Valneva Se · EURONEXT:VLA
Valneva — 9M 2020 Earnings Presentation
32 slides from Valneva's earnings presentation, Nov 3, 2020
Slide 1: Valneva presents its 9M 2020 financial results
Valneva presents its 9M 2020 financial results Analyst Presentation November 3, 2020
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The Valneva shares may not be offered or sol
Slide 3: Agenda
Agenda Introduction R&D Update Financial Report 9M 2020 Financial Outlook Newsflow Q&A Valneva 9M 2020 Analyst Presentation November 3, 2020 3
Slide 4: 9M 2020 Results Marked by Further Major Corporate Achievements and Strong Cash Position
9M 2020 Results Marked by Further Major Corporate Achievements and Strong Cash Position Q3 milestones Operating financial results impacted by COVID-19 pandemic Major COVID-19 vaccine partnership with UK Limited product sales in Q3 Government › Pre-clinical and industrialization activities Gros
Slide 5: Agenda
Agenda Introduction R&D Update Financial Report 9M 2020 Financial Outlook Newsflow Q&A Valneva 9M 2020 Analyst Presentation November 3, 2020 5
Slide 6: VLA15: Lyme Disease Vaccine Candidate Partnering Deal with Pfizer, Positive Phase 2 Results
VLA15: Lyme Disease Vaccine Candidate Partnering Deal with Pfizer, Positive Phase 2 Results Exclusive, worldwide partnering deal with Pfizer for late stage development and future commercialization1. ▪ Valneva and Pfizer will work closely together throughout the development of VLA15 Positive initial
Slide 7: VLA15-202: Study Design
VLA15-202: Study Design Observer-blind, Randomized, Multicenter, Phase 2 Study Study population: 246 subjects (Safety Population) 18-65 years were enrolled, 213 subject included in PP population Day 208 Interim Analysis Safety to Day 208 ELISA Day 1/Day 85/Day 208 SBA Day 1/Day 208 VLA15 135 µg w/
Slide 8: VLA15-202: Overall Study Conclusions
VLA15-202: Overall Study Conclusions Phase 2 Study VLA15-202 Met its Endpoints VLA15 was generally safe across all doses and age groups tested. The tolerability profile including fever rates was comparable to other lipidated recombinant vaccines or lipid containing formulations. No related Serio
Slide 9: VLA1553: Chikungunya Vaccine Candidate Phase 3 Initiated, PRIME Designation Granted
VLA1553: Chikungunya Vaccine Candidate Phase 3 Initiated, PRIME Designation Granted Valneva initiated a pivotal Phase 3 study in September 2020 and is currently the most advanced chikungunya vaccine program worldwide. ▪ The sponsor of the first chikungunya vaccine Biologics License Application (BLA)
Slide 10: VLA1553-301: Pivotal Phase 3 Study
VLA1553-301: Pivotal Phase 3 Study Double-Blinded, Controlled, Randomized Study 1 Objectives: pivotal safety and immunogenicity; Seroprotection rate at D29 based on an immunological surrogate (defined in NHPs for baseline negative subjects). 1 2 Population: Healthy subjects aged 18 years and above
Slide 11: VLA2001: Only inactivated COVID-19 vaccine candidate in the US and the EU
VLA2001: Only inactivated COVID-19 vaccine candidate in the US and the EU 1 UK government deal worth up to €1.4 billion1 with development and manufacturing funding Leveraging Valneva's existing capabilities: BSL3 labs recommissioned for pre-clinical 2 activities; Plug-and-play at Valneva’s FDA-appro
Slide 12: VLA2001: Agreement to Provide 60-190 Million Doses of Inactivated Vaccine to the UK
VLA2001: Agreement to Provide 60-190 Million Doses of Inactivated Vaccine to the UK UK Government Agreement Worth up to €1.4 Billion ▪ Valneva to supply up to 190 million doses in a deal worth up to €1.4 billion1 ▪ UK government has purchased 60 million doses worth approximately €470 million for 202
Slide 13: VLA2001: Target Product Profile
VLA2001: Target Product Profile (20102020) Based on platform experiences, expected to meet preferred/ critical criteria defined in WHO TPP* Vaccine Properties Vaccine type Inactivated, adjuvanted (Alum, + „Th1“ adjuvant), whole virus, Vero cell substrate Indication For active immunization of at-
Slide 14: VLA2001: SARS-CoV-2 inactivated vaccine
VLA2001: SARS-CoV-2 inactivated vaccine Clinical Entry December 2020, Initial Safety & Immunogenicity Data: April 2021 Study Initiation 12/2020 Phase 1 Objective: Initial Safety and Dose Confirmation, N=150 18-55 yrs // 3 dose levels, Day 0/21 schedule Day 1 8 22 36 208 Initial safety and immunogeni
Slide 15: Agenda
Agenda Introduction R&D Update Financial Report 9M 2020 Financial Outlook Newsflow Q&A Valneva 9M 2020 Analyst Presentation November 3, 2020 15
Slide 16: Several Key 2020 Events Affect Cash and P&L
Several Key 2020 Events Affect Cash and P&L 1. Pfizer Lyme collaboration 2. UK Government COVID-19 partnership 3. $85 million debt financing arrangement 4. COVID-19 pandemic impact on travel business Cash P&L Valneva 9M 2020 Analyst Presentation November 3, 2020 16
Slide 17: Cash position of €156 million at end of September
Cash position of €156 million at end of September High September Receivables Turning Into Cash in Q4 FY 2020 cash outlook expected at between €180 million and €200 million ▪ UK government COVID-19 vaccine partnership deal executed in September, advance payments invoiced in September create high Q3 r
Slide 18: Cash Bridge September 2020 to December 2019
Cash Bridge September 2020 to December 2019 Cash Positively Impacted by Issuance of U.S. loan Facility & Pfizer Deal * Financing includes the issuance of a USD denominated loan facility ($60m drawn), the repayment of the EIB facility (€20m), and other costs related to financing activities 03.11.2020
Slide 19: 9M 2020 Product Sales Adversely Affected by the COVID-19 Pandemic
9M 2020 Product Sales Adversely Affected by the COVID-19 Pandemic 9M 2020 product sales at AER (unaudited) Product sales² DUKORAL® -47% AER / -48% CER €13.2m IXIARO® US Military Net €16.8m product sales Direct sales €45.9m 74% TPP1 Gross €1.9m margin³ IXIARO®/JESPECT® 37.4% Travel market €14.1m AER:
Slide 20: 9M 2020 Product Sales Analysis
9M 2020 Product Sales Analysis 9M 2020 to 9M 2019 Comparison (unaudited) €m 9M 2020 9M 2019 9M 2019 CER1 (unaudited) (AER) (CER) % (AER) IXIARO®/JESPECT® 30.8 64.2 65.3 -52.8% DUKORAL® 13.2 19.8 20.0 -34.0% Third party products 1.9 2.4 2.4 -21.3% Total 45.9 86.4 87.6 -47.6% 1 CER at constant exchang
Slide 21: Total Revenues of €58.8 Million in 9M 2020
Total Revenues of €58.8 Million in 9M 2020 (€81.4 Million in 9M 2019) Overall FY 2020 revenue guidance now expected at around €120 million ▪ Product sales revenue of €45.9 million in 9M 2020 were adversely affected by COVID-19 pandemic (€86.4 million in 9M 2019) and the US military phasing in Q4 ▪ F
Slide 22: 9M 2020 Gross Margin Analysis – Commercial Products
9M 2020 Gross Margin Analysis – Commercial Products Lower Product Sales Having Knock-on Effects on Gross Margin €m 9M 2020 9M 2019 Change vs. Inventory Idle Other 9M 2019 write-offs Capacity IXIARO®/JESPECT® 47.5% 70.0% -22.5% -18.0% -4.0% -0.5% DUKORAL® 15.4% 53.9% -38.5% -18.4% -11.4% -9.0%* Third
Slide 23: EBITDA Loss Reflecting Increasing R&D Expenses / Lower Sales
EBITDA Loss Reflecting Increasing R&D Expenses / Lower Sales 9M Profit & Loss Report at AER (unaudited) €m 9M 2020 9M 2019 Product sales 45.9 86.4 Revenues from collaboration, licensing and services 13.0 (5.0) Revenues 58.8 81.4 Cost of goods and services (35.1) (33.4) Research and development expen
Slide 24: 9M 2020 Margins Adversely Affected by the COVID-19 Pandemic
9M 2020 Margins Adversely Affected by the COVID-19 Pandemic Gross and Net Operating Margin at AER (unaudited) Gross Margin 9M 2020 9M 2019 Total product sales revenues (€m) 45.9 86.4 Total Product Sales Gross Margin (IXIARO®, DUKORAL® and Third Party Products) 37.4% 65.2% Net Operating Margin (€m) 9
Slide 25: 9M 2020 G&A Analysis
9M 2020 G&A Analysis Increased Spend Driven by Non-operational Expenses Total G&A spend increased in 9M 2020 to €19.3 million from €13.0 million in 9M 2019 ▪ Employee Stock Option / Long-term-incentive programs including employer contribution costs: €3.5 million (non-cash) ▪ Higher costs related to
Slide 26: EBITDA loss of €45.2 million in 9M 2020
EBITDA loss1 of €45.2 million in 9M 2020 (EBITDA profit of €3.0 million in 9M 2019) 1 Nine-month 2020 EBITDA was calculated by excluding €7.3m of depreciation and amortization (€6.2m in the first nine months of 2019) from the €52.5m operating loss (€3.2m in the fist nine months of 2019) as recorded
Slide 27: Agenda
Agenda Introduction R&D Update Financial Report 9M 2020 Financial Outlook Newsflow Q&A Valneva 9M 2020 Analyst Presentation November 3, 2020 27
Slide 28: FY 2020 Cash Outlook Expected at Between €180m and €200m
Valneva Guidance Update 9M2020 FY 2020 Cash Outlook Expected at Between €180m and €200m Including Pfizer collaboration impact Initial Guidance (Pre-COVID-19) 9M Guidance Update Product sales revenues €125m – €135m ~€70m Other revenues €10m ~€50m Total revenues €135m – €145m €120m - €140m ~€120m R&D
Slide 29: Agenda
Agenda Introduction R&D Update Financial Report 9M 2020 Financial Outlook Newsflow Q&A Valneva 9M 2020 Analyst Presentation November 3, 2020 29
Slide 30: Key Upcoming Newsflow
Key Upcoming Newsflow Lyme disease vaccine candidate VLA15 ▪ Valneva and Pfizer will prepare for next development steps in the coming months Chikungunya vaccine candidate VLA1553 ▪ Phase 3 recruitment completion expected in Q4 2020 Initiation of Phase 1 COVID-19 vaccine clinical trial ▪ Top line dat
Slide 31: Agenda
Agenda Introduction R&D Updates Financial Report H1 2020 Financial Outlook Newsflow Q&A Valneva 9M 2020 Analyst Presentation November 3, 2020 31
Slide 32: Thank you
Thank you Merci Danke Tack WaAvalneva