Ascendis Pharma A/S Business Update Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : Hey, guys. Good morning and congrats on the approval with the hypopara treatment indication. Two questions. Can you talk about the degree to which data on urinary calcium is captured on the label. I know the E part talks about the product normalizing urinary calcium. And then second, given you were previously ready to launch in the US last year, can you talk about the launch time lines as it relates to a product you're currently completing manufacturing of and when we might hear if you get clearance to commercialize the existing manufactured product. Thank you. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board First question, I will transfer over to Aimee, but I believe we have presented the positive data, that is also on restoring the PTH level of the kidney function. But the Aimee you can basically reflect how it integrated.

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : And does it speak to where that goes?

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : Thank you.

Question: Li Watsek - Cantor Fitzgerald LP - Analyst : Okay, great. And congrats on the approval. I wonder if you can maybe give us some guidance on pricing and how your conversations with payers go with respect to pre-authorization and if there's any step added. And then we also notice that the maximum dose in the US label is 30 meg versus 16 meg for the European label. So maybe just clarify if there's a difference in terms of the maximum does and what's the implication. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board Yeah. Let me take the first question related to the pricing. Our vision for [SASA] product is the same as may other product. We want to come out to as many patients as possible. We feel that the hydropower patients deserve to have a treatment with PTH with some basic also as (inaudible) reflecting in the guidelines. We are now integrating four different aspects. So we can have an holistic view about how we are optimally addressing this unique goals in the US. And in this regard we have not decided on basic the price yet. We are initiating discussion with reimbursement firm. It's complete now and that is that integrated part of that discussion, too. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:00PM, ASND.OQ - Ascendis Pharma A/S Business Update Call So when we come to the next event we have, I think it will be our Q2 call. I would expect that we could come with much more clarity related to how our US prices would be. The second question was related to the leasing between 6 to 30 and 6 to 60. And Aimee can talk about how that patients basically were in a position that in our primary endpoint at that time, the last four weeks that was only very few patients that basic were over searching micrograms. So we always have very few patients being over 30 microgram. And then we feel that those are two different agencies, FDA and EMA, sometime value conversation data by different views. What we're feeling here is that we basically have a product that is really in the US also between 6 to 30, really keep for the majority of patients really and treatment that really are the treatment of hypoparathyroidism. Aimee, do you have any comments?

Question: Li Watsek - Cantor Fitzgerald LP - Analyst : Okay. Thank you.

Question: Tazeen Ahmad - Bank of America Cor - Analyst : Hi, guys. Can you hear me? Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board Yes.

Question: Kelly Shi - Jefferies LLC - Analyst : Congrats on achieving a great milestone. So regarding the first wave of patients for the US launch, except for the patients who had experience with [Natpara]. How do you see PTH therapy awareness improve over time? And what would be the size by our estimate of the new patient groups could be immediately prescribed. Thank you. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board Yeah. When I look on the patient group and either you come in as a new diagnosed hypopara patients or you come with a definition of having chronic hypopara, for perhaps 1 year, 2 years, 5 years, 10 years, all of them deserve a treatment. And I also believe when I see the guidelines at Aimee reflected on them and talked about the patient that is basic is reflected in that they should be treated. So I believe I cannot guess where the patient would come from because I don't believe that will come from everywhere. We saw the same thing in Germany where I expected that seeing most, most smaller patients, but we saw more and more new patients. For example, in Austria, where we also have commercial launch. I think half of their patient basic are new patients. And I think illustrate the unmet medical need, this new patient has [exactly]. And so therefore, when I look on the patient group in the US, sure, we have a huge ability for the hypopara patients, that potential will have a different time of treatment on that path because of it recall. And we need to be quite sure we will do everything we can do for this patient group. So that don't need to move over to conventional therapy, but also believe that the unmet medical need with the new patient is at a high. And this is why I'm not really describing where belief the patient we've come from a specific place, I believe that would come from everywhere. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:00PM, ASND.OQ - Ascendis Pharma A/S Business Update Call

Question: David Lebowitz - Citigroup Inc - Analyst : Thank you very much for taking my question. With respect to the net par experienced patients, how many of those patients are still in the system given they haven't had a drug for quite some time. Do you need patients still see their doctors regularly or is going to be more of an active effort actually get in touch with them to bring them back. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board I think David, you're referring to our best knowledge. There was about 4,000 patients on Natpara, I think that is our best estimate. And when the -- have the recall of Natpara that only managed to give treatment to about 400 patients. It means that 92% of the patient basic didn't have any treatment option except to go down to conventional therapy, basic taking calcium supplement or active vitamin D. All these patients will be contact with physicians because they need to get a prescription of active vitamin D. Potential also to help to the hurdle of the daily day how to manage with the seats. So to our best knowledge, and this is where we see (technical difficulty) potential. The limitation will be how fast can many of these high-power patient bases get an appointment by the physician that end that basic can facility that can be starting virtually.

Question: David Lebowitz - Citigroup Inc - Analyst : Thank you for taking my question.

Question: Joseph Schwartz - Leerink Partners LLC - Analyst : Great. Congratulations on the approval. It seems like this is an indication that payers have been motivated to manage access to more than others. And so I was just wondering what do you think that is, and how are you preparing to how patients get access? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:00PM, ASND.OQ - Ascendis Pharma A/S Business Update Call One thing we've heard potentially occurring from a couple of physicians was perhaps having access limited to those patients that have had acute episodes of Hypo PTH in the past, and I'm like in the last year. So I was just wondering if you've heard that if that's a possibility and how you prepare to help patients get access. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board Aimee, you are most near the patient that -- I do not know, you have heard or reflected about that comes on.

Question: Joseph Schwartz - Leerink Partners LLC - Analyst : Yes, I think it was that [latter] point.

Question: Joseph Schwartz - Leerink Partners LLC - Analyst : Okay. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:00PM, ASND.OQ - Ascendis Pharma A/S Business Update Call Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board Thank you.

Question: Gavin Clark-Gartner - Evercore ISI Group LLC - Analyst : Hey, guys. Thanks for taking the question. I first just wanted to ask on your ability to supply the market in 2025. So but first off for the existing manufactured product, how many patients do you believe you could supply? And '25 an additionally, for the commercial manufacturing that's coming online, how many patients do you believe you could supply with that? And I had a follow-up. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board So one of the things we have been actually extremely proud about is our robustness in our supply chains. We have now been in the market with scratch offer for multiple years, never been in a position that the never, never could not supply to a patient if the patient wanted to be on treatment. We will do the same thing with your OpEx. We scaling also that. We will be in a position that we can be and hope we can treat as many as possible. We should not be the limitation, and we hope renewal will be done. So from that perspective is that we are doing everything so we always will have to say, acknowledged from the patient from the physician that we are reliable company.

Question: Derek Archila - Wells Fargo & Co - Analyst : Hey, good morning, and let me add my congrats on the approval. I just wanted to know how much do you think Natpara's removal from the market later this year may factor into the FDA's decision to potentially improve your currently manufactured product? I guess do you think it increases the odds that they will? Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:00PM, ASND.OQ - Ascendis Pharma A/S Business Update Call Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board I believe the FDA will always take the right decision. And from that perspective, I hope everyone see the unmet medical need. Everyone sees the situation this group of patient are in. So I think everyone is in the same boat, everyone wants to do the right thing for the patients and their firm always about [possessive] person when I think about how we can come up to the patients as fast as possible.

Question: Alex Thompson - Stifel Financial Corp - Analyst : Great. Thanks for taking my question and congrats on the approval as well. I guess as a follow-up on the manufacturing part of this, could you walk through the timeline around when FDA might be able to approve the currently manufactured product and when you'd be able to disseminate that to the street. Thanks. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board (inaudible) as we said in the press release, we have already plant manufacturing that are already on wires that getting released and everything. And we will be ready for the market in Q1 '25 with all the new materials. Currently, we have existing manufacturing batches that be, for example, our utilizing to other places in the world to patients there, and is what we would like to discuss if we can move them into the patients in the US until the basic we'll be in a position we can have the plant manufacturing capacity ready in Q1.

Question: Paul Choi - Goldman Sachs Group Inc - Analyst : Hi, good morning and thank you for taking our questions and congratulations. My first question is on, as you think about your marketing efforts, which in the minds of patients and physicians is most important in terms of promotion with regard to symptomatic relief among PTH patients. And my second question is on for Scott. As you look at the guidance here for the remainder of the year, you're comfortable with more of the upper band at the end of the range at this point? Or just any thoughts on with regard to incremental OpEx versus the top end of the range would be appreciated. Thank you. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board I think, Aimee, would you take the first question. And I think the Scott you've been asked with the second question. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:00PM, ASND.OQ - Ascendis Pharma A/S Business Update Call

Question: Paul Choi - Goldman Sachs Group Inc - Analyst : That's great. Thank you.

Question: Yaron Werber - TD Cowen - Analyst : Great. Thanks for taking my question. I got a two sort of related. Just the first one, you mentioned that you look to get the normal expiration that you want on the pen. Can you discuss what that is relative to what you have a Phase 3? And then secondly, for the patients that did take a BID dosing in the Phase 3, what was the reason to BID (inaudible). Thank you. Jan Moller Mikkelsen - Ascendis Pharma A/S - President, Chief Executive Officer, Executive Director, Member of the Executive Board The first question is that, initial we will start with the 12 months exploration data. And what we often do and we already have a step is when we have to do it and that is basic as fast as possible, we will go for 18 months and then you go for 20 months. And then you can nearly imagine the tragic of 36 months. And this is a typical way where you basic up building long gone longer expiration date when you get more and more data in exactly the manner that it is required by basic regulatory agency. And your second question, I forgot it.