Announcement PDF ASX Announcement 07/06/2021 Emyria data validated, care model reduces opioids, opening new opportunities Highlights: ● Analysis of large drug community dispensing data shows a significant reduction in opioid use following commencement of a personalised treatment program involving cannabinoid medicine at Emyria’s Emerald Clinics ● Opioid prescription dispensing data provided by IQVIA (NYSE: IQV) and NostraData validates the quality and utility of Emyria’s proprietary clinical data ● The data show that, on average opioid consumption reduces after commencing care at Emerald Clinics from a previous 12 month steady-state of opioid-use ● Opioid abuse continues to be a major health issue worldwide, with nearly 50,000 people dying per year in the USA alone from opioid-involved overdoses [1] ● Emyria will further and deeply analyse the data to assess potential for new registered treatments with the FDA for opioid-sparing[AV1] . ● Emyria to present data to health insurers and payers for increased clinic and patient funding and expansion support for better health outcomes and potential health economic benefits ● Emyria has engaged Professor David Preen, Chair of Public Health at UWA and Chief Investigator for the Centre of Research Excellence in Medicines Intelligence to continue independent research on Emyria Data [2] ● Emyria to continue investment in care model innovation and proprietary, software-powered clinical decision support tools backed by Emyria Data Emyria Limited (ASX: EMD) (Emyria or the Company), a data-backed treatment development and clinical services company, is pleased to share preliminary results of an engagement between Emyria, IQVIA and NostraData. Emyria Managing Director and CEO, Dr Michael Winlo, will present these findings on Monday, June 7th 2021 at the Annual National Summit of the Association of Regulatory and Clinical Scientists (ARCS). The ARCS presentation covering the first phase of analysis accompanies this ASX release. Emyria engaged the Real World Evidence (RWE) analytics team of IQVIA - a $44B contract research organisation - and NostraData, to validate Emyria’s medication tracking data and build comparison patient cohorts. Comparison cohorts can be used as external controls and improve the analysis of Emyria’s care models and drug development programs. 1 Emyria’s Managing Director, Dr Michael Winlo, said: “I’m very pleased to present the early findings of a world-first data-linkage project combining Emyria’s clinical data with prescription drug dispensing data from partners IQVIA and NostraData. This project allowed us to understand the historical opioid usage patterns of our patients in the 12 months prior to receiving personalised care at our Emerald Clinics through an anonymous matching process. The analysis shows that patients receiving personalised care at Emerald Clinics reduce their opioids substantially while also gaining improvements in pain symptoms and quality of life measures. Importantly, the analysis demonstrates both the validity, reach and richness of Emyria Data assets as well as the effectiveness of Emyria’s Care programs. Emyria has engaged academic partners to continue independent research and will further analyse the data for intellectual property, potential treatments for the USA and the development of proprietary clinical decision support software tools.” Figure 1. Average oral morphine equivalent daily dose (OMEDD) scores for Emyria patients 12 months before and 12 months during care. The company expects to produce further reports on the data analysis in due course. This announcement has been approved and authorised by the Board of Emyria Limited. For further information on Emyria: Dr Michael Winlo Managing Director (08) 6559 2800 mwinlo@emyria.com Lexi O’Halloran Investor Relations + 61 (0) 404 577 076 lexi@janemorganmanagement.com.au Andrew Williams Media Relations +61 (0) 412 614 125 andreww@profilemedia.com.au REFERENCES [1] https://www.cdc.gov/mmwr/volumes/70/wr/mm7015a1.htm [2] https://newsroom.unsw.edu.au/news/health/new-centre-monitors-medicine-use-and-safety 2 Investor Webinar Emyria’s Managing Director and CEO, Dr, Michael Winlo will present an overview of today’s release “EMD’s care model reduces opioid use” and provide the latest preliminary results of a collaboration between Emyria, IQVIA and NostraData. Details of the event are as follows: ● ● ● ● Event: Emyria Investor Webinar Webinar Presenter: Emyria’s Managing Director, Dr, Michael Winlo Date and Time: Tuesday 8 June 2021, 11:45am AEDT Where: Zoom Webinar - details to be provided upon registration To register your interest in the webinar please click through to the link below. Registration Link: https://janemorganmanagement-au.zoom.us/webinar/register/WN_qCzy0GPsT0ivAYi4RgjLVw After registering your interest, you will receive a confirmation email with information about joining the webinar. Participants will be able to submit questions via the panel throughout the presentation, however, we encourage shareholders and investors to send through questions via email beforehand to Lexi O’Halloran at: lexi@janemorganmanagement.com.au About Emyria (www.emyria.com) Emyria Limited is a data-backed, drug development company. Emyria’s Treatments target unmet needs and are focused on obtaining approval from major global regulators. Emyria’s drug development programs are informed by insights generated from extensive analysis of Emyria Data - deep, ethically-sourced clinical evidence that is gathered with patients across Emyria’s independent clinical services (Emerald Clinics - www.emeraldclinics.com.au) Emyria Data provides deep treatment insights and is therefore a source of unique IP, strategically designed drug development and personalised care programs. Emyria’s first drug development program, EMD-003 is targeting unmet needs in mental health. Specifically psychological distress and the symptoms of anxiety, depression and stress. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, the company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for its product candidates. In addition, the forward-looking statements included in this press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. 3 Innovation in Real World Evidence: Pioneering new frontiers Bridging the clinic to the community Dr Michael Winlo, Managing Director, Emyria Disclaimer and notices This presentation has been prepared by Emyria Limited ACN 625 085 734 (Company or Emyria). This presentation is not a financial product or investment advice or recommendation, offer or invitation by any person or to any person to sell or purchase securities in Emyria in any jurisdiction. This presentation contains general information only and does not consider the investment objectives, financial situation and needs of individual investors. Investors should make their own independent assessment of the information in this presentation and obtain their own independent advice from a qualified financial adviser having regard to their personal objectives, financial situation and needs before taking any action. No representation or warranty, express or implied, is made as to the accuracy, completeness, reliability or adequacy of any statements, estimates, opinions or other information, or the reasonableness of any assumption or other statement, contained in this presentation. Nor is any representation or warranty (express or implied) given as to the accuracy, completeness, likelihood of achievement or reasonableness of any forecasts, prospective statements or returns contained in this presentation. Such forecasts, prospective statements or returns are by their nature subject to significant uncertainties and contingencies, many of which are outside the control of Emyria. To the maximum extent permitted by law, Emyria and its related bodies corporate, directors, officers, employees, advisers and agents disclaim all liability and responsibility (including without limitation any liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use or reliance on anything contained in, or omitted from, this presentation. An investment in Emyria securities should be considered speculative and is subject to investment and other known and unknown risks, some of which are beyond the control of Emyria. Emyria does not guarantee any rate of return or the absolute or relative investment performance of Emyria securities. The distribution of this presentation including in jurisdictions outside Australia, may be restricted by law. Any person who receives this presentation must seek advice on and observe any such restrictions. This release may contain certain forward-looking statements with respect to matters including but not limited to the financial condition, results of operations and business of Emyria and certain of the plans and objectives of Emyria with respect to these items. These forward-looking statements are not historical facts but rather are based on Emyria's current expectations, estimates and projections about the industry in which Emyria operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates", "guidance" and similar expressions are intended to identify forward looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of Emyria, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward looking statements. Emyria cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Emyria only as of the date of this release. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Emyria will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. Presentation release authorised by Michael Winlo, CEO and Managing Director Tensions between Care + Research: ARCS Summit 2021 Tensions between Care + Research: Care of individual PURPOSE Systematic investigation ARCS Summit 2021 Tensions between Care + Research: Exercise of profession DECISION-MAKING Adherence to protocols ARCS Summit 2021 Tensions between Care + Research: Inclusive PARTICIPATION Exclusive ARCS Summit 2021 Tensions between Care + Research: Required but… variable quality DOCUMENTATION Good clinical practice (GCP) ARCS Summit 2021 Tensions between Care + Research: Advancing the frontier ARCS Summit 2021 Emyria creates registered treatments for under-served populations using our proprietary clinical evidence “Emyria owns clinics, cares for patients, invests in technology, generates data, creates evidence and develops programs to accelerate the registration of new treatments, including our own.” Dr Michael Winlo, MD and CEO DRAFT ARCS Summit 2021 Creates Informs • Access to patients & clinicians • Data capture technology Emyria Care • Ongoing patient monitoring & evaluation Emyria Emyria data Emyria • We learncare from every • In-house analytics • Clinical trial & drug registration expertise patient to improve care Informs Treatment development Data informs Accelerates ARCS Summit 2021 Emyria Care Emyria Data Emyria’s current treatment development programs Mental health - CBD medicine - Entering clinical outcomes studies - Seeking Schedule 3 registration EMD-003 Emyria data Emyria care • 7 sites around Australia • GCP-trained clinical team • 4,000 patients and growing • Patients aged 2 - 96years • Over 40 clinical indications • Validated assessments • Clinical-trial-grade data • Millions of data points • Unique dose response insights • Source of IP Others - Irritable Bowel Syndrome (EMD-004) informs - Chronic Pain EMD-00X ARCS Summit 2021 Emyria patients: Primary indication seeking care Mental Health • Insomnia • PTSD • Anxiety disorders 12% Chronic Non-Cancer Pain • Neuropathic • Inflammatory • Mixed • Migraine 66% 9% 6% 8% Cancer symptoms • Pain • CINV • Anorexia Neurological disorders • Dementia • Multiple Sclerosis • Parkinson’s Disease • Epilepsy Other • Irritable Bowel Syndrome • Inflammatory Bowel Disease • Fibromyalgia • Alcohol and other drug abuse ARCS Summit 2021 Chronic pain patients at Emyria • Age 60.1 years (SD 17.01) • FT work 19% • Gender: 61.4% female • CNCP: • Poly-pharmacy • opiates: • synthetic 49.3%, • non-synthetic 77.3% • Neuropathic (55.9%), • paracetamol 74.4% • Inflammatory (5.6%), • antidepressants 54.7% (including duloxetine, amitriptyline) • Mixed (30.6%), • anticonvulsants 35.8% (pregabalin, gabapentin, valproate) • “other” (7.9%) • benzodiazepines 38.8% • >2 years 90% (>5 yrs 63%) • Multi-morbidity • Interventions 38.4% • facet joint injections 39.8% • Insomnia 76.1% • cryorhizotomies 21.7% • OA 45.1% • surgery 34.6% • MH disorders 43.1% • GI disorders 35.4% • others 42.1% • Recent cannabis use 15.1% ARCS Summit 2021 Emyria’s chronic pain care model: Detailed patient consent Regular, in-depth assessments and reviews to measure what’s working Personalised treatment schedule - informed by our data and the prior experience of similar, “patients like you” ARCS Summit 2021 Case Study - Bob • Vietnam Veteran | injured by fall in 1969 | multiple fractures • Chronic back pain | peripheral neuropathy from Agent Orange | PTSD • At initial visit: oxycontin | buprenorphine | pregabalin | gabapentin | PEA duloxetine – with little relief and side effects. • Now: Stable at 15mg 1:1 THC/CBD | ceased all opiates, pregabalin and PEA Scores Initial assessment Visit 5 BPI Pain severity score 5.0 1.75 BPI Pain interference score 5.29 0.86 Visual analogue scale 5.0 1.0 Insomnia severity score 12.0 1.0 DASS 42 Depression 14 4 DASS 42 Anxiety 16 2 DASS 42 Stress 16 12 ARCS Summit 2021 Opioid use disorder: Massive global problem Opioids for chronic pain Australia USA The U.S. economic cost of opioid use disorder ($471B) and fatal opioid overdose ($550B) during 2017 totalled $1,021 billion. [1] [2] Sources: [1] https://ndri.curtin.edu.au/news-events/ndri-news/media-release-the-cost-of-opioid-use-to-australia [2] https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates [3] https://www.cdc.gov/mmwr/volumes/70/wr/mm7015a1.htm [3] We need more effective, evidence-backed treatments ARCS Summit 2021 CASE STUDY: How effective is Emyria’s unique care model at reducing opioid use*? * measured via average oral morphine equivalent daily dose (“OMEDD”) DRAFT ARCS Summit 2021 Emyria Care: OMEDD Results over 6 months (n=503) High. >90mg/day 34.2% reduction (p-value <0.0001) Moderate 40-90mg/day Low <40mg/day 33.1% reduction (p-value 0.01) Patients also reported: - Decreased pain severity + interference - Improvements in psychological distress and quality of life (QoL) 25% reduction ARCS Summit 2021 Emyria Care: Questions? Q2: - What is the OMEDD trend of our patients, “before” they receive Emyria Care? Q1: - Can we validate our findings with external, third-party Real-World Evidence? Q3: - What happens to patients once they stop treatment? - Can we make a control? ARCS Summit 2021 The TEAM! • NostraData collects dispensed prescription data from over 4,500 retail community pharmacies across Australia • Using special technology, NostraData can safely and securely collect the cleanest and most accurate data in the industry • NostraData can then load, cleanse, map, stack and rack the data in visually stunning reports and datasheets • IQVIA is a global (NYSE: IQV) biopharmaceutical development company focussed on Phase I-IV clinical trials, laboratory and analytical services • IQVIA Real World Solutions enables customers to generate and disseminate real world evidence to answer crucial questions • IQVIA has a network of more than 70,000 employees in more than 100 countries ARCS Summit 2021 Linking the DATA: Is it RESEARCH-GRADE? Source verification (can you trust it?) Data quality Completeness (QMS) (can you use it?) Standards (can you link + generalise results?) Patient consent (are patients involved? Can you share data?) Data Governance De-identification process (is privacy protected?) Secure transfer + tracking (can you manage cyber risk?) ARCS Summit 2021 STEP 1: LINK THE DATA Data Patients provided by Emyria 1029 patients Patients found with Master Patient IDs in ND 1020 patients Patients with more than 1 visit LRx 786 patients Patients with at least 1 dispensation of analgesics (ATC N02) or opioids between the first visit +/- n days where n can be either 365 days or the cannabinoid treatment duration, whichever is the greatest. * * Ensures the ND panel captures dispensations of analgesics or opioids in the proximity of the first visit of each active patient. 711 patients Patients with analgesics dispensations for at least 50% of the months in the observation period 470 patients ARCS Summit 2021 STEP 2: BUILD AN OMEDD MODEL FOR LRx one-month lookback window Palexia SR 200mg 28 Regular opioids a a a b a b b b b d1 days Norspan patch 25mcg/hr 2 c c c c d2 days Tramadol SR 100mg 20 d d d d d d d d3 days Shortacting opioids Endone 5mg 20 Palexia IR 50mg 20 Time 1. 2. 3. 4. 5. Emyria Visit date Look back one month prior to the Emyria visit date. For each regular opioid dispensation, calculate the oMEDD score based on the SKU strength and the label instruction. The theoretical days of supply are calculated based on the number of packs dispensed and the daily dose decoded from the label instruction. As shown above, the blue rectangles and the letters represent the days of supply and the oMEDD scores respectively. If the label instruction does not give any useful daily dose (e.g. “Use as directed”), the most common day of supply for that SKU is used. For each regular opioid SKU, determine the longest span ended on the visit date, which are denoted as d1, d2 and d3 days above. The average oMEDD score for each SKU is calculated by dividing the sum of the scores within the span by the span in days. For the short-acting opioids, label instructions might not be indicative of the actual daily doses because patients are likely to use the drugs “when required”, e.g. Take two capsules four times a day when required. Therefore, a 30-day supply is assumed and the average oMEDD score is derived from the total mg dispensed divided by 30 days. Sum all the average oMEDD scores from all SKUs. ARCS Summit 2021 STEP 3: ANALYSIS oMEDD LRx vs oMEDD Emyria 3000 oMEDD LRx 2250 Correlation coefficient = 0.76 1500 750 0 0 250 500 750 1000 oMEDD Emyria ARCS Summit 2021 EARLY RESULTS - significant decrease in oMEDD Average oMEDD scores by oMEDD category (Pre vs Post) < 40 > 90 * 40 - 90 Patients with 6+ months of cannabinoid usage 260 260 Prior care 240 220 220 200 200 180 180 160 160 140 140 120 120 100 100 80 80 60 60 40 40 20 20 0 -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 Months since rst visit 4 5 6 7 8 9 10 11 12 0 Prior care -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 Months since rst visit * The oMEDD category is derived from the average oMEDD score over a 1-year period prior to the first visit. fi ARCS Summit 2021 fi oMEDD score 240 Patients with <6 months of cannabinoid usage Commentary + Take-Aways • Emyria’s personalised care model appears effective • INVEST IN DATA • People • Technology • Data governance • Emyria patients reduce opioid use against background of improving symptoms and Quality of Life (“QoL”) measures and this is sustained beyond 6 months • Emyria’s data has high validity • Demonstrated ability to link Emyria’s data to thirdparty sources securely to support robust analysis • Implications for future research, treatment and care model innovation • WORK WITH PARTNERS • IQVIA + NostraData • SCALE CARE MODEL • Approach payers • Continue to refine models to maximise benefit ARCS Summit 2021 What’s possible with research-grade data and what’s next? • Produce deeper analysis + publications • Cost and service utilisation analysis • Peer-reviewed publications • ENGAGED UWA • Create data-backed assets • Emyria will launch new Rx programs Prof. David Preen - Chair of Public Health at UWA - working on a coordinated research program to accelerate the development and translation of evidence about real-world medicine use and outcomes to improve the quality use of medicines and reductions in medicine-related harm. • Emyria is building clinical decision support tools • Develop innovative care models • Emyria to approach payers and insurers to present findings of model of care • Continuous refinement of care models to maximise benefit ARCS Summit 2021 Thank-you and QUESTIONS? DRAFT ARCS Summit 2021