Rigel Pharmaceuticals, Inc.

Greetings and welcome to Rigel Pharmaceutical's financial conference call for the third quarter of 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.

Hello. Welcome to our third quarter 2024 financial results and business update conference call. The financial press release for the third quarter 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 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 product development. These statements are subject to risks and uncertainties that may cause actual results to differ in those forecasted. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2021. 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 of 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 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 Shorno, our Chief Financial Officer. I will begin on slide four with an overview of Rigel's business and our third quarter results. In the first three quarters of the year, we made significant progress in our strategy to grow our hematology and oncology business. Our corporate strategy is focused on three main objectives. One, expanding our commercial portfolio and increasing product sales. Two, advancing and growing our pipeline through strategic collaborations and importantly, internal pipeline development. And three, maintaining financial discipline. I will now summarize each of these. Firstly, in the third quarter, we generated strong growth across our commercial portfolio with a total net sales of 38.9 million. This was up 44% compared to the third quarter of 2023. This robust revenue growth was driven by the addition of Gavretto, which generated 7.1 million in net product sales for its first full quarter with Rizal, as we transitioned the majority of patients and prescribers into our network. In addition, we saw continued year-over-year growth for Tavalis and Reslydia, with both achieving another record quarter for bottles shipped to patients and clinics. We continue to expand our product presence outside the U.S. as well this quarter with a new Kisei agreement to develop and commercialize Reslydia in Japan, the Republic of Korea, and Taiwan. This agreement included a $10 million upfront payment that we received in Q3 and the potential for up to $152 million in future development, regulatory, and commercial milestone payments. Secondly, regarding our objective to grow our pipeline, we continue to advance the development of R289, our dual IRAC1 and IV inhibitor, in a Phase 1b study in lower-risk MDS. Initial safety and efficacy data from that trial was published in an ASH abstract earlier this week, and we look forward to sharing additional data from a more recent data cut at the ASH meeting in December. Also at ASH, we'll have additional data for olutacitinib. Our strategic collaborations with MD Anderson and Connect are progressing well. These trials provide us with the opportunity to explore res lydia in a broad range of IDH1 mutant cancers in a cost and time efficient manner. Our first trial with MD Anderson, evaluating res lydia in a combination with two other agents in patients with mutant IDH1 AML, enrolled its first patient in September. And as we did with Reslydia and Gravita earlier this year, we continue to evaluate opportunities to in-license or acquire late-stage hematology and or oncology assets to further expand our portfolio. In 2025, we will discuss our development plans for both R289 in lower-risk MDS and Ulicitinib. Lastly, as we execute on our strategy to grow our business, we're doing so in a financially disciplined manner. Our strong commercial execution has enabled us for the first time to generate positive third quarter and year to date net income. In summary, in the third quarter, we made significant progress in growing our business while achieving net income breakeven. We are well positioned to continue to drive value as we head into 2025. And with that, I'll turn the call over to Dave to provide a commercial update. Dave.