Rigel Pharmaceuticals, Inc.

conference call for the fourth quarter and full year 2023. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce you to our first speaker, Ray Fury, Ryan Willis, Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Fury. You may begin.

Welcome to our fourth quarter and year-end 2023 financial results and business update conference call. Financial press release for the fourth quarter and year-end 2023 was issued a short while ago. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. ended December 31st, 2023 on file with the SEC. Any forward looking statements are made only as of today's date, and we undertake no obligation subsequent events or circumstances. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez.

Raul? Thank you, Ray, and thank you, everyone, for joining today. Also with me today are Dave Santos, our Chief Commercial Officer, Francois DiTropani, our Senior Vice President of Medical Affairs, Joe LaSaga, our Executive Vice President in Corporate Development, and Dean Shorto, our Chief Financial Officer. We have an exciting presentation today and we will provide substantial information on Gravetto, our most recent addition to our portfolio. Because of this, this presentation would run approximately 40 to 45 minutes to be followed by Q&A. Let me begin on slide four. We are thrilled with the significant progress we made in growing our hematology and oncology business in 2023 and in the early part of 2024. We look forward to maintaining this momentum throughout the remainder of the year. Our two marketed therapies, Tavalisan ITP and ResLydia in mutant IDH1 relapse or refractory AML, saw record sales in 2023 of 104 million, a 36% growth over 2022. This is an outstanding performance for both products, and this growth can be attributed to the execution of our initiatives by our commercial and medical affairs teams, and frankly, across the entire organization. We are focused on continuing this growth to drive growth for these two important treatments. Most recently, we expanded our commercial product portfolio with the acquisition of Gavretto. An FDA-approved therapy for the treatment of red fusion positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer, Gavretta is a compelling addition to our portfolio, representing a valuable, targeted treatment option for the non-small cell lung cancer patients with red fusion positive disease. This acquisition is part of the execution of our corporate strategy, leveraging our existing commercial and medical affairs infrastructure and providing top-line growth. We will have Dave and Francois speak more about this product later on today's call. In addition to our commercial efforts, we are continuing to advance our development programs with two recent and important strategic alliances, advancing our goal of evaluating res lydia in a broad range of IDH1 mutant cancers, including AML, MDS and glioma. These alliances with MD Anderson and Connect greatly enhance our ability to further evaluate Resilidia's potential in a cost-efficient and time-efficient manner. We'll touch more on these plans later on on this call. In addition, R289, our IRAC 1 and 4 inhibitor, is advancing in a Phase 1b study of lower-risk MDS. With the growth of Tavolis and ResLydia sales and the addition of GrabVreto, which we expect to be start recognizing revenue in the third quarter of 2024, as well as our cost efficient and disciplined approach to clinical development, we are well positioned to continue growing our business and to reach financial breakeven. Now, let me give you an overview of the acquisition of GrabVreto and why we're so excited to add this product to our portfolio. to continue making this treatment available to patients in need. What makes this acquisition so compelling to us are the synergies between this product in our existing portfolio, infrastructure, and expertise. We believe we have the right people and the right systems in place to bring this product to patients and their physicians. Gavaretta is a once daily oral red inhibitor with an established foothold in the U.S. market and having generated 28 million in U.S. net product sales in 2023. Further, with patents that are issued or expected to issue with a statutory expiration date between 2036 and 2041, we're well positioned to make Gavaretta available for years to come. In exchange for U.S. rights to Gavaretta, We will pay our partner, Blueprint, a purchase price of $15 million, $10 million of which will be payable upon first commercial sale, and $5 million, which will be payable upon the first anniversary of the closing date. The deal also includes potential future regulatory and commercial milestone payments to Blueprint, as well as tiered royalties on net sales of Gabretto. We believe these are very good economics for Rigel and put us in a great position to begin recognizing product sales in the third quarter of 2024 and to begin capturing the value from this program in the near term. With that, I'll turn the call over to Dave and then Francois to talk more about Gavaretto and the opportunity it presents. Dave? Thank you, Raoul.