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2/4/2025
Greetings and welcome to Rigel Pharmaceutical's financial conference call for the fourth quarter and full year 2024. 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 our first speaker, Ray Fury, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Fury. You may begin.
Welcome to our fourth quarter and full year 2024 financial results and business update conference call. The financial press release for the fourth quarter and full year 2024 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of our investor 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. A description of these risks can be found on our most recent annual report on Form 10-K for the year ended December 31st, 2024, on file with the SEC. Any forward-looking statements are made as of today's date only, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I'd 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, Lisa Royker, our Chief Medical Officer, and Dean Shornow, our Chief Financial Officer. Beginning on slide four, we will provide an overview of Rigel's business and our numerous accomplishments in 2024. For those that are new to the company, let me take a moment to review Rigel's overall corporate strategy to grow our hematology and oncology business. Our strategy is focused on three main goals. First, expand our commercial portfolio and increasing product sales. Second, advancing and growing our pipeline through internal development and strategic collaborations. And third, maintaining financial discipline. 2024 was a transformational year for Rigel. As we delivered on all three of these goals, I will take you through each of these accomplishments in more detail. In 2024, we set another record year of sales. As a result of our effective commercial execution, we reached our highest commercial portfolio sales ever at 145 million, 39% growth over 2023. This significant revenue growth was driven by the strength of Tavalise and ResLadia sales and the addition of Gavretto, our third product, and our second in-license product, which contributed $17.1 million in net product sales since we added it to our portfolio in June. We also generated revenues from our partners where Tavalise is commercially available, and our partners continue to make progress towards expanding Tavalise access in other geographies. Recently, Knight and Kisei announced regulatory approvals for Tavalis in two new countries, Mexico and the Republic of Korea, respectively. Once commercially launched, ITP patients in these countries can also benefit from Tavalis. For ResLydia, we actively pursued new collaborations and executed new license agreements with our partner Kisei in three countries in Asia and with Dr. Reddy for numerous territories outside of the U.S. Also in 2024, on our second goal, we made significant progress in our development pipeline. We continue to evaluate R289, our dual IRAC1 and 4 inhibitor, in an ongoing Phase 1B study in patients with lower-risk MDS. We presented encouraging initial safety and efficacy data from that study at the ASH annual meeting in December. enrollment in the dose escalation portion of the trial, where we recently completed the fifth dose level and have now opened for enrollment a new six-dose level at 500 milligrams BID. For alutacitinib, our strategic collaborations with MD Anderson and Connect Organization continue to progress. These trials provide us with the opportunity to explore alutacitinib in a range of IDH1 mutant cancers in a time- and cost-efficient manner. We're excited to report that all four studies from our multi-year strategic development alliance with MD Anderson have now opened for enrollment. And the phase two study of olusudinib in high-grade glioma in collaboration with Connect has also recently opened for enrollment. Lisa will provide you an update on these development programs in a few minutes. And lastly, in 2024, on our third goal, maintaining financial discipline. By maintaining financial discipline, we were able to, for the first time, generate full year net income of $17 million. And our cash balance increased by more than 20 million for the year. All of these accomplishments enabled Rigel to continue to successfully implement our strategy. Moving on to the next slide. We have continued to grow our net product sales over time. With a compound annual growth rate of 32% between 2021 and 2024, Tavalise grew nicely over that period. And the addition of ResLydia in late 22 and Gavretto in 2024 has provided additional contributions to that growth. All three of these products achieved new highs in 2024. And in 2025, as you can see on slide six, we're expecting approximately $145 million to $192 million in net product sales for the year. Approximately a 28% to 32% growth compared to 2024. So just to summarize, 2024 was a transformational year where we continued to grow our hematology and oncology business while at the same time becoming a profitable company. And with that, I'll turn the call over to Dave to provide a commercial update. Dave?
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