A leading pure play vaccine company

Transcription

1 A leading pure play vaccine company Company Presentation Jefferies Autumn 2015 Global Healthcare Conference 19 November 2015 Reinhard Kandera

2 Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The Valneva shares may not be offered or sold in the USA. The offer and sale of the Valneva shares has not been and will not be registered under the US Securities Act. Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial statements and information may be prepared according to accounting standards which may not be comparable to those used generally by companies in the United States. This presentation includes only summary information and does not purport to be comprehensive. Any information in this presentation is purely indicative and subject to modification at any time. Valneva does not warrant the completeness, accuracy or correctness of the information or opinions contained in this presentation. None of Valneva, or any of their affiliates, directors, officers, advisors and employees shall bear any liability for any loss arising from any use of this presentation. Certain information and statements included in this presentation are not historical facts but are forward-looking statements. The forward-looking statements (a) are based on current beliefs, expectations and assumptions, including, without limitation, assumptions regarding present and future business strategies and the environment in which Valneva operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results, performance or achievements to be materially different from those expressed or implied by these forward-looking statements, (b) speak only as of the date this presentation is released, and (c) are for illustrative purposes only. Investors are cautioned that forward-looking information and statements are not guarantees of future performances and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Valneva. VALNEVA - Company Presentation - Jefferies London 19 November

3 Company highlights Pure play vaccine company Independent and fully-integrated Revenues from commercialized products Promising portfolio of pre-commercial products Partnerships with leading pharmaceutical and biotech companies Towards financial break-even VALNEVA - Company Presentation - Jefferies London 19 November

4 Valneva SE company overview A fully integrated company focused on vaccines development & commercialization Corporate profile + Created in May 2013 through the merger of Vivalis SA and Intercell AG; expanded its business by acquiring a commercial product from Crucell/Janssen in February Focus on development, manufacture and commercialization of vaccines Stock information + Number of ordinary shares 1 : 74,698,099 + Market cap: approx. EUR 261 m (Sept 1 st 2015) + ISIN: FR Shareholder structure*: + Incorporated in Lyon, France + Approximately 400 employees + Principal sites in: - Vienna, Austria - Nantes, France - Solna, Sweden - Livingston, Scotland + Listed on NYSE Euronext Paris and Vienna Stock Exchange Free Float % * other shareholders with up to 5% 16.2% Groupe Grimaud 10.0% Bpifrance Participations 2.0% Other 1.0% registered Management shareholders & employees 1 Excluding 17.8m preferred shares which convert into approximately 9.4m ordinary shares following approval of the Pseudomonas vaccine candidate VALNEVA - Company Presentation - Jefferies London 19 November

5 Valneva s business model Building on commercial revenues and R&D upside COMMERCIAL R&D AND TECHNOLOGIES Japanese encephalitis vaccine (JEV) EUR 28.1 m (2014)* Cholera (ETEC) vaccine EUR 25.6 m (2014)** Research & pre-clinical Pseudomonas aeruginosa Clostridium difficile Lyme borreliosis New targets* Cell-based platform EB66 IC31 adjuvant Ph I / II Ph II / III * viral / travel Third party products distribution Nordics EUR 10.8 m (2014)** Vaccines research & laboratory services 1 Product sales reported under IFRS, audited; 2 revenue according to Johnson & Johnson pro forma management reporting, unaudited figures VALNEVA - Company Presentation - Jefferies London 19 November

6 Commercial product: Japanese encephalitis vaccine Protecting travelers from the most common encephalitis in Asia 1 Japanese encephalitis vaccine Designed to protect travelers, military and populations in endemic regions against Japanese encephalitis Indicated for active immunization against JE in adults, adolescents, children and infants aged two months and older 2 Market potential Commercial position million travellers to Asia in Travellers to Asia expected to grow by 4.4% per year 3 + Global Japanese encephalitis vaccines market valued at ~EUR 150m EUR 200m 4 Traveller 65%, Military 15%, Endemic 20% 4 + Improved awareness and updating travel recommendations and military policies + Currently, there is no effective treatment for the disease 1 + Valneva s vaccine is the only approved product available for US and European travellers 2 month of age 2 No competition exists in US and Europe Exclusive supplier agreement in place with US Military + Asian manufacturers mainly serve local public markets 1 CDC. MMWR 2010;59: UNWTO Tourism Highlights 2014; 2 Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed. The currently available presentation for IXIARO can be used in children from 3 years of age. Prior to availability of the new presentation, no attempt should be made to adjust the syringe volume or to administer a 0.25mL/3µg dose in children less than 3 years of age; 3 UNWTO Tourism Highlights 2014; 4 Nomura Code estimates (October 2012) and Valneva Management estimates. VALNEVA - Company Presentation - Jefferies London 19 November

7 Commercial product: Japanese encephalitis vaccine Licensed in more than 35 countries Annual sales development (EUR m) Split of product net sales revenues 2014 (EUR m) Change in revenue recognition ~25³ expected 30.1 % 9.0 % 30.2 % US military US private Europe Other % Total: EUR 28.1m Valneva takes direct control over M&D Upside from Asian endemic partnerships Valneva expects to significantly improve IXIARO s sales margin and profitability in 2016 and beyond. + Valneva has terminated the agreement with its main distribution partner GSK to take control over marketing and distribution of IXIARO in order to increase margin and profitability. Valneva receives royalties + JEEV India, Indian subcontinent Produced locally based on Valneva s technology Valneva receives revenues from transfer prices + Local trade name (tbd) Taiwan Produced locally based on Valneva s bulk supply Biological E. Limited 1 Transition of US military sales responsibility to Novartis resulted in Valneva recognizing only 2/3 of the total sales revenue to the US military instead of 100% previously; pro forma sales; 3 Transition impact (Valneva PR, June 22, 2015 : Valneva takes direct control over Marketing & Distribution of IXIARO to increase margin and profitability); 4 H1 2015, unaudited; VALNEVA - Company Presentation - Jefferies London 19 November

8 Commercial product: Japanese encephalitis vaccine Strong growth of IXIARO /JESPECT in-market sales Product sales revenues (EUR m) Revenue recognition of in-market sales Now ~50 Direct distribution 50% 100% ~25 Valneva In-market Direct distribution to U.S. military 66% 100% Distribution with partners 50% 50-75% 2014a 2015e 2016e Transition impact Valneva expects to significantly improve sales margin and profitability of its JE vaccine in 2016 and onwards. * For detailed explanation of pro forma assumptions and reconciliation to IFRS results see the Company s website VALNEVA - Company Presentation - Jefferies London 19 November

9 Commercial product: cholera/ (ETEC) 1 vaccine Established vaccine in the field of diarrhea Cholera (ETEC)* vaccine Aimed to protect travelers against cholera and, in some countries, against ETEC and/or diarrhea caused by ETEC 1 Indicated for adults and children from 2 years of age who will be visiting endemic areas Market potential Commercial position million travelers to Asia/South America/Africa in Revenue 2014: EUR 25.6m 3 Canada, Sweden, Australia account for ~75% of sales 4 + Growth driven by ongoing travel to risk regions, improved awareness and updating travel recommendations Significant growth potential in key markets (penetration rate <1%) 3 + Only approved cholera/etec 1 vaccine available for European, Canadian and Australian travelers WHO pre-qualification / widely used in other countries Protection against ETEC 1 is part of selected country approvals Asian manufacturers predominantly serve local markets and primarily on cholera only + US based PaxVax vaccine candidate in Phase III (US only), for Cholera indication only 1 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. 2 UNWTO Tourism Highlights 2014; 3 Johnson & Johnson pro forma management reporting, unaudited figures; Source picture: VALNEVA - Company Presentation - Jefferies London 19 November

10 Commercial product: cholera/ (ETEC) 1 vaccine DUKORAL analysis of sales and growth potential Annual sales development (in EUR m, pro forma) Geographic 2014 sales breakdown ~25.0 expected Other countries 15% UK 6% Norway 7% Australia 5% Sweden 13% Canada 54% Total: EUR 25.6m 2 Growth driven by promotional efforts and geographical expansion Strengthen and motivate key marketing team + Own sales and marketing force in Canada with the objective to directly control commercialization + Marketing and distribution network is being set up for other territories: combination of Valneva s own sales and marketing teams and country-specific agreements Increased focus on marketing activities + Reinforced Key Opinion Leader (KOL) management + Develop different marketing channels 1 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium.; 2 Johnson & Johnson pro forma management reporting, unaudited figures, 3 including sales achieved by the previous owner between Jan 1 and Feb 9, 2015 VALNEVA - Company Presentation - Jefferies London 19 November

11 Pre-commercial product: Pseudomonas aeruginosa vaccine Targeting hospital-acquired pneumonia, with a market potential of USD 1bn Pseudomonas aeruginosa + Causes ~20% of all nosocomial (hospital-acquired) infections 1,2 Presence of Pseudomonas aeruginosa in ventilated patients associated with increased mortality rate 3 + Resistance to antimicrobial agents is increasingly common 4 + Target population: patients in intensive care units on mechanical ventilation Up to 1,000,000 in the U.S. and Europe per year 5 All-cause mortality rate of 20% to 40% in this target population 6 Commercial position + Hospital-acquired pneumonia is a major healthcare burden with additional costs estimated ~USD10,000 per case 6 No commercial vaccine available Medical need expected to result in fast adoption by specialist and insurers, even in case of modest efficacy Valneva has most advanced late-stage vaccine candidate of the industry + Total market estimate of USD 1bn for U.S. and Europe in target population Picture from 1 Pseudomonas Infection, Selina SP Chen, Russell W Steele, MD Chapter on Epidemiology 2 Vincent JP et al, JAMA, 1995; p ; 3 Robert Koch Institut: Gesundheitsbericht des Bundes Heft 8; 4 Rosenthal VD et al. International Nosocomial Infection Control Consortium (INICC) report, data summary for , issued June McConville, M.D., John P. Kress, M.D. Weaning Patients from the Ventilator, N Engl J Med 2012; 367: ; 6 Vincent et al, JAMA 1995; 274: ; VALNEVA - Company Presentation - Jefferies London 19 November

12 Pre-commercial product: Pseudomonas aeruginosa vaccine Valneva s vaccine candidate VLA43 is being tested in a clinical phase II/III study Valneva s vaccine candidate + Recombinant OprF/I fusion produced in E.coli + No preservatives + Liquid formulation + 2 injections (days 0 and 7) Advantages + Only clinical vaccine program + Resistance not expected + OprF/I are highly conserved proteins => broad strain coverage possible Current development status patients enrolled (co-financed by GSK 1 ) + Reduction in mortality as primary endpoint + Interim analysis after 400 patients 2 confirmed clinically meaningful effect but less pronounced + Valneva considers 5% absolute difference licensable product + Valneva conducted additional post-hoc analysis and amended trial protocol Addition of a secondary endpoint for subgroup of patients Competition + No vaccine on the market + Antibiotic treatment on the market + Vaccines in pre-clinical development: Astrogenetix, GlycoVaxyn, Vaxdyn + Many active antibody programs in pre-clinical stages Data release expected in Q Valneva will release data from the ongoing phase II/III efficacy trial, including day 180 follow-up time-points 1 GSK opt-in rights under pre-defined terms: GSK will have rights to opt in, under SAA with GSK: Intercell Annual report 2012, p. 39,45; 2 Valneva PR and Fully blinded, analysis conducted by Data Monitoring Committee; VALNEVA - Company Presentation - Jefferies London 19 November

13 Pre-commercial product: Clostridium difficile vaccine Vaccine targeting healthcare-associated diarrhea, an increasing threat to elderly Clostridium difficile + Single most common pathogen of acute healthcare-associated infections in the U.S. 1 Estimated 450,000 cases of Clostridium difficile annually 2 Approximately 29,000 died within 30 days after diagnosis 2 + Estimated 172,000 cases in EU member states per year 3 + Current antibiotic treatments have significant limitations with recurrence in ~20% of cases 4 + Wide range of severity, complicated cases may require emergency surgical intervention associated with up to 80% mortality 4 Commercial position + Infections associated with significant economic burden due to prolongation of hospitalization, est. USD 4.8 billion for U.S. acute care facilities alone 5 + About one-third of cases are community-acquired, indicating need for prevention beyond the hospital setting 2 + No commercial vaccine available + One amongst three clinical stage programs in the industry Potential competitive advantage on more cost efficient production + Target groups: elective admissions and long-term care facility residents + Total market estimate of >USD 1 bn/year target groups 6 Source picture: 1 Magill S, Edwards J R, Bamberg W et al. Multistate Point-Prevalence Survey of Health Care Associated Infections. New England Journal of Medicine 2014;370: ; 2 Lessa et al, Burden of Clostridium difficile Infection in the United States. N Engl J Med 2015;372: Clostridium difficile infection in Europe. A CDI Europe Report.; 4 Leffler et al, Clostridium difficile infection. N Engl J Med 2015;372: ; 5 Dubberke ER, Clinical Infectious Diseases 55, no. suppl 2 (2012): S88-S92; 6 VacZine Analytics Clostridium difficile prophylactic vaccines Market View, January 2014; VALNEVA - Company Presentation - Jefferies London 19 November

14 Pre-commercial product: Clostridium difficile vaccine Current development status VLA84 (Phase II) Valneva s vaccine candidate + Vaccine targeting primary prevention through active immunization of risk groups, potentially extending towards more universal prophylaxis in the elderly population + Recombinant fusion protein of relevant parts of toxins A and B + Liquid formulation (w/ and w/o Alum) + 3 injections on days 0, 7 and 28 Advantages + Production at low cost of goods possible + Excellent stability profile + Fully characterized recombinant protein Current development status + Phase I in healthy adults and elderly successfully completed 1 + Vaccine highly immunogenic and generally safe 2 + Phase II to confirm final vaccine candidate in older adults and elderly ( 50 years of age) ongoing 3 + Study conducted in U.S. & Germany Competition Vaccine candidates + Sanofi: clinical phase III study ongoing 5 + Pfizer: clinical phase II study ongoing 6 Merck s monoclonal antibody + Targeting recurring Clostridium difficile only First phase II results expected to be disclosed within next weeks + GSK will have rights to opt in 4 1: NCT ; 2 Valneva CSR IC84-101; 3 NCT ; 4 If Phase II successful under pre-defined terms, under SAA with GSK: Intercell Annual report 2012, p. 39,45; 5 NCT ; 6 NCT VALNEVA - Company Presentation - Jefferies London 19 November

15 Pre-commercial product: Lyme borreliosis vaccine Targeting Lyme borreliosis, with market potential of above EUR 500m Lyme borreliosis + Transmitted by Ixodes ticks 1, causing Lyme borreliosis + Most common vector borne illness in the Northern Hemisphere Estimated ~300,000 cases per year in U.S. 3 and ~85,000 cases per year in Europe 2 + Delayed or inadequate treatment can lead to very serious symptoms, involving the joints, heart, and central nervous system, and can be disabling. + A vaccine needs to protect against the major species causing the disease Targeting the outer surface protein A (OspA) of Borrelia (several serotypes present) Commercial position + No commercial vaccine available + Market potential of >EUR 500m for Europe and U.S. 5 Priority in Europe markets where high awareness on tick transmitted diseases exists In key high-incidence territories penetration rates of up to 10% can be expected, given likely reimbursement status Current development status VLA15 (Pre-clinical) + Pre-clinical testing completed + IND submission initiated + Clinical entry planned for GSK opt-in rights 4 Source picture: PHIL Public Health Photo Library; 1 Stanek et al. 2012, The Lancet 379: ;2 Estimated from available national data. However, this number is largely underestimated as case reporting is highly inconsistent in Europe and many LB infections go undiagnosed, based on WHO Europe Lyme Report; ECDC tick-borne-diseases-meetingreport; 3 Latest data from the CDC (PR on Aug 19, 2013); 4 If Phase II successful under pre-defined terms, under SAA with GSK: Intercell Annual report 2012, p. 39,45; 5 Estimate of Valneva, concentrated in private markets VALNEVA - Company Presentation - Jefferies London 19 November

16 EB66 cell line platform for efficient vaccine production Potential additional milestones of up to EUR 80m and royalty payments from existing licenses Revenue generating platform Yearly target of 7 new licenses per year reached EB66 s regulatory approvals & commercialization status + Fully characterized cell-line (avian embryonic stem cell derived) for efficient large scale manufacturing of human and veterinary vaccines + Over 35 agreements with the world s largest pharmaceutical companies + 7 new licenses signed on average per year + EUR 34m in upfront, milestones & research fees received to date + Exclusive license to Jianshun Biosciences to commercialize EB66 in China (granted in March 2015) Research Commercial Approved human vaccines + Prototype influenza vaccine, Japan Kaketsuken + H5N1 pandemic vaccine, Japan Kaketsuken Approved veterinary vaccines: + Duck Parvovirus (MDPV), Europe Merial + Inclusion body hepatitis (IBH), Latin America Farvet + Egg drop Syndrome, Japan Kaketsuken VALNEVA - Company Presentation - Jefferies London 19 November

17 Valneva Financials Summarized Income Statements* (EUR in thousands) 9M M 2015 Product sales 19,282 44,169 Revenues from collaborations and licensing, grants 10,031 16,513 Revenues and grants 29,315 60,682 Cost of goods and services (10,150) (37,711) R&D expenses (15,220) (18,730) S,G&A expenses (10,225) (16,169) Other income and expenses, net (241) 309 Amortization and impairment (7,446) (5,689) OPERATING LOSS (13,966) (17,308) Finance and income tax expenses / income (787) (2,530) LOSS FOR THE PERIOD (14,752) (19,838) EBITDA** (3,610) (8,012) Summarized Balance Sheet* (EUR in thousands) 09/30/15 All cash*** 37,258 Shareholders equity 145,208 Borrowings (excluding finance lease) (58,566) Finance lease obligations (net of cash deposit****) (18,112) *unaudited; ** calculated by excluding amortization, depreciation & impairment from the operating loss; *** consisted of EUR 35.6 million in cash and cash equivalents, EUR 0.6 million in restricted cash, and EUR 1.0 million in short-term deposits; **** EUR 11.3 million cash deposit included in other non-current assets; VALNEVA - Company Presentation - Jefferies London 19 November

18 Event calendar and anticipated news flow 2015/2016 Continued progress reported and multiple near-term events ahead Commercialized products + IXIARO transition including new commercial partners/infrastructure + Integration Valneva Sweden/DUKORAL + Overall 2015 Group revenues and grants are expected to be above EUR 75 million Technologies & Services + Additional EB66 and IC31 licensing agreements expected + Clinical entry (phase I/II) for EB66 based seasonal influenza vaccine anticipated + First Japanese stockpiling for EB66 based pandemic influenza vaccine expected R&D programs + Phase II clinical results from Clostridium difficile vaccine candidate by end of Pseudomonas aeruginosa vaccine candidate: phase II/III data release in Q Phase I clinical study for Lyme borreliosis vaccine candidate to be initiated in 2016 VALNEVA - Company Presentation - Jefferies London 19 November

19 Thank you Merci Danke Tack