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Evotec SE Interim / Quarterly Report 2014

Aug 12, 2014

151_ip_2014-08-12_12b3acc9-893a-4cd2-8ac1-e28c56d859fb.pdf

Interim / Quarterly Report

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H1 2014 – Strong Execution for more Innovation

Evotec AG, H1 2014 Interim Report, 12 August 2014

Forward-looking statements

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.

Welcome from the Evotec management team

H1 2014

Agenda

Highlights H1 2014

Operational progress

Financial performance and outlook

Improved operational performance, increased revenues, guidance confirmed

H1 2014 – State of play

Financials

1

2

3

  • Group revenues for H1 2014 of € 40.1 m (2013: € 36.7 m), an increase of 9%; at constant 2013 FX rates up 12%
  • Positive adjusted1) Group EBITDA of € 0.6 m; positive adjusted1) EBITDA of € 5.5 m for EVT Execute
  • Strong liquidity position at € 85.6 m; high and stable equity ratio at 71.1%
  • Guidance 2014 confirmed

Operations in EVT Execute and EVT Innovate

  • New integrated collaboration with Shire to discover drug candidates in rare disease
  • New pain alliance with Convergence
  • Collaboration with Vifor extended and expanded
  • Collaboration with Active Biotech extended
  • Milestones achieved: Roche (biomarker); Boehringer Ingelheim; TargetAD collaboration with Johnson & Johnson Innovation
  • Innovative partnership with Debiopharm™ to develop cancer treatment (TargetCanMet)
  • Collaboration with Fraunhofer IME in joint drug discovery programmes2)

Product pipeline

  • Phase III of DiaPep277® now being developed & commercialised by Hyperion Therapeutics after acquisition of Andromeda Biotech
  • Recruitment of Phase IIb trial within Roche Alzheimer disease alliance completed, study expanded
  • Janssen to continue developing the EVT100 series in CNS diseases
  • Good progress within EVT201 and EVT401 programmes in China
  • Beta cell regeneration programme with Janssen phased out; CureBeta alliance between Harvard and Evotec continues

  • 4 Acquisition update • Acquisition of Bionamics GmbH to accelerate EVT Innovate

  • Acquisition of Euprotec to enter and build capabilities in new disease area of infectious diseases

1) Adjusted EBITDA: EBITDA was adjusted for changes in contingent considerations as well as for extraordinary effects with regards to the bargain purchase resulting from the acquisition of Bionamics.

Agenda

Highlights H1 2014

Operational progress

Financial performance and outlook

Evotec's business model for innovation efficiency

ONE company – TWO segments

EVT Execute

"Low risk, service business"

EVT Execute

  • Strict fee for service, highest quality offering
  • Platform selling with low risk
  • Selectively milestone and royalty driven projects

EVT Innovate (Cure X/Target X)

  • First-in-class investments within core competences
  • Early partnering strategy
  • Performance-based alliances with upfronts, milestones and product royalties

EVT Innovate "High risk – high reward innovation business"

Strong performance in H1 2014 and more to come

EVT Execute – Comprehensive drug discovery platforms

Good growth in innovation out-sourcing business

  • New integrated projects (e.g. Convergence, Shire ...)
  • Extensions of existing partners (e.g. Active Biotech, Vifor…)
  • Milestones achieved (Roche biomarker, BI)
  • Cardioxyl moved into clinical testing with CXL-1427

Constant upgrade along core competences

Consolidation for integrated drug discovery platform

Growth driven by long-term alliances and technology upgrade strategy

EVT Execute strategy 2014

  • New long-term alliances with big and mid-sized Pharma and biotech
  • New integrated alliances with EU biotech and especially US East Coast start-ups

• Expansion of technology/disease portfolio offering

Systematic, unbiased and comprehensive pipeline building in major disease areas

EVT Innovate – Cure X and Target X initiatives

Leader in the provision of biology services in infectious disease

Acquisition of Euprotec

  • Specialty CRO1) delivering extensive and innovative portfolio of biology services to treat infections
  • Founded in 2008/09, based in Manchester Science Park, UK;
  • Privately funded
  • Long-term contract with University of Manchester for in vivo pharmacology
  • About 20 employees, first class management and scientific leadership

Growing portfolio of product opportunities

Partnership portfolio

Molecule Indication Partner Discovery Pre-clinical Phase I Phase II Phase III Market
DiaPep277®1) Diabetes –
type 1
EVT3022) AD
al EVT201 Insomnia
c Somatoprim Acromegaly
ni
Cli
EVT100 CNS diseases
EVT401 Inflammation
ND3) Oncology
ND3) Oncology
al ND3) Pain
c
ni
ND3) Oncology
cli Various Endometriosis
e- EVT770 Diabetes –
type 2/1
Pr ND3) Pain
Various Inflammation
EVT070 Diabetes –
type 2
y
er
Various Diabetes –
type 2/1
v
o
Various4) Diabetes –
type 2/1
c
s
Various Kidney disease
Di Various Oncology
Various Alzheimer's disease
Various CNS/MS NEU2 / Bionamics

1) In April 2014, Hyperion Therapeutics acquired Andromeda and rights on DiaPep277® – completed in H1 2014 2) RO4602522 3) Not disclosed

4) Beta cell regeneration programme with Janssen phased out; CureBeta alliance between Harvard and Evotec continues

DiaPep277® progressing to market

Product development alliance with

Diabetes type 1

  • Type 1 diabetes results from the body's failure to produce insulin and presently requires life long insulin therapy by injection
  • Each year, approx. 35,000 adults and 24,000 children are newly diagnosed with type 1 diabetes across the U.S. and Europe

DiaPep277®

  • DiaPep277®, a first-inclass immune intervention therapy for new onset type 1 diabetes
  • DiaPep277® is a unique peptide of 24 amino acids derived from human heat shock protein HSP 60
  • The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin in response to elevated blood glucose levels

Status

  • Hyperion Therapeutics acquired Andromeda Biotech, the owner of DiaPep277®, in H1 2014
  • Orphan drug status in USA granted
  • Excellent safety profile
  • 2nd Phase III recruitment completed

Expected key milestones

  • 2nd Phase III trial results expected Q1 2015
  • Potential market entry 2016/17

EVT302 – Recruiting of Phase IIb completed

Product development alliance with

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

EVT 302/RG1577/ RO4602522

A potent small molecule inhibitor of monoamine oxidase-B (MAO-B) which reduces the formation of toxic reactive oxygen species in the brain of Alzheimer's disease patients where overexpression of MAO-B is postulated to contribute to neuronal damage

Status

  • One of the very few latestage small molecule AD clinical trials in this specific AD patient population
  • Patient recruitment for Phase IIb, multicentre, randomised, doubleblind, parallel-group, placebo-controlled study to evaluate the efficacy and safety in patients with moderate severity Alzheimer disease completed (n=544, 52 week trial)

Expected key milestones

• Results of Phase IIb trial expected in 2015

Expanding portfolio in diabetic complications

Diabetes and diabetic complications pipeline overview

Project(s) Indication (mechanism) Partner Status Next milestone Commercials
DiaPep277® Type 1 diabetes
(immunomodulation)
2nd Phase III recruitment
closed
Final Phase III data Up to €
40 m milestones,
single-digit royalties
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
EVT070 Type 2 diabetes
(insulin resistance)
Discovery Pre-clinical candidate
7 m upfront
high margin research payments,
up to €
237 m milestones,
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

Multiple options in CNS

Neurology pipeline overview

Molecule(s) Indication (mechanism) Partner Status Next milestone Commercials
EVT302 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 / Bionamics Pre-clinical/Various ND1) ND1)
Various Huntington's
disease
Discovery ND1) Research payments
Not disclosed Neurodegeneration Discovery ND1) Research payments
Not disclosed Fabry's
disease
Discovery ND1) Research payments
TargetAD Alzheimer's disease
(Novel MoA)
Discovery ND1) Up to \$ 10 m research payments,
approx. \$ 125-145 m milestones,
royalties
TargetASIC Multiple sclerosis Undisclosed
Pharma
Discovery Lead status Co-funded
CureMN Amyotrophic lateral
sclerosis (ALS)
ND1) Pharma partnership

Novel pain and inflammation targets

Pain and inflammation pipeline overview

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
Various Inflammation Discovery Pre-clinical Research payments,
up to €
183 m milestones/product,
significant royalties
Not disclosed Pain Discovery Pre-clinical Milestones,
significant royalties

Long-term vision in novel fields of oncology

Oncology pipeline overview

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 Oncology Phase I ND1) Success-based milestones
ND1) Oncology Pre-clinical ND1) Research payments,
milestones,
royalties
TargetImmuniT Various
(Immunotherapy)
Discovery Pharma partnership Shared research costs,
milestones,
royalties
TargetKDM Various
(Epigenetic targets)
Discovery Pharma partnership ND1)
TargetDBR Glioblastoma
(brain tumour)
Discovery Pharma partnership ND1)
TargetCanMet Various Discovery ND1) Research payments,
milestones,
royalties

Establishing an infectious disease portfolio

Anti-infectives pipeline overview

Project(s) Indication Partner Status Next milestone Commercials
TargetPicV Viral host targets Discovery Pre-clinical candidate
TargetPGB Antibiotics Discovery Pre-clinical candidate

Expanding and broadening "The Bridge"

EVT Innovate initiated R&D projects

2011 2012 2013 2014 (H1)
CureBeta
(Harvard Stem Cell
Institute)
CureNephron1)
(Harvard, BWH, USC,
AstraZeneca)
TargetSP
(Internal)
TargetASIC1)
(BMBF/undisclosed
Pharma partner)
Somatoprim
(Aspireo)
TargetPicV
(Haplogen)
TargetCanMet1)
(Debiopharm)
TargetImmuniT
(Apeiron)
TargetDBR
(Yale)
TargetFX
(Internal)
TargetPGB
(Harvard)
TargetKDM
(Dana-Farber, Belfer)
CureMN
(Harvard)
TargetEEM
(Harvard)
TargetAD1)
(NBB/J&J)
TargetSX
(undisclosed)
TargetBCD
(Internal)
TargetDR
(Internal)
TargetNX
(Internal)
TargetKX
(undisclosed)
TargetCytokine
(Internal)
Undisclosed
(Fraunhofer)

Raising awareness for our offerings

DDups

Even stronger portfolio of partnerships

EVT Innovate strategy 2014

  • Expansion of network of top-class academic alliances
  • Accelerated investments in existing and new Cure X/Target X initiatives
  • Progress of clinical pipeline within partnerships

• Partnering of at least one Cure X/Target X initiative

Agenda

Highlights H1 2014

Operational progress

Financial performance and outlook

Group revenues up 12% at constant 2013 FX rate

Key financials H1 2014: Condensed profit & loss statement (IFRS)

In €
m
----------- --
H1 2013 H1 2014 % vs. 2013
Revenues 36.7 40.1 9
Gross margin 28.8% 29.4%

R&D expenses
(4.8) (6.3) 30

SG&A expenses
(8.2) (8.9) 9

Amortisation of intangible assets
(1.7) (1.4) (21)

Other op. income (expenses), net
(0.2) 1.2
Operating income (loss) (4.4) (3.6)
Net income (loss) (4.6) (4.4)
EBITDA, adjusted1) 0.5 0.6
  • Mix of a stable base business and upfront & milestone revenues leads to higher revenues and margin
  • Higher investments in Innovate R&D
  • Increase in SG&A driven by expansion of business development team to support growth

1) Adjusted EBITDA: EBITDA was adjusted for changes in contingent considerations as well as for extraordinary effects with regards to the bargain purchase resulting from the acquisition of Bionamics.

Adjusted EBITDA of EVT Execute strongly positive despite low milestone contribution in H1

Condensed profit & loss statement based on segments for H1 2014

In € m

EVT
Execute
EVT
Innovate
Inter
segment
elimination
Evotec
Group
Revenues 39.7 8.6 (8.2) 40.1
Gross margin 23.1% 44.7% 29.4%

R&D expenses
(0.5) (7.0) 1.2 (6.3)

SG&A expenses
(6.7) (2.2) (8.9)

Amortisation of intangible assets
(1.2) (0.2) (1.4)

Other op. income (expenses), net
0.9 0.2 1.2
Operating income (loss) 1.7 (5.3) (3.6)
EBITDA, adjusted1) 5.5 (4.9) 0.6
  • Increased investments in Cure X/ Target X initiatives
  • Positive adjusted EBITDA of € 5.5 m in EVT Execute despite low milestone contribution in H1
  • Strong Innovate margin shows value in partnered assets, but depends on milestones

1) Depreciation split on estimated basis/Adjusted EBITDA: EBITDA was adjusted for changes in contingent considerations as well as for extraordinary effects with regards to the bargain purchase resulting from the acquisition of Bionamics.

Strong Q2, adverse FX impact more than offset by one-time effects

Key financials Q2 2014: Condensed profit & loss statement (IFRS)

In €
m
Q2 2013 Q2 2014
Revenues 19.6 22.5
Gross margin 31.1% 31.9%

R&D expenses
(2.5) (3.3)

SG&A expenses
(4.3) (4.5)

Amortisation of intangible assets
(0.8) (0.6)

Other op. income (expenses), net
(0.2) 1.2
Operating income (loss) (1.7) (0.1)
Net income (loss) (1.7) (0.4)
EBITDA, adjusted1) 0.8 1.9
  • Revenue increase of 18% and gross margin at 34.3% (both at constant 2013 FX rate)
  • Mix of a stable base business and upfront & milestone revenues leads to higher margin
  • Higher investments in Innovate R&D

1) Adjusted EBITDA: EBITDA was adjusted for changes in contingent considerations as well as for extraordinary effects with regards to the bargain purchase resulting from the acquisition of Bionamics.

Continuing growth trend and solid gross margin

Revenues & gross margin H1

Strategic and accelerated investments in R&D

Overview R&D and SG&A

In € m

Clear investment strategy in Cure X and Target X initiatives

SG&A increase to strengthen and support growth

Guidance confirmed: Strong organic growth, higher profitability, increased R&D investments

Guidance 2014

1 Revenues
High single-digit percentage growth excluding milestones, upfronts
and licences

Ongoing high volatility of milestones from quarter to quarter
2 Improved
profitability

Positive EBITDA1)
before changes in contingent considerations at a
similar level to 2013

Positive operating cash flow2)

Liquidity is expected to exceed €
90 m at the end of 2014
3 R&D
investments

Investments of approx. €
10–14 m mainly in the strategic Cure X/
Target X
initiatives

Capacity and capability building continued with approx. €
5–7 m

1) EBITDA is defined as earnings before interest, taxes, depreciation, and amortisation of intangibles. EBITDA excludes impairments on intangible and tangible assets as well as the total non-operating result

Others

New appointments

Strengthening of management capacities

  • Dr Timm Jessen as EVP Business Development EVT Innovate
  • Dr Lloyd Payne as SVP Anti-infectives Operations
  • Dr Peter Warn as SVP Anti-infectives Discovery

New Supervisory Board

  • Prof. Dr Wolfgang Plischke (New member/Chairman)
  • Prof. Dr Iris Löw-Friedrich (New member)
  • Prof. Dr Paul Linus Herrling (New member)
  • Dr Walter Wenninger, Dr Claus Braestrup and Bernd Hirsch re-elected

A solid H1, positive indications for H2

Expected key events 2014

Key milestones in 2014

EVT Execute

  • Expansion of existing drug discovery alliances
  • New long-term deals with big and mid-sized Pharma and biotech
  • At least 1 new integrated technology/disease alliance

EVT Innovate

  • Expansion of network of top-class academic alliances
  • Increased investments in Cure X/Target X initiatives
  • Strong progress of clinical pipeline within partnerships (at least 2 clinical starts in 2014)
  • Partnering of at least one Cure X/Target X initiative