Ascendis Pharma A/S

Ladies and gentlemen, thank you for standing by and welcome to Ascendus Pharma first quarter 2025 earnings conference call. At this time, all participants are in the 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Scott Smith, Vice President and Chief Financial Officer. Please go ahead, sir.

Thank you so much, operator. And thank you, everyone, for joining our first quarter 2025 Financial Results Conference Call. I'm Scott Smith, Chief Financial Officer at Ascendus Pharma. Joining me on the call today are Yen Mickelson, President and Chief Executive Officer, Sherry Glass, Chief Business Officer, Jay Wu, Executive Vice President and President Ascendus US, and Amy Hsu, Chief Medical Officer. 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 Skytrofa and Yorvapath for the U.S., European, and other markets, as well as certain financial expectations, our pipeline candidates, and our expectations with respect to their continued progress and potential commercialization. Our strategic plans, partnerships, and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of regulatory decisions, expected market developments, and our exploration of market opportunities and therapeutic areas outside of endocrinology rare disease. These statements are based on information that is available to us as of today. Actual results may differ. 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 for additional information concerning the fact that actual results to differ materially. Please see our forward-looking statement section in today's press release and the risk factor section of our most recent annual report on Form 20-F filed with the SEC on February 12, 2025. Transcon Growth Hormone, or Transcon HGH, is approved in the U.S. by the FDA and in the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. Transcon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults, and the European Commission and the United Kingdom's Medicine and Healthcare Products Regulatory Agency have granted marketing authorization for Transcon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Otherwise, please note that our product candidates are investigational and not approved for commercial use. As an investigational product, the safety and effectiveness of product candidates has 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 2025 financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Yen.

Thanks, Scott. Good afternoon, everyone.