Valneva Se · EURONEXT:VLA
Valneva — Q3 2016 Earnings Presentation
27 slides from Valneva's earnings presentation, Nov 9, 2016
Slide 1: Valneva presents its Q3/9M 2016 financial results
Valneva presents its Q3/9M 2016 financial results Analyst Presentation November 9, 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 Q3/9M 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q3/9M 2016 Analyst Presentation November 9, 2016 3
Slide 4: 9M 2016 Highlights
Strong business performance confirms the Company’s successful development into financial self-sustainability 9M 2016 Highlights Strong financial performance in 9M 2016 + Total revenues grew to €70.7 million (17% increase compared to 9M 2015) + Positive EBITDA of €3.5 million (vs. an EBITDA loss of €
Slide 5: 9M 2016 Highlights (continued)
Strong business performance confirms the Company’s successful development into financial self-sustainability 9M 2016 Highlights Vaccine development + Successful completion of Phase II for Clostridium difficile vaccine candidate + Successful generation of a highly-purified Zika vaccine candidate usin
Slide 6: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q3/9M 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q3/9M 2016 Analyst Presentation November 9, 2016 6
Slide 7: Q3 2016 financial results
Q3 2016 financial results Compared to Q3 2015 (IFRS, € million, unaudited*) Revenues & Grants COGS R&D Expenses Q3 2016 Q3 2015 Q3 2016 Q3 2015 (6.3) (6.2) (8.3) (10.0) 19.4 21.5 Q3 2016 Q3 2015 EBITDA* Net profit/loss Cash position Q3 2016 Q3 2015 Q3 2016 Q3 2015 1.0 42.6 40.3 (7.0) (5.2) (1.2) 30/
Slide 8: Q3/9M 2016 profit & loss (unaudited)
Q3/9M 2016 profit & loss (unaudited) € in thousand 3 months ended Sep 30, 9 months ended Sep 30, 2016 2015 2016 2015 Revenues and grants 19,354 21,468 70,741 60,682 Cost of goods and services (8,291) (9,988) (29,981) (33,646) R&D expenses (6,262) (6,241) (18,719) (18,730) Distribution and marketing
Slide 9: Business segment overview 9M 2016
Business segment overview 9M 2016 Two profitable segments funding R&D pipeline and overhead Revenues Operating profit/loss (before amortization*) Commercial products €56.8m €17.2m 55% gross margin 30% operating margin Technologies & services €8.6m €2.6m 46% gross margin 30% operating margin Propriet
Slide 10: Financial analysis 9M 2016
Financial analysis 9M 2016 Performance ahead of initial expectations 28.3% increase to €56.6m - driven by strong IXIARO®/JESPECT® sales Product sales (up 61.3% compared to 9M 2015) Total revenues €70.7m (up 16.5% compared to 9M 2015) - on track towards higher end of & grants FY 2016 revenue goal €30
Slide 11: Financial analysis (continued)
Financial analysis H1 2016 (continued) €39.5m non-cash amortization charges on acquired intangible assets Amortization of (includes one-time impairment charges of €34.1m related to the intangible assets Pseudomonas aeruginosa project from Q2) Financial income and Negative effects from EUR/GBP exchan
Slide 12: 2016 financial outlook
2016 financial outlook Financial guidance increased on the back of strong 9M performance Revenues €95 – 100m total revenues (up to 20% growth vs. 2015) €75 – 80m product sales (up to 30% growth vs. 2015) Commercial products Higher than 50% gross margin on product sales (vs. 32% in 2015) R&D investme
Slide 13: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q3/9M 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q3/9M 2016 Analyst Presentation November 9, 2016 13
Slide 14: 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 15: IXIARO/JESPECT: additional revenue margins under new network
Leading commercial product: Japanese encephalitis vaccine IXIARO®/JESPECT®: additional revenue margins under the new sales and distribution network Revenues in € million IXIARO®/JESPECT® Q3/9M 2016 revenue analysis 9M 2016 revenues grew 61.2% to €40.1m: € 39.9m product sales and €0.2m royalties 9M ~
Slide 16: 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 17: DUKORAL update
Commercial product: Cholera/ (ETEC1) vaccine DUKORAL® update Revenues in € million DUKORAL® Q3/9M 2016 revenue analysis 9M 2016 revenues reached €14.9m 9M (vs. €12.6m of Valneva sales in 9M 2015) FY + Increase sales due to sustained promotional efforts by Under previous owner Valneva and its distrib
Slide 18: EB66 platform for efficient large scale vaccine production
EB66® platform for efficient large scale vaccine production The technology is becoming increasingly profitable Revenue generating platform 6 new agreements signed Recent highlights in 2016 + Fully characterized cell-line GE Healthcare and Valneva (avian embryonic stem cell Research Commercial collab
Slide 19: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q3/9M 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q3/9M 2016 Analyst Presentation November 9, 2016 19
Slide 20: Valneva's pipeline of vaccine candidates
Valneva’s pipeline of vaccine candidates New pre-clinical candidates for future clinical development 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 propr
Slide 21: 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- + One of three clinical programs associated infection
Slide 22: Clostridium difficile vaccine: Next steps
Pre-commercial product: Clostridium difficile vaccine Next steps Phase II study close-out + Final Phase II results of Valneva’s Clostridium difficile vaccine candidate confirmed positive initial Phase II data that were released at the end of 2015. VLA 84 – ready for Phase III + The study design was
Slide 23: 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 24: Pre-clinical candidate: Zika virus vaccine
Pre-clinical candidate: Zika virus vaccine Targeting a Public Health Emergency of International Concern Zika virus disease Valneva’s vaccine candidate + Transmitted mostly by Aedes species mosquito, same + Vero cell based, highly purified, species also transmits Dengue, Yellow Fever etc. inactivated
Slide 25: Event calendar and anticipated news flow 2016
Event calendar and anticipated news flow 2016 + FY 2016 product sales guidance narrowed to the upper end of the expected range to reach €75 to €80m (up to 30% growth) Commercialized + Successful establishment of own global marketing & distribution network leading to products IXIARO®/JESPECT® sales e
Slide 26: Agenda
Agenda 1. Introduction – Newsflow – Thomas Lingelbach 2. Financial report Q3/9M 2016 – Reinhard Kandera 3. Commercialized products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. 2016 outlook – Thomas Lingelbach 6. Q&A Valneva Q3/9M 2016 Analyst Presentation November 9, 2016 26
Slide 27: Thank you.
Thank you. WAvalneva