Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Tim Lee, Ascendis Pharma, Investor Relations. Please go ahead.
Thank you, operator, and thank you everyone for joining our conference call this morning. I'm Tim Lee, Senior Director, Investor Relations of Ascendis Pharma. Joining me on the call today is Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, and Dr. Aimee Shu, Senior Vice President, Chief Medical Officer, Endocrine Medical Sciences. Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by a Private Securities Litigation Reform Act.
Examples of such statements may include, but are not limited to, statements regarding our expected timing of U.S. commercial launch and product shipments for Yorvipath, our expectations regarding the potential benefits of Yorvipath, the potential market size and size of the potential patient population for Yorvipath, our patient services for Yorvipath, our Vision 2030, and our plans and objectives for future operations and commercialization activities. These statements are based on information that is available to us today. Actual results and events could differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law.
For additional information concerning the factors that can cause actual results to differ materially, please see our forward-looking statement section in today's press release and the Risk Factors section of our most recent annual report on Form 20-F, filed February 7th, 2024. On today's call, we'll discuss the U.S. Food and Drug Administration's approval of Yorvipath and our plans to commercially launch Yorvipath. As part of today's webcast, we have an accompanying slide deck that you can find on the Investor Relations section of our company website. Following some prepared remarks, we'll then open up the call for questions. With that, let me pass the call over to Jan.
Thank you, Tim, and welcome everyone to this Ascendis Pharma call. I would like to start at the J.P. Morgan conference. I got asked, "Will there be an approval of TransCon PTH?" I only said one single word, "Yes." And I really is extremely happy today that I could live up to the promise I have given, specifically all the patients, also in the U.S., that they will get a treatment option. Today, we are celebrating that for first time, there is a treatment option for hypoparathyroid patient, also in the U.S. We have worked on this product for nearly 10 years.
We are in a position, we see the benefit on a global basis, how it's helping the patient, and are feeling proud for all the hard work, everyone at Ascendis, the patient groups, the physician, really have been working together to ensure that we get this treatment option also available in the US. We're looking forward to be in a position that we, as fast as possible, can move this product opportunity out to the patients. I would now like to go to the next slide 4. The key takeaways is basically described in slide 4. When we look on the labeling, we feel it representing its best-in-class potential. It have a label on cause treatment of hypoparathyroidism, independent of the background of... Except that it is a adult and with the only limitation that it cannot be a good post-surgical. No REMS or black box warning.
As we did in our clinical studies, really covering pregnant women, and we are obligated also to be as a post-marketing to collect data, so we also can ensure that we basically can be in a situation that we can prove the benefit for this patient group, too. We are now transitioning over to commercial, and we are in a position that we hope we can launch in as fast as possible for this patient. We are engaging with the healthcare provider, and our market access team is really working already from today to ensure that we can get the commercial product out to the patients. Going to slide five. This is an overview of selected highlights from our U.S. prescribing information. I will not go into detail of that slide. Today, in the U.S., we have two products approved now.
Our first two products we developed with the TransCon technology, Skytrofa and Yorvipath. At Ascendis, we develop our specific algorithm for product development. I, when I see in combination with the TransCon technology to be in a position to develop two independent products out of two to the market, feel really, really proud. We focus on huge unmet medical need in the rare disease area. We focus on, on making highly differentiated product. But we also have shown that the combination of the TransCon technology and our specific algorithm for product innovation are basically beating the odds of traditional product development. But we are not compromising any way, in any way, not to make highly differentiated product that really are addressing major unmet medical need. Two out of two, but we're not stopping there.
Our next product is our TransCon CNP, that we now focus on to getting the people the data here in the rest of the year. I will now turn it over to Aimee Shu, that will talk about hypoparathyroidism and the unmet medical need.
Thank you, Jan. I will start with slide nine, and it is really my pleasure to be able to take us back to the fundamentals and remember the void that Yorvipath fills. Here on slide nine, on the right-hand side, you see the image of an intact parathyroid axis. The recognition has been for many decades that hypoparathyroidism is the last classical hormone deficiency, which has not had a hormone replacement. It has long been recognized that an ideal replacement would accomplish the things mentioned at the bottom of the slide here. A reduction in the amounts of calcium and vitamin D requirements, a reduction in urinary calcium, an improvement in quality of life, a reduction in ectopic soft tissue calcification, and an improvement in abnormal bone remodeling dynamics.
This all stems back to how the parathyroid hormone axis works physiologically and when the axis is intact. What I want to show here is that parathyroid hormone, represented in the purple here, has three major target organs, including the bone, kidney, and intestine, that act in concert to handle serum and urine, calcium and phosphate, most importantly, as electrolytes, and together it is this that maintains normal serum, calcium, and phosphate. It's a little bit like saying we are treating historically, like we are treating type one diabetes, which results in high glucose by saying, "Please don't eat extra glucose," right? It's as rudimentary as trying to treat type one diabetes without insulin. Now we are very happy to be able to say we can bring parathyroid hormone, the missing hormone, to hypoparathyroidism, a hormone deficiency that has broad-ranging effects.
On slide 10, to continue this, we show the various multi-organ manifestations of hypoparathyroidism. I know this audience knows it from before, but it is once again to highlight how systemic this condition is, including impacts on the central nervous system, renal system, and here you also see respiratory, cardiovascular, the peripheral nervous system, neuropsychiatric, ophthalmological, dental, dermatological, and musculoskeletal. So it is truly a major step forward that we are able to replace the missing hormone that impacts so many systems. In fact, as shown on slide 11, it has also been mentioned as recently as two years ago, when world experts convened the second international workshop on hypoparathyroidism, evaluation, treatment, and management. And here, they recommended to consider parathyroid hormone replacement, if it were one day available, in patients not adequately controlled on conventional therapy.
Conventional therapy, as you remember, is forcing calcium and active vitamin D, which cannot be made in the absence of parathyroid hormone, just to support serum levels, but doesn't impact all of those three organ systems, as mentioned before. Within those guidelines, these are the possibilities for considering when a prescriber should consider parathyroid hormone replacement. Those include things such as symptomatic hypocalcemia, hyperphosphatemia, renal insufficiency, hypercalciuria, and poor quality of life. In general, this is quite broad and safe to say that nearly all patients with hypoparathyroidism experience at least one of these, and in most, all of these. In addition, individuals with poor compliance, malabsorption of food and medications, and those who are intolerant of large doses of calcium, such as limited by constipation and nausea, and intolerant of active vitamin D, may also benefit from direct PTH replacement therapy.
And now I turn to slide 13, where we look at the demonstrated efficacy in adults with hypoparathyroidism. This is from the pivotal PaTHway Trial at the primary efficacy endpoint evaluated at week 26. And we'll go through row by row, and what you can see here, the overall response at week 26 was incredibly strong with treated patients, so patients randomly allocated to TransCon PTH, Yorvipath, 69% of them reaching a multicomponent endpoint versus only 1.5% in the placebo arm. Baseline demographics for these patients very much represent who is treated in the United States and globally today.
Majority were women, nearly 50 years old in age and represented a broad swath of etiologies, including post-surgical hypoparathyroidism as the majority, idiopathic reasons, autoimmune polyglandular syndrome type 1, autosomal dominant hypocalcemia type 1, that's a calcium-sensing receptor mutation, DiGeorge syndrome, and hypoparathyroid renal deafness syndrome, which is a GATA3 mutation. So it's safe to say that this trial also included and encompassed the various ways to arrive at hypoparathyroidism, both congenital, acquired, and unexplained. Now I'll go line by line at the components that comprise the multicomponent endpoint. One had to be considered a responder, a trial subject had to meet every single component on here to get that 69% above. But here we show individually broken out how many, the proportion that reached each component. So as an example, 80% had achieved a normal serum calcium at week 26.
95% were independent from active vitamin D, the downstream hormone that requires PTH to be produced, but now they were making it themselves. Independence from therapeutic doses of calcium. No increase in study drug from, since week 22, so this is a 4-week period in which the dose stayed stable. And then finally, you see here there is a fifth component that was added by FDA, and that is the study drug dose has been 30 micrograms or less per day through week 26. So that is for the duration of the blinded period of this trial. And that came from FDA in acknowledgment that they recommend a maximum dose of 30 micrograms once per day, addressing the concerns about risk of unintended changes in serum calcium due to potential variability of delivered dose.
And then not shown in this particular slide 13, but discussed in the label and text, during the extension trial through 1.5 years or week 78, there are some response rates shown. And the initial set of numbers shows the response rate for this exact endpoint, stable dose since week 22 in Yorvipath. And that seems to go downwards from 69%. The next part of the explanation shows that when one allows for titration, which I will add is very realistic for any hormone replacement, such as insulin, thyroid hormone replacement, estrogen replacement, over time, one needs to titrate. And so when allowing for the normal expected titration for failing glands or failed glands, then the efficacy rate is back up in the high 60% range. So very similar to what was seen at week 26.
This is what we would expect to see also long-term in the real world. Now we'll turn to slide 14. These are the adverse reactions as reflected in the label for Yorvipath. These are events greater than that occurred in greater than 5% of subjects with hypoparathyroidism treated with Yorvipath, and at least 2% or higher frequency when compared to those who were allocated to the placebo arm. As expected for an injectable drug, the most common adverse drug reaction were injection site reactions, followed by vasodilatory signs and symptoms, then headache, diarrhea, back pain, hypercalcemia, and orop haryngeal pain or sore throat.
... And now, Jan, I will turn it back to you for the remainder of the presentation.
Thanks, Aimee, for your presentation. I will move fast to slide 15, because it's giving the U.S. demographic. To our best knowledge, there's about 70-90 adult patients with chronic hypoparathyroidism in the U.S. And we describe them in three different boxes. The one that actually have experience with PTH, about 4,000-5,000, and then we also seeing an influx of new patients, which we have calculated to be around 3,000 a year, where the majority of these patients is coming from the post-surgical. So you can see that hypoparathyroidism is a rare disease. It has less than 100,000 patients. But as Aimee said, all these patients really deserve to have a treatment with PTH. As you can say, if you have type 1 diabetes, you should also be treated with insulin.
The largest group are the post-surgical patient, but as Aimee described, we have covered a lot of other groups of hypoparathyroid patient with a diverse background, like ADH1 and other genetic, but also immunological part of it. Going to slide 15, or 16 now. We are in a position, we are transforming now from our pre-commercial to our commercial activities. We had, before our approval, been working with the physician on education on the disease. Now we can move to our next stage, telling about Yorvipath and the benefit it providing. As Yorvipath is our second product we are launching in the US, we already have an established commercial organization. We have seen the success of Skytrofa here in the US, and we were utilizing the same successful setup, really to bringing Yorvipath out to as many patients as possible, as fast as possible. Going to slide 18.
There is about 6,000 HCP that we someway believe is covering 80% of the patients. They will be our primary focus, and this is what we're building the sales organization to cover together with our medical affairs teams. Going to slide 19. We will use the same way that we launched Skytrofa. We have as a program, where we really are helping the patient in the journey from starting the treatment through the entire journey, to be a patient that really can achieve the optimal treatment through help from all different places. This is our established organization that we now have seen successful launching Skytrofa, and really will drive the Yorvipath, too. Going to the last slide, summary and next step. Yorvipath is now approved. It's the first and only product to treat hypoparathyroidism in adults.
When I look on the labeling, I feel that it really are reflecting everything what Aimee said about the benefit for the patient, and the launch begins today. We have had an extremely productive dialogue engagement with the hypoparathyroidism patient organization, the physicians community, and all have been extremely engaged in having the same mutual dream to get out and treat the hypoparathyroidism patient with an treatment option. Now we are here. The first thing I had was a call with the patient organization, because they are the most important part. We have kicked out now our commercial launch, and I feel when I think about our product opportunities, that we now are developing in rare disease endocrinology.... Skytrofa and now Yorvipath in the US. The next one will be TransCon CNP.
We're building an integrated pipeline of three independent product opportunity, and we will continue to do what we believe we are: a company focused on the patient and really bringing treatment difference out to them, specific in the endocrinology rare disease. Thank you a lot, and it has been a pleasure to be part of this journey, and I'm really looking forward to be in a position that we can continue the journey that we now have started. Now we ready for questions.
Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. In the interest of time, we do kindly ask that you please limit yourselves to one question and one follow-up at this time. Please stand by while we compile the Q&A roster. Our first question will come from Jessica Fye from J.P. Morgan. Your line is open.
Hey, guys. Good morning. Congrats on the approval with the hypoparathyroidism treatment indication. Two questions: Can you talk about the degree to which data on urinary calcium is captured on the label? I know the ePAR talks about the product normalizing urinary calcium. And then second, given you were previously ready to launch in the U.S. last year, can you talk about the launch timelines as it relates to product you're currently completing manufacturing of, and when we might hear if you get clearance to commercialize the existing manufactured product? Thank you.
The 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 on the kidney function. But, Aimee, you can basically reflect how it's integrated-
Thank you
In the labeling.
Yeah. So Jess, in the label, it's under section 14, where we describe the baseline demographics of the clinical trial patients and how at baseline they start out with a high abnormal urine calcium level.
Does it speak to where that goes?
It does not.
The urinary calcium was one of the element we not got included inside the labeling on it. We feel that the way we are communicating on that will be through our publications, which are proving how we also have a benefit on that. There's a lot of good reason and a lot of good discussion we have with the regulatory agencies on taking this into our labeling, and I feel that it's a way where as long we have seen the benefit of this and it's recognized, I feel that it's not really what's the most important thing for us to win on. Going back to your second question, yes, from a commercial perspective, we are ready. We have the established infrastructure for being ready to move into the market.
What we are waiting for is ensuring we have the drug product ready for the U.S. commercial launch. You know, we are in many different countries today. From Austria and Germany, we have our direct commercial launch, and then we are providing named patient program, different places in the world. From the U.S., as you will see later on, and we have, and for the initial batch and shelf life, or we can say an expiration date, that are starting in 12 months, meaning that we are producing batches, so we're quite sure we can get them into the U.S. market as fast as possible. This is one of the things that we basically will improve very fast after launch, so we can move up to the normal level of expiration dates that we would like to have.
Thank you.
Thank you. Our next question will come from Li Watsek from Cantor. Your line is open.
Hey, 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 see if there's any step edits. And then we also noticed that the maximum dose in the U.S. label is 30 mg versus the 60 mg for the European label. So maybe just clarify if there's a difference in terms of the maximum dose and what's the implication?
Yeah. Let me take the first question related to the pricing. Our vision for such a product is the same as every other product. We want to come out to as many patients as possible. We feel that every hypoparathyroid patient deserve to have a treatment with PTH, which is basically, as Aimee told, reflecting in the guidelines. We are now integrating all different aspects so we can have an holistic view about how we are optimally addressing this unique goal in the U.S. And in this regard, we have not decided on a specific price yet. We are initiating discussion with a reimbursement company now, and that is the integrated part of that discussion, too.
So when we come to the next event we have, I think it will be our Q2 call, I will expect that we can come with much more clarity related to how our US prices will be. The second question was related to the labeling between 6-30 and 6-60. And, Aimee can talk about how the patients basically were in a position that in our primary endpoint at the time, the last 4 weeks, there was only very few patients that basically were over 30 micrograms. So we always have very few patients being over 30 micrograms. And, we feel that there is 2 different agencies, FDA and EMEA, sometimes they look on the same data by different views.
But what we're feeling here is that we basically have a product that really in the US, also between 6-30, really give for the majority of the patients, really, and treatment that really are a treatment of hypoparathyroidism. Aimee, do you have further comments?
Speaker, if you're muted, please unmute.
Thank you. Thank you, Lee. So as you know, the dosing of up to 60 micrograms was used in our clinical trials and is what is approved in Europe, and the U.S. label reflects up to 30 micrograms. And as Jan was mentioning, a lot of the data that is summarized in the publications and also in the label includes safety and efficacy up to 60 micrograms. Safety up to 60, and then efficacy up to 30 micrograms. But given that there were very few patients who, at any one point, required doses above 30 micrograms, the efficacy is by and large very similar between when we have used the 60- up to 60 microgram data set and the 30 microgram data set.
Okay, thank you. Thank you. Our next question comes from Tazeen Ahmad from Bank of America. Your line is open.
Hi, guys. Can you hear me?
Yes.
Good morning. Maybe just wanted to follow up on the question around the dose. Since you've launched in Europe, do you have a sense of what the average dose is being used for the adults since the launch in maybe, let's say, Germany? And in the past, Jan, I think you've talked about not to think about the dynamics of the launch in Europe necessarily as reflective of what to expect in the US. Now that you have the final label in hand, could you give us your updated thoughts on what you think the trajectory of pickup will be for PTH in the US relative to what you've seen in Europe? Thanks.
Yes. I actually expected this question. So I actually went back to the U.S. or the German, team and asked them this question. Now, we have patients, more than 200, I think more than 250 patients now. How many are basically taking a double dose? And, to their knowledge, I could not get a confirmation of any patient yet, that basically were in position to take a double dose. So from that perspective, you can say that you can see that the vast majority are all patients, they see, are having an optimal treatment in less than 30.
The question which are potentially the most relevant is that if you potentially need an addition to your 30 microgram daily dose, you will potentially still benefit dramatically for having a 30 microgram dose, and then potentially add either calcium supplement or potentially some active vitamin D for that. The physicians are the end, the one that describe what is the best for the patients, so the physician will always be in a position to do the optimal for the patients. Related to your second question, related to when I look on the penetration we see in Germany, when I look on the labeling we have here in the U.S. I believe based both labels are really best in class labeling for really treatment optimal for the patients. There is, when you look on the broadness of the patient group, you need to be adult.
In Europe, you need to have chronic hypoparathyroidism. In Europe, you don't need to, in the US, you cannot be coming from the acute. There is no limitation in the background where you got the hypoparathyroidism, so you basically can treat every patient with hypoparathyroidism. There is no limitation in REMS. There is no limitation in other things. So I feel both labelings are optimal for really coming out and treating the patients. So Tazeen, when I think about it, I'm more and more positive after I saw the US labeling than I ever thought I will be.
Thank you. Our next question will come from Kelly Shi from Jefferies. Your line is open.
Congrats on achieving a great milestone. So regarding the first wave of patients for the U.S. 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 your estimate, of the new patient group could be immediately prescribed? Thank you.
Yeah. When I look on the patient group, and either you come in as a newly diagnosed hypoparathyroid patient, or you come with a diagnosis of having chronic hypoparathyroidism 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 that Aimee reflected on them and talked about the patients, that it basically is reflected in that they should be treated. So I believe I cannot guess where the patient would come from, because I believe they will come from everywhere. We saw the same thing in Germany, where I expected that seeing much, much more Natpara patients, but we saw more and more naive patients. For example, in Austria, where we also have commercial launch, I think half of the patients basically are naive patients.
I think it illustrates the unmet medical need this naïve patient has, exactly. So therefore, when I look on the patient group in the US, sure, we have a huge responsibility for the hypoparathyroid patients that potentially will have a limited time of treatment on Natpara because of its recall, and we need to be quite sure we will do everything we can do for this patient group, so that they don't need to move over to conventional therapy. But I also believe that the unmet medical need with the naïve patient is as high, and this is why I'm not really describing where I believe the patient will come from a specific place. I believe they will come from everywhere.
Thank you.
Thank you. Our next question will come from David Lebowitz from Citi. Your line is open.
Thank you very much for taking my question. With respect to the Natpara experienced patients, how many of those patients are still in the system, given they haven't had a drug for quite some time? Do these patients still see their doctors regularly, or is it going to be more of an active effort to actually get in touch with them to bring them back?
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 they had the recall of Natpara, they only managed to give treatment to about 400 patients. It means that 90% of the patients basically didn't have any treatment option except to go down to conventional therapy, basically taking calcium supplement or active vitamin D. All these patients will be in contact with physicians because they need to get a prescription of active vitamin D. Potentially, also to help them through the hurdle of the daily day, how to manage with the disease.
So to our best knowledge, and this is where we see potential, the limitation will be, how fast can many of these hypoparathyroid patients basically get an appointment by the physician, the endo, that basically can facilitate, that can be starting the treatment?
David, I can add that the short answer is that patients with hypoparathyroidism generally would continue to see their physicians. So I think even had they been previously exposed and now without, they are still in close touch with their endocrinologist.
Thank you for taking my question.
Thank you. Our next question will come from Joseph Schwartz, from Leerink Partners. Your line is open.
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 why do you think that is, and how are you prepared to help patients get access? One thing we've heard of 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 like in the last year or so. I was just wondering if you've heard that, if that's a possibility and how you're prepared to help patients get access.
Aimee, you are most near the patient that I am, and I do not know if you have heard or reflected about the comments.
So Joseph, do you mean acute hypopara, as in post-surgical and before six months, as an example? Or do you mean those who are having hypocalcemic crises from time to time, so that means they've had long-standing, established hypopara and then are hospitalized every so often because they cannot manage?
Yeah, I think it was that latter, latter point.
Sure. So whether those would be the... Your question is whether those would be the ones that would be more convincing to payers to,
Exactly.
To keep upfront.
Yeah.
Yeah, it's all speculation, and we are working through. You could certainly think that they cost the hospital system a lot of money, but I think that will be one compelling way, and has historically been a compelling way to get access to the, for instance, Natpara, is to say that one has been hospitalized many times. That's certainly the way that the patients have, the 400 patients out of the 4,000 have had been able to access-
But-
- the special use program.
But I think, the simple answer is, Joe, and it's basically going back to Aimee's slide. How I often see it is that the prioritization or the approval of the prioritization is in, are you inside exactly the labeling and also the guidelines? And when I see the labeling, when I look up the guidelines, I actually believe that the vast majority of all hypoparath patients are exactly qualified to and positive pre-authorization. Scott, do you have any other comments to that point?
Sure. Yeah. So I would say, Joe, all of our experience and research would indicate that the prior authorizations, which you expect as standard for the specialty category, would be to label.
Okay, thank you.
Thanks.
Thank you. Our next question will come from Gavin Clark-Gartner from Evercore ISI. Your line is open.
Hey, guys. Thanks for taking the question. I first just wanted to ask on your ability to supply the market in 2025. So first off, for the existing manufactured product, how many patients do you believe you could supply in 25? And 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.
So one of the things we have been extremely proud about is our robustness in our supply chains. We have now been in the market with Skytrofa for multiple years, never been in a position that we never could not supply to a patient if the patient wanted to be on treatment. We will do the same thing with Yorvipath. We are scaling up for 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 we never will be that. So from that perspective, it is that we are doing everything, so we always will have the same acknowledgment from the patient, from the physician, that we are a reliable company.
Got it. Do you have an estimate how many patients in the U.S. are on PTH today, whether that's your expanded access program for Yorvipath, any ongoing extension studies for Yorvipath, or any patients that may be on teriparatide? Thank you.
That was a lot of questions. So I really do not know. We know how many patients that, for example, are on Forteo or Tymlos or anyone else. We know how many patients we are on our EAP program, and we will convert them as possible to this. So, that is what we intend to do, get them over as commercial patients as fast as possible.
Thank you. Our next question will come from Derek Archila from Wells Fargo. Your line is open.
Hey, good morning, and, let me add my congrats on the approval. I just want 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 approve your currently manufactured product? I guess, do you think it increases the odds that they will? Thanks.
I believe FDA will always take the right position, and from that perspective, I hope everyone see the unmet medical need. Everyone sees the situation this group of patients are in. So I think everyone is in the same boat. Everyone wants to do the right thing for the patients, and therefore, I'm always a very positive person when I think about how we can come out to the patients as fast as possible.
Thank you.
Thank you. Our next question will come from Alex Thompson from Stifel. Your line is open.
Great. Thanks for taking my question and, congrats on the approval as well. I guess as a follow-up on, on the manufacturing part of this, could you walk through sort of the timeline around, you know, when FDA might be able to approve the currently manufactured product and when you'd be able to, disseminate that to the street? Thanks.
Just for clarification, as we said in the press release, we have already planned manufacturing. They're already on file. They're getting released and everything, and we will be ready for the market in Q1 2025 with all the new material. Currently, we have existing manufacturing batches that we, for example, are utilizing in other places in the world for patients there, and that is what we would like to discuss, if we can move them to the patients in the US until we basically will be in a position we can have the planned manufacturing batches ready in Q1 2025.
Thank you. One moment for our next question. Our next question will come from Paul Choi from Goldman Sachs. Your line is open.
Hi, good morning, and thank you for taking our questions, and congratulations. My first question is, as you think about your marketing efforts, you know, 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, for Scott. As you look at the guidance here for the remainder of the year, are you comfortable with more of the upper band at band of the range at this point? And just any thoughts, with regard to incremental OpEx or putting the top end of the range would be appreciated. Thank you.
I think, Aimee, will you take the first question, and I think, Scott, if you are being asked the second question.
Sure. I think, Paul, it's actually quite variable, what might be most important for each patient and physician combination. And among the many things mentioned, for instance, in the label and the many manifestations across the systemic situation with hypoparathyroidism, any of those can be compelling. And, so I think once again, it would go along with what, what one could see in the label and from the guidelines, consensus statement guidelines.
And Paul, for your second question on guidance updates, I would refer to prior statements, even on this call, that we have an existing infrastructure through which we will commercialize the Yorvipath. So that's been in place for a while. Incremental changes to the infrastructure and/or changes to guidance will come with you on our Q2 call. But just keep in mind, we've had infrastructure in place in the U.S. ready to launch a second product for some time.
Okay, great. Thank you.
Thank you. Our next question will come from Vikram Purohit from Morgan Stanley. Your line is open.
Good morning, everyone. This is Kasper Amfort for Vikram. Congrats on the approval. Could you talk a bit more detail what the size of the field force is that will be detailing Yorvipath, and how you will be phasing in the targeting effort for the 6,000 HCPs you mentioned in the presentation? Thank you.
Yeah. So our sales force is basically, consisting of two parts, what we call direct and what we call the virtual sales force. And we are already building up the sales force now. We have hired the first part of that. So we are ensuring that we basically can be ready all the places where we want to be ready. And from my perspective is that we have shown it, how we did it with Skytrofa, where we did the same strategy, trying to address 80% of the prescribing physicians, and I think we will do the same successful way this time. We're never really discussing how many we have in our sales force. But you know, this is a rare disease, and it's typical, pretty much specialized.
I feel that it's exactly the same structure we will use here compared to what we did in Skytrofa. No surprises, I can guarantee you.
Thank you.
Thank you. And we'll take our final question from Yaron Werber from TD Cowen. Your line is open.
Great. Thanks for taking my question. I got two sort of related. Just the first one, you mentioned that you're looking to get the normal expiration date that you want on the pen. Can you discuss what that is relative to what you use in the phase 3? And then secondly, for the patients that did take BID dosing in the phase 3, what was the reason to do BID dosing? Thank you.
The first question is that initial, we will start with the 12 months expiration data. And what we often will do, and we already have established when we will do it, and that is basic, as fast as possible. We will go for 18 months, and then we go for 20 months, and then you can nearly imagine we will try to go for 36 months. And this is a typical way where you basically are building a longer and longer expiration date when you get more and more data in exactly the manner that that is required by basic regulatory agencies. And your second question? I forgot it.
Yeah. Thanks, Jan. And the few patients that did take more than one injection, presumably two injections per day in the development studies, what was the reason for that?
Typically, the reason was that, that you had a serum calcium less than 8.3. Many patients have been used to be lower than 8.3. I will say, Aimee can correct me, but I believe that the majority of patients are under 8.3 before they come into treatment. But because from the protocol perspective is that it was aiming them always to be higher than 8.3, you basically increase the dosing. Will we see the same thing happening in what I call the more real-life situation? That is a good question, and therefore it was a very, very relevant question. What is now happening in Germany now, where we have more than 250 patients in treatment, are they really moving up to a double dose?
So first of all, I just need to clarify, there was not a BID injection. It was basically just, they're used to get the right dose. They use two pens. There was not because anything else. So it was basically a two-pen system. You used to have it in this way.
Thank you. This does conclude today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.