Ascendis Pharma A/S (NASDAQ:ASND) Q1 2024 Earnings Call Transcript

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Jan Mikkelsen: Yeah. UK is part of our Europe Direct plan. And we have a rollout on all our countries that is in our EU Direct and UK is integrated in this rollout. So, after we basically had the UK approval, which are now separated from an EU approval like other countries that we are also getting approval in now, we have continued filing everywhere from the different countries. And for example, Australia, everywhere, where we also need an independent approval, we will then come in and go in and do what we call [indiscernible] filing of a dossier that really are describing the health economic impact as we have done in many EU Direct countries, what we’re also doing in other countries. And when we have reached an agreement with the agencies in this specific country about reimbursing price, your [indiscernible] will come into what we call a full commercial launch.

What we’re doing in the meantime, until we have this full commercial launch, we’re building up the infrastructure, and we have done that in most of the EU Direct countries where we have a general manager, we have medical affairs, we have market assessment teams, all that is basically already being established and they are ready to be coming out and doing a full commercial launch that, for example, which we have done in Germany and Austria. In the meantime, a physician, patient can go to a named patient program, where we can get fully reimbursed patient with a built on a named patient program or similar structures in lot of different countries. In this timeframe, until you will be fully commercial, you basically can provide commercial reimbursed product to the patient to all these specific programs.

So, this is what we call the dual strategy we are utilizing in the Europe Direct, which we also will someway implement in the International Market, but we will not be the M&A holder in the International Market. It will typically be handed to our sales and distribution agents. For the other thing about hypochondroplasia, it really, really is an interesting aspect for us, because we are the only company that have two cornerstone in growth disorders. Growth disorder is about 30, 40 different diseases. We are the only company that have a once-weekly growth hormone, a once-weekly CNP molecule with really the best-in-class properties for both of these two mode of actions. So, what we are doing and that is part of our Vision [2030] (ph), making an integrated strategy how we are going to be the leading company in growth disorder.

And that is not only to address hypochondroplasia, but address the other — including the other — 30 other diseases that is in growth disorder. And we believe some of them will be best treated with growth hormone, some of them will be best treated with CNP, but also many of them will potentially be integrated in a combination therapy. And this is why we believe why we can be positioned to be the leader in growth disorder because we have the two cornerstone for basically to handle all the 30 diseases. So, much more to come when we come up next year, where we will come with our integrated strategy, how we’re building up to be the leading company in growth disorders.

Leland Gershell: Thanks.

Operator: Thank you. And our last question comes from Sushila Hernandez with Kempen. Your line is open.

Sushila Hernandez: Yes, thank you for taking my question. Could you elaborate on SKYTROFA becoming a blockbuster in the US alone? What needs to happen? What are the key drivers? Thank you.

Jan Mikkelsen: The key driver is continue what we’re doing. This is exactly what we’re doing. We are doing — continue showing the physician, the patient to really getting the treatment benefit of SKYTROFA as the best-in-class product opportunity inside the growth disorder. We will be helped by a lot of different things. The consolidation of the daily growth hormone market. We saw one of the major player is now stopping. We see all of the major player with daily growth hormone stopping. So, the consolidation of the daily growth hormone, where potentially one or two player will be left in more or less in a cash segment, it’s really, really, really only the beginning of it. We’re still in a small part of it. We believe we have less than 20% of the growth hormone deficiency, pediatric growth hormone deficiency.

We can also grow it now in adult growth hormone deficiency. We have our Turner trial coming in now. And then, we also see where more and more experienced people get of the long-acting, they’ll realize there’s only one choice. And I don’t need to say that name because there’s only the sky that really somewhere keep the limit for this product.

Sushila Hernandez: Thank you.

Operator: Thank you. There are no further questions. Thank you for your participation. This does conclude the program and you may now disconnect. Everyone, have a great day.

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