxone resistance is as high as 30%, and the rate of growth is alarming. The U.S. is expected to follow the same trend, and we are already seeing early signs of this. Secondly, even before injectable ceftriaxone resistance develops, there is an unmet need for an efficacious and convenient oral therapy compared 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 common practice with STIs.

All of this 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. A brief summary of our earnings for the first half of this year illustrate how the business is growing across the portfolio. In addition to substantial revenue growth over the past year, we've seen a 2% increase in the royalties, as well as approximately 50% in the therapeutic area business. We've also had exciting achievements in the first two quarters of this year, which include updated guidelines, which resulted in preferred placement for both XACDURO as well as XERAVA in the respective therapeutic areas.

We recently announced the approval of XACDURO in China, which brought with it approximately $14 million in milestone-related payments, and XACDURO was recently nominated as a finalist for the prestigious Prix Galien Award. And we recently completed, earlier this year, a $100 million share buyback program that we believe signals our continued confidence in the trajectory of the company. It's a very exciting time for Innoviva, and we are proud to be delivering innovation to patients in areas of critical unmet need. And so, to summarize, we are very confident in the prospects of our business. We feel we are ideally positioned in the current environment, given our profitability, our cash position, our attractive assets, as well as our strong team. All of these will enable us to take advantage of exciting near-term growth opportunities ahead of us.

We see tremendous potential for both organic as well as inorganic growth in our business. On the organic side, we still have untapped growth for each of our marketed drugs and additional global opportunities to create more value and get our products to more patients who need them. We believe that with one more year of growth, our therapeutic area business will be profitable as a standalone entity. Looking at inorganic growth opportunities as well as other capital deployment priorities, there are also a wealth of options.

We are seen as a partner of choice in the critical care and infectious disease space, and we believe that our platform would have significant synergies with any other related asset we would bring in. And now is a good time on the market, as there are many differentiated assets and attractive valuations in this space. We're very fortunate, in summary, to be in this position, and we are excited about what the next years hold. Thank you for your time.

Powered by