Karyopharm Therapeutics Inc.

My name is Andrea, and I will be your conference operator today. At this time, I would like to welcome everyone to the Carrier Farm Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Elhan Webb, Senior Vice President of Investor Relations. Please go ahead.

Thank you, Andrea. And thank you all for joining us on today's conference call to discuss the Carrier Farms fourth quarter and full year 2022 financial results and recent company progress. We issued a press release this morning detailing our financial results for the fourth quarter and full year 2022. This release, along with a slide presentation that we will reference during our call today, are available on our website. For today's call, as seen on slide two, I'm joined by Richard, Sohania, Reshma, and Mike. Richard will start the call with some opening remarks, Sohania will provide a commercial update, and Reshma will provide an update on our clinical development programs. Mike will then present an overview of financial highlights from the quarter and full year 2022 and provide guidance for 2023. Richard will end with some closing remarks before we open up the call for questions. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995 as outlined on slide 3. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent 10Q form, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update them at some point in the future, We specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any later date. In addition, we will also be providing on this call an outlook for our non-GAAP R&D and SG&A expenses for 2023. We are not providing reconciliations of these forward-looking non-GAAP measures because projections of stock compensation expense which is required for such reconciliations are not available without unreasonable efforts. I will now turn the call over to Richard. Please turn to slide four.

Good morning. Thank you, Alhan, and thank you everyone for joining us today for CarioFarm's Q4 and full year 2022 earnings call. My name is Richard Paulson, President and Chief Executive Officer of CarioFarm. As you can see on slide five, Keriopharm was founded in 2008 as an innovation and patient-focused company developing first-in-class oral selective inhibitors and nuclear export, which target XPO1 to improve patient outcomes in cancer. Fast-forwarding to Keriopharm today, where we are successfully leveraging this fundamental mechanism of action to build upon our existing multi-myeloma franchise, anchored around our commercial drug Expovio, which is now approved in 40 countries and continues to move into earlier lines of therapy in multiple myeloma. With our U.S. Expovio revenue, milestone and royalty payments from our ex-U.S. partners, we have generated 157 million total revenues in 2022, meeting our guidance range for the year. For 2023, we are well positioned for our next phase of growth, where we expect to further grow our total revenue and U.S. Expovio sales, which Sohanya and Mike will go into more detail later on. We have a focused pipeline comprised of mid- and late-stage clinical development programs that can help patients who suffer from cancers with high unmet need demonstrate efficacy at lower doses with improved tolerability, and where we believe we will have the highest probability of success. We are conducting pivotal phase three studies in both multiple myeloma and endometrial cancer with a third pivotal phase three study in myelofibrosis, which we expect to start in the first half of 2023, pending regulatory feedback. Through continuing a disciplined and focused approach in advancing our pipeline and a strengthened balance sheet from our recent financing, which included participation by both existing stockholders and new investors, we have extended our cash runway through late 2025. Collectively, we believe we have the potential to achieve multiple product approvals over the next two to four years as we deliver our next phase of growth, leveraging our proven and established commercialization and mid to late stage development capabilities as we work to generate value for patients and shareholders. Turning now to slide six, let's review some key accomplishments from our four core programs in 2022 as we have made considerable progress across all programs. In multiple myeloma, despite increased competition, we grew Expovio U.S. net sales by 22% in 22 compared to 21. So Hanya will go into more details on our U.S. sales performance in multiple myeloma in a moment. In endometrial cancer, we are excited to be moving forward with a novel biomarker-driven Phase III study by leveraging the potential substantial benefit of Selenexor that we've observed in patients that are TP53 wild type. Our partnership with Foundation Medicine will enable us to develop a companion diagnostic. In myelofibrosis, we are very encouraged by the preliminary results observed from our phase one study across three relevant domains, including SVR35, TSS50, and hemoglobin stabilization. Finally, in high-risk relapsed refractory MDS, a population with a very high unmet need, we completed recruitment for the interim analysis and are looking forward to seeing the overall survival data mature in our phase two study. As we turn now to slide seven, I would like to turn the call over to Suhanya for her review of the commercial performance for the quarter and full year 2022. Suhanya?