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Evotec SE — Interim / Quarterly Report 2014
Aug 12, 2014
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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