Ascendis Pharma A/S

Thank you for standing by and welcome to the Q1 2023 Ascender's Farmer Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentations, there'll be a question and answer session. To ask a question at that time, please press star 11 on your telephone. As a reminder, today's call is being recorded. I will now turn the call over to your host, Mr. Tim Lee, Senior Director of Investor Relations. Please go ahead.

Thank you, operator, and thank you, everyone, for joining our first quarter 2023 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendus Pharma. Joining me on the call today is Yen Mickelson, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Steena Singhal, Executive Vice President and Head of Clinical Development Oncology, and Joe Kelly, Senior Vice President and Head of Commercial Endocrinology. 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 hardware provided by the Private Securities Litigation Reform Act. Examples of such statement may include but are not limited to our U.S. commercialization and continued development of Skytropha for the U.S. market, our revenue projections for Skytropha, the commercialization of Transcon HGH for the EU market, Statements regarding the expected timing of potential approval and launch of Transcon PTH in the US market. Statements regarding the expected timing of the potential approval of Transcon PTH in Europe. Statements regarding the potential market size for Transcon PTH. 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, including the timing of clinical results, statements regarding our pipeline product candidates, statements regarding our ongoing and planned regulatory filings and our expectations regarding the timing of the results of regulatory decisions, our expansion into new therapeutic areas, and statements regarding our ability to create a sustainable, profitable, leading global biopharma company. These statements are based on information that is available to us today. Actual results and events could differ materially from those in our forward-looking statements, and we may not be able to achieve our goals, carry out our plans, our intentions, our expectations, or our 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 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 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 February 16th, 2023. Transcon Human Growth Hormone, or Transcon HGH, is approved by the FDA in the U.S. under the brand name Skytropha for the treatment of pediatric patients one year and older weighing at least 11.5 kilograms and having growth failure due to inadequate secretion of endogenous growth hormone. In addition, the European Commission has granted a marketing authorization for Skytropha Two ascendant pharma developed under the name Transcon HGH as a once-weekly subcutaneous injection for the treatment of children and adolescents aged 3 to 18 for growth failure due to insufficient secretion of endogenous growth hormone. In general, we refer to this product as Transcon growth hormone unless referring to the product in the context of particular jurisdictions such as the United States or the European Union. Otherwise, please note that our product candidates are investigational and are not approved for commercial use. As investigational products, the safety and effectiveness of the product candidates have not been reviewed or approved by any regulatory agency. None of the statements made on the conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our first quarter 2023 financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. I'll now turn the call over to Jan Mikkelsen, President and Chief Executive Officer. Jan, to you.

Thank you. Good afternoon, everyone.