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Evotec SE — M&A Activity 2008
Feb 12, 2008
151_ip_2008-02-12_88081ab6-ae73-4a86-9b1b-f1b0597a6251.pdf
M&A Activity
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Evotec AGFebruary 2008
Translating Innovation into Results
Forward-looking statements
Information set forth in this communication contains forward-looking state ments, which involve a number of risks and uncertainties. Such forward-l oking statements include, but are not limited to, state ments about theanticipated benefits of Evotec´s products, the timing of the co mpleti on of the transaction betweenEvotec and Renovis, the anticipated benefits of the business combination transaction involving Evotec and Renovis, including future financial and o p erating results, the combined company's plans, objectives, e xpectations an d intentions, the anticipated timing and results of the combined company's clinical and preclinical progra ms, and other state ments that are not historical facts. Evotec and Renovis caution readers that any forward-looking inform ation is not a guarantee offuture performance and that actual results could differ materially from those contained in the forw ard-looking infor mation. These include risks and uncertainties relating t o: the ability to obtain regulator y approvals of the transaction on the proposed terms and schedule; the parties' ability to complet e the transaction becauseconditions to the closing of the transaction may not be satisfied; the failure to successfully integrate the businesses; unexpected costs or liabilities resulting from the transaction; the risk that s ynergies fro m the transaction may not be fully r ealized or may take longer to realize than expe cted; disruption fro m the transaction making it more difficult to maintain relationships with custo mers, e mplo yees or suppliers; competition and its effect on pricing, spending, thir d-party r elationships and revenues; the need to develop new products and adapt to significant technological change; imple mentation of strategies for improvin g internal growth; use and protection of intellectual property; general world wide economic conditions and related uncertainties; future legislative, regulatory, or ta x chang es as well as other economic, business and/or competitive factors; and the effect of exchange rate fluctuations on international operations. The risks included above are not exhaustive. The most recent reports on Form 10-K, Form 10-Q, For m 8-K and other periodic reports filed by Renovis with the Securities and Exchange Commission contain additional factors that could impact the combined company's businesses and financial performance. The parties expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such state ments to reflect any change in the parties' e xpe ctations or any change in events, conditions or circumstances on which any such state ment is based.
Additional Information
Renovis fileda Current Report on Form 8-K with the Securities an d Exchange C ommission on Septe mber 24, 2007, that includes as an exhibit the Agreem ent andPlan of Merger between Evotec and Renovis. Evotec filed a Registration State ment on Form F-4 with the Securities and Exchange Commission in connection with the proposed merger. Evotec and Renovis expect to mail a joint proxy statement/ prospectus, which will for m part of the Registration Statement on Form F-4, t shareholders of Renovis in connection with the proposed merger. This document will c ontain important information about the merg er and should be read beforeany decision is made with respect t o the merger. Inv estors and stockholders will be able to obtain free copies of this docu ment and any other documents filed or furnished by Evotec or Renovis through the website maintained by the Securities and Exchange Commission at w ww.sec.go v. Free copies of these documents may also be obtained fro m Evotec, b y dire cting a request to Evotec's Investor Relations dep artment at Schnackenburgallee 114, 22 525 Hamburg, G ermany, or from Renovis, by directing a request to Renovis' Investor Relations department at T wo Corporate Drive, South San Francisco, California 9 4080.
In addition to the documents referenced above, Renovis files or furnishes annual, quarterly and current reports, proxy state ments and other information with the Securities and Exchange C ommission. You may read and copy any reports, state mentsor other information filed or furnished by Renovis at the S EC's PublicReference Room at Station Place, 100 F Street, N.E., W ashington, D.C. 20549. You can request copies of these documents b y writin g to the SEC and paying a fee for the cop ying cost. Please call the SEC at 1-800-SEC-0330 for more inform ation about the operation of the Public Reference Room. Renovis's SEC filings are also available to the public at the SEC's web site at www.sec. g ov, or at their we b site at www.renovis.com.
Evotec highlights
- z Powerful track record in drug discovery and development
- z Attractive CNS pipeline with compounds in blockbuster indications
- z€30 - 35m in partnership revenues
- z Proposed merger with Renovis to build global CNS pure play
- z Frankfurt SE listed company, anticipated NASDAQ listing 03/04 2008
CNS Pipeline
Management-led strategic transformation
Management-led strategic transformation
Management-led strategic transformation
*Note: Proceeds from the disposal of Evotec's Chemical Development business to Aptuit for aprox. US\$ 64 m and transaction cost when disposal effective end of 11/2007.
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The combination: Multi-faceted pipeline, strong fit and differentiating science
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Evotec
Lead compound: EVT 201 in insomnia
- z Small molec ule partial positive allosteric modulator (pPAM) of GABA Areceptors
- z Addresses limitations of market-leading insomnia drugs
- Sleep onset, maintenance, no hangover
- Same dose for young and elderly
- z Proof-of-concept established
- Strong Phase II POC data from 149 elderly insomniacs in October 2007
- Phase II in 67 primary adult insomniacs:
- Strong POC in patients
- Phase I and I/II studies with a total of 153 subjects
- -Strong safety profile, well tolerated
- zPartner-ready, best-in-class opportunity
Study EVT 2004: Objective efficacy from polysomnography Total Wake Time hour-by-hour
EVT 201 significantly reduced Total Wake Time each hourexcept of hour 7 (where p=0.058)
Study EVT 2004: Subjective residual effects Patient reported residual sedation
No subjective residual sedation at either dose of EVT 201
Study EVT 2004: Subjective efficacy Patient reported sleep quality
Both doses markedly & significantly improved categorical ratings of sleep quality
Study EVT 2005: Daytime sleepiness Multiple Sleep Latency Test (MSLT)
Multiple Sleep Latency Test (MSLT)
Error bars represent 95% confidence interval
Study EVT 2005: Summary of Phase II in elderly primary insomniacs
- zResults in elderly confirm results in young
- z Same doses in elderly insomniacs and normal adults lead to robust effects on both sleep onset and sleep maintenance
- zNo significant residual effects
- z Patients significantly less sleepy the day after 1 week treatment determined Multiple Sleep Latency Test (MSLT)
- zEVT 201 safe, well tolerated
- zFurther analysis is ongoing
EVT 201: Potential advantages for chronic insomniacs
| R b f f i t o u s e c a c y |
S l t, i t h z e e p o n s e m a n e n a n c e n o a n g o v e r , |
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S i i f i l d d d i l i t t z g n c a n y r e u c e a y m e s e e p n e s s |
| "G S N l, b t l d t o v e u o a n " O d d i i M A a r n s o m n a |
H i h l l i d t d t h z g a a e p a a y v w y L i d f f t i k z o e r s e e e c r s w |
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O i l P K f l l i t t t z p m a o r a p a e n s N d f t i d l z o n e e o r s s a n e r e e a s e u C f d i d d l t d l d l z o r r e s p o n n g o s e r a n g e o r a s a n e e r u y |
| D i f f i i h t t t e r e n a o n v s o e r G A B A b d t t a s e r e a - i l d l i t t t m e n s : p a r a m o u a o n |
H i h f f i i 1 f i i l i i l l i d l t t t t t z g a n y α p r e e r r n g p a r a p o s v e a o s e r c m o u a o r , L i l l f G A B A i i t t t t t z o w e r m a x m u m e v e o r e c e p o r s y s e m p o e n a o n A R d d i d f f i l ( d d l l h l t t t t z e u c e s e- e e c p o e n a e g e p e n e n c e o e r a n c e a c o o , , i i d i b f l h i ) t t t t t n e r a c o n s u r a n c e o s e e p a r c e c u r e , 2 / 1 2 / 2 0 0 8 P 1 4 a g e |
EVT 101: Oral NR2B subtype selective NMDA receptor antagonist
- z Subtype selectivity of EVT 101 NMDA supports hypothesis of better side effect profile, better efficacy in Alzheimer's
- z Memantine / Namenda, a non-selective NMDA drug in Alzheimer's disease, reached blockbuster sales in year 3
- z Potential in neurodegenerative diseases, peri-operative and neuropathic pain
- zStatus
Revenues 2006
- Phase I successfully completed
- Phase Ib studies ongoing
- Phase II POC study planned to start mid 2008
Namenda/Ebixa US\$ 0.9bn
EVT 101 ongoing trials and plans
- z Phase Ib cognition and brain imaging study
- Randomized, double-blind, single dose (8mg, 15mg) in 19 healthy volunteers
- Determine changes in neuronal activity, CNS penetration, dose response
- Read-out: Q1 2008
- z Phase Ib repeat dose cognition study
- Randomized, double-blind, ascending dose, 4 wk, 48 young / elderly subjects
- Determine effects of longer term treatment on cognition, safety and tolerability
- Read-out: Q2 2008
- zPhase II POC planned
EVT 302: Selective MAO-B inhibitor smoking cessation and Alzheimer's
- z Orally active, potent, highly selective MAO-B inhibitor
- Potential for once weekly dosing
- Competitive safety & tolerability profile over other MAO-B inhibitors –no food effect / label
- z Validating MOA data in addiction & neurodegeneration
- Phase II in smoking cessation (selegiline, lazabemide)
- Phase III in Alzheimer's Disease
- z Smoking cessation - a large consumer-driven market
- zStatus
Revenues 2007
- Phase I safety study successfully completed
- Additional Phase I data in H1 2008
- POC Phase II in smoking cessation: H1 2008
Chantix US\$ 0.9bn
EVT 302 ongoing trials
zPhase I safety study
- Randomized, double-blind, MAD, placebo-controlled, 84 young (2 wks, 2.5/5/15mg) / elderly (4 wks, 2.5/10mg)
- Well tolerated up to highest dose levels, AE's mild and transient, no liver findings
- Finished successfully
- z Phase I Positron Emission Tomography (PET) studies
- Open-label, single and multiple dose, 18 subjects/study, 5 or 15mg
- Completed, data in Q1 2008
- z Tyramine interaction study
- Double-blind, placebo-controlled, 60 subjects, against Selegiline
- To demonstrate lack of tyramine interaction (cheese and wine effect, cardiovascular liability)
- Read-out H1 2008
EVT 302 trial plans
- z 2 Phase II POC studies
- Effects of EVT 302 on craving alone / in combination with nicotine replacement therapy, results in 2008
- Effectiveness of EVT 302 in Smoking Cessation (quit rate), results in 2009
- z Phase II study of EVT 302 in Alzheimer's Disease
- To be decided in 2008
- Not budgeted for
VR1 - VanilloidReceptor 1 antagonist
Potential for safe, best-in-class analgesic, non-addictive, minimal side effects
zNon-selective cation channel
- Activated by capsaicin & resiniferatoxin
- Gated endogenously by heat, protons, lipid metabolites & eicosaniods
- Multimodal channel – detects more than chemical & thermal noxious stimuli
- zWidespread PNS & CNS distribution
- z Preclinical & clinical validation
- Gene disruption and small molecule agonist & antagonist studies
- z Potential in various diseases
- Up-regulated in chronic neuropathic pain
- Urinary incontinence, IBD, Asthma, etc.
zStatus
Revenues 2007
Pfizer partnership: Multiple clinical candidates
Celebrex US\$ 2.3bn
Planned Phase I start: 06/2008
P2X7 receptor antagonist Potential best-in-class molecule
- zNon-selective ATP-gated ion channel
- z Restricted cellular distribution
- Cells of immune & hematopoietic lineage: macrophages, mast cells, monocytes & lymphocytes
- z Involved in multiple signaling pathways: broad anti-inflammatory potential
- Mediates release of pro-inflammatory cytokines IL-1β & IL-18, MMP-9 release, caspase-1 activation, pore formation& necrotic cell death
- z Multiple large potential indications
- Pain, RA, IBD, MS, COPD, diabetes
- zPreclinical & clinical validation
- z Status
- Clinical candidate identified, back-up series
- Planned Phase I in 2008
P2X2/3receptor antagonist
- z First-in-class and best-in-class P2X2/3 receptor antagonist
- Very good drugability
- zPotential in pain and overactive bladder
- zPreclinical validation by Roche
- z Status
- Industry has struggled to find drug-like molecules
- Lead series with superior properties
- Potential clinical candidate within next 12 months, Phase I to start in H1 2009
Neuropathic pain US\$ 3.0bn
Validated research track record, ongoing revenue source
High-value partnerships: Milestones expected in 2008, 2009
Post-merger partnership profile
Key facts on Renovis acquisition
Data un-audited, pro-forma
- zNASDAQ listing condition to closing, planned for 03 2008
- zClosing subject to shareholder vote 04/05 2008
- z R&D budget under review
- Project prioritization will determine combined budget
- zCash as of September 2007: US\$ 231m*
- zExpected headcount at closing: approx. 420
- zNumber of shares outstanding: 108.27m
- zMarket capitalization as of year end 2007: > US\$ 350 m
Note: Based on end of September 2007 cash plus proceeds from the disposal of Evotec' s Chemical Development Business, prior to transaction costs. All exchanges are based on currency exchange rates of period end September 2007.
Combined newsflow2007 - 2008
- Data: EVT 201 Phase II elderly insomniacs 9
- EVT 101: Initiate Phase Ib fMRI study 9 Initiate Phase Ibhigher repeat dose study 9
- Data: EVT 101 Phase IbfMRI cognition study (Q407/Q108)
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Data: EVT 302 Phase I safety 9
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NASDAQ listing and merger close
- Partnership: EVT 201 insomnia
- EVT 302: Initiate Phase II in smoking cessation Additional Phase I data
- EVT 101: Initiate Phase II POC
- VR1: Initiate Phase I
- P2X7: Initiate Phase I
- EVT 103: Initiate Phase I
- Data: EVT 101 Phase Ib(cogn. full data)
Our "1/2/3/4 in 08"plan Subject to contingencies
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Evotec & RenovisA compelling CNS investment
- zGlobal CNS pure play
- z Differentiated lead insomnia compound EVT 201
- Partner-ready, best-in-class
- z Broad and deep pipeline, with clinical momentum
- Proprietary and partnered
- zFully integrated discovery-through-development core competencies
- zMultiple partners generating collaborative revenues: Roche, BI, Pfizer
- zStrong pro-forma cash position of US\$ 231 m*; Nasdaq liquidity
Note: Based on end of September 2007 cash plus proceeds from the disposal of Evotec's Chemical Development Business, prior to transaction costs. All exchanges are based on currency exchange rates of period end September 2007.
Tomorrow's Drugs Today™
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