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Evotec SE — Interim / Quarterly Report 2015
Aug 12, 2015
151_ip_2015-08-12_174c4074-b08b-4434-9db2-de8c4b303b66.pdf
Interim / Quarterly Report
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EVT Execute & EVT Innovate – Innovation Efficiency
Evotec AG, H1 2015 Interim Report, 12 August 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
The Management Team
Agenda
Highlights H1 2015
EVT Execute
EVT Innovate
Financial performance and outlook
Excellent performance of EVT Execute services, Cure X/Target X strategy accelerated
First six months of 2015 – State of play
EVT Execute
- New alliances and extensions with biotech and Pharma
- Milestones in endometriosis collaboration with Bayer and smaller milestones with Pharma
- Sanofi collaboration for multiple services up and running
- Integration of site in Toulouse (France) on track
- Opening of new research site in Princeton (USA)
EVT Innovate
- Phase IIb of Sembragiline with Roche missed primary endpoint
- TargetImmuniT alliance in immuno-oncology partnered with Sanofi and Apeiron Biologics
- TargetBCD in diabetes partnered with Sanofi
- Good progress within other clinical and pre-clinical partnerships
- Gladstone Institute (USA) extends academic network
Corporate
Dr Elaine Sullivan (former Eli Lilly) new member of Supervisory Board
Substantial growth, accelerated EVT Innovate strategy
Financial highlights H1 2015 – Guidance 20151)
Financial highlights
- Group revenues +37% to € 55.0 m (2014: € 40.1 m)
- EVT Execute revenues up 49%
- EVT Innovate increased R&D by 48%
- Group EBITDA2),3) positive at € 0.8 m
- Strong EBITDA of € 9.8 m for EVT Execute
- Strongest liquidity in Company history at € 140.9 m
Guidance 20151)
- More than 35% revenue growth excluding milestones, upfronts and licences
- Adjusted EBITDA positive3)
- R&D expenses between € 15 m and € 20 m
- Capex investments up to € 10 m
- Liquidity is expected to be well in excess of € 100 m at the end of 20154)
1) As a result of the Sanofi collaboration, Evotec raised its revenue guidance that was published in Evotec's Annual Report 2014 two times, firstly on 24 March 2015 and secondly on 12 May 2015. All elements of the financial guidance 2015 as of 12 May 2015 are confirmed
2) 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
3) Before contingent considerations and excluding impairments on other 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
The business model works – No. 1 in drug discovery
EVT Execute & EVT Innovate
Agenda
Highlights H1 2015
EVT Execute
EVT Innovate
Financial performance and outlook
Expansion in EU and USA
Evotec's global footprint incl. approx. 1,000 employees
Strong base business – EBITDA of € 9.8 m
EVT Execute – Highlights H1 2015
- New alliances initiated and cooperations extended (e.g. Facio Therapies, C4X Discovery, Biogen, Padlock, Spero, UCB...)
- Milestone achievements in existing alliances with Bayer and other Pharma
- Drug discovery services as part of Sanofi alliance up and running
- "Come back" and expansion of Asian business through various new alliances with Japanese Pharma partners
- Strong growth in USA with Pharma and biotech
Posititve outlook
EVT Execute strategy: Expected key milestones 2015
New long-term deals with large and mid-sized Pharma, foundations and biotech
New integrated technology/disease alliances
Milestones from existing alliances
Agenda
Highlights H1 2015
EVT Execute
EVT Innovate
Financial performance and outlook
Despite missed Phase IIb endpoint with Roche, strong portfolio of > 70 product opportunities
Partnership portfolio
| Molecule | Indication | Partner | Discovery | Pre-clinical | Phase I | Phase II | Phase III | |
|---|---|---|---|---|---|---|---|---|
| EVT3021) | Alzheimer's disease | |||||||
| EVT201 | Insomnia | |||||||
| al c ni Cli |
Somatoprim | Acromegaly | ||||||
| EVT100 | CNS diseases | |||||||
| EVT401 | Inflammation | |||||||
| ND2) | Oncology | |||||||
| ND2) | Oncology | |||||||
| al c ni cli |
ND2) | Pain | ||||||
| ND2) | Oncology | |||||||
| Various | Endometriosis | |||||||
| EVT770 | Diabetes – type 2/1 |
|||||||
| e- | 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 |
1) Sembragiline/RO4602522; Missed Phase IIb endpoint
2) Not disclosed
Two significant new alliances
EVT Innovate – Fields of core expertise
TargetImmuniT: Joining forces for novel small molecule-based cancer immunotherapies
Strategic partnership to support broad development track
Background
Based on partnership between Apeiron and Evotec initiated in 2012/13
Mission
Development of small molecule-based cancer immunotherapies for next-generation immunooncological therapies to complement current offerings of checkpoint inhibitors
Agreement with Sanofi
- Multi-year research payments for Evotec and Apeiron
- Significant pre-clinical, clinical and regulatory milestones exceeding € 200 m
- Significant royalties upon commercialisation
- Integrated collaboration involving more than 20 scientists between Evotec, Sanofi and Apeiron
The use of the immune system to fight cancer
The market opportunity – Cancer immunotherapy
- Immuno-oncology will become a new pillar of cancer therapy Market potential estimated to be \$ 35 bn in 2023
- Current cancer immunotherapies and late-stage pipelines are dominated by biologics
- Monoclonal antibodies are considered 'first wave' of targeted therapies
- Cell therapies on the rise (e.g. CAR T-cells)
- Small molecules will follow
Small molecules complementing cancer immunotherapies
Apeiron Biologics, Evotec and Sanofi – First-in-class approach
Cancer immunotherapy – Restoring the immune system's ability to eliminate cancer cells
TargetBCD: Restoring beta cell function via replacement therapy and function restoring drugs
Strategic collaboration between Sanofi and Evotec in diabetes
Background
- Evotec has long-term expertise in beta cell biology and regenerative medicine – TargetBCD was initiated in 2014
- Sanofi is one of Top 3 global diabetes players
Mission
Development of beta cell replacement therapy and drug discovery based on functional human beta cells derived from stem cells
Agreement with Sanofi
- Upfront fee of € 3 m
- Potential pre-clinical, clinical, regulatory and commercial milestones exceeding € 300 m
- Significant royalties upon commercialisation
- Integrated collaboration resources involving more than 15 scientists at Evotec and Sanofi
Disease-modifying therapies are urgently needed
The market opportunity – Diabetes
- Prevalence of diabetes is increasing at alarming rates
- Diabetes is driven by loss in beta cell function
- Current insulin market exceeds >\$ 22 bn in 2014
- Human beta cells offer disease-modifying product opportunities
- Beta cell replacement therapy
- Beta cell protective/ regenerative drugs
Addressing the diabetes pandemic by restoring beta cell function
Human stem cell derived beta cells for transplantation
Human beta cells from stem cells
- Edmonton protocol provides clinical POC for beta cell therapy
- Transplantation of beta cells can effectively restore blood glucose control
- Clinical trial with embryonic stem cell derived beta cell therapy has been initiated
- Viacyte: VC-01TM in Phase I/II
- Key issues
- Immature beta cells with limited functionality
- Requires large impractical device
- New differentiation protocols create mature beta cells
- Fewer cells need to be transplanted
- Encapsulation becomes more manageable
EVT Innovate works
"The Bridge"
| 2011 | 2012 | 2013 | 2014 | 2015 |
|---|---|---|---|---|
| CureBeta (Harvard Stem Cell Institute) |
CureNephron (Harvard, BWH, USC, AstraZeneca) TargetASIC (BMBF/undisclosed Pharma partner) Somatoprim (Cortendo) TargetPicV (Haplogen) |
TargetImmuniT (Apeiron/Sanofi) TargetDBR (Yale) TargetSP (Internal) TargetFX (Internal) TargetPGB (Harvard) TargetKDM (Dana-Farber, Belfer) CureMN (Harvard) TargetEEM (Harvard) TargetAD (NBB/J&J) |
TargetBCD (Sanofi) TargetSX (undisclosed) TargetDR (Internal) TargetATD (Internal) TargetKX (undisclosed) TargetCytokine (DRFZ) Fraunhofer Initiative |
French Academic Bridge Ohio State University New York University Gladstone Institutes … |
First-in-class discovery to build sustainable 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 H1 2015
EVT Execute
EVT Innovate
Financial performance and outlook
Group revenues +37%, positive EBITDA, one-time effect leads to positive net income
Key financials H1 2015: Condensed income statement (IFRS)
in € m
| H1 2014 | H1 2015 | % vs. 2014 | |
|---|---|---|---|
| Revenues | 40.1 | 55.0 | 37% |
| Gross margin | 29.4% | 28.7% | – |
| R&D expenses |
(6.3) | (8.5) | 35% |
| SG&A expenses |
(8.9) | (12.4) | 39% |
| Amortisation of intangible assets |
(1.4) | (1.5) | 8% |
| Impairment of intangible assets |
– | (0.1) | – |
| Income from bargain purchase |
0.2 | 18.5 | – |
| Other op. income (expenses), net |
1.0 | 1.1 | 10% |
| Operating income (loss) | (3.6) | 12.9 | – |
| EBITDA1) | 0.6 | 0.8 | 31% |
| Net income (loss) | (4.4) | 13.6 | – |
- Revenue growth driven by base business, Sanofi collaboration, milestone contribution, and favourable fx effects
- Higher investment in EVT Innovate R&D
- Increase in SG&A driven by Sanofi transaction including higher compensation expenses
- Income from bargain purchase with regards to Evotec (France) still preliminary
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 and Bionamics GmbH in 2014
Sharp revenue increase in EVT Execute
Condensed income statement based on segments for H1 2015
| in € m |
Inter | ||||
|---|---|---|---|---|---|
| EVT Execute |
EVT Innovate |
segment elimination |
Not allocated |
Evotec Group |
|
| Revenues | 59.2 | 8.2 | (12.4) | – | 55.0 |
| Gross margin | 23.8% | 45.7% | 16.6% | – | 28.7% |
| R&D expenses |
(0.2) | (10.4) | 2.1 | – | (8.5) |
| SG&A expenses |
(9.3) | (3.1) | – | – | (12.4) |
| Amortisation of intangible assets |
(1.3) | (0.2) | – | – | (1.5) |
| Impairment of intangible assets |
– | (0.1) | – | – | (0.1) |
| Income from bargain purchase |
– | – | – | 18.5 | 18.5 |
| Other op. income (expenses), net |
0.7 | 0.4 | – | – | 1.1 |
| Operating income (loss) |
3.9 | (9.5) | – | 18.5 | 12.9 |
| EBITDA1) | 9.8 | (9.0) | – | – | 0.8 |
- Revenue in EVT Execute: Primarily attributable to growth in base business (e.g. in anti-infectives and Sanofi collaboration)
- Increased investment in Cure X/Target X initiatives in EVT Innovate
- Strong adjusted EBITDA of € 9.8 m in EVT Execute
1) Adjusted for changes in contingent considerations; Group EBITDA was 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
Revenue increase of 49% in Q2
Key financials Q2 2015: Condensed profit & loss statement (IFRS)
| In € m |
|||
|---|---|---|---|
| Q2 2014 | Q2 2015 | Revenue |
|
| Revenues | 22.5 | 33.4 | increase of 49% |
| Gross margin | 31.9% | 27.4% | compared to Q2 2014 Q2 2014 margin |
| R&D expenses |
(3.3) | (4.7) | extraordinarily |
| SG&A expenses |
(4.5) | (7.3) | impacted by termination of |
| Amortisation of intangible assets |
(0.6) | (0.9) | CureBeta collaboration |
| Impairment of intangible assets |
– | (0.1) | Increase in SG&A driven by Sanofi |
| Income from bargain purchase |
0.2 | 18.5 | transaction including |
| Other op. income (expenses), net |
1.0 | 1.5 | higher compensation expenses |
| Operating income (loss) | (0.1) | 16.2 | Income from bargain |
| Net income (loss) | (0.4) | 14.6 | purchase with regards to Evotec (France) still |
| EBITDA, adjusted1) | 1.9 | 1.1 | preliminary |
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 and Bionamics GmbH in 2014.
Strong revenue growth and solid gross margin
Revenues & gross margin H1
Key figures illustrate clear strategy for both segments
Performance overview EVT Execute & EVT Innovate
Guidance confirmed1)
Guidance 2015
| 1 | Double digit top line growth |
More than 35% growth excluding milestones, upfronts and licences |
|---|---|---|
| 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) As a result of the Sanofi collaboration, Evotec raised its revenue guidance that was published in Evotec's Annual Report 2014 two times, firstly on 24 March 2015 and secondly on 12 May 2015. All elements of the financial guidance 2015 as of 12 May 2015 are confirmed
2) Before contingent considerations and excluding impairments on other 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
Strong outlook for H2 2015
Expected key milestones in 2015
EVT Execute
- New long-term deals with large and midsized Pharma, foundations 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