Valneva Se · EURONEXT:VLA
Valneva — FY2016 Earnings Presentation
28 slides from Valneva's earnings presentation, Mar 23, 2017
Slide 1: Valneva presents its FY 2016 financial results
Valneva presents its FY 2016 financial results Analyst Presentation March 23, 2017
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. 2016 review – Thomas Lingelbach 2. Financial report Q4 & FY 2016 – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2017 outlook and 2020 strategy – Thomas Lingelbach 6. Q&A Valneva FY 2016 Analyst Presentation March 23, 2017 3
Slide 4: Valneva's business year 2016
Valneva’s business year 2016 Excellent operational performance Significant sales growth following establishment of new commercial network + IXIARO ® /JESPECT ® revenues increased by 73.1% to €53.2 million in 2016 (vs €30.7 million in 2015) + Taking over marketing and distribution responsibilities in
Slide 5: Valneva's business year 2016
Valneva’s business year 2016 Our vaccines R&D efforts are of strategic importance in order to generate long-term returns Clinical vaccine candidates + Successful completion of Phase II study announced in 2016; Phase III-ready Clostridium difficile vaccine candidate partnering agreement sought in 201
Slide 6: Agenda
Agenda 1. 2016 review – Thomas Lingelbach 2. Financial report Q4 & FY 2016 – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2017 outlook and 2020 vision – Thomas Lingelbach 6. Q&A Valneva FY 2016 Analyst Presentation March 23, 2017 6
Slide 7: Full Year 2016 financial results
Full Year 2016 financial results Compared to FY 2015 (IFRS, € million, audited) Revenues & Grants COGS R&D Expenses FY 2016 FY 2015 FY 2016 FY 2015 (24.6) (25.4) (43.1) (47.0) 97.9 83.3 FY 2016 FY 2015 EBITDA* Net profit/loss Cash position Q3 2016 Q3 2015 FY 2016 FY 2015 (20.6) 42.2 42.6 2.8 (49.2)
Slide 8: Full Year 2016 Profit & Loss (audited)
Full Year 2016 Profit & Loss (audited) € in thousand 3 months ended Dec 31, 12 months ended Dec 31, 2016 2015 2016 2015 Revenues and grants 27,151 22,652 97,892 83,335 Cost of goods and services (13,094) (13,315) (43,076) (46,961) R&D expenses (5,871) (6,636) (24,589) (25,367) Distribution and marke
Slide 9: Business segment overview Full Year 2016
Business segment overview Full Year 2016 Two profitable segments funding R&D pipeline and overhead Revenues Operating profit/loss (before amortization & impairment*) Commercial products €80.8m €23.4m 54% gross margin 29% operating margin Technologies & services €10.1m €2.1m 39% gross margin 21% oper
Slide 10: Financial analysis Full Year 2016: Performance ahead of initial expectations
Financial analysis Full Year 2016 Performance ahead of initial expectations 30.7% increase to €80.4m - driven by strong IXIARO®/JESPECT® sales Product sales (up 73.1% compared to FY 2015) Total revenues & grants €97.9m (up 17.5% compared to FY 2015) €43.1m total COGS yielding 56.0% gross margin, inc
Slide 11: Financial analysis Full Year 2016: First year of positive EBITDA
Financial analysis Full Year 2016 First year of positive EBITDA in 2016 €41.2m non-cash amortization & impairment charges on acquired intangible assets Amortization of (includes €34.1m Pseudomonas write off);€59.0m intangible assets remaining, 82% intangible assets relating to IXIARO® Positive EBITD
Slide 12: 2017 financial outlook
2017 financial outlook Continued revenue growth and positive EBITDA trend 2016 Actual 2017 Outlook Growth up to 17% growth vs. Revenues €97.9m €105 – 115m 2016 IXIARO® €53.0m €58 – 62m 10 – 15% Product sales DUKORAL® €24.6m €27m 10% R&D investments (20% of revenues) €24.6 €21 – 23m – EBITDA €2.8 €5
Slide 13: Agenda
Agenda 1. 2016 review – Thomas Lingelbach 2. Financial report Q4 & FY 2016 – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2017 outlook and 2020 vision – Thomas Lingelbach 6. Q&A Valneva FY 2016 Analyst Presentation March 23, 2017 13
Slide 14: Valneva's new global marketing & distribution network established
Valneva’s new global marketing & distribution network established With commercial teams in the US, Canada, the UK, Austria and the Nordics, Valneva is well positioned to directly serve the key markets for its own and third-party products. + More than 68% of 2016 product sales are expected to be gene
Slide 15: 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 and populations in endemic regions against Japanese encephalitis (JE) + Indicated for active immunization
Slide 16: Japanese encephalitis vaccine: Product financials
Leading commercial product: Japanese encephalitis vaccine Product financials 2015 FY 20161 2020 Valneva product sales in Geographic split Gross margin € million Valneva COGS 10% annual Other growth countries, expected 10% ~70% US military, +73.1% 40% Europe, 53.0 30% >55% US 46% private, 30.6 20% Sp
Slide 17: Commercial product: Cholera/ETEC vaccine
Commercial product: Cholera/ (ETEC1) vaccine Established vaccine in the field of cholera/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, indi
Slide 18: Cholera/ETEC vaccine: Product financials
Commercial product: Cholera/ (ETEC1) vaccine Product financials 2015 20162 2020 Product Sales in € million Canada remains the most Gross margin important market Valneva COGS Other countries; 20% 26.33 5 to 10% annual 5.3 >55% growth Australia/New ~45% expected Zealand; 10% 13% 24.6 Canada; 50% 21.0
Slide 19: EB66 platform for efficient large scale vaccine production
EB66® platform for efficient large scale vaccine production A technology becoming increasingly profitable Revenue generating platform 10 new agreements signed in 2016 2016 highlights + Fully characterized cell-line + First royalties for an EB66 ® (avian embryonic stem cell Research Commercial based
Slide 20: Agenda
Agenda 1. 2016 review – Thomas Lingelbach 2. Financial report Q4 & FY 2016 – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2017 outlook and 2020 vision – Thomas Lingelbach 6. Q&A Valneva FY 2016 Analyst Presentation March 23, 2017 20
Slide 21: Valneva's pipeline of vaccine candidates
Valneva’s pipeline of vaccine candidates With a focus on urgently needed vaccines Product Candidate Discovery Pre-clinical IND Phase I Phase II Phase III Partner research research enabling candidates Clostridium difficile TBD Clinical Lyme borreliosis proprietary Chikungunya proprietary Pre-clinical
Slide 22: Pre-commercial product: Clostridium difficile vaccine
Pre-commercial product: Clostridium difficile vaccine Vaccine targeting healthcare-associated diarrhea, an increasing threat to the elderly Clostridium difficile (C. diff) Valneva’s vaccine candidate + Single most common pathogen of acute healthcare- + One of three clinical programs associated infec
Slide 23: Pre-commercial product: Lyme disease vaccine
Pre-commercial product: Lyme disease vaccine Market potential of approximately €700m - €800m5 Lyme disease 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 the Northern Hemisphere (
Slide 24: Agenda
Agenda 1. 2016 review – Thomas Lingelbach 2. Financial report Q4 & FY 2016 – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2017 outlook and 2020 vision – Thomas Lingelbach 6. Q&A Valneva FY 2016 Analyst Presentation March 23, 2017 24
Slide 25: Valneva – expected newsflow and outlook
Valneva – expected newsflow and outlook + IXIARO® /JESPECT® sales expected to grow by 10-15% to €58-62m in 2017 Products + DUKORAL ® sales expected to grow by 10% to €27m in 2017 + Upside from additional distribution agreements for third party products + Lyme Phase I progression and acceleration tow
Slide 26: 2020 strategy – A journey to success
2020 strategy – A journey to success Becoming a leading independent pure play vaccine company Products R&D Growing revenues from Investing 15-20% of annual existing and future revenues in R&D programs products to €250m delivering patient benefit and long-term value Financials Growth Achieving financ
Slide 27: Agenda
Agenda 1. 2016 review– Thomas Lingelbach 2. Financial report Q4 & FY 2016 – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2017 outlook and 2020 vision – Thomas Lingelbach 6. Q&A Valneva FY 2016 Analyst Presentation March 23, 2017 27
Slide 28: Thank you.
Thank you. WAvalneva