UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On February 14, 2023, Accuray Incorporated (the “Company”) intends to present the management presentation slides attached hereto as Exhibit 99.1 during the virtual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference to discuss, among other things, the long-term business and growth strategies for the Company. Such slides may be used in additional presentations to investors and analysts from time to time. The management presentation slides will also be posted on the investor relations portion of the Company’s website.
The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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Management Presentation Slides of Accuray Incorporated dated February 2023 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ACCURAY INCORPORATED |
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Date: |
February 14, 2023 |
By: |
/s/ Jesse Chew |
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Jesse Chew |
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Corporate Overview Innovation Driven Growth Strategy February 2023 Exhibit 99.1
Proprietary and Confidential Property of Accuray 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 1995. Forward-looking statements in this presentation relate, but are not limited, to: expectations regarding fiscal 2023 full-year adjusted EBITDA and revenue; our positioning and strategy for accelerating revenue growth and market share; expectations regarding radiation therapy and its position for value-based care and potential as a first-line therapy; expectations regarding the size and growth of the radiation therapy market; expectations regarding our areas of strategic focus; expectations regarding new product enhancements or offerings and partnerships, including with respect to the China JV and related products; and expectations related to our revenue growth, market share, growth catalysts, customer demand and installed base. Forward-looking statements generally can be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “projects,” “may,” “will be,” “will continue,” and similar expressions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from expectations. These risks and uncertainties include, but are not limited to: risks related to the current global economic environment and the effects of the COVID-19 pandemic on our business, financial condition, results of operations or cash flows; disruptions to our supply chain, including increased logistics costs; our ability to achieve widespread market acceptance of our products, including new product offerings and improvements; our ability to develop new products or enhance existing products to meet customers’ needs and compete favorably in the market; our ability to realize the expected benefits of the joint-venture and other partnerships; risks inherent in international operations; our ability to effectively manage our growth; our ability to maintain or increase our gross margins on product sales and services; delays in regulatory approvals or the development or release of new offerings; our ability to meet the covenants under our credit facilities; our ability to convert backlog to revenue; and other risks identified under the heading “Risk Factors” in our quarterly report on Form 10-Q, filed with the Securities and Exchange Commission (the “SEC”) on February 2, 2023, and as updated periodically with our other filings with the SEC. Forward-looking statements speak only as of the date the statements are made and are based on information available to Accuray at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. Accuray 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 place undue reliance on any forward-looking statements. Non-GAAP Financial Measures This presentation also contains non-GAAP financial measures. Management believes that non-GAAP financial measures provide 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, these non-GAAP financial measures assist management in analyzing future trends, making strategic and business decisions, and establishing internal budgets and forecasts. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP measure is provided in the slides at the end of this presentation. Accuray has also reported certain operating results on a constant currency basis in order to facilitate period-to-period comparisons of its results without regard to the impact of foreign currency exchange rate fluctuations. Management believes disclosure of non-GAAP constant currency results is helpful to investors because it facilitates period-to-period comparisons of the company’s results by increasing the transparency of the underlying performance by excluding the impact of foreign currency exchange rate fluctuations. Accuray calculates the constant currency amounts by translating local currency amounts in the current period using the same foreign translation rate used in the prior period being compared against rather than the actual exchange rate in effect during the current period. There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the company’s consolidated financial statements prepared in accordance with GAAP. Medical Advice Disclaimer Accuray Incorporated as a medical device manufacturer cannot and does not recommend specific treatment approaches. Individual results may vary. Forward-looking Statements This presentation is intended exclusively for investors. It is not intended for use in Sales or Marketing.
Accuray Overview Global Leader in Precision Radiation Therapy Vision: To expand the curative power of radiation therapy to improve as many lives as possible Systems Installed in Over 60 Countries1 1: As of October 20, 2022 2: Estimated percentage of revenue invested into R&D Installed Base Milestone Expected by 1H of 2023 Main Manufacturing Facility Madison, WI 22% $430M R&D Spend In FY222 Patents In Portfolio1 14% 392 Key FY22 Financials Total Revenue YOY Product Revenue Growth 1,000th 1,000+ Global Employee Presence1 3 2 Precision Platforms Proprietary and Confidential Property of Accuray
Suzanne Winter President and CEO Ali Pervaiz Senior Vice President, Chief Financial Officer Sandeep Chalke Senior Vice President, Chief Commercial Officer Jesse Chew Senior Vice President, General Counsel Mike Hoge Senior Vice President, Global Operations Patrick Spine Senior Vice President, Chief Administrative Officer Jim Dennison Senior Vice President, Global Quality & Regulatory Affairs Accuray Executive Leadership Team 4
RT Strongly Positioned for Value-based Care 5 U.S. Cancer Expenditures Estimate ($ Billion)1,2 1: Dieguez G., Ferro C., Pyenson B.S. A multi-year look at the cost burden of cancer care: Milliman research report. https://milliman-cdn.azureedge.net/-/media/Milliman/importedfiles/uploadedFiles/insight/2017/cost-burden-cancer-care.ashx (Published 2017. Accessed August 21, 2020) 2: NIH National Cancer Institute Cancer Trend Progress Report https://progressreport.cancer.gov/after/economic_burden (Data as of April 2022) 3: https://www.cancer.gov/publications/patient-education/radiation-and-you-2021-508.pdf Proven Outcomes Enhanced Patient Experience Non-Invasive Cancer patients treated with radiation therapy3 ~60% $6.30 $23.00 $48.00
6 The Golden Age of Radiotherapy Radiation therapy/radiosurgery potential as a first-line therapy Shorter Treatment Regimens Imaging Innovation Correct for Changes Powerful Partnerships Clinical Innovation Reduced Patient Burden – Advanced Precision – Clinical Evidence Proprietary and Confidential Property of Accuray
7 Accuray Systems: Differentiated Solutions CT-Linac System Radixact® System Robotic System CyberKnife® Accuray Precision® Premium Performance Radiosurgery/SBRT System Connectivity to the RT Department Treatment Planning System Proprietary and Confidential Property of Accuray
The Radixact® System: a Universal Workhorse Synchrony® 4D Dynamic Delivery Simple VOLO™ Ultra Planning Unique Helical Platform Any Case Complexity Precise Helical Dose Painting ClearRT™ Imaging Quick Installation Vendor Neutral Connectivity 8 Proprietary and Confidential Property of Accuray
The CyberKnife® Radiosurgery System Unique Robotic Platform Submillimeter Accuracy Fast Delivery Versatile SRS/SBRT System Thousands of Beam Angles Flexible Collimation For Various Cases Powerful Planning Choices Moving Or Stationary Targets 9 Proprietary and Confidential Property of Accuray
Accuray Software Solutions Accuray Precision® Treatment Planning iDMS® Data Management Synchrony® Motion Adaptation Technology High-quality Plans All Case Types Strategic Software Partnerships1 10 1: C-RAD, Brainlab, RaySearch, Limbus AI OIS Compatibility Seamless Integration AI-Driven Real-Time Adaptive Therapy
Radiation Therapy Market1 1: ReAnin Radiotherapy Market, Global Industry insights and trends 2017-2027. $3.3B $2.5B $- $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 Proton Therapy Cobalt Brachytherapy Systemic Therapy Software Total: $5.8B $M Accuray competes in Premium and Specialty Markets Proprietary and Confidential Property of Accuray Accuray competes in $1.6B market 27% share in FY22 Total Addressable Market: $3.3B; Low Single Digit % growth Linacs MR-linac GammaKnife CyberKnife Radixact Addressable Market Total RT Market Size 11
FY23-25 Radiation Therapy Market Mature versus growth markets 1: Based on COCIR radiotherapy age profile & density, December 2019 Edition, DIRAC database and proprietary data, data on file 2: Infoholic and COCIR reports on proportion of systems and system ageing: ASP estimated at $2-2.3B, data on file 3: DIRAC database and proprietary data Replacement 2 New 3 MATURE MARKETS US, Western Europe, Japan, Australasia 2,200 systems are 10+ years of age (representing a $5B market opportunity over time1) Pent up demand for technology replacement Average life cycle increased from 10 to 12.5 years due to COVID GROWTH MARKETS China, Asean, LATAM, Eastern Europe $1.3 B Annual New System Market3: China: $600-$700 annual market opportunity 12% CAGR Brazil and India: $300M annual market opportunity Other markets: $300-400M 65% 35%
13 Strategic Areas of Focus Proprietary and Confidential Property of Accuray Drive market share through disruptive innovation Expand service business Transform through strategic partnerships Drive margin and profitability initiatives
Ultra-Hypofractionation is Ready for Prime-Time 20% Adoption0 growing with Phase II-III clinical evidence 70%5 Breast, prostate, lung cancer, and metastases Patient Mix Phase II-III Trials Fast-Forward PACE-B STARS SABR-COMET Adoption 20% HF UHF0 HF: hypofractionation UHF: ultra-hypofractionation Fast-Forward Trial Early-stage breast cancer1 PACE-B Trial Localized prostate cancer2 STARS Trial Early-stage lung cancer3 SABR-COMET Trial Oligometastatic disease4 Growing Clinical Evidence Supports UltraHF Treatments 0 Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey 1 Brunt et al. Lancet. 2020;395(10237):1613-1626. doi:10.1016/S0140-6736(20)30932-6 2 Van As et al. Journal of Clinical Oncology 37, no. 7_suppl (March 01, 2019) 1-1. DOI: 10.1200/JCO.2019.37.7_suppl. 3 Chang JY, et al. Lancet Oncol. 2021 Oct;22(10):1448-1457. doi: 10.1016/S1470-2045(21)00401-0. Epub 2021 Sep 13. PMID: 34529930; PMCID: PMC8521627. (revised) STARS 4 Harrow et al. International Journal of Radiation Oncology, Biology, Physics. 2022, doi: https://doi.org/10.1016/j.ijrobp.2022.05.004 5 Incidence based model (Globocan data), Fractionation (The Lancet Oncology), Metastatic percentage (Rosenblatt et al.) 14
15 Service quality and customer satisfaction Clinical technology adoption Expansion of direct-service markets JV Partner and distributor performance Commercial Focus on Service Deal support and blended-margin analysis Market analytics Service Offering Expansion Monetizing value-added services Expanded training and professional services offerings Parts cost productivity Service training and tools Design-for-serviceability Inventory Optimization Securing and Growing Installed Base (IB) Increasing Service Profitability Driving Service Growth Beyond the IB Multi-year Service Strategic Focus FY23 and beyond
16 Accuray - GE Healthcare Partnership Global commercial collaboration agreement Proprietary and Confidential Property of Accuray Expand access to innovative precision solutions from diagnosis to treatment Accuray radiation therapy technologies + GE Healthcare’s imaging solutions Emphasis on early detection; functional diagnostics; targeted, precise treatment delivery Drive digitalization and interoperability Personalized care at each stage of the treatment
17 Establish domestic presence, brand, product Launch Tomo® C for Type-B, critical for growth Continue to harvest share in Type-A Leverage CAMT infrastructure for COGS reduction & value product manufacturing (margin, capacity, risk) China JV Strategy CAMT (JV) is our path to winning share in the growing RT market in China Formation of CAMT Build the Commercial Team Build the Factory & Training Center Tomo C Design Release Tomo C BIMT Type-Testing Tomo C NMPA Submission Tomo C Full-year Volume COVID The CAMT Start-up Journey 2019* 2020* 2021* 2022* 2023* 2024* 2025* Tomo C NMPA License Tomo C Introduction & Ramp up CyberKnife® S7™ & Radixact® Synchrony® NMPA Licenses 17 Proprietary and Confidential Property of Accuray *Accuray fiscal years
Q2’FY23 Highlights NMPA regulatory submission completed for Tomo® C, the joint venture product for the China Type B segment Awarded 18 systems in the November 2022 Ministry of Health Type A central bidding process in China1 Received IMV Award for Best in Service in Radiation Oncology for 2022 Completed production and testing of the first Tomo C unit in Tianjin manufacturing operations 34 new orders globally for Radixact® and CyberKnife® Systems with 92% year over year growth in Americas region 1 ccgp.gov.cn; chinabidding.com 18
Q2’FY23 and 1H’FY23 Financials Strong financial performance KEY FINANCIAL METRICS $M Q2 Y/Y Highlights Steady orders performance amidst significant currency fluctuations Total Q2 revenue decline of 1% due to supply chain constraints and unfavorable foreign currency fluctuations OPEX includes ~$2M of restructuring charges Reaffirmed FY23 full year adjusted EBITDA guidance of $26M to $30M1,3 1 Adjusted EBITDA is a non-GAAP measure. Please see Slide 23, 24 and 26 for a reconciliation of Adjusted EBITDA to the most directly comparable GAAP measure. 2 Percentages shown on a constant currency basis are non-GAAP measures. 3 FY23 guidance affirmed February 1, 2023. Nothing contained herein should be construed as reaffirmation of such guidance. 1H Y/Y Q2 Y/Y XFX2 1H Y/Y XFX2 Gross Orders $79.0M (7%) (3%) $148.9M (4%) 1% Revenues $114.8M (1%) 4% $211.3M (6%) 0% Product $63.3M 4% 8% $107.9M (5%) (1%) Service $51.5M (7%) 0% $103.4M (6%) 1% Op. Expenses $40.3M 4% $77.0M 2% R&D $14.6M (0%) $28.7M (1%) SG&A $25.6M 7% $48.3M 3% Adj. EBITDA1 $8.5M 24% $10.4M (15%)
FY23 Guidance Affirmed February 1, 20231 Revenue Adjusted EBITDA2 $429.9M $22.8M FY23 Guidance Range1 FY22 Actual $ in millions % = YoY Growth $447M - $455M +4% - 6% $26M - $30M +14% - 32% 1 FY23 guidance affirmed February 1, 2023. Nothing contained herein should be construed as reaffirmation of such guidance. 2Adjusted EBITDA is a non-GAAP measure. Please see Slides 25 and 26 for a reconciliation of Adjusted EBITDA to the most directly comparable GAAP measure
In Summary Growing momentum with 34 orders in the quarter Strongest product portfolio and pipeline in company’s history Multiple growth catalysts and global commercial execution Focused on margin expansion and free cash flow Positioned for Long-Term Revenue Growth and Market Share Gain 21
Thank you
$K GAAP net income (loss) Stock-based compensation Interest expense, net Provision for income taxes Adjusted EBITDA Depreciation and amortization Three Months Ended December 31, Three Months Ended December 31, 2021 2022 $ $ $ $ (1,874) 1,151 3,126 2,642 1,049 8,498 179 1,422 2,695 2,070 480 6,846 ERP and ERP related expenditures 466 Restructuring charges 1,938 0 0 GAAP to Adjusted EBITDA Q2 FY23 and Q2 FY22 Actual Reconciliation of Net Income (Loss) to Adjusted Earnings Before Interest, Taxes, Depreciation, Amortization and Stock-Based Compensation (Adjusted EBITDA) 23
$K GAAP net income (loss) Stock-based compensation Interest expense, net Provision for income taxes Adjusted EBITDA Depreciation and amortization Six Months Ended December 31, Six Months Ended December 31, 2021 2022 $ $ $ $ (7,323) 2,327 6,042 4,898 1,390 10,393 (849) 2,841 5,211 4,106 911 12,220 ERP and ERP related expenditures 1,121 Restructuring charges 1,938 0 0 GAAP to Adjusted EBITDA 1H FY23 and 1H FY22 Actual Reconciliation of Net Income (Loss) to Adjusted Earnings Before Interest, Taxes, Depreciation, Amortization and Stock-Based Compensation (Adjusted EBITDA) 24
GAAP to Adjusted EBITDA FY22 Actual Reconciliation of Net Income (Loss) to Adjusted Earnings Before Interest, Taxes, Depreciation, Amortization and Stock-Based Compensation (Adjusted EBITDA) $K GAAP net income (loss) Stock-based compensation Interest expense, net Provision for income taxes Adjusted EBITDA Depreciation and amortization Twelve Months Ended June 30, 2022 $ $ (5,347) 5,522 10,600 8,109 3,345 22,823 ERP and ERP related expenditures 594 One-time charge related to debt refinance and convertible exchange 0 25
$K GAAP net income (loss) Stock-based compensation Interest expense, net Provision for income taxes Adjusted EBITDA Depreciation and amortization To From $ $ $ $ (5,500) 6,300 11,600 8,000 2,000 26,000 (1,500) 6,300 11,600 8,000 2,000 30,000 ERP and ERP related expenditures 1,600 Restructuring charges 2,000 1,600 2,000 GAAP to Adjusted EBITDA FY23 – Forward Looking Guidance Actual Reconciliation of Net Income (Loss) to Adjusted Earnings Before Interest, Taxes, Depreciation, Amortization and Stock-Based Compensation (Adjusted EBITDA) Twelve Months Ended June 30, 2023 26