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Evotec AG, Company presentation, Jefferies 2015 Global Healthcare Conference, 04 June 2015, New York
Innovation Efficiency –
Evotec Company Overview
PAGE
Forward-looking statements
1
Information set forth in this presentation contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this presentation. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks 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. 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.
PAGE
Agenda
2
Evotec at a glance
Innovation efficiency
Financials & outlook
PAGE
Leadership in drug discovery
3
Our mission
Based on the highest quality drug discovery science, and through innovative collaborations, we are building a partnered product pipeline.
PAGE
Clear long-term strategy
4
Strategy overview – Action Plan 2016
• Business segmentation
• Investments in discovery service platform
• Performance-based integrated discovery and clinical alliances
• Cure X/Target X strategy
• Restructuring
• Capital efficiency for sustainability
• First EVT Innovate investments
2009 • Partnered product pipeline to gain
milestones and royalties
• Highest quality discovery and pre-clinical service – EVT Execute
• “Academic bridge” and Cure X/Target X strategy – EVT Innovate
2012 2015
2020
PAGE 5
Improving R&D capital efficiency Pre-clinical development candidate “PDC” – Evotec’s “Sweet spot”
Source: Paul et al. Nature Reviews 9: 2013
Duration
Phase II Phase III Approval
Academia Target ID/-Vali-dation
Hit-Identi- fication
Lead Optimi- sation
Phase I Pre-clinical
> 14 years
Market
Cost Approx. $ 1–3 bn
Partner Evotec
Clinical Phase
Pre-clinical Phase
Approx. 3–6 years Approx. 6–10 years
PDC – Pre-clinical development
candidate
Evotec’s core competencies
Approx. $ 5–15 m
PAGE
The megatrend – Improvement of R&D productivity
6
Market dynamics in drug discovery
Source: Visiongain; Drug Discovery Outsourcing: World Market 2015
Growth driver Drug discovery outsourcing is a macro trend Market overview – Revenues, in $ bn
1 Increasing comfort with outsourcing
2 Higher R&D capital efficiency for innovation
3 Ability to adjust investments proportional to portfolio 2012
11.1
2015(e)
16.6
2014
14.5
2013
12.8
2017(e) 2018(e)
24.5 21.8
2016(e)
19.2
5–10% p.a.
PAGE
A global company with a complete offering
7
Evotec’s footprint
San Francisco, Branford and Princeton, USA ~65 employees • Compound ID, selection and
acquisition • Compound QC, storage and
distribution • Cell & Protein production
Abingdon and Manchester, UK ~280 employees • Medicinal chemistry • ADMET • Structural biology • In vitro & in vivo Anti-infective
platform/screening
Hamburg (HQ), Göttingen and Munich, Germany ~375 employees • Hit identification • In vitro & in vivo biology • Chemical proteomics &
Biomarker discovery and validation
• Cell & protein production
Toulouse, France ~210 employees • Compound management • Hit identification • In vitro & in vivo oncology • Medicinal chemistry • ADME & PK • Early drug formulation & Solid
form screening • Cell, protein & antibody
production
PAGE
Significant Sanofi alliance initiated in 2015
8
Summary of Sanofi alliance1) & Next steps
• Guaranteed commitment of approx. € 250 m over the next five years, including upfront cash receipts of more than € 40 m
• Master service agreement for drug discovery services with Sanofi improves revenue growth and profitability
• Increased capacity for EVT Innovate and EVT Execute with minimal Evotec funded Capex investment and dilution to shareholders
• Addition of first-class team with significant oncology expertise
• Addition of more than 15 oncology projects
• Sanofi screening library available for third-party collaborations
• “Bridge” from academia to Pharma in France & EU
Financials
Pipeline & Innovation
Next steps • Expansion of Pharma and biotech
service network
• Offering of combined libraries of 1.7 million compounds for third-party screening
• Build a sustainable oncology pipeline by progressing development stage projects towards IND
• Accelerate discovery stage projects and progress towards PDC nomination
• Expand academic network in France for future Cure X/Target X initiatives
1) Closing on 31 March 2015 (effective 01 April 2015)
PAGE
Agenda
9
Evotec at a glance
Innovation efficiency
Financials & outlook
PAGE
ONE company – TWO segments
10
EVT Execute & EVT Innovate
PAGE
EVT Execute – Comprehensive drug discovery platforms
Broad stand-alone innovation services
11
High-quality service business
The “Western” strategic outsourcing partner of choice
PAGE
Focus on causes not symptoms
12
EVT Innovate – Systematic, unbiased, comprehensive drug discovery
OTHER FIELDS OF KEY EXPERTISE Pain Anti-infectives Anti-inflammatory
NEUROSCIENCE Patient-derived iPS
cells as disease models with initial focus
in neurodegeneration
DIABETES & DIABETIC COMPLICATIONS Accessing unlimited supply of human beta cells; Pursuing podocyte-related mechanisms
ONCOLOGY Novel targeted therapies
Cancer immunity & cancer cell metabolism Resistance to SoC therapies
PAGE
Fast growing portfolio of > 70 product opportunities
13 1) RO4602522; Name of compound recently changed to Sembragiline by Roche 2) Not disclosed
Partnership portfolio
Molecule Indication Partner Discovery Pre-clinical Phase I Phase II Phase III
Clin
ical
EVT3021) AD
EVT201 Insomnia Somatoprim Acromegaly EVT100 CNS diseases
EVT401 Inflammation ND2) Oncology ND2) Oncology
Pre-
clin
ical
ND2) Pain ND2) Oncology Various Endometriosis EVT770 Diabetes – type 2/1 ND2) Pain ND2) Inflammation Various Oncology
Dis
cove
ry
Various Inflammation Various Diabetes – type 2/1 Various Diabetes – type 2/1 Various Kidney disease Various Oncology Various Alzheimer’s disease Various Oncology Various CNS/MS NEU2 Various Diabetes >5 further programmes Various Neurology >5 further programmes Various Oncology >10 further programmes Various Pain & Inflammation >5 further programmes
PAGE
Significant options in CNS
14
Neurology overview
1) RO4602522; Name of compound recently changed to Sembragiline by Roche 2) Not disclosed
Molecule(s) Indication (mechanism) Partner Status Next milestone Commercials
EVT3021) Alzheimer’s disease (MAO-B)
Phase IIb, recruitment completed
Completion of Phase II, Phase III start
$ 10 m upfront, up to $ 820 m milestones, significant royalties
EVT201 Insomnia Phase II Start clinical trials Milestones, royalties
EVT100 series CNS diseases (TRD) Phase II/Pre-clinical Confirmation of pre-clinical study/ Phase II start
$ 2 m upfront, up to $ 173 m milestones, significant royalties
Various CNS/Multiple sclerosis NEU2 Pre-clinical/Various ND2) ND2)
Various Huntington’s disease
Discovery ND2) Research payments; fund up 52 FTEs
Not disclosed Neurodegeneration
Discovery ND2)
Research payments
Not disclosed Fabry’s disease Discovery ND2) Research payments
TargetAD Alzheimer’s disease (Novel MoA)
Discovery ND2)
Up to $ 10 m research payments, approx. $ 125-145 m milestones, royalties
TargetASIC Multiple sclerosis Undisclosed Pharma
Discovery Lead status
Co-funded
Orexin-1 Stress-related addictive disorder programme
ND2) ND2) Research payments
CureMN Amyotrophic lateral sclerosis (ALS)
ND2)
Pharma partnership
PAGE
Phase IIb data for Sembragiline expected in H1 2015
15
Product development alliance with
1) EVT 302/RG1577/ RO4602522 Source: Alzheimer’s Disease International
Sembragiline1)
• A potent small molecule inhibitor of monoamine oxidase-B (MAO-B)
• Reduces the formation of toxic reactive oxygen species in the brain of Alzheimer’s disease patients where over expression of MAO-B is postulated to contribute to neuronal damage
Status
• One of the very few late-stage small molecule AD clinical trials in this specific AD patient population
• Patient recruitment for Phase IIb, multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety in patients with moderate severity Alzheimer disease completed (n=495, 52 week trial)
Expected key milestones
• Results of Phase IIb trial expected in Q2 2015
Alzheimer’s disease (AD)
• AD is the most common form of dementia
• 44 m people diagnosed with dementia in 2013 worldwide
• Approx. 7.7 m new cases of dementia are diagnosed each year
PAGE
Strategic focus on diabetes and diabetic complications
16
Diabetes and diabetic complications overview
Project(s) Indication (mechanism) Partner Status Next milestone Commercials
EVT770 Type 1 and 2 diabetes (beta cell regeneration)
Pre-clinical Phase I € 5 m upfront, high margin research payments, up to € 254 m milestones, significant royalties
ALM Type 1 and 2 diabetes (beta cell regeneration)
Discovery Phase I € 2 m upfront, high margin research payments, up to € 183 m milestones/product, significant royalties
Various Kidney disease ND1) ND1) Undisclosed upfront, high margin research payments, milestones/product, royalties
TargetEEM Type 1 and 2 diabetes (enteroendocrine)
Discovery Pharma partnership
CureNephron Chronic kidney disease Discovery Pharma partnership
CureBeta Type 1 and 2 diabetes (beta cell regeneration)
Discovery Pharma partnership
1) Not disclosed
PAGE
World-class pipeline-building in oncology
17
EVT Innovate & Sanofi
Molecule(s) Indication (mechanism) Partner Status Next milestone Commercials
Somatoprim (DG3173)
Acromegaly/NET Phase IIa
Pharma partnership Consulting fees, royalties
ND1) Oncology Phase I ND1) Research payments, milestones, royalties
ND1) /Biomarker platform
Oncology Phase I ND1) Success-based milestones
ND1) Oncology Pre-clinical
ND1) Research payments, milestones, royalties
TargetCanMet Various (Epigenetic targets)
H2L2) ND1) Research payments, milestones, royalties
TargetKDM Various (Epigenetic targets)
Pre-clinical
Pharma partnership ND1)
TargetImmuniT Various (Immunotherapy)
Pre-clinical
Pharma partnership ND1)
TargetDBR Glioblastoma H2L2) Pharma partnership ND1)
KRas Oncology Dis-covery
ND1) ND1)
• Four pre-clinical oncology assets
• Multiple early discovery projects
• Multiple Cure X/Target X initiatives as opportunities
1) Not disclosed 2) Hit to Lead
PAGE
Significant partnerships in pain, inflammation and anti-infectives
18
Pain, inflammation and anti-infectives
1) Proof of Concept
Molecule(s) Indication (mechanism) Partner Status Next milestone Commercials
EVT401 Inflammation (P2X7 inhibitor)
Phase I/II Phase II start Up to € 60 m milestones, royalties
Various Endometriosis Pre-clinical Pre-clinical candidate
€ 12 m upfront, up to approx. € 580 m milestones, royalties
Various Various/Pain
Pre-clinical Phase I start Undisclosed upfront, research payments, milestones, royalties
Not disclosed Various/Pain Pre-clinical Successful PoC1) Research payments, milestones, royalties
Not disclosed Inflammation Pre-clinical Phase I start Undisclosed upfront payment, milestones, royalties
Various Inflammation Discovery Pre-clinical
Research payments, up to € 183 m milestones/product, significant royalties
TargetPicV Viral host targets Discovery Pre-clinical candidate
TargetPGB Antibiotics Discovery Pre-clinical candidate
Protein-arginine deiminases (PADs)
Inflammation Discovery Pre-clinical candidate
Research payments, milestones up to approx. $ 13 m
PAGE
Translating first-in-class science to Pharma
19 1) Today at least partly progressed under commercial partnership
“The Bridge”
CureBeta (Harvard Stem Cell Institute)
TargetImmuniT (Apeiron) TargetDBR (Yale) TargetSP (Internal) TargetFX (Internal) TargetPGB (Harvard) TargetKDM (Dana-Farber, Belfer) CureMN (Harvard) TargetEEM (Harvard) TargetAD1) (NBB/J&J)
CureNephron1) (Harvard, BWH, USC, AstraZeneca) TargetASIC1) (BMBF/undisclosed Pharma partner) Somatoprim (Aspireo) TargetPicV (Haplogen) TargetCanMet1) (Debiopharm)
TargetBCD (Internal) TargetSX (undisclosed) TargetDR (Internal) TargetColCan (Internal) TargetKX (undisclosed) TargetCytokine (DRFZ) Fraunhofer Initiative
French Academic Bridge Ohio State University New York University Office of Therapeutic Alliances …
2011 2012 2013 2014 2015
PAGE
Agenda
20
Evotec at a glance
Innovation efficiency
Financials & outlook
PAGE
Strong revenue performance in EVT Execute, outstanding gross margin in EVT Innovate
21
Condensed income statement based on segments for Q1 2015
in € m • Revenue in EVT
Execute: Primarily attributable to strong growth in base business especially in anti-infectives
• Increased invest-ment in Cure X/ Target X initiatives
• Positive adjusted EBITDA of € 3.5 m in EVT Execute due to solid gross margin
EVT Execute
EVT Innovate
Inter- segment
elimination Evotec Group
Revenues 23.1 3.8 (5.4) 21.5
Gross margin 24.8% 46.2% – 30.7%
• R&D expenses (0.1) (4.6) 0.9 (3.8)
• SG&A expenses (3.8) (1.3) – (5.1)
• Amortisation of intangible assets (0.5) (0.1) – (0.6)
• Other op. income (expenses), net (0.5) 0.1 – (0.4)
Operating income (loss) 0.7 (4.0) – (3.3)
EBITDA1) 3.5 (3.8) – (0.3)
1) Adjusted for changes in contingent considerations
PAGE 22
Key metrics
Revenues (in € m)
R&D expenses (in € m)
EBITDA adjusted1) (in € m)
Liquidity2) (in € m)
Alliances
Employees3)
55.3
>100
2010 2015e
72
>150
2010 2015e
6.1
15-20
2010 2015e
Accelerated path to growth and sustainability
1) 1) Adjusted for changes in contingent considerations 2) 2) Cash and cash equivalents; 3) 3) Effective on 01 April 2015, Evotec acquired Sanofi’s scientific operations in Toulouse, France; 2015 number including the employees from this transaction
70.4
>100
2010 2015e
519
> 950
2010 2015e
6.5
2010 2015e
PAGE 23
Guidance 20151)
1) Varies from the guidance provided in the Annual Report 2014 following the financial impact of the Sanofi transaction 2) EBITDA excludes impairments on intangible and tangible assets and goodwill as well as the total non-operating result 3) Excluding any potential cash outflow for M&A or similar transactions
Increase in revenue guidance, all other elements of guidance confirmed
• More than 35% growth excluding milestones, upfronts and licences due to Sanofi alliance (previously: more than 20%)
• Positive adjusted EBITDA2) • Liquidity is expected to be well in excess of € 100 m3)
• Increased R&D investments of approx. € 15–20 m in strategic Cure X and Target X initiatives to accelerate long-term clinical pipeline building
• Continued capacity and capability building with up to € 10 m
Double- digit top- line growth
Profitable
Accelerated investments
1
2
3
PAGE
Strong team for innovation Management & shareholder structure
Number of shares: 131.7 m Listing: Frankfurt TecDAX, OTCBB 52 week high/low: € 4.32/€ 2.42
Management Board • Werner Lanthaler (CEO)
Long-time experience in Pharma & biotech
• Mario Polywka (COO) 18 years Evotec experience
• Cord Dohrmann (CSO) Outstanding background in metabolics
• Colin Bond (CFO) Big industry multi-national background
Key scientific advisor • Doug Melton
Harvard University/HHMI
Supervisory Board • Wolfgang Plischke
Ex-Bayer • Walter Wenninger
Ex-Bayer • Claus Braestrup
Ex-Lundbeck • Paul Herrling
Ex-Novartis • Bernd Hirsch
Symrise AG • Iris Löw-Friedrich
UCB
24
68% Free float
~13.0%
6% TVM Capital 12% BVF1)
1% Management
13% Roland Oetker/ROI
1) BVF Partners L.P. and its affiliates
PAGE
EVT Execute
• New long-term deals with large and mid-sized Pharma and biotech
• New integrated technology/disease alliances
• Milestones from existing alliances
EVT Innovate
• Strong progress of clinical pipeline within partnerships
• Phase IIb data with Roche in AD alliance
• Expansion of network of top-class academic alliances
• Partnering of Cure X/Target X initiatives
25
Expected key milestones in 2015
Starting a strong 2015
PAGE 26
Reporting dates 2015
12 May
09 June
12 August
10 November
3M/Q1 Interim Report
AGM in Hamburg
6M/Q2 Interim Report
9M/Q3 Interim Report
Your contact:
Dr Werner Lanthaler Chief Executive Officer
+49.(0).40.560 81-242 +49.(0).40.560 81-333 Fax [email protected]