Good day ladies and gentlemen, and welcome to the First Quarter 2018, Ascendis Pharma Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I'd now like to introduce your host for today's conference, Mr. Scott Smith, Chief Financial Officer. Sir you may begin.

Thank you, operator. Thank you everyone for joining our first quarter 2018 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 progress on our pipeline candidates and our expectations with respect to their continued progress. Statements regarding our strategic plans, our goals regarding our clinical pipeline of rare disease endocrinology programs, statements regarding the market potential of our pipeline candidates and statements regarding the planned regulatory filings. 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 to 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 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 in the Risk Factors section of our annual report on Form 20-F filed on March 28, 2018. On today's call, we will discuss our first quarter 2018 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 to Jan Mikkelsen, our President and Chief Executive Officer. Jan?

Thanks Scott and good afternoon. My introduction today will summarize the excellent progress we are making across our rare disease endocrinology pipeline. And then, I will discuss some reflection related to why TransCon PTH has the potential to be the first true PTH replacement therapy. We have now three product candidates in clinical development, all of which will have significant clinical milestones in the next 12 months. For our most advanced candidate, TransCon Growth Hormone, the Phase 3 program continues with three trials ongoing and top-line results expected for the pivotal heiGHt trial in the first quarter of 2019. Our next program, TransCon PTH has highlighted again that we can translate positive preclinical results into successful clinical data reinforcing the target product profile. Supported by this positive Phase 1 data, TransCon PTH is proceeding towards a planned Phase 3 in this agent in Q1 2019 pending discussion with regulatory agencies. Also, we recently began dosing subject for our third endocrinology candidate TransCon CNP with a goal of top-line Phase 1 results in the fourth quarter of this year. For this program, we plan to repeat what we observed in preclinical studies and show that TransCon CNP can deliver an effective therapy through continuous CNP exposure without dose limiting cardiovascular side effects and with a once weekly demonstration. With these three candidates, we have built a diversified rare disease endocrinology pipeline. We intent to further expand this franchise by label expansion beyond the three initial indications. On this call, I would like to reflect on why Ascendis is positioned to create the first true PTH replacement therapy, one that could offer patients a treatment to more fully address all aspects of the disease. Our development process start by identifying the unmet medical need. In this case, there are around 200,000 [ph]…

Thanks Jan. The first quarter has been highly productive for our pipeline and we now have three rare disease endocrinology candidates in clinical trials. We are on track with all of our clinical milestones. Let me summarize our progress starting with TransCon growth hormone. Early in the first quarter, we wrapped up recruitment of the heiGHt trial exceeding our target enrollment with final randomization of 161 subjects. The expanded enrollment further strengthens the statistical power of the trial to demonstrate non-inferiority of TransCon growth hormone to a daily growth hormone. As noted in today's press release, the observed aggregate data from the heiGHt trial continued to demonstrate a safety profile consistent with the reported safety profile of the active comparator, Genotropin. In other words, there have been no unusual safety findings to-date and our trial continues as planned. Our fliGHt trial is actively enrolling subjects and has been picking up steam. You'll recall that fliGHt evaluates TransCon growth hormone in subjects who switch from daily growth hormone providing more data on the safety and tolerability of TransCon growth hormone administered weekly as well as providing physicians real-world evidence on how to switch existing patients onto long acting growth hormone therapy. We currently have around 25 sites mainly in the U.S. nearly all of whom participated in our heiGHt trial. We are pleased with the response to fliGHt indicating interest on the part of patients and investigators to switch from daily to weekly growth hormone. fliGHt also enlarges our safety package with TransCon growth hormone. We are on track with our goal to complete enrollment of 150 subjects during the third quarter of this year. Additionally, we have been successfully rolling over the initial group of subjects from heiGHt sites to the enliGHten trial, our long-term extension study. This trial is…

Thanks Jonathan. Turning to our financial results for the three months ended March 31, 2018, let me review some highlights. For the first quarter, we reported a net loss of €41.4 million or €1.07 per basic and diluted share compared to a net loss of €25.1 million or €0.78 per basic and diluted share during the same period in 2017. The first quarter 2018 net loss included an unrealized €7 million finance expense due to foreign currency exchange rate fluctuations of our cash holdings. Research and Development costs for the first quarter were €30.5 million compared to €20.6 million during the 2017 quarter. The higher costs were primarily attributable to, for TransCon growth hormone, continued execution and expansion of our Phase 3 clinical program including the heiGHt, fliGHt and enliGHten trials in the ongoing development of the auto-injector and cost associated with our Phase 3 program clinical supply and initiation of the manufacturing of TransCon PTH validation batches. These batches are required as part of the regulatory approval process and will be recognized as R&D cost when incurred. However, they go into inventory and may be used for either clinical trial supply or upon approval for commercial sale. For TransCon PTH costs related to the Phase 1 clinical trial and activities related to Phase 3 initiation including manufacturing and device development. And for TransCon CNP costs associated with preparation of the Phase 1 trial an ongoing Phase 2 enabling activities. General and administrative expenses for the first quarter of 2018 were €4.7 million compared to €3.3 million during the first quarter of 2017. We ended the first quarter with cash and cash equivalents of €348.4 million and 41,523,765 ordinary shares outstanding, which includes the February 2018 public offering. We expected the increase in R&D cost to continue throughout the remainder of 2018 as we advance our wholly-owned internal pipeline programs and invest in the TransCon technology platform. R&D will include the TransCon growth hormone, cost associated with our Phase 3 program in manufacturing our validation batches as well as development and manufacturing of the auto-injector. For TransCon PTH, Phase 3 enabling activities including non-clinical tox, manufacturing regulatory and device development activities. And finally, for TransCon CNP, cost associated with the ongoing Phase 1 trial and Phase 2 enabling activities including non-clinical toxin manufacturing. We believe Ascendis is very well positioned with three wholly-owned rare disease endocrinology products in clinical development each representing a market opportunity greater than $1 billion. We plan to continue to create opportunities as we apply our innovative TransCon technology and algorithm across other therapeutic areas. Operator, we are now ready to take questions.

Thank you. [Operator Instructions] Our first question comes from Jessica Fye with JPMorgan. Your line is now open.

Hi. This is [Hugo] [ph] on the call for Jessica. Thank you for taking our questions. For TransCon CNP, do you think we could get insight into whether TransCon CNP would have lower rates of hypotension with the top-line data in 4Q? And then, also as we think about the potential for TransCon to expand into new therapeutic verticals, were there disease areas that lend themselves more or less to the long-acting approach?

Hi, Hugo. It's Jonathan. Thanks for the questions. Yes. I think we can very clearly establish the lack of hypotension in the Phase 1 volunteer study. We will push to relatively high doses. Notably, we've been unable to cause hypotension in our preclinical models and we fully expect that we will reproduce that finding in the Phase 1 study. So we should pretty clearly be able to demonstrate that. As far as other therapeutic indications, hypochondroplasia comes to mind but there's a whole host of other FGFR3 and R2 related disorders any one of which would lend themselves to a once-weekly therapy over a daily therapy, so scientifically there's a lot of rationale for multiple diseases.

Thank you.

Thank you. [Operator Instructions] Our next question comes from Joseph Schwartz with Leerink Partners. Your line is now open.

Great. Thanks very much. Congrats on the progress. I was wondering if you could talk a little bit more about your takeaways from the Adcom on achondroplasia. I think the panelists were asked to vote on things like the evidence required to establish a dose response, study design, and duration, and the like endpoints and things like that. I was just wondering if you could talk a little bit about those things and how they might impact your strategy, if at all.

Thanks Joe. It's Jonathan here. So we were very interested obviously in the advisory committee. I don't think there were any terrific surprises. We were really pleased that they like us are very focused on what are the clinically meaningful endpoints in this population whereas there was a lot of support for heiGHt as an endpoint that's validated and easy to measure. We certainly can do that. But we are far more interested in other meaningful endpoints such as proportionality and others maybe even radiographic endpoints. And I think there was a general interest from the panel in all of those things and it really aligns with what our thinking has been all along. It's not about just heiGHt, it's obviously about the comorbidities and making a clinically important impact in this disease and intervening as young as you possibly can because the benefits are going to accrue much, much higher, the earlier you intervene. And I think there was general support for that approach.

Okay. Great, thanks. And then, on TransCon PTH, do you think there's any way that you can improve the dosing schedule to once weekly, so that it could have a more patient friendly administration than once daily subcutaneous injections like Natpara?

Joe, this is a great question and it's something we've had a lot of thought about when we made the initial target product profile. But what we actually considered at that time was that we will prefer that daily dosing profile because at that way we can have the most optimal way to titrate each single patient to the optimal dose in the fastest possible way. We see the once weekly dosing profile as a potential way where we can go into lifecycle management and patient that now is stabilized on the right PTH concentration, potentially we would see it as a way to transfer them over to a once weekly dosing profile. But what we are addressing in this product opportunity is really what I call having a highly effective compound that really can give a true replacement therapy in this patient population, really, really addressing what I call all aspects of the disease specific element like [Technical Difficulty].

And dose ranging for Natpara was pretty challenging because there were episodes of hypoparathyroidism and hyperparathyroidism. How do you expect that to compare for TransCon PTH given the longer half-life. Is it [Technical Difficulty]?

I think Joe, the fundamental is when we see this product opportunity, it goes to back what we thought two techniques to be fulfilled in what I call in a true replacement therapy. Point one is that you need to give back to the patient the right product they're missing, which are reflecting the natural counterpart in the body. But what is also extremely important is that you give it in the right PK profile, and you only can have the right and optimal placement therapy when both of these are fulfilled. So, if for example, not enough just to give back PTH 1-84 as Natpara, you also need to ensure it's been giving back in the right PK profile that they are providing PKs always in the physiological level 24 hours a day. And therefore, I’ll say you need to combine the true element to having a true replacement therapy.

Thanks for taking my questions.

Thank you. I'm not showing any further questions at this time.

Thanks everyone for joining us on the call today. See you, bye-bye.