Rigel(US:RIGL)2025-11-04 21:06Revenue Performance - TAVALISSE net product sales for the nine months ended September 30, 2025, were $113.3 million, an increase of $39.5 million or 54% compared to $73.8 million in the same period in 2024[128]. - REZLIDHIA net product sales for the nine months ended September 30, 2025, were $21.4 million, an increase of $5.9 million or 38% compared to $15.6 million in the same period in 2024[129]. - GAVRETO net product sales for the nine months ended September 30, 2025, were $31.9 million, compared to $9.0 million in the same period in 2024[130]. - For the three months ended September 30, 2025, total revenues were $69.462 million, an increase of 25.6% compared to $55.307 million for the same period in 2024[205]. - Product sales for the three months ended September 30, 2025, were $64.067 million, up 64.5% from $38.927 million in the same period of 2024[205]. - TAVALISSE net product sales for the three months ended September 30, 2025, were $44.7 million, a 70% increase compared to $26.3 million for the same period in 2024[206]. - REZLIDHIA net product sales for the three months ended September 30, 2025, were $8.3 million, reflecting a 50% increase from $5.5 million in the same period of 2024[206]. - GAVRETO net product sales for the three months ended September 30, 2025, were $11.0 million, compared to $7.1 million for the same period in 2024, following its commercialization in late June 2024[207][208]. Clinical Trials and Drug Development - R289 is currently in a Phase 1b study with an expected enrollment of approximately 86 patients, focusing on safety, tolerability, and preliminary efficacy in lower-risk MDS[132]. - The FDA granted R289 Orphan Drug designation for myelodysplastic syndromes in January 2025 and Fast Track designation for previously-treated transfusion dependent lower-risk MDS in November 2024[135]. - A strategic collaboration with MDACC was established to evaluate olutasidenib in AML and other hematologic cancers, with $15.0 million in milestone payments over five years[136]. - A collaboration with CONNECT aims to conduct a Phase 2 trial evaluating olutasidenib in combination with temozolomide for HGG, with funding up to $3.0 million[137]. - Lilly is advancing ocadusertib in a Phase 2a clinical trial for rheumatoid arthritis, with a notice received on October 1, 2025, regarding the termination of the CNS disease program[139]. - The Phase 1b study of R289 is expected to enroll approximately 86 patients, with the first patient dosed in December 2022[191]. - As of July 15, 2025, 33 patients were enrolled in the dose escalation part of the R289 study, with a median age of 75 and 61% classified as high transfusion burden[193]. - The collaboration with MDACC includes five studies evaluating olutasidenib in various hematologic cancers, with ongoing enrollment[196]. - The company has strategic collaborations with CONNECT to evaluate olutasidenib in combination with temozolomide for HGG, with the first patient enrolled in October 2025[198]. Regulatory Approvals and Designations - TAVALISSE is approved for chronic ITP treatment in adult patients, with an estimated 81,300 affected individuals in the US[143]. - Fostamatinib received FDA approval in April 2018 and was launched in the US in May 2018[146]. - Olutasidenib, granted orphan drug designation by the FDA, is designed to selectively inhibit mIDH1 and has the potential for durable remissions[161]. - The FDA approved REZLIDHIA for R/R AML with IDH1 mutation in December 2022, with a recommended dosage of 150 mg taken orally twice daily[164]. - R289 was granted Fast Track designation by the FDA in November 2024 for the treatment of previously-treated transfusion dependent lower-risk MDS[194]. Financial Performance and Expenses - Research and development expenses for the three months ended September 30, 2025, increased to $7.4 million from $6.2 million in 2024, reflecting a $1.2 million increase due to clinical trial expenses and personnel-related costs[217]. - Selling, general and administrative expenses for the three months ended September 30, 2025, rose to $28.9 million from $27.0 million in 2024, primarily due to a $1.6 million increase in personnel-related costs[229]. - Interest income for the three months ended September 30, 2025, was $1.1 million, up from $0.4 million in 2024, indicating improved cash and investment balances[232]. - The cost of product sales for the three months ended September 30, 2025, was $4.8 million, down from $8.0 million in 2024, primarily due to a decrease in product costs related to drug supply deliveries[211]. - Research and development expenses for the nine months ended September 30, 2025, totaled $22.6 million, an increase from $17.7 million in 2024, driven by clinical trial activities[218]. - The company anticipates significant increases in selling, general and administrative expenses as it expands commercial activities and engages with healthcare providers[231]. - As of September 30, 2025, the company had approximately $137.1 million in cash, cash equivalents, and short-term investments, compared to $77.3 million as of December 31, 2024, reflecting an increase of 77.5%[240]. - Net cash provided by operating activities for the nine months ended September 30, 2025, was $53.7 million, a significant increase from $17.0 million in the same period of 2024[241]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $67.0 million, primarily due to net purchases of short-term investments[242]. Collaborations and Agreements - The company entered into a collaboration agreement with Kissei for the development and commercialization of olutasidenib in Japan, Korea, and Taiwan in September 2024[175]. - The company paid an upfront fee of $2.0 million for the licensing of REZLIDHIA, with potential additional payments of up to $67.5 million upon achieving development milestones[163]. - The total potential future contingent payments under existing collaboration agreements amount to approximately $1.1 billion, factoring in the impact of Lilly's notice to terminate the CNS disease program[246]. - The company has contractual commitments for potential milestone payments and tiered royalty payments under its agreements with Forma and Blueprint, including unpaid purchase price consideration[258][259]. Market and Competitive Landscape - The AML market is estimated to have an incidence of approximately 22,000 cases in the US in 2025, with 1,000 adult patients identified as having mIDH1 R/R AML[160]. - REZLIDHIA achieved a complete remission (CR) plus complete remission with partial hematologic recovery (CRh) rate of 35% in patients with R/R AML, with over 90% of responders in complete remission[162]. - The Phase 2 registrational trial showed an overall response rate (ORR) of 46% and a median duration of overall response of 11.7 months[165]. - REZLIDHIA demonstrated a median duration of complete response of 28.1 months, significantly longer than standard care[167]. - The National Comprehensive Cancer Network (NCCN) included REZLIDHIA as a recommended targeted therapy for adult patients with R/R AML with IDH1 mutation in January 2023[166]. - GAVRETO, an oral kinase inhibitor for RET fusion-positive NSCLC, became commercially available in June 2024, following the transfer of the NDA[182]. - GAVRETO received FDA exclusivity until September 2025 for metastatic RET fusion-positive NSCLC and until December 2027 for advanced thyroid cancer indications[184]. - GAVRETO is recommended as a preferred first-line treatment option for RET+ patients in the NCCN Guidelines for NSCLC[183]. Future Outlook and Funding - The company expects future revenues to include product sales from both existing and new commercial products, influenced by customer demand and rebate programs[210]. - The company expects its existing capital resources to be sufficient to support current and projected funding requirements for at least the next 12 months[244]. - The company may consider raising additional funds through public and/or private offerings of equity securities or debt financing to support ongoing operations and corporate development activities[250]. - As of September 30, 2025, the company has a potential cancellation fee obligation of approximately $22.6 million related to a contract manufacturing agreement, with $3.0 million due in the remainder of 2025 and $10.5 million due in 2026 and 2027[256]. - The company released a $40.0 million remaining cost share liability after deciding not to exercise its opt-in right for co-funding development costs under the Lilly Agreement[257]. - As of September 30, 2025, the outstanding principal amount of the company's loan with MidCap was $60.0 million, with $30.0 million principal payments due within 12 months[260]. - The company has a lease commitment of $1.3 million related to its lease agreement with 611 Gateway, with $0.7 million payable in the next 12 months[261].