Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q1 2025 Earnings Presentation
38 slides from Rigel Pharmaceuticals's earnings presentation, May 6, 2025
Slide 1: Q1 2025 Financial Results Presentation
Q1 2025 Financial Results Presentation May 6, 2025 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1955 (“PSLRA”) relating to, among other things, continued development and expansion of our business, projected financial performance including sales
Slide 3: Rigel Participants
Rigel Participants Raul Rodriguez Ray Furey, J.D. Dave Santos President & Executive Vice President, Executive Vice President & Chief Executive Officer General Counsel & Corporate Secretary Chief Commercial Officer Lisa Rojkjaer, M.D. Dean Schorno Executive Vice President & Executive Vice President &
Slide 4: Growing Our Hematology and Oncology Business
Growing Our Hematology and Oncology Business Commercial Execution Development & Expansion Development Programs1 • Continue evaluation of R289, a dual IRAK1/4 inhibitor, in Phase 1b study in R/R lower-risk MDS • Expand olutasidenib beyond mIDH1 R/R AML, with plans to initiate a Phase 2 study in recur
Slide 5: Commercial Portfolio
Commercial Portfolio rigel.
Slide 6: Indications and Important Safety Information reference
Please see Indications and Important Safety Information on slides 33-37. Please visit www.TAVALISSE.com for Full Prescribing Information. Please visit www.REZLIDHIA.com for Full Prescribing Information, 6 including Boxed WARNING. Please visit www.GAVRETO.com for Full Prescribing Information.
Slide 7: US Net Product Sales Growth
US Net Product Sales Growth Q1 2025 Net Portfolio Sales grew $17.6M (68%) vs. Q1 2024 Annual Net Portfolio Sales ($M) 160 144.9 140 120 46.5 104.3 100 76.7 29.5 80 38.9 63.1 60 22.8 27.1 17.6 43.6 40 19.2 33.5 16.0 23.9 20 17.1 18.5 43.6 23.8 26.0 +68% 12.4 16.2 0 2021 2022 2023 2024 2025 YTD Q1 Q2
Slide 8: Q1 2025 Commercial Performance
Q1 2025 Commercial Performance Net Product Sales ($M) TAVALISSE GAVRETO REZLIDHIA $28.5M 35% Growth vs. Q1 2025 Net Product Sales Q1 2024 43.6 6.1 $9.0M 9.0 29.5 Available Axis Title June 2024 4.9 Q1 2025 Net Product Sales 28.5 $6.1M 21.1 25% Growth vs. Q1 2025 Net Product Sales Q1 2024 Q124 Q125 8
Slide 9: Q1 2025 Commercial Performance
Q1 2025 Commercial Performance • Quarterly demand • Seamless transition of • Continued to generate continued to grow through existing patients provided new patients as new patient starts and platform for growth awareness grows carryover • Continued demand • Additional focus on • Successfully streaml
Slide 10: Expanding Commercial Availability in Global Markets
Expanding Commercial Availability in Global Markets TAVALISSE is commercially available in Japan, key European countries (TAVLESSE), Canada and Israel Q1 2025 Collaboration Revenues • Grifols $4.7M • Kissei $4.6M1 • Medison $0.4M TAVALISSE Regulatory Approvals • Knight announced regulatory approval
Slide 11: Clinical Development Program Update
Clinical Development Program Update 11
Slide 12: Hematology and Oncology Portfolio Expansion
Hematology and Oncology Portfolio Expansion Leverage Hematology/Oncology Capabilities Development Pipeline1 In-Licensing & Product Acquisition R289 IRAK1/4 Inhibitor Olutasidenib Fostamatinib • Differentiated asset(s) in • Evaluating in • Expand beyond • Investigator hematology, oncology or lower-ri
Slide 13: R289 IRAK1/4 Inhibitor
R289 IRAK1/4 Inhibitor rigel.
Slide 14: R289 Program Value Proposition for Lower-Risk MDS
R2891 Program Value Proposition for Lower-Risk MDS • ~12,200 lower-risk MDS patients that have been previously treated 2 Unmet Medical • Therapies for previously-treated3 transfusion dependent lower-risk MDS Need patients are lacking (HMAs approved >20 years ago) • Dysregulated inflammatory signalin
Slide 15: Lower-Risk MDS Treatment Landscape
Lower-Risk MDS Treatment Landscape • MDS is a clonal disorder of hematopoietic stem cells (HSCs) leading to dysplasia and ineffective hematopoiesis – Consequences: Cytopenias (anemia), infections, iron overload and organ dysfunction, progression to AML • Primary goal of therapy: Reduce/limit transfu
Slide 16: Phase 1b Study in Relapsed/Refractory Lower-Risk MDS
R2891: Phase 1b Study in Relapsed/Refractory Lower-Risk MDS Open-label, multicenter study to evaluate the safety, tolerability, PK and preliminary activity of R289 in patients with LR-MDS (NCT05308264) Key Eligibility Criteria • R/R LR-MDS or inadequate response to prior therapies. Dose Escalation P
Slide 17: Safety
Safety Treatment-related AEs Occurring in ≥2 Patients by Dose Level • The most common AEs (≥20%) 250 mg QD 500 mg QD 750 mg QD 250 mg BID 500/250 mg QD Total were diarrhea and fatigue (n=3) (n=6) (n=6) (n=6) (n=1) (n=22) (each 6,27%), chills, nausea Preferred Term All G3/4 All G3/4 All G3/4 All G3/4
Slide 18: Efficacy: Hematologic Responses
Efficacy: Hematologic Responses RBC Transfusion Frequency by Dose Level • 18 patients were evaluable for efficacy • 3 patients achieved RBC-TI ≥8 wks: 1 at 500 mg QD and 2 at 750 mg QD • 2 patients achieved RBC-TI ≥ 24 wks • Median duration of RBC-TI: 29 wks (range 12.7-51.9 wks) • 1 HTB patient at
Slide 19: Efficacy: Summary of Responders
Efficacy: Summary of Responders Patient Profiles Pt ID Sex, Age Dose Level BL RBCs Prior Therapies HI-E Response Response Duration 4 76, M 500 mg QD HTB ESA, canakinumab, ALK2 inhibitor, decitabine TI 51.9 w 5 75, M 500 mg QD HTB ESA, azacitidine, luspatercept, fostamatinib, anti-TIM 3-ab Minor (64%
Slide 20: Olutasidenib mIDH1 Inhibitor
Olutasidenib mIDH1 Inhibitor 20
Slide 21: mIDH1 Glioma Has a Clear Unmet Need
mIDH1 Glioma Has a Clear Unmet Need High unmet need remains in glioma • Diffuse gliomas are the most common primary brain tumor in adults, affecting ~20K people in the US each year1 • IDH1 mutations are common in Grade 2/3 glioma (in 70%) 2, and are found in up to 35% of HGGs in adolescents and youn
Slide 22: Advancing Olutasidenib into mIDH1 Glioma
Advancing Olutasidenib into mIDH1 Glioma1 CONNECT’s TarGeT Phase 2 Clinical Study • Gliomas account for 29-35% of CNS tumors in children, adolescents & young adults2 • As part of CONNECT’s “TarGeT” study in HGG, olutasidenib is being evaluated in combination with temozolomide as a maintenance regime
Slide 23: Strategic Alliance with MD Anderson Cancer Center
Strategic Alliance with MD Anderson Cancer Center to Advance Olutasidenib in AML and Other Cancers1 All four studies are now open for enrollment Rigel and The University of Texas MD Anderson Cancer Center will evaluate olutasidenib in combination with other agents to treat newly-diagnosed and relaps
Slide 24: RIPK1 Inhibitor Partner Program
RIPK1 Inhibitor Partner Program 24
Slide 25: RIPK1 Inhibitor Programs in Immune and CNS Diseases
RIPK1 Inhibitor Programs in Immune and CNS Diseases with Partner Lilly Immune Diseases • R552, a potent and selective RIPK1 inhibitor, completed a Phase 1 study which demonstrated potential best-in-class status compared to competition • Lilly initiated a Phase 2a clinical trial studying ocadusertib
Slide 26: Expected Development Key Milestones in 2025
Expected Development Key Milestones in 2025 R289 • Completion of dose escalation part of Phase 1b study • Initiate dosing in expansion phase • Interactions with the FDA regarding potential registrational path • Present dose escalation data from Phase 1b study at a medical meeting in the second half
Slide 27: Financials
Financials rigel.
Slide 28: Q1 2025 Financial Highlights
Q1 2025 Financial Highlights Q1 2025 Net Product Sales: $43.6M Net Product Sales ($M) TAVALISSE GAVRETO REZLIDHIA • TAVALISSE $28.5M 46.5 • GAVRETO $9.0M 43.6 • REZLIDHIA $6.1M 38.9 7.4 6.1 33.5 5.5 8.1 Q1 2025 Contract Revenues 29.5 9.0 5.2 7.1 from Collaborations: $9.8M 27.1 3.9 26.0 Axis Title 1.
Slide 29: Q1 2025 Financial Results and 2025 Financial Outlook
Q1 2025 Financial Results and 2025 Financial Outlook (In thousands, except for per share amounts) Three Months Ended March 31, Cash, cash equivalents & short-term 2025 2024 Revenues investments as of March 31, 2025 Net Product Sales $ 43,550 $ 26,003 was $77.1M compared to $77.3M as Contract revenue
Slide 30: Continued Net Product Sales Growth
Continued Net Product Sales Growth Anticipate approximately 28% to 32% year-over-year growth in 2025 at the midpoint of guidance Annual Net Portfolio Sales ($M) 185.0 – 192.0 200 180 160 144.9 140 17.1 120 104.3 23.0 100 10.6 76.7 80 63.0 60 93.7 104.8 40 75.8 63.0 20 0 2021 2022 2023 2024 2025 Outl
Slide 31: 2025 Value Drivers
2025 Value Drivers Grow Product Sales for TAVALISSE, GAVRETO and REZLIDHIA • Expand adoption of commercial portfolio • Expect strong year-over-year growth in net product sales Advance Development Programs1 • Complete dose escalation part of R289 Phase 1b clinical study in lower-risk MDS and initiate
Slide 32: Well Positioned to Drive Future Growth
Well Positioned to Drive Future Growth Continued Financial Commercial Discipline Portfolio Advancing Generating Development Strong Revenue Opportunities Growth 32
Slide 33: TAVALISSE Tablets Indication and Safety Information
TAVALISSE® (fostamatinib disodium hexahydrate) Tablets DRUG INTERACTIONS • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the INDICATION major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may re
Slide 34: About REZLIDHIA
About REZLIDHIA® (olutasidenib) INDICATION REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. IMPORTANT SAFETY INFORMA
Slide 35: Important Safety Information (Cont.)
IMPORTANT SAFETY INFORMATION (Cont.) WARNINGS AND PRECAUTIONS Hepatotoxicity Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal dis comfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZ
Slide 36: About GAVRETO
About GAVRETO® (pralsetinib) INDICATIONS GAVRETO (pralsetinib) is indicated for the treatment of: • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test • Adult and pediatric patients 12 years of ag
Slide 37: Important Safety Information (Cont.)
IMPORTANT SAFETY INFORMATION (Cont.) • Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) sig naling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRET
Slide 38: Thank You
Thank You www.rigel.com rigel.
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