AtCor Medical ASX:ACG

Transcription

1 AtCor Medical ASX:ACG Business Update July 2013 Duncan Ross CEO Peter Manley CFO 1

2 Investment t Summary ASX Code: ACG Ordinary Shares on Issue:150.7m Market $0.073: $11.0m Enterprise Value (30 Jun 13): $8.1m Options on Issue: 22.6m (price range $ $0.21) 52 week share price range: $ $0.135 Average daily share volume (2013): 0.415m FY13 Product Revenues: $9.0m (unaudited) Cash 30 Jun: $2.9m Employees: 31, 13 in US including Group CEO Corporate & Manufacturing Headquarters: Sydney, Australia 2

3 Core Technology - SphygmoCor the global gold standard in non-invasive central (aortic) blood pressure testing and measures of arterial stiffness AtCor s platform and core product offering is called SphygmoCor, a point of care (clinician office) device allowing for the early detection of cardiovascular risk and management of cardiovascular disease. Prior to SphygmoCor development these measures were only available by an invasive catheter into the heart Central aortic blood pressure has been found to be superior to brachial pressure as a predictor of cardiovascular events including stroke, heart attack and kidney disease, and provides valuable insight into anti-hypertensive drug selection and management. Traditional cuff measures of blood pressure can provide inaccurate or misleading information on the effects of drugs on the central pressure, the pressure on the central organs such as the heart, brain, and kidneys. SphygmoCor is cleared for sale in all major global markets. >3,200 systems installed globally with > 700 peer reviewed publications and >1, citations Used in all 18 hospitals in US News and World Reports Best Hospitals Honour Roll Common Procedural Terminology Reimbursement (CPT) code III in effect from 1 January 2013 in USA. 3

4 SphygmoCor Explained Capturing a Waveform SphygmoCor XCEL Designed to replicate standard blood pressure testing (e.g. doctor s office) Proprietary Transfer function Derives Central Pressure Waveform from Periphery Brachial plus central BP in under sixty seconds 4

5 Targeting Four Distinct t Market Segments..Annual global market potential US$500m Clinical Specialist Cardiologists, Hypertension, Nephrologists (kidneys), Endocrinologists (diabetes) Academic-based specialists Only 0.9% penetrated to date. Clinical - Primary Care GP s, internists, executive health, wellness centres, etc. Future market opportunity. Clinical - specialist $100m Clinical - primary care $268m Pharma trials $110m Pharmaceutical trials Cumulative 5 year sales $23m or approx. 5% of potential Research $22m Research - Academia Universities & Hosp. Affiliated 11% market penetration Current served market US$232m * Early Days-Big Runway Ahead! * i.e. all sectors except Clinical primary care 5

6 Fiscal 2013 Company Highlights Financial Full year sales approx. $9.0m (unaudited) 40% growth pcp Record sales for Pharma trials, USA Research and USA Clinical Cash flow positive for 4 consecutive quarters Cash balance now $2.9m, an improvement of $1.8m Reimbursement CPT code (0311T) effective from 1 Jan 2013 Product US FDA clearance for next generation product-xcel Approved in Europe, Australia and selected Asian countries Joint development of new product with SunTech Medical well underway Intellectual property New study strongly supports measurement of central pressures reported in April new studies published last 12 months that used SphygmoCor 2 patents granted in last 12 months another in progress 6

7 Financial i Performance FY2013 Cash Flow Statement (A$ 000) 4Q13 FY13 FY12 Cash flows from operating activities Receipts from customers 2,549 8,551 7,108 Payment to suppliers and employees (1,970) (7,983) (8,851) Other income (grants, R&D tax etc) 79 1, ,778 (1,182) 182) Cash flows from investing activities Payments for P,P&E (10) (60) (392) (10) (60) (392) Cash Flows from financing activities Net proceeds from issue of shares, etc - (14) (14) 932 Net increase (decrease) in cash and equivalents 648 1,704 (643) Cash and equivalents at beginning of period/year 2,167 1,117 1,714 Effect of FX rate changes Cash and equivalents at end of year 2,874 2,874 1,117 7

8 Objective a self-sustaining business Profitable and cash flow positive Opportunity In Feb 2011 AtCor identified 4 pillars on which to focus to ensure underlying goal of building a self-sustaining business. Four Pillars Commercialise an easier to use cuff-based device Drive US reimbursement gives access to large US clinical market Pharmaceutical expansion Leverage our technology and IP assets 8

9 Pillar 1 - SphygmoCor XCEL Develop & launch easier to use cuff based device New SphygmoCor XCEL product augments current offering expanding breadth Augments current portfolio-sphygmocor EM series Two follow on releases of SphygmoCor XCEL planned to expand functionality & market reach Key milestones & metrics in product launch Launched at European Society of Hypertension (ESH) meeting in London, May 12 US FDA clearance Nov 12 Cleared for sale in USA, Europe, Australia and selected Asian countries Customer response to enhanced ease of use extremely positive Registration applications active in China, Korea, Canada, Mexico. 9

10 Pillar 2 Reimbursement Historical timeline Successfully secure a CPT code covering SphygmoCor test Timeline & Process 2010 & 2011 Work with KOL s and US Renal Physicians Association (RPA) to prepare for code application November RPA files formal CPT code application to AMA (American Medical Association) January RPA notified that t code application accepted for review February RPA presents code application at AMA CPT advisory panel meeting March RPA notified by AMA that category III CPT code will be awarded From August 2012 AtCor & KOL s begin meeting with payers medical directors Educate on code & SphygmoCor test Establish test utilisation patterns Negotiate coverage & reimbursement rates for health plans Jan 2013 CPT Code becomes effective for coding test and filing for reimbursement Physician claims submitted under Category III code RPA Files for CPT 1 -Target is 24 months 10

11 Pillar 2 - Reimbursement Aligning critical resources for success AtCor Medical Coordinate activities, execute strategy to assure transition to CPT Category I code at earliest possible date KOLs / Advocacy Include thought leaders, experienced researchers with clinical interest and associations NMA (National Medical Association-health disparities) Collaborate on best practices for clinical implementation Conduit to carrier medical directors CPT STRATEGY Renal Physicians Association (RPA) Aligned & supporting strategy,corporate patrons program advocacy NCAP (Nephrology coverage advocacy committee) advocacy March 2013 best demonstrated practices for clinical implementation SphygmoCor symposium at annual meeting Consultants Advise on geographic prioritization, messaging, relationships Coordinate advisory of former medical directors 11

12 Pillar 2 Reimbursement Key tactics to build foundation for Category I code Targeting Medicare Regions Private payers follow Medicare s lead 11 regions in total covering 47.5m lives (2010 census data*) Estimated 58%** of Medicare patients with Hypertension-highest clinical & economic value Key criteria - percentage of covered lives that can utilise technology (rather than total covered lives) Which regions-medicare contractors? Primary target-two large regions covering ~14m lives* Secondary target-regions regions covering ~6.5m lives Why these regions? Align with geographic concentration of installed SphygmoCor base Strong KOL support & relationships with local Medicare e carrier Medical Directors * ** gov/research-statistics-data-and-systems/statistics-trends-and-reports/chronic-conditions/downloads/2012chartbook and Systems/Statistics and Reports/Chronic Conditions/Downloads/2012Chartbook.pdf 12

13 Pillar 2 Reimbursement Key tactics to build foundation for Category I code Objective to secure minimum of 2 region wide coverage decisions with negotiated reimbursement rate for code Easiest path for physicians Operates in geography just like a Category 1 code would - fully automated Ensures optimum number of users to support Category 1 application Process Physician plays primary role Initiates billing with new code & appeals any non coverage ruling to carrier Writes justification for coverage to carrier MD with supporting clinical evidence Request to remove code from non coverage list - first step Removal from non coverage does not guarantee payment but opens door for step 2 With increased support, billings, appeals Medicare carrier understands there is demand for test Door is open to negotiate region wide reimbursement rate and automate 13

14 Pillar 3 Pharmaceutical trials expansion Pharmaceutical clinical trials AtCor continues to build on its reputation as best in class provider of both technology and data management and site support services for pharmaceutical clinical trials Focus remains on ease of use and data quality maximization i through h product and Data Management systems innovation Clinical trials equipment and product development partnership pwith SunTech Medical positions AtCor as the blood pressure core lab >30 pharma trials complete or in progress as of 30 June 2013 Total cumulative pharma trials subjects enrolled: >9,500 Potential deal pipeline opportunities under management - US$13.6m 14

15 Pillar 3 Pharmaceutical trials expansion Pharma revenue trend $7.0 $6.0 $5.0 $4.0 $3.0 $2.0 $1.0 $0.0 Pharma revenue by year (US$M) 1st Half 2nd Half Opportunities under management - US$13.6m 15

16 Pillar 3- Pharmaceutical trials expansion Initiatives and focus assure growth Expand pharma segment selling resources Drive client penetration Broaden reach (clients and drug classes) Significant time investment in market development over past 8 months-now harvest! Focus on key value drivers: our people and the quality of our services The product being sold is clinical trial data, the output of the process, so data management quality and expertise are key differentiators SphygmoCor XCEL (new product) shifts the competitive balance further as enhanced ease of use increases clinical trial throughput and reduces cost Assure status as best innovator in product and service Product development/evolution l ti (SphygmoCor XCEL and follow-on products) Continued innovation in data handling and efficiency of QA Continue to assess options for expanding breadth of offering in trials 16

17 Pillar 4 Leverage Technology and IP SphygmoCor is a platform technology What have we been working on? New Alliances Expanding Technology to new applications Complementary IP Clinical studies-advance market up take & clinical reimbursement 17

18 Pillar 4 Leverage Technology & IP SphygmoCor is a platform technology New Alliances Strengthen & expand our focus markets (pharmaceutical & clinical specialists) Alliance with SunTech Medical for jointly developed, branded and marketed product with unique reconfiguration of SphygmoCor technology to launch < 12 months Marketing alliance (new) with Xion Medical, Inc (US urology disease management company) to market SphygmoCor to urology specialists 18

19 Pillar 4 Leverage Technology & IP SphygmoCor is a platform technology AtCor as OEM technology supplier SphygmoCor in High-end Self- testing Alliance with Young at Heart B.V. for high end self testing market announced June 12 Technology integrated and pilot study underway SphygmoCor in Cardiac Rhythm (pacemaker) Management New AtCor IP secured Field pilot studies with partner to begin in September While not assured, success here could be a game changer! SphygmoCor in cerebral vascular and intensive care medicine Working with Macquarie University on development and application, including IP Parallel commercial investigation with European based device company 19

20 Pillar 4 Leverage Technology & IP SphygmoCor is a platform technology New IP & Clinical Studies AtCor retains 8 commercially relevant patents in multiple geographies with 2 granted since 2011 Optimisation for Pacemaker settings granted in 2012 Method and Apparatus for determination of central aortic pressure granted in 2013 Other patent applications under review or in development SphygmoCor in clinical studies Well in excess of 700 peer reviewed publications supporting SphygmoCor as Global Gold Standard 153 such publications in fiscal 2013 alone Important, commercially relevant studies for clinical adoption to report in fiscal 2014 (heart failure management, hypertension management/drug selection, meta analysis) 20

21 Key Milestones FY14 Building momentum-delivering on commitments Continue to enhance financial strength Continue cash flow & earnings positive Currently US$20.2m in sales opportunities under management Grow Pharma business & diversify customer base Currently US$13.6m in sales opportunities under management Harvest opportunities from strong business development & diversification focus Launch new products and market segment presence New product developed with SunTech Medical to launch by fiscal year end Sales in new market segments e.g., high-end self testing and urology 2 Medicare Regions contracted t Build foundation for Category 1 code application 21

22 Key Milestones FY14 Building momentum-delivering on commitments Advance New Business & IP Development Complete pilot studies in cardiac rhythm management, plan steps to market launch Complete cerebral vascular feasibility studies with European partner Implement new central aortic pressure IP Key Scientific Studies Expected to be Published in the Coming Year Joint Heart Failure study with the Mayo Clinic and Uni Arizona. Demonstrate improved heart function and reduced care costs BP Guide use of central pressure, to manage HTN patients t improves patient t care and reduces costs. Central vs. brachial pressure in CV risk assessment; Meta-Analysis. >22,000 patients Successful completion of these studies will further demonstrate the superiority of utilising central pressures to manage high cost disease states through improved clinical and economic outcomes and improved patient quality of life 22

23 Summary Cash Flow and Earnings Positive Core Focus- Pharma & Clinical Specialist Markets Key Alliance Partners for Core Markets & OEM True Platform Technology $US 500m Annual Market Opportunity-Massive Runway Delivering On Commitments 23

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