Canaccord Genuity 34th Annual Growth Conference August 14, 2014

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Presentation transcript:

Canaccord Genuity 34th Annual Growth Conference August 14, 2014 Nasdaq: APPY

Important Cautions Regarding Forward-Looking Statements Certain statements made in this presentation are "forward-looking statements" of Venaxis, Inc. (“Venaxis") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this presentation that address activities, events or developments that Venaxis believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors Venaxis believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Venaxis. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product development and modifications in a timely and cost effective manner, complete clinical trial activities for the APPY1™ Test required for FDA submission, obtain FDA clearance or approval, maintain CE Mark, cost effectively manufacture and generate revenues from the APPY1 products at a profitable price point, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, Venaxis does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this presentation should be considered in conjunction with the risk factors contained in Venaxis’ recent filings with the SEC, including its Form 10-K for the period ended December 31, 2013 and its most recent 10-Q for the period ended June 30, 2014. This presentation is © 2014 Venaxis, Inc., All Rights Reserved.

Investment Highlights 1 The APPY1 Test* is the first multi-marker blood test to aid in the diagnosis of acute appendicitis 2 Successful clinical trial results 3 Submission accepted by FDA for review 4 “Razor-Razor Blade” revenue model 5 Planned menu expansion *The APPY1 Test is under FDA review and is currently not available for sale in the U.S.

Pathophysiology of Appendicitis Clinical Conundrum 1 1"Neutrophiler Aktion" by Uwe Thormann is licensed under Creative Commons Attribution-Share Alike 3.0 Unported

Current Workflow Very Imaging Intense Patient presents at Emergency Department High risk for AA Low / Moderate risk for AA Minimal risk for AA Preliminary clinical assessment Surgery Observation Discharged Target population Ultrasound CBC (and other labs) CT Scan

Significant Problems with Imaging 1 CT Scan Radiation Risk of malignancy later in life (greater risk for children)1,2,3 Inefficiency Prolonged emergency department (ED) stays/treatment delays4 Contributes to ED crowding, which contributes to medical errors5 2 Ultrasound Inconsistency 48% visualization rate6 (meta-analysis, 10 pediatric academic tertiary care centers) Poor Sensitivity Range: 35-86%6 Availability Only 46% of community hospital physicians (64% academic / children’s) report having access to 24/7 ultrasound9

A Single CT Scan Significantly Increases Cancer Risk Lifetime Attributable Risk of Death from Cancer per Million Patients Exposed to 10mCy1 According to a study recently published in JAMA “approximately 4,870 future cancers could be induced by pediatric CT scans each year”2 Risk of Death from Cancer “For girls, a radiation induced solid cancer is projected to result from every 300-390 abdomen/pelvis scans…., depending on age”2 Age at Exposure (yr)

Significant Need for an Objective, Actionable Blood Test Estimated 22 million emergency visits for abdominal pain in U.S. and Europe annually1,2 Objective Data High Negative Predictive Value Rapid Results Turnaround

The APPY1 Test – Designed to Aid in the Rule out of Appendicitis Multi-marker blood test: MRP8/14, CRP, WBC APPY1 Test result using proprietary algorithm Immunoassay quantitatively measures MRP 8/14 and CRP Hospital lab WBC value entered into instrument

Benefits of a Multi-Marker Approach Neutrophil Activation Leukocytosis Acute Phase Response Cell Recruitment Cytokine Signaling Cytokine Signaling Neutrophil Proliferation Bone Marrow Liver Appendix Heterodimer Appendix White Blood Cells Appendix Acute Phase Proteins MRP 8/14 WBC C-Reactive Protein Three markers combined using a proprietary patient assessment algorithm to generate the qualitative APPY1 Test result.

Clinical Study Results Exceed Expectations Pilot Study (CP-11) Clinical Trial Results (CP-12) Subjects 503 1887 NPV Probability that a patient with a negative test result will not have the disease 97% (92.9-98.7) (95.5-98.3) Sensitivity 96.5% (92.1 – 98.5) 96.9% (94.9 – 98.1) Specificity 43.2% (38.2 – 48.3) 37.8% (35.3 – 40.4) Prevalence 29% (24.9-32.7) 25% (23.4-27.3)

Appendicitis Work-Up with the APPY1 Test Patient presents at Emergency Department High risk for AA Low / Moderate risk for AA Minimal risk for AA Preliminary clinical assessment Surgery Negative, Low Probability for Appendicitis Non-Informative for Appendicitis APPY1 Test Current hospital protocols *Consider conservative management Observation Discharged Target population *In conjunction with other clinical signs and symptoms.

Potential Power of Negative APPY1 Test Result Pilot Study Results Subjects Enrolled N = 503 Home n = 63 Imaging n = 397 Surgery n = 43 Appendicitis n = 0 No Appendicitis n = 63 n = 309 n = 88 Appendicitis n = 41 No Appendicitis n = 2 n = 97 Ultrasound / Other n = 309 CT Scan n = 185 (total) AA+ n = 21 AA– n = 76     Two that went home were “inconclusive” by APPY1 2 that had un-necessary surgery with no imaging were “inconclusive” by APPY1 9 of the 28 un-necessary surgeries overall were negative by APPY1 Home AA+ n = 0 AA– n = 157 Surgery AA+ n = 50 AA– n = 5 Home AA+ n = 5 AA– n = 128 Surgery AA+ n = 48 AA– n = 4     Patients underwent US but did not have appendicitis 46% were negative by APPY1 Test Patients underwent CT but did not have appendicitis 43% were negative by APPY1 Test AA+ = Acute Appendicitis AA– = No Acute Appendicitis

2014 APPY1 Regulatory Update/Timeline Completion of patient enrollment January Filing of a 510(k) premarket submission and request for concurrent de novo determination March Press release announcing the FDA Additional Information (AI) request July Call with the FDA to discuss questions and comments Agreement on following actions: Venaxis product insert and training materials to be field tested with clinicians to ensure compliance with intended use Some additional analytical work on APPY1 to satisfy FDA requirements August Q4 2014 Planned supplemental filing to the FDA

Large Market Potential for the APPY1 Test U.S.1 Europe2 10.4 million ED visits for abdominal pain 7.5 million blood tests (CBC) for abdominal pain 1 million blood tests age 2 – 20 11.8 million ED visits for abdominal pain 8.6 million blood tests (CBC) for abdominal pain 2 million blood tests age 2 – 20 Total Addressable Market APPY1 Test Initial Target Market

Go to Market Strategy U.S. EU Under FDA Review CE Marked Direct Sales Approach 2 senior hires (Q2) 8 direct reps later 2014 Market Development Underway KOLs Profiling of top 2500 hospitals Engaging hospital systems CE Marked Hybrid Direct Sales and Distribution 2 senior hires Country specific distributors Market Development Underway Country specific studies Distributor purchases 2 exclusive distributors- Benelux and Spain

Market Development “Learnings” Reinforce Need for the APPY1 Test U.S. Workup of patients includes intense use of imaging Ultrasound – large hospitals/academic medical centers Poor sensitivity (visualization) leads to many follow-up CT scans Not available 24/7 CT scans – community hospitals Low yield – typically 80% negative Significant need to improve ED throughput EU CT is less utilized but ultrasound problematic Significant patient time under observation Many abdominal pain patients admitted to hospital Significant need to better utilize limited funds Hospitals typically operate under annual fixed budget

APPYAnalytics: Potential Impact on Imaging 56 fewer CT scans 46% reduction 273 fewer Ultrasounds 33% reduction Using data collected at the hospital, the impact of the APPY1 Test is assessed using sophisticated analytics Assesses up to 9 clinical and economic outcomes 450-bed community hospital

APPYAnalytics: Demonstrates Potential to Reduce ED Length of Stay 777 Hours Saved 17% reduction 450-bed community hospital Calculates change based on current and use of modified practice using the APPY1 Test

Illustrative Revenue Opportunity Initial Target Market* Assumed % Penetration - Pediatrics (age 2-20) (In thousands except for ASP) 5% 10% 20% 30% United States ($75 - $85 USD ASP) Potential APPY1 Tests 50 100 200 300 U.S. Revenues $3,750 - $4,250 $7,500 - $8,500 $15,000 - $17,000 $22,500 - $25,500 Europe ($60 - $70 USD ASP)1,2 400 600 OUS Revenues $6,000 - $7,000 $12,000 - $14,000 $24,000 - $28,000 $36,000 - $42,000 Total Potential Revenue $9,750 - $11,250 $19,500 - $22,500 $39,000 - $45,000 $58,500 - $67,500 Note: The APPY1 Test is initially expected for use in pediatric patients (age 2-20). TAM is based upon total potential population. The APPY1 Test is under FDA review and is currently not available for sale in the U.S. 1ASP based on preliminary estimated revenues for our APPY1 products. Actual pricing has not yet been established. 2Represents estimated Venaxis sales price to distributors. *For illustrative purposes only and does not constitute a financial forecast or projection of future company performance

Next Generation Product Development Underway Clinical Samples Biomarker Discovery Assay Development Algorithm Development Trial Regulatory Approvals Goals Elevated specificity – greater clinical utility Pediatric AND adult indication – larger market opportunity Finger stick/whole blood – improved ease of use and adoption Strategy Utilize over 2500 well-characterized samples for next generation development Development partner – Somalogic Inc. Over 1100 proteins screened – high potential of new, useful biomarkers

Financial Information Highlights (in millions) As of 6/30/14 Cash Equivalents & Short Term Investments $29.1 Total Assets $33.2 Total Liabilities $4.9 Working Capital $27.8 Shares Outstanding 31 Current Market Cap ~55 Source: APPY Form 10-Q for the period ending 6/30/14.

Experienced Management Team Steve Lundy President & CEO 25 years commercial leadership in several high growth diagnostic companies resulting in combined exit value of >$1 billion Don Hurd Senior Vice President & Chief Commercial Officer 30 years commercial leadership in medical diagnostic & device companies. Commercial experience in both large corporate companies and start up Jeff McGonegal, CPA Chief Financial Officer Former audit partner with national CPA firm for 20+ years, expertise in public company SEC reporting, financings and M&A Glen Paul Freiberg, RAC Regulatory Affairs Regulatory, quality, and clinical expertise, numerous 510(k) & PMA clearances/approvals; world-wide regulatory experience Lyndal Hesterberg, Ph.D. R&D & Product Development 30 years experience in medical diagnostics industry including research, product development, clinical operations, and development and launch of multi-marker diagnostic tests Board Members with Diagnostic Experience Daryl J. Faulkner – Prior CEO Digene (acquired by QIAGEN), Invitrogen (merged w/ Life Technologies Corp.), Abbott Labs John Landon – Prior Director of Digene, Chair of Cholestech (acquired by Alere), and VP & General Manager, DuPont Medical Products Susan Evans – Former VP Scientific Affairs Beckman Coulter, Past President AACC (American Assoc. Clinical Chemistry) Stephen Williams – Chief Medical Officer of SomaLogic, ex-Pfizer executive

Investment Highlights 1 The APPY1 Test* is the first multi-marker blood test to aid in the diagnosis of acute appendicitis 2 Successful clinical trial results 3 Submission accepted by FDA for review 4 “Razor-Razor Blade” revenue model 5 Planned menu expansion *The APPY1 Test is under FDA review and is currently not available for sale in the U.S.

References Slide 6 Slide 7 Slides 8 & 15 M00040 01 1Brennan GDM. Pediatric appendicitis: pathophysiology and appropriate use of diagnostic imaging. Can J Emerg Med 2006;8(6):425-32. 2Berrington de González A, Mahesh M, Kim K-P, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169:2071-2077. 3Brenner, et al. Estimated Risks of Radiation- Induced Fatal Cancer from Pediatric CT. AJR 2001;176:289–296. 4Davis, et al. Factors affecting ED length-of-stay in surgical critical care patients.. Am J Emerg Med. 1995 Sep;13(5):495-500. 5Epstein, et al. Emergency department crowding and risk of preventable medical errors. Intern Emerg Med. 2012 Apr;7(2):173-80. 6Mittal, et al. Performance of Ultrasound in the Diagnosis of Appendicitis in Children in a Multicenter Cohort. Acad Emerg Med. 2013 July;20(7):697-702. 7Howell, et al. Clinical Policy: Critical Issues in the Evaluation and Management of Emergency Department Patients With Suspected Appendicitis. Ann Emerg Med. 2010;55:71-116. 8Brown, et al. An Epidemiologic Study of Closed Emergency Department Malpractice Claims in a National Database of Physician Malpractice Insurers. Acad Emerg Med. 2010; 17:553–560. 9Venaxis Physician Survey, American College of Emergency Physicians Meeting, October 2013. Slide 7 1Brenner et al. New England Journal of Medicine. 2007; 357:2277-84. 2Miglioretti et al. JAMA Pediatr. 2013;167(8):700-707. Slides 8 & 15 1Extracted From CDC data NHAMCS 2010 by Venaxis. 2EU Market Study 2012 by Venaxis, Inc. (Benelux, France, Italy, Germany, UK). M00040 01