Welcome everyone to the Ascendis Pharma Second Quarter 2017 Financial Results Conference Call. Following some prepared remarks from the Company, we will open up the call for Q&A. I will now turn the call over to Scott Smith, Senior Vice President and Chief Financial Officer at Ascendis Pharma.

Thank you, Operator. Thank you everyone for joining our second quarter financial results conference call today. I’m Scott Smith, Chief Financial Officer of Ascendis. Joining me on today’s call are Jan Mikkelsen, President and Chief Executive Officer; and Dr. Jonathan Leff, Chief Medical Officer. Before we begin, I would 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 the Private Securities Litigation Reform Act. Examples of such statements may include but are not limited to our potential to become a leading, integrated rare disease company; our progress on our pipeline candidates; and our expectations with respect to their continued progress; statements regarding our strategic plan, our goals regarding our clinical pipeline of rare disease endocrinology program; statements regarding the plans for our Phase 3 heiGHt Trial of TransCon Growth Hormone and the fliGHt and enliGHten trials. These statements are based on information that is available to us today. Actual results or events could differ materially from those in the forward-looking statements, and we may not achieve our goals, carry out our plans or intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these statements. Our forward-looking statements do not reflect the potential impact of any in-licensing agreements, acquisitions, mergers, dispositions, joint ventures or investments that we may enter into or terminate. We assume no obligation to update these statements as circumstances change except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statements section in today’s press release and the risk factors section of our annual report on Form 20-F filed on March 22, 2017. Today, we will discuss our first quarter 2017 financial results and provide a business update. Following some prepared remarks, we will then open up the call to questions. I will now turn the call over Jan Mikkelsen, our President and Chief Executive Officer.

Thank you for joining our call today. This is a transformative period for Ascendis. During the last two years, we have been executing our Vision 2020 strategy to build a pipeline on multiple rare disease product. In keeping to our planned timelines, we are now transitioning from having a single clinical program to having two product candidates in clinical development, TransCon Growth Hormone and TransCon PTH. Early next year, we expect to initiate clinical development of our third product candidate, TransCon CNP. All of our endocrinology rare disease product candidates, TransCon Growth Hormone, TransCon PTH and TransCon CNP are designed to provide best-in-class efficacy, safety and tolerability, and address high-value market with significant unmet medical needs. For TransCon Growth Hormone, our Phase 3 program in pediatric growth hormone deficiency is well underway. We are on track to complete enrollment, as planned, of our Phase 3 heiGHt trial in the fourth quarter. We also expect to initiate the fliGHt and enliGHten trials shortly. These studies will provide additional data to support our regulatory submission for TransCon Growth Hormone. For TransCon PTH, we have completed the regulatory filing in Australia that enables us to initiate our Phase 1 trial during the third quarter, as planned. For TransCon CNP, we are preparing an IND of similar filing during the fourth quarter of this year. With this progress, we expect to have three products in clinical development by early 2018. We are advancing our pipeline and taking important steps to realize our Vision 2020 goal to become a leading integrated rare disease company with an initial focus on endocrinology. We are often asked about the competitive landscape for our pipeline. I would like to take a few minutes today to reflect on the market landscape for each of our programs. All three of these…

Thanks, Jan. I’m very pleased with the progress we are making to advance and expand our pipeline. During the second quarter, we made continued progress with our TransCon Growth Hormone program as well as our TransCon PTH program, which we expect to enter the clinic soon. We are also advancing TransCon CNP, which should enter the clinic in early 2018. We believe our pipeline will soon include three unique programs, all in the clinic, addressing unmet needs in three rare endocrine disorders. As mentioned, the pivotal program for TransCon Growth Hormone is well underway with our Phase 3 heiGHt trial, enrolling patients worldwide. A key objective of this program is to demonstrate similar safety, efficacy, and tolerability of TransCon Growth Hormone to daily human growth hormone. We believe that this is a minimum requirement for patients and physicians to use a long-acting product, as they will not be compromising the established benefits of daily therapy for a more convenient dosing regimen. The bar for efficacy has been well-established by the currently marketed daily growth hormone products, where data from registration trials consistently show first year growth of 10.5 to 12.2 centimeters at the dose of 0.21 milligrams per kilogram per week. With this in mind, we were highly encouraged by results of our randomized controlled Phase 2 trial, which suggested a dose response and height velocity that was comparable to daily growth hormone. Another key aspect of our long-acting growth hormone program is that it uses a unique technology. Prior efforts to develop long-acting growth hormone therapies have used fusion proteins, permanent PEGylation or depot formulations, none of which have resulted in a commercially successful program, despite regulatory approval. With our TransCon technology, growth hormone is transiently bound to the inert carrier via the TransCon linker molecule. Through autohydrolysis, fully…

Thank you, Jonathan. Turning to our financial results for the three months ended June 30, 2017, let me review some highlights. We ended the second quarter with cash and cash equivalents of €127.3 million and approximately 32.5 million shares outstanding. For the second quarter, we reported a net loss of €30.7 million or €0.94 per basic and diluted share compared to a loss of €13.3 million or €0.53 per basic and diluted share during the same period in 2016. Research and development costs for the second quarter were €21.9 million, compared to €13.3 million during the 2016 quarter. R&D costs in the 2017 quarter reflect greater development costs related to our ongoing global Phase 3 study of TransCon Growth Hormone including increased manufacturing cost for this product candidate, increased preclinical development and manufacturing cost for TransCon PTH and TransCon CNP reflecting further progress of those two programs towards the clinic, and increased personnel and related costs due to a higher number of employees in research and development functions. General and administrative expenses for the second quarter of 2017 were €3.2 million compared to €2.7 million during the second quarter of 2016. G&A expenses in the 2017 quarter reflect increased administrative personnel costs, partly offset by decrease in professional fees. We continue to expect our R&D cost to vary from quarter-to-quarter as we invest in and advance our wholly-owned internal pipeline programs. We expect these costs to reflect the following: Advancing and expanding our Phase 3 program for TransCon Growth Hormone including clinical supply and validation of our commercial manufacturing progress; Increased costs related to initiation of a Phase 1 clinical trial and Phase 3 enabling chronic tox, manufacturing and other activities for TransCon PTH; and ongoing preclinical development and manufacturing activities to support an IND or equivalent filing by year-end for TransCon CNP. We are pleased with our execution this year in advancing our rare disease pipeline. Looking ahead, we’re even more excited to share clinical updates with you on all three of our programs in the coming quarters. We’re focused on developing products that both directly address market needs and also establish a new standard of care. Operator, we’re now ready to take questions.

[Operator Instructions] Our first question comes from the line of Tazeen Ahmad of Bank of America. Your line is now open.

Good morning, guys. Thanks for taking my questions. Jan, can you give us a little bit of color on what you think the added information from the fliGHt study could do to help you not only collect safety data for FDA but in the commercial setting, once you launch? Secondly, can you give us an update on when you think you would be able to transition patients from the devices you’re currently using to the device that would be used for commercial launch, and then I have a question on hyperparathyroidism.

Thanks a lot for the questions. So, I think related to the first question, I’ll let Jonathan answer that and I’ll move to the next one.

Sure. So, the fliGHt trial will greatly increase our safety database. This will increase our numbers to as many as 300 subjects with at least six months of exposure, which is quite a lot, and that’s even approaching ICH numbers, which is meant for guidance for much larger populations. Also importantly, the fliGHt trial will investigate children as young as six months of age. So, we were encouraged to go down to six months, even younger, by FDA. So that age range is not covered in the heiGHt trial and that will also be very valuable. So, we’ll really have a broad view of a broad bunch of patients, worth of safety exposure with fliGHt.

Related to the device, we still think that the device is an extensive integrated part of having an optimal product opportunity in the growth hormone market. And therefore, we want to have as many as possible, patient exposure on our device. Therefore, in the extension study, we will be ready to transfer the patients over to our device and that will happen sometime in next year. The device in acceleration where we have made and actually have produced all the device now. We are integrating the cartridge into the device, so we -- and all the double packing and single packing to be sure that we have the optimal way to give the patient our TransCon Growth Hormone drug.

Okay. And then just on follow-up. Is it possible then that your label would allow for use of TransCon in babies as young as six months, should the study be successful?

Sure. Typically you get what you study. So, if we studied six months of age and above, and it’s safe and efficacious, then we would presumably get that in our label.

Okay, thanks. And then, on hyperparathyroidism, before Natpara launched, I think there was a view that there wasn’t as much awareness of the condition and therefore perhaps patients were being properly identified. But in the couple of years, since that drug has launched, have you guys been able to get any market data on whether or not awareness of that condition has increased, and whether or not patients who are diagnosed, may not yet be choosing to take therapy, and just to get a sense of what the untapped population might be?

So, patients who have hyperparathyroidism, it’s usually not a very subtle disease. I mean, it is extremely symptomatic from the hypocalcemia, the very painful muscle spasms all throughout the body. These are very educated patients. They often even know their levels of urinary calcium. And they usually become stockpiled in physicians’ practices because the onset of the disease is very clearly known, it’s usually the time of surgery and within hours or a day after surgery their hypocalcemia becomes uncomfortably evident. So, we think there is very good awareness and we think when physicians understand the product profile, there will be a very deep penetration into that marketplace.

And so, what’s your view of what the addressable population in the U.S. is?

75,000, I believe patients of all types in U.S. and roughly maybe one-third of those have severe disease which would certainly be terrific candidates; but even working into the moderate range, I think that will happen overtime as well.

I believe our end goal will be all patients that is missing it should have the opportunity get the true replacement therapy for what we really have in the disease. So, sure, we will focus on what we call the severe, moderate in the beginning. But I think and believe, the vision will be that all patients should have the opportunity to have such an important treatment.

Thank you. Our next question comes from the line of Jessica Fye of JP Morgan. Your line is now open.

I wanted to ask about the competitive landscape, if that’s okay. I guess, heading into the -- for service, top-line data for their pediatric growth hormone study, what would you be watching in that top-line readout, recognizing that we may not get the full details with that update? But, what are you looking for in that?

Thank you for this question and it’s certainly a question that we have been asked multiple, multiple time in the last months. And what I would like to do, go through the more holistic view and take it into the growth hormone market. The growth hormone market in pediatric growth hormone deficiency is extremely well penetrated with daily growth hormone. So, who is really taking out the benchmark for how you need to compete against this daily growth hormone. And if you take the parameter that is important, shown to be important in the market, has never been who is first in the market but what is really the characteristic of the product. So, daily growth hormone has established a really clear benchmark related to efficacy, safety, tolerability and other product features. And when you go through efficacy, from another product, I will like everyone to compare the efficacy to what there is in daily growth hormone. Can you receive the same effect on growth velocity, can you get the same effect on all tissue, like fat tissue with indirect [indiscernible] BMI. So, you will expect that when you go for safety, you will look about another long-acting product, how to that really turn into safety related to daily growth hormone. Do you see other unexpected adverse events, do you see an immunogenic potential that is different compared to daily growth hormone, do you see anything of having neutralizing antibodies? When you go through tolerability, I basically believe that the standard that has been set out with daily growth hormone is a pain-free injection and it’s only happened because you have small volume, you have a small needle and high level biocompatibility. And then there is obviously some product features like having and easy to use device, having room temperature stability. All of that is integrated part of driving adherence. So, I believe and I think really that you need to be having a competitive story related to all these different elements. And I personally don’t believe that you can compromise efficacy, safety or tolerability. And if you really want to build a market product, you need to have optimal product features. So therefore, compare all long-acting growth hormones to what has been established with daily growth hormone and then you really can just yourself, are there really any kind of reasons that you will actually compromise efficacy, safety or tolerability.

Okay. I guess, what about this argument that the bar is lower than whatever daily growth hormone will show in a clinical study because real world compliance isn’t as great as in the clinical studies with daily growth hormone? How do we think about that argument that the real bar isn’t as high as what daily will show in a clinical study?

I believe, if I was sitting as a physician in front of a patient, I always have the strong belief that my patient will be in compliance. What I prescribe and treatment regime to this patient that gives less efficacy, less safety, less tolerability because I always have this assumption my patient will be adherent. So, upfront, would I take them into a group that I take the efficacy, safety that we have optimized for at least 15, 20 years down to what we have in the 2018, 2019, I don’t believe that. So therefore, I have no belief there can be any kind of compromise related to efficacy, safety because you need to take it on the patient basis. So, it basically will take the 20% today that is 100% compliant will suddenly get less effective treatment. I have never seen that being implemented anyway in any system.

Thank you. Our next question comes from line of Alethia Young of Credit Suisse. Your line is now open.

Hey, guys. Thanks for taking my question. I guess, maybe talk a little bit about for the heiGHt trial, like how the process has been with enrollment, and like has anything kind of come as a surprise? I also just have a hypothetical question. I mean, if you treat someone earlier with growth hormones, should you expect faster growth velocity as well? I guess, some of the basis for that question is thinking about as you treat younger and some of the very -- distribution of age of the study as well. Thanks.

I’ll take that, Alethia. Thanks for the question. So, enrollment is going very well. We’re enrolling all over the world. There is a lot of enthusiasm with our investigators. So, there is no particular issues anywhere. People really are engaged with the technology. And the more they learn about it, the more intrigued they are with the technology and more interested in heiGHt and our other trials. In terms of age, the age is a predictor of growth. So, the younger you start therapy, the more you tend to get better growth. There are other predictors as well as smaller height. The shorter you are, the more you grow; lower the IGF-1 levels at diagnosis but more you grow; the lower your skin testing results, the more you grow. So, age is an important one. And of course the earlier you start, the better chance you have of attaining your midparental height or your maximal potential height.

And also, just as a follow-up to that before I go PTH. Is there a lot of overlap between sites, Versartis and you guys or, is it kind of separate?

There is a reasonable amount of overlap. As you might expect, there is certain number of expert sites around the world. Certainly, we’re heavily investigating in patients in the U.S.; that’s where most of the Versartis sites are. But we have a very large program outside the U.S. and Versartis I believe has relatively few sites outside the U.S. So, overall, there is pretty small overlap of sites, if you think of it globally.

Okay. And then on PTH, did you guys say how many people you actually expect on a number basis? And do you have any kind of theory on how long it might take to enroll, like this bigger population?

So, In Phase 1, these are healthy volunteers, so we’re literally lining them up. I mean, you get a cohort of 10 that come in on a given day and they stay in the unit overnight and for many nights, then you literally just go right down the line from bed to bed to bed injecting them all. In all, we’ll probably have over 100 subjects in Phase 1, but it depends on how far we go into the cohorts and how high the dose we go in the SAD and the MAD cohorts. But it will very likely be over 100 patients. So, this will be a substantial experience to define the safety and pharmacodynamic effects in healthy volunteers which will be very informative for Phase 3 transition.

And then, where are you conducting the study?

In Australia.

Okay, great. Thanks.

Thank you. Our next question comes from the line of Jim Birchenough of Wells Fargo. Your line is now open.

Hi, guys, thanks for taking the questions and congrats on all the progress. Just on the fliGHt study, and how we should think about that as a gating factor to your filing timelines. Can you remind us of the filing timelines for TransCon Growth Hormone? And then, separately, just on that fliGHt study, how do we think about the efficacy part of it, given that you’re going to be switching patients at different points in their growth phase and maybe growing earlier as well, what should be the expectations? Should we look at each individual patient and expect their prior growth trajectory to continue? Just trying to get a sense of how to think about efficacy in that study and then impact on timeline?

Sure. So, the fliGHt trial is obviously starting after the heiGHt trial. But on the other hand, it should recruit very quickly. So, this is a trial of taking patients who are already on growth hormone, they’ve already been diagnosed, relatively loose inclusion criteria, because this is a safety study. So, it will enroll quickly. It should actually enroll and finish at about the same time as the heiGHt trial. So, it will not extend any timelines. As far as filing timelines, we’ve not disclosed those as of yet, we will at some point. But we don’t anticipate that the fliGHt trial, adding that into our program will delay any filing timelines at all. It will go very quickly and we’ll share progress next year as we progress. In terms of efficacy, the fliGHt trial, as you know is really clearly a safety trial as a primary objective of the study. That said, there will be some efficacy readouts, but it will be very challenging to draw definitive conclusions. There will be patients who have been on growth hormone for varying periods of time, who have been on various products, who have varying levels of pre-study compliance rates. So, we will look at all of that and we will make our best cut of patients who have been on therapy, maybe for zero to three months or three to six months, or six to nine months. So, we will generate some efficacy data. But, I wouldn’t anticipate a lot of very clear unambiguous efficacy data. That data will come from the heiGHt trial.

Great. And then, maybe just going back to the upcoming Versartis data. When you think about some of the clinical features you highlighted, how do we think about their ability to titrate further versus yours, your device versus what you understand of theirs, your volume versus theirs, your needle gauge versus theirs, things like injection site pain? Can you remind us how we should think about those things side by side in advance of getting the data?

It’s certainly a great question, Jim. It was an element that we actually integrated early stage in our product profile, because it’s pretty well known that pain of an injection are driven by the following three elements, the volume of injection; the needle size; and sure the biocompatibility of a material new injection. And the knowledge is that if you want to have what we call not a high comfort or just as a nearly a pain-free injection on pediatric setting, you need to be down on the 0.5 to 0.6 milliliter for an injection. So, basic, if you wanted to have an attractive product with optimal adherence building up, you need to have this pain-free injection. So, therefore we went in and said that we needed to be quite sure to have a product opportunities where we can dose all the patients from 20 kilo up to 60 kilo and also less than 20 kilo now because we are enrolling children down to six months, with a very, very small volume. And this is why we define that we never want to have higher than 0.6 milliliter, which are giving out to children with 60 kilo. Related to uptitrating, I actually think this is a great question, because all of the Phase 3 trials that is run currently including our trial, including Versartis trial, they are actually using a daily growth hormone of 0.24 milligram per kilo per week, which are actually less than what you could say that typical dose that is used in a U.S. setting. So, even if you get, what I call, the same numeric growth velocity on the lower 0.24 milligram, you still need to show that you have the possibility to increase that. And I personally get little bit worried, I see some of the other products where they don’t have the opportunity really to increase the dose either because the volume is always extremely large related to more than 0.5 milliliter but also you can see that they have hit some kind of saturation level on the IGF-I level. Meaning that if you are already in the current setting in the Phase 3, it has uptitrated upto the top level of accessible IGF-I, you basically have no possibility to increase the dose, and that is basic what we have seen for some of the other products. So, it’s a great question.

And then, just one final question on PTH, and I think we’re all trying to understand the same thing. If you got 25,000 patients with severe disease and the reasonably identifiable and they have got a great morbidity of disease, why aren’t they getting Natpara or is it the case that they’re getting Natpara but the product features are not sufficient to keep them on the drug? I guess, I’m trying to understand what’s going on with those patients and why aren’t they being treated right now because one would think Natpara would be bigger drug if they were being treated.

Great question. When we see Natpara, it’s not really addressing the fundamental effect of the disease. It has no effect on urinary calcium, which are one of the important parts that executes the long-term morbidities related to renal damage; it is not really a major effect on hypo and hypercalcaemia because you need still to titrate them down to the lower level of the normal calcium level. So, basic, when I take the Natpara product, I believe still it is impressive, if that can hit the projected market potential, when I look on the shortcoming of this product opportunity. So, I think this is more indication there is a huge medical need out in this area for this patient group that you can take such a non-superior product and still place it into the market.

Thank you. And our next question comes from the line of Joseph Schwartz of Leerink Partners.

Thanks very much. A lot of my questions have been answered, but I was curious if you could talk a little bit more about the commercial implications of different clinical outcomes for the long-acting growth hormones? In particular, how much of the growth hormone market do you think that the long-acting growth hormone treatments such as yours and the competitors can garner? And how is that long-acting growth hormone market share driven by safety and efficacy profiles that could emerge? Is it everything but the generic shares that we see today that you think is up for grabs, are there any parts and pieces of the market that might be more challenging to garner?

Thanks Joe for the question. Let me see if I get all aspect of your question. If I don’t get that, please come back. So, what we have done, we have done a lot of, what I call, financing modeling related to penetration in the growth hormone market. We have done a lot of modeling about the competitive landscape, what is really needed to take market share from daily growth hormone product opportunities. And this is widely -- coming pretty much firm about if you really want to be a market leader, really want to take sustainable market share that you cannot compromise with the efficacy, safety and tolerability. And really to be a market winner, move up to for example 40%, 50% market share, you need to have optimal product feature like an easy to use device, room temperature stability, all this built into the product opportunities. And this is what we have integrated in the market potential. So, for us, it’s really always to have a competitive product profile related daily growth hormone, because this is where the market share is, where we need to take the market from. So, my basic answer to this is that in our intention model, if we feel that we can take a sustainable large portion of the market by our long-acting growth hormone, if we not compromise efficacy, safety and tolerability, and if we build up the optimal product features, we believe that the potential can be the market leader in this area. And this is where we are focused on today, and this is why we’re so tight on ensuring that we could show that in all our clinical trials to be convincing not only physician but also we can convince patients, parents that really are giving the safe, optimal attitude that have in daily growth hormone together with an easy to remember, weekly administration treatments.

Thank you. And those are the questions we have for today. Ladies and gentlemen, that does conclude today’s program. You may all disconnect. Everyone, have a great day.