Ascendis Pharma A/S

Good day and welcome to the Q1 2024 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, please press star 1-1. We ask that you please limit yourselves to one question and a follow-up. As a reminder, this call may be recorded. I would now like to turn the call over to Tim Lee, Senior Director, Investor Relations, Ascendance Pharma. Please go ahead.

Thank you, operator, and thank you, everyone, for joining our first quarter 2024 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendus Pharma. Joining me on the call today are Yen Mickelson, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Sina Singhal, Executive Vice President of Clinical Development Oncology, and Joe Kelly, U.S. General Manager. Before we begin, I'd like to remind you that this conference call will contain four linking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statement may include, but are not limited to statements regarding our commercialization and continued development of Skytropha for the US and European markets, as well as certain financial expectations for 2024, our commercialization and development of your path in the EU and expected timing of the FDA review and potential launch of TransCon PTH in the US, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, our ongoing and planned regulatory filings, and our expectations regarding the timing and the results of regulatory decisions our ability to create value in multiple therapeutic areas outside of endocrinology rare disease, and our progress towards Vision 2030. These statements are based on information that is available to us today. Actual results may differ, could differ materially from those in our four linking statements, and you should not place undue reliance on these statements. We assume no obligation to up these statements as circumstantial change, except as required by law. For additional information concerning the factors that can cause actual results to differ materially, please see our forward linking statement 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 7, 2024. Transcon Growth Hormone, or Transcon HGH, is approved in the U.S. by FDA and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. The European Commission and the United Kingdom Medicines and Healthcare Product Regulatory Agency have granted marking authorization for Transcon PTH as 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 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 2024 financial results and we'll provide further business updates. Following some prepared remarks, we'll open the call up for questions. With our PDUFA date for Transcon PTH coming up in less than two weeks, we will not comment on our ongoing discussions with FDA, and we will not be taking any questions on this topic today. With that, let me turn it over again.

Thank you, Tim. Good afternoon, everyone.