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Evotec SE — Interim / Quarterly Report 2016
Aug 10, 2016
151_ip_2016-08-10_9ca4a629-9cd3-436a-9b1d-de0be4508895.pdf
Interim / Quarterly Report
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Leading innovation efficiency
Evotec AG, H1 2016 Interim Report, 10 August 2016
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.
Change in presentation:
The presented financial statements include a change in presentation in the first half of 2015 and 2016. From 01 January 2016 onwards, amortisation of intangible assets is no longer presented in a separate line in the consolidated income statement but is allocated to the relating cost lines in the income statement. The prior-year period was changed accordingly resulting in additional costs of revenue in the amount of € 1.5 m.
Welcome
The "new" Management Team
Agenda
Highlights H1 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Strong operational performance in H1
First six months of 2016 – State of play
EVT Execute
- Important milestone achievements
- Extension of key collaborations
- Expansion of compound management network and alliances
- Continued expansion of existing drug discovery platforms
- Expansion of network with foundations
- Phase I clinical start for the treatment of endometriosis (after period-end)
EVT Innovate
- Expansion of first-in-class targets and platforms
- Acceleration of TargetNASH programme
- Partnership with ex scientia to develop bispecific small molecule therapeutics
- Expansion of network with academia
- Company formation of Topas Therapeutics
Profitability guidance raised, strong outlook for H2
Financial highlights H1 & Guidance 2016
Strong financial performance
- Group revenues up 37% to € 75.5 m (H1 2015: € 55.0 m)
- EVT Execute revenues up 35%
- EVT Innovate revenues up 44%
- Significantly improved adjusted Group EBITDA1) at € 15.8 m
- Increased R&D expenses +6% to € 9.0 m
- Strong liquidity position of € 118.3 m
- Initiation of loan repayments
Updated guidance 2016
- More than 15% revenue growth excluding milestones, upfronts and licences
- Adjusted Group EBITDA1) expected to more than double2) compared to 2015 (previously: positive and significantly improved compared to prior year; 2015: € 8.7 m)
- R&D expenses of approx. € 20 m
- Similar level of liquidity3) compared to 2015
- Capex investments up to € 10 m
The business model works
Evotec's strategy overview
Agenda
Highlights H1 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Strong operations and milestone achievements
EVT Execute – Key performance indicators H1 2016
- Increase in revenues primarily attributable to growth of the base business and milestone achievements and two full quarters of Sanofi contributions
- Significant upswing of adjusted EBITDA mainly due to the strong increase in revenues and milestone achievements
- H1 2016 includes € 16.2 m of intersegment revenues
Growth trend continues
EVT Execute – Highlights H1 2016
- Milestone achievements with Bayer, BI and Padlock
- Three-year extension of Genentech alliance
- Extension of proteomics contract with Janssen Pharmaceutica NV, now in 10th year
- Initiation of antibiotic discovery alliance with ANTRUK
- New licences enhancing Evotec's platform (Trianni, CRISPR)
- Phase I clinical start in endometriosis (after periodend)
Validation of drug discovery services in key alliances
EVT Execute – Extensions
- Three-year extension of integrated drug discovery alliance with Genentech to discover novel small molecule therapeutics (entered in 2010)
- Extension of proteomics collaboration with Janssen Pharmaceutica NV, providing quantitative mass spectrometry proteomics platform across a broad range of applications (entered in 2006)
- Ongoing MSA-driven collaboration with Sanofi exceeding initial scope and progressing well (entered in 2015)
- UCB and other compound management initiatives on schedule
- Significant growth in screening business over 2015
CRISPR@Evotec
EVT Execute – Technology upgrades
Background
- CRISPR/Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats) is a programmable endonuclease system consisting of the Cas9 enzyme and a target specific gRNA
- CRISPR allows for genetic manipulation with unpreceded specificity and effectivity
- CRISPR is active in across cell types and organisms
- Non-exclusive licence agreement with the Broad Institute of MIT and Harvard for the use of CRISPR/Cas9 gene editing technology
Goals
- Combined with our leading stem cell expertise, Evotec utilises Cas9-iPS lines for target identification & gene knock-out
- Accessible as stand-alone solution or in combination with small molecule HTS
- Perform genome-wide or target class specific screening
Science breakthrough of the year 2015
World-leading effort in endometriosis with Bayer
EVT Execute – First clinical candidate
Endometriosis
- Endometriosis affects approx. 200 million women worldwide, 10% of women of reproductive age
- There is no known cure for endometriosis
Collaboration
- Strategic, five-year multi-target collaboration started in 2012
- Goal of developing three clinical candidates for the treatment of endometriosis within five years
- Both parties contribute innovative drug targets and high-quality technology infrastructures
Agreement
- € 12 m upfront payment
- Up to € 580 m in potential milestone payments based on the achievement of pre-clinical, clinical and sales milestones, up to double-digit royalties
- Integrated collaboration involving more than 30 scientists at Evotec
- Bayer will be responsible for subsequent clinical development and commercialisation
Status
- To date, the alliance has delivered four preclinical candidates
- Phase I clinical development started1)
Very well-balanced global customer mix
EVT Execute – Selected customer and revenue metrics
| Revenues by customer segment ytd 20161) (in %) |
Customer type ytd 20161) (in %) |
Revenues by region ytd 20161) (in %) |
||||||
|---|---|---|---|---|---|---|---|---|
| Remaining Top 10-30 Customers |
10% 17% |
100% | Mid-sized Pharma Foundations |
10% 17% |
100% | ROW USA |
44% | 100% 1% |
| Biotech | 22% | |||||||
| Top 10 Long-term Strategic Alliances |
73% | Top 20 Pharma |
51% | Europe | 55% |
Strong outlook for 2016
EVT Execute – Expected key milestones 2016
Expansion of foundations and biotech network in USA/EU
New performance-based integrated technology/disease alliance
Milestones from existing alliances
Agenda
Highlights H1 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Strong revenue growth reflects new partnerships
EVT Innovate – Key performance indicators H1 2016
- Strong revenue growth & improved EBITDA mainly resulting from new partnerships signed in 2015
- In-line with strategy: Increased R&D expenses due to an in-creased number of projects within the portfolio
- Full impairment of EVT100 series (€ 1.4 m)2) in first six months of 2016
PAGE 16
1) Adjusted for changes in contingent considerations
2) In Q1 2016, Evotec was informed by Janssen Pharmaceuticals, Inc. that Janssen intends to phase out the licence agreement regarding NMDA antagonist with effect from August 2016
Constantly growing pipeline of co-owned product opportunities
EVT Innovate – Partnership portfolio
| Molecule | Therapeutic Area/Indication | Partner | Discovery | Pre-clinical | Phase I | Phase II | Phase III | |
|---|---|---|---|---|---|---|---|---|
| EVT3021) | CNS – Alzheimer's disease |
|||||||
| al c |
EVT201 | CNS – Insomnia |
||||||
| EVT1001) | CNS – Depression |
|||||||
| ni | EVT401 | Immunology & Inflammation | ||||||
| Cli | ND2) | Oncology | ||||||
| ND2) | Oncology | |||||||
| Various | Women's health – Endometriosis |
NEW | ||||||
| ND2) | CNS – Pain |
|||||||
| al | ND2) | Oncology | ||||||
| c | EVT770 | Metabolic – Diabetes (type 2/1) |
||||||
| ni | ND2) | Respiratory | ||||||
| cli | ND2) | Immunology & Inflammation | ||||||
| e- Pr |
EVT801 | Oncology | ||||||
| EVT701 | Oncology | |||||||
| EVT601 | Oncology | |||||||
| Various | Immunology & Inflammation | |||||||
| Various | Metabolic – Diabetes (type 2/1) |
|||||||
| Various | Metabolic – Diabetes (type 2/1) |
|||||||
| Various | Nephrology | |||||||
| y | Various | Metabolic – Diabetes |
||||||
| er v |
Various | CNS – Alzheimer's disease |
||||||
| o c |
Various | Oncology – Immunotherapy |
||||||
| s | Various | Immunology & Inflammation – Tissue fibrosis |
||||||
| Di | Various | CNS – Multiple Sclerosis |
NEU2 | |||||
| Various | Metabolic – Diabetes |
>5 further programmes | ||||||
| Various | CNS | >5 further programmes | ||||||
| Various | Oncology | >10 further programmes | ||||||
| Various | CNS – Pain & Inflammation |
>5 further programmes |
17 1) EVT302 and EVT100: Evotec has regained the licence rights and is currently assessing potential business opportunities 2) Not disclosed
First-in-class Cure X/Target X platform strategy
EVT Innovate – Strategy highlights
- Continued expansion of first-in-class targets and platforms
- TargetNASH programme funded by Ellersbrook
- Partnership with ex scientia to develop bispecific small molecule immuno-oncology therapeutics
- Company formations e.g. Topas Therapeutics
- Expansion of academic initiatives
NASH – A disease with a substantial medical need
Evotec & Ellersbrook – TargetNASH
Background
- Non-alcoholic steatohepatitis ("NASH") is caused by fatty liver disease and leads to liver fibrosis, cirrhosis and HCC
- In the US and EU, an estimated 6.5 million patients have advanced NASH
- Currently, there is no approved therapy for NASH on the market
- Incidence growing worldwide with obesity and diabetes epidemic
- Acceptance of high priced therapy
Goal
- Accelerate TargetNASH projects during an incubator period to tangible value points which will form the basis of either an independently financed spin-off company or a strategic Pharma partnership
- Ellersbrook and Evotec jointly commit more than € 5 m in funding of up to three years
More than 10 projects primed for partnering
EVT Innovate – Cure X/Target X
| 2011 | 2012 | 2013 | 2014 | 2015 | 2016 |
|---|---|---|---|---|---|
| CureBeta (Harvard Stem Cell Institute) |
CureNephron (Harvard, BWH, USC, AstraZeneca) TargetASIC (BMBF/undisclosed Pharma partner) Somatoprim (Cortendo) TargetPicV (Haplogen) TargetFibrosis (Pfizer) |
TargetImmuniT (Apeiron/Sanofi) TargetDBR (Yale) TargetMB (Second Genome) TargetPGB (Harvard) TargetKDM (Dana-Farber, Belfer) TargetIDX (Debiopharm) CureMN (Harvard) TargetEEM (Harvard) TargetAD (NBB/J&J) |
TargetBCD (Sanofi) TargetDR (Internal) TargetATD (Internal) TargetFX (Internal) TargetKX (undisclosed) TargetCytokine (DRFZ/BMBF) Various (Fraunhofer Institute) |
TargetFRX (Internal) TargetNTR (Internal) TargetKras (OSU) Various (Gladstone Institute) … |
TargetaSN (MJJF) TargetBispecifics (ex scientia) TargetRhoB (undisclosed) TargetNASH (Ellersbrook/ Internal) … |
Outlook 2016
EVT Innovate – Expected key milestones 2016
- New clinical initiations and good progress of clinical pipeline within partnerships
- Expansion of network of top-class academic alliances
Partnering of Cure X/Target X initiatives
Strong focus on iPSC (induced pluripotent stem cells) platform
Agenda
Highlights H1 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Revenues up 37%, significant EBITDA improvement
Key financials H1 2016: Condensed income statement (IFRS)
| in € m |
||||
|---|---|---|---|---|
| H1 2015 | H1 2016 | % vs. 2015 | ||
| Revenues | 55.0 | 75.5 | 37% | |
| Gross margin | 26.0% | 34.5% | – | |
| R&D expenses |
(8.5) | (9.0) | 6% | |
| SG&A expenses |
(12.4) | (11.8) | (5)% | |
| Impairment of intangible assets |
(0.1) | (1.4) | – | |
| Income from bargain purchase |
18.5 | – | – | |
| Other op. income (expenses), net |
1.1 | 4.6 | – | |
| Operating income (loss) | 12.9 | 8.4 | – | |
| Adjusted Group EBITDA1) | 0.8 | 15.8 | – | |
| Net income | 13.6 | 2.7 | – |
- Strong revenue increase due to growth in core EVT Execute business, contribution of Sanofi collaboration and milestone achievements
- SG&A expenses in 2015 included one-time M&A and related costs with regards to Sanofi transaction
- R&D tax credits in UK/France affect other operating income in H1 2016
- Impairment of EVT100 series
- Net income in H1 2015 included income from bargain purchase (€ 18.5 m )
23 1) Adjusted for changes in contingent consideration as well as for one-time effects with regards to the bargain purchase resulting from the acquisition of Evotec (France) SAS in 2015
Both segments deliver
Condensed income statement based on segments for H1 2016
| in € | m* |
|---|---|
| EVT Execute |
EVT Innovate |
Inter segment elimination |
Evotec Group |
|
|---|---|---|---|---|
| Revenues | 79.8 | 11.8 | (16.2) | 75.5 |
| Gross margin | 28.8% | 50.0% | – | 34.5% |
| R&D expenses |
(0.0) | (11.9) | 2.9 | (9.0) |
| SG&A expenses |
(9.4) | (2.4) | – | (11.8) |
| Impairment of intangible assets |
– | (1.4) | – | (1.4) |
| Other op. income (expenses), net |
3.3 | 1.3 | – | 4.6 |
| Operating income (loss) | 16.9 | (8.5) | – | 8.4 |
| Adjusted EBITDA1) | 22.5 | (6.7) | – | 15.8 |
- Revenue growth in EVT Execute: Strong base business and milestone achievements
- Higher R&D expenses in EVT Innovate compared to H1 2015 due to an increased number of projects within the portfolio
- Significantly improved adjusted EBITDA of EVT Execute compared to H1 2015 (€ 9.8 m)
- Strong gross margin in EVT Innovate
Very strong second quarter 2016
Key financials Q2 2016: Condensed income statement (IFRS)
| in € m |
||||
|---|---|---|---|---|
| Q2 2015 | Q2 2016 | |||
| Revenues | 33.4 | 38.0 | Revenue increase of |
|
| Gross margin | 24.7% | 35.6% | 14% compared to Q2 2015 |
|
| R&D expenses |
(4.6) | (4.7) | High gross margin in |
|
| SG&A expenses |
(7.3) | (6.4) | Q2 2016 resulting from revenue growth and |
|
| Impairment of intangible assets |
(0.1) | – | milestone achievements | |
| Income from bargain purchase |
18.5 | – | Q2 2015 included |
|
| Other op. income (expenses), net |
1.5 | 3.1 | income from bargain purchase with regards |
|
| Operating income (loss) | 16.2 | 5.6 | to Evotec (France) | |
| Adjusted Group EBITDA1) | 1.1 | 8.6 | Other operating income in Q2 2016 included |
|
| Net income | 14.6 | 3.9 | R&D tax credits |
25 1) EBITDA was adjusted for changes in contingent considerations as well as for one-time effects with regards to the bargain purchase resulting from the acquisition of Evotec (France) SAS in 2015
Strong performance trend continues, increased milestone income in 2016
Revenues & gross margin H1
Strong base business incl. collaborations as well as milestone achievements (in %)
1) In the first six months of 2016, Sanofi contributed revenues of € 25.4 m. Excluding the Sanofi contribution, Evotec Group revenues increased by 16% compared to the prior-year period.
2) From 01 January 2016 onwards, amortisation of intangible assets are no longer presented in a separate line in the consolidated income statement but are allocated to the relating cost lines in the income statement. The 2014 and 2015 figures were changed accordingly.
Strong H2 2016 ahead
Expected key milestones 2016
EVT Execute
New long-term deals with large and mid-sized Pharma
Expansion of foundations and biotech network in USA/EU
- New performance-based integrated technology/disease alliance
- Milestones from existing alliances
EVT Innovate
- New clinical initiations and good progress of clinical pipeline within partnerships
- Expansion of network of top-class academic alliances
- Partnering of Cure X/Target X initiatives
- Strong focus on iPSC (induced pluripotent stem cells) platform