Vaxcyte, Inc. · NASDAQ:PCVX
Vaxcyte — FY2022 Earnings Presentation
22 slides from Vaxcyte's earnings presentation, Feb 27, 2023
Slide 1: 4Q & FY 2022 Financial Results and Business Update
4Q & FY 2022 Financial Results and Business Update February 27, 2023
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 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s vaccine candidates, including bread
Slide 3: Vaxcyte Mission Statement
VAXCYTE MISSION STATEMENT We are on a global mission to engineer high- fidelity vaccines that protect humankind from the consequences of bacterial diseases. February 27, 2023 3
Slide 4: 2022 Key Accomplishments & Recent Highlights
2022 Key Accomplishments & Recent Highlights February 27, 2023 4
Slide 5: 2022 Key Accomplishments and Recent Highlights
2022 Key Accomplishments and Recent Highlights 2022 Key Accomplishments • Reported positive topline safety, tolerability and immunogenicity data from Phase 1/2 poof-of-concept study of VAX-24 in adults aged 18-64; data indicate potential best-in-class profile • Completed enrollment of Phase 2 study
Slide 6: Pipeline of High-Fidelity Vaccines
Pipeline of High-Fidelity Vaccines Broad-Spectrum Conjugate and Novel Protein Vaccines to Prevent or Treat Bacterial Infectious Diseases Preclinical Phase 1 Phase 2 Phase 3 Approved Adults 18-64 Lead Candidate VAX-24 Adults 65+ 24-Valent PCV Infants Next-Generation VAX-31 Adults & Infants 31-Valent
Slide 7: Critical Manufacturing Foundation Established for PCV Franchise
Critical Manufacturing Foundation Established for PCV Franchise Long-term Investment and Strategic Partnerships to Deliver Commercial, Scalable Manufacturing Capabilities STRATEGIC ALIGNMENT WITH LONGSTANDING RELATIONSHIP WITH WORLD-CLASS CDMO SUPPLIER OF KEY VACCINE COMPONENT • End-to-end “turn-key
Slide 8: PCV Franchise
PCV Franchise February 27, 2023 8
Slide 9: Topline VAX-24 Phase 1/2 Proof-of-Concept Safety, Tolerability and Immunogenicity Results in Adults 18-64
Topline VAX-24 Phase 1/2 Proof-of-Concept Safety, Tolerability and Immunogenicity Results in Adults 18-64 POSITIVE RESULTS SUPPORT BEST-IN-CLASS POTENTIAL FOR VAX-24 AND CARRIER-SPARING PCV FRANCHISE • VAX-24 demonstrated a safety and tolerability profile similar to PCV20 at all three doses studied
Slide 10: Design of VAX-24 Phase 2 Clinical Study in Adults 65 Years & Older
Design of VAX-24 Phase 2 Clinical Study in Adults 65 Years & Older Design: Randomized, Observer-Blind, Dose-Finding, Controlled Study to Evaluate Safety, Tolerability & Immunogenicity of VAX-24 vs SOC in Adults Aged 65 and Older • The study is evaluating safety, tolerability Phase 2 Study and immuno
Slide 11: Key Objectives & Expectations for VAX-24 Phase 2 Study in Adults 65+
Key Objectives & Expectations for VAX-24 Phase 2 Study in Adults 65+ Topline safety, tolerability and immunogenicity data expected in Q2 2023 KEY CONSIDERATIONS IMMUNOGENICITY FOCUS AREAS • Smaller study with ~50 subjects per cohort vs. ~200 • Key immunogenicity readouts are point estimates for per
Slide 12: Age Stratified OPA GMR for 2.2mcg VAX-24 Dose Compared to PCV20
Age Stratified OPA GMR for 2.2mcg VAX-24 Dose Compared to PCV20 Similar Results Between Age Groups With Higher Variability in Older Population Due to Smaller Sample Size VAX-24 2.2mcg 50 - 64 yrs VAX-24 2.2mcg 50 - 59 yrs VAX-24 2.2mcg 60 - 64 yrs n=175 (VAX-24), 174 (PCV20) n=122 (VAX-24), 116 (PCV
Slide 13: Design of VAX-24 Phase 2 Clinical Study in Infants
Design of VAX-24 Phase 2 Clinical Study in Infants; Initiation Expected in Q2:231 Randomized, Observer-Blind, Active-Controlled, Dose-Finding, Clinical Study to Evaluate Safety, Tolerability & Immunogenicity of VAX-24 vs SOC in Healthy Infants Stage 1: Dose Escalation (n~48) Stage 2: Main Study (n~7
Slide 14: Early-Stage Pipeline Programs
Early-Stage Pipeline Programs February 27, 2023 14
Slide 15: VAX-A1: Group A Strep Conjugate Vaccine Program
VAX-A1: Group A Strep Conjugate Vaccine Program Novel Conjugate Vaccine Designed to Provide Universal Protection UNMET • Group A Strep results in 700M cases of illness annually worldwide, including pharyngitis, or strep throat, and certain severe invasive infections NEED such as sepsis, necrotizing
Slide 16: VAX-PG: Periodontitis Vaccine Program
VAX-PG: Periodontitis Vaccine Program Therapeutic Vaccine Targeting Gingipains to Address Large, Underserved Market UNMET • Periodontal disease is a chronic oral inflammatory disease leading to destruction of soft & hard tissues supporting the teeth NEED • Highly prevalent: estimated 65 million US a
Slide 17: VAX-GI: Shigella Vaccine Program
VAX-GI: Shigella Vaccine Program Novel Shigella Vaccine UNMET • Shigella is a bacterial illness with no available preventative treatment NEED • Affects an estimated 180 million people worldwide each year and results in approximately 164,000 deaths annually, mostly among children under five years of
Slide 18: Financial Update
Financial Update February 27, 2023 18
Slide 19: Financial Update
Financial Update (in millions) FY 2022 FY 2021 Cash, Cash Equivalents and Investments $957.9 $273.1 R&D Expenses $169.5 $78.4 Acquired Manufacturing Expenses 23.0 - SG&A Expenses 39.8 25.3 Total Operating Expenses 232.3 103.7 Net Loss $(223.5) $(100.1) For 2023: • Expect substantial increase in tota
Slide 20: Upcoming Milestones
Upcoming Milestones February 27, 2023 20
Slide 21: Anticipated PCV Franchise Milestones for 2023-2025
Anticipated PCV Franchise Milestones for 2023-20251 Vaxcyte is Advancing Clinical Development of VAX-24 and VAX-31 with Several Key Upcoming Milestones VAX-24 VAX-24 VAX-31 Adult Infant Adult • Topline safety, tolerability and • Infant Phase 2 study initiation in Q2:23 • Adult IND application submis
Slide 22: Thank you
Thank you For questions, contact: Jennifer Zibuda, Senior Director, Investor Relations 860-729-8902 investors@vaxcyte.com vaxcyte.com February 27, 2023 22