Gavin Clark-Gartner: Great, thank you.
Operator: Kelly Shi with Jefferies, your line is open.
Kelly Shi: Thank you for taking my questions. SKYTROFA, could you provide your perspective into the competitive landscape, given that two other long-acting growth hormone commercial products are there and one of them, if we check on the scripts, actually approaching schedule for — on both TRx and Rx? And also, like are you curious like whether your launch strategy remain the same?
Jan Mikkelsen: So, one of the complication, at least I always have, is to utilizing the different databases you can get to get scripts. In this case, you can use this kind of datasets is to look on trends, but never absolute levels because the sampling is really different between different provider. So, you are only sampling a small amount of the prescribing base of where you get the information from. So, out from that perspective, you cannot really compare the absolute level. You cannot compare also because when we talk about the unit, the unit is really different between the different products. So, some unit is giving — providing you that. So therefore, if you really want to get a really effective and most solid data, you need to take each single company, go into the line item and look on the revenue basis. This is where I get the best confirmation about data and how we see their progression. And there is no doubt when we look on that.
Kelly Shi: Thank you…
Jan Mikkelsen: For the growth hormone market, it was a very difficult Q1. And what we saw really have seen how we were the only one of the reported data really have growing, where everyone had declined, which you typically will see in the first quarter.
Kelly Shi: Thank you.
Operator: Thank you. Our next question comes from Derek Archila with Wells Fargo. Your line is open.
Derek Archila: Hey, thanks for taking the questions. Congrats on the progress. So, we have a question on the OpEx progression this year. I guess based on the 1Q OpEx, it seems like you might come in a fair bit below the €600 million guidance. So just, any color there on how we should be thinking about that? Thanks.
Jan Mikkelsen: I think Scott is so happy today because he’s really getting a good question.
Scott Smith: Yeah, Derek, thanks for the question. We’ve been pretty — yeah, no, we’re pretty proud of the our ability to basically reduce OpEx pretty significantly while growing — doubling revenue. It’s not a bad thought, but as of now, our guidance remains $600 million OpEx for the full year based on current plans.
Operator: Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Good afternoon, and thank you for taking my question. And also let me offer my congratulations on the progress. I want to turn maybe to CNP for a moment. And if you could maybe sort of comment on what your market research ahead of your top line results later this year, such as in terms of how endocrinologists might be thinking about using TransCon CNP, either as new patient starts, or do you possibly anticipate switches from VOXZOGO, just given the different dosing frequency and how you’re thinking about what those kind of shares might look like in terms of the launch? And then, could you maybe comment on what your sort of post approval requirements might potentially look like for TransCon CNP, pending an approval down the road from the FDA? Thank you.
Jan Mikkelsen: It’s really extremely interesting question from the perspective on when we’re looking on all the research we have done, because the key topic and the key feedback we’re getting in all interaction with physician, caregivers, patients is addressing comorbidities. Being short is not a disease, but really to have the sign of comorbidities is really providing really the impact on having achondroplasia. And this is why we have so much strong focus really to address the comorbidity and also sure to address also linear growth, but the key objective of our program is to do address the comorbidities. We cannot avoid a primary efficacy endpoint is linear growth because it has been established from regulatory agencies, both in US and Europe.
And it’s really, really difficult to change that. If we have been the first, it will not have been linear growth, it will be addressing comorbidity as the fundamental of the disease. And this is how our integrated program has really been built up to show that in all our programs, and I think where we both addressed the linear growth, but also muscle weakness and other things like that. And when I see how we can already get the feeling about what it means for the patient is when we look on the quality of life questions that we are giving to both patient and caregivers, how they really are addressing the benefit of our treatment. And we also see that in our retentions. When we see the retention and our recruitment, we recruited our pivotal trial in less than four months.
On site, we have — vosoritide had [accepted] (ph) other treatment, it got recruited in four months. I’ve never seen that before. And this is because the physician could talk to the parents about the benefit they have seen basically on providing our TransCon CNP product to them. Related to commitment afterwards, we have no comments or anything we have received from regulatory agencies in all the different places we have been and discussed the pathway for regulatory approval to any kind of commitment.
Paul Choi: Thank you.
Operator: Thank you. Our next question comes from Vikram Purohit with Morgan Stanley. Your line is open.
Vikram Purohit: Hi. Thanks for taking our questions. We just had one on the pipeline. So a few months ago, you discussed with us a novel TransCon carrier platform and you cited your work here with semaglutide through a case study. I just wanted to see how your internal work with this novel platform and the GLP-1 program is progressing? And what the next milestones could be here that we could learn about? Thanks.
Jan Mikkelsen: We are extremely as excited about this lead candidate that we were for when we came out. There’s no doubt that once the treatment regime is the way to go, and we’re building up the same fundamentals that we built up all our pipeline. I call it a pipeline because we basically are not taking the target engagement risk that you typically have when you make highly differentiated products because we’re building through TransCon technology on semaglutide molecule that basically had the broadest way to show clinical benefit everywhere. We are progressing with that. At the same time, we also have an intense discussion about how we basically are doing the best value proposition of this compound and this area of metabolic diseases because we’re talking about metabolic diseases and we will keep you updated as soon as we someway have made a decision what way we’re going.
Operator: Thank you. Our next question comes from Yaron Werber with TD Cowen. Your line is open.
Unidentified Analyst: Hey, guys. This is [Joyce] (ph) on for Yaron. Thanks for taking our question. In the US, can you talk about your planned launch strategy for TransCon PTH in terms of the initial target population and prescriber base? And how much of it will marry your strategy in Germany, where you’re initially targeting roughly one-third of the total population? Thank you.
Jan Mikkelsen: I think what we’re doing now is to really integrating the learning from the first country where you’re launching a product. And the first country we launched is in Germany, Austria, and we’re getting a lot of good learning. I have to say, we basically got confirmation about how we should do it because we basically have seen everything what we have hoped for in this launch. So it’s not like we’re coming on with a complete different strategy. We are more proud about the commercial execution from our people in this region, how we basically made it exactly after what I call the playbook. So when I come to the playbook of US, there is always Hartvig, our — Camilla, that is our Head of our Global Commercial Operation.
She is coordinating everything from US, coordinating into International Market, coordinating into EU Direct, every place to be sure that we’re building up the right strategic approach for basically have the optimal commercial launch on a global base. We will be here and we basically have seen really the huge interest. I can say we have the first commercial US product or person on commercial product for YORVIPATH. There’s a person living in US that took the consequence on the delay in the US to basically fly to Germany and get the product out there. So we know it, we see it, we know YORVIPATH making really a huge difference for the patients really get them their life back and we really have seen how patients also see this benefit.
Unidentified Analyst: Thank you.
Operator: Thank you. Our next question comes from Leland Gershell with Oppenheimer. Your line is open.
Leland Gershell: Hey, good afternoon. Thanks for taking our questions. Two from us. First, Jan, if you could just comment on the plan for rolling out YORVIPATH in Great Britain following the approval? Is that something you’re doing immediately or will there be any delay? And secondly, in the past, you had mentioned hypochondroplasia is a indication that you were — you’ve decided to not pursue. Just wondering if that outlook might change following the data from the achondro Phase 3 that you’ll be seeing later this year and/or any information that may be coming out from the companies that are pursuing achondroplasia? Thank you.
