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11/4/2025
Greetings, and welcome to the Rigel Pharmaceuticals financial conference call for the third quarter 2025. At this time, all participants are in your listen-only mode. A brief question and answer session will follow the formal presentation. If anyone would require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is my pleasure to introduce our first speaker, Ray Fury, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Peer. You may begin.
Welcome to our third quarter 2025 financial results and business update conference call. The financial press release for the third quarter 2025 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 relations site on Rigel.com. 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 in our most recent annual report on Form 10-K from the year ended December 31st, 2024, and subsequent filings with the SEC, including our Q3 quarterly report on Form 10Q on file with the SEC. Any forward-looking statements are made only as today's date, 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 CEO, Raul Rodriguez.
Raul. Thank you, Ray, and thank you all for joining us today. Also with me today are Dave Santos, our chief commercial officer, Lisa Royker, our chief medical officer, and Dean Shorno, our chief financial officer. On today's call, I will provide an overview of Rigel's business, along with our accomplishments and financial results for the third quarter of 2025. Starting on slide four, you will see an outline of Rigel's corporate strategy. Our strategic objectives are to grow our hematology and oncology business through commercial performance, pipeline expansion, coupled with financial discipline. Our continued execution of this strategy has led to another outstanding quarter for Rigel. For the third quarter, we reported total revenue of 69.5 million, including record net product sales of 64.1 million, a 65% year-over-year increase. Later in the call, Dave will provide more detailed information on our commercial performance for this quarter. Moving to our development pipeline, we continue to fund and advance our programs during the quarter. This includes our ongoing phase 1B study of R289, Rigel's potent and selective dual IRAC1 and IRAC4 inhibitor that is being studied in patients with relapse or refractory lower risk MDS. We have completed enrollment of the dose escalation phase of the study, and we will present data from this phase in an oral presentation at the ASH annual meeting in December. In addition, we recently announced the first patient was enrolled in the dose expansion phase of the study, where we will compare two doses of R289 to determine the recommended dose for future registrational and other clinical studies. Moving on to olosutinib. We will have four posters with data in patients with mutant IDH1-AML at the ASH meeting, supporting the use of olisutinib in a range of difficult-to-treat mutant IDH1-AML patient populations. We continue to evaluate olisutinib in other areas where IDH1 plays a role through various strategic collaborations. A fifth study with MD Anderson opened for enrollment in September. And in October, the first patient enrolled in the Connect Phase 2 targeted D study evaluated olosutinib in patients with high-grade gliomas. In addition, we are planning a collaboration with MiloMatch to evaluate olisutinib in first-line AML and MDS. Lisa will provide the latest updates on our development pipeline later in the call. In terms of Rajal's own study in glioma, we are continuing to evaluate our options. Along with our commercial and development execution, we continue to pursue additional in-licensing deals or asset acquisitions that are synergistic with our capabilities, strategy, and focus, allowing us to add additional avenues to achieve significant growth. Underpinning all our efforts is a continued emphasis on financial discipline, which allowed us to generate 27.9 million of net income in the third quarter and to increase our cash balance to 137.1 million. Now onto slide five, which illustrates the growth of our net product sales year over year. We have consistently delivered strong top line growth. We are accelerating this trend in 2025, already having generated 166.6 million in net product sales year-to-date, already surpassing net product sales for all of 2024. As a result of our outstanding commercial performance year-to-date, we are raising our 2025 revenue guidance. We now expect total revenue of 285 to 290 million, an increase from the prior range of 270 to 280 million, Our new guidance includes net product sales of 225 to 230 million. This new 2025 outlook reflects anticipated growth of 55 to 59% compared to 2024, exceeding the growth rate that we have delivered over the last four years. Rigel has made tremendous progress in our unique approach that combines strong commercial execution, adding additional products through in-license or acquisition, and financial discipline, all resulting in our ability to fund a potentially transformative internal development pipeline. We continue to focus on executing on our strategy to achieve significant long-term growth. Now with that, I will turn the call to Dave to discuss our commercial business in more detail. Dave?
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