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Evotec SE — Interim / Quarterly Report 2016
Nov 10, 2016
151_ip_2016-11-10_d095a8ce-e4d9-43ff-b680-1d5ebf30474d.pdf
Interim / Quarterly Report
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Leading R&D Efficiency & Accelerating Innovation – Building BRIDGES
Evotec AG, Nine-month 2016 Quarterly Statement, 10 November 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.
Note:
The 2015 and 2016 results are not fully comparable. The difference stems mainly from the acquisition of Evotec (France) SAS, effective 01 April 2015. While the results of Evotec (France) SAS are fully included in the accompanying consolidated income statement for the first nine months of 2016, they were not fully included in the comparable period of the previous year. In addition, effective 09 December 2015, Evotec acquired 51% of the shares in Panion Ltd., London, UK. This acquisition has been fully consolidated since that date. The accounting policies used to prepare interim information are the same as those used to prepare the audited consolidated financial statements for the year ended 31 December 2015.
Change in presentation:
The presented financial statements include a change in presentation in the first nine months of 2015 and 2016. 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 prioryear period was changed accordingly resulting in higher costs of revenue (€ 2.2 m).
Welcome
The Management Team
Agenda
Highlights 9M 2016
EVT Execute
EVT Innovate
Financial performance and outlook
The leading innovation efficient discovery platform
EVT Execute & EVT Innovate – The business model
Strong performance and new ways for innovation
First nine months of 2016 – State of play
EVT Execute
- Important milestone achievements
- New long-term strategic drug discovery alliances
- Continued good progress of operations in Toulouse
- Continued expansion of existing drug discovery platforms
- First Phase I clinical start for the treatment of endometriosis with Bayer
EVT Innovate
- New multi-target alliance with Bayer in kidney diseases
- First research collaboration under French Academic Bridge with Inserm
- Acceleration of TargetNASH programme
- Partnership with ex scientia to develop bispecific small molecule therapeutics
- Company formation of Topas Therapeutics
- Participation in Series A funding of Carrick Therapeutics
- LAB282: BRIDGE partnership with Oxford University, OSI and OUI (after period-end)
Strong growth trend continues
Financial highlights first nine months 2016 & Guidance 2016
Strong financial performance
- Group revenues up 37% to € 120.6 m (9M 2015: € 88.2 m)
- EVT Execute revenues up 36%
- EVT Innovate revenues up 26%
- Adjusted Group EBITDA1) at € 30.6 m
- Net income at € 11.4 m
- R&D expenses of € 12.8 m
- Strong liquidity position of € 120.0 m2)
- Significant reduction of loans
Confirmation of updated guidance 2016
- More than 15% revenue growth excluding milestones, upfronts and licences
- Adjusted Group EBITDA1) expected to more than double3) compared to 2015 (2015: € 8.7 m)
- R&D expenses of approx. € 20 m
- Similar level of liquidity4) compared to 2015
- Capex investments up to € 10 m
1) Before contingent considerations and excluding impairments on other intangible and tangible assets and goodwill as well as the total non-operating result 2) Year-to-date 2016, short and long-term debt was reduced by € 8.1 m.
3) On 19 July 2016, Evotec raised its profitability guidance mainly as a result of an increased margin contribution and a positive outlook for the remainder of the year. 4) Excluding any potential cash outflow for M&A or similar transactions
Proposed acquisition of Cyprotex follows strategy
Strategy overview
Our "Sweet spot"
Generating the Pre-clinical Development Candidate (PDC)
Acquisition of Cyprotex expected to close still 2016
Summary and rationale of acquisition of Cyprotex
- World leader in pre-clinical ADME-Tox and DMPK testing1)
- 136 employees operating from 4 sites in the UK and USA
- H1 2016 revenues of ₤ 8.73 m (€ 9.78 m**); underlying EBITDA of ₤ 2.34 m (€ 2.62 m**)
- Listed on UK AIM market
- Strong addition to Evotec's drug discovery platform
- Strengthens EVT Execute stand-alone capabilities
- Early screening and predictive ADME accelerates early decision making in integrated drug discovery projects
- Offer: Issued share capital and funding of all existing debt of Cyprotex PLC for approx. ₤ 55.36 m (€ 62.0 m**) paid in cash
- Offer of 1.60 ₤/share represents a 9.4% premium to VWAP of past 30 trading days
-
50% Cyprotex shareholder irrevocables in place; intention to implement and secure transaction by a scheme of arrangement
- Full financial commitment for acquisition covered through Evotec's cash on balance sheet
- Acquisition adds high-quality revenue and accretive EBITDA
- If accepted by >75% of shareholders, deal should close by end of 2016
| # RESEARCHNEVERSTOPS |
|---|
Agenda
Highlights 9M 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Strong growth in EVT Execute
EVT Execute – 9M 2016 versus prior-year period
- Increase in revenues attributable to growth in the base business, milestone achievements and three full quarters of Sanofi contribution
- Significant upswing of adjusted EBITDA mainly due to the strong growth in revenues and milestone payments
- 9M 2016 includes € 23.9 m of intersegment revenues
Most comprehensive platform in the industry
EVT Execute – Highlights first nine months of 2016
- Milestone achievements with Bayer, BI and Padlock
- Extension of drug discovery alliances (Genentech, Janssen Pharmaceutica NV)
- New long-term strategic drug discovery alliances (C4X Discovery, Antibiotic Research UK, UCB)
- New licences enhancing Evotec's platform (Trianni, CRISPR)
- Compound management gaining momentum (Pierre Fabre, UCB)
- Phase I clinical start in endometriosis in Bayer alliance
- Offer to acquire Cyprotex PLC (after period-end)
Integration of additional capacity works very well
Progress update Evotec (France)
- Evotec (France) 18-month retrospective
- Complex integration successfully ongoing
- Evotec is now fully independent and operational on site in Toulouse and increased headcount by >30% since April 2015
- Evotec fulfilled its commitment to further develop and sustain activity and employment on site in Toulouse
- Innovative partnerships, also with third parties
- Pipeline-building partnership (e.g. partnered Target X initiatives)
- Outsourcing partnerships (Sanofi, UCB, Pierre Fabre, Institut Claudius Regaud, …)
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 |
12% 16% |
100% | Mid-sized Pharma Foundations |
10% 16% |
100% | ROW USA |
41% | 100% 1% |
| Biotech | 21% | |||||||
| Top 10 Long-term Strategic Alliances |
72% | Top 20 Pharma |
53% | Europe | 58% |
Outlook 2016
EVT Execute – Expected key milestones 2016
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
Agenda
Highlights 9M 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Strong revenue growth and focused R&D expenses
EVT Innovate – 9M 2016 versus prior-year period
- Revenue growth of 26% and improved adjusted EBITDA resulting from new partnerships signed in 2015
- No material change in R&D expenses
- Full impairment of EVT100 series (€ 1.4 m)2)
PAGE 17
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 – more than 70
Partnership portfolio
| Molecule | Therapeutic Area/Indication | Partner | Discovery | Pre-clinical | Phase I | Phase II | Phase III | |
|---|---|---|---|---|---|---|---|---|
| al c ni |
EVT3021) | CNS – Alzheimer's disease |
||||||
| EVT201 | CNS – Insomnia |
|||||||
| EVT1001) | CNS – Depression |
|||||||
| EVT401 | Immunology & Inflammation | |||||||
| Cli | ND2) | Oncology | ||||||
| ND2) | Oncology | |||||||
| Various | Women's health – Endometriosis |
|||||||
| ND2) | CNS – Pain |
|||||||
| ND2) | Immunology & Inflammation | |||||||
| al | ND2) | Oncology | ||||||
| c ni |
EVT770 | Metabolic – Diabetes (type 2/1) |
||||||
| cli | ND2) | Respiratory | ||||||
| e- Pr |
ND2) | Immunology & Inflammation | ||||||
| EVT801 | Oncology | |||||||
| EVT701 | Oncology | |||||||
| EVT601 | Oncology | |||||||
| ND2) | Nephrology | NEW | ||||||
| Various | Immunology & Inflammation | |||||||
| Various | Metabolic – Diabetes (type 2/1) |
|||||||
| Various | Metabolic – Diabetes (type 2/1) |
|||||||
| Various | Nephrology | |||||||
| y er |
Various | Metabolic – Diabetes |
||||||
| v o |
Various | CNS – Alzheimer's disease |
||||||
| c s |
Various | Oncology – Immunotherapy |
||||||
| Di | Various | Immunology & Inflammation – Tissue fibrosis |
||||||
| 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 |
18 1) EVT302 and EVT100: Evotec has regained the licence rights and is currently assessing potential business opportunities
First-in-class and best-in-class approaches – New paths of sourcing innovation
EVT Innovate – Strategy highlights
New treatments to fight kidney diseases
Bayer & Evotec in CKD – Since 2016
Mission
Evotec and Bayer develop novel and highly innovative therapeutics in the field of kidney diseases such as chronic kidney disease ("CKD") in diabetes patients
Background1)
- CKD is a huge unmet medical need \$ 35 bn annual Medicare costs
-
10% of population worldwide is affected by CKD
-
2 million people worldwide currently receive dialysis treatments or a kidney transplant
- Alliance includes assets discovered within Evotec's CureNephron initiative
Agreement with Bayer
- Minimum of € 14 m including research payments and an undisclosed licence fee
- Potential pre-clinical, clinical and sales milestone payments of potentially over € 300 m; tiered royalties of up to a low doubledigit percentage of net sales
- Integrated collaboration with substantial efforts from both partners
- Strategic five-year collaboration
From Academia to transformative projects
Evotec's academic network continues to grow
- Carefully select projects in indications of high unmet medical need
- Dramatically reduce "search costs" for capital
- Advance projects to tangible value inflection points, i.e. licensing or spin-offs
- Put experienced "drug hunting" teams/projects together right from the start
EVT BRIDGE addresses challenges of innovation
EVT BRIDGE value proposition
Oxford BRIDGE "LAB282" is the first larger scale implementation of a BRIDGE fund
Partnership between Oxford University, OSI, OUI and Evotec
1) Oxford Sciences Innovation 2) ₤ 13 m 3) Oxford University Innovation Ltd 4) Proof of Concept
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, Bayer) 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 Institutes) … |
TargetaSN (MJFF) TargetBispecifics (ex scientia) TargetRhoB (Inserm) TargetNASH (Ellersbrook/ Internal) … |
Efficient approaches for participation in first-in-class innovation
Strategic rationale & examples for Evotec's innovation acceleration
Accelerating innovation on EVT platform
- Spin off valuable platforms outside of Evotec's main areas of interest for potential broader/ later stage applications
- Participate in financing rounds of promising companies, built on EVT platforms, via strategic investments
- Company formations with the aim of developing assets to next value inflection points
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 9M 2016
EVT Execute
EVT Innovate
Financial performance and outlook
Significantly increased EBITDA
Key financials 9M 2016: Condensed income statement (IFRS)
| in € m* |
||||
|---|---|---|---|---|
| YTD 2015 |
YTD 2016 |
% vs. 2015 | Revenue growth mainly due to an increase in base |
|
| Revenues | 88.2 | 120.6 | 37% | revenues, full 9 months Sanofi contribution and |
| Gross margin | 27.2% | 38.5% | – | milestone achievements |
| R&D expenses |
(13.5) | (12.8) | (5)% | Gross margin increase due to milestones, Sanofi |
| SG&A expenses |
(19.0) | (17.8) | (7)% | collaboration and higher base margin |
| Impairment of intangible assets |
(0.1) | (1.4) | – | Decrease in SG&A due to |
| Income from bargain purchase |
18.5 | – | – | one-off M&A and related costs in 2015 |
| Other op. income (expenses), net |
2.4 | 6.0 | – | € 1.4 m for full impairment of EVT100 in 2016 |
| Operating income | 12.3 | 20.4 | 66% | Bargain purchase of |
| Adjusted Group EBITDA1) | 3.4 | 30.6 | – | € 18.5 m in 2015 |
| Net income | 10.7 | 11.4 | 7% | R&D tax credits in UK and France (€ 2.9 m increase) |
1) EBITDA in 2015 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 from both segments
Condensed income statement based on segments for 9M 2016
in € m*
| EVT Execute |
EVT Innovate |
Inter segment elimination |
Evotec Group |
|
|---|---|---|---|---|
| Revenues | 126.6 | 17.9 | (23.9) | 120.6 |
| Gross margin | 32.9% | 45.6% | – | 38.5% |
| R&D expenses |
(0.0) | (16.3) | 3.5 | (12.8) |
| SG&A expenses |
(13.9) | (3.9) | – | (17.8) |
| Impairment of intangible assets |
– | (1.4) | – | (1.4) |
| Other op. income (expenses), net |
5.3 | 0.7 | – | 6.0 |
| Operating income (loss) | 33.1 | (12.7) | – | 20.4 |
| Adjusted EBITDA1) | 41.3 | (10.7) | – | 30.6 |
- Strong base business and milestone achievements
- R&D expenses on similar level as in prioryear period
- Significantly improved adjusted EBITDA of EVT Execute compared to 9M 2015 (€ 16.1 m)
- Strong gross margin in EVT Innovate
Strong gross margin
Key financials Q3 2016: Condensed income statement (IFRS)
| in € m |
|||
|---|---|---|---|
| Q3 2015 | Q3 2016 | Q3 2016 gross margin | |
| Revenues | 33.2 | 45.2 | improved by milestone achievements and |
| Gross margin | 29.2% | 45.1% | improved capacity |
| R&D expenses |
(5.0) | (3.8) | utilisation |
| SG&A expenses |
(6.7) | (6.0) | |
| Other op. income (expenses), net |
1.3 | 1.4 | |
| Operating income (loss) | (0.6) | 12.0 | |
| Adjusted Group EBITDA1) | 2.6 | 14.8 | |
| Net income (loss) | (2.9) | 8.7 |
1) EBITDA in 2015 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.
Business grows and with improved gross margin
Revenues & gross margin trend 9M 2016
PAGE 31 1) In the first nine months of 2016, Sanofi contributed revenues of € 38.5 m. Excluding the Sanofi contribution, Evotec Group revenues increased by 29% 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 2016, strong visibility and outlook for 2017
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
Milestones from existing alliances
- 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
Important next dates
Financial Calendar 2017
| Annual Report 2016 | 28 March 2017 |
|---|---|
| Quarterly Statement Q1 2017 | 10 May 2017 |
| Annual General Meeting 2017 | 14 June 2017 |
| Half-year 2017 Interim Report | 10 August 2017 |
| Quarterly Statement 9M 2017 | 08 November 2017 |