5/7/2026

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to the first quarter Ascendance Pharma earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 101 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, Please press star 1-1 again. Please revise that today's conference is being recorded. I'd like to hand the conference over to your first speaker today, Chad Fugere, Vice President of Investment Relations. Please go ahead.

speaker
Chad Fugere
Vice President of Investment Relations

Thank you, Operator, and thank you, everyone, for joining our first quarter 2026 Financial Results Conference call. I'm Chad Fugere, Vice President of Investment Relations at Ascendus Pharma. Joining me on the call today are Ian Mickelson, President and Chief Executive Officer, Scott Smith, Chief Financial Officer, Sherry Glass, Chief Business Officer, and Jay Wu, EVP and President, U.S. Market. 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 the Private Securities Litigation Reform Act. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of URBPath, UBWell, and SkyTropa, as well as certain expectations regarding patient access and financial our strategic plans, partnerships and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing planned regulatory filings, and our expectations regarding timing and the result regulatory decisions. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements. You should not place undue reliance on the statements. We assume no obligation to update these statements if circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see our forward-looking statements section in today's press release and the risk factors section of our most recent annual report on Form 20F, filed with the SEC on February 11, 2026. Transcon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults in the European Commission, in the United Kingdom's Medicines and Healthcare Products Regulatory Agency have granted marketing authorization for Transcon TTH as a replacement therapy indicator for the treatment of adults with chronic hypoparathyroidism. Transcon TMP is approved in the U.S. by the FDA for the treatment of achondroplasia in children aged two years and older. Continued approval for this indication, which is based on an improvement in annualized growth velocity, may be contingent upon verification of description of clinical benefit and confirmatory trials. Transcon HGH is approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, in addition to the treatment of pediatric growth hormone deficiency. And the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our first quarter 2026 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for your questions.

speaker
Sherry Glass
Chief Business Officer

With that, let me turn it over to Yen. Thanks, Chad.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-