Agios Pharmaceuticals, Inc. · NASDAQ:AGIO
Agios Pharmaceuticals — Q1 2020 Earnings Presentation
22 slides from Agios Pharmaceuticals's earnings presentation, Apr 30, 2020
Slide 1: First Quarter 2020 Financial Results
First Quarter 2020 Financial Results April 30, 2020 1
Slide 2: Agios Conference Call Participants
Agios Conference Call Participants TOPIC PARTICIPANT Introductions Holly Manning, Director of Investor Relations Business Update & COVID-19 Response Jackie Fouse, Ph.D., Chief Executive Officer Clinical Development Update Chris Bowden, M.D., Chief Medical Officer Darrin Miles, Senior Vice President,
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: COVID-19 Response Focused on Key Priorities
COVID-19 Response Focused on Key Priorities Our Patients Our Employees Our Communities • Continued to provide • Vast majority of employees are • Organized a donation of Agios’s uninterrupted commercial working from home PPE supply to local hospitals supply of TIBSOVO® and • Increased support and res
Slide 5: Clinical Development Updates
Clinical Development Updates Chris Bowden, M.D., Chief Medical Officer 5
Slide 6: Rare Genetic Diseases Updates: PK Deficiency, Thalassemia, Sickle Cell
• Enrollment complete in mitapivat PK deficiency pivotal trials ACTIVATE (80 PK DEFICIENCY patients) and ACTIVATE-T (27 patients) • ACTIVATE and ACTIVATE-T topline data now expected between YE 2020 and mid-2021 vs. previous guidance of YE 2020 based on anticipated challenges with clinical trial site
Slide 7: PKR Activation Represents Unique Mechanism of Action
PKR Activation Represents Unique Mechanism of Action with Potential to Address Broad Range of Hemolytic Anemias Normal Red Cell Pyruvate Kinase Deficiency Other Hemolytic Anemias PEP PEP PEP wtPKR mPKR wtPKR Pyruvate Pyruvate Pyruvate Cellular demand: Cellular demand: Cellular demand: ATP production
Slide 8: Mitapivat Potential First Disease-modifying Therapy for 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: Clinical Proof-of-concept for Mitapivat in Thalassemia
7 of 8 efficacy evaluable patients achieved a hemoglobin increase of ≥1.0 g/dL from baseline in at least one assessment (weeks 4 – 12) Clinical Proof-of- concept for Mitapivat In responding patients, the mean hemoglobin increase from baseline Established in was 1.76 g/dL (range, 0.9 – 3.3 g/dL) Non-
Slide 10: Therapeutic Hypothesis for PKR Activation in Sickle Cell Disease
Therapeutic Hypothesis for Wildtype PKR Activation in Sickle Cell Disease: 2,3-DPG and ATP Modulation Improves Anemia and Reduces Sickling 2,3-DPG Shifts the Oxygen Saturation Curve Water and ion homeostasis Ca2+ entry3 Low DPG Water and ATP-dependent ion loss3 regulation of High ion concentration ↓
Slide 11: Malignant Hematology Updates: AML, MDS, Lymphoma
• EU regulatory process for TIBSOVO® in R/R AML remains on track with a CHMP opinion expected by YE 2020 • Phase 3 AGILE enrollment completion now expected in 2021 vs. previous What’s New: AML guidance of YE 2020 due to COVID-19 related delays in site start-up activities and enrollment interruptions
Slide 12: 50K AML Patients Diagnosed Per Year in U.S. and EU
50K AML Patients Diagnosed Per Year in U.S. and EU 6-10% with an IDH1 Mutation TIBSOVO® Approved in U.S. MAA Under Review Advancing Toward Largest Opportunity for mIDH1 AML: HOVON Phase HOVON 7+3 3 7+3 Phase Combo 3 ~50% Phase 1 combo data: 79% CREligible in de for novo AML Intensive and Enrolling E
Slide 13: Solid Tumors Updates: Cholangiocarcinoma, Glioma, NSCLC
CHOLANGIOCARCINOMA • Mature OS data from ClarIDHy Phase 3 study of TIBSOVO® expected in mid-2020, but delays anticipated in collecting data from trial sites and executing the data cleaning process • sNDA for TIBSOVO® in previously treated IDH1 mutant cholangiocarcinoma What’s New: now expected betwe
Slide 14: Positive ClarIDHy Phase 3 Study of TIBSOVO in Cholangiocarcinoma
Established Utility of IDH Inhibition in Solid Tumors with Positive ClarIDHy Phase 3 Study of TIBSOVO® in Second-line or Later Cholangiocarcinoma Mature OS from ClarIDHy Phase 3 expected mid-2020; sNDA planned between YE 2020 and mid-2021 Phase 3 ClarIDHy Study Achieved Primary Endpoint, Demonstrati
Slide 15: Global Phase 3 INDIGO Study of Vorasidenib in Low-Grade Glioma
Global Phase 3 INDIGO Study of Vorasidenib in IDH Mutant Low-Grade Glioma IMPRESSIVE Vorasidenib SIGNIFICANT PRELIMINARY ENCOURAGING 50 mg QD orally 2-HG EFFICACY PHASE 1 DATA Continuous 28-day cycles SUPPRESSION DATA 1:1 double-blind (n=183) randomization (n=366) Stratified by 1p19q status and base
Slide 16: TIBSOVO Commercial Update
TIBSOVO® Commercial Update Darrin Miles, Senior Vice President, U.S. Commercial & Global Marketing 16
Slide 17: Significant Q1 Growth Driven by Increased Demand
Significant Q1 Growth Driven by Increased Demand in Both R/R and Frontline AML Segments and Expanding Customer Base TIBSOVO® Revenue (in millions) $23 16% Growth In Product Revenue Quarter-over-Quarter $20 $17 $105 – 115M $14 U.S. Net Sales Guidance for 2020 $9 25% Increase In Unique Prescribers Qua
Slide 18: Patient Access to TIBSOVO Remains Uninterrupted Despite COVID-19
Despite Potential Disruptions Related to COVID-19, Patient Access to TIBSOVO® Remains Uninterrupted and Performance Outlook Unchanged • Current inventory is more than sufficient to meet anticipated demand for TIBSOVO® even if COVID-19 disruptions were to persist • The TIBSOVO® distribution strategy
Slide 19: First Quarter 2020 Financial Results
First Quarter 2020 Financial Results Andrew Hirsch, Chief Financial Officer and Head of Corporate Development 19
Slide 20: Cash Conservation Efforts Extend Runway to End of June 2022
Cash Conservation Efforts Extend Runway to the End of June 2022 • In order to conserve cash while supporting the execution of critical business objectives, Agios made the following decisions: – Cease in-house development of AG-636, a DHODH inhibitor in Phase 1 clinical development, and evaluating op
Slide 21: First Quarter 2020 Financial Results
First Quarter 2020 Financial Results Three Months Three Months Year Ended Statement of Operations Ended 3/31/20 Ended 3/31/19 12/31/19 Total Revenue $87.1M $30.2M $117.9M Collaboration Revenue 61.1M 18.9M 47.5M TIBSOVO® Net Sales 22.7M 9.1M 59.9M Royalty Revenue 3.3M 2.2M 10.5M Cost of Sales 0.5M 0.
Slide 22: Q&A
Q&A 22
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