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Evotec SE — Interim / Quarterly Report 2020
May 14, 2020
151_ip_2020-05-14_77684261-6c8b-4021-869e-7ab5ef95b085.pdf
Interim / Quarterly Report
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Multimodality = More Opportunity
Forward-looking statement
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:
Just-Evotec Biologics (JEB, former Just.Bio) was acquired effective July 2, 2019 and was fully consolidated in the group numbers from the respective date onwards. Hence, 2019 and 2020 numbers are not fully comparable for Q1, in particular with reference to the EVT Execute segment.
Welcome
The Management Team
#Researchneverstops
Mastering COVID-19
| What is paramount in this situation | |||
|---|---|---|---|
| Protect | Respect | Focus | Help |
| and Vaccines ("ACTIV") and vaccines … |
Involved in multiple activities to combat COVID-19 | NIH-led initiative Accelerating COVID-19 Therapeutic Interventions "COVID R&D", global initiative, leading repurposing workstream Conducing concept work for a COVID-19 proof of concept research project for N4 Pharma's novel delivery system for cancer treatments Partnership with Ology for the evaluation and analytical characterisation of antibodies against SARS-CoV-2 virus |
Agenda
Highlights
Financial performance Q1 2020
Scientific and operational performance Q1 2020
Guidance 2020
Our mission is more relevant than ever before
Our long-term mission in drug discovery and development
Manfred Eigen Nobel Prize 1967
We design and apply innovative technologies and processes across all modalities. We want to expand access to more precise and effective medicines together with our partners.
Strong start into 2020
Q1 highlights
- Multiple new and extended drug discovery and development agreements on all platforms
- Entering gene therapy through establishing Evotec GT and alliance with Takeda
- Just Evotec Biologics on track; J.POD® on track
- Further programme from multi-target alliance with Bayer in Phase I
- Expansion of iPSC therapy platform through alliance with panCELLa
- Strategic partnership with leon-nanodrugs
- Rights to beta cell replacement therapy regained start of "QRbeta Therapeutics" initiative (after period-end)
Guidance on track
Financials Q1 2020 & FY 2020 Guidance1)
Good financial performance
- Increase of revenues by 15% to € 119.4 m (Q1 2019: € 103.8 m)
- Adjusted EBITDA2) stable at € 30.0 m (Q1 2019: € 30.0 m)
- Increased unpartnered R&D expenses of € 11.4 m (Q1 2019: € 8.1 m)
- Strong liquidity position of € 320.7 m (31 December 2019: € 320.0 m)
Guidance - Confirmed (despite: COVID-19; loss of Sanofi subsidy; ramping up J.POD® capacities)
- Total Group revenues € 440 480 m (2019: € 446.4 m)
- Adjusted Group EBITDA2) € 100 120 m, (2019: € 123.1 m)
- Unpartnered Group R&D3) expenses of approx. € 40 m (2019: € 37.5 m)
1) Given current global insecurities, a likely negative impact from the ongoing Corona pandemic is already estimated within the introduced guidance for revenues & adjusted EBITDA
2) Before contingent considerations, income from bargain purchase & excl. impairments on goodwill, other intangible & tangible assets as well as the total non-operating result
3) Evotec focuses its guidance & upcoming reporting on the "unpartnered R&D" part. ID-related R&D expenses will be fully reimbursed by its partner Sanofi ("partnered R&D").
Multimodality = More Opportunities
Small molecules, Biologics, Cell & Gene therapy in R&D
Agenda
Highlights
Financial performance Q1 2020
Scientific and operational performance Q1 2020
Guidance 2020
Continued growth despite slow start of milestones
Condensed income statement Q1 2020 – Evotec Group
in € m1)
| Q1 2020 | Q1 2019 | % vs. 2019 | |
|---|---|---|---|
| Revenues from contracts with customers | 119.4 | 103.8 | 15% |
| Gross margin | 27.9% | 30.5% | – |
| R&D expenses |
(15.1) | (14.4) | 5% |
| SG&A expenses |
(17.3) | (14.8) | 17% |
| Other op. income (expenses), net |
15.1 | 16.5 | (8)% |
| Operating income | 16.1 | 19.1 | (16)% |
| Adjusted Group EBITDA2) | 30.0 | 30.0 | 0% |
| Net income | 17.1 | 13.1 | 31% |
- Revenue driven by strong performance in base business across all business lines, as well as Just – Evotec Biologics (€ 7.9 m)
- SG&A reflects organic and strategic growth
- Other operating income mainly influenced by reduced R&D tax credits in Italy
- Favourable FX effect from strengthened USD vs EUR
1) Differences may occur due to rounding
2) Before contingent considerations, income from bargain purchase & excl. impairments on goodwill, other intangible & tangible assets as well as the total non-operating result
Strong base business and gross margin
Revenues & Gross margin overview Q1 2020
Both segments with strong performance
Segment information Q1 2020 – Evotec Group
in € m1)
| EVT Execute |
EVT Innovate |
Inter segment elimination |
Not allocated (IFRS 15)3) |
Evotec Group |
|
|---|---|---|---|---|---|
| Revenues | 118.2 | 23.3 | (26.3) | 4.1 | 119.4 |
| Gross margin | 29.3 % | 4.6 % | – | – | 27.9 % |
| R&D expenses |
(1.3) | (16.2) | 2.5 | – | (15.1) |
| SG&A expenses |
(14.1) | (3.2) | – | – | (17.3) |
| Other op. income (expenses), net |
3.6 | 11.5 | – | – | 15.1 |
| Operating result | 22.9 | (6.8) | – | – | 16.1 |
| Adjusted EBITDA2) | 35.4 | (5.4) | – | – | 30.0 |
- Increase of 18% in EVT Execute reflects strong base business growth
- Revenue growth of 24% in EVT Innovate driven by long-term alliances
- R&D expenses in EVT Execute in context of Just - Evotec Biologics
- R&D expenses in EVT Innovate as planned
- Adjusted EBITDA of EVT Execute improved
2) Before contingent considerations, income from bargain purchase & excl. impairments on goodwill, other intangible & tangible assets as well as the total non-operating result
3) Not allocated to segments: Material charges according IFRS 15
1) Differences may occur due to rounding
Strong balance sheet and liquidity position
Balance sheet and liquidity – 31 March 2020 versus 31 Dec. 2019
Agenda
Highlights
Financial performance Q1 2020
Scientific and operational performance Q1 2020
Guidance 2020
Important strategic expansion on many fronts
EVT Execute – Major achievements Q1 2020
- Important step into gene therapy and longterm research alliance with Takeda
- New integrated agreement with Amgen
- Strategic INDiGO collaboration with Ildong Pharmaceutical Co., Ltd.
- Very good start for Just Evotec Biologics:
- Continued good construction progress of first J.POD®
- Multi-year collaboration with MSD around the J.POD®
- Development and manufacturing agreement with OncoResponse
- Development of library of a new class of humanoid antibodies using a novel, AI-derived approach (HAL)
- Partnership with Ology on COVID-19
Well-balanced global customer mix
EVT Execute – Selected KPIs Q1 2020
| Revenues by customer segment YTD1) (in %) |
Customer type YTD1) (in %) |
Revenues by region YTD1) (in %) |
||||||
|---|---|---|---|---|---|---|---|---|
| 100% | Mid-sized Pharma |
15% | 100% | Rest of World |
100% 4% |
|||
| Remaining | 34% | Foundation/ NFP/ Academic |
7% | USA | 40% | |||
| Top 11-30 customers |
23% | Biotech | 48% | |||||
| Top 10 long-term strategic alliances |
43% | Top 20 Pharma |
30% | Europe | 56% | |||
| Q1 2020 | Q1 2020 | Q1 2020 |
Expanding the multimodality "Autobahn"
Establishing Gene Therapy
Evotec GT – Gene Therapy
- Strong leadership team with acknowledged expertise in gene therapy
- Extensive disease insights and expertise in gene therapy applications for hemophilia, hematology, metabolic and muscle diseases
- World-class expertise and know-how in the field including vectorology, virology, analytics & assays, etc.
- Smooth entry into the gene therapy market planned – starting with Takeda alliance
J.POD® – The Biologics Facility of the Future
J.POD® – relatively low CAPEX and primary OPEX-driven manufacturing
First J.POD® facility – exterior complete
J.POD® – construction progress
Clinical & commercial facility for biologics. Building size: 130,000 SF1)
Continued expansion of iPSC leadership
EVT Innovate – Major achievements Q1 2020
- Good pipeline progress, e.g. new clinical entries with Bayer, Exscientia, NIH
- Regained rights to beta cell replacement therapy – "QRbeta Therapeutics" initiative (after period-end)
- Expansion of iPSC-based cell therapy platform with panCELLa
- Important role in global initiatives to fight Tuberculosis and COVID-19
Fully invested pipeline, gaining visibility
Partnership portfolio pre-clinical and clinical
| Molecule | Therapeutic Area/Indication | Partner | Discovery | Pre-clinical | Phase I | Phase II | Phase III | |
|---|---|---|---|---|---|---|---|---|
| EVT201 | CNS – Insomnia |
|||||||
| BAY-1817080 | Chronic cough | |||||||
| Backup 1817080 | Chronic cough | |||||||
| CT7001 | Oncology | |||||||
| CT7001 | Oncology | |||||||
| EVT401 | Immunology & Inflammation | |||||||
| Clinical | ND1) | Multiple targets – Endometriosis |
||||||
| ND1) | Multiple targets – Endometriosis |
|||||||
| ND1) | Multiple targets – Endometriosis |
|||||||
| Various | Respiratory | |||||||
| ND1) | Oncology | |||||||
| ND1) | Immunology & Inflammation | |||||||
| DSP-1181 | Obessive-compulsive disorder | |||||||
| Chick V | Antibody project | |||||||
| ND1) | Pain | |||||||
| Various | Multiple targets – Endometriosis |
|||||||
| EVT801 | Oncology | |||||||
| Pre-clinical | TargetImmuniT | Oncology – Immunotherapy |
||||||
| ND1) | Oncology (+ several discovery programmes) | |||||||
| ND1) | Fibrosis | |||||||
| Various ND1) | Nephrology | |||||||
| Various ND1) | Metabolic – Diabetes |
|||||||
| Various | Neurodegeneration | |||||||
| Various | CNS, Metabolic, Pain & Inflammation | >10 further programmes |
>100 discovery projects are progressing rapidly
Partnership research and discovery portfolio
| Molecule | Therapeutic Area/Indication | Partner | Discovery | Pre-clinical | Phase I | Phase II | Phase III | |
|---|---|---|---|---|---|---|---|---|
| Various ND1) | Nephrology | |||||||
| ND1) | Nephrology | |||||||
| ND1) | PCOS | |||||||
| ND1) | PCOS | |||||||
| INDY inhibitor | Metabolic | |||||||
| Various | Oncology | |||||||
| ND1) | Oncology | |||||||
| ND1) | Oncology – Colorectal cancer |
|||||||
| ND1) | Oncology – DNA damage response |
|||||||
| ND1) | Novel antibiotics | |||||||
| ND1) | Novel antibiotics | |||||||
| ND1) | Anti-bacterial | |||||||
| Discovery | TargetPicV | Antiviral | ||||||
| Various | Anti-infectives | >5 programmes | ||||||
| Various | All indications | |||||||
| ND1) | Dermatological diseases | |||||||
| ND1) | Facioscapulohumeral Dystrophy | |||||||
| Various | Immunology & Inflammation – Tissue fibrosis |
|||||||
| Various | Fibrotic disease | Fibrocor Therap./ Galapagos | ||||||
| Various ND1) | Immunology & Inflammation | |||||||
| ND1) | Inflammatory | |||||||
| ND1) | Cancer | |||||||
| Various | Internal: Oncology, CNS, Metabolic, Pain & Inflammation | >40 further programmes |
Development of beta cell therapy product
Despite successful pre-clinical development project returns to Evotec
Durable normalisation of blood glucose levels
iPSC-derived beta cells in diabetic animal PoC study
- Sustained normoglycemia
- Normoglycemia achieved upon vascularisation
- Circulating human insulin levels are consistent with full glucose control1)
Paradigm shift to provide a cure
Current insulin therapy versus beta cell therapy
Beta cell therapy - the new standard of care
Off-the-shelf iPSC-derived beta cells
1) Induced pluripotent stem cells
2) Transplantation of cadaveric human islets into the liver for the treatment of diabetes; Shapiro et al., 2017
Non-encapsulated beta cells will be next
Enabled by enhanced iPSC lines – panCELLa1)
| Cloaking | Genetic modifications to prevent rejection by the host immune system (auto- and allo-immunity) Avoids the need for immunosupressants or immunoisolating device |
CTLA4-Ig T-cells NK-cells HLA-G Examples for cloaking strategies |
|---|---|---|
| Inducible kill switch |
Fail-safe concept through suicide gene approach2) Allows to selectively eliminate tumour-forming, dividing cells pre-transplantation or in patients Establishes safety handle for device-less cell transplantation |
Gancyclovir Dividing graft cell expresses TK and is suceptible to killing by Gancyclovir |
1) https://www.evotec.com/en/invest/news--announcements/p/evotec-expands-its-ipsc-based-cell-therapy-platform-evocells-through-licensing-agreement-withpancella-5921 2) www.pancella.com
Disruption of one of the biggest healthcare markets
Market potential for treatment of insulin-dependent diabetes
- Insulin-dependent diabetes is high and rising globally1)
- ~ \$ 30 bn market in 20182)
- 578 million diabetes patients predicted for 2030
- ~90% of which are T2D patients, which eventually progress to insulin injections
- Tremendous commercial potential with market entry expected 2027
3) Globaldata list more than 500 companies active in diabetes (count includes affiliates or large pharma companies)
4) Insulin and its analogues, with or without additional technical devices like pumps, closed loop systems, etc.
Co-owned pipeline of equity holdings is expanding
Equity participations
| Equity participation Facioscapulo humeral mus cular dystrophy Initiated 2011 |
Equity participation Metabolic disorders Initiated 2016 |
Spin-off Nanoparticle based therapeutics Initiated 2016 |
Equity participation Targeting metallo enzymes Initiated 2016 |
Equity participation Innovative pathways in oncology Initiated 2016 |
Equity participation Fibrosis partnership Initiated 2017 |
Consortium membership Kidney diseases Initiated 2017 |
Equity participation AI for auto mated drug design Initiated 2018 |
|---|---|---|---|---|---|---|---|
| Joint Venture with Vifor Pharma |
Spin-off DNA damage |
Equity participation |
Equity participation |
Equity participation |
Equity participation |
Equity participation |
|
| Kidney diseases Initiated 2019 |
response Initiated 2019 |
Inflammatory disease Initiated 2019 |
Oncology/ Biologics Initiated 2019 |
Women's health Initiated 2019 |
Formulation nanotechno logies Initiated 2020 |
Failsafe cloaking for cell therapies Initiated 2020 |
More to come … |
Agenda
Highlights
Financial performance Q1 2020
Scientific and operational performance Q1 2020
Guidance 2020
Experts strengthen long-term vision
New appointments
| Friedrich Scheiflinger EVP Head of Gene Therapy |
30+ years of GT experience with Baxter, Baxalta, Shire, Takeda Strong science background in hematology, LSDs and gene therapy |
|---|---|
| Markus Dangl EVP Head of Innovate Oncology |
19 years experience in leading oncology projects at e.g. Roche Former CSO at Achilles Therapeutics |
| Volker Braun SVP Head of ESG & Investor Relations |
20+ years capital market participant as sell-side analyst at equinet Bank, Commerzbank & Bankhaus Lampe Strong interest and background in ESG |
On track to master also pandemic challenges
Guidance 2020
| 1 | Good top line growth |
Total Group revenues expected to range from € 440 – 480 m, despite loss of € 20 m subsidy from Sanofi, and certain COVID-19 challenges1) |
|---|---|---|
| 2 | Strong EBITDA | Adjusted Group EBITDA2) expected to be in the range of € 100 – 120 m, at comparable level as in 2019, despite loss of € 20 m subsidy from Sanofi, significant ramping up J.POD® capacities, and certain COVID-19 challenges |
| 3 | Focused R&D investments |
Unpartnered Group R&D expenses of approx. € 40 m3) |
1) Given current global insecurities, a likely negative impact from the ongoing Corona pandemic is already estimated within the introduced guidance for revenues and adjusted EBITDA
2) Before contingent considerations, income from bargain purchase & excl. impairments on goodwill, other intangible & tangible assets as well as the total non-operating result
3) Evotec focuses its guidance and upcoming reporting on the "unpartnered R&D" part. ID-related R&D expenses will be fully reimbursed by its partner Sanofi ("partnered R&D").
Upcoming important dates
Financial calendar 2020
| Annual Report 2019 | 26 March 2020 |
|---|---|
| Quarterly Statement Q1 2020 | 14 May 2020 |
| Virtual Annual General Meeting 20201) | 16 June 2020 |
| Half-year 2020 Interim Report | 12 August 2020 |
| Quarterly Statement 9M 2020 | 12 November 2020 |
1) Invitation went out on May 6; the entire annual general meeting, will be live-streamed (audio and video) for shareholders and their representatives via a passwordprotected internet service; all further information available on the Evotec website under https://www.evotec.com/en/invest/annual-general-meeting
Your contact:
Dr Werner Lanthaler Chief Executive Officer
+49.(0).40.560 81-242 +49.(0).40.560 81-333 Fax [email protected]