Valneva Se · EURONEXT:VLA
Valneva — Q1 2016 Earnings Presentation
28 slides from Valneva's earnings presentation, May 11, 2016
Slide 1: Valneva presents its Q1 2016 financial results
Valneva presents its Q1 2016 financial results Analyst Presentation May 11, 2016
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commerc
Slide 3: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q1 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q1 2016 Analyst Presentation May 11, 2016 3
Slide 4: Valneva's newsflow
Valneva’s newsflow March 2016 + Valneva presented at the 16th World Vaccine Congress in Washington D.C. + Valneva announced FY 2015 results, confirmed positive trend towards strong revenue growth and EBITDA break-even, and presented its 2020 strategy + Valneva signed $42 million IXIARO® supply contr
Slide 5: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q1 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q1 2016 Analyst Presentation May 11, 2016 5
Slide 6: Q1 2016 financial results
Q1 2016 financial results Compared to Q1 2015 (IFRS, € million) Revenues & Grants COGS R&D Expenses Q1 2016 Q1 2015 Q1 2016 Q1 2015 (5.8) (5.5) (12.9) (12.1) 24.7 19.5 Q1 2016 Q1 2015 EBITDA* Net profit/loss Cash position Q1 2016 Q1 2015 Q1 2016 Q1 2015 9.8 42.6 33.4 0.0 (1.0) (5.0) 31/03/2016 31/12
Slide 7: Q1 2016 profit & loss (unaudited)
Q1 2016 profit & loss (unaudited) € in thousand 3 months ended March 31 2016 2015 Revenues and grants 24,687 19,501 Cost of goods and services (12,921) (12,110) R&D expenses (5,798) (5,504) Distribution and marketing expenses (3,295) (1,218) General and administrative expenses (3,765) (2,768) Amorti
Slide 8: Business segment overview
Business segment overview Two profitable segments funding R&D pipeline Revenues Operating profit/loss (before amortization*) Commercial products €20.5m €4.8m 45% gross margin 23% operating margin Technologies & services €2.7m €0.6m 41% gross margin 23% operating margin Proprietary R&D €1.4m (€2.6m)
Slide 9: Financial analysis Q1 2016
Financial analysis Q1 2016 35.1% increase to €20.4m Product sales Driven by strong IXIARO®/JESPECT® sales (up 50.2% compared to Q1 2015) Total revenues €24.7m (up 26.6% compared to Q1 2015) - on track to meet €90-100m & grants revenue goal for FY 2016 €12.9m total COGS yielding 47.7% gross margin, i
Slide 10: Financial analysis Q1 2016 (continued)
Financial analysis Q1 2016 (continued) Amortization of €1.7m non-cash amortization charges on acquired intangible assets intangible assets Financial income and Last year’s Q1 2015 includes €13.2m retrospective gain related to Crucell expenses Sweden and DUKORAL® acquisition EBITDA (Slightly) positiv
Slide 11: 2016 financial outlook confirmed
2016 financial outlook confirmed Strong revenue growth and positive trend towards EBITDA break-even Revenues €90 – 100m total revenues (up to 20% growth vs. 2015) €70 – 80m product sales (up to 30% growth vs. 2015) Commercial products 50% gross margin on product sales (vs. 32% in 2015) R&D investmen
Slide 12: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q1 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q1 2016 Analyst Presentation May 11, 2016 12
Slide 13: Leading commercial product: Japanese encephalitis vaccine
Leading commercial product: Japanese encephalitis vaccine Protecting travelers from the most common encephalitis in Asia1 Japanese Encephalitis vaccine + Designed to protect travelers, military personnel and populations in endemic regions against Japanese encephalitis (JE) + Indicated for active imm
Slide 14: IXIARO/JESPECT: significant growth in Q1 2016
Leading commercial product: Japanese encephalitis vaccine IXIARO®/JESPECT ®: significant growth in Q1 2016 Product sales revenues in € million Q1 2016 sales analysis IXIARO®/JESPECT® product sales increased to €14.6m + Compared to €9.7m (Q1 2015) Q1 ~50 FY Growth mainly driven by strong sales to the
Slide 15: Commercial product: Cholera/(ETEC) vaccine
Commercial product: Cholera/ (ETEC1) vaccine Established vaccine in the field of diarrhea DUKORAL® + For the prevention of diarrhea caused by Vibrio cholera (cholera) and/or heat-labile toxin producing enterotoxigenic Escherichia coli (ETEC)1 + In a number of countries including the EU, indicated to
Slide 16: DUKORAL update
Commercial product: Cholera/ (ETEC1) vaccine DUKORAL® update Product sales revenues in € million Q1 2016 sales analysis DUKORAL® product sales reached €5.4m Q1 + Compared to €4.5m (Q1 2015) FY + Compared to €9.8m pro-forma revenues² (Q1 2015 ) sales under previous owner Lower sales due to updated pr
Slide 17: EB66 platform for efficient large scale vaccine production
EB66® platform for efficient large scale vaccine production Potential additional milestones of up to €80m Revenue generating platform 10 new agreements signed Highlights in 2015 + Fully characterized cell-line New R&D collaboration agreement (avian embryonic stem cell Research Commercial with GSK fo
Slide 18: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q1 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q1 2016 Analyst Presentation May 11, 2016 18
Slide 19: Valneva's pipeline of vaccine candidates
Valneva’s pipeline of vaccine candidates New research candidates for future clinical development Product Candidate Discovery Pre-clinical IND Phase I Phase II Phase III Partner research research enabling Pseudomonas Co-development Clinical vaccine aeruginosa with GSK candidates Clostridium difficile
Slide 20: Pre-commercial product: Pseudomonas aeruginosa vaccine
Pre-commercial product: Pseudomonas aeruginosa vaccine Data release from Phase II/III trial expected in Q2 2016 Pseudomonas aeruginosa Valneva’s vaccine candidate + Causes ~20% of all hospital-acquired infections 1,2 Only program in clinical development + Target population: patients in intensive car
Slide 21: Pseudomonas aeruginosa vaccine: potential routes to marketing approval
Pre-commercial product: Pseudomonas aeruginosa vaccine Potential routes to marketing approval 3 options for the product to reach the market Phase II/III primary endpoint met (reduction of all-cause mortality on Day 28) + Trial in support of product licensure Study does not meet primary endpoint but
Slide 22: Pre-commercial product: Clostridium difficile vaccine
Pre-commercial product: Clostridium difficile vaccine Vaccine targeting healthcare-associated diarrhea, an increasing threat to elderly Clostridium difficile (C. diff) Valneva’s vaccine candidate + Single most common pathogen of acute healthcare- + Vaccine targeting primary associated infections in
Slide 23: Clostridium difficile vaccine: next steps
Pre-commercial product: Clostridium difficile vaccine Next steps Phase II study close-out + Immune response and safety parameters monitored until Day 210, final study close-out expected mid 2016. VLA 84 – ready for Phase III + The study design was agreed with regulators in Europe and the US with the
Slide 24: Pre-commercial product: Lyme borreliosis vaccine
Pre-commercial product: Lyme borreliosis vaccine Targeting Lyme borreliosis, with market potential of above €500m4 Lyme borreliosis Valneva’s vaccine candidate + Transmitted by Ixodes ticks1, causing Lyme + Only active clinical program, no vaccine on the market + Most common vector borne illness in
Slide 25: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q1 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q1 2016 Analyst Presentation May 11, 2016 25
Slide 26: Event calendar and anticipated newsflow 2016
Event calendar and anticipated newsflow 2016 + Product sales in the expected range of €70 to €80m (up to 30% growth) Commercialized + Successful implementation of own global marketing & distribution network with products IXIARO®/JESPECT® sales of ~€50m + Expected gross margin on product sales of app
Slide 27: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q1 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q1 2016 Analyst Presentation May 11, 2016 27
Slide 28: Thank you.
Thank you. WaAvalneva