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8/2/2023
Good morning. My name is Jason, and I will be your conference operator today. At this time, I would like to welcome everyone to the CarioPharm Therapeutics second 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 Ellen Webb, Senior Vice President of Investor Relations.
Thank you, operator. And thank you all for joining us on today's conference call to discuss Carefarm's second quarter 2023 financial results and recent company progress. We issued a press release this morning detailing our financial results for the second 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, Reshma, Sohani, and Mike, who will provide an update on our results for the second quarter and recent clinical developments. Before we begin our formal comments, I'll remind you that various remarks we'll make today constitute forward-looking statements for the 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 10Q, 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 these FLS at some point in the future, we specifically disclaim any obligations to do so, even if our views change. Therefore, you should not rely on these 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, Elhan. Good morning, everyone, and thank you for joining CarioFarm's second quarter 2023 earnings call. Turning to slide five, we had a strong second quarter as we accelerate KaryoPharm to its next stage of growth with our novel sign compounds, Selinexor and Eltenexor. As Raishma will discuss further, we are advancing a focused clinical pipeline with three ongoing phase three pivotal studies based upon a strong foundation of supportive data, a recently obtained fast track designation of myelofibrosis, and a set of pivotal catalysts over the next two years. With our current approved multiple myeloma indication in the U.S. with Selinexor, we continue to expand and shift into earlier lines. As Sohanya will discuss further, year-over-year total demand for Expovio continues to grow in a competitive multiple myeloma marketplace. Selinexor is also expanding its global footprint with approvals in various indications in approximately 40 countries outside of the US, providing us with a growing stream of payments from royalties and milestones from our partners as launches move forward globally. As part of our continued prioritization of our late stage clinical pipeline, we have taken additional actions to streamline our operations and optimize our cost structure. As a result, We have reduced our workforce by approximately 20%, which is expected to enhance our financial strength, provide us with the capital needed to deliver on our three phase three studies, and maximize value for our shareholders. This was an extremely difficult decision given the direct impact this has on our employees. However, after careful consideration, this action was imperative in order to further focus the organization on the near-term opportunities ahead of us. I am sincerely grateful for the tireless work and commitment of all colleagues who are being impacted and to the colleagues that will enable CarioFarm's success moving forward. As we move to slide six, presented here is an overview of the timing of the upcoming key data readouts, which we expect in 2024 and 2025. Each of our ongoing phase three clinical trials, if successful, represents an incredibly meaningful growth opportunity for our organization with the potential to deliver roughly $2 billion in annual peak revenues. Starting with multiple myeloma, a successful phase three trial with SPD anticipated in the second half of next year would accelerate Selinexort into the second line treatment and enable continued growth in multiple myeloma. In endometrial cancer, we believe Selinexor has the potential to transform the treatment paradigm for TP53 wild-type endometrial cancer patients, given the unprecedented data, which was presented at the virtual ASCO plenary series last week, of which Reshma will speak to momentarily. Finally, in myelofibrosis, we recently announced the initiation of our pivotal phase three with the potential to transform the frontline treatment for patients with myelofibrosis as we build upon the rapid, deep, and sustained responses we have seen thus far. 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 late stage development capabilities. Shifting to Cell and XOR's position internationally on slide seven, our continued global expansion with our partners provides further opportunities to treat patients in need with Cell and XOR as our partners continue to commercialize and launch in additional global territories. Our license agreements with our partners provides us with a steady stream of revenues through growing double digit future royalties and potential development and sales milestone payments of up to 400 million. Moving to slide eight, I would now like to turn the call over to Reshma to expand further on our clinical pipeline progress. Reshma.
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