Agios Pharmaceuticals, Inc. · NASDAQ:AGIO
Agios Pharmaceuticals — Q3 2020 Earnings Presentation
18 slides from Agios Pharmaceuticals's earnings presentation, Nov 5, 2020
Slide 1: Third Quarter 2020 Financial Results
Third Quarter 2020 Financial Results November 5, 2020 1
Slide 2: Agios Conference Call Participants
Agios Conference Call Participants TOPIC PARTICIPANT Introductions Holly Manning, Director of Investor Relations Business Update Jackie Fouse, Ph.D., Chief Executive Officer Clinical Development Update Chris Bowden, M.D., Chief Medical Officer Darrin Miles, Senior Vice President, U.S. TIBSOVO® Perfo
Slide 3: Forward Looking Statements
Forward Looking Statements This presentation and various remarks we make during this presentation contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Agios’ plans, strategies and expect
Slide 4: Q3 2020 Business Updates
Q3 2020 Business Updates Rare Genetic Hematologic Solid Tumors Diseases Malignancies • Initiated Phase 1 healthy • TIBSOVO® net sales of $31.7 • Reported topline mature overall volunteers study of AG-946, a million, a 15% increase from Q2 survival results from ClarIDHy study next-generation PKR acti
Slide 5: Anticipated Upcoming Milestones
RARE GENETIC DISEASES • Report topline data from ACTIVATE, the global pivotal trial for mitapivat in adults with PKD who do not receive regular transfusions, by YE 2020 • Report topline data from ACTIVATE-T, the global pivotal trial for mitapivat in adults with PKD who receive regular transfusions,
Slide 6: Clinical Development Updates
Clinical Development Updates Chris Bowden, M.D., Chief Medical Officer 6
Slide 7: PKR Activation Represents Unique Mechanism of Action with Potential to Address Broad Range of Hemolytic Anemias
PKR Activation Represents Unique Mechanism of Action with Potential to Address Broad Range of Hemolytic Anemias GLYCOLYSIS Glucose Mutant PKR Wildtype PKR Normal Red Cell Pyruvate Kinase Deficiency Other Hemolytic Anemias FBP PEP PEP PEP wtPKR mPKR wtPKR 1,3-DPG 2,3-DPG Pyruvate Pyruvate Pyruvate 3-
Slide 8: Mitapivat has Potential to be First Disease-modifying Therapy for Patients with PK Deficiency
Mitapivat has Potential to be First Disease-modifying Therapy for Patients with PK Deficiency Improvements in Hemoglobin and Other Hemolysis Markers Maintained for More Than 3 Years in Responding Patients from DRIVE PK Extension COMPLICATIONS & COMORBIDITIES HIGH RISK SUPPORTIVE REGARDLESS OF OF IRO
Slide 9: Interim Phase 2 Results in Thalassemia
Interim Phase 2 Results in Thalassemia: Activation of wPKR by Mitapivat Improved Hb and Associated Markers of Hemolysis and Erythropoiesis Treatment with mitapivat induced Hb increase of ≥1.0 g/dL in 12 of 13 evaluable patients, including 4 of 4 α-thalassemia patients; 7 of 8 evaluable patients achi
Slide 10: Clinical Proof-of-concept for Mitapivat Established in Sickle Cell Disease
Clinical Proof-of-concept for Mitapivat Established in Sickle Cell Disease 7 of 8 (88%) efficacy evaluable patients experienced a Hb increase, and 5 of 8 (63%) patients achieved a Hb increase of ≥1.0 g/dL from baseline (range 1.0-2.7 g/dL) at doses of 50 mg BID or lower. Treatment with mitapivat was
Slide 11: PKR Activation Has Potential Broad Utility Across Hemolytic Anemias
PKR Activation Has Potential Broad Utility Across Hemolytic Anemias ~18- ~120- ~3-8K PATIENTS IN 23K 135K U.S. & EU PATIENTS IN PATIENTS IN U.S. & EU U.S. & EU Pyruvate Kinase Deficiency β- and α-Thalassemia Sickle Cell Disease Phase 3 enrollment complete; NTD β- and α- Phase 2 enrollment NIH CRADA;
Slide 12: Significant Growth Potential in Malignant Hematology
Significant Growth Potential in Malignant Hematology ~4K <1K PATIENTS IN PATIENTS IN U.S. & EU U.S. IDH1 Mutant Acute Myeloid IDH1 Mutant Myelodysplastic Leukemia (AML) Syndrome (MDS) TIBSOVO® TIBSOVO® R/R AML U.S. Approval R/R MDS Phase 1 Expansion 1L Monotherapy U.S. Approval 1L HMA Combo Phase 3
Slide 13: Four Distinct Solid Tumor Opportunities Across Three Clinical Molecules
Four Distinct Solid Tumor Opportunities Across Three Clinical Molecules ~2-3K ~9K ~9K ~10K PATIENTS IN PATIENTS IN PATIENTS PATIENTS U.S. & EU U.S. & EU IN U.S. IN U.S. IDH1 Mutant IDH Mutant MTAP-Deleted Non- MTAP-Deleted Cholangiocarcinoma Low Grade Glioma Small Cell Lung Cancer Pancreatic Cancer
Slide 14: TIBSOVO Performance Update
TIBSOVO® Performance Update Darrin Miles, Senior Vice President, U.S. Commercial & Global Marketing 14
Slide 15: Q3 Growth Driven by Increased Demand in Both R/R and Frontline AML Segments
Q3 Growth Driven by Increased Demand in Both R/R and Frontline AML Segments and Expanding Customer Base TIBSOVO® Revenue (in millions) $32 15% Growth In Product Revenue Quarter-over-Quarter $28 $23 $113 – 115M $20 Revised U.S. Net Sales Guidance for 2020 $17 $14 17% Increase $9 In Unique Prescribers
Slide 16: Third Quarter 2020 Financial Results
Third Quarter 2020 Financial Results Jonathan Biller, Chief Financial Officer, Head of Legal and Corporate Affairs 16
Slide 17: Third Quarter 2020 Financial Results
Third Quarter 2020 Financial Results Three Months Ended Three Months Ended Statement of Operations 9/30/20 9/30/19 Total Revenue $34.7M $26.0M Collaboration Revenue 2.3M 5.9M TIBSOVO® Net Sales 31.7M 17.4M Royalty Revenue 0.7M 2.7M Cost of Sales 0.6M 0.4M Research & Development Expense 89.6M 101.7M
Slide 18: Q&A
Q&A 18
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