Invivyd, Inc. · NASDAQ:IVVD
Invivyd — Q1 2024 Earnings Presentation
22 slides from Invivyd's earnings presentation, May 9, 2024
Slide 1: Q1 2024 Financial Results & Business Highlights
Exhibit 99.2 INVIVYD Q1 2024 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 9, 2024 © 2024 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
Slide 2: Cautionary Note Regarding Forward-Looking Statements
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words
Slide 3: Agenda
AGENDA • Introduction/Overview • Financials • PEMGARDA EUA & Commercial Launch • CANOPY Clinical Data • Pathway to Potential Treatment EUA • Variant Monitoring & Predictive Modeling • Product Pipeline • Q&A 3
Slide 4: Invivyd Has Entered a Transformational Period of Growth
INVIVYD HAS ENTERED A TRANSFORMATIONAL PERIOD OF GROWTH • Invivyd has been built to address the unique challenges presented by SARS-CoV-2, and potentially other viruses in the future • We are pioneering a still brand-new approach to antibody therapeutics and prophylactics, starting with SARS-CoV-2 •
Slide 5: Financials
FINANCIALS Cash and cash equivalents were $189.4 million as of March 31, 2024 Invivyd is maintaining its existing guidance of $150-$200 million in anticipated 2024 PEMGARDA net product revenue and year-end cash guidance of at least $75 million in cash and cash equivalents – Previously issued guidanc
Slide 6: PEMGARDA EUA Makes an Important Therapy Available to Certain Patients
PEMGARDA EUA MAKES AN IMPORTANT THERAPY AVAILABLE TO CERTAIN PATIENTS & PROVIDES PROOF-OF-CONCEPT FOR PLATFORM PEMGARDA has not been approved, but has been authorized for emergency use by FDA under an emergency use authorization (EUA), for pre-exposure prophylaxis of COVID-19 in certain adults and a
Slide 7: Invivyd Is Rapidly Executing on Its Commercial Strategy
INVIVYD IS RAPIDLY EXECUTING ON ITS COMMERCIAL STRATEGY Product Securing Full Commercial Availability Reimbursement Implementation & Access Deploy national account managers Fully deploy contracted Key Publish WAC in pricing compendia √ √ √ focused on payor engagement Account Managers (KAMs) Make pro
Slide 8: PEMGARDA EUA Based on Immunobridging Clinical Trial (CANOPY)
THE PEMGARDA EUA FOR PRE-EXPOSURE PROPHYLAXIS IS BASED ON AN IMMUNOBRIDGING CLINICAL TRIAL (CANOPY) CANOPY CLINICAL TRIAL OVERVIEW VYD222 4500 mg IV (n≈300) COHORT A Open Label Moderate-to-severe immune // compromise (N≈300) Day 1 Month 3 Month 12 (Dosing) (Redosing) (Last visit) Primary endpoints:
Slide 9: sVNA Titers & Exploratory Efficacy Data from Immunocompromised Cohort
SVNA TITERS & EXPLORATORY EFFICACY DATA FROM IMMUNOCOMPROMISED COHORT IN CANOPY CLINICAL TRIAL Cohort A - Calculated VYD222 sVNA titers against JN.1 based on observed PK concentration by timepoints Additional exploratory COVID-19 clinical event data anticipated mid-year 2024 Proportion of participan
Slide 10: Interim Exploratory Data from CANOPY Clinical Trial
INTERIM EXPLORATORY DATA FROM CANOPY CLINICAL TRIAL While not part of the primary immunobridging endpoint of the CANOPY clinical trial, interim exploratory data may be hypothesis generating for future Invivyd discovery and development work Cohort B (Randomized, placebo-controlled cohort without mode
Slide 11: Rapid Regulatory Pathway to Potential COVID-19 Treatment EUA
RAPID REGULATORY PATHWAY TO A POTENTIAL COVID-19 TREATMENT EUA REFLECTS THE DEMONSTRATED UTILITY OF MONOCLONAL ANTIBODIES Old therapy vs old variants New therapy vs new variants Immunobridging approach (known clinical efficacy) (Unknown clinical efficacy) STAMP clinical trial of PEMGARDA (pemivibart
Slide 12: Immunocompromised People Disproportionally Impacted by Severe COVID-19 Outcomes
DESPITE VACCINATION, IMMUNOCOMPROMISED PEOPLE ARE DISPROPORTIONALLY IMPACTED BY SEVERE COVID-19 OUTCOMES 1 The recent INFORM study, conducted during the Omicron period, found that in a sample of nearly 12 million people: Immunocompromised (IC) people represented only IC individuals accounted for IC
Slide 13: No One-Time Outpatient COVID-19 Treatment Currently Exists
NO ONE-TIME OUTPATIENT COVID-19 TREATMENT CURRENTLY EXISTS BUT MAY BE AN IMPORTANT THERAPEUTIC OPTION Indication or Authorized Use Treatment Dosing Select Limitations for Treatment (Abbreviated) Setting Mild-to-moderate COVID-19 in adults and Oral dose twice daily Studied in non- Significant drug-dr
Slide 14: COVID-19 Treatment Represents a Large Opportunity
COVID-19 TREATMENT REPRESENTS A LARGE OPPORTUNITY 1 Paxlovid script data reflects ongoing need for COVID-19 treatments Recent reporting underscores the compelling potential opportunity in COVID-19 treatment: • Pfizer reported $2 billion in Paxlovid revenues for 1Q 2024, with $1.8 billion from the U.
Slide 15: Variant Insights Powered by VivydTools Analytics
INVIVYD’S SARS-COV-2 VARIANT INSIGHTS ARE POWERED BY VIVYDTOOLS ANALYTICS VivydTools SARS-CoV-2 Variant Dashboard • Variant tracking and analysis is automated using proprietary bioinformatics • Clinical sequence data is supplemented with wastewater data • Internal analysis provides a detailed view o
Slide 16: Epitopic Analysis Is Built from Individual Residue Analysis
EPITOPIC ANALYSIS IS BUILT FROM INDIVIDUAL RESIDUE ANALYSIS SARS-CoV-2 spike protein evolution is Individual residue analysis yields two observations tracked at the residue (amino acid) level 1. Observed mutational potential at individual amino acid positions or for a complete epitope are increasing
Slide 17: Viral Analysis Enables Synthetic Antigen Design and Intelligent Antibodies
VIRAL ANALYSIS ENABLES SYNTHETIC ANTIGEN DESIGN AND INCREASINGLY INTELLIGENT ANTIBODIES Analysis of convergent evolution yields patterns of prediction regarding spike / RBD mutations Predictive data is computationally combined with deep mutational scanning data specific for our mAbs to inform synthe
Slide 18: Discovery Process Incorporates Synthetic Evolutionary Intelligence
INVIVYD DISCOVERY PROCESS NOW INCORPORATES SYNTHETIC EVOLUTIONARY INTELLIGENCE Circulating Ags Synthetic Ags EVOLUTIONARY INTELLIGENCE BOOLEAN MAB Proprietary incorporation DISCOVERY SCREENS of probabilistic future evolution into today’s mAb discovery and qualification PREDICTIVE VARIANT NEUTRALIZAT
Slide 19: Pipeline Rapidly Advancing Toward Higher Intelligence Antibodies
INVIVYD’S PIPELINE IS RAPIDLY ADVANCING TOWARD HIGHER INTELLIGENCE AND ANTICIPATED IMPROVED PHARMACEUTICAL PROFILES • First generation, mined from SARS-CoV-1 survivor serum and optimized against Wuhan Adintrevimab • Optimized on one dimension (ACE2:RBD affinity) (ADG20) • 2nd generation, engineered
Slide 20: Summary: Key Elements of Strategy
SUMMARY: KEY ELEMENTS OF STRATEGY Variant Monitoring Pipeline Development & Commercial Opportunity • Virus is in constant motion • Pemivibart reflects Invivyd’s first generation technology • Individual residue mutations and combinations are • Invivyd now almost two years into analytics and technolog
Slide 21: Invivyd
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Slide 22: Invivyd
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