Valneva SE · EURONEXT:VLA
Valneva — H1 2015 Earnings Presentation
27 slides from Valneva's earnings presentation, Aug 31, 2015
Slide 1: Valneva SE presents its Q2/H1 2015 financial results
Valneva SE presents its Q2/H1 2015 financial results Analyst Presentation August 31, 2015
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer Forward Looking Statements These materials contain certain forward-looking statements relating to the business of Valneva SE (the “Company”), including with respect to the progress, timing and completion of the Company’s research, development and clinical trials for product candidates, th
Slide 3: Agenda
Agenda 1. Introduction – Key Events – Thomas Lingelbach 2. Financial report Q2/H1 2015 and outlook – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A Valneva - H1 2015 results August 31, 2015 3
Slide 4: Valneva's newsflow
Valneva’s newsflow July 2015 + New EB66® agreements with Fatro and Kaketsuken, 7 deals signed since beginning of year + Valneva and PaxVax enter into marketing and distribution agreement June 2015 + Valneva takes direct control over M&D of IXIARO® to increase margin and profitability May 2015 + Euro
Slide 5: Agenda
Agenda 1. Introduction – Key Events – Thomas Lingelbach 2. Financial report Q2/H1 2015 and outlook – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A Valneva - H1 2015 results August 31, 2015 5
Slide 6: Q2 2015 Financial Results
Q2 2015 Financial Results Compared to Q2 2014 (IFRS, EUR million, unaudited*) attributable to acquired Crucell Sweden AB and DUKORAL business Revenues & Grants COGS R&D Expenses 19.7 Q2 2015 Q2 2014 Q1 2015 Q2 2014 8.6 -4.9 -6.7 -1.6 -0.3 9.4 -4.8 -7.0 -7.9 11.1 -12.8 Q2 2015 Q2 2014 EBITDA** Net lo
Slide 7: Q2/H1 2015 Profit & Loss
Q2/H1 2015 Profit & Loss* (EUR in thousands) 3 months ended June 30, 6 months ended June 30, 2015 2014 2015 2014 Product sales 12,360 5,941 27,497 9,764 Revenues from collaborations and licensing, grants 7,353 3,434 11,717 6,707 Revenues and grants 19,713 9,376 39,214 16,471 Cost of goods and servic
Slide 8: H1 2015 Financial Analysis
H1 2015 Financial Analysis Compared to H1 2014 figures Revenues + Increase of aggregate revenues & grants by EUR 22.7 to EUR 39.2m; includes EUR 14.9 from newly acquired Crucell Sweden/Dukoral business + Product sales include: IXIARO®/JESPECT®: EUR 15.1m (+54.0%) DUKORAL® : EUR 8.1m (new) Nordics tr
Slide 9: H1 2015 Financial Analysis
H1 2015 Financial Analysis Compared to H1 2014 figures Research and development expenses + Increase to EUR 12.5m from EUR 10.6m driven by clinical study costs for late stage pipeline projects Sales, general and administrative expenses + Increase by EUR 3.3m to EUR 10.7m; includes EUR 4.2m SG&A costs
Slide 10: Financial Outlook
Financial Outlook 2015 marked by integration of Crucell Sweden/DUKORAL® and temporary IXIARO® transition impact FY 2015 revenues and grants: expected at lower end of communicated EUR 75 to EUR 85 m range + Growth driven by acquired Crucell Sweden and Dukoral® business + Negative short-term transitio
Slide 11: Agenda
Agenda 1. Introduction – Key Events – Thomas Lingelbach 2. Financial report Q2/H1 2015 and outlook – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A Valneva - H1 2015 results August 31, 2015 11
Slide 12: Commercial product: Japanese encephalitis vaccine 1/2 IXIARO/JESPECT update
Commercial product: Japanese encephalitis vaccine 1/2 IXIARO®/JESPECT® update Product sales revenues (in EUR m) Q2/H1 2015 update JE vaccine product sales revenues increased by 54% to EUR 15.1m in H1 2015 vs. EUR 9.8m in H1 2014 H1* + Benefiting from continued growth of in-market sales FY 28,1 Q2 20
Slide 13: Valneva takes direct control over marketing and distribution of IXIARO
Commercial product: Japanese encephalitis vaccine 2/2 Valneva takes direct control over marketing and distribution of IXIARO® to increase margin and profitability Valneva has terminated the IXIARO®-related Significant improvement of sales margin and marketing and distribution agreement with GSK prof
Slide 14: Commercial product: Cholera/ETEC vaccine DUKORAL
Commercial product: Cholera/ (ETEC) vaccine DUKORAL® analysis of sales and growth potential DUKORAL® sales (in EUR m, pro forma**) Q2/H1 Update H1 2015 DUKORAL® pro forma product sales revenues amounted to EUR 13.4m** compared to 11.5m pro forma in H1 H1 2014 FY + Strong sales in key markets (Canada
Slide 15: Commercial platform – Nordics Trade
Commercial platform – Nordics Trade Leveraging presence in the European Nordic countries with complementary products Sales of third party products (in EUR m, pro forma**) SBL Vaccin Distribution + Business established historically to distribute the company’s own vaccines H1 FY + Marketing, sales & d
Slide 16: EB66 cell line platform
EB66® cell line platform A breakthrough technology in vaccine production Revenue generating platform Yearly target of 7 new licenses EB66®’s regulatory approvals & per year reached commercialization status + Fully characterized cell-line (avian Approved human vaccines embryonic stem cell derived) fo
Slide 17: Agenda
Agenda 1. Introduction – Key Events – Thomas Lingelbach 2. Financial report Q2/H1 2015 and outlook – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A Valneva - H1 2015 results August 31, 2015 17
Slide 18: Pseudomonas aeruginosa vaccine 1/3
Pre-commercial product: Pseudomonas aeruginosa vaccine 1/3 Targeting hospital-acquired pneumonia, with a market potential of USD 1bn Pseudomonas aeruginosa + Causes ~20% of all nosocomial (hospital-acquired) infections1,2 › Presence of Pseudomonas aeruginosa in ventilated patients associated with in
Slide 19: Pseudomonas aeruginosa vaccine 2/3
Pre-commercial product: Pseudomonas aeruginosa vaccine 2/3 Overview of study findings, phase II post-hoc analysis and update of phase II/III study Pre-clinical1 Additional findings from phase II post-hoc analysis Protective in a murine lethal Pseudomonas aeruginosa + Interesting findings in sub-pati
Slide 20: VLA43-202 confirmatory efficacy study
Pre-commercial product: Pseudomonas aeruginosa vaccine 3/3 VLA43-202 – a confirmatory efficacy study with pivotal character + Phase II/III, double-blind, randomized, multi-center, placebo- Possible positive outcomes of phase II/III study: controlled pivotal efficacy study* + Participating countries:
Slide 21: Clostridium difficile vaccine
Pre-commercial product: Clostridium difficile vaccine Targeting healthcare-associated diarrhea, with market potential of USD 1bn Clostridium difficile + Single most common pathogen of acute healthcare-associated diarrhea in the US1 › Estimated 470,000 cases of Clostridium Difficile globally in 2013
Slide 22: Lyme borreliosis vaccine
Pre-commercial product: Lyme borreliosis vaccine Targeting Lyme borreliose, with market potential above EUR 500m Lyme borreliosis + Is transmitted by Ixodes ticks1, causing Lyme borreliosis + Lyme disease is the most common vector borne illness in the Northern Hemisphere › Estimated ~85,000 cases pe
Slide 23: Agenda
Agenda 1. Introduction – Key Events – Thomas Lingelbach 2. Financial report Q2/H1 2015 and outlook – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A Valneva - H1 2015 results August 31, 2015 23
Slide 24: Anticipated news flow/progress till year end 2015/2016
Anticipated news flow/progress till year end 2015/2016 + Deliver on financial performance targets Commercialized + IXIARO® transition including new commercial partners/infrastructure products + Integration Valneva Sweden/DUKORAL® + Additional EB66® and IC31® licensing agreements expected Technologie
Slide 25: Update on transition and integration of DUKORAL and Crucell Sweden AB
Update on transition and integration of the acquired DUKORAL® and Crucell Sweden AB business + Acquired business showed negative gross margin Revenues in EUR m, pro forma and moderate net loss in H1 2015 + Integration into Valneva is progressing and restructuring of the cost base of manufacturing si
Slide 26: Agenda
Agenda 1. Introduction – Key Events – Thomas Lingelbach 2. Financial report Q2/H1 2015 and outlook – Reinhard Kandera 3. Commercialized Products & EB66® – Franck Grimaud 4. R&D programs – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A Valneva - H1 2015 results August 31, 2015 26
Slide 27: Thank you
Thank you Merci Danke Tack WAvalneva