Karyopharm Therapeutics Inc.

Good morning. My name is Ryan, and I will be your conference operator today. At this time, I would like to welcome everyone to the CarioPharm Therapeutics First Quarter 2023 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 Elan Webb, Senior Vice President, Investor Relations. Thank you. Over to you.

Thank you, operator. And thank you all for joining us on today's conference call to discuss Carrier Farms' first quarter 2023 financial results and recent company progress. We issued a press release this morning detailing our financial results for the first quarter 2023. 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, who will provide an update on our Key 1 results and recent clinical developments. 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 three. Actual results may differ materially from those indicated by these forward-looking statements, FLS, as a result of various important factors, including those discussed in the risk factors section of our most recent Form 10-K, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any FLS represent our views as of today only. While we may elect to update this FLS 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 this FLS as representing our views as of any later date. I will now turn the call over to Richard. Please turn to slide four.

Thank you, Alhen, and thank you all for joining us today for CarioFarm's Q1 2023 earnings call. As we turn to slide five, we are making strong progress as we execute on KarioPharm's next stage of growth by deploying our novel mechanism of action, selective inhibition of nuclear export, to expand our existing multi-myeloma franchise, currently centered around our commercial drug, Expovio, which is now approved in over 40 countries and continues to move into earlier lines of therapy in multiple myeloma. As Sohanya will discuss further, year over year, total demand for Expovio continues to grow. However, this is not translating into growth in net product revenue due to increased distribution of free product through our carry forward patient assistance program, PAP, and higher gross to net discounts. These factors have caused us to revise our total revenue guidance for 2023 to a new range of 145 to 160 million. In addition, we have accelerated our closure of non-priority programs, thus lowering our spend in 2023, and we are maintaining our guidance for cash runway through late 2025. We believe the factors resulting in the significant increased use of our PAP programs are expected to be mostly limited to 2023, and while we are not specifically commenting on our revenue expectations for 2024, we believe we will see a decreased impact of this challenge next year, given the IRA-related Medicare Part D redesign. We have a focused pipeline and are rapidly advancing our 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'll 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 of myofibrosis which we expect to start in the first half of 2023. 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. As we look at our first quarter highlights on slide six, we achieved $28.3 million in Expovio next product revenue for the quarter, which is consistent with the first quarter last year. Total demand for Expovio grew year over year in a very competitive multi-myeloma marketplace, and we are encouraged by the continued growth in the community setting. Shifting to sell an ex-source position internationally, Our continued global expansion provides further opportunities to treat patients in need, with the additions of new licensed territories with Menorini in the Middle East and Africa, as well as full marketing authorization for Nexpovio in the UK, broadening our international footprint. We continue to advance a streamlined clinical pipeline focused on our four core programs, I want to highlight our recent data presented at AACR in treatment-naive myelofibrosis, where Selanexor 60 milligram in combination with ruxolitinib demonstrated rapid, deep, and sustained spleen response. Based on this, we are planning to initiate a pivotal phase three study this quarter, as we believe Selanexor 60 milligram plus ruxolitinib has the potential to transform standard of care for frontline myelofibrosis. Additionally, earlier this week we announced encouraging interim efficacy data from the phase two study of Eltenexor, our second novel sign compound, in 30 patients with hard to treat, higher risk, relapsed, or refractory MDS, which Reshma will discuss. With that, I would now like to turn the call over to Sahanya on slide seven for her review of the commercial performance for the quarter and perspectives on our updated guidance for 2023. So, Anya?