Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q3 2024 Earnings Presentation
37 slides from Rigel Pharmaceuticals's earnings presentation, Nov 7, 2024
Slide 1: Q3 2024 Financial Results Presentation
Q3 2024 Financial Results Presentation November 7, 2024 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, expected commercial and financial results; Rigel’s ability to earn and receive milestone payments; ex
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 • Evaluate REZLIDHIA in a broad range of IDH1- mutant cancers including AML, MDS and glioma • Complete enrollment of R289, IRAK1/4 inhibitor, Phase 1b trial in lower-risk MDS In-Licensing
Slide 5: Commercial Portfolio
Commercial Portfolio rigel.
Slide 6: US Net Product Sales Growth
US Net Product Sales Growth Q3 2024 Net Portfolio Sales grew $11.8M (44%) vs. Q3 2023 Annual Net Portfolio Sales ($M) 120 104.4 98.4 100 29.6 80 76.7 38.9 63.1 +44% 22.8 60 27.1 17.6 40 19.2 33.5 16.0 23.9 18.5 20 17.1 23.8 26.0 12.4 16.2 0 2021 2022 2023 2024 YTD Q1 Q2 Q3 Q4 6
Slide 7: Grow Sales of TAVALISSE in ITP
Grow Sales of TAVALISSE in ITP 7
Slide 8: TAVALISSE indication and select safety information
Kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (cITP) who have had an insufficient response to a previous treatment. Select Important Safety Information Adverse Reactions: • Serious adverse drug reactions in the ITP double-blin
Slide 9: TAVALISSE Q3 2024 Performance $26.3M
TAVALISSE Q3 2024 Performance 3000 30.0 2,797 Bottles Shipped to 2797 2793 2551 26.3 Patients and Clinics in Q3 2024 2500 2412 25.0 24.5 16% Growth vs. Q3 2023 2000 20.0 2,793 Bottles Sold in Q3 2024 1500 15.0 9% Growth vs. Q3 2023 1000 10.0 500 5.0 $26.3M Q3 2024 Net Product Sales 0 Bottles Shipped
Slide 10: Grow Sales of REZLIDHIA in mIDH1 R/R AML
Grow Sales of REZLIDHIA in mIDH1 R/R AML 10
Slide 11: REZLIDHIA approved and available in the U.S.
APPROVED AND AVAILABLE IN THE U.S. REZLIDHIA is 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. Please see Important Safety Information on slides 33 & 34, including Boxed WARN
Slide 12: REZLIDHIA Q3 2024 Performance $5.5M
REZLIDHIA Q3 2024 Performance 450 444 429 6.0 444 Bottles Shipped to Patients 5.5 and Clinics in Q3 2024 400 5.0 350 101% Growth vs. Q3 2023 300 4.0 250 429 Bottles Sold in Q3 2024 221 210 3.0 2.7 200 104% Growth vs. Q3 2023 150 2.0 $5.5M 100 1.0 Q3 2024 Net 50 Product Sales 0 Bottles Shipped to Bot
Slide 13: Expanding Access to REZLIDHIA in Global Markets
Expanding Access to REZLIDHIA in Global Markets Expanded Relationship with Kissei • Kissei gains exclusive rights in all potential indications in Japan, the Republic of Korea and Taiwan • Rigel received an upfront cash payment of $10.0M with the potential for up to $152.5M in future milestone paymen
Slide 14: GAVRETO in RET Fusion-Positive NSCLC or Thyroid Cancer
GAVRETO in RET Fusion-Positive NSCLC or Thyroid Cancer
Slide 15: GAVRETO approved in the U.S.
APPROVED IN THE U.S. GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA-approved test, and adult and pediatric patients 12 years of age and older with advanced or metastatic RE
Slide 16: GAVRETO Q3 2024 Performance $7.1M
GAVRETO Q3 2024 Performance 800 8.0 752 717 7.1 700 7.0 717 Bottles Shipped to Patients and Clinics in Q3 2024 600 6.0 60-count equivalent bottles 500 5.0 752 Bottles Sold in Q3 2024 400 4.0 60-count equivalent bottles 300 3.0 228 * $7.1M 1.9 * 200 2.0 Q3 2024 Net Product Sales 100 1.0 0* 0 0.0 Bott
Slide 17: GAVRETO Transition Continues as Planned
GAVRETO Transition Continues as Planned Patient Services Distribution Network Early Insights • RIGEL ONECARE continues to • Specialty Distributors shipped • While most previously identified provide assistance in 320 bottles of GAVRETO to top direct accounts have transitioning patients, direct purcha
Slide 18: Clinical Development Program Update
Clinical Development Program Update 18
Slide 19: 66th ASH Annual Meeting: Abstracts (Dec 7-10)
66th ASH Annual Meeting: Abstracts (Dec 7-10) Abstract #4595: R289, a Dual IRAK 1/4 Inhibitor, in Patients with Relapsed/Refractory (R/R) Lower -Risk Myelodysplastic Syndrome (LR-MDS): Initial Results from a Phase 1b Study Presenter: Guillermo Garcia-Manero, M.D. Abstract #1514: Time to Response and
Slide 20: Hematology and Oncology Pipeline Expansion
Hematology and Oncology Pipeline Expansion Development Opportunities 1 In-Licensing & Product Acquisition Olutasidenib • Broad range of IDH1-mutant • Differentiated asset(s) in cancers including AML, MDS and hematology, oncology or glioma Leverage related areas Heme/Onc • Late-stage programs Capabil
Slide 21: Strategic Alliance with MD Anderson Cancer Center
Strategic Alliance with MD Anderson Cancer Center to Advance Olutasidenib in AML and Other Cancers1 • Rigel and The University of Texas MD Anderson Cancer Center will evaluate olutasidenib in combination with other agents to treat newly-diagnosed and relapsed/refractory patients with IDH1-mutated: A
Slide 22: Collaboration with CONNECT to Advance Olutasidenib in Glioma
Collaboration with CONNECT to Advance Olutasidenib in Glioma1 • Gliomas account for 29-35% of CNS tumors in children, adolescents and young adults; approximately 1/3 are high grade gliomas (HGG) (800-1000 new cases/year in US)2 • IDH1 mutations are found in up to 36% of HGGs in adolescents and young
Slide 23: 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 – Risk of cytopenias, infections, iron overload and organ dysfunction, progression to AML • Primary goal of therapy: Reduce/limit transfusion-dependency
Slide 24: Targeting Inflammatory Pathways in LR-MDS with R289
Targeting Inflammatory Pathways in LR-MDS with R289, a Dual IRAK 1/4 Inhibitor1 Dysregulation of immune/inflammatory signaling is associated with MDS • Treatment options are limited for LR-MDS patients, especially for those with recurrent disease or who are refractory to prior lines of therapy • IRA
Slide 25: R289 Phase 1b Trial in Relapsed/Refractory Lower-Risk MDS
R2891: Phase 1b Trial in Relapsed/Refractory Lower-Risk MDS Open-label, multicenter trial to evaluate the safety, tolerability, PK and preliminary activity of R289 in patients with LR-MDS (NCT05308264) Dose Escalation Phase Dose Expansion Phase Primary Endpoints: Standard 3+3 Design2 • Incidence of
Slide 26: RIPK1 Inhibitor Programs in Immune and CNS Diseases 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 27: Financials
Financials rigel.
Slide 28: Q3 2024 Financial Highlights
Q3 2024 Financial Highlights Q3 2024 Net Product Sales: • TAVALISSE: $26.3M Net Product Sales ($M) • REZLIDHIA: $5.5M 38.9 TAVALISSE REZLIDHIA GAVRETO • GAVRETO: $7.1M 33.5 7.1 1.9 Q3 2024 Total Bottles Shipped: 29.5 27.1 5.2 5.5 • TAVALISSE: 2,793 3.9 26.0 23.8 23.9 2.7 • REZLIDHIA: 429 22.8 1.5 4.
Slide 29: Q3 2024 Financial Results
Q3 2024 Financial Results (In thousands, except for per share amounts) Three Months Ended September 30, 2024 2023 Q3 2024 Highlights Revenues Net Product Sales $ 38,927 $ 27,129 • Contract revenues from Contract revenues from collaborations 16,380 1,005 Total revenues 55,307 28,134 collaborations of
Slide 30: 2024 Value Drivers
2024 Value Drivers Grow Product Sales for TAVALISSE, REZLIDHIA and GAVRETO • Continue to broaden product awareness and adoption • Identify ex-US collaboration(s) for olutasidenib Advance Development Programs1 • Enroll and generate preliminary data for R289 Phase 1b study in lower-risk MDS • Initiate
Slide 31: Well Positioned to Drive Future Growth
Well Positioned to Drive Future Growth Continued Commercial financial portfolio Advancing discipline generating development strong revenue opportunities growth 31
Slide 32: 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 reactions. Monitor for toxicities that may re
Slide 33: 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 34: 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 35: 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 36: 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 37: Thank You
Thank You www.rigel.com rigel.
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