A New Standard of Care. ASTRO 2017 Update (NASDAQ: VRAY) 1

Transcription

1 A New Standard of Care ASTRO 2017 Update (NASDAQ: VRAY) 1

2 Disclaimer Forward-Looking Statements This presentation may contain forward-looking statements that are based on our current expectations of the market and regulatory environments, estimates and projections about our industry as well as management s beliefs and assumptions. Words such as anticipates, expects, intends, plans, believes, seeks, estimates, may, will and variations of these words or similar expressions are intended to identify forward-looking statements. These statements include projections about the growth of the market for radiation oncology, and speak only as of the date hereof. Such statements are based upon the information available to us now and are subject to change. We will not necessarily inform you of such changes. Unless the context requires otherwise, references to ViewRay, the company, we, us and our refer to ViewRay, Inc. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors. Factors which could cause actual results to differ materially from those in the forward-looking statements include, among others, the availability of competitive alternatives to our products, domestic or international economic uncertainty and other events beyond our control. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC, available at 2

3 5 key takeaways 3+ years of clinical experience show clear advantages of MRI guided RT Only system to adapt and reshape the dose with patient on-table Unique 4 Tesla quality imaging at the right (RT) field strength for therapy Henry Ford Health Center treating with MRIdian Linac since July Reiterating guidance of $45-$50M on 7-8 systems by year end ViewRay believes that we will enable a new standard of cancer care. 3

4 This is why it matters Can you believe, without ViewRay Clinicians are blind while delivering radiation X-rays cannot see soft tissue tumors Now ViewRay has a patented solution: MRIdian Linac MRIdian users see how tumors & organs change shape Radiation Oncologists can see and adapt like a surgeon 4

5 This is why it matters Can you believe, without ViewRay Clinicians are blind while delivering radiation X-rays cannot see soft tissue tumors Now ViewRay has a patented solution: MRIdian Linac MRIdian users see how tumors & organs change shape Radiation Oncologists can see and adapt like a surgeon * Henry Ford Cancer Institute 5

6 ViewRay investment opportunity Right Breast Mediastinum Head/Neck Right Lung Bladder Mesenteric Aortic Arch World s only commercially available MRI-guided radiation treatment system First 9 systems proved breakthrough is real Hilum Soft Tissue ABD Pancreas Mediastinal LN Adrenal Rib Pelvic LN FDA clearance of MRIdian Linac transforms profitability profile 25 Systems, $144.9M in Backlog Paraaortic Liver Iliac Stomach Spine Soft Tissue Neck Left Lung $3.7 billion radiation oncology opportunity Spleen Colon Periaortic Left Breast 6 Prostate Soft Tissue Pelvis Rectum Confidential Information 1

7 Confidential Information 7

8 * Washington University Here s how MRIdian makes a difference Cone-beam CT Align MRIdian - MRI Adapt MRIdian - On-table Adapting FX 1 ADAPTED FX 2 ADAPTED Track MRIdian - Direct Tracking Most accurate soft tissue alignment today Make changes to match daily soft tissue anatomy See what you treat as you treat 8

9 Reshaping the dose with MRI on-table adaptive NSCLC Adrenal Metastasis treatment Original Plan Day of Treatment Today s standard is to use this initial plan every day of the treatment Henke et al. Int J Radiation Oncol Biol Phys, Vol. 96, No. 5, pp. 1078e1086, 2016

10 Reshaping the dose with MRI on-table adaptive NSCLC Adrenal Metastasis treatment Original Plan Day of Treatment Today radiation is often delivered this way missing parts of the target and irradiating healthy tissue Best case, some technologies will detect the move, but not the changed shape Today s standard is to use this initial plan every day of the treatment MRIdian shows tumor has moved significantly and changed shape Henke et al. Int J Radiation Oncol Biol Phys, Vol. 96, No. 5, pp. 1078e1086, 2016

11 Reshaping the dose with MRI on-table adaptive NSCLC Adrenal Metastasis treatment Original Plan Day of Treatment Just accounting for the shift is only part of the story The tumor has also changed shape Only ViewRay s Adaptive planning can RESHAPE the prescription Matching the tumor s shape and position All without moving the patient Henke et al. Int J Radiation Oncol Biol Phys, Vol. 96, No. 5, pp. 1078e1086, 2016

12 Reshaping the dose with MRI on-table adaptive NSCLC Adrenal Metastasis treatment Original Plan Day of Treatment This is the plan that was expected to be delivered every day for the duration of the treatment This is what the MRIdian saw the first day of treatment, the tumor has moved significantly to the right Just accounting for Only ViewRay has the Integrated the shift is only software tools to RESHAPE the part of the story, prescription to match the tumor s since the tumor shape and position RIGHT BEFORE has also changed TREATMENT shape With this unique capability clinicians can further increase dose without increasing toxicity and that has exciting benefits Henke et al. Int J Radiation Oncol Biol Phys, Vol. 96, No. 5, pp. 1078e1086, 2016

13 Clinical benefits of adaptive and higher dose Updated pancreas data presented here at ASTRO 2017 Compelling early results from higher doses delivered through adaptive planning Overall Survival Retrospective data on locally advanced Pancreatic cancer from UCLA, UW, VUMC, & Wash U ViewRay announced a multi-institutional prospective clinical trial on (Primary) Toxicity N=23, BED >90 - on-table adapted N=19, BED <90 non--adapted (Secondary) Overall Survival Higher Maximum Biologic Effective Dose Utilizing Adaptive MRI Guided Radiation Therapy Improves Survival of Inoperable Pancreatic Cancer Patients Rudra S, Jiang N, Rosenberg S, Olsen J, Lagerwaard F, Bruynzeel A, Parikh P, Bassetti M, Lee P; ASTRO

14 Clinical benefits of adaptive and higher dose Updated pancreas data presented here at ASTRO 2017 Compelling early results from higher doses delivered through adaptive planning Overall Survival Retrospective data on locally advanced Pancreatic cancer from UCLA, UW, VUMC, & Wash U The LAP07 Randomized Clinical Trial Pascal Hammel, MD 1 ; Florence Huguet, MD 2 ; Jean- Luc van Laethem, MD 3 ; et al ViewRay announced a multi-institutional prospective clinical trial on (Primary) Toxicity N=23, BED >90 - on-table adapted N=19, BED <90 non--adapted (Secondary) Overall Survival Higher Maximum Biologic Effective Dose Utilizing Adaptive MRI Guided Radiation Therapy Improves Survival of Inoperable Pancreatic Cancer Patients Rudra S, Jiang N, Rosenberg S, Olsen J, Lagerwaard F, Bruynzeel A, Parikh P, Bassetti M, Lee P; ASTRO

15 Latest clinical proof of MRIdian value Presented at ASTRO 2017 Outcomes Utilizing MRI-guided and Real-Time Adaptive Pancreas Stereotactic Body Radiotherapy (SBRT) Stereotactic MR-Guided Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Tumors Stereotactic MR-Guided Adaptive Radiotherapy (SMART) for Ultra-Central Thorax Lesions: Results of a Phase 1 Trial Differential Response Rates of Gastrointestinal Tumors During Real-timeMRI-Guided Radiation Therapy: Opportunities for TreatmentIndividualization Treatment Plan Quality of Tri-Co-60 Intensity Modulated Radiation Therapy Compared to Volumetric Modulated Arc Therapy for Cervical Cancer Towards Tumor Margins Reduction: Tracking Accuracy Evaluation of an MRI-RT System 15

16 Ready for all cancer centers MRIdian treats the full range of cancers handled by conventional linacs Right Breast Mediastinum Head/Neck Right Lung Bladder Mesenteric Aortic Arch Hilum Soft Tissue ABD Pancreas Mediastinal LN Adrenal Rib Pelvic LN Paraaortic Liver Iliac Stomach Spine Soft Tissue Neck Left Lung Spleen Colon Periaortic Left Breast Prostate Soft Tissue Pelvis Rectum Confidential Information 1 16

17 Ready for all cancer centers MRIdian treats the full range of cancers handled by conventional linacs MRIdian advantages in breast, prostate, and lung (60% of radiotherapy cases) 100% Good to Excellent Cosmesis >50% reduction in overall dose 17

18 Ready for all cancer centers MRIdian treats the full range of cancers handled by conventional linacs MRIdian advantages in breast, prostate, and lung (60% of radiotherapy cases) Stereotactic MR-Guided Adaptive Radiation Therapy (SMART) for Prostate Cancer Poster Number:3626 ASTRO 2017 Authors: F. Lagerwaard, A. Bruynzeel, S. Tetar, S. S. Oei, C. Haasbeek, B. J. Slotman, S. Senan, O. Bohoudi, and M. Palacios; VU University Medical Center, Amsterdam, Netherlands Daily re-optimization is mandatory to ensure appropriate target coverage when performing prostate SBRT with 3mm CTV to PTV margins, even with ideal pre-treatment setup. 18

19 Ready for all cancer centers MRIdian treats the full range of cancers handled by conventional linacs MRIdian advantages in breast, prostate, and lung (60% of radiotherapy cases) ASTRO 2017 Stereotactic MR-Guided Adaptive Radiotherapy (SMART) for Ultra-Central Thorax Lesions: Results of a Phase 1 Trial Session Title:eP 18 : Lung eposter Discussion 2 - SBRT Date:9/27/ Time:3:15 p.m. - 4:45 p.m. Presentation Number:1152 AuthorsL. E. Henke 1, R. Kashani 2, O. L. Green 3, A. Curcuru 1, M. C. Roach Jr 4, S. Mutic 3, J. Michalski 4, P. J. Parikh 4, J. D. Bradley 3, J. R. Olsen 3, and C. G. Robinson 4 ; 1 Washington University, St. Louis, MO, Parkview Place, Saint Louis, MO, 3 Washington University School of Medicine, St. Louis, MO, 4 Washington University School of Medicine, Department of Radiation Oncology, St. Louis, MO SMART allows PTV coverage improvement and/or OAR sparing compared to non-adaptive SBRT, and may widen the therapeutic index of UCT SBRT. This technique is clinically feasible and offers excellent local control with no observed acute Grade>=3 toxicity. Impact of Daily Adaptive Plans for Stereotactic MR-Guided Radiation Therapy (SMART) in Early Stage Lung Cancer Poster Number:3713 Authors: S. Senan, S. Tetar, O. Bohoudi, M. Palacios, B. J. Slotman, A. Bruynzeel, and F. Lagerwaard; VU University Medical Center, Amsterdam, Netherlands 19

20 Ready for all cancer centers MRIdian treats the full range of cancers handled by conventional linacs MRIdian advantages in breast, prostate, and lung (60% of radiotherapy cases) MRIdian s RayZR MLC and sharp edged beams enable Radiosurgery 20

21 Value of adaptive therapy recognized with reimbursement Hospitals and physicians receiving extra when anatomical changes necessitate a revised plan using existing codes (over 3 years experience) With better visualization patients can be treated in fewer fractions (IMRT to SBRT) reducing overall cost of care SBRT (5 Fx) IMRT (30 Fx) $24,045 Revenue per Patient $11,213 $19,792 Revenue per Patient $17,636 VMAT MRIdian (3 replan) VMAT MRIdian (2 replan) 21

22 With shorter, high dose treatments - everybody wins Patients receive shorter courses of treatment Physicians recognize potential of high dose SBRT Hospitals and free-standing clinics gain capacity Payors pay less per patient ViewRay customers positioned well for shift to value-based payment system SBRT 3D Conf IMRT Other Projected Market Growth of SBRT 6% 41% 13% 40% % 45% 18% 32% 1 Morgan Stanley Research; Global Medical Devices April 7, 2016, 2 As reported by centers shown here 1 43% % MRIdian SBRT Utilization 2-3x Higher 5% 95% 51% 45% 65% 4% 35% 2 30% 48% 22% 47% 46% 7% 22

23 ViewRay well positioned competitively Continuous MRI instead of poor contrast X-rays Unique on table adaptive capability Fits into existing vaults Standard Linac Elekta Research MRIdian Linac Elekta Vault size No MRI Massive, no regulatory clearance and costly construction 23 Plug-and-Play

24 ViewRay well positioned competitively Continuous MRI instead of poor contrast X-rays Unique on table adaptive capability Fits into existing vaults Standard Linac Elekta Research MRIdian Linac Standard Linac Vault size No MRI Massive, no regulatory clearance and costly construction 24 Plug-and-Play

25 ViewRay well positioned competitively Continuous MRI instead of poor contrast X-rays Unique on table adaptive capability Fits into existing vaults Standard Linac Elekta Research MRIdian Linac Standard Linac Vault size No MRI Massive, no regulatory clearance and costly construction 25 Plug-and-Play

26 5 key takeaways 3+ years of clinical experience show clear advantages of MRI guided RT Only system to adapt and reshape the dose with patient on-table Unique 4 Tesla quality imaging at the right (RT) field strength for therapy Henry Ford Health Center treating with MRIdian Linac since July Reiterating guidance of $45-$50M on 7-8 systems by year end ViewRay believes that we will enable a new standard of cancer care. 26

27 A New Standard of Care ASTRO 2017 Update (NASDAQ: VRAY) 27