Valneva Se · EURONEXT:VLA
Valneva — Shareholder Meeting (June 2016)
73 slides from Valneva's shareholder meeting presentation, Jun 30, 2016
Slide 1: Annual General Meeting Valneva SE
Annual General Meeting Valneva SE June 30, 2016 Lyon
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. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 4: AGM preliminary formalities
AGM preliminary formalities Sign attendance sheet (all) Appoint AGM committee (chairman, observers, secretary) Validation of the Quorum (secretary) Agenda (chairman) Documents filed with the AGM committee (secretary) VALNEVA - Annual General Meeting June 30, 2016 4
Slide 5: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 6: Introduction
Introduction http://www.worldometers.info/fr/ VALNEVA - Annual General Meeting June 30, 2016 6
Slide 7: Valneva successfully becomes an independent vaccine company
Valneva successfully becomes an independent vaccine Company Successful establishment of global S&M network. Valneva Valneva takes opens commercial offices in Acquisition of direct control of Canada and the UK Cholera/ETEC marketing & vaccine + S&M* distribution of Valneva sells structure in the IXIA
Slide 8: Valneva's share price development since 2013
Valneva’s share price development since 2013 Valneva’s constant evolution and revenue growth not reflected in the share price € 9.00 8.00 7.00 6.00 5.00 4.00 3.00 2.00 1.00 0.00 5/28/2013 5/28/2014 5/28/2015 5/28/2016 Valneva share price in € (Paris, closing price) VALNEVA - Annual General Meeting J
Slide 9: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 10: Valneva, a leading pure play and independent vaccine company
Valneva, a leading pure play and independent vaccine company Offering commercial Products, R&D Portfolio and Platforms 2 commercial products Products + Valneva expects a 30% increase in product sales leading to total revenues of €90-100m1 in 2016, and an improvement in profitability 2 clinical produ
Slide 11: Vaccine market: global trends drive continued growth
Vaccine market Global trends drive the continued growth of the vaccine market Health economics increase focus on prevention Market development1 ($bn) of diseases (vs. treatment) 85.0 77.9 72.0 66.7 Increased prevention awareness resulting in a 61.8 53.1 57.5 higher vaccination rate 48.0 42.9 38.
Slide 12: Valneva SE corporate profile
Valneva SE corporate profile A leading pure play vaccine company Corporate profile Stock information + Created in May 2013 through the merger of Vivalis + Listed on NYSE Euronext Paris and Vienna Stock SA and Intercell AG; Exchange + Expanded its business by acquiring a commercial + Number of ordina
Slide 13: Valneva's unique business model dedicated to vaccines
Valneva’s unique business model dedicated to Vaccines Marketed products, R&D portfolio and technology platforms Products/Commercial R&D and Technologies Research & Phase I / II Phase II / III Japanese encephalitis pre-clinical vaccine Pseudomonas aeruginosa – to be discontinued ~€50m sales in 20161
Slide 14: Valneva's new global marketing & distribution network
Valneva’s new global marketing & distribution network, well positioned to serve key markets More than 60% of 2016 product sales are expected to be generated by Valneva’s own teams in the US, Canada, the UK and the Nordics Canada UK Nordic countries France US (government business) (commercial operati
Slide 15: Valneva's pipeline of vaccine candidates
Valneva’s pipeline of vaccine candidates Product Candidate Discovery Pre-clinical IND Phase I Phase II Phase III Partner research research enabling Pseudomonas To be discontinued Co-development Clinical vaccine aeruginosa with GSK candidates Clostridium difficile Active partner search initiated Lyme
Slide 16: 2020 strategy – a journey to success
2020 strategy – a journey to success Becoming the leading independent pure play vaccine company Products R&D Growing revenues from Investing at least 20% of existing and future revenues in R&D programs products to €250m delivering patient benefit and long-term value Financials Growth Achieving finan
Slide 17: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 18: Valneva's business year 2015
Valneva’s business year 2015 Excellent operational performance and major strategic steps, focusing on growing revenues and profitability Valneva acquired and successfully integrated DUKORAL® + Expansion of commercial vaccine portfolio with the addition of a cholera /(ETEC1) vaccine as a second produ
Slide 19: Valneva's business year 2015
Valneva’s business year 2015 Our vaccine R&D efforts are of strategic importance in order to generate long-term returns Technology business segment further developed into positive cash generator offering a basis for internal programs and partnerships + 10 new license agreements on the EB66® vaccine
Slide 20: Valneva's H1 2016 highlights
Valneva’s H1 2016 highlights Delivering on financial guidance and milestones Pseudomonas vaccine candidate + Valneva´s Pseudomonas aeruginosa candidate (VLA43) did not confirm positive vaccine effect in Phase II/III trial Japanese encephalitis vaccine + Valneva signed $42 million IXIARO® supply cont
Slide 21: Pseudomonas aeruginosa vaccine candidate Phase II/III data
Pseudomonas aeruginosa vaccine candidate Phase II/III top line data did not confirm previous findings Phase II 1 Phase II/III 2 Phase II/III top line (400 patients) (interim/400 patients**) (800 patients) VLA43 100µg w/o Alum comparably Immunogenic in ICU patients / best Not assessed immunogen
Slide 22: Leading commercial product: Japanese encephalitis vaccine
Leading commercial product: Japanese encephalitis vaccine Strong growth through new commercial channels and continued improved usage Product sales revenues in € million Expected split of 2016 product sales Other countries; 5% Q1 US military; FY 41% Europe; 33% US private; ~50 Further 21% Expected :
Slide 23: DUKORAL – sales and growth potential
2nd Commercial product: cholera/ (ETEC1) vaccine DUKORAL® – Analysis of sales and growth potential Product sales revenues in € million Expected split of 2016 product sales Other countries; 14% Q1 FY Australia/New sales under previous owner Canada; 51% Zealand; 16% Nordics; 19% 26.3* Expected: €23m3
Slide 24: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 25: Full year 2015 financial results
Full year 2015 financial results Compared to FY 2014 (IFRS, € million) attributable to acquired Crucell Sweden AB and DUKORAL ® business Revenues & Grants COGS R&D Expenses FY 2015 FY 2014 FY 2015 FY 2014 83.3 -18.2 -17.1 36.4 -24.3 -22.2 -28.8 -1.1 -25.4 46.9 -47.0 42.4 FY 2015 FY 2014 EBITDA* Net
Slide 26: Two profitable business segments
Two profitable business segments Investments in R&D pipeline Revenues Operating Profit/Loss (before amortization*) Commercial products €62.1m €8.5m 32% gross margin 14% operating margin Technologies & services €12.6m €4.6m 60% gross margin 36% operating margin Vaccine candidates €8.7m (€11.2m) €19.8
Slide 27: Full Year 2015 Profit & Loss
Full Year 2015 Profit & Loss € in thousand 12 months ended December 31 2015 2014 Revenues and grants 83,334 42,429 Cost of goods and services (46,961) (17,144) R&D expenses (25,367) (22,242) S,G&A and other expenses (23,667) (14,537) Amortization and impairment (7,273) (12,323) OPERATING LOSS (19,93
Slide 28: 2016 financial outlook
2016 financial outlook 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 investments €25m R&
Slide 29: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 30: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 31: Opinion from the Auditors
Statutory and Consolidated financial statements 2015 Opinion from the Auditors + On the consolidated financial statements (Excerpt of the Auditors report on the consolidated accounts, March 18, 2016) « In our opinion, the consolidated financial statements give a true and fair view of the assets and
Slide 32: Excerpt from the Auditors' report
Related-party agreements and commitments Excerpt from the Auditors’ report + Agreements and commitments authorized during the year 2015 Management Agreement executed betweeen Valneva SE and Mr. Franck Grimaud, Deputy CEO (authorized by the Supervisory Board, on June 25, 2015): Compensation and b
Slide 33: Excerpt from the Auditors' report
Related-party agreements and commitments Excerpt from the Auditors’ report + Agreements approved in previous years and continued in 2015 Management Agreement executed betweeen Valneva SE and Mr. Franck Grimaud, Deputy CEO (authorized by the supervisory board on May 31, 2013, approved by the Shareh
Slide 34: Excerpt from the Auditors' report on the Chairman's report
Internal control, risks management and corporate governance Excerpt from the Auditors’ report on the Chairman of the Supervisory Board report + Assessment procedures implemented by the Auditors obtaining an understanding of the internal control and risk management procedures relating to the prepar
Slide 35: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 36: Resolutions agenda and voting
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting IMPORTANT NOTE: Some of the resolutions shown on the following slides have been summarized. For the full text and for voting purposes, please refer to the print-outs that have been distributed. The English resolutions a
Slide 37: Resolution 1 – Statutory financial statements
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 1 – Approval of the statutory financial statements for the year ended December 31, 2015 The shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordinary General M
Slide 38: Resolution 2 – Consolidated financial statements
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 2 – Approval of consolidated financial statements for the year ended December 31, 2015 The shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordinary General Me
Slide 39: Resolution 3 – Discharge of board members
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 3 – Discharge of Management Board and Supervisory Board members for the performance of their duties The shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordina
Slide 40: Resolution 4 – Appropriation of earnings
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 4 – Appropriation of earnings for the year ended December 31, 2015 The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings, resolve to allocate
Slide 41: Resolution 5 – Regulated agreements
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 5 – Regulated agreements and commitment governed by articles L 225-86 et seq. of the commercial code The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary Gen
Slide 42: Resolution 6 – Agreement for Mr. Franck Grimaud
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 6 – Approval of the regulated agreement and commitments made in the financial year ended December 31, 2015 for the benefit of Mr. Franck Grimaud The shareholders, acting in accordance with the quorum and majo
Slide 43: Resolution 7 – Commitments for Mr. Thomas Lingelbach
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 7 – Approval of the regulated commitments made in the financial year ended December 31, 2015 for the benefit of Mr. Thomas Lingelbach The shareholders, acting in accordance with the quorum and majority requir
Slide 44: Resolution 8 – Commitments for Mr. Reinhard Kandera
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 8 – Approval of the regulated commitments made in the financial year ended December 31, 2015 for the benefit of Mr. Reinhard Kandera The shareholders, acting in accordance with the quorum and majority require
Slide 45: Resolution 9 – Reappointment of Frédéric Grimaud
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 9 – Reappointment of a Supervisory Board member (Mr. Frédéric Grimaud) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareholders,
Slide 46: Resolution 10 – Reappointment of James Sulat
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 10 – Reappointment of a Supervisory Board member (Mr. James Sulat) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareholders, rea
Slide 47: Resolution 11 – Reappointment of Anne-Marie Salaun
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 11 – Reappointment of a Supervisory Board member (Ms. Anne-Marie Salaun) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareholder
Slide 48: Resolution 12 – Reappointment of Alexander von Gabain
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 12 – Reappointment of a Supervisory Board member (Mr. Alexander von Gabain) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Sharehol
Slide 49: Resolution 13 – Reappointment of Alain Munoz
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 13 – Reappointment of a Supervisory Board member (Mr. Alain Munoz) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareholders, rea
Slide 50: Resolution 14 – Appointment of Louisa Mary Shaw
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 14 – Appointment of a new Supervisory Board member (Ms. Louisa Mary Shaw) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareholde
Slide 51: Resolution 15 – Appointment of Ralf Clemens
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 15 – Appointment of a new Supervisory Board member (Mr. Ralf Clemens) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareholders,
Slide 52: Resolution 16 – Appointment of Bpifrance Participations
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 16 – Appointment of a new Supervisory Board member (Bpifrance Participations) The shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings of Shareh
Slide 53: Resolution 17 – Attendance fees
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 17 – Setting the attendance fees for Supervisory Board members The shareholders, ruling based on the quorum and majority voting requirements applicable to ordinary general meetings, set the total amount of at
Slide 54: Resolution 18 – Registered office relocation
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Resolution 18 – Approval of registered office relocation The shareholders, having reviewed the Management Board’s report, expressly approve the Supervisory Board’s decision dated May 12, 2016 to relocate the Company’s r
Slide 55: Authorization for transactions on own shares
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 19 – Authorization and powers to be given to the Management Board for the purpose of allowing the Company to make transactions on its own shares The Company may: purchase its own shares up to a max
Slide 56: Authorization to cancel own shares
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 20 – Authorization granted to the Management Board for cancellation by the Company of its own shares The shareholders authorise the Management Board, for a period of eighteen months from this meeti
Slide 57: Capital increase with preferential subscription right
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 21 – Grant of authority to the Management Board to increase the share capital by issuing ordinary shares or any securities giving access to the capital while maintaining the preferential subscripti
Slide 58: Capital increase by public offering
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 22 – Grant of authority to the to the Management Board to increase the capital by issuing ordinary shares and all securities conferring rights to the capital, through a public offering, canceling p
Slide 59: Capital increase by capitalization of reserves
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 23 – Grant of authority to the Management Board in order to increase the share capital through the capitalization of reserves, earnings or premium The shareholders: + resolve, in accordance with th
Slide 60: Capital increase by private placement
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 24 – Grant of authority to the Management Board to increase the share capital by issuing shares and/or securities giving present and/or future access to the Company's share capital through private
Slide 61: Setting the issue price, up to 10% of capital
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 25 – Grant of authority to the Management Board in order to implement the issue of Company ordinary shares and/or securities giving immediate and/or later access to the capital of the Company with
Slide 62: Capital increase for contributions in kind
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 26 – Grant of authority to the Management Board to increase the share capital by issuing shares and/or securities giving immediate and/or future access to the capital of the Company, in considerati
Slide 63: Maximum aggregate amount of capital increases
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 27 - Maximum aggregate amount of capital increases The shareholders, subject to the adoption of resolutions 21 to 26: + resolve that the maximum aggregate amount of capital increases that may be ca
Slide 64: Issue of convertible preferred shares
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 28 – Grant of authority to the Management Board in order to increase the share capital by issuing preferred shares convertible into ordinary shares, and canceling the preferential subscription righ
Slide 65: Cancellation of preferential rights for selected persons
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 29 – Cancellation of preferential subscription rights for the benefit of selected categories of persons The shareholders, in accordance with the conditions of quorum and majority that apply at Extr
Slide 66: Free award of preferred shares to employees
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 30 – Authorization for the Management Board to freely award preferred shares of the Company for the benefit of employees and/or corporate officers of the Company and its subsidiaries, entailing wai
Slide 67: Grant of stock options
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 31 – Grant of authority to the Management Board for the purpose of granting stock options, through one or more issues, for the benefit of employees and/or corporate officers of the Company and its
Slide 68: Issue of equity warrants
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 32 – Issue of equity warrants The shareholders resolve, subject to approval of the next resolution concerning cancellation of the preferential subscription right for the benefit of a defined catego
Slide 69: Cancellation of preferential rights for warrants
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 33 – Cancellation of preferential subscription rights for the benefit of selected categories of persons The shareholders resolve: + to cancel the preferential subscription right of shareholders to
Slide 70: Capital increase reserved for employees
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 34 – Grant of authority to the Management Board for the purpose of deciding to carry out a capital increase reserved for employees The shareholders resolve to reserve in favour of Company employees
Slide 71: Powers for formalities
Shareholders annual general meeting, June 30, 2016 Resolutions agenda and voting Summary of Resolution 35 – Powers for formalities The shareholders grant all powers to the holder of an original copy, an excerpt or a copy of these minutes certified as authentic to carry out all necessary processes, f
Slide 72: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2015 business highlights & recent newsflow 5. Valneva 2015 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 73: Thank you.
Thank you. WaAvalneva