Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q2 2024 Earnings Presentation
38 slides from Rigel Pharmaceuticals's earnings presentation, Aug 6, 2024
Slide 1: Q2 2024 Financial Results Presentation
Q2 2024 Financial Results Presentation August 6, 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: GAVRETO is the only once daily, oral RET inhibitor approved
GAVRETO is the only once daily, oral, RET inhibitor approved for patients with metastatic NSCLC or thyroid cancer* with RET gene fusions *Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be c
Slide 5: 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 6: Commercial Portfolio
Commercial Portfolio rigel.
Slide 7: US Net Product Sales Growth
US Net Product Sales Growth Quarterly Net Product Sales ($M) Annual Net Portfolio Sales ($M) 35 33.5 140 1.9 29.6 30 27.1 5.2 120 3.9 26.0 104.4 23.8 23.9 2.7 25 100 1.5 4.9 2.6 29.6 20 76.7 80 63.1 59.5 22.8 15 60 27.1 24.5 25.7 26.4 17.6 22.3 21.3 19.2 10 21.1 40 16.0 33.5 23.9 18.5 5 20 17.1 23.8
Slide 8: Grow Sales of TAVALISSE in ITP
Grow Sales of TAVALISSE in ITP 8
Slide 9: 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 10: TAVALISSE Q2 2024 Performance $26.4M
TAVALISSE Q2 2024 Performance Bottles Shipped to Patients and Clinics 2500 $26.4M Q2 2024 Net Product Sales 2000 24% Growth vs. Q1 2024 1500 25% Growth vs. Q2 2023 1000 2,672 Bottles Shipped to Patients and Clinics in Q2 2024 500 8% Growth vs. Q1 2024 0 18% Growth vs. Q2 2023 Q1 Q2 Q3 Q4 2020 2021 2
Slide 11: TAVALISSE Q2 2024 Sales Growth
TAVALISSE Q2 2024 Sales Growth Bottles Shipped to Patients and Clinics Per Day 3500 45 Sales Growth Accelerated in Q2 41.8 37.7 39.1 38.8 40 • Growth of 3 bottles shipped per day 3000 35.3 35.4 2672 over Q1 is the largest increase in 2 35 2500 2412 2463 2483 years 2257 2265 30 • Bottles shipped per
Slide 12: Grow Sales of REZLIDHIA in mIDH1 R/R AML
Grow Sales of REZLIDHIA in mIDH1 R/R AML 12
Slide 13: 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 34 & 35, including Boxed WARN
Slide 14: REZLIDHIA Q2 2024 Performance $5.2M
REZLIDHIA Q2 2024 Performance Rezlidhia Sales 424 Bottles Shipped to Patients and Clinics in Q2 2024 400 424 401 390 30% vs. Q1 2024 350 300 326 127% vs. Q2 2023 308 250 278 200 221 150 187 200 210 $5.2M Q2 2024 Net Product Sales 100 113 109 5% vs. Q1 2024 50 102% vs. Q2 2023 0 Bottles Shipped to Pa
Slide 15: REZLIDHIA Q2 2024 Sales Growth
REZLIDHIA Q2 2024 Sales Growth Growing Community Usage Q2 2024 Growth Drivers • Community volume represented nearly 25% of sales in Q2, representing strong growth vs. Q1 • Awareness and support continues to grow, as more clinicians are finding the post-venetoclax data clinically relevant • Significa
Slide 16: GAVRETO Transition Update
GAVRETO Transition Update rigel.
Slide 17: 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 18: GAVRETO Transition Plan Implementation
GAVRETO Transition Plan Implementation Patient Services Customer Support Field Team Activation • www.RigelONECARE.com and • www.GAVRETO.com and • Field team trained and ready to www.GAVRETOcopay.com www.GAVRETO-hcp.com active deliver the GAVRETO availability active within 2 hours of the within 2 hou
Slide 19: GAVRETO Stocked and Now Shipping
GAVRETO Stocked and Now Shipping Supply Smooth Transition Under Way Chain • 3PL shipments to distributors began Commercial Regulatory on June 27th • Product stocked in Rigel distribution network on June 28th, ahead of July 1st target Medical Distribution Affairs • Distribution network began shipping
Slide 20: GAVRETO Q2 2024 Sales
GAVRETO Q2 2024 Sales GAVRETO is available in 2 bottle sizes • 60 count bottle • 90 count bottle (1.5x 60 count bottle) • Will report 60 count equivalent bottles 228 60 ct. eq. bottles sold in Q2 (initial stocking of Rigel distribution network) $1.9M Q2 2024 Net Product Sales 20
Slide 21: Clinical Development Program Update
Clinical Development Program Update 21
Slide 22: 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 23: 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 24: Olutasidenib: Phase 1b/2 Triplet Therapy Trial in IDH1-mutated AML
Olutasidenib: Phase 1b/2 Triplet Therapy Trial in IDH1-mutated AML Phase 1b/2 open-label, non-randomized clinical trial to evaluate the safety and efficacy of decitabine and venetoclax in combination with olutasidenib for mIDH1 AML (n=78)1 Phase 1b: R/R mIDH1 AML/HR-MDS Phase 2: ND and R/R mIDH1 AML
Slide 25: 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 26: Targeting Inflammatory Pathways in MDS with R289
Targeting Inflammatory Pathways in 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 • IRAK 1
Slide 27: 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 Standard 3+3 Design2 Primary Endpoints: • Incidence of
Slide 28: 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 29: Financials
Financials rigel.
Slide 30: Q2 2024 Financial Highlights
Q2 2024 Financial Highlights Q2 2024 Net Product Sales: • TAVALISSE: $26.4M Net Product Sales ($M) • REZLIDHIA: $5.2M TAVALISSE REZLIDHIA GAVRETO • GAVRETO: $1.9M 33.5 1.9 Q2 2024 Total Bottles Shipped: 29.5 27.1 5.2 • TAVALISSE: 2,722 3.9 26.0 23.8 23.9 2.7 • REZLIDHIA: 401 22.8 1.5 4.9 0.9 2.6 • G
Slide 31: Q2 2024 Financial Results
Q2 2024 Financial Results (In thousands, except for per share amounts) Three Months Ended June 30, 2024 2023 Q2 2024 Highlights Revenues Net Product Sales $ 33,450 $ 23,881 • Contract revenues from Contract revenues from collaborations 3,391 2,005 Government contract - 1,000 collaborations of $3.4M
Slide 32: 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 Identify In-License and Product Acquisition Opportunities • Pursue late-stage assets which leverage current capabilities
Slide 33: 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 34: 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 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 (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 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) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO
Slide 38: Thank You
Thank You www.rigel.com rigel.
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