Rigel(RIGL) - 2024 Q3 - Quarterly Report

Revenue Performance - For the nine months ended September 30, 2024, net product sales of TAVALISSE were $73.8 million, an increase of$5.7 million or 8% compared to $68.1 million in the same period in 2023[122]. - For the nine months ended September 30, 2024, net product sales of REZLIDHIA were$15.6 million, an increase of $8.9 million or 133$6.7 million in the same period in 2023[123]. - GAVRETO recognized $9.0 million in net product sales for the nine months ended September 30, 2024, following its commercialization beginning June 27, 2024[124]. - Product sales for the three months ended September 30, 2024, were$38.9 million, an increase of 43% compared to $27.1 million for the same period in 2023[190]. - Total revenues for the three months ended September 30, 2024, reached$55.3 million, up from $28.1 million in the same period in 2023, marking an increase of$27.2 million[190]. - TAVALISSE net product sales for the three months ended September 30, 2024, were $26.3 million, an 8$24.5 million in the same period in 2023[192]. - REZLIDHIA net product sales for the three months ended September 30, 2024, were $5.5 million, a 107$2.7 million in the same period in 2023[192]. - GAVRETO net product sales recognized for the three months ended September 30, 2024, were $7.1 million, following its commercialization in June 2024[192]. Collaborations and Agreements - The acquisition of GAVRETO included a purchase price of$15.0 million, with $10.0 million paid upon the first commercial sale and an additional$5.0 million payable on the first anniversary of the agreement[124]. - The strategic collaboration with MDACC includes $15.0 million in milestone payments over five years for the evaluation of olutasidenib in AML and other hematologic cancers[130]. - The collaboration with CONNECT involves a Phase 2 clinical trial for olutasidenib in combination with temozolomide, with funding up to$3.0 million over four years[131]. - The expansion of the relationship with Kissei includes a one-time upfront cash payment of $10.0 million and potential additional payments of up to$152.5 million in milestones[132]. - The company in-licensed olutasidenib from Forma with exclusive worldwide rights for development, manufacturing, and commercialization, with Forma entitled to a portion of sublicensing revenue, including $2.3 million upon receipt of a$10.0 million upfront payment expected in Q4 2024[133][134]. - The company entered a collaboration and license agreement with Kissei for the development and commercialization of olutasidenib in Japan, Korea, and Taiwan in September 2024[169]. Clinical Development - The company is advancing the R289 dual IRAK 1/4 inhibitor program in a Phase 1b study for patients with lower-risk MDS, with an expected enrollment of approximately 40 patients[127]. - As of July 15, 2024, 4 out of 11 patients receiving R289 doses ≥500 mg/daily achieved transfusion independence or hematologic improvement responses[129]. - Lilly is advancing ocadusertib, a selective RIPK1 inhibitor, with a Phase 2a trial involving approximately 100 patients for rheumatoid arthritis, with preliminary results expected in H1 2025[136]. - Under the Lilly Agreement, the company is responsible for 20% of development costs for ocadusertib in the US, Europe, and Japan, with a funding commitment capped at a specified amount through April 1, 2024, totaling $21.4 million provided to Lilly[137]. - The Phase 2 trial of olutasidenib showed a complete remission (CR) plus CR with partial hematologic recovery (CRh) rate of 33.3$10.0 million upfront payment from Kissei as part of a collaboration and license agreement during the nine months ended September 30, 2024[222]. - Future contingent payments under existing collaboration agreements could exceed $1.4 billion if all potential product candidates achieve specified payment triggering events[227]. - The company has a credit agreement with MidCap providing a$60.0 million term loan credit facility, fully funded as of September 30, 2024[229]. - The company expects to continue to generate cash from operating activities to support its commercialization efforts for at least the next 12 months[225]. - As of September 30, 2024, the company had approximately $61.1 million in cash, cash equivalents, and short-term investments, up from$56.9 million as of December 31, 2023[221]. - Net cash provided by operating activities for the nine months ended September 30, 2024 was $16.968 million, significantly higher than$497,000 for the same period in 2023[222]. Expenses and Costs - Cost of product sales for the three months ended September 30, 2024, was $8,026,000, an increase of$6,758,000 compared to $1,268,000 for the same period in 2023[196]. - Research and development expense for the three months ended September 30, 2024, was$6,182,000, a decrease of $293,000 from$6,475,000 in the same period in 2023[198]. - Selling, general and administrative expense for the three months ended September 30, 2024, was $27,043,000, an increase of$2,187,000 compared to $24,856,000 for the same period in 2023[211]. - The increase in cost of product sales was primarily due to increased royalty expense and sublicensing revenue fees of$3.4 million and $4.5 million, respectively[197]. - Research and development expenses related to ongoing clinical development programs for olutasidenib increased by approximately$2.0 million[202]. - The company expects to incur significant selling, general and administrative expenses as it expands commercial activities for TAVALISSE, REZLIDHIA, and GAVRETO[214]. - The decrease in research and development expense in the nine months ended September 30, 2024, was partly due to decreased clinical trial related expenses of $2.8 million[200]. Regulatory and Market Considerations - The FDA granted orphan drug designation for fostamatinib in August 2015, and it was approved in April 2018 for adult patients with chronic ITP who had insufficient response to previous treatments[144]. - REZLIDHIA was added to the NCCN Clinical Practice Guidelines for AML as a recommended targeted therapy in January 2023[162]. - GAVRETO received new chemical entity exclusivity until September 2025 and orphan drug exclusivity until September 2027 for specific indications[174]. - GAVRETO faces competition from Lilly's selpercatinib and other therapies for RET fusion-positive NSCLC and advanced thyroid cancers[175]. - The company is subject to claims related to patent protection and securities class action lawsuits, requiring careful assessment of potential losses[240]. - There were no material changes to the company's market risk disclosures during the nine months ended September 30, 2024[241].