Valneva SE · EURONEXT:VLA
Valneva — H1 2019 Earnings Presentation
22 slides from Valneva's earnings presentation, Aug 1, 2019
Slide 1: Valneva Presents its H1 2019 Financial Results
Valneva Presents its H1 2019 Financial Results Analyst Presentation August 1, 2019
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 Financial Report H1 2019 R&D Portfolio Update Outlook Q&A Valneva H1 2019 Analyst Presentation August 1, 2019 3
Slide 4: Valneva reports H1 2019 marked by strong operational performance and major corporate progress
Valneva reports H1 2019 marked by strong operational performance and major corporate progress Strong product ✔ + Product sales €61.6m, 12% CER1 growth sales, improved margins, positive + Gross margin of 66.1% EBITDA + EBITDA €2.4m, EBITDA €13.1m adjusted2 ✔ + VLA15: final Phase 1/first booster data
Slide 5: Agenda
Agenda Introduction Financial Report H1 2019 R&D Portfolio Update Outlook Q&A Valneva H1 2019 Analyst Presentation August 1, 2019 5
Slide 6: Strong product sales and gross margin
Strong product sales and gross margin H1-2019 DUKORAL® Product sales €15.2m growth (CER) 12% Net product sales Direct sales TPP1 88.4% €61.6m €1.4m Gross margin2 IXIARO®/ 66.1% JESPECT® €45.1m CER: at constant exchange rates; 1 Third party products sold by Valneva‘s commercial organization, 2 Gross
Slide 7: IXIARO contributes > 70% of sales and is the primary sales growth driver
IXIARO® contributes > 70% of sales and is the primary sales growth driver €m (CER1) H1 2019 H1 2018 CER H1 2018 (unaudited) CER % Actual Actual IXIARO®/JESPECT® 45.1 39.1 15% 37.6 DUKORAL® 15.2 14.3 7% 14.2 Third party products 1.4 1.8 -23% 1.7 Total 61.6 55.1 12% 53.5 1 CER at constant exchange rat
Slide 8: GSK SAA termination reduces revenues by €10.7m
GSK SAA termination reduces revenues by €10.7m Net revenue effect according to IFRS €m Total revenues (excl. effect of GSK SAA termination) 65.2 Settlement Fee (Fixed) (9.0) Settlement Fee (Conditional; discounted)1 (6.0) Release of SAA related contract liability 4.3 Net effect of GSK SAA terminatio
Slide 9: Financial results highlights (IFRS, € million) incl. GSK SAA termination effects
Strong year on year financial performance Financial results highlights (IFRS, € million) incl. GSK SAA termination effects Total revenues Net product sales 65.2 GSK SAA 10.7 termination effects 61.6 59.0 54.5 53.5 H1 2019 H1 2018 H1 2019 H1 2018 EBITDA Net profit/(loss) Cash 69.9 13.1 8.3 5.8 37.7 1
Slide 10: On an adjusted basis, best H1 result in Company's history
On an adjusted* basis, best H1 result in Company´s history 2019 Profit & Loss Report (all figures at AER) * excluding SAA termination accounting / revenue recognition effect €m 6 months ended June, 2019 2019 2018 excl. SAA effect Product sales 61.6 53.5 Revenues from collaboration, licensing and ser
Slide 11: ASP and operational efficiency have improved gross margin
ASP and operational efficiency have improved gross margin Gross margin at AER Gross Margins ∆ in H1 2019 H1 2018 pps TOTAL PRODUCT SALES REVENUES (€m) 61.6 53.5 Total Product Sales Gross Margin (IXIARO®, DUKORAL® and Third Party Products) 66.1% 60.0% ASP: Average Selling Price Valneva H1 2019 Analys
Slide 12: Net operating margin has also improved
Net operating margin has also improved All figures at AER excluding GSK SAA termination effects €m 6 months ended June 30th, 2019 2018 Product sales 61.6 53.5 Revenues from collaboration, licensing and 0.1 0.1 services Revenues 61.7 53.6 Cost of goods and services (20.9) (21.4) Commercial costs1 (19
Slide 13: Agenda
Agenda Introduction Financial Report H1 2019 R&D Portfolio Update Outlook Q&A Valneva H1 2019 Analyst Presentation August 1, 2019 13
Slide 14: Lyme disease is a serious unmet medical issue
Lyme disease is a serious unmet medical issue VLA15 is the only vaccine candidate in clinical development today 1 Multivalent vaccine (six serotypes) to protect against Lyme disease in N. America and Europe Targets OspA of Lyme borrelia, preventing spirochetes from migrating through the tick’s mid-
Slide 15: Lyme disease vaccine candidate VLA15: progression on track
Lyme disease vaccine candidate VLA15: progression on track Status update Final Phase 1 data and first booster data for Lyme vaccine candidate reported ✔ Successful outcome of Phase 2 Run-In (June) and initiation of second Phase 2 study VLA15-202 + Based on DSMB clearance, two lead dosage levels have
Slide 16: Chikungunya is a major public health threat
Chikungunya is a major public health threat VLA1553 is a unique, differentiated single-shot vaccine candidate 1 Currently no preventive vaccines or effective antiviral treatments exist for chikungunya VLA1553 is a monovalent, single dose, live attenuated1 prophylactic vaccine targeting 2 chikungunya
Slide 17: Chikungunya vaccine candidate VLA1553: progression on track
Chikungunya vaccine candidate VLA1553: progression on track Status update Further Phase 1 results for single-shot chikungunya vaccine candidate reported ✔ + Day 28 safety and immunogenicity after single dose + Viremia data at Days 3, 7 and 14 post-vaccination + Month 6 safety and immunogenicity data
Slide 18: Agenda
Agenda Introduction Financial Report H1 2019 R&D Portfolio Update Outlook Q&A Valneva H1 2019 Analyst Presentation August 1, 2019 18
Slide 19: 2019 financial guidance confirmed irrespective of GSK SAA termination effects
2019 financial guidance confirmed irrespective of GSK SAA termination effects 2018 2019 Product sales €103.5m €115m - €125m revenues Total revenues €113.0m €125m - €135m R&D investments €25.3m €35m - €40m Gross margin 60.7% > 60% Net operating 24.1% 25% - 35% margin1 EBITDA €13.1m €5m - €10m 1 Net o
Slide 20: Important most recent and expected upcoming newsflow
Important most recent and expected upcoming newsflow Overview Valneva held its R&D Investor Day in New York CEPI agreement, award of up to $23.4 million for late-stage development of a single- dose chikungunya vaccine Establishment of a Scientific Advisory Board announced On track to deliver 15-20%
Slide 21: Agenda
Agenda Introduction Financial Report H1 2019 R&D Portfolio Update Outlook Q&A Valneva H1 2019 Analyst Presentation August 1, 2019 21
Slide 22: Thank you
Thank you Merci Danke Tack WAvalneva