Best in Class Drug Discovery solutions Evotec Company Overview

Transcription

1 Best in Class Drug Discovery solutions Evotec Company Overview Evotec AG, Company presentation, September 2012

2 Forward-looking statements Information set forth in this presentation contains forward-looking statements, which involve a number of risks and uncertainties. The forward-lo oking statements contained herein represent the judgement ofevotecasof 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 wh hich 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. PAGE 1

3 Agenda Evotec at a glance Action Plan 2016 Innovation Efficiency Financial strategy & Outlook PAGE 2

4 Solutions to accelerate Innovation Efficiency Evotec overview 1) Hamburg Oxford Thane München Göttingen San Francisco Best-in- Class Drug Discovery Solutions Strong track record after >15 years drug discovery history >100 lead series > 30 preclinical candidates > 20 clinical compounds Systematic, comprehensive & unbiased infrastructure Innovative disease biolog gy for new drug targets More than 640 top-scientists Our Mission PAGE 3 1) Founded in 1993, Publicly listed on TecDAX (Germany), > 70% free float, >600 employees, Headquarter in Hamburg, Germany

5 Leader in Innovation Efficiency Evotec at a glance 1 Best-in-class in R&D efficiency Complete, systematic, unbiased and most comprehensive infrastructures to significantly reduce costs and accelerate time to discovery decisions 2 3 Profita able & fast growing Double-digit y-o-y revenue growth, profitable, cash generating, strong portfolio of significant strategic alliances First-in-class in targets and deep-pipeline Matured partnered product pipeline includes Phase III, Phase II and Phase I assets, and first-in-class targets for future drug discovery alliances PAGE 4

6 Agenda Evotec at a glance Action Plan 2016 Innovation Efficiency Financial strategy & Outlook PAGE 5

7 External innovation delivers higher capital efficiency Key factors underpinning Evotec s mission 1 Need for higher R&D capital efficiency Discovery outsourcing relative to other stages of value chain 1) In bn US$ ) Not outsourced Outsourced EVT core competence Other EVT competencies Need for more variable than fixed costs Faster investment or Stop loss decisions i 1.8 Discovery 8% Preclinical Phase I Phase II Phase III 53% 33% 36% 19% % Outsourcing PAGE 6 1) Major players: Wuxi Pharma, Biofocus, AMRI, Syngene, PPD, Evotec, ca. 100 fragmented smaller players 2) WallStreet research 2008; evaluate Pharma; BioWorld

8 Action Plan 2016 for sustainable growth Action Plan Forces at work 1 2 Over the next 5 years, outsourcing in discovery will grow by ca. 5-10% p.a., mainly driven by pharma restructuring Attrition for early targets will most likely increase as hurdles for new therapies get higher Requirements for drug discovery solution providers 1 Industrial scale, quality and cost structures (EVT Execute) 3 4 Western technology solutions will be combined with Asian capacities and cost structures Significantly larger integrated drug discovery solution providers will emerge 3 2 Innovative biology Best in class drug and targets discovery platforms (EVT Innovate) (EVT Integrate) PAGE 7 Source: Biocentury; and validated by analysis from e.g. Merck, sanofi, BMS, J&J, several consulting firms, invstment analysts

9 The offering for Innovation Efficiency Action Plan EVT Innovate 2 EVT Integrate Product Development Partnerships and Cure X Initiatives First-in-class discovery and product developments Investments for upfronts, higher milestones and higher royalties 1 EVT Execute Integrated t drug discovery all liances on partner targetst Best-in-class integrated drug discovery projects Risk-shared performance-based alliances with research fees, milestones and royalties Stand alone screening, medicinal chemistry, compound management, compound profiling, Highest quality solution tools and processes No risk-exposure, lower margin, but long-term repeat business and built up of infrastructure PAGE 8

10 Broad stand alone execution business Comprehensive Drug Discovery Platform EVO Apps Compound Management High Throughput Screening Protein Production Struct tural Biology Project management & processes deliver up to 30% faster execution Target Deconvolution Compound Profiling In vitro and in vivo Pharmacology Computational and Medicin nal Chemistry 30% cost reduction versus pharma internal costs accessed on a variable basis PAGE 9

11 Highest quality outsourcing services EVT Execute Major milestones and actions for H2 1 Expansion of counter screening and protein production initiatives with improved gross margins 2 Improvement of compound management business 3 Completion of commercial offering with 4-Antibody 4 Expansion of EVT Ex xecute capabilities strengthen risk shared initiatives PAGE 10

12 Disease biology is the processor for integrated drug discovery alliances Alliance model Core disease biology know-how Metabolics Respiratory Diseases Regenerative Medicine Best-in-class systematic, unbiased and comprehensive infrastructures Immunology & Inflammation Oncology CNS & Pain PAGE 11

13 Faster to Decisions business model aligns incentives Business model Examples of integrated alliances Milestones and royalties create significant long-term upside Illustrative % % Fixcost EVT Pharma Base MS 1 MS 2 MS 3 MS 4 Clinical Start MS 5 MS 6 MS 7 Total Royal- Outsour- ties cing- cost PAGE 12

14 Strong portfolio of top-class partners Selected integrated drug discovery alliances targets provided by partners Partners Focus area Upside for Evotec Oncology, inflammation +++ Huntington disease + Various ++ Description Performance-based, multi-target long-term alliance Long-term alliance, focused on the fight against Huntington disease Long-term alliance, focused on multiple targets 1. CNS 2. Immunology ++ Performance-based, long-term alliance, focused on CNS / Immunology targets Pain ++ Performance-based alliance, focused on pain Various ++ Performance-based, multi-target long-term alliance PAGE 13

15 Building an even stronger portfolio of upside opportunities EVT Integrate Major milestones and actions for H2 1 Expansion of portfolio with at least one more strategic multi-target alliance 2 Further milestone ac hievements in ongoing alliances 3 Expansion of customer reach to even more biotech, mid-sized and large pharma customers PAGE 14

16 A strategic pharma a portfolio without financial risk EVT Innovate Indication Partner Status Diabetes 1) 2 Phase III clos se Final Phase III data to completion Alzheimer s Disease 2) Phase II Phase IIb initiation Treatment resistant Open Phase II depression 3) Insomnia 4) Phase II Next milestone New partnering Phase IIb start Commercials Approx. 40 m milestones, royalties; potential market approx. 500 m Approx. $ 820 m milestones, royalties; potential market $ 3 5 bn Open Milestones, royalties Inflammation 5) Phase I / II Phase II start Approx. 60 m milestones, royalties Inflammation in Phase I/II animal health 6) Diabetes Janssen Research Others 7) Open Pre-clinical Phase II start Pre-clinical Partnering Milestones, royalties Upfront $ 8 m; research payment; up to $ 300 m milestones per product; royalties li Open CURE X Initiatives Open Research Initiation Open PAGE 15 1) DiaPep277 is being developed by Andromeda Biotech Ltd and has been partnered with TEVA Pharmaceuticals Industries Ltd 2) EVT 302 (Mao-B ) ; 3)EVT 101/103 series; 4) Chinese rights only; safety and Phase IIb study planned starting 2012 (EVT 201) 5) EVT 401 (P2X7) ; 6)Animal Health (undisclosed) (EVT 401 (P2X7) ); 7) EVT 501 (H3), P2X3,

17 Novel treatment for T1D met Phase III endpoints Product development alliance with Andromeda/Teva (Phase III) DiaPep 277 A therapeutic treatment for newly diagnosed type 1 diabetes Type 1 diabetes results from the body s failure to produce insulin, and presently requires life long insulin therapy by subcutaneous injection Today there is no therapy able to slow the destruction of insulin secreting pancreatic beta cells DiaPep 277 is targeted to treat newly diagnosed patients, with residual insulin secreting cells About DiaPep 277 DiaPep 277, is a unique peptide of 24 amino acids, derived from human heat shock protein 60 (HSP 60) The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin in response to elevated blood glucose levels PAGE 16

18 DiaPep 277 is pro ogressing g towards market entry; orphan drug status in USA granted Example 1: Product development alliance with Andromeda/Teva Development background All development, regulatory responsibilities and costs have been transferred to Andromeda/Teva 1) Phase I and Phase II studies were successfully conducted d Two Phase III studies have to be conducted for registration Teva has a world wide exclusive license to DiaPep 277 Status DiaPep 277 met primary endpoint of 1 st Phase III trial (Beta cell funct tion) and triggered a 3.9m milestone DiaPep 277 demonstrated a significant ifi preservation of C-peptide levels, a marker for assessing insulin secretion by pancreatic cells Additional clinical, safety and efficacy analysis ongoing 2 nd Phase III with approx. 500 patients was already initiated Expected key milestones for Evotec Next milestone is triggered upon completion of 2 nd Phase III study Final data of 2 nd Phase III in 2014/2015(e) First sales projected for 2015(e)/2016 PAGE 17 1) DiaPep 277 was owned by DeveloGen (Evotec Göttingen)

19 Novel treatment of Alzheimer s disease Product development alliance with Roche (Phase II) EVT 302 an orally active MAO-B inhibitor to slow down progression of Alzheimer's disease (AD) Alzheimer disease (AD) is the most common form of is diagnosed in people over 65 There is no cure for the disease, which worsens as it predicted to affect 1 in 80 people by dementia, most often AD progresses. AD is RG 1577 EVT 302 is targeted to slow down the sy ymptoms of AD. This would be demonstrated in cognitive tests such as ADAS-cog 1). About RG 1577 EVT 302 MAO-B is normally present in brain and is responsiblee for break-down of certain neurotransmitters Activity of MAO-B is linked to production of reactive oxygen species, molecules that can cause neuronal damage Blocking the activity of MAO-B should reduce oxidative stress which is expected to slow progression of AD PAGE 18 1) Alzheimer s disease assessment scale cognitive subsection. Current gold standard in AD clinical trial endpoints

20 RG 1577/EVT302 high unmet medical need Example 2: Product development alliance with Roche Development background All development, regulatory responsibilities and costs have been transferred to Roche Phase I and Phase II trials have been conducted partially with different therapeutic goals Safety profile is established Development profile can potentially target stand alone application or treatments Licensing agree ement No further costs to Evotec Upfront payment of $ 10 m Milestones of $ 820 m Double digit royalties Status and expected key milestones for Evotec Large Phase IIb trial in preparation for start in 2012 Phase IIb completion and Phase III start (2015e) PAGE 19

21 Building up a portfolio of high-value assets Update on assets EVT 302 Development, regulatory responsibilities and all costs have been transferred to Roche Development profile can potentially target stand alone application or combination treatments in AD Large Phase IIb trial in preparation for start in H EVT 401 Exclusive licence for China only granted to Conba Pharma one of the largest Chinese pharma companies Small upfront, approx. 60 m milestones and tiered double-digit royalties for inflammation diseases Ongoing trials in Animal Health, partnering process for humans ongoing EVT 101 / 103 Completed multiple dose finding studies, solid safety profile Completed satisfactory long term-tox study for EVT 101/103 Partnering process ongoing Other clinical / pre-clinical programmes EVT 201 Phase IIb start expected for China in 2012, currently pending with Chinese regulatory authorities VR 1 Update from Pfizer expected in Q / Q Others: B1, P2X3, H3 still active PAGE 20

22 Multiple highly innovative, potentially disease modifying approaches Evotec s unique diabetes franchise Targeting the root causes of diabetes Metabolic alliances Pain & Inflammation alliances Oncology alliance CNS alliances Type 1 diabetes (Andromeda /Teva) DiaPep277 targeting autoimmunity, HSP60 derived peptide 3.9 m milestone achieved in Q1 as DiaPep277 met primary endpoint of 1 st Pha ase III trial (Beta cell function) payment expected in Q4 Recruitment of 2 nd Phase III with approx. 500 patients is expected to be completed in Q3 Type 2 diabetes (Boehringer Ingelheim) Insu ulin sensitizer targeting insulin resistance, undisclosed target identified and validated by Evotec Up to 237 m milestones, significant royalties Status preclinical Type 1 and 2 diabetes (MedImmune/AstraZeneca) Therapeutic protein targeting beta cell mass, undisclosed target identified and validated by Evotec Up to 254 m milestones, significant royalties Stat tus pre-clinical Type 1 and 2 diabetes CureBeta ( Harvard Evotec Janssen) Largest collaboration in beta cell regeneration, undisclosed targets identified and validated by Harvard / Evotec Stat tus discovery PAGE 21

23 Win Win Win situation rolled over into pharma CureBeta terms Win/Win/Win alliance Starting point for innovation efficiency and external innovation Upfront $ 8 m, potential milestones up to $ m per product (pre-clinical, clinical, regulatory, commercial) Significant royalties Research payments Janssen: Accessing first-in-class biologics and small molecule discovery and development platform and expertise in diabetes Evotec: Expanding leadership i n beta cell regeneration highly systematic, unbiased and comprehensive approach to beta cell replication Harvard: Accelerating development of innovative science with big commercial upside Pharma industry appreciates the approach & seems keen to enter these type of deals Optimal translational strategy fo or academia or early biotech ideas as targets get immediately on pharma grade infrastructures PAGE 22

24 Building a Cure X pipeline High unmet medical need and paucity of disease modifying targets CureBeta Started collaboration with Harvard University in March 2011 Partnered CureBeta with Janssen in July 2012 Significant research payments, milestones, royalties CureNephron Started collaboration with Harvard University in February 2012 Highly productive in generating candidate targets & compounds CureNeuron Concept phase for internal projects Exploring potential collab boration opportunities CureHeart Concept phase for intern nal projects Exploring potential collaboration opportunities PAGE 23

25 First-in-class innovation with focus in CNS, oncology and metabolics EVT Innovation Major milestones and actions for H2 1 Define strategy for EVT 101 / Build portfolio of more academic partnerships 3 Define 1 2 more strategic Cure X initiatives for 2013 PAGE 24

26 Agenda Evotec at a glance Action Plan 2016 Innovation Efficiency Financial strategy & Outlook PAGE 25

27 Positive trend of all key metrics reflect strength of underlying business Key metrics for 2012 in m Double digit revenue growth to 88 m - 90 m Focused R&D and Capex investments for first in class innovation Sales Key trends approx. 12 Gross margin % 2012(e) (e) Accelerated operating profitability ) R&D expense SG&A ratio Free cash flow CAPEX ~ 12 m investments Top class scientists (e) Strong liquidity despite significant investments 1 Technology 4 India 12 DeveloGen 15 Kinaxo 12 Compound Focus 44 Acquisitions from >62 Cash status end 11 PAGE 26 1) Including impairment and restructuring expenses

28 Strong profitable growth H1 2012: Condensed consolidated statement of operations in m Revenues Gross margin R&D expenses SG&A expenses Amortisation Other op. (income) expenses net Operating income Net income H H % vs % 43.3% 35.2% % % ) ) % % PAGE 27 1) Mainly amortisation for Evotec San Francisco customer list 2) Including expenses for planned underutilisation from parallel rental in Hamburg ( 1.1m) and fair value adjustments in the context of the contingent consideration (earn-out) for Evotec Goettingen ( 0.3m) and Evotec San Francisco ( -1.0m)

29 All elements of guidance comfortably confirmed Guidance overview In m Guidan nce 2012 FY 2011 Revenues Operating income 1) Innovation investments (R&D Expenses) Improved over Approx Capex investments > Liquidity at period end Above PAGE 28 1) Before impairment and changes in contingent consideration

30 Visit the Manfred Eigen Campus in Hamburg Significant upgrading processes at all sites Hamburg, Germany Manfred Eigen 1) Campus San Francisco, US ~30 employees Compound Procurement Compound QC and storage Abingdon, UK ~215 employees Medicinal chemistry ADMET Structural biology ~185 employees Screening HTS,NMR in vitro & in vivo biology Munich, Germany ~30 employees Phosphoproteomics Chemical proteomics Göttingen, Germany ~40 employees Metabolics Regenerative Medicine Thane, India ~130 employees Library synthesis & mgmt. Development chemistry Sales representation (Boston, Tokyo) Operations & sales representation PAGE 29 1) Manfred Eigen (*1927), German biophysical chemist and one of the worldwide leading pioneers in biotechnology.in 1967, he won the Nobel Prize in Chemistry for his work on a special measuring method of fast chemical reactions, which, until then, were considered to be immeasurable. He initiated the foundation of Evotec AG.

31 The right team to deliver innovation, growth and industrialisation Management & shareholder structure TVM Capital Roland ~10.0% Oetker/ ROI ~15.0% Management ~0.5% Number of shares: m Listing: Frankfurt TecDAX, OTCBB 52 week high/low: 2.95 / 1.58 Management Board Werner Lanthaler (CEO) Long time experience in biotech & pharma growth organisations Mario Polywka (COO) 18 years Evotec experience Cord Dohrmann (CSO) Outstanding background in metabolics Colin Bond (CFO) Big industry multi-national background Key scientific Advisors Doug Melton Harvard University / HHMI William Jenkins Ex-Novartis Supervisory Board Flemming Ørnskov Bayer Hubert Birner TVM Capital Mary Tanner Peter J. Solomon Walter Wenninger Ex Bayer Roland Oetker ROI Andreas Pinkwart Dean of Leipzig Graduate School of Management PAGE 30

32 Strong news flow to come Outlook and next steps for 2012 ff Key milestones for EVT Execute Double digit revenue growth Expansion success of existing alliances Significant long-term deals with major pharma 2 3 EVT Integrate EVT Innovate At least 2 significant ifi new integrated t technology/disease alliances Deliver significant and accelerated preclinical/clinical milestones Show operational synergies of recent acquisitions At least 1 strategic deal for early assets Expand offering into larger molecules offering (e.g. Antibodies) Commercialise innovation (e.g. Cure X, ) Phase III data in DiaPep277 and Phase IIb start within AD product development partnershipp PAGE 31

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