Ascendis Pharma A/S Ordinary Share Morgan Stanley 24th Annual Global Healthcare Conference
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I am Max Skor, biotech analyst with Morgan Stanley. Welcome. Just to start off, for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. With that, I would like to welcome Jan Mikkelsen, CEO, Scott T. Smith, CFO, Jay Wu, head of U.S. market. Thank you very much for joining us today, team.
Jan, thanks a lot for inviting us.
Really appreciate it. I think in regards to the Ascendis story, let's start with last night's announcements. You have recaptured full rights to the metabolic and cardiovascular franchise. How are you thinking about what comes next for Ascendis?
That is an open question where I can come with a lot of answers because a lot of things is happening at Ascendis. First of all, we also had a press release yesterday related to buying back shares for $400 million. I think that is part of our integrated strategy that we lay out in our Vision 2030, how to be a leading biopharma. Before I start, I think Scott would like to say a few words related to our financial positioning, how we are generating a profitable company, and how we will progress in the next years.
Thanks so much, Jan. As Jan mentioned, we announced a $400 million share repurchase agreement, and that is really on the back of the strength of the financial transformation that happened with Ascendis this year in 2026, going from historically R&D, to having approval and launch of three highly differentiated products with YORVIPATH achieving blockbuster status this year. As you know, we have guided to over EUR 500 million of operating cash flow, and with the strength of the launch, as well as the new launch of YUVIWEL, we expect that that could potentially double next year or even more. It is a great time for Ascendis to buy back shares and we still retain all the capital we need to continue to advance R&D.
In particular, I think with the other announcement we made, it gives us a lot of opportunity to basically ensure the growth of Ascendis beyond 2030 into the 2040s.
When I see Ascendis, and this relate out really well in our Vision 2030, because I really like this framework where we go out and lay a five years plan and how we follow on it and how we execute it. There are two cornerstones in our 2030 plan. One is to hit EUR 5 billion in product revenue. That is EUR 5 billion coming from our three approved product, SKYTROFA, YORVIPATH, and YUVIWEL. That is the cornerstone in our revenue generation, and it is coming from U.S. and also coming from our key effort. We have to be independent on the U.S. revenue, but building up a sustainable part of our revenue flow from the ex-U.S. I think we are one of the few biotech that really have this effort going on, where we are building up a global organization.
We recognize revenue more than for 40 countries now, and it takes longer time in the ex-U.S. segment. When we come to 2027, 2028, we will see about 10 to 20 countries every year being full commercial with our product. Jay will say a few words about U.S. because U.S. is still a cornerstone in our revenue generation. Also explain a little bit about the effort we are doing really so we can grow the revenue every year.
Sure. Thanks, Jan. As Jan mentioned, from a U.S. standpoint, we now have three approved products in the U.S. We're feeling encouraging about all three of them. YORVIPATH, I know we spent a lot of time talking about, given from a pure scale standpoint, it represents tremendous opportunity as you think about not only what it's generating in the near term, but also the longer-term potential of the hypoparathyroidism space overall. Within that, we've been investing quite heavily in a few areas. One, we've talked a lot about prescriber education as being a key area. We launched during a time where following that hypopara, this is a differentiated product, and we're reshaping people's expectations for what patients that have hypoparathyroidism need and what the condition actually entails. I think the second area where we've been investing quite heavily in is patient activation.
If you think about 70,000 to 90,000 patients in the U.S. having hypoparathyroidism, this is a space where many of those patients aren't actively either seeking care, have established care with their specialist, and/or are searching for something more above and beyond the conventional therapy that they're on. That takes time, but we're seeing some really encouraging signs of some of those behaviors and beliefs changing. Then lastly, with the ever-evolving access landscape patient experience, we know that this condition in particular, these patients go through things like brain fog. They might go through fatigue and making sure that they have the requisite level of patient support, both during their journey to get a prescription, as well as post-prescription, is another area that we've been ensuring that we're supporting from a seamless experience standpoint. YUVIWEL, we just recently launched this year.
You've seen some of the numbers that we've shared previously. Incredibly encouraged by what we're seeing with that new product launch to date. Again, really speaking to the fact that this is a clinically differentiated profile we believe is best in class. From a standpoint of offering something unique to this community, we're seeing really positive sentiment across providers, patients, patient advocacy groups, and conversations with payers have all been going very well.
Of course, we mentioned the cornerstone of SKYTROFA. We're still seeing continued growth in that segment, tracking with what we see in prescriptions. Because SKYTROFA is continually being developed in other areas as well, we do see SKYTROFA as a foundation to start with a very bright future ahead.
What Jay has talked about, how he implemented an excellent center of commercialization in the U.S., we are doing the same Ex-US. Building up a global organization where we want to reach more than the 400,000 to 500,000 patients, for example, with hypoparathyroidism. That is sitting Ex-US. Huge amount of patients. This is one of the efforts we will continue to doing. When we talk about revenue in 2030, the EUR 5 billion, we have a strong fundament to achieve that just with our three current products. This is the fundament to hit the EUR 5 billion. This is not peak sales of this portfolio. The peak sales comes years after that. We continue label expansion. We have 5 to 10 trials ongoing now.
Many of them are late stage, both in label expansion, combination therapy, really to build on further how to really reach the best kind of treatment to all the different patients. At the same time, and it is coming to the second part, if in our Vision 2030, how to be sustainable with a continued new flow of new chemical entity. Like one like SKYTROFA, like one like YORVIPATH, like one like YUVIWEL. We have now a strategic strategy to take at least one new NCE in clinical development, besides all the label expansion we continue to do with our current portfolio of products. It is coming both in rare disease endocrine. It will come in other indications outside. Part of our strategic approach for 2030 is that we have built a new fundament for a new therapeutic areas beside our rare disease endocrine.
We are not limiting ourselves to rare diseases more. We have the capacity as a company. We have the infrastructure to move outside rare diseases. When we see how we built up our rare disease endocrine, it was built on a product at least three, where we add one product more after the time. Really have the economy of scales and synergies both in commercial organization, in manufacturing, regulatory, Ex-US, really to do it. We will do the same thing in the new therapeutic area. We are not dependent on in-licensing. We are a company built on an R&D development on our strong technology platform, the TransCon technology, which have given us three out of three. Scott is still calculating what is the chance to start with three preclinical and get three products approved. He still believes it is very low.
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