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Evotec SE — Investor Presentation 2007
May 4, 2007
151_ip_2007-05-04_0b9580c3-5fed-487b-876f-ecb0b873ed18.pdf
Investor Presentation
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Evotec AGFY 2006 Results Presentation, 29 March 2007
Translating Innovation into Results
Evotec highlights
- z Established biotech company with powerful track record in drug discovery and development
- z Small molecule engine
- €67m in revenues in partnerships, cash generative
- Attractive CNS pipeline with compounds in blockbuster indications
- z€79m in cash
- zFSE listed public company
CNS Pipeline
Agenda
- 01Highlights 2006
- 02Pipeline
- 03 Collaborations
- 04 FY 2006 Results
- 05Outlook 2007
Small molecule machine to build internal pipeline and partnership business
Highlights 2006
- z CNS pipeline - value inflection points ahead
- Phase I/II study for insomnia candidate EVT 201 confirmed findings of previous study
- 2 US Phase II patient studies for EVT 201 - results expected in Q3/2007
- z Strong performance of Service business
- New partnerships, revenues grow by 5%
- Strong financial results
- -Positive operating income before amortisation and impairment
- -Cash generative (Group reserves increased to € 78.7m)
- zDivestment of Evotec Technologies sharpens focus on future business
- zAll major financial objectives reached or exceeded
Our CNS pipeline
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Pipeline progressed during 2006
zEVT 300
- In-licensed 2 MAO-B inhibitors, EVT 301 and EVT 302
- Changed focus to EVT 302 from EVT 301 following Phase I results
- z EVT 100
- Successful completion of Phase I studies for EVT 101
- Progressed EVT 103 towards clinical trials
- z EVT 201
- Finished second Phase I/II proof-of-principle insomnia study, data positive and consistent with initial Phase I/II study
- Start of 2 US Phase II trials in primary insomniacs and elderly insomnia patients with daytime sleepiness
Agenda
- 01Highlights 2006
- 02Pipeline
- 03 Collaborations
- 04 FY 2006 Results
- 05Outlook 2007
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 in AD
zClinical status
- Phase I SAD finished
- Further Phase I studies during 2007
- Phase II in smoking cessation planned to begin mid 2008
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
- Cost ~ \$3.50/day; treatment course (6 months) ~ \$600
- 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
EVT 201: Insomnia candidate with differentiated mode of action
z Potential novel insomnia treatment on GABAAreceptor complex
(partial positive allosteric modulator)
zDifferentiated profile
- Partial agonism
- Ideal T1/2: approx. 3.5 hrs
- Similar PK in young and elderly
- Strong preclinical characteristics
zClinical status
- Well tolerated in Phase I
- Encouraging results in 2 Phase I/II proof-of-principle studies
- 2 US Phase II studies ongoing
- Proof-of-concept expected Q3/2007
Insomnia market: Under-penetrated and consumer driven
zSymptoms of insomnia very frequent
(2005 Sleep in America Poll Survey, Nature Reviews / Drug Discovery)
- 54% encounter symptoms at least 1x per month,
- Only 7% use RX sleep aid
zSignificant consumer driven growth potential
(Morgan Stanley survey of global sleep specialists (Feb 2006))
- 62% of sleep physicians expect > 20% growth of prescriptions
- 50% of prescriptions based on patient requests
GABAA modulation is Gold Standard for Insomnia > 90 % of drugs use this mechanism, incl. market leaders
US market share data according to IMS, January 2007
GABAA modulation: Gold Standard mechanismClinically validated
> \$ 3.5 bn annual US sales in 2006
Significant unmet needs remain
"One of the major challenges is to develop a drug that induces sleep quickly, helps individuals remain asleep and allows them to awaken feeling refreshed rather than hung over."
Datamonitor, Pipeline and Commercial Perspectives: Insomnia, 12/2005
"The elderly form a large part of the insomnia population and are particularly ill served by current medicines, both in terms of efficacy and side effects."
Physician Interview, IMTA Survey, 2006
Road traffic noise model in a sleep laboratory: Good model to measure sleep maintenance
EVT 201 shows efficacy in sleep maintenance in both first and second half of the night
- zEVT 201 (1.5, 2.0 & 2.5 mg) significantly reduced WASO over the whole night
- zSignificant reduction in Wake after Sleep Onset in hours 0-4 and hours 5-8
- zNo subjective residual effects
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)
- Enhanced 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
- z2 Phase II results in primary insomnia in Q3/2007
Agenda
- 01Highlights 2006
- 02Pipeline
- 03 Collaborations
- 04 FY 2006 Results
- 05Outlook 2007
Research results for a top quality customer network
Partnering at all stages of the value chain
4/2/2007 Folie 23
Small molecule engine allows to build significant early stage product equity
| D i s c o e r v y |
P l i i l r e c n c a |
P h I a s e |
P h I I a s e |
P h I I I a s e |
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| E V T 2 0 1 G A B A i l t t r e c e p o r p a r a p o A |
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03 Our Collaborations
4/2/2007 Folie 25
High-value added, results-based collaboration: Research payments, milestones, royalties, rights back
zGoal of collaboration
- Deliver preclinical candidates
- Exploit Evotec's GPCR and other target class expertise
zScope
2004
- Duration 5 years
- 76 FTE committed (36 from Evotec)
Expanded scope and content
Milestones achieved in 2005 + 2006
2005 2006 2007 2008 2009
Expanding the partnership into another area of strength
- z Multi-year collaboration to identify novel Alzheimer's disease targets
- z Applying Evotec's proprietary and well validated disease models
- z Boehringer Ingelheim (BI) will select and further validate target candidates
- z Contract includes option for Evotec to support BI in the validation process
- Milestone payments of up to €20m plus royalties
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
Traditional ServicesA strong year for chemical and pharmaceutical development
- zStrong pilot plant and formulation sales
- z Moving down the value chain with a number of discovery customers
- e.g. Panacos lead project moved into preclinical development
- z Large pharmaceutical companies are returning for larger FTE-based contracts
- z Commercial manufacture of four APIs
- Vernalis, Panacos, AnorMED, US biotech
- z Integration of formulation business propelled further growth
- Increased need for niche, small volume, parenteral clinical products
- Average deal size increased, repeat orders
Acquisition of Neuro3d to support pipeline expansion
- zTake over of Neuro3d with all remaining assets effective 01/04/2007
- z Evotec acquires
- Assay and know-how on a target with potential in a number of CNS diseases
- A focused compound library
- Up to €22m in cash
- zAll Neuro3d shares against approx. 6.0 million Evotec shares
Agenda
- 01Highlights 2006
- 02Pipeline
- 03 Collaborations
- 04 FY 2006 Results
- 05Outlook 2007
Financial guidance for 2006 fully achieved
Evotec Group including ET (in €m)
| 2 0 0 5 |
2 0 0 6 |
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| R e v e n u e s |
8 0 |
8 5 |
6 % + |
0 h 5 t % g r o w – |
| C i i b i t o n n n g s n e s s u u - |
6 4 |
6 7 |
5 % + |
S i e r c e s v 0 h t % g r o w |
| & R D e x p e n s e s |
1 4 |
3 3 |
1 3 7 % + |
3 0 3 5 – |
| N i t e n c o m e |
( ) 3 4 |
( ) 3 2 |
3 % + |
- |
| C h t d a s a e a r e n y |
4 5 |
8 1 |
1 5 % + |
3 0 > |
Services business continuedto be cash generative
Services Division 2006 (pro-forma calculation) in €m
| O i i t p e r a n g n c o m e b f i i & i i t t t e o r e a m o r s a o n m p a r m e n |
2 5 |
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| D i i t e p r e c a o n |
5 9 + |
| O " i h f l " * t p e r a n g c a s o w |
8 4 |
| C a p e x |
3 1 - |
| C f h l * f f a s o b l i w e o r e e a s e n a n c e |
5 3 |
04 FY 2006 Results
Cash development 2006: Capital increase and divestment of ET improve cash level
in €m
Agenda
- 01Highlights 2006
- 02Pipeline
- 03 Collaborations
- 04 FY 2006 Results
- 05Outlook 2007
Financial guidance 2007
zRevenues are expected to reach €65m - €70m
- Depending on success-based milestone payments
- Results-based deals and clinical out-licensing are likely to lead to more revenue volatility in the mid-term
- z Operating result expected to decline slightly compared to 2006
- Ramp up of internal discovery effort to capture value of early stage research
- Increased level of spending in clinical development
- Profitability could improve significantly in 2008/2009 with successful outlicensing and milestone payments
- zLiquidity at year end is targeted to exceed €40m
Significant clinical news flow in 2007
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Tomorrow's Drugs Today™
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