Invivyd, Inc. · NASDAQ:IVVD

Invivyd — Q2 2024 Earnings Presentation

29 slides from Invivyd's earnings presentation, Aug 14, 2024

  1. Slide 1: Invivyd Q2 2024 Financial Results & Business Highlights

    Exhibit 99.2 INVIVYD Q2 2024 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS August 14, 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.

  2. 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

  3. Slide 3: Agenda: Executive Summary

    u Executive Summary u Commercial Update Pipeline Virology Finance Q&A 3

  4. Slide 4: A Quarter of Business Preparation, Evolution & Acceleration

    A QUARTER OF BUSINESS PREPARATION, EVOLUTION & ACCELERATION • PEMGARDA uptake accelerating nicely after a slow start early in the quarter • Key respiratory disease season approaching; activation preparations underway • Pipeline offering improved clinical & commercial profile advancing • Ongoing evol

  5. Slide 5: It's 2024 and Yet... COVID-19 Deaths in the U.S.

    IT’S 2024 AND YET… Approximately every 8 MINUTES, a person in the U.S. DIES with COVID-19* COVID-19=coronavirus disease 2019. *Calculation based on provisional CDC data (from Oct 1, 2023 start date of RESP-NET, through June 15, 2024, ~45,200 people in the U.S. died with COVID-19). Reference CDC. COV

  6. Slide 6: The Virus Will Never Go Away

    THE VIRUS WILL NEVER GO AWAY 2021 2024 2022–2023 July 2, 2021 June 11, 2021 August 31, 2022 January 10, 2024 July 2, 2021 December 22, 2023 June 19, 2024 August 12, 2021 December 22, 2023 January 23, 2024 EVERY YEAR, THE SAME STORY: COVID-19 IS IN NONSTOP EVOLUTION COVID-19=coronavirus disease 2019.

  7. Slide 7: COVID-19 Vaccines Insufficient for Immunocompromised People

    WE BELIEVE COVID-19 VACCINES ARE INSUFFICIENT FOR REAL PROTECTION, ESPECIALLY FOR IMMUNOCOMPROMISED PEOPLE 1 Adults≥18 years by 2023–2024 COVID-19 Vaccine immunocompromise/ Adjusted Vaccine Effectiveness Against Hospitalization The sole 2023-24 Vaccine vaccination status/days since dose [%, (95% Con

  8. Slide 8: mAbs May Be Critical for Managing Endemic Virus

    WE BELIEVE MABS MAY BE CRITICAL FOR MANAGING ENDEMIC VIRUS OVER THE LONG TERM • COVID-19 disease remains a pervasive human health threat, with particular burden imposed on immunocompromised people. • Vaccinations, infections, and the associated immunologic imprinting have left humans with measurable

  9. Slide 9: Agenda: Commercial Update

    u Executive Summary u Commercial Update Pipeline Virology Finance Q&A 9

  10. Slide 10: Commercial Overview: Rapid Evolution to Growth

    COMMERCIAL OVERVIEW: RAPID EVOLUTION TO GROWTH Situation at Start of Q2 Today • Legacy leadership & strategy • Best-in-class biopharma commercial team • Low ambient COVID-19 in the US* • Low PEMGARDA awareness • Strong HCP perception of COVID-19 • High ambient COVID-19* seasonality • Significantly e

  11. Slide 11: Key Launch Metrics

    KEY LAUNCH METRICS As of May 1 As of June 30 As of July 31 HCP Interactions 34 1,338 2,029 Logged Unique Accounts 33 679 909 Called On Accounts Ordered 7 115 208 • Centers for Medicare and Medicaid Services (CMS) had issued product specific HCPCS codes for PEMGARDA drug and administration with no co

  12. Slide 12: HCP Perception of COVID-19 Seasonality Despite Constant Threat

    RESEARCH SHOWS HCP PERCEPTION OF COVID-19 SEASONALITY DESPITE CONSTANT THREAT Select Highlights from Survey of Transplant Surgeons, Hematologists-Oncologists (n=45) Conducted Over Aprilà May 2024* HCP Feedback On Risk COVID-19 Poses to their Patients Not a Risk at All 7.52 / 10 An Immense Risk 0 1 2

  13. Slide 13: Impending Respiratory Season: Post-Labor Day Push

    IMPENDING RESPIRATORY SEASON: POST-LABOR DAY PUSH 2023-2024 Season Historical • COVID-19 prophylaxis habits COVID-19 Vaccine Utilization Trends shaped by vaccine conventions • Majority of vaccine utilization in the preventative “season”, despite: ü Clear persistence of COVID-19 outside of the season

  14. Slide 14: Opportunity to Offer Additional Protection to the Vulnerable

    THIS IS OUR OPPORTUNITY TO OFFER ADDITIONAL PROTECTION TO THE VULNERABLE Commercial focus: • ~485K who are moderately to severely immunocompromised and at highest risk for severe COVID-19: – 67K: stem cell transplants >9M 485K – 86K: solid organ transplants (liver/lung/kidney) immunocompromised – 33

  15. Slide 15: Invivyd Fall Activation Plan

    INVIVYD FALL ACTIVATION PLAN • Digital campaign on disease awareness & antibody therapies • Hiring and deploying Regional Clinic Specialists • Developing updated corporate positioning and awareness • Developing a class of trade strategy to increase access to infusion sites • Educational HCP webinars

  16. Slide 16: Agenda: Pipeline

    u Executive Summary u Commercial Update u Pipeline Virology Finance Q&A 16

  17. Slide 17: Next Up: VYD2311, a mAb with High In Vitro Potency

    NEXT UP: VYD2311, A MAB WITH HIGH IN VITRO POTENCY SHOWN AGAINST POST-OMICRON COVID-19 VARIANTS TESTED TO DATE Our next-generation mAb, VYD2311, improves biophysical properties; shows continued in vitro neutralization activity in pseudovirus assays against KP1.1 FLiRT, KP.2 FLiRT, and KP.3 variants

  18. Slide 18: VYD2311 Open FIH Protocol with IV and Intramuscular Formulations

    VYD2311 OPEN FIH PROTOCOL WITH IV AND INTRAMUSCULAR FORMULATIONS; SUBCUTANEOUS FOLLOWING SHORTLY Depending on the target clinical SVNA titer, VYD2311 pharmacokinetic profile, and antiviral potency (IC50), there may be many ways to achieve and hold attractive titers for PrEP Long interval IV Loading

  19. Slide 19: Near Term VYD2311 Goals

    NEAR TERM VYD2311 GOALS • Determine first-in-human safety at escalating doses • Determine pharmacokinetic profile (PK), including in vivo half-life • Explore Safety and PK across posologies / routes of administration • Determine authorization pathways and titer thresholds with regulators going forwa

  20. Slide 20: Agenda: Virology

    u Executive Summary u Commercial Update u Pipeline u Virology Finance Q&A 20

  21. Slide 21: COVID-19 Immunobridging Endpoints Require a Titer Point Estimate

    COVID-19 IMMUNOBRIDGING ENDPOINTS REQUIRE A TITER POINT ESTIMATE BASED ON VIROLOGY Pemivibart Titer Bridge Calculation • 12 total EVADE study clinical events: 71% relative risk reduction against Delta through Day 90 Calculated titer for adintrevimab against Delta • AVNA estimated adintrevimab potenc

  22. Slide 22: Single SVNA Titer Point Estimates Are Obsoleted by Virus Evolution

    SINGLE SVNA TITER POINT ESTIMATES ARE OBSOLETED BY CONSTANT VIRUS EVOLUTION… … So what is the average IC50 over any given time for a specific mAb? 22 Source: CDC and Our World In Data

  23. Slide 23: Arithmetic of Average IC50 and Authorization

    ARITHMETIC OF AVERAGE IC50 AND AUTHORIZATION • Calculated weighted average PVNA IC50s for past antibodies authorized under EUA against prior mixes of circulating viruses • Studied regulatory withdrawal actions and associated potencies • Imputed ancestral removal thresholds (reliant on data prior to

  24. Slide 24: Average IC50 Deauthorization Threshold

    AVERAGE IC50 DEAUTHORIZATION THRESHOLD ~Average IC50 at deauthorization: 1.0 ug/mL sotrovimab (GSK/VIR) Recent treatment mAbs have lost EUA at an average of 1.2 ug/ml 1.3 ug/mL bebtelovimab (LLY) PrEP mAb combo Evusheld lost EUA at approximately 2 2.1 ug/mL Evusheld (AZN) ug/mL 24 Source: Published

  25. Slide 25: VYD222 and VYD2311 IC50 Values Appear Essentially Stable

    VYD222 (PEMIVIBART) AND VYD2311 IC50 VALUES APPEAR ESSENTIALLY STABLE, AS A STABLE EPITOPES MIGHT PREDICT • VYD222 / pemivibart has not experienced a major deviation from the average IC50 baseline • VYD2311 has shown greater potency/stability (orange line at bottom of graph) • Pemivibart epitope str

  26. Slide 26: Potential Vendor Contamination Event Requires Regeneration of One AVNA Value

    A POTENTIAL VENDOR CONTAMINATION EVENT REQUIRES REGENERATION OF ONE AVNA VALUE • In mid-July, Invivyd learned and promptly notified the FDA of a potential contamination event at a vendor that provides authentic viral neutralization assay (AVNA) testing services to the industry, including Invivyd • I

  27. Slide 27: Agenda: Finance

    u Executive Summary u Commercial Update u Pipeline u Virology u Finance Q&A 27

  28. Slide 28: Financials

    FINANCIALS • Ended Q2 2024 with cash and cash equivalents of $147.9 million • Revenue and cash guidance re-iterated ($150-$200m in revenue), $75m in year-end cash • Previously announced operating efficiencies began to take effect in Q2 • VYD2311 clinical and launch material production; meaningful qu

  29. Slide 29: Q&A

    u Executive Summary u Commercial Update u Pipeline u Virology u Finance u Q&A 29

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