Building innovative drug discovery alliances. Company Presentation. Evotec AG, November 2010

Transcription

1 Building innovative drug discovery alliances Company Presentation n Evotec AG, November 2010

2 Forward-looking statements Information set forth in this presentation contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about our expected 2010 financial results and financial growth in 2011, our anticipated financing needs, our ability to deliver on our liquidity guidance, our belief that we are on course to sustainable profitability latest in 2012, our expectations and assumptions concerning regulatory, clinical and business strategies, the progress of our clinical l development programmes and timing of the commencement and results of our clinical trials, strategic collaborations and management s plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a varie ety of risks ik 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. In particular, the risks and uncertainties include, among other things: risks ik thatt product candidat tes may fail in the clinic or may not be successfully marketed or manufactured; the risk that we will not achieve the anticipated benefits of our collaborations, partnerships and acquisitions in the timeframes expected, or at all; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; our inability to further identify, develop and achieve commercial success for new products and technologies; the risk that competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; our inability to protect our intellectual property and the cost of enforcing or defending our intellectual property rights; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; the risk that clinical trials may not result inmarketable products; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. The list of risks ik above is notexhaustive. Our most recent Annual Report on Form 20-F, filed with the Securities and Exchange Commission, and other documents filed with, or furnished to the Securities and Exchange Commission, contain additional factors that could impact our businesses and financiali performance. We expressly disclaim i 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 Strategic background & business model Discovery alliances & development partnerships Financial strategy & governance Outlook PAGE 2

4 The outsourcing opportunity in drug discovery Strategic position & key growth factors Strong demand for increased productivity in R&D Outsourcing of integrated projects leads to higher efficiency and risk mitigation Fixed costs become variable Only a few players meet scientific quality and size for sustainable growth Discovery outsourcing relative to other stages of value chain 1) In bn US$ ) Discovery Preclinical Phase I Not outsourced Outsourced Evotec core competence Other Evotec offerings Phase II Phase III 8% 53% 33% 36% 19% % Outsourcing PAGE 3 1) Major players: Wuxi Pharma, Biofocus, AMRI, PPD, Evotec, ca. 100 fragmented smaller players 2) WallStreet research 2008; evaluate Pharma; BioWorld

5 Leader in building Evotec at a glance drug discovery alliances Hamburg Oxford Thane Göttingen Founded in 1994 Strong track record after >15 years drug discovery history >100 lead series > 30 preclinical candidates > 20 clinical compounds Comprehensive integrated approach Innovative disease biology Small molecule drug discovery platform Expertise in various therapeutic areas Flexible / mostly performance based deal structures Strong financial position 1), critical mass Our value proposition Providing high quality drug discovery and development solutions to our partners within long-term alliances PAGE 4 1) Listed on TecDax Frankfurt Stock Exchange

6 One stop shop from target to clinic Value chain acceleration Target ID & validation Screening Hit-to-lead Lead optimisation Preclinical development Ph I/II Clinical development Molecular biology and cloning Bioinformatics In vitro target validation In vivo target validation Assay development & screening (u)hts High content screening Electrophysiology In silico screening technologies Fragment-based drug discovery Disease biology expertise Medicinal chemistry Hit expansion Library design High throughput chemistry Protein-ligand crystallography In vitro biology Early ADMET Medicinal chemistry In vitro biology Disease biology and target class expertise Computational chemistry and structure-based drug design In silico ADMET Custom synthesis Analytical development Process R&D Large scale synthesis In vivo pharmacology Clinical alliances Clinical project management 1 2 Higher quality Faster stop loss / investment decisions CNS Inflammation Pain Oncology Metabolic Diseases 3 Lower costs Proven programme management and delivery focus >300 assays developed >100 hit to lead and lead optimisation projects >30 PDC Cs > 20 compounds approved for clinical trials Flexible / mostly performance-based deal structures PAGE 5

7 Discovery alliances represent long-term, high-quality revenues with strategic upside Portfolio of discovery alliances Current cash Partners Focus area impac ct Oncology / Inflammation / Diabetes CNS Undisclosed Upside for Evotec ~75% of revenues generated within long-term alliances Pain Undisclosed Anaemia Pain neutral +++ Q3 highlights: - New alliances Various various various - Genentech - Genentech deal expanded - BI milestone PAGE 6

8 Product developm ment partnerships p represent meaningful upside Portfolio of product development partnerships Cash Upside for Indication Partner Status impact Evotec Next milestone Treatment resistant depression (TRD) Phase II Neutral ++++ Phase II data H / H Type 1 diabetes 1) Phase III Neutral Insomnia 2) Phase II Neutral Neuropathic pain Phase I Neutral ++ Phase III data 2012 Q3 highlights: - New alliance for EVT Clinical start in -Optimal China ) balance of risk / + Phase I data 2011 / Phase II start reward Other un-partnered clinical projects e.g. EVT 401(P2X7), PAGE 7 1) DiaPep277 is being developed by Andromeda Biotech Ltd and has been partnered with TEVA Pharmaceuticals Industries Ltd 2) Chinese rights only / 3) Safety and Phase IIb study planned starting 2011

9 Agenda Strategic background & business model Discovery alliances & development partnerships Financial strategy & governance Outlook PAGE 8

10 Integrated drug dis scovery and development process Business model Pain & Inflammation alliances: Novartis Boehringer Ingelheim Pfizer Metabolic alliances Boehringer Ingelheim Andromeda / Teva CNS alliances Roche Ono Pharmaceutical Genentech Core disease biology know-how Oncology alliance Boehringer Ingelheim Technology platform PAGE 9

11 Disease biology guides discovery Understanding, identifying, exploring, translating Core disease biology know-how Understanding Medical need Identifying Disease relevant mechanisms Exploring Key mechanisms and targets Translating Discoveries into clinical testing Considering the Potential to deliver Based on perspective of Significant benefit State-of-the art Patients to patients technology platform Accelerated by Defining critical path Physicians Payers New options to physicians Reasonable cost/benefit ratios Best practices and process Dedicated scientists Seamless integration of technology Biotech spirit and pharma know how e.g. Targeting causes not symptoms e.g. Beta cell regeneration e.g. P2X3 e.g. EVT101 PAGE 10

12 Highest quality track record delivering Core disease biology know-how Assay development and screening >300 assays developed >180 uhts screens Hit-to-lead-to-candidates >100 hit-to-lead and lead optimisation projects > 30 predevelopment candidates nominated Clinical studies 20 compounds progressed to the clinic PAGE 11

13 Industrialized platf form to find hits, leads and development candidates Overview technology platform Technology platform HTS Medicinal chemistry Computational chemistry & structural biology Proprietary screening technology for HTS, high content, label free and NMR screening Best in class set-up for vi rtual screening EVOlution : powerful fragment-based drug discovery platform Core expertise in assay development and high throughput screening Unique compound collection differentiated through quality, novelty and diversity Expertise and a track record of success in all major therapeutic areas and target classes Structure-based, rational design expertise or ligand-based design Fully integrated t biology for in vitro and in vivo support Integrated computational chemistry and structural biology capabilities Structure and ligand-bas sed design technologies: homology modeling, scaffold hopping, pharmacophore studies, quantitative structure activity relationship (QSAR) Pharmacology & toxicology Leading zebrafish screen Leading portfolio of in vitro ADMET assays L di b fi h ning platform for rapid and cost efficient i in vivo toxicity, safety pharmacology and access to various disease models In vivo PK capabilities (rodents), several proprietary animal models PAGE 12

14 Experts in CNS a unique product opportunity in TRD CNS alliances CNS alliances EVT 100 1) alliance with Roche Status: Phase II Roche funds clinical development of EVT 101 & EVT 103 in Treatment-Resistant Depression (TRD) EVT 101 Phase II POC results triggering $ 65m option, total deal value with Roche up to $ 300m; plus double-digit royalties Other CNS alliances Status: Pre clinical CHDI Multi-year alliance to find new treatments for Huntington s disease using integrated discovery offering; collaboration extended twice since 2006 Others: ONO Pharmaceutical Multi-target, multi-year alliance Genentech Multi-target, multi-year alliance Next value points: Phase II data and Roche buy-back decision in H / H Milestones in other programmes PAGE 13 1) EVT 101 /103 are high affinity, selective antagonists of N-methyl-D-aspartate (NMDA) receptor subtypes containing the NR2B subunit; they bind preferentially to the activated form of the receptor (activity-dependent); they modulate channel activity by inhibiting channel opening probability

15 Recently entered in diabetes METABOLIC DISEASEE alliances Metabolic alliances DiaPep 277 alliance with Andromeda/TEVA Status: Phase III Potential treatment of type 1 diabetes Development and commercialisation with Andr romeda/teva Short-to-mid-term milestone potential, Single-digit product royalties Other metabolic alliance Status: Pre clinical Partnership with Boehringer Ingelheim in the field of diabetes, obesity and metabolic syndrome Research funding, 7m upfront, 237m milest tone potential, ti single-digit royalties Next value points: End of Phase III milestone payment 1) Nomination of PDC by BI - High single-digit million milestone payment PAGE 14 1) Two Phase III studies ongoing; milestone expected after first Phase III study

16 Broad franchise in pain and inflammation PAIN & INFLAMMATION alliances Pain & Inflammation alliances Pain & Inflammation alliance Initiated 2006 Status: Phase I Partnership with Boehringer Ingelheim for trea atment of Next value points: neuropathic pain Significant number of other targets in pre clinical stages Clinical Progress Short-to-mid-term milestone potential, single-di git product royalties Nomination of clinical Other Pain & Inflammation alliances candidates Status: Pre-clinical Others: Genentech Multi-target, multi-year alliance Pfizer Alliance focused on VR1 Antagonist Novartis Alliance focused on pain target Pre-clinical milestones PAGE 15

17 One of the largest joint innovation teams in the industry ONCOLOGY alliance with BI Oncology alliances Oncology alliance Initiated 2009 Long-term joint innovation task force with focus on oncology Optimal use of Boehringer Ingelheim target and biology knowhow with Evotec science and technologies Incentives based on success and long-term product upside; minimum of four years; minimum 15m base contract; significant milestones and royalty upside Next value points: Additional milestones for preclinical progress Key strategic focus to expand oncology alliances PAGE 16

18 Investing for the right value points to build new alliances or stop loss Strategy overview of selected un-partnered assets Asset Potential indication Status Scientific rationale Upside Next value point EVT Cognition, Preclinical H3 recep tors act as +++ Phase I data in 2011/2012 histamine H3 narcolepsy inhibitory auto- and hetero- antagonist receptors regulating the activity of multiple neurotransmitters EVT P2X 7 antagonist Under evaluation Phase I (completed) Non-selective ATP-gated ion channel with restricted cellular distribution ++ Definition of potentially valuable indication P2X 3 / P2X 2/3 antagonist Neuropathic & inflammatory pain; urinary incontinence Preclinical ATP-gated homo- and heteromeric ion channels with distinct pharmacological and biophysic cal properties ++++ Definition Pre-clinical Development Candidate (PDC) Beta cell technology Metabolics e.g. Diabetes Preclinical Novel targets selected based on novelty and drugability ++++ Definition Pre-clinical Development Candidate (PDC) Others: e.g. ASIC, Orexin, BACE, FAAH, PAGE 17

19 Strategic imperatives for our business model Next steps Strengthen core business Expand quality leadership position in small molecule drug discovery Invest in highly innovative approaches to open new therapeutic routes in major markets (e.g. beta cell technology, regenerative medicine, oncology, ) Technology platform Invest in best-in-class technologies to accelerate stop-loss or investment decisions in discovery (e.g. HTS, in vivo models, ) Drug discovery alliances & product development partnerships Build even stronger portfolio of long-term high-quality partners Selectively increase EVT risk component in selected partnerships PAGE 18

20 Agenda Strategic background & business model Discovery alliances & development partnerships Financial strategy & go overnance Outlook PAGE 19

21 Strong performance, improvement of key indicators Key financials first nine months 2010 vs Revenues, in m Operating Profits, in m % 38.8 Strong growth in core business ) % Path to profitability becomes visible R&D, in m SG&A, in m % Accelerated partnering & focus on core programmes % 11.6 Cost saving and better capital efficiency PAGE 20 1) Including impairment of 6,6 m and restructuring expenses of 4,7 m

22 Improvement of all key parameters First nine months 2010: Condensed consolidated income statement (IFRS) in m ) ) % vs Revenues 29.1 Gross margin 38.3% R&D expenses 19.5 SG&A expenses 13.1 Amortisation & impairment 6.9 Restructuring expenses 4.7 Other op. (income) expenses, net -0.1 Operating income (loss) Net income (loss) % 44.0% Discovery % alliances growing % significantly without sacrificing gross margin, % operating and net result positive 0.7 PAGE 21 1) Nine months ended 30 September

23 70m liquidity operating cash flow under control First nine months 2010: Condensed cons. statement of cash flows (IFRS) in m ) ) Net cash provided by (used in) Operating activities Investing activities Financing activities Exchange rate difference Cash and cash equivalents at end of period Investments Auction rate securities Liquidity at beginning of period Net increase/decrease in liquidity Liquidity at end of period First time indicator that operating business is generating cash Includes capex of 1.9m PAGE 22 1) Nine months ended 30 September

24 Revenue guidance and all growth targets confirmed; stronger liquidity position New guidance for 2010 in m Revenue guidance for FY 2010 confirmed Internal R&D focused on key programmes ) ~ ) ) ) Liquidity position will stay strong despite 2.5m working capital needs for DeveloGen acquisition Potentially not loss making clear path to profitability latest in > ) ) ) ) ) ) ) PAGE 23 1) Continuing business 2) Excluding potential US$ 65m milestone income from Roche buy-back of the EVT 100 compound family 3) Including Renovis acquisition 4) Including impairment and restructuring expenses of 8.9m 5) Including impairment and restructuring expenses of 27.7m 6) Including impairment and restructuring expenses of 22.7m 7) Net income before extraordinary effects

25 Global reach for global projects Ca. 500 Evotec employees worldwide Abingdon, UK ~225 employees Medicinal chemistry Zebrafish screening ADMET Structural biology Thane, India ~140 employees Library synthesis and management Medicinal chemistry support Development chemistry Hamburg, Berlin & Göttingen, Germany ~150 employees Screening HTS NMR in vitro & in vivo biology Singapore Zebrafish screening Sales representation (San Francisco, San Diego, Boston, Tokyo) Operations & sales representation PAGE 24

26 Strong team committed to innovation and growth Management & new shareholder structure Roland Oetker / ROI LBBW AM TVM Management Capital ~3.0% ~10.5% ~0.5% 13.5% ~13.5% 76% Number of shares 1) : 115,595,129 Listing places: Frankfurt TecDAX, NASDAQ 2) 52 week high/low: 2.60 / 0.71 Management Board Werner Lanthaler (CEO) Intercell AG, McKinsey&Co, Federation of Industrialists Mario Polywka (COO) 17 years Evotec & OAI Cord Dohrmann (CSO) CEO of DeveloGen, MPI, Harvard Medical School, Massachusetts General Hospital Colin Bond (CFO) Most recently CFO at Novelis Europe Supervisory Board Flemming Ornskov Bausch & Lomb Hubert Birner TVM Capital Peter Fellner Vernalis Mary Tanner Peter J. Solomon Walter Wenninger Ex Bayer William Jenkins Chairman of the Scientific Advisory Board Heinz Riesenhuber Honorary Chairman PAGE 25 1) Former Develogen shareholders agreed to a 6 months lock-up (up to 7 m shares) 2) Delisted since November 2009

27 Agenda Strategic background & businessmodel Discovery & development alliances Financial strategy & governance Outlook PAGE 26

28 Strong news flow to come end 2010 / 2011 Q3 overview of expected key events Key milestones 1 Grow discovery alliances, build joint innovation alliances Expand all existing alliances (e.g. CHDI, Novartis, Ono Pharmaceutical ) Build several new integrated technology/disease alliances (e.g. Genentech) Deliver significant ifi preclinica i al/clinical li i l milestones 2 Generate optimal pipeline progress & value EVT 103 Phase I results s in Q1 Start of Phase II with EVT 101 in June 2010; partner EVT 201 At least 1 strategic deal for an early asset Initiate Phase I in H3 Manage growth Grow revenues by more than 15% y-o-y 3 and path to Optimise R&D and strategic innovation investments to approx. 10m profitability Keep strategic liquidity above 64m PAGE 27

29 Leader in a growth industry Investment rationale for Evotec Sustainable > 15% y-o-y ygrowth business with very strong gross margin and significant near-term biotech upside options Unique portfolio of long-term drug discovery alliances (e.g. Boehringer Ingelheim, CHDI, Genentech, Novartis, Roche, Biogen Idec, Pfizer, ONO Pharmaceutical...) EVT 100 Roche alliance near-term blockbuster product and $ 65m milestone opportunity (2011/2012) Wealth of preclinical assets and technologie s available for partnering and to initiate new discovery alliances Solid liquidity of > 64m provides very good strategic flexibility Strong news flow 2010/11 ff PAGE 28

30 Building innovative drug discovery alliances Your contact: Dr Werner Lanthaler Chief Executive Officer +49.(0) (0) Fax