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Evotec SE — Investor Presentation 2008
Sep 10, 2008
151_ip_2008-09-10_be0beb03-3b2f-47f9-b066-1811dae258aa.pdf
Investor Presentation
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Evotec AGSeptember 2008
Focus on Pharma
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 expectations and assumptions concerning regulatory, clinical and business strategies, the progress of our clinical development programs and timing of the 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 variety of risks and uncertainties, m any 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 that product candidates may fail in the clinic or may not be successfully marketed or manufactured; 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; 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 in marketable 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 above is not exhaustive. Our 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 financial performance. 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.
Evotec highlights
- z Global CNS discovery and development company
- z Attractive pipeline with compounds in blockbuster indications
- At or near to POC, key for partnering
- z Financials 2008e:
- Revenues: € 34 – 36 m
- R&D expenses: € 46 – 51 m
- Liquidity at 12/31/08: > € 80 m
- z 420 employees
- 140 (D), 215 (UK), 65 (US)
- zFrankfurt SE and NASDAQ listed
ClinicalPipeline
Renovis
History
- z Preclinical discovery established
- zInflammation and pain
- z Clinical development
- zStroke
- z Positive results in 1st Phase III →Market cap: ~\$700 m
- z Negative results in 2nd Phase III →Market cap: ~\$100 m
Opportunity for Evotec
- zAttractive preclinical pipeline
- zSelf financing
- zUS footprint and NASDAQ listing
Multi-faceted pipeline, many clinical opportunities
| D i s |
c o v e r 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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| 2 0 1 E V T |
I i n s o m n a |
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| E V T 3 0 2 |
S k i C i t + m o n g e s s a o n |
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| E l D i a r s c o e r y v y |
EVT 201: Lead insomnia compound
Partial positive allosteric modulator (pPAM) of GABAAreceptors
- z Compelling product advantages
- Improved sleep onset and maintenance without hang-over
- Potential for one dose for all patients
- Superior safety profile
z Partner-ready, best-in-class opportunity Proof-of-concept (Phase II) established
GABAAagonists as dominating players
Performance of the key insomnia therapies 2005-2006
There is no ideal sleep drug today Advantages of EVT 201
| S f G h t i A B A o r c o m n g s o |
E V T 2 0 1 d t a v a n a g e |
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|---|---|---|---|---|---|---|---|---|---|
| 1 f f I i i t l i t n s u c e n s e e p m a n e n a n c e |
f f I d l h l l i e a a e - |
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| 2 f R i k i d l h s o r e s u a a n g o v e r - |
f f I d l h l l i e a a e - |
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| 3 P t l b i l i t i t h l d l o o r o e r a y n e e e r y |
f f I d l h l l i l i t h l d l e a a e a s o n e e e r y - , |
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| 4 T l o e r a n c e |
P A M h i p m e c a n s m |
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| 5 A b i l t t u s e p o e n a |
P h l h i h d t a r m a c o o g y a g e r o s e s |
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| 6 R i k f l l b h i s o c o m p e x s e e p e a v o r s |
P A M h i p m e c a n s m |
Partial agonist (pPAM) limits side effect risk
α1 ( β 2γ2)
pPAM + ideal half-life = New Gold Standard
9/2/2008Page 9
Results from 2 studies in adult + elderly insomniacs: Strong efficacy in the following six areas
- zWake After Sleep Onset (WASO)
- zSleep onset (LPS)
- zWake time in second half of the night
- zDaytime sleepiness in the elderly
- zResidual sedation
-
zCategorical ratings of sleep quality
-
→Significantly reduced
- →Significantly improved
- →Significantly reduced
- →Significantly reduced
- →Minimal at either dose
- →Significantly improved
EVT 201 well positioned against competition
| C d / o m p o u n d l r u g c a s s |
D i f f i i t t e r e n a o n i l t t p o e n a |
S l a e s t t i l p o e n a |
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| G A B A A P A M p ( E V T 2 0 1 ) |
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| M l i t e a o n n A i t g o n s |
f ( ) N i d i d i t i l l t z a r r o w w n o w o n c a o n o n y s e e p o n s e S f i i h f i d 8 d i i t t t z a n o w r s m o v e r a v a n a g e c o m p o u n s n p p , P h i i d d d l h i h l f f i t t z y s c a n s o n o r e g a r r u g c a s s a s g y e e c v e M k f R b l i t t t z a r e s u c c e s s o o z e r e m e o w e x p e c a o n s |
l i e n e |
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| 5 H T 2 A A i t t n a g o n s |
f f N t l t z o e e c o n s e e p o n s e f f L i i t d t l i t z m e e e c o n s e e p m a n e n a n c e S f i i h f i d i l l j i t t- t t z a n o w r s m o v e r- a v a n a g e w s e c u r e m a o r y k h t m a r e s a r e |
f o |
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| O i r e n x I h i b i t n o r |
f N l d t i z o e m o e o a c o n v f f f P t l i d t i d i t z r o o o c o n c e p o r s e e p n c o n a n m a n e n a n c e u H i h i k d i f F D A t t z g r s u e o s c r u n y o W i l l k i i f i i i h i i b t t t t t z a e s g n c a n m e o c o n v n c e p y s c a n s a o u |
l M A v e r y n o v e o |
EVT 302: Phase II program in Smoking Cessation Highly selective, orally active MAO-B inhibitor
- z Validating mechanism of action data
- Phase II, Smoking Cessation Phase III, Alzheimer's Disease
- z Expected product advantages
- New therapeutic option
- Comparable efficacy as mono-therapy
- Potential for enhanced efficacy in combination with nicotine replacement therapy
- Improved tolerability
- Favorable dosing
- z Path to proof-of-concept
- Phase II ongoing
- POC results expected in H1 2009
Smoking Cessation: Enormous market potential
| 1 H i l t t u g e p a e n p o o |
2 H i h l t g r e a p s e r a e H h R ü k f l l t o e c a r a e |
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|---|---|---|---|---|---|---|---|---|
| f f 1 0 0 l t d z m p e o p e e e c e ~ |
f 6 9 t t t i t i t h i l i t i z a e m p s o q u w n e m e - |
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| 0 % 5 i l t i t d t i t z s e r o u s y m o v a e o q u ~ |
O 6 % l h i t b t i z n y a c e v e p e r m a n e n a s n e n c e |
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| 0 i l l i i 5 t t m o n p a e n s |
F / i t t t a c o r p a e n x |
Geringer Wettbewerb
- zNicotine replacement "Standard of Care"
- zOnly 2 drugs marketed: Zyban, Chantix
Große Kostenakzeptanz 3. Low competition 4. High willingness to pay
- zHigh healthcare cost for public
- zPublic pressure on smokers increases
Underdeveloped market with significant growth in 2007 and strong US dominance
Source: MIDAS Sales Data, IMS Health, July 2007, Copyright ©, reprinted with permission.
EVT 302: Pathto POC for partnering
- z Phase II POC quit rate study
- 4 week quit rate of smokers withdrawing from cigarettes
- Read-out: H1 2009
- z Phase II acute craving study
- Influence on acute craving / withdrawal after short-term deprivation of cigarettes
- Read-out: Q3 2008
- z Tyramine interaction study
- To demonstrate lack of tyramine interaction (cheese and wine effect, cardiovascular liability)
- Read-out: Q4 2008
EVT 101: Selectivity for better treatment options
Oral NR2B subtype selective NMDA receptor antagonist
- z Potential in numerous indications
- Alzheimer's (AD), Pain, Depression
- z Expected product advantages
- Improved side effect profile
- Better efficacy in AD
- New option in high need indications
- z Memantine (non-selective NMDA antagonist)
- Blockbuster in AD in year 3
- z Status
- Phase I / Ib: well tolerated, 1st evidence of effect on human brain
- Phase II planned for H2 2008
Product supply into clinical pipeline Three candidates transitioning into Phase I
VR1 antagonists
- Innovative analgesic
- Multiple further indications
- -- Urinary incontinence --Asthma
- Significant collaboration with Pfizer
- Phase I started
P2X7 antagonists
- Enormous market potential in rheumatoid arthritis, irritable bowel disease, etc
- Potential best-in-classmolecule
- Phase I to start shortly
P2X3 antagonists
- -Pain, urinary incontinence
-
- Industry has struggled to find drug-like molecules
-
- Potential first-in-class molecule
- -Phase I planned to start 2009
Product supply into clinical pipeline Significant partnering potential
VR1 antagonists Partnered with Pfizer
License payments of \$20 m
- Milestones of > \$170 m
- Double-digit royalties
P2X7 antagonists Partnering interest
High interest
P2X3 antagonists Partnering interest
High interest
High-value and strategic partnerships: Milestones expected in 2008, 2009
Post-merger partnership profile
Evotec stock price: Significant increase in volume following Renovis transaction
Important value inflection points in 08 and 09
- zPartnering of EVT 201 (2008)
- zPhase II proof-of-concept for EVT 302 (2009)
- zPhase II proof-of-concept for EVT 101 (End of 2009 / Beginning of 2010)
- z Phase I results for VR1 and P2X 7(2009)
- zStart of Phase I with P2X3 (2009)
- z Potential further partnerships
- Development and commercialization partnerships for clinical assets
- Preclinical discovery alliances
Evotec –a compelling biotech investment
- z Strong CNS pipeline
- 4 products in the clinic
- Attractive discovery portfolio
- zSignificant partnership potential
- zLong-lasting discovery collaborations
- z Operations financed at least until the end of 2010(€101 million as of June 30, 2008)
- z US facility in the core of the Bay Area in California
- zLow valuation of biotech stocks
Tomorrow's Drugs Today™
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