Innovation Efficiency Evotec Company Overview

Transcription

1 Innovation Efficiency Evotec Company Overview Evotec AG, Company presentation October 2015

2 Forward-looking statements Information set forth in this presentation contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this presentation. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based. 1

3 Agenda Evotec at a glance Innovation efficiency Financials & outlook 2

4 Leadership in drug discovery Our mission Based on the highest quality drug discovery science, and through innovative collaborations, we are building a partnered product pipeline. 3

5 Clear long-term strategy Strategy overview Action Plan Restructuring Capital efficiency for sustainability First EVT Innovate investments 2012 Business segmentation Investments in discovery service platform Performance-based integrated discovery and clinical alliances 2015 Partnered product pipeline to gain milestones and royalties Highest quality discovery and pre-clinical service EVT Execute Academic bridge and Cure X/Target X strategy EVT Innovate 2020 Cure X/Target X strategy 4

6 Improving R&D capital efficiency Pre-clinical development candidate PDC Evotec s Sweet spot Academia Target ID/-Validation Hit- Identification Lead Optimisation Pre-clinical Phase I Phase II Phase III Approval Market Pre-clinical Phase Clinical Phase Duration > 14 years Evotec Approx. 3 6 years PDC Pre-clinical development candidate Partner Approx years Cost Approx. $ 1 3 bn Approx. $ 5 15 m Evotec s core competencies 5 Source: Paul et al. Nature Reviews 9: 2013

7 The megatrend Improvement of R&D productivity Market dynamics in drug discovery Growth driver Drug discovery outsourcing is a macro trend Market overview Revenues, in $ bn 1 Increasing comfort with outsourcing 2 Higher R&D capital efficiency for innovation % p.a Ability to adjust investments proportional to portfolio (e) 2016(e) 2017(e) 2018(e) 6 Source: Visiongain; Drug Discovery Outsourcing: World Market 2015

8 A global company with a global offering Evotec s footprint San Francisco, Branford and Princeton, USA ~70 employees Compound ID, selection and acquisition Compound QC, storage and distribution Cell & protein production Abingdon and Manchester, UK ~300 employees Medicinal chemistry ADMET Structural biology In vitro & in vivo anti-infective platform/screening Toulouse, France ~230 employees Compound management Hit identification In vitro & in vivo oncology Medicinal chemistry ADME & PK Early drug formulation & Solid form screening Cell, protein & antibody production Hamburg (HQ), Göttingen and Munich, Germany ~400 employees Hit identification In vitro & in vivo biology Chemical proteomics & Biomarker discovery and validation Cell & protein production 7

9 Agenda Evotec at a glance Innovation efficiency Financials & outlook 8

10 Leadership in drug discovery with two segments EVT Execute & EVT Innovate 9

11 Broad stand-alone innovation services EVT Execute Comprehensive drug discovery platforms High-quality service business No. 1 in drug discovery The strategic outsourcing partner of choice 10

12 Focus on causes not symptoms EVT Innovate Fields of core expertise Recent Cure X/Target X alliances: Immuno-oncology TargetImmuniT Diabetes TargetBCD Tissue fibrosis TargetFibrosis NEUROSCIENCE DIABETES & COMPLICATIONS Accessing unlimited supply of human beta cells Fibrosis PAIN ONCOLOGY Small molecule-based cancer immunotherapies ANTI- INFECTIVES 11

13 Discovery Pre-clinical Clinical Strong portfolio of > 70 product opportunities Partnership portfolio Molecule Indication Partner Discovery Pre-clinical Phase I Phase II Phase III EVT302 1) EVT201 Somatoprim EVT100 EVT401 ND 2) ND 2) ND 2) ND 2) Various Alzheimer s disease Insomnia Acromegaly CNS diseases Inflammation Oncology Oncology Pain Oncology Endometriosis EVT770 Diabetes type 2/1 ND 2) ND 2) Various Various Pain Inflammation Oncology Inflammation Various Diabetes type 2/1 Various Diabetes type 2/1 Various Various Various Various Various Kidney disease Diabetes Alzheimer s disease Immunotherapies Tissue fibrosis Various CNS/MS NEU 2 Various Diabetes >5 further programmes Various Neurology >5 further programmes Various Oncology >10 further programmes Various Pain & Inflammation >5 further programmes 12 1) Sembragiline/RO ; under evaluation 2) Not disclosed

14 Significant options in CNS Neurology overview Molecule(s) Indication (mechanism) Partner Status Next milestone Commercials EVT302 1) Alzheimer s disease (MAO-B) Phase IIb, recruitment completed Completion of Phase II, Phase III start EVT201 Insomnia Phase II Start clinical trials Milestones, royalties EVT100 series CNS diseases (TRD) Phase II/Pre-clinical Confirmation of preclinical study/ Phase II start Various CNS/Multiple sclerosis NEU 2 Pre-clinical/Various ND 2) ND 2) Various Huntington s disease $ 10 m upfront, up to $ 820 m milestones, significant royalties $ 2 m upfront, up to $ 173 m milestones, significant royalties Discovery ND 2) Research payments; fund up 52 FTEs Not disclosed Neurodegeneration Discovery ND 2) Research payments Not disclosed Fabry s disease Discovery ND 2) Research payments TargetAD Alzheimer s disease (Novel MoA) TargetASIC Multiple sclerosis Undisclosed Pharma Discovery ND 2) Up to $ 10 m research payments, approx. $ m milestones, royalties Discovery Lead status Co-funded Not disclosed Alzheimer s disease Discovery Lead status ND 2) Orexin-1 CureMN Stress-related addictive disorder programme Amyotrophic lateral sclerosis (ALS) ND 2) ND 2) Research payments ND 2) Pharma partnership 13 1) Sembragiline/RO ; under evaluation 2) Not disclosed

15 Strategic focus on diabetes and diabetic complications Diabetes and diabetic complications overview Project(s) EVT770 TargetBCD ALM Indication (mechanism) Partner Status Next milestone Commercials Type 1 and 2 diabetes (beta cell regeneration) Type 1 and 2 diabetes (beta cell regeneration) Type 1 and 2 diabetes (beta cell regeneration) Pre-clinical Phase I 5 m upfront, high margin research payments, up to 254 m milestones, significant royalties Discovery/Pre-Clinical ND 1) 3 m upfront, research payments, potentially over 300 m milestones, significant royalties Discovery Phase I 2 m upfront, high margin research payments, up to 183 m milestones/product, significant royalties Various Kidney disease ND 1) ND 1) Undisclosed upfront, high margin research payments, milestones/product, royalties TargetFibrosis Tissue fibrosis Discovery ND 1) Undisclosed upfront, Potential milestone payments based on the achievement of specific development and sales milestones (undisclosed) TargetEEM Type 1 and 2 diabetes (enteroendocrine) Discovery Pharma partnership CureNephron Chronic kidney disease Discovery Pharma partnership CureBeta Type 1 and 2 diabetes (beta cell regeneration) Discovery Pharma partnership 14 1) Not disclosed

16 TargetBCD: Restoring beta cell function via replacement therapy and function restoring drugs Strategic collaboration between Sanofi and Evotec in diabetes Background Evotec has long-term expertise in beta cell biology and regenerative medicine TargetBCD was initiated in 2014 Sanofi is one of Top 3 global diabetes players Mission Development of beta cell replacement therapy and drug discovery based on functional human beta cells derived from stem cells Agreement with Sanofi Upfront fee of 3 m Potential pre-clinical, clinical, regulatory and commercial milestones exceeding 300 m Significant royalties upon commercialisation Integrated collaboration resources involving more than 15 scientists at Evotec and Sanofi 15

17 Disease-modifying therapies are urgently needed The market opportunity Diabetes Prevalence of diabetes is increasing at alarming rates Diabetes is driven by loss in beta cell function Current insulin market exceeds >$ 22 bn in 2014 Human beta cells offer disease-modifying product opportunities Beta cell replacement therapy Beta cell protective/ regenerative drugs World 387 m World 592 m People living with diabetes Africa 53% 93% Middle East and North Africa South East Asia 64% South and Central America Western Pacific 46% Europe 33% North America and Caribbean 85% 55% 30% (e) 16 Source: International Diabetes Federation;

18 Addressing the diabetes pandemic by restoring beta cell function Human stem cell derived beta cells for transplantation Human beta cells from stem cells Insulin Nkx6.1 Stem cell derived human beta cells Primary human beta cells Edmonton protocol provides clinical POC for beta cell therapy Transplantation of beta cells can effectively restore blood glucose control Clinical trial with embryonic stem cell derived beta cell therapy has been initiated Viacyte: VC-01 TM in Phase I/II Key issues Immature beta cells with limited functionality Requires large impractical device New differentiation protocols create mature beta cells Fewer cells need to be transplanted Encapsulation becomes more manageable 17 Images from Pagliuca et al,. Cell 2014; see also Rezania et al., Nature Biotechnology 2014

19 Evotec enters integrated cooperation with Pfizer in tissue fibrosis Evotec/Pfizer collaboration Mission Evotec and Pfizer will explore potential novel mechanisms as targeted anti-fibrotics in multiorgan fibrosis Next steps Evotec will contribute its comprehensive drug discovery platform; Pfizer will provide key technologies and industrial scope as well as pharmaceutical development expertise and marketing Agreement with Pfizer Undisclosed upfront payment Potential milestone payments based on the achievement of specific development and sales milestones (undisclosed) Strategic four-year collaboration 18

20 Nearly 45% of all deaths worldwide are associated with chronic fibroproliferative diseases Estimated tissue fibrosis market potential Tissue fibrosis is a huge unmet medical need Total market value up to $ 100 bn Four major indications: liver, kidney, cardiac, lung fibrosis Industry analysts have forecast annual sales pirfenidone of about $ 2 bn for IPF 1), a pulmonary fibrosis form (lung) that is rather rare compared to liver, kidney and cardiac fibrosis Chronic kidney disease market in the range of $ bn Areas of fibrotic disease Ophthalmic Glaucoma Age-related Macular Degeneration (AMD) Diabetic Macular Edema (DME) Diabetic Retinopathy Dry Eye Disease Liver Alcoholic Cirrhosis Hepatitis C Cirrhosis Nonalcoholic Steatohepatitis (NASH) Renal Transplant Nephropathy Diabetic Nephropathy Lupus Nephritis FSGS Systemic Fibrotic Diseases Scleroderma Nephrogenic Systemic Fibrosis Cystic Fibrosis Chronic Graft vs. Host Disease Atherosclerosis Pulmonary Idiopathic Pulmonary Fibrosis Scleroderma Lung Disease Moderate-to-severe Asthma COPD ARDS Heart Heart Attack (MI) Congestive Heart Failure (CHF) Bone marrow Idiopathic & druginduced Myelofibrosis Skin Hypertrophic Scarring Keloids Injury-associated Fibrotic Diseases Surgical-induced Fibrosis Burn-induced Scarring & Contraction Radiation-induced Fibrosis 19 1) Idiopathic Pulmonary Fibrosis; 2) Nonalchoholic Steatohepatitis Sources: J Clin Invest Mar;117(3):524-9.

21 World-class pipeline-building in oncology EVT Innovate & Sanofi Molecule(s) Indication (mechanism) Partner Status Next milestone Commercials Somatoprim (DG3173) Acromegaly/NET Phase IIa Pharma partnership Consulting fees, royalties ND 1) Oncology Phase I ND 1) Research payments, milestones, royalties ND 1) /Biomarker Oncology Phase I ND 1) Success-based platform milestones ND 1) Oncology Preclinical ND 1) Research payments, milestones, royalties Four preclinical oncology assets Multiple early discovery projects TargetKDM TargetImmuniT Various (Epigenetic targets) Cancer immunotherapy Preclinical Pharma partnership ND 1) H2L 2) ND 1) Research payments, milestones, royalties Multiple Cure X/Target X initiatives as opportunities TargetDBR Glioblastoma H2L 2) Pharma partnership ND 1) KRas Oncology Discovery ND 1) ND 1) 20 1) Not disclosed 2) Hit to Lead

22 TargetImmuniT: Joining forces for novel small molecule-based cancer immunotherapies Strategic partnership to support broad development track Background Based on partnership between Apeiron and Evotec initiated in 2012/13 Mission Development of small molecule-based cancer immunotherapies for next-generation immunooncological therapies to complement current offerings of checkpoint inhibitors Agreement with Sanofi Multi-year research payments for Evotec and Apeiron Significant pre-clinical, clinical and regulatory milestones exceeding 200 m Significant royalties upon commercialisation Integrated collaboration involving more than 20 scientists between Evotec, Sanofi and Apeiron 21

23 The use of the immune system to fight cancer The market opportunity Cancer immunotherapy Immuno-oncology will become a new pillar of cancer therapy Market potential estimated to be $ 35 bn in 2023 Cancer immunotherapy market projections 30bn Current cancer immunotherapies and late-stage pipelines are dominated by biologics Monoclonal antibodies are considered first wave of targeted therapies Cell therapies on the rise (e.g. CAR T-cells) Small molecules will follow 20bn 10bn 0bn 2016(e) Annual growth of ~ 24% 2023(e) 22

24 Small molecules complementing cancer immunotherapies Apeiron Biologics, Evotec and Sanofi First-in-class approach Recent successes Opportunity for further improvements Cellular immunotherapies CAR T-cells Antibody therapies Checkpoint inhibitors Vaccination and targeted therapies DC vaccines Antigen release Treatment of nonresponder and partial responder patients Opportunity for small molecule therapy to overcome immune cell unresponsiveness in cancer Combination therapies Cancer immunotherapy Restoring the immune system s ability to eliminate cancer cells 23

25 Significant partnerships in pain, inflammation and anti-infectives Pain, inflammation and anti-infectives Molecule(s) EVT401 Indication (mechanism) Partner Status Next milestone Commercials Inflammation (P2X7 inhibitor) Phase I/II Phase II start Up to 60 m milestones, royalties Various Endometriosis Pre-clinical Pre-clinical candidate 12 m upfront, up to approx. 580 m milestones, royalties Various Various/Pain Pre-clinical Phase I start Undisclosed upfront, research payments, milestones, royalties Not disclosed Various/Pain Pre-clinical Successful PoC 1) Research payments, milestones, royalties Not disclosed Inflammation Pre-clinical Phase I start Undisclosed upfront payment, milestones, royalties Various Inflammation Discovery Pre-clinical Research payments, up to 183 m milestones/product, significant royalties TargetPicV Viral host targets Discovery Pre-clinical candidate TargetPGB Antibiotics Discovery Pre-clinical candidate Protein-arginine deiminases (PADs) Inflammation Discovery Pre-clinical candidate Research payments, milestones up to approx. $ 13 m 24 1) Proof of Concept

26 EVT Innovate works The Bridge CureBeta (Harvard Stem Cell Institute) CureNephron (Harvard, BWH, USC, AstraZeneca) TargetASIC (BMBF/undisclosed Pharma partner) Somatoprim (Cortendo) TargetPicV (Haplogen) TargetFibrosis (Pfizer) TargetImmuniT (Apeiron/Sanofi) TargetDBR (Yale) TargetSP (Internal) TargetFX (Internal) TargetPGB (Harvard) TargetKDM (Dana-Farber, Belfer) CureMN (Harvard) TargetEEM (Harvard) TargetAD (NBB/J&J) TargetBCD (Sanofi) TargetSX (undisclosed) TargetDR (Internal) TargetATD (Internal) TargetKX (undisclosed) TargetCytokine (DRFZ) Fraunhofer Initiative French Academic Bridge Ohio State University New York University Gladstone Institutes 25

27 The partner of choice for disruptive technologies Translating first-in-class science to Pharma Carefully selected discovery stage projects in indications of high unmet medical need Advancing and partnering projects at tangible value inflection points Fuelling Evotec s pre-clinical and clinical opportunities 26

28 Agenda Evotec at a glance Innovation efficiency Financials & outlook 27

29 Sharp revenue increase in EVT Execute Condensed income statement based on segments for H in m EVT Execute EVT Innovate Intersegment elimination Not allocated Evotec Group Revenues (12.4) 55.0 Gross margin 23.8% 45.7% 16.6% 28.7% R&D expenses (0.2) (10.4) 2.1 (8.5) SG&A expenses (9.3) (3.1) (12.4) Amortisation of intangible assets Impairment of intangible assets Income from bargain purchase Other op. income (expenses), net Operating income (loss) (1.3) (0.2) (1.5) (0.1) (0.1) (9.5) EBITDA 1) 9.8 (9.0) 0.8 Revenue in EVT Execute: Primarily attributable to growth in base business (e.g. in anti-infectives and Sanofi collaboration) Increased investment in Cure X/Target X initiatives in EVT Innovate Strong adjusted EBITDA of 9.8 m in EVT Execute 28 1) Adjusted for changes in contingent considerations; Group EBITDA was adjusted for changes in contingent consideration as well as for one-time effects with regards to the bargain purchase resulting from the acquisition of Evotec (France) SAS in 2015

30 Key figures illustrate clear strategy for both segments Performance overview EVT Execute & EVT Innovate Revenues (in m) Gross margin (in %) EVT Execute EVT Innovate EVT Execute EVT Innovate H H H H H H H H R&D expenses (in m) EBITDA 1) (in m) EVT Execute EVT Innovate EVT Execute EVT Innovate H H (4.9) H H H H H H (9.0) 29 1) Adjusted for changes in contingent considerations

31 Accelerated path to growth and sustainability Key metrics Revenues (in m) EBITDA adjusted 1) (in m) Alliances >100 > e e e R&D expenses (in m) Liquidity 2) (in m) Employees 3) > > e e e 30 1) 2) 3) 1) Adjusted for changes in contingent considerations 2) Cash and cash equivalents and investments 3) Effective on 01 April 2015, Evotec acquired Sanofi s scientific operations in Toulouse, France; 2015 number including the employees from this transaction

32 Strong team for innovation Management & shareholder structure 13% Roland Oetker/ROI ~13.0% 65% Free float 6% TVM Capital 12% BVF 1) 3% AGI 2) 1% Management Management Board Werner Lanthaler (CEO) Long-time experience in Pharma & biotech Mario Polywka (COO) 18 years Evotec experience Cord Dohrmann (CSO) Outstanding background in metabolics Colin Bond (CFO) Big industry multi-national background Supervisory Board Wolfgang Plischke Ex-Bayer Bernd Hirsch Symrise AG Claus Braestrup Ex-Lundbeck Paul Herrling Ex-Novartis Iris Löw-Friedrich UCB Elaine Sullivan CEO Carrick Therapeutics Number of shares: m Listing: Frankfurt TecDAX, OTCBB 52 week high/low: 4.14/ ) BVF Partners L.P. and its affiliates 2) Allianz Global Investors GmbH

33 Guidance confirmed 1) Guidance Doubledigit topline growth Approx. 45% growth excluding milestones, upfronts and licences 2 Profitable Positive adjusted EBITDA 2) Liquidity is expected to be well in excess of 100 m 3) 3 Accelerated investments Increased R&D investments of approx m in strategic Cure X and Target X initiatives to accelerate long-term clinical pipeline building Continued capacity and capability building with up to 10 m 32 1) As a result of the Sanofi collaboration, Evotec raised its revenue guidance that was published in Evotec s Annual Report 2014 two times, firstly on 24 March 2015 and secondly on 12 May On 15 September 2015, Evotec raised its revenue guidance due to a strong business performance and a positive outlook for the remainder of the year. All elements of the financial guidance 2015 as of 12 May 2015 are confirmed. 2) Before contingent considerations and excluding impairments on other intangible and tangible assets and goodwill as well as the total non-operating result 3) Excluding any potential cash outflow for M&A or similar transactions

34 Strong outlook for H Expected key milestones in 2015 EVT Execute New long-term deals with large and midsized Pharma, foundations and biotech New integrated technology/disease alliances Milestones from existing alliances EVT Innovate Strong progress of clinical pipeline within partnerships Phase IIb data with Roche in AD alliance Expansion of network of top-class academic alliances Partnering of Cure X/Target X initiatives 33

35 Your contact: Dr Werner Lanthaler Chief Executive Officer +49.(0) (0) Fax