For personal use only OSPREY MEDICAL INC EXECUTIVE SUMMARY Q1 2015

Transcription

1 OSPREY MEDICAL INC EXECUTIVE SUMMARY Q1 2015

2 Disclaimer This presentation has been prepared by Osprey Medical, Inc. ( Osprey or the Company ) for the sole purpose of providing general and background information on Osprey. This presentation does not contain all information necessary to make an investment decision. This presentation does not constitute an offer, invitation, solicitation or recommendation by any person to sell or apply for securities in Osprey in any jurisdiction, and none of this presentation document or its contents shall form the basis of any contract or commitment. This presentation is not intended to constitute legal, tax or accounting advice or opinion, or financial product advice and should not be relied upon as a representation of any matter that a person should consider in evaluating Osprey. You must not rely on the presentation provided but make your own independent assessment of the presentation and seek and rely upon your own independent taxation, legal, financial or other professional advice in relation to the presentation. This presentation does not take into account an your investment objectives, taxation situation, financial situation or needs. Osprey is not licensed to provide financial product advice in respect of its securities or any other financial products. Cooling off rights do not apply to the acquisition of Osprey securities. None of Osprey, its officers, directors, employees and agents, nor any other person makes any representation or warranty, express or implied, as to, or endorsement of, Osprey, the accuracy or completeness of any information, statements or representations contained in this presentation and none of them accepts any responsibility or liability for any errors or omissions in this presentation whatsoever. The information in this presentation is subject to change without notice and Osprey does not have any responsibility or obligation to inform you of any matter arising or coming to their notice, after the date of this presentation, which may affect any matter referred to in this presentation. The distribution of this presentation may be restricted by law and you should observe any such restrictions. This presentation contains certain forward looking statements which involve known and unknown risks, uncertainties, and other factors which may cause the actual results or performance of Osprey to be materially different from the results or performance expressed or implied by such forward looking statements. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward looking statements or other forecast. [All figures in the presentation are A$ thousands on a constant currency basis based on an exchange rates of A$ 1 : US$ [ ] unless stated otherwise and all market shares are estimates only. The pro- forma historical financial information included in this presentation does not purport to be in compliance with Article 11 of Regulation S - X of the rules and regulations of the US Securities and Exchange Commission. This presentation may contain certain financial data that is "non-gaap financial measures" under Regulation G under the U. S. Securities Exchange Act of 1934, as amended. The disclosure of such non-gaap financial measures in the manner included in this presentation would not be permissible in a registration statement under the Securities Act. These non-gaap financial measures do not have a standardised meaning prescribed by AIFRS and, therefore, may not be comparable to similarly titled measures presented by other entities, nor should they be construed as an alternative to other financial measures determined in accordance with AIFRS. Although we believe these non-gaap financial measures provide useful information to users in measuring the financial performance and condition of our business for the reasons set out in this presentation, you are cautioned not to placed undue reliance on any non-gaap financial measures and rations included in this presentation. ] AVERT System Regulatory Status: Europe CE Mark obtained; Australia TGA approval obtained; United States CAUTION Investigative device, limited by Federal (or United States) law to investigational use 2

3 Company Details Company headquartered in Minneapolis Technology developed by Dr David Kaye at Melbourne s Baker Heart Research Institute Key Corporate Data CDI price March 16, 2015: $0.58 CDIs on issue: 123,216,826 Market capitalization: $71.5M Cash (as at 31 December 2014): US$11.6m Protecting kidneys 3

4 Osprey Protecting patients kidneys from dye Heart and leg vessels imaging (x-ray) requires the injection of x-ray dye which is then cleared by the kidney 4

5 Kidney damage caused by dye - CIN Patients with poor kidney function (CKD) are at high risk of dye induced kidney damage (CIN) Over 25% of all patients receiving heart and vessel imaging are at risk of CIN CIN events lead to 22% in hospital mortality 1. CIN events can lead to kidney failure and dialysis NCDR Cath-PCI Registry Problem of CIN participating hospitals 985K PCI Patients analyzed for CIN CKD patients CIN risk is >20% CIN risk all patients ~ 7% Rihal, S, et. al. Incidence and Prognostic Importance of Acute Renal Failure after Percutaneous Coronary Intervention. Circulation. 2002; 105: Tsai, et al. JACC, Jan 2014, 1-9.

6 CIN Market Opportunity 7M patients annually in Western EU and the US undergo a heart or leg angiogram or stenting procedure Market opportunity CKD - 1.6M per year with a 20% occurrence of CIN Diabetes 1.2M per year with a 15% occurrence of CIN STEMI - 440K per year with a 15% occurrence of CIN 3.2M procedures per year in US and W. EU can benefit from AVERT 6

7 Current CIN Prevention Methods are Limited Current CIN preventative strategies have had limited impact: Extensive pre-procedure hydration Dye management: minimise dye volume usage low osmolar/iso-osmolar dyes Development of safer dyes not likely: Many previous attempts to develop safer dye Must follow drug development regulatory route costly and time consuming Other options have significant limitations: Drugs limited effectiveness in protecting kidney Hemofiltration expensive, commercially unviable Power injectors designed for large volume and timed delivery of dye 7

8 reducing dye dose to protect kidneys Protecting kidneys 40% dye savings Uncompromised image quality Please go to our website to see a video animation of the AVERT System at 8

9 Dye savings AND monitoring + Dye monitoring 9

10 Benefits of Dye Monitoring Real-Time volume threshold monitoring Accurate dye dosage documentation 10

11 Reducing dye, decreases CIN risk Source: Nyman, et al. Acta Radiolog. 2005;46: Pilot Data 40% dye savings, reflux reduction and. comparable image quality* 11 * Catheterization and Cardiovascular Interventions. 1 January 2014, Page: n/a, David M. Kaye, Dion Stub, Vivian Mak, Tuan Doan, Stephen J. Duffy Published Online : 7 JAN :28AM EST, DOI : /ccd.25348

12 Regulatory approval in place and strengthening Claim Controlled delivery of dye, strengthening. claims with post market clinical trial 12

13 Post market trial to upgrade FDA product label claims Straightforward trial design targeted to expand AVERT claims: Up to 60 trial sites across the US, Europe and Australia; 700 patients with advanced CKD undergoing angiography or stenting procedure; Randomized 1:1 (AVERT : Std Care); Efficacy measured at discharge and 72 hours after procedure; Patient follow-up out to 30 days post-procedure; Trial cost approx. US$6M-US$7M; and Trial on track for results in 3Q 2015 and FDA submission 4Q claims targeted from AVERT trial: Dye Savings Reflux Reduction Image Quality CIN Reduction Cost Savings 13

14 trial progress Hospitals approval hospitals approved to enroll patients hospitals in approval process Patient enrolment rate 1. Enrolment rate very strong result of new training & targeted site selection 2. Passed study midpoint, statistical power analysis expected in April

15 Trial Update Total Enrollment each Month Total Sites Activated Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 For personal use only 30 enrolled in the first 2 week of March Following statistical power analysis (April 2015): On track to complete trial mid 2015 Trial results to be reported 4Q 2015 Submit to FDA for enhanced claims 4Q

16 Reducing CIN saves money for hospitals and payers CIN is costly to Hospitals Additional 4 day (avg) hospital length of stay ($15K) Hospital acquired condition no additional reimbursement CIN is costly to Payers ~3% of CIN patients CIN end up on dialysis which costs >US$72,000 p/year CIN increases the risk of worsening heart and kidney function leading to further medical costs for governments and/or insurers 16

17 market opportunity 17

18 commercialization strategy With CIN reduction and cost savings claims in 2015 Worldwide launch following AVERT claims for CIN reduction and cost savings data At risk patients are channelled to large US hospitals; allows for a modest sales force of direct sales reps Current New Houston Sales rep hired First rep has demonstrated adoption and penetration in a focused market New sales rep hired for Houston, 25 year sales veteran in Medical Device sales 18

19 sales progress Our Texas commercial experience to date has defined the sales process for broad scale AVERT adoption 19

20 sales process tools Targeting physician champions who are passionate about the problem of CIN with new sales brochure Key Tools for VAC Success Cardiology, Nephrology, Radiology Advocates Osprey economic model Population Health advocate or NCDR specialists Doctors don t need to change current methods to see dye savings, reflux reduction and image quality with the AVERT. 100% success with demos to date. Purchasing & Contracting Hospital & GPO approved vendor National pricing research Consignment & purchase contract BioMed Engineering Expand to all MD s Advocacy from lab staff Broaden indications Added to Cardiology treatment standards 20

21 sales progress VAC approval for all Baptists System hospitals Downtown Baptist Hospital First revenue account Repeat orders with multiple MD users North Central Baptist Hospital Ordering account with multiple MD users Mission Trace Baptist Hospital Ordering account with multiple MD users North East Baptist Hospital Physician evaluation complete orders pending 21

22 sales expansion Nix Hospital (San Antonio) Ordering account with multiple MD users University Hospital (San Antonio) Physician evaluation and VAC complete, in purchasing department for ordering VA Hospital (San Antonio and Houston) San Antonio and Houston at VAC stage Doctors Hospital Renaissance (McAllen) Physician evaluation stage Christus Santa Rosa (San Antonio) Physician evaluation stage 22

23 Simple system to assist doctors to comply with new guidelines is helping drive market adoption New stent procedure performance guidelines Obama Care is driving new performance standards to improve outcomes and reduce cost Professional heart societies in 2014 published new performance improvement standards for stenting* The new standards recommend documentation of preprocedural kidney function and dye dose delivered during the case helps comply with new guidelines Monitors and displays threshold volume which is based on pre-procedural kidney function Records dye dose delivered to the patient during the case AVERT Pilot study showed an average of 40% reduction in dye used without compromising image quality ** 23 *Nallamothou et al. Circulation: Published online December 19, 2013 ahead of Print **Kaye et al, Catheter Cardiovasc Interv. Vol 83, April 1, 2014.

24 LIMBREC VERY randomized trial enrollment complete Our technology permits focal dose antibiotics to be delivered to the lower limb Advanced diabetes-related limb infections affect over 300,000 patients per year in the US and AU Safety trial of 5 patients complete Mid patients treated with one application of Osprey LIMBRECOVERY system Abstract poster presentation at DFCON meeting 2014 Randomized efficacy trial enrolment complete Data analysis and reporting expected Q

25 Future R&D efforts and business development opportunities Potential Future Opportunities Further AVERT product enhancements (Automatic- no adjustments) AVERT usability and margin improvements (Wireless) High volume injection compatible AVERT AVERT for Chronic Total Occlusions Industry opportunities Recent nonbinding detailed due diligence request for business and AVERT trial results diligence 25

26 Near term news flow Complete enrolment AVERT Post Market trial 3Q 2015 AVERT post market trial results available in 4Q 2015 FDA submission for AVERT enhanced claims in 4Q 2015 Limb recovery randomized study results 2Q 2015 Sales progress reports from two Texas sales territories Preparation for full US launch in 1Q 2016 Ongoing development of dye reduction product pipeline 26

27 THANK YOU