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Evotec SE — Investor Presentation 2007
Jun 12, 2007
151_ip_2007-06-12_dfbf9426-e3b6-4aa7-96d9-98368e87a280.pdf
Investor Presentation
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Evotec AG:June2007
Forward-looking statements
Any forward-looking statements in this presentation are subject to a number of risks and uncertainties. While this presentation represents management's current judgement on the future direction of the Company's business, the actual results could differ materially from those anticipated in these forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to reflect events or circumstances arising after the date hereof.
Evotec highlights
- z Established biotech company with powerful track record in drug discovery and development
- z €67m in revenues in partnerships, cash generative
- z Attractive CNS pipeline with compounds in blockbuster indications
- z> €75m in cash
- zFSE listed public company
CNS Pipeline
Agenda
- 01Evotec Overview
- 02CNS Pipeline
- 03Collaborations
- 04 Financials and Outlook
Small molecule capabilities from 'Target to Clinic'
*PDC = Preclinical Development Candidate; IND = Investigational New Drug; POCD = Proof of Concept Drug
Small molecule capabilities to build internal pipeline and partnership business
Agenda
- 01Evotec Overview
- 02CNS Pipeline
EVT 201: GABAA Modulator for Insomnia EVT 101: Subtype-selective NMDA Receptor Antagonist EVT 302: MAO-B Inhibitor
- 03Collaborations
- 04 Financials and Outlook
Three clinical CNS programmes: First proof-of-concept in patients
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EVT 201: Insomnia candidate with differentiated mode of action
z Potential novel insomnia treatment on GABAAreceptor complex
(partial positive allosteric modulator)
zDifferentiated profile
- Partial agonist
- Ideal T1/2: approx. 3.5 hrs
- Similar PK in young and elderly
- Strong preclinical characteristics
zClinical status
- Successful Ph II in primary insomniacs
- 1 US Phase II in elderly ongoing
- 2 successful Phase I/II studies
- Well tolerated in Phase I
EVT 201: Clinical Development Summary
Study BP15911 (Roche) Single ascending dose study 0.3 mg – 20 mg 65 subjects (39 active)
Study EVT-2001 Dose finding 2.5 mg – 10 mg Road Traffic Model of Insomnia12 subjects (healthy male volunteers)
Study EVT-2002 Dose finding 1 mg – 2.5 mg Road Traffic Model of Insomnia12 subjects (healthy male volunteers)
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Study EVT-2004 Phase II proof-of-concept 1.5 mg & 2.5 mg doses primary insomnia patients Cross-over study in 67 completed patients
Study EVT-2005 Phase II elderly patients 1.5 mg & 2.5 mg doses elderly primary insomnia patients Parallel group study in 135 patients
EVT 201 Study 2004: Top-Line Efficacy Results
EVT 201 has robust effects on both sleep onset and sleep maintenance.
Results from 67 patients - intention to treat (ITT) analysis
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EVT 201 Study 2004: Top-Line Results
Secondary endpoints
- z Patients reported highly significant improvements in subjectively assessed quality of sleep (p<0.001 both doses)
- zNo effect on subjectively assessed residual sedation the next day
- z A small decremental effect on the digital symbol substitution test (DSST) assessed at nine hours post dose
- zNo impairment of Slow Wave Sleep (SWS)
Analysis of other secondary endpoints is ongoing.
02 Our Pipeline
EVT 201 insomnia drug: Potential for differentiation
- z "Gold Standard" clinical mechanismin insomnia
- z High affinity, α1 preferring partial positive allosteric modulator
- Potentially also reducing symptoms of anxiety
- Low potential for dependence
- z Sleep inducing, but not a "knock out" (partial agonist)
- No disruption of sleep architecture
- z Close to optimal PK profile supports sleep maintenance
- 3.5 hr T1/2ideal for good sleep maintenance and no hangover
- zSimilar PK in young and elderly, ease of use across patient spectrum
- zSubjective feeling of a good night's sleep
- z Strong proof-of-Concept for EVT 201 demonstrated in patients
- A key piece of the data package for partnering EVT 201 is now in place
EVT 302: Smoking cessation and Alzheimer's
- z Orally active, potent, highly selective MAO-B inhibitor
- z Potential in neurodegenerative diseases (AD, PD) and addiction
- Phase II clinical validation in smoking cessation (selegiline, lazabemide)
- Phase III clinical validation for MAO-B inhibition in AD
zClinical status
- Phase I SAD finished
- Further Phase I studies during 2007
- Phase II in smoking cessation planned to begin mid 2008
02 Our Pipeline
Smoking cessation: Enormous market potential
- zNicotine replacements - market value ~ \$1bn today
- z Large market, consumer driven and agile
- 44.5 million smokers in the US
- 70% of smokers desire to quit = 30 million
- Average smoker will make 6 – 9 attempts to quit during their lifetime
- z 2 non-nicotine prescription therapies approved
- Buproprion SR - originally an antidepressant (available generically), branded by GSK as Zyban for smoking cessation
- Chantix by Pfizer
- Launched in Aug 2006
- Peak sales expectation at \$1bn in 2011/2012
EVT 302: Strong product characteristics
z Smoking cessation - lower development risk and cost, strong competitive potential
- Clinically effective MAO-B mechanism
- Superior competitive safety profile over first generation MAO-B inhibitors with potential for no food restriction and better tolerability than Chantix
- Potential for once per week dosing
- Use as mono-therapy or in combination with nicotine based therapies
zAlzheimer's disease - higher development risk for disease modification
- Clinically validated mechanism
- Existing preclinical and Phase I programme for smoking cessation also validates compound for Alzheimer's disease at no extra cost
- Go/No Go decision to start Phase II in light of competitive scenario at that time
EVT 101: Selectivity provides key differentiation
- z Oral NR2B subtype selective NMDA receptor antagonist
- z Potential in neurodegenerative diseases and pain
- z 'Memantine' - a non-selective NMDA competitor drug - shows blockbuster potential in Alzheimer's disease
zClinical status
- Phase I successfully completed
- Phase Ib/IIa to start in H1 2007
- Preclinical toxicology in progress to allow longer-term clinical studies
Multi indication potential (Alzheimer, Pain, other indications)
- z Symptomatic Alzheimer's disease treatment, potential for disease modification
- NR2B selectivity should translate into clinical advantages over 'memantine'
- z Novel approach for treatment of neuropathic pain
- Clinical proof-of-concept for NR2B antagonists in neuropathic pain, plus a wealth of preclinical evidence
- zNovel perioperative pain indication
- z Status and plans:
- EVT 101 has a highly desirable preclinical profile
- -Potent and highly NR2B subtype selective NMDA antagonist
- -Excellent drug-like properties, oral adsorption, PK and brain penetration
- Phase I successfully completed; EVT 101 ready for Phase II proof-of-concept
- Choice of EVT 101 Phase II to be determined after Phase Ib/IIa studies
- Back up EVT 103 and injectable programmes
Agenda
- 01Evotec Overview
- 02CNS Pipeline
- 03Collaborations
- 04 Financials and Outlook
Research results for a top quality customer network
Partnering at all stages of the value chain
Small molecule engine allows to build significant early stage product equity
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| S H T & F B D D |
Global high-value, results-based collaboration
High-value, results-based collaboration
- z CNS project initiated at Evotec
- Undisclosed target
- Assay development, initial screen, identified chemical matter
Innovative business model
- z Joint research in areas of strength allows maximum efficiency
- z Flexible deal structure to add further targets to grow the alliance
- z Option rights, milestones (potentially > €100m), royalties
Expanding the partnership into another area of strength
zResults-based discovery collaboration
- Jointly deliver preclinical candidates
- 5 years, 76 FTEs (36 from Evotec)
- Research payments, milestones, royalties, rights back
- Milestones achieved in 2005 + 2006
zAlzheimer's disease target identification
- Multi-year collaboration
- Applying Evotec's proprietary and well validated disease models
- Includes option for Evotec to support BI in the target validation process
Expanding with our partners
- zBoehringer Ingelheim
- z Panacos
- A partner since 2004
- Extended into 4th year
- Expanded into chemical development
- z CHDI
- Started in March 2006
- 5 contracts signed
- Covering Evotec's entire drug discovery offering
- No. of Evotec scientists constantly growing
Agenda
- 01Evotec Overview
- 02Clinical CNS Pipeline
- 03Partnerships
- 04 Financials and Outlook
Q1 results inline with guidance for 2007
Evotec Group
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* Comparing Q1 2006 with Q1 2007 as reported
IFRS** Not including cash balances held by Neuro3d
Significant clinical news flow in 2007
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Emerging CNS company underpinned by profitable collaborative business
- z Established biotech company with powerful track record
- z Attractive CNS pipeline
- Compounds in blockbuster indications
- First Proof-of-Concept in Q2 2007
- z €67m revenues, cash generative partnership business
- z> €75m in cash
Tomorrow's Drugs Today™
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