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Evotec SE — Interim / Quarterly Report 2015
Jul 29, 2015
151_ip_2015-07-29_d56f4454-8088-4858-a3c1-3a7d397a29b9.pdf
Interim / Quarterly Report
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EVT Execute & EVT Innovate – World-class drug discovery
Evotec AG, First Quarter Report 2015, 12 May 2015
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
First Quarter Report 2015
Agenda
Highlights Q1 2015
Business and strategy update
Financial performance and outlook
Strong performance from EVT Execute, big upside potential from EVT Innovate
First three months of 2015 – State of play
EVT Execute
- Long-term collaboration for multiple drug discovery services signed as part of Sanofi alliance (effective 01 April 2015)
- New CNS alliance with C4X Discovery
- Evotec and New York University Office of Therapeutic Alliances initiate multiple programmes
- Various screening projects with Japanese Pharma companies
- Extension with Padlock
- Opening of protein production facility in Princeton (USA)
- Evotec Hamburg receives AAALAC accreditation
EVT Innovate
- Alliance with Roche for EVT302 in Alzheimer's disease on track to deliver results from Phase IIb study in first half of 2015
- Development collaboration with Second Genome (USA)
- Significant expansion of oncology portfolio planned through Sanofi alliance
- Further product development alliances on track (EVT100 series, EVT201, EVT401)
Corporate
Closing of multicomponent alliance with Sanofi effective 01 April 2015
Profitable growth in EVT Execute – Accelerated EVT Innovate investments – Revenue guidance raised
Financial highlights Q1 2015 – Guidance 20151)
Financial highlights
- Group revenues +22% to € 21.5 m (2014: € 17.6 m)
- EVT Execute revenues up 21% compared to the prior year
- EVT Innovate increased R&D investments by 41%
- Group EBITDA before contingent considerations at € (0.3) m significantly improved compared to the same period of the previous year (2014: € (1.3) m)
- Positive EBITDA of € 3.5 m for EVT Execute
- Very strong liquidity position of € 95.8 m (before more than € 40 m cash from Sanofi transaction)
Full-year revenue guidance 2015 raised due to Sanofi alliance
- Revenues: >35% growth2) (raised from > 20%) due to refinement of the accounting treatment of the Sanofi alliance
- Adjusted EBITDA positive3)
- R&D expenses between € 15 m and € 20 m
- Liquidity is expected to be well in excess of € 100 m at the end of 20154)
- Capex investments up to € 10 m
1) Varies from the guidance provided in the Annual Report 2014 following the financial impact of the Sanofi transaction 2) Excluding milestones, upfronts and licences
3) EBITDA excludes impairments on intangible and tangible assets and goodwill as well as the total non-operating result 4) Excluding any potential cash outflow for M&A or similar transactions
Agenda
Highlights Q1 2015
Business and strategy update
Financial performance and outlook
Leadership in drug discovery with two segments
EVT Execute & EVT Innovate
Capacity expansion in Toulouse and Princeton
Evotec's footprint
Evotec (France) up and running
Evotec (France) – Started on 01 April 2015
Excellent capabilities and pipeline projects transitioned into Evotec's value chain
Summary of Sanofi alliance1) & Next steps
| Financials | 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 |
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 |
|---|---|---|
| Pipeline & Innovation |
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 |
towards IND Accelerate discovery stage projects and progress towards PDC nomination Expand academic network in France for future Cure X/Target X initiatives |
Expanding portfolio of discovery alliances and strong base business
EVT Execute – Comprehensive drug discovery platforms
Highlights Q1 2015
- New alliances concluded and existing alliances extended (e.g. C4X Discovery, Padlock, ...)
- Signing of various alliances with Japanese Pharma partners
- Long-term collaboration for multiple drug discovery services signed as part of Sanofi alliance
- Opening of protein production facility in Princeton (USA)
- Evotec Hamburg receives AAALAC accreditation
Strong start of the year and more to come
EVT Execute strategy: Expected key milestones 2015
New long-term deals with large and mid-sized Pharma and biotech
New integrated technology/disease alliances
Milestones from existing alliances
Focus on causes not symptoms
EVT Innovate – Systematic, unbiased, comprehensive drug discovery
Fast growing portfolio of > 70 product opportunities
Partnership portfolio
| Molecule | Indication | Partner | Discovery | Pre-clinical | Phase I | Phase II | Phase III | |
|---|---|---|---|---|---|---|---|---|
| al c ni Cli |
EVT3021) | AD | ||||||
| EVT201 | Insomnia | |||||||
| Somatoprim | Acromegaly | |||||||
| EVT100 | CNS diseases | |||||||
| EVT401 | Inflammation | |||||||
| ND2) | Oncology | |||||||
| ND2) | Oncology | |||||||
| ND2) | Pain | |||||||
| al | ND2) | Oncology | ||||||
| c ni |
Various | Endometriosis | ||||||
| cli e- |
EVT770 | Diabetes – type 2/1 |
||||||
| ND2) | Pain | |||||||
| Pr | ND2) | Inflammation | ||||||
| Various | Oncology | |||||||
| Various | Inflammation | |||||||
| Various | Diabetes – type 2/1 |
|||||||
| Various | Diabetes – type 2/1 |
|||||||
| Various | Kidney disease | |||||||
| y er |
Various | Oncology | ||||||
| v o |
Various | Alzheimer's disease | ||||||
| c s |
Various | Oncology | ||||||
| Di | 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 |
14 1) RO4602522; Name of compound recently changed to Sembragiline by Roche
2) Not disclosed
Phase IIb data for Sembragiline expected in H1 2015
Product development alliance with
Alzheimer's disease (AD)
Sembragiline1)
- 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
- 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 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=495, 52 week trial)
Expected key milestones
Results of Phase IIb trial expected in Q2 2015
Acceleration and broadening of oncology portfolio
Oncology portfolio
| Project | Hit finding/ Target ID |
Hit-to-Lead | Lead optimisation |
Pre-clinical development |
Phase I | |
|---|---|---|---|---|---|---|
| Advanced | Growth Factor 1 |
|||||
| projects | Cancer Metabolism 1 | |||||
| Immunotherapy 2 |
||||||
| Growth Factor 2 | ||||||
| Early | Immunotherapy 3 | |||||
| projects | Microenvironment 1 | |||||
| Microenvironment 2 | ||||||
| TargetImmuniT | ||||||
| TargetKDM | ||||||
| TargetDBR | ||||||
| Cancer Metabolism 2 | ||||||
| Cancer Metabolism 3 | ||||||
| Growth Factor 3 | ||||||
| Microenvironment 3 |
Significant pipeline for strategic partnering
Translating first-in-class science to Pharma
"The Bridge"
| 2011 | 2012 | 2013 | 2014 | 2015 |
|---|---|---|---|---|
| CureBeta (Harvard Stem Cell Institute) |
CureNephron1) (Harvard, BWH, USC, AstraZeneca) TargetASIC1) (BMBF/undisclosed Pharma partner) Somatoprim (Aspireo) TargetPicV (Haplogen) TargetCanMet1) (Debiopharm) |
TargetImmuniT (Apeiron) TargetDBR (Yale) TargetSP (Internal) TargetFX (Internal) TargetPGB (Harvard) TargetKDM (Dana-Farber, Belfer) CureMN (Harvard) TargetEEM (Harvard) TargetAD1) (NBB/J&J) |
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 … |
Building a strategic partnered product pipeline
EVT Innovate strategy: Expected key milestones 2015
Phase IIb data with Roche in AD alliance
Strong progress of clinical pipeline within partnerships
Expansion of network of top-class academic alliances
Partnering of Cure X/Target X initiatives
Agenda
Highlights Q1 2015
Business and strategy update
Financial performance and outlook
Group revenues +22%, higher gross margin reflects top-line growth
Key financials Q1 2015: Condensed income statement (IFRS)
in € m
| Q1 2014 | Q1 2015 | % vs. 2014 | |
|---|---|---|---|
| Revenues | 17.6 | 21.5 | 22% |
| Gross margin | 26.2% | 30.7% | – |
| R&D expenses |
(3.0) | (3.8) | 29% |
| SG&A expenses |
(4.4) | (5.1) | 17% |
| Amortisation of intangible assets |
(0.8) | (0.6) | – |
| Other op. income (expenses), net |
0.0 | (0.4) | – |
| Operating loss | (3.5) | (3.3) | – |
| EBITDA1) | (1.3) | (0.3) | – |
| Net loss | (4.0) | (1.1) | – |
- Revenue growth driven by Company's existing drug discovery alliances and new collaborations
- Higher investment in EVT Innovate R&D
- Increase in SG&A driven by costs related to the Sanofi transaction
in € m
Strong revenue performance in EVT Execute, acceleration of investments in EVT Innovate
Condensed income statement based on segments for Q1 2015
| 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) |
- Revenue in EVT Execute: Primarily attributable to strong growth in base business especially in anti-infectives
- Increased investment in Cure X/ Target X initiatives
- Positive adjusted EBITDA of € 3.5 m in EVT Execute due to solid gross margin
Strong revenue growth and gross margin
Revenues & gross margin Q1
Clear strategy for both segments
Overview
Increase in revenue guidance
Guidance 20151)
| 1 | Double digit top line growth |
More than 35% growth excluding milestones, upfronts and licences due to Sanofi alliance (previously: more than 20%) |
|---|---|---|
| 2 | Profitable | Positive adjusted EBITDA2) 100 m3) Liquidity is expected to be well in excess of € |
| 3 | Accelerated investments |
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 |
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
Very strong start into a strong 2015
Expected key milestones in 2015
EVT Execute
- New long-term deals with large and midsized 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