Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q4 2024 Earnings Presentation
40 slides from Rigel Pharmaceuticals's earnings presentation, Feb 4, 2025
Slide 1: Q4 & FY 2024 Financial Results Presentation
Q4 & FY 2024 Financial Results Presentation March 4, 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: Continued Net Product Sales Growth
Continued Net Product Sales Growth Annual Net Portfolio Sales ($M) 185.0 – 192.0 200 180 160 144.9 140 17.1 120 104.3 23.0 100 10.6 76.7 80 63.0 60 93.7 104.8 40 75.8 63.0 20 0 2021 2022 2023 2024 2025 Outlook TAVALISSE REZLIDHIA GAVRETO 5 CAGR, compound annual growth rate.
Slide 6: Continued Net Product Sales Growth
Continued Net Product Sales Growth Anticipate approximately 28% to 32% year-over-year growth in 2025 at the midpoint of guidance Annual Net Portfolio Sales ($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 7: Commercial Portfolio
Commercial Portfolio rigel.
Slide 8: Indications and Important Safety Information reference
Please see Indications and Important Safety Information on slides 35-39. Please visit www.TAVALISSE.com for Full Prescribing Information. Please visit www.REZLIDHIA.com for Full Prescribing Information, 8 including Boxed WARNING. Please visit www.GAVRETO.com for Full Prescribing Information.
Slide 9: US Net Product Sales Growth
US Net Product Sales Growth Q4 2024 Net Portfolio Sales grew $17.0M (58%) vs. Q4 2023 Annual Net Portfolio Sales ($M) 160 144.9 140 120 46.5 104.3 100 +58% 76.7 29.5 80 38.9 63.1 60 22.8 27.1 17.6 40 19.2 33.5 16.0 23.9 20 17.1 18.5 16.2 23.8 26.0 12.4 0 2021 2022 2023 2024 Q1 Q2 Q3 Q4 9
Slide 10: Q4 2024 Commercial Performance
Q4 2024 Commercial Performance $31.0M Net Product Sales ($M) Q4 2024 Net TAVALISSE REZLIDHIA GAVRETO Product Sales 46.5 8.1 21% Growth vs. Q4 2023 29.5 3.9 7.4 $7.4M Q4 2024 Net Product Sales Axis Title 92% Growth vs. Q4 2023 $8.1M 31.0 25.7 Q4 2024 Net Product Sales Available June 2024 Q423 Q424 10
Slide 11: Strong 2024 Commercial Performance
Strong 2024 Commercial Performance • Achieved significant milestone • More than doubled 2023 • Seamlessly transitioned of >$100 million in annual net demand and net product GAVRETO to Rigel following product sales in 2024 sales in 2024 NDA transfer in late June • Achieved new demand highs • Awarenes
Slide 12: 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 Q4 2024 Collaboration Revenues • Grifols $3.6M • Kissei $2.9M • Medison $0.3M TAVALISSE Regulatory Approvals • Knight announced regulatory approval i
Slide 13: Clinical Development Program Update
Clinical Development Program Update 13
Slide 14: Hematology and Oncology Portfolio Expansion
Hematology and Oncology Portfolio Expansion Development Pipeline1 In-Licensing & Product Acquisition R289 IRAK1/4 Inhibitor • Evaluating in lower-risk MDS • Granted Fast Track and Orphan • Differentiated asset(s) in Drug designations by the FDA2 hematology, oncology or Leverage related areas Olutasi
Slide 15: R289 IRAK1/4 Inhibitor
R289 IRAK1/4 Inhibitor rigel.
Slide 16: 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 treated2 Unmet Therapies for previously-treated3 transfusion dependent lower-risk MDS patients are medical need lacking (HMAs approved >20 years ago) Novel Dysregulated inflammatory signaling
Slide 17: 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 18: R289: 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: Dose Escalation Phase Dose Expansion Phase • R/R LR-MDS or inadequate re
Slide 19: Patient Characteristics
Patient Characteristics Elderly, heavily pre-treated patient population with a high transfusion burden • Data on 22 patients All Patients (n=22) (data cutoff: 25 Oct 24) Median age, years (range) 76 (50 - 84) are reported ≥ 75 years 13 (59%) • Median duration of Sex (M : F) 14 : 8 treatment: 4.6 mon
Slide 20: Safety
Safety R289 was well tolerated with a low incidence of grade 3/4 cytopenias and infections Treatment-related AEs Occurring in ≥2 Patients by Dose Level • The most common AEs (≥20%) were diarrhea and fatigue (each 6,27%), Preferred 250 mg QD 500 mg QD 750 mg QD 250 mg BID 500/250 mg Total chills, nau
Slide 21: 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 22: Efficacy: Summary of Responders
Efficacy: Summary of Responders Response Pt ID Sex, Age Dose Level BL RBCs Prior Therapies HI-E Response Duration 4 76, M 500 mg QD HTB ESA, canakinumab, ALK2 inhibitor, decitabine TI 51.9 w Patient ESA, azacitidine, luspatercept, fostamatinib, anti- 5 75, M 500 mg QD HTB Minor (64% RBC ↓) 16.9 w pr
Slide 23: Olutasidenib mIDH1 Inhibitor
Olutasidenib mIDH1 Inhibitor 23
Slide 24: 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 young
Slide 25: 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 26: 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 rela
Slide 27: RIPK1 Inhibitor Partner Program
RIPK1 Inhibitor Partner Program 27
Slide 28: RIPK1 Inhibitor Programs with Partner Lilly
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 29: 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 30: Financials
Financials rigel.
Slide 31: Q4 2024 Financial Highlights
Q4 2024 Financial Highlights Q4 2024 Net Product Sales: $46.5M Net Product Sales ($M) TAVALISSE REZLIDHIA GAVRETO • TAVALISSE $31.0M 46.5 • REZLIDHIA $7.4M • GAVRETO $8.1M 38.9 8.1 33.5 7.1 7.4 Q4 2024 Contract Revenues 29.5 1.9 from Collaborations: $11.1M 27.1 3.9 26.0 5.2 5.5 Axis Title 23.8 23.9
Slide 32: Q4 & Full Year 2024 Financial Results and Outlook
Q4 & Full Year 2024 Financial Results and Outlook (In thousands, except for per share amounts) Cash, cash equivalents & short-term Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 investments as of December 31, 2024 Revenues Net Product Sales $ 46,522 $ 29,539 $ 144,902 $
Slide 33: 2025 Value Drivers
2025 Value Drivers Grow Product Sales for TAVALISSE, REZLIDHIA and GAVRETO • 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 34: Well Positioned to Drive Future Growth
Well Positioned to Drive Future Growth Continued Commercial financial portfolio Advancing discipline generating development strong revenue opportunities growth 34
Slide 35: TAVALISSE Indication and Important 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 • TAVALISSE® (fostamatinib disodium hexahydra
Slide 36: About REZLIDHIA (olutasidenib)
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 37: 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 discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZL
Slide 38: About GAVRETO (pralsetinib)
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 39: 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) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO
Slide 40: Thank You
Thank You www.rigel.com rigel.
Rigel Pharmaceuticals — Q4 2024 Earnings Presentation on 6ix