Commercializing Precision Testing: 2020 An introduction to investors 40MG ? + EGFR PD-1 PD-2 TEST TEST Better testing. Better treatment.
Introduction Precision Testing Disclaimer The information contained in this presentation document (the “Presentation”, which term includes any information provided verbally in connection with this presentation document) does not constitute an Contents offer or solicitation to hold, sell or invest in any security and should not be considered as investment advice or as a sufficient basis on which to make investment decisions. This presentation is being What we do provided to you for information purposes only. The Presentation may contain forward-looking statements. These statements relate to the future What is Precision Medicine? prospects, developments and business strategies of Diaceutics PLC. Forward-looking statements are identified by the use of such terms as “believe”, “could”, “envisage”, “estimate”, “potential”, “intend”, Market Opportunity “may”, “plan”, “will” or the negative of those, variations or comparable expressions, including references to assumptions. The forward-looking statements contained in the Presentation are based on NSCLC Closer Look -Patient Pathway - Data current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by those statements. If one or more of these risks or Examples -Current Services -Nexus- uncertainties materialises, or if underlying assumptions prove incorrect, the Company’s actual results may vary materially from those expected, estimated or projected. Given these risks and uncertainties, Introduction and Functions potential investors should not place any reliance on forward-looking statements. These forward-looking statements speak only as at the date of the Presentation. The Company is under no obligation to, and Financial Overview expressly disclaims any intention to, update or revise such forward-looking statements, estimates or projections. The Company, its directors, officers, partners, employees or advisers do not accept or resume responsibility to any person to who this document is shown or into whose hands it may come, and any such responsibility or liability is expressly disclaimed. 2
What we do What we do Diagnostics Commercialization Platform Key statistics 2500 Laboratories Pharma needs: Diaceutics benefits: 35 top Pharma clients Diagnostic testing is required for precision Average 30% revenue growth for last 5 years therapeutics Profitable and cash generative since inception 400+ project launched Multi country installation of better testing in Normalised EBITDA 20%+ Labs to drive treatment 120M patients in data lake Majority employee owned – Reduced time to peak sales and reduced Personalised therapeutic test market expected to 500k patients better tested complexity of testing for doctors grow to $2.5bn in 2023 High ROI for precision test/ therapy 110 employees in 19 countries investments (2019) Some of the companies in Precision Medicine today Successful IPO on LSE 2019 £18M raised 3
What is Precision Medicine? Precision Testing Data analytics and implementation services for major pharmaceutical What is precision companies medicine? Precision Medicine (PM) is a medical model that proposes the customization of healthcare, with medical decisions, practices, and/or products being tailored to the individual patient In oncology this is implemented primarily through the use of biomarker tests to identify the patients that are most likely to benefit from a targeted therapy Goal of Precision Medicine in oncology is to identify: The right patient, for the right therapy, at the right time 4
Market Opportunity Precision Testing ONCOLOGY TOTAL AVAILABLE MARKET 2030 Total Patient diagnostic journey to treatment for all therapies Multi sided market – transformative collaborations Market Opportunity :$25bn Key Precision Medicine Drivers Doubling by 2026+ SERVICEABLE MARKET 2021- 2025 300 test dependent therapy brands rolling out over all key treatment Pharma commitment markets globally towards PM moving from - $10m per brand 10% to 80% of pipeline Mkt Opportunity: $2.5bn pa TODAYS TARGET MARKET 150 test dependent therapy brands FDA PM drug approvals moving from needing to eliminate testing hurdles 20% in 2015 to 50% in 2020 at launch - $1.5m per brand Market Opportunity : $250m pa DATA COMMERCIALIZATION 5
Todays Business Model Case Study Example in NSCLC Precision Testing 16 Non small cell lung carcinoma Number of brands in $13.4 M accountable for Diaceutics has development that Diaceutics has 11.6% 1 of the worlds supported diagnostic Diaceutics has worked with 25 cancer burden and is commercialization in supported with data therapy brands in the leading cause of Total revenue gained $2.5B the following alone NSCLC leveraging cancer related deaths from NSCLC (USD) 71% countries the following 2 biomarkers 20 Incidence PD-L1 Potential value ($B) US Of the NSCLC EGFR of additional revenue ~230k population are BRAF based on Diaceutics Number of on market 1.1M covered in the ALK support in removing brands Diaceutics EUROPE biomarker driven NTRK barriers to testing in continually supports ~210k assets Diaceutics has KRAS NSCLC with data and supported total number of RET commercialization China patients globally MET ~600K impacted by TMB Diaceutics 6 Diaceutics has supported from development to on market 6
NSCLC Patient Pathway Precision Testing NSCLC 235,000 New Patients Diagnosed Only 35% Patients Access Per Annum Precision Therapy 1- 4.5 years Dx Journey i Data 1 st visit Refers to NSCLC and Biopsy flows subtype diagnosed Thoracic Surgeon / Predictive tests to Patien PCP or ED LAB specialis radiologist inform therapy t Pathologist t Biopsy/ Lung ALK Imaging Biopsy cytology EGFR Oncologist function ROS1 test Therapy decided PD-L1 EBUS CT NTRK H+E medical TBNA ultrasound TMB IHC stains exam X-ray CNB BRAF Patient starts treatment Re-biopsy or liquid 1 ST PM Therapy biopsy Outcome Value of Managing Patient Pathway Progression in solid No Therapy 100 tumor response response 80 % of Patients Monitoring 5 year Survival 60 Resistance Monitoring Death 40 Liquid biopsy Imaging Molecular genetic 20 testing 2 ND PM Therapy 0 Phase 1&2 Phase 3&4 ALK, EGFR, ROS1,PD-L1, NTRK, TMB, BRAF: biomarkers; CNB: Core Needle Biopsy; CT: Computerized Tomography; EBUS: Endobronchial Ultrasound; ED: Emergency Department; H+E: Hematoxylin+Eosin stain; IHC: immunohistochemistry; NSCLC: Non-Small Cell Lung Cancer; PCP: Primary Care Practitioner; TBNA: Transbronchial Needle Aspiration.
Diaceutics Datalake: NSCLC Precision Testing Key Metrics % Testing rates in NSCLC Distribution of top 30 NSCLC labs by market share ▪ Patient demographics 100% ▪ Treating physician 80% ▪ Test ordering physician 60% ALK ▪ Test performing physician 40% ▪ Longitudinal testing journey EGFR 20% ▪ Time sample booked into lab PD-L1 0% ▪ Tests ordered Q2'13 Q4'13 Q2'14 Q4'14 Q2'15 Q4'15 Q2'16 Q4'16 Q2'17 Q4'17 Q2'18 Q4'18 Q2'19 ▪ Test result ▪ Test reimbursement ▪ Patient co-pay amount N of new N of treating HCPs N of treating HCPs ▪ Test report patients per N of labs newly diagnosed overall annum ▪ Methodology/technology ▪ Instrument/assay 110,000 2,967 labs 10,889 HCPs 36,448 HCPs ▪ Rejection reasons ▪ Sample requirements Leakage ≈ 57% ▪ CPT codes used N=1000 ▪ Testing performed in-house or send-out ▪ Laboratory performing test ▪ Test turnaround time (TAT) N = 427 ▪ Test failures (QNS Rates) 8
Nexus Precision Testing Networking all the key stakeholders on a platform Diagnostic Commercialization Platform "Nexus” is a DIAGNOSTIC COMMERCIALIZATION PLATFORM, implemented as a software platform. It allows its multiple end users, to oversee and coordinate all aspects of diagnostic testing that is relevant to a particular therapeutic or disease pathway. 9
Finance Precision Testing Revenue analysis Sales analysis Product units FY18 FY19 FY18-FY19 Data & Analytics 80 94 18% Key Points - YOY variance Implementation services 45 53 18% Total 125 147 18% Revenue £13.4m increase 29% Revenue £000 Data & Analytics 8,061 9,685 20% Clients 31 increase 19% Implementation services 2,312 3,718 61% Brands 53 increase 71% Total (GBP) 10,373 13,403 29% EBITDA £2.2m Average price per project* ASIA REGION REVENUE £000 1,900 Cash £11.7m £'000s FY18 FY19 FY18-FY19 Data and analytics 98 108 10% Revenue mix - Data - Services Implementation services 60 69 15% Total products average 83 92 11% "Real world evidence has seen a rapid increase in Brand engagement applicability to healthcare as part of the big data boom" UNITS FY18 FY19 FY18-FY19 Brands contracted in period 31 53 71% 28% Data & Analytics Deloitte 2020 JPM Brands carried forward 15 18 20% % of brands carried forward 45% 58% 28% Implementation 400 72% services High rollers £'000s FY18 FY19 FY18-FY19 Merck 1,101 1,568 42% Novartis 828 1,522 84% 2018 2019 Astellas 281 1,058 277% Astra Zeneca 935 1,038 11% Bayer 946 1,027 9% 10 Janssen 535 961 79% The 2019 figures are subject to Audit Ely Lilly - 780 100% GSK - 775 100%
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