Innoviva, Inc. (INVA)
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H.C. Wainwright 27th Annual Global Investment Conference

Sep 8, 2025

Speaker 2

Thank you for joining us for our next company presentation. We have Pavel Raifeld, the CEO of Innoviva. Pavel, thank you for joining us today. Please take it away.

Pavel Raifeld
CEO & Director, Innoviva

Great, thank you so much. It's really a pleasure to be here at the conference, and I appreciate the opportunity to tell the Innoviva story. I would like to start today by giving an introduction to the company and also the unique three-part structure of our business. I would like to discuss why we're so excited about the progress we've made to date and also talk a little bit about the direction of our business on a going-forward basis. Perhaps, you know, just to give a bit of a history, Innoviva was originally formed to maximize the value of the royalty streams coming from respiratory products that we developed with and licensed through Glaxo Group Limited (GSK) to commercialize. These royalty streams have done very well and have turned Innoviva into a highly profitable company with significant cash flows that we expect to continue for years to come.

As these royalty revenues grew over time, we began to focus more on our capital allocation strategy to thoughtfully deploy our cash flows in the areas of high unmet medical need with strong growth potential in order to create long-term value for our shareholders. Our largest investment to date was the creation of a critical care and infectious disease therapeutics platform that is now an industry leader. As a result, today we have three main assets. The first one is our royalty portfolio from the respiratory drugs marketed by Glaxo Group Limited (GSK). That's expected to provide over $1 billion in royalty revenue to Innoviva over the next five years based on analyst consensus. The second asset is the high-growth critical care and infectious disease therapeutics platform, which we call Innoviva Specialty Therapeutics or IST, which is currently comprised of four marketed products and one late-stage pipeline candidate.

IST achieved approximately $130 million in sales and license revenue in the last 12 months, and it's been growing at over 50% a year. Last but not least, this third part of our business is a diversified portfolio of strategic healthcare investments that's currently valued at approximately $450 million. You know that's composed of assets which we believe have a very attractive risk-reward profile with a relatively small financial exposure to us and an asymmetric payoff potential. Perhaps, if I could talk... Yes, thank you. If I could talk about the revenue generation of our business, our core businesses continue to demonstrate meaningful top-line growth and durability. Our therapeutics business has nearly tripled since its formation in 2022. IST's global product sales grew by over 60% in 2024, driven largely by a re-energized commercial strategy for GIAPREZA®, as well as a successful launch of another of our products, XACDURO®.

We see room for further growth acceleration with additional meaningful revenue generation opportunities with the recent launch of ZEVTERA® and the potential approval of zoliflodacin at the end of this year. Our royalty business, despite these products being more mature, has continued to deliver strong year-over-year performance, consistently beating analyst expectations and providing a reliable source of cash flows and profitability for us. If we look at the first half of this year, we continue to deliver the same momentum. We've been very pleased with over 50% year-on-year growth in US product sales from our therapeutics business, which has been driven by a very strong launch of XACDURO® and continued expansion of the market for GIAPREZA® with new data generation and positive real-world evidence. Meanwhile, our royalty portfolio continues to provide a stable source of revenue to Innoviva and again beat expectations in the first half of this year.

I'd like now to go into a bit more detail on the royalty portfolio and the therapeutics platform and outline why we're so excited about the prospects of these two areas of our business. Starting with our royalty portfolio, we get sizable revenues from two best-in-class respiratory therapies commercialized by Glaxo Group Limited (GSK) called ANORO® ELLIPTA® and RELVAR®/BREO® ELLIPTA®. These products are some of the best-selling respiratory drugs in the world, achieving over $2 billion in sales over the last 12 months. They are trusted maintenance therapies and, as a result, are more resilient in the face of potential new competition or potential generic entrants. Although these are more mature drugs in the US, the majority of revenues now come from ex-US territories, where the competition is often not as strong, allowing for continued excellent growth in select regions.

Finally, both royalty streams have meaningful additional longevity backed by strong intellectual property protection, perhaps going into the early 2030s, with additional buffer to generic entry provided by the manufacturing and regulatory complexity. We have very high hopes for this part of our business. Now, to turn onto IST. IST originated from a very specific investment thesis that we developed over the years. We saw the challenges that infectious disease companies faced, which resulted in depressed valuations across the board. We thought that with a smart asset selection, intelligent capital allocation, and a hawkish focus on scale and efficiency, we could create a profitable business via a roll-up strategy. We believe that we accomplished just that with IST. It was specifically designed to serve as a profitable platform in the infectious disease and hospital space, and so far it has exceeded our expectations.

The business is built on a portfolio of truly differentiated products that have strong synergies with each other. It's been commercialized with an efficient, targeted operational platform with an experienced team that I believe has some of the best concentration of therapeutic area expertise in the industry across commercial, medical, regulatory, CMC, and other key functional areas. We are in a very favorable financial position where we have a strong revenue base and a long remaining growth runway. As a robust and growing business in infectious disease and critical care, we think that IST has tremendous growth potential ahead. Each of our products has patent protection going into the 2030s, oftentimes well into the late 2030s, with options for further extension and exclusivity. We are quite confident in the durability of this business.

We also believe that the current platform is just the beginning, and it can serve as a foundation for further investment to drive both organic and inorganic growth. We are quite excited about that. Perhaps I'll take a few minutes to briefly address each of the IST assets and the growth drivers in the indications that they address. To start with GIAPREZA®, which is our largest product to date, it was developed to treat shock patients and is the most advanced of our products and a leading revenue generator for our commercial platform. We are several years into what we like to think of as a relaunch of GIAPREZA® following our acquisition of its originator, La Jolla Pharmaceutical Company. This relaunch has been supported by a new commercial strategy and sales force optimization.

We think that there is a very significant runway ahead for GIAPREZA® from the revenue perspective, and we believe that some of the more impactful drivers could be potential inclusion into the guidelines as well as the new data generation. Moving on to XACDURO®, which is the first anti-infective drug designed and approved to target acinetobacter infections, which is a critical unmet medical need in the U.S. and more globally. XACDURO®, unlike other branded antibiotics, is not positioned for broadened peer reviews, but rather for very specific identifiable cases. It means that the potential stewardship and budget impact concerns are not as strong, and this has helped with improved access. We believe that it's had one of the most successful anti-infective launches in the last half a decade, and we're very comfortable with the continued momentum for this product.

The next product is XERAVA®, and it's a novel tetracycline antibiotic that was designed as a powerful, broad-spectrum empiric option with coverage of multiple resistant organisms. We think that rising rates of ESBL-mediated resistance are going to drive the unmet medical need for XERAVA® in the U.S., which will then translate into potential revenue growth. ZEVTERA® is a very interesting product. It's an advanced generation cephalosporin, which is indicated for treatment of adults with Staphylococcus aureus bacteremia infections, in addition to certain skin and pneumonia indications. It's the first and only cephalosporin specifically approved for Staphylococcus bacteremia, which is critical due to the rise of resistant MRSA strains and now increasingly vancomycin and daptomycin resistant strains as well. We launched ZEVTERA® in the U.S. this quarter, and while it's still very early days, we're quite optimistic about the market receptivity and peak potential for this business.

Finally, our late-stage candidate zoliflodacin is in development for the treatment of gonorrhea, including strains resistant to the current standard of care, injectable ceftriaxone. There is a very significant unmet medical need in this space, and we believe that the availability of this option would both allow us to serve unique populations such as telehealth and those requesting expedited partner therapy, as well as will become increasingly relevant given the potential rise of resistance to the standard of care in the U.S. We are very excited about the clinical and regulatory progress we've achieved with zoliflodacin and look forward to providing you with a regulatory update following the PDUFA date set for mid-December. To summarize, with IST, we are extremely proud of the therapeutics platform that we have assembled and believe that each of the products in the IST platform is addressing a very sizable market.

We anticipate that the current portfolio could reach over $500 million of annual sales in the U.S. alone. Perhaps I would like to share one way that I think about our business and why I feel quite confident in its prospects. We think, obviously, we are in a fairly volatile environment right now, and we feel that we are ideally positioned to weather potential storms across a very wide range of market conditions, given our profitability, cash position, attractive assets, and an expert team. The diversified three-part structure of our business enables us to enjoy insulation from market volatility while taking advantage of attractive near-term opportunities. We see tremendous potential both for organic and inorganic growth for our business. Our therapeutics business in particular is now generating meaningful revenue that we expect to continue growing quickly into the future.

It's a very exciting time for us, and we are proud to be delivering innovation to patients in areas of critical unmet medical need. With that, let me pause and take the last few minutes and see if there are any questions on Innoviva and anything else that might be of relevance. Okay, perfect. Thank you very much. It's really a pleasure to be here, and I look forward to more updates as the Innoviva story unfolds. Thank you.

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