Analyst & Investor Day. May 20, Accuray and/or its affiliates. All rights reserved.
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1 Analyst & Investor Day May 20, 2016 All rights reserved.
2 Agenda Welcome Kevin Waters Senior Vice President and CFO Strategic Overview Joshua Levine President and CEO Commercial Strategies Kelly Londy Executive Vice President and COO Intermission Differentiated Technology and Product Innovations Robert Hill Senior Vice President, R&D All rights reserved. Precise, innovative tumor treatments Precise, innovative tumor treatments 2
3 Agenda Clinical Perspectives on Solutions Dr. John Kresl Dr. Shalom Kalnicki Dr. Dwight Heron Question and Answer Session Intermission Financial Overview Kevin Waters Senior Vice President and CFO Closing Summary Joshua Levine President and CEO Question and Answer Session All rights reserved. Precise, innovative tumor treatments Precise, innovative tumor treatments 3
4 Forward Looking Statement Safe Harbor Statement Statements in this presentation (including the oral commentary that accompanies it) that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor provisions of the Private Securities Litigation Reform Act of Forward-looking statements in this presentation relate, but are not limited to, the size and growth of the global market for radiation therapy systems, market position of our products, product roadmap, our business opportunities and focus, including strategies for commercial execution, product positioning, customer accounts and emerging markets, and our expected financial results for the fourth quarter and full fiscal year Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to: anticipated regulatory approvals and launches of new products; the extent of market acceptance for the company s products and services, including market adoption of newly launched products; the company s ability to convert backlog to revenue; the success of its worldwide sales and marketing efforts; the ability to control operating expenses; continuing uncertainty in the global economic environment; potential differences between the Company s preliminary financial analysis and the final results for the applicable period as a result of the completion of internal reporting process and review, and other risks detailed under the heading "Risk Factors" in the company s report on Form 10-K for fiscal 2015, filed on August 28, 2015, the company s reports on Form 10-Q filed on November 5, 2015, February 1, 2016 and April 29, 2016, and the company s other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements are made and are based on information available to the company at the time those statements are made management s good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements. This presentation also contains non-gaap financial information. Management believes that this non-gaap financial measure provides useful supplemental information to management and investors regarding the performance of the company and facilitates a more meaningful comparison of results for current periods with previous operating results. Additionally, it will assist management in analyzing future trends, making strategic and business decisions and establishing internal budgets and forecasts. A reconciliation is available in the Appendix. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 4
5 Poised for Growth May 20, 2016 All rights reserved.
6 Josh Levine President and CEO May 20, 2016 All rights reserved. Precise, innovative tumor treatments 2
7 : Poised for Growth Radiation therapy is underutilized Clinically effective Cost effective All rights reserved. Precise, innovative tumor treatments 7
8 Radiation Therapy: Opportunity for Growth 10% 50% $2T of cancer patients would benefit from radiation therapy of patients have access to RT in low income countries Global Economic Burden in 2010 Source: Expanding global access to radiotherapy, published in The Lancet Oncology in September 2015 All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 4
9 : A Strategic Transformation Initial Needs of the Business: Improve product performance and reliability Sustainable cost structure Product roadmap aligned with customer needs Revenue growth All rights reserved. Precise, innovative tumor treatments 9
10 Transformative Strategies Customer focus and enhanced commercial execution Improve product portfolio Growth outside the US: China, Japan, Europe a Partnerships Fiscal discipline affiliates. All rights reserved. itsits affiliates. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments Precise, innovative tumor treatments 1010
11 Transformational Performance Strategic Approach Customer Focus and Commercial Execution Pathway to Profitability All rights reserved. All rights reserved. confidential. Sales and Marketing Reliability and Service Fiscal Discipline Installed base S growth of 16%; Backlog growth of 28% (since 2013) Commercial and operational improvements driving improved financial results Precise, innovative tumor treatments 7
12 Four Years of Transformational Progress Americas All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 12
13 2013: Business Stabilization and Reset Focus on customers Cost restructuring Completed TomoTherapy integration Launched CyberKnife M6 and TomoH Series All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 13
14 2014: Establishing Success Factors Fixed reliability issues in TomoTherapy installed base Repositioned TomoTherapy as a mainstream device Significant service margin improvement Initiated strategic account selling All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 14
15 2015: Building New Strengths Launched the InCiseTM MLC for CyberKnife Introduced new product development process Continued improving financial performance All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 15
16 2016: Acceleration Driving efficiency Improved capital structure Increasing multi-system orders Introducing Radixact and Onrad Systems and Precision Treatment Planning All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 16
17 Benefits of Transformation Fixed installed base reliability Increased customer loyalty and satisfaction Improved product performance Reduced costs Improved margins Financial growth All rights reserved. Precise, innovative tumor treatments 17
18 Focus on Our Four Pillars PRODUCTS PROCESSES All rights reserved. PARTNERSHIPS PEOPLE Precise, innovative tumor treatments 18
19 Products and Positioning Expanding clinical capabilities All rights reserved. Precise, innovative tumor treatments 19
20 Processes Building confidence, sustaining growth All rights reserved. Precise, innovative tumor treatments 20
21 Partnerships Expand product portfolio and innovate faster All rights reserved. Precise, innovative tumor treatments 21
22 Transforming our Roadmap Highly differentiated new products and features Internal innovation: hardware and software Partnerships with other innovators to bring critical solutions to market, faster *The Radixact Treatment Delivery System, Precision Treatment Planning System and idms Data Management System are pending FDA 510(k) clearance and not available for sale within the United States. These products may also be subject to international regulatory approval or licensing processes such that the availability of these products may vary according to geographical location. All rights reserved. Precise, innovative tumor treatments 22
23 People Committed to the fight against cancer All rights reserved. Precise, innovative tumor treatments 23
24 Increasing Commercial Momentum More than 2,000 out of 3,000 attendees at the recent ESTRO meeting attended the unveiling of our new product. Buzz at the show focused on new product announcements Radixact System Precision Treatment Planning System idms Data Management System All rights reserved. Precise, innovative tumor treatments 24
25 Summary: Poised for Growth and Profitability We are growing faster than the overall market Macro market drivers represent opportunities for Expanding clinical utility of our products We are innovating, faster, through internal expertise and external partnerships Financial discipline is driving towards sustainable profitability All rights reserved. Precise, innovative tumor treatments 21
26 Thank you. All rights reserved. Precise, innovative tumor treatments 22
27 Kelly Londy Executive Vice President, Chief Operating Officer May 20, 2016 All rights reserved. Precise, innovative tumor treatments
28 Commercial Execution Four primary business initiatives to drive revenue and margin growth Customer Satisfaction Strategic Accounts Products China Commercial Opportunity All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 28
29 Commercial Success gaining U.S. share TomoTherapy acceptance, MLC availability and competitive wins driving growth Gross Bookings Share ($) FY14 Gross Bookings Share ($) FY15 +3% 6% 9% 8% Elekta 33% Varian 61% Elekta 25% Varian 66% +5% Source: Financial statements of each respective company and internal estimates All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 29
30 Improved Reliability and Service 459 U.S. radiation therapy departments surveyed The level of reliability provided by s systems is exceptional. * rated #1 in overall system performance** Net Promoter Score increased 10 points YOY to 45 percent** *MD Buyline Market Intelligence Briefing - Q **imv ServiceTrak Radiation Oncology 2015 All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 4
31 Q1 16: Highest User Satisfaction Ratings For two years Independent analysis Six key metrics considered Ratings based on opinions of those who use the product every day * Potential for quarter to quarter variability exists All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments
32 Service and Support Enhancements Classroom Training Customer Call Center a North American Parts Depots affiliates. All rights reserved. itsits affiliates. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments Precise, innovative tumor treatments 532
33 Market Visibility and Funnel Acceleration CRM-supported processes Competitive vault takeaway All rights reserved. All rights reserved. confidential. Win/Loss analysis Replacement and upgrade opportunities IDN and process management Precise, innovative tumor treatments 33
34 Catalyst for Growth Installed base replacement opportunities 75-80% win rate for replacement units ~200 total systems will reach 10 year mark in the next 3 years WW Active Installed Base Growth by Year System Quantity TomoTherapy 500 CyberKnife 400 Grand Total All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 34
35 Commercial Organization ProductAmericas Portfolio Commercial Structure Global Sales and Support Commercial Execution All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 8
36 US Field Sales Structure Optimized roles and responsibilities to drive commercial success Key Account Management Focus Sales and Service Alignment Consider adjusting Direct and Indirect Channel Signed master/volume agreements with 50% of IDN targets affiliates. All rights reserved. itsits affiliates. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments Precise, innovative tumor treatments 36 9
37 China Growth Potential Cancer incidence and mortality rates continue to rise, fueled by the aging population and environmental and lifestyle factors 65+ population will almost double in 15 years affiliates. All rights reserved. itsits affiliates. All rights reserved. All rights reserved. confidential. All rights reserved. Precise, innovative tumor treatments Precise, innovative tumor treatments 37 37
38 Radiotherapy Treatment Capacity - China Major capacity gap when compared to developed markets Estimated RT Penetration* 50% RT Penetration 3 57% % 40% 30% 20% 20% 10% 0% RT Systems Per 1,000 New Cancer Patients 60% RT Systems Per 1,000 Cancer Patients* US Japan China US Japan China 1,117 linear accelerators installed in China as of May 2016** Estimated 5,000 systems needed to address patient need*** All rights reserved. All rights reserved. confidential. * internal estimates ** accessed 5/6/2016 ***China Medical Equipment Association 2013 Precise, innovative tumor treatments 38
39 Commercial Progress - China Through fiscal Q Since 2013, products were placed in >85% of bunkers where Class A radiotherapy licenses were issued Well-recognized and respected by Chinese KOL and NHFPC Strong presence in PLA and large public sector facilities 34 out of 39 licenses awarded to hospitals for products Private sector hospitals/cancer treatment facilities purchasing non-type A product offering will drive growth going forward All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 39
40 affiliates. All rights reserved. itsits affiliates. All rights reserved. Precise, innovative tumor treatments Precise, innovative tumor treatments 14
41 Thank you. All rights reserved. Precise, innovative tumor treatments 19
42 Robert Hill Senior Vice President R&D and Chief Product Officer May 20, 2016 All rights reserved. Precise, innovative tumor treatments 1
43 The Path Forward R&D and partnerships Expanding our product portfolio and innovating faster All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 43
44 CyberKnife M6 InCise MLC Faster treatments, expanded clinical applications Commercial status Commercial rollout initiated spring 2015 Faster treatment speed 30-40% reduction in average treatment times Expanding clinical utilization More than 500 patients have been treated Treatment sites have included cranial, prostate, spine, lung, and liver Treatment techniques have included SRS, SBRT and IMRT All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 44
45 Radixact Treatment Delivery System Designed for increased throughput, higher reliability, ease of serviceability Next generation TomoTherapy System Mainstream product adoption Differentiation for premium segment Capture the installed base upgrade opportunity The Radixact Treatment Delivery System, Precision Treatment Planning System and idms Data Management System are pending FDA 510(k) clearance and not available for sale within the United States. These products may also be subject to international regulatory approval or licensing processes which may vary by geographical location. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 45
46 Onrad System A new TomoTherapy configuration for the core market segment Goal Capitalize on Chinese growth opportunities Our Solution Based upon TomoH platform IG-IMRT and 3DCRT system using fixed beam angles Treats extensive range of cases Streamlined and productive workflows Fast planning Compact footprint and on-board beam shielding Integrated QA tools All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 5
47 Precision Treatment Planning and idms Improved planning process, enhanced connectivity, integrated Adaptive Therapy Increase adoption of systems Integrated, full-featured treatment planning for all our product platforms Centralized patient database Upgrades and new systems Enhance workflow efficiencies Advanced manual and automatic organ delineation features Simple planning option Seamless patient transfer Improved OIS integration Differentiate on precision New Adaptive Therapy application More accurate planning for retreatments The Precision Treatment Planning System is pending FDA 510(k) clearance. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 47
48 PreciseART Adaptive Solution Automatic organ delineation, dose calculation and dose accumulation Goal Efficiently replan when changes in patient anatomy make it necessary Our solution makes it uniquely easy to adapt Acquires daily quantitative CT images then executes image processing algorithms for dose accumulation Automatically highlights when replanning is needed and provides tools to make the replanning easy Includes reporting for payers to demonstrate medical need for replanning All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 8
49 RaySearch Laboratories Partnerships in Treatment Planning and Oncology Information Systems RayCare Increase ease of integration within radiation oncology departments/clinics A next-generation Oncology Information System (OIS) being developed by RaySearch Laboratories Leverage RayStation advanced treatment planning features and functions RayCare * is a modern OIS designed to meet current and future radiation oncology workflows products will be fully integrated Give customers more choices *Technology under development at RaySearch Laboratories ** RayStation and RayCare are registered trademarks of RaySearch Laboratories All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 8
50 New Imaging Ring for CyberKnife R&D and Supply Agreement signed, initiating Product Development Collaboration with medphoton Enhances treatment precision Ease of adoption Image courtesy of MedAustron All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 50
51 New Product Launch Video All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 51
52 Thank you. affiliates. All rights reserved. itsits affiliates. All rights reserved. Precise, innovative tumor Precise, innovative tumortreatments treatments 1152
53 Clinical Speaker TomoTherapy mainstream product John J. Kresl, MD, PhD, DABR, FACRO, FACR Medical Director of the Phoenix CyberKnife and Radiation Oncology Center and the Department of Radiation Oncology at Banner Good Samaritan Medical Center Dr. John Kresl is an internationally recognized expert in stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). Dr. Kresl has experience with and provides leading-edge treatments for his patients with the CyberKnife System, TrueBeam STx with Novalis Radiosurgery and TomoTherapy HDA. His expertise spans a wide array of cancer treatments including: IMRT, IGRT, SRS, SBRT, surface, interstitial and intracavitary brachytherapy, radioimmunotherapy, standard external beam radiation therapy. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 53
54 The TomoTherapy System as a Tool of Differentiation in Quality and Marketability John J. Kresl, MD, PhD, FACRO, FACR Medical Director Phoenix CyberKnife & Radiation Oncology Center Managing Partner Radiation Oncologists of Central Arizona Phoenix, Arizona Chief Clinical Officer Select Healthcare Solutions Rancho Santa Fe, CA Chief Medical Officer Alliance Oncology, US Radiosurgery Newport Beach, CA Radiation Oncologists of Central Arizona
55 Disclosure The views expressed in this presentation are those of the presenter and do not necessarily reflect the views or policies of Incorporated or its subsidiaries. No official endorsement by Incorporated or any of its subsidiaries of any vendor, products or services contained in this presentation is intended or should be inferred. I have been and currently am a paid consultant of. Radiation Oncologists of Central Arizona
56 The TomoHDA enables me and my team to provide our patients with the most advanced and compassionate cancer care available. Radiation Oncologists of Central Arizona
57 IMRT, IGRT, SRS, SBRT Experience >5000 SRS treatments >4750 SBRT treatments 1997 Peacock/Corvus IMRT program 1997 Gamma Knife program 2003 CyberKnife program 2003 Novalis Brainlab program 2006 Tomotherapy program 2006 Varian Trilogy program 2009 Elekta Axesse program 2009 Novalis Tx with RapidArc program 2011 CyberKnife VSI program 2011 TrueBeam STx with RapidArc program 2013 CyberKnife M6 program 2014 TomoTherapy HDA program Radiation Oncologists of Central Arizona
58 The TomoTherapy System Versatile, efficient and effective for the range of radiation oncology patients OVERVIEW: Unique ring-gantry architecture: Integrates imaging into the therapeutic process and helps facilitate the adoption of IG-IMRT for all clinics The TomoTherapy System enables precise radiation treatments to be delivered to a wide range of cases, from routine to complex Reduced MUs Other? Radiation Oncologists of Central Arizona
59 The TomoTherapy System Precision IG-IMRT with improved functionality Plan Image Deliver and Monitor Radiation Oncologists of Central Arizona
60 Efficiency Without Compromise VoLO Treatment Planning and TomoEDGE Dynamic Jaws Rapid treatment planning Fixed Jaw Mode Highly conformal plan 6.5 minute treatment Better dose distribution in less time Routine and complex cases Dynamic Jaw Mode Maintains conformality 3.7 minute treatment Radiation Oncologists of Central Arizona
61 Focus on Breast Cancer Delivering versatility and efficiency with VoLO Treatment Planning and TomoEDGE Dynamic Jaws Quick and interactive 3D-CRT, IMRT and SRS/SBRT planning Daily 3D CT localization, enabling margin reduction while sparing healthy tissue Precise delivery for complex and routine cases 50% faster treatments with even better dose distributions Radiation Oncologists of Central Arizona
62 Case Load at Palo Verde Commonly treated cases: breast, CNS, head and neck, sarcoma, lung, and GI Average treatment time: 6-7 minutes Easily treat approximately 25 patients/day, in an 8 hour day Majority of patients are treated with 3-D conformal TomoHelical treatment plans and IMRT Radiation Oncologists of Central Arizona
63 The TomoHDA Making a Difference for Our Patients Case #1 59-year-old man Head and neck Case #2 65-year-old woman Brain Case #3 77-year-old male Scalp Case #4 71-year-old male Sarcoma 10 Radiation Oncologists of Central Arizona
64 The TomoHDA Differentiating Palo Verde Cancer Center in Our Community With VoLO Treatment Planning and TomoEDGE Dynamic Jaws we can spend less time and deliver a better treatment plan. The TomoHDA has exceeded our expectations in its precision, efficiency and use for our first 500 patients treated. Radiation Oncologists of Central Arizona
65 Significant Increases in Throughput, Significant increases in throughput, "Top 10" Sites in the Americas: Median Time Between Patients 20 The most efficient sites in the Americas now average <15 minutes between patients "Top 10" Sites in the Americas: Median # of Patients per Day 35 The most efficient sites in the Americas now average >32 patients per day Based upon summary data from calendar years shown Radiation Oncologists of Central Arizona
66 Typical Durations for Stages of Treatment Initial Setup MVCT Beam-On Time Patient Registration Register-toTreat Treatment Beam-On Time Idle Time Between Patients Palo Verde throughput comparable to best in US idle time will decrease as we add more patients * Based upon calendar year 2014 data obtained from machine logs ** Based upon 30-day logs retrieved 04 Feb 2015 primarily data from January 2015 Radiation Oncologists of Central Arizona
67 The TomoHDA + Palo Verde Cancer Center Overcoming Cancer Together Radiation Oncologists of Central Arizona
68 Thank you! Radiation Oncologists of Central Arizona
69 Clinical Speaker TomoTherapy /Radixact Shalom Kalnicki, MD, FACRO Professor and Chairman of the Department of Radiation Oncology at Montefiore Medical Center and Albert Einstein College of Medicine A physician leader, researcher and teacher, Dr. Kalnicki leads an internationally recognized radiation oncology department since July 2004, when he rejoined the ranks of Montefiore-Einstein. Dr. Kalnicki has focused on researching and implementing new technologies in the radiation treatment of cancer. He pioneered the use of intensity modulated radiation therapy (IMRT), image-guided radiation therapy (IGRT), target motion management with 4-D radiation planning, stereotactic body radiation therapy (SBRT) and functional tumor imaging with PET-CT fusion techniques. His research has implications for radiation treatment planning and techniques used for most clinical situations in radiation oncology, including brain, head and neck, thoracic, upper abdominal and pelvic malignancies. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 69
70 Precision Medicine and Radiation Oncology Shalom Kalnicki, MD, FACRO May 20, 2016
71 Disclosures The views expressed in this presentation are those of the presenter and do not necessarily reflect the views or policies of Incorporated or its subsidiaries. No official endorsement by Incorporated or any of its subsidiaries of any vendor, products or services contained in this presentation is intended or should be inferred. An honorarium is provided by for this presentation.
72 Background Radiotherapy (RT) is used as definitive therapy, preoperatively, or postoperatively in the management of most solid tumors. In curative settings, RT is typically delivered 5 days/week for 3-8 weeks in an outpatient setting. RT is used in approximately 62% of all cancer patients and plays a role in over 75% of curative cancer therapy Could be the most cost effective and most quality of life friendly cancer curative modality ACS, ASTRO
73 Where is Radiation Oncology Going? Times of Rapid Change Biology: From normal tissue tolerance based prescriptions to the radiation dose the tumor actually needs From many low dose daily fractions to tumor cell sensitivity driven hypo-fractionation Physics: From large regional beams to precision tumor targeting From treating large normal tissue volumes by uncertainty driven fears of geographic misses to target motion management Clinical Results: Biology and evidence driven integration with systemic therapy From palliation to remission / cure From acceptance of suffering due to sequellae to quality survivorship
74 The Radiation Oncology Technology Menu Intensity Modulated Radiation Therapy (IMRT) Image Guided Radiation Therapy (IGRT) Stereotactic Radiosurgery (SRS) Stereotactic Body Radiation Therapy (SBRT) Target Motion Management Precision Radiation Oncology or Adaptive Radiation Therapy: Biologically and Response Assessment Guided Treatment Planning
75 Radiation Oncology Goals The Precision Medicine Tool Cure: Precise tumor targeting Quality of Life: Maximal normal tissue sparing Excellence: All patients are treated to the correct dose and the correct site 100% of the time. Safety: Accomplished through a team of expert and dedicated clinicians, physicists, radiation therapists, nurses, managers, researchers and educators
76 From Conventional Planning to 4D Dose Sculpting
77 Normal Tissue Sparing Conventional vs. IMRT
78 Does it Work? And how.. Billion dollar allergy drugs and chemotherapeutic agents are valued for less than these differences Late Grade 2-3 Xerostomia (RTOG Criteria) Definitive Patients Post-op patients Conventional 84% 77% IMRT 30% 17% Acute Grade 3-4 Mucositis (RTOG Criteria) Conventional 25% 18% IMRT 42% 25% IJROPB 2001; 49:
79 Adaptive Planning? Why should we treat last weeks tumor today? Ability to adapt today s treatment to yesterday s delivered dose pattern Tumor response adaptation Target and normal structures shifting adaptation What can happen? Setup error / patient movement Weight loss Tumor shrinkage Normal tissue shrinkage
80 Adaptive Planning Original Plan All is well again with new plan! Images Property of Montefiore Medical Center With shrinkage in tumor size, greater dose on mucosa and cord. Hotspot is greatly increased
81 What happens if you have to stop? Delaying 2 or more treatments is BAD!!! Noncompliant, n=266 Compliant, n= Overall Survival Cumulative Incidence Rate for Recurrence Compliant, n=961 Noncompliant, n= p < p < Time after Radiotherapy (months) Tumor Regrowth Time (months) 40 Patient Survival Ohri N et al. International J Radiat Oncol Biol Phys 2016:95(2):
82 New Paradigm for the Future: ADAPTIVE IMAGE GUIDED INTENSITY MODULATED RADIATION THERAPY Permits adjustments accounting for change in target and normal tissues: Position Movement with respiration Size Shape Advantages: Accurate daily patient set-up Accurate targeting of tumor and normal tissues as they are NOW!!! Conformal avoidance of radiosensitive structures Dose sculpting around complex shaped target volumes
83 Evolution of the TomoTherapy System 1993 First Paper and Vision Hi-Art TomoDirect TomoTherapy H Series 2013 TomoEDGE VoLO Radiation Oncology development HAS to be an incremental thoughtful process emphasizing patient outcomes and safety 2015 Delivery Analysis
84 THANK YOU!!!! QUESTIONS?
85 Clinical Speaker CyberKnife MLC Dwight E. Heron, MD, FACRO, FACR Vice Chairman of Clinical Affairs, UPMC Shadyside Professor of Radiation Oncology, Otolaryngology and Head & Neck Surgery at the University of Pittsburgh School of Medicine Director of Radiation Services, UPMC CancerCenter Chairman, Department of Radiation Oncology, UPMC Shadyside Dr. Heron specializes in stereotactic radiosurgery, high-dose rate brachytherapy, and intensity modulated radiation therapy (IMRT). His research interests include stereotactic radiotherapy for benign and malignant brain and body tumors, evaluation of PET/CT in staging and management of head & neck, lung and a variety of other cancers including the use of 4D PET-CT for thoracic and abdominal malignancies as well as identifying and addressing factors contributing to differences in cancer care in various populations in Western Pennsylvania. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 85
86 The CyberKnife M6 System with InCise Multileaf Collimator Dwight E. Heron, MD, MBA, FACRO, FACR Professor & Vice Chairman Depts of Radiation Oncology, Otolaryngology, Head & Neck Surgery University of Pittsburgh Cancer Institute UPMC CancerCenter 86
87 Disclosure The views expressed in this presentation are those of the presenter and do not necessarily reflect the views or policies of Incorporated or its subsidiaries. No official endorsement by Incorporated or any of its subsidiaries of any vendor, products or services contained in this presentation is intended or should be inferred. I am current President of Exchange in Radiation Oncology (AERO), an users' community. 87
88 The InCise Multileaf Collimator Our innovative approaches have advanced the field of SBRT and SRS. The CyberKnife System, its robotic architecture, and the InCise MLC enable us to do things in a way that we ve never had an opportunity to do before. 3
89 The InCise Multileaf Collimator Faster treatment times 4 Expanded patient population More patients treated per day
90 The InCise MLC: Making a Difference for our Patients Our 1st Patient treated with InCise MLC 5
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101 The InCise MLC: Making a Difference for our Patients Case #2 Multiple Tumors 16
102 The InCise MLC: Making a Difference in our Hospital 17 Increased Throughput Center Benefits Patient Benefits 2-3 patients per day ~20% increase Faster treatment (reduction to <45 min) Great patient comfort New treatment options Less time Reduced MUs Better plans
103 The InCise MLC: Differentiating UPMC in Our Community The addition of the InCise MLC enables us to achieve equivalent precision in tumor targeting and sparing healthy tissue, but it takes us ~30% less time. 18 The InCise MLC has exceeded our expectations in its efficiency and use.
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105 Innovation in Action 20
106 The CyberKnife System with the InCise Multileaf Collimator Helping UPMC to Provide Life Changing Medicine 21
107 Thank you. 22
108 Kevin Waters Senior Vice President, Chief Financial Officer May 20, 2016 All rights reserved. Precise, innovative tumor treatments 1
109 Significant Financial Progress Building a path to sustainable profitability Key metrics Improving financial performance Consider adjusting Strengthening capital structure and cash flow Path to sustained profitability affiliates. All rights reserved. itsits affiliates. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments Precise, innovative tumor treatments 2 109
110 Key Metrics Significant growth: fiscal year 2015 vs. fiscal year 2013 $ millions $ millions +22% Gross Orders $219 FY'13 $263 $268 FY'14 FY'15 Gross orders drive backlog +22% growth FY 15/ 13 All rights reserved. All rights reserved. confidential. Backlog $317 FY'13 +18% $365 $375 FY'14 FY'15 Backlog drives revenue +18% growth FY 15/ 13 Precise, innovative tumor treatments 110
111 Key Metrics Significant growth: fiscal year 2015 vs. fiscal year 2013 $ millions +20% Revenue $316 $369 aebitda +$79 Million $380 $13 $23 FY'14 FY'15 ($56) FY'13 FY'14 FY'15 Significant revenue growth +20% growth FY 15/ 13 FY'13 Has led to significant improvement in our cash generation +79 million FY 15/ 13 *Actual results; FY15 EBITDA currency adjusted; $12 million as reported All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 111
112 Key Metrics Recent results and guidance: significant growth relative to market $ millions 2015 Full-Year Actual Months YTD* 2016 Full-Year Guidance 2016 Guidance vs Actual** Gross Orders $268 $188 $280 - $290 +6% Backlog $375 $371 ~ $405 +8% Revenue $380 $304 $395 - $405 +5% aebitda $12 $20 $25 - $ % Fiscal Year *Actual results **YOY growth calculated at mid-range of guidance All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 112
113 Gross Orders Driving future revenue growth $ millions Gross orders $285 $263 $268 9% annual growth (CAGR) Increased order momentum driving future revenue $219 FY'13 FY'14 FY'15 FY'16* *Represents the mid-point of FY 16 guidance All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 113
114 Backlog Driving future revenue growth $ millions Backlog $405 $365 9% annual growth (CAGR) Declining age-outs as a percentage of backlog Seeing previously aged out orders aging back in $375 $317 FY'13 FY'14 FY'15 FY'16* *Represents forecasted ending backlog for FY 16 at mid-point of guidance All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 114
115 Revenue Improving financial performance: FY2013 to FY2016 guidance $ millions Services Products FY 13 FY 15 CAGR: +8% $369 $380 $400 $316 $195 $174 $179 $179 $196 $201 $205 FY'13 FY'14 FY'15 FY'16* $137 *FY 16 data based on guidance All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 115
116 Gross Margin Improving financial performance: FY 13 to FY 16 guidance Total GM Service GM Product GM 43.8% 43.0% 41.5% 37.8% 38.7% 34.1% 38.3% 39.9% 36.9% 35.4% 30.9% 25.6% FY'13 FY'14 FY'15 FY'16* *FY 16 data based on trailing 12-months as of Q3 FY 16 All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 116
117 Strong Financial Discipline Leading to improved financial performance: revs, OpEx and aebitda OPEX $ millions Revenue and OpEx $369 Revenue $380 $400^ $316 $178 $161 $165 $165 FY 13 FY 14 FY 15* FY 16** $36 $13 FY 13 FY 14 $23 FY 15* FY 16** aebitda $(56) *FY 15 data based on constant currency as compared to FY 14 due to significant currency impact on aebitda in FY 15 **FY 16 data represents the mid-point of guidance as adjusted for the one-time $7.9M impact of Cowealth legal fees ^FY 16 data represents the mid-point of guidance ^^FY 16 data represents the trailing 12-month as of Q3 FY 16 All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 117
118 Improving Cash Flow Forecasted first year of positive cash flow in the Company s history $ millions CASH GENERATION* $11 FY 13 FY 14 FY 15 ($3) Q3 YTD FY 16^ ($28)** ($80) *Represents annual change in cash and short term investments excluding any capital raised for the year **FY 15 ended the year with higher level of receivables and inventory than FY 14 ^FY 16 data represents year-to-date change for the 9-months ended 3/31/16 adjusted for the one-time payment of $5.5M in Cowealth legal fees All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 118
119 Balance Sheet Improving capital structure: our approach to the August 2016 converts Improving cash position strengthens our capital structure announced straight debt financing on January 12, 2016 Shares Raised $70M straight debt Retired $63M of the $100M August 2016 convertible notes Full retirement of August 2016 notes eliminates the potential issuance of approximately 10.6M shares All rights reserved. All rights reserved. confidential. Weighted Average Shares Outstanding YTD 3/31/ M 2016 Convertible Notes (potential dilution) 10.6 M $100M principle, $9.46 conversion price Shareholder Dilution Avoided 13% Precise, innovative tumor treatments 119
120 Balance Sheet Today An improved capital structure $150M in cash, cash equivalents and investments as of Q3 FY 16 and growing Debt Maturities $ millions $140.0 $115 $120.0 $100.0 $70 $80.0 $60.0 $36.6 $40.0 $20.0 $Jan-15 Jan % '16 Conversion Price $9.47 Jan-17 Jan % '18 & Series A $5.33 Jan-19 Jan-20 Jan-21 Secured Term Loan '21 N/A We intend to utilize current cash, in conjunction with exploring additional debt refinancing, to settle the existing debt obligations. All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 120
121 A Path to Profitability Where we were, where we are and where we are heading Past Present Future Goals Revenue 100% 100% 100% Gross Margin 31% 40%* ~45% Operating Income (26%) (1%)* 10% + EBITDA (18%) 7%^ 15% + Where we were: represents FY 2013 financials *LTM ^Mid point of guidance All rights reserved. All rights reserved. confidential. Precise, innovative tumor treatments 121
122 Josh Levine President and CEO May 20, 2016 All rights reserved. Precise, innovative tumor treatments 2
123 Closing Remarks All rights reserved. Precise, innovative tumor treatments 123
124 Closing Remarks We are a highly competitive radiation therapy company, continuing to drive innovative cancer care, on a clear path to profitability. Josh Levine, President and CEO May 20, 2016 All rights reserved. Precise, innovative tumor treatments 124
125 Poised for Growth 2016 Analyst and Investor Day May 20, 2016 All rights reserved.
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