Accuray(ARAY) - 2024 Q1 - Quarterly Report

PART I. Financial Information Item 1. Unaudited Condensed Consolidated Financial Statements Accuray's unaudited condensed consolidated financial statements for Q1 FY24 are presented, covering balance sheets, operations, equity, cash flows, and key notes Unaudited Condensed Consolidated Balance Sheets Total assets slightly decreased to $476.8 million, liabilities marginally increased, and stockholders' equity decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:------------------------|-------------:|-------------:|-----------:|-----------:| | Total Assets | $476,830 | $479,214 | $(2,384) | (0.5%) | | Total Liabilities | $425,886 | $425,555 | $331 | 0.1% | | Total Stockholders' Equity | $50,944 | $53,659 | $(2,715) | (5.1%) | - Cash and cash equivalents decreased from $89.4 million to $76.9 million, a reduction of $12.5 million[9] - Accounts receivable, net, increased by $2.6 million, from $74.8 million to $77.4 million[9] Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss Accuray reported an 8% increase in total net revenue for Q1 FY24, driven by product sales, significantly reducing net and comprehensive loss Condensed Consolidated Statements of Operations Highlights (in thousands, except per share) | Metric | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | Change ($) | Change (%) | |:-----------------------------|-----------------------:|-----------------------:|-----------:|-----------:| | Net Revenue | $103,892 | $96,493 | $7,399 | 7.7% | | Gross Profit | $39,493 | $34,597 | $4,896 | 14.1% | | Income (Loss) from Operations | $2,213 | $(2,182) | $4,395 | 201.4% | | Net Loss | $(2,969) | $(5,449) | $2,480 | (45.5%) | | Net Loss Per Share - Basic and Diluted | $(0.03) | $(0.06) | $0.03 | (50.0%) | | Comprehensive Loss | $(5,107) | $(9,104) | $3,997 | (43.9%) | - Product revenue increased by 19.6% to $53.4 million, while service revenue decreased by 2.6% to $50.5 million[13] - Gross profit margin improved from 35.9% in Q1 FY23 to 38.0% in Q1 FY24[13] Unaudited Condensed Consolidated Statements of Stockholders' Equity Total stockholders' equity decreased to $50.9 million due to net loss and foreign currency adjustments, partially offset by share-based compensation Changes in Stockholders' Equity (in thousands) | Item | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | |:--------------------------------------|-----------------------:|-----------------------:| | Balance at June 30 | $53,659 | $53,189 | | Share-based compensation | $2,392 | $2,906 | | Net loss | $(2,969) | $(5,449) | | Foreign currency translation adjustment | $(2,138) | $(3,655) | | Balance at September 30 | $50,944 | $46,991 | Unaudited Condensed Consolidated Statements of Cash Flows Accuray experienced a net decrease in cash, cash equivalents, and restricted cash of $12.5 million for Q1 FY24, primarily from operating activities Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | |:------------------------------------|-----------------------:|-----------------------:| | Net cash (used in) provided by operating activities | $(8,591) | $46 | | Net cash used in investing activities | $(1,092) | $(1,272) | | Net cash used in financing activities | $(1,500) | $(4,365) | | Effect of exchange rate changes | $(1,328) | $(2,173) | | Net decrease in cash | $(12,511) | $(7,764) | | Cash, cash equivalents and restricted cash at end of period | $78,691 | $82,390 | - Operating activities shifted from providing $46 thousand in cash in Q1 FY23 to using $8.6 million in Q1 FY24, mainly due to increases in inventories and accounts receivable, and decreases in customer advances[20] Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed disclosures on Accuray's financial statements, covering accounting policies, revenue, leases, assets, debt, and recent restructuring Note 1. The Company and its Significant Accounting Policies Accuray designs and sells advanced radiosurgery systems globally, facing macroeconomic risks, but maintains sufficient liquidity and debt compliance - Accuray designs, develops, and sells advanced radiosurgery and radiation therapy systems for tumor treatment globally[23] - Accuray is subject to risks from rising inflation, interest rates, foreign currency fluctuations, and geopolitical conflicts, which are expected to adversely affect gross margins and net income through at least fiscal year 2024[28][29] - Accuray believes it has sufficient cash resources and anticipated cash flows to fund operations for at least the next 12 months and was in compliance with debt covenants as of September 30, 2023[30][31] Note 2. Revenue Accuray's revenue recognition involves contract assets and liabilities; total remaining performance obligations were $1,034.4 million as of September 30, 2023 Contract Balances (in thousands) | Contract Balance Item | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:-------------------------------|-------------:|-------------:|-----------:|-----------:|\n| Unbilled accounts receivable – current | $13,805 | $9,847 | $3,958 | 40% | | Customer advances | $19,372 | $20,777 | $(1,405) | (7%) | | Deferred revenue – current | $71,764 | $72,185 | $(421) | (1%) | | Deferred revenue – non-current | $26,939 | $27,079 | $(140) | (1%) | - Total remaining performance obligations were $1,034.4 million as of September 30, 2023. Of this, $68.2 million relates to long-term warranty and non-cancellable post-warranty services[40] - For the remaining $966.2 million of performance obligations, 28% to 31% is estimated to be recognized in the next 12 months. Approximately 20% of the $915.4 million open system sales contracts as of September 30, 2023, may never result in revenue[41] Note 3. Supplemental Financial Information This note details balance sheet components, showing decreases in financing receivables and other accrued liabilities, with increases in inventories and property/equipment Financing Receivables (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:--------------------------|-------------:|-------------:|-----------:|-----------:|\n| Financing receivables | $4,870 | $5,854 | $(984) | (16.8%) | | Allowance for credit losses | $(798) | $(798) | $0 | 0.0% | | Total, net | $4,072 | $5,056 | $(984) | (19.5%) | Inventories (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:----------------|-------------:|-------------:|-----------:|-----------:|\n| Raw materials | $64,889 | $62,945 | $1,944 | 3.1% | | Work-in-process | $11,028 | $17,469 | $(6,441) | (36.9%) | | Finished goods | $74,060 | $64,736 | $9,324 | 14.4% | | Total Inventories | $149,977 | $145,150 | $4,827 | 3.3% | Property and Equipment, Net (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:------------------------|-------------:|-------------:|-----------:|-----------:|\n| Software | $12,887 | $5,191 | $7,696 | 148.2% | | Leasehold improvements | $33,774 | $26,641 | $7,133 | 26.8% | | Construction in progress | $3,821 | $13,499 | $(9,678) | (71.7%) | | Total, net | $24,963 | $20,926 | $4,037 | 19.3% | Other Accrued Liabilities (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:-------------------------------|-------------:|-------------:|-----------:|-----------:|\n| Commissions due to third parties | $6,685 | $10,499 | $(3,814) | (36.3%) | | Total other accrued liabilities | $36,634 | $38,271 | $(1,637) | (4.3%) | Other Expense, Net (in thousands) | Metric | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | Change ($) | Change (%) | |:-----------------------------|-----------------------:|-----------------------:|-----------:|-----------:|\n| Interest expense | $(2,922) | $(2,262) | $(660) | 29.2% | | Foreign currency exchange loss | $(956) | $(251) | $(705) | 280.9% | | Total other expense, net | $(3,681) | $(2,558) | $(1,123) | 43.9% | Note 4. Leases Accuray's operating lease costs increased to $2.6 million in Q1 FY24, with liabilities at $28.9 million and a 9.1-year weighted average lease term - Operating lease costs were $2.6 million for the three months ended September 30, 2023, up from $2.3 million in the prior year[60] Operating Lease Liabilities Maturities (in thousands) | Fiscal Year | Amount | |:------------|-------:| | 2024 (remaining nine months) | $4,342 | | 2025 | $5,757 | | 2026 | $3,762 | | 2027 | $3,654 | | 2028 | $3,349 | | Thereafter | $23,306 | | Total operating lease payments | $44,170 | | Less: imputed interest | $(15,287) | | Present value of operating lease liabilities | $28,883 | - Weighted average remaining lease term is 9.1 years, and the weighted average discount rate is 9.7%[63] Note 5. Goodwill and Intangible Assets Goodwill remained stable at $57.7 million with no impairment, while net intangible assets slightly decreased to $163 thousand due to amortization Goodwill Activity (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | |:-------------------------------|-------------:|-------------:| | Balance at the beginning of the period | $57,681 | $57,840 | | Currency translation | $(25) | $(159) | | Balance at the end of the period | $57,656 | $57,681 | Purchased Intangible Assets, Net (in thousands) | Metric | Sep 30, 2023 | Jun 30, 2023 | |:------------------------|-------------:|-------------:| | Patent license, net | $71 | $107 | | Other intangibles, net | $92 | $103 | | Total intangible assets | $163 | $210 | - No goodwill impairment was identified as of September 30, 2023[65] Note 6. Derivative Financial Instruments Accuray uses foreign currency forward contracts to manage exchange rate exposure, with $59.5 million outstanding and an $818 thousand loss in Q1 FY24 - Accuray uses foreign currency forward contracts to manage exposure to fluctuations in foreign currency exchange rates, primarily for Japanese Yen, Swiss Franc, and Euro[70] Notional Amount of Outstanding Forward Currency Exchange Contracts (in thousands) | Currency | Sep 30, 2023 | Jun 30, 2023 | |:---------------|-------------:|-------------:| | Swiss Franc | $30,679 | $26,867 | | Chinese Yuan | $4,054 | $249 | | Euro | $11,618 | $17,885 | | Japanese Yen | $9,919 | $12,492 | | Total | $59,531 | $61,548 | - A foreign currency exchange loss of $818 thousand on forward contracts was recorded for the three months ended September 30, 2023[72] Note 7. Fair Value Measurements Accuray measures assets and liabilities at fair value using Level 2 inputs, with outstanding currency forward contracts at $59.4 million and convertible notes at $90.1 million fair value - Fair value measurements are categorized into Level 1, Level 2, and Level 3 inputs. Accuray's fair value measurements for currency forward contracts and debt are considered Level 2[74][75][76] - The fair value of open currency forward contracts was $59.4 million as of September 30, 2023[75] Carrying Value and Estimated Fair Value of Debt (in thousands) | Debt Instrument | Sep 30, 2023 Carrying Value | Sep 30, 2023 Fair Value | |:-------------------------------|----------------------------:|------------------------:|\n| 3.75% Convertible Notes due 2026 | $98,335 | $90,122 | | Term Loan Facility | $67,686 | $67,686 | | Revolving Credit Facility | $10,000 | $10,000 | | Total | $176,021 | $167,808 | Note 8. Commitments and Contingencies Accuray is involved in legal proceedings but anticipates no material losses, with bank guarantees of $1.2 million and royalty costs of $0.5 million for Q1 FY24 - Management believes there are no probable and reasonably estimable material losses related to current legal proceedings and claims[80] - Accuray provides indemnification for software infringement and leased facilities, with no associated liabilities recorded as of September 30, 2023[81][82] - Bank guarantees totaled $1.2 million as of September 30, 2023, and royalty costs were $0.5 million for the three months ended September 30, 2023[83][84] Note 9. Debt Accuray's debt includes $100.0 million convertible notes and $78.5 million outstanding on credit facilities, with an 8.3% weighted average interest rate and covenant compliance - Outstanding debt includes $100.0 million aggregate principal of 3.75% Convertible Senior Notes due 2026[85][87] - Credit Facilities include a $40.0 million Revolving Credit Facility ($10.0 million outstanding) and an $80.0 million Term Loan Facility ($68.5 million outstanding) as of September 30, 2023[88] - The weighted average effective interest rate on the Term Loan Facility and Revolving Credit Facility was approximately 8.3% for the three months ended September 30, 2023[89] - Accuray was in compliance with all covenants under the Credit Agreement as of September 30, 2023[91] Note 10. Stock Incentive Plan and Employee Stock Purchase Plan Total share-based compensation expense decreased by 18% to $2.4 million for Q1 FY24 compared to the prior year Share-Based Compensation Expenses (in thousands) | Functional Line Item | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | Change ($) | Change (%) | |:---------------------------|-----------------------:|-----------------------:|-----------:|-----------:|\n| Cost of revenue | $236 | $366 | $(130) | (35.5%) | | Research and development | $401 | $368 | $33 | 9.0% | | Selling and marketing | $408 | $486 | $(78) | (16.0%) | | General and administrative | $1,347 | $1,696 | $(349) | (20.6%) | | Total | $2,392 | $2,916 | $(524) | (18.0%) | Note 11. Net Loss Per Common Share Basic and diluted net loss per share improved to $(0.03) for Q1 FY24, reflecting a reduced net loss, with 17.1 million potentially dilutive shares excluded Net Loss Per Common Share (in thousands, except per share amounts) | Metric | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | |:------------------------------------------|-----------------------:|-----------------------:|\n| Net loss | $(2,969) | $(5,449) | | Weighted average shares outstanding - basic and diluted | 96,555 | 93,529 | | Basic and diluted net loss per share | $(0.03) | $(0.06) | - Approximately 17.1 million shares from the 3.75% Convertible Notes due 2026 were excluded from diluted EPS calculation as they were anti-dilutive[98] Note 12. Segment Information Accuray operates as a single segment, with total net revenue increasing by 7.7% to $103.9 million in Q1 FY24, driven by 102% China revenue growth - Accuray operates as one operating and reporting segment: Oncology systems group[99] Revenue by Geographic Region (in thousands) | Region | Q1 FY24 (Sep 30, 2023) | Q1 FY23 (Sep 30, 2022) | Change ($) | Change (%) | |:----------------------------|-----------------------:|-----------------------:|-----------:|-----------:|\n| Americas | $20,557 | $27,285 | $(6,728) | (24.7%) | | EIMEA | $39,533 | $36,746 | $2,787 | 7.6% | | China | $26,215 | $13,000 | $13,215 | 101.7% | | Japan | $12,592 | $11,488 | $1,104 | 9.6% | | Asia Pacific, excluding China | $4,995 | $7,974 | $(2,979) | (37.4%) | | Total | $103,892 | $96,493 | $7,399 | 7.7% | Long-Lived Assets by Geographic Region (in thousands) | Region | Sep 30, 2023 | Jun 30, 2023 | Change ($) | Change (%) | |:----------------------------|-------------:|-------------:|-----------:|-----------:|\n| Americas | $44,317 | $41,569 | $2,748 | 6.6% | | EIMEA | $2,621 | $3,074 | $(453) | (14.7%) | | China | $1,056 | $501 | $555 | 110.8% | | Japan | $913 | $1,096 | $(183) | (16.7%) | | Asia Pacific, excluding China | $434 | $539 | $(105) | (19.5%) | | Total | $49,341 | $46,779 | $2,562 | 5.5% | Note 13. Joint Venture Accuray holds a 49% equity interest in a China JV, whose revenue increased by 19.1% to $31.9 million in Q1 FY24, with $431 thousand net income attributable to Accuray - Accuray owns a 49% interest in the CNNC Accuray (Tianjin) Medical Technology Co. Ltd. (JV) in China, accounted for using the equity method[106][107] Summarized Financial Information of the JV (in thousands) | Metric | Q1 FY24 (Jun 30, 2023) | Q1 FY23 (Jun 30, 2022) | |:------------------------------------------|-----------------------:|-----------------------:|\n| Revenue | $31,855 | $26,740 | | Gross profit | $5,813 | $4,596 | | Net income (loss) | $879 | $(752) | | Net income (loss) attributable to the Company | $431 | $(368) | - The total change in deferred intra-entity profit margin from sales was $1.6 million for the three months ended September 30, 2023[111] Note 14. Income Tax Income tax expense increased to $1.9 million in Q1 FY24, primarily due to foreign taxes, with GILTI offset by NOLs and no material impact from R&D capitalization changes - Income tax expense increased to $1.9 million for the three months ended September 30, 2023, from $0.3 million in the prior year, primarily due to foreign taxes[112] - The global intangible low tax income (GILTI) inclusion is expected to be fully absorbed by net operating loss carryforwards for fiscal year 2024[112] - The change in U.S. tax law requiring capitalization and amortization of R&D expenditures had no material impact on Q1 FY24 financial statements[113] Note 15. Subsequent Events Accuray announced a restructuring initiative on October 25, 2023, to reduce operating expenses by eliminating 5.9% of its global workforce at an estimated cost of $2.5 million - On October 25, 2023, Accuray announced a cost savings initiative to reduce operating expenses by eliminating approximately 5.9% of its global workforce[114] - The total estimated cost of this initiative is approximately $2.5 million for employee-related costs, expected to be recorded in the second quarter of fiscal year 2024[114] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides an overview of Accuray's business, economic conditions, and recent restructuring, detailing Q1 FY24 results, liquidity, capital resources, and critical accounting policies Overview Accuray develops and sells advanced radiosurgery systems globally, navigating macroeconomic challenges, with a China JV device approval and a recent 5.9% workforce reduction - Accuray develops, manufactures, sells, and supports advanced radiosurgery and radiation therapy systems (CyberKnife and TomoTherapy platforms) for tumor treatment[118][119] - Accuray continues to navigate significant macroeconomic headwinds, including rising inflation, supply chain challenges, and adverse foreign currency exchange rate fluctuations, which are expected to negatively impact gross margins and net income through at least fiscal year 2024[121][122] - Accuray's joint venture in China received approval for its Class B device in September 2023, aiming to manufacture and sell locally branded radiotherapy devices[126] - A restructuring initiative announced on October 25, 2023, will eliminate approximately 5.9% of the global workforce, with an estimated cost of $2.5 million[128] Backlog Accuray's order backlog decreased to $489.0 million at September 30, 2023, with gross orders down but net orders up, resulting in a 1.2 book-to-bill ratio Gross Orders, Net Orders, and Order Backlog (in thousands) | Metric | Q1 FY24 (2023) | Q1 FY23 (2022) | |:-----------------------------|---------------:|---------------:|\n| Gross orders | $63,734 | $69,848 | | Age-ins | $8,726 | $5,891 | | Age-outs | $(30,993) | $(51,176) | | Cancellations | $(8,841) | $(1,460) | | Currency impacts and other | $(886) | $(3,532) | | Net orders | $31,740 | $19,571 | | Order backlog at the end of the period | $489,031 | $538,447 | - Gross orders decreased by $6.1 million, primarily due to decreased orders in China and Americas regions, partially offset by increases in Asia Pacific and Japan[133] - The book-to-bill ratio was 1.2 for the three months ended September 30, 2023, compared to 1.6 in the prior year, with a ratio greater than 1.2 indicating strong demand[134] Results of Operations — Three months ended September 30, 2023 and 2022 Accuray's net revenue increased by 8% year-over-year, driven by 20% product revenue growth and 102% China revenue surge, improving gross profit by 14% and reducing net loss by 45.5% Net Revenue by Sales Classification (in thousands) | Sales Classification | Q1 FY24 (2023) | Q1 FY23 (2022) | Percent Change | |:---------------------|---------------:|---------------:|---------------:|\n| Products | $53,350 | $44,623 | 20% | | Services | $50,542 | $51,870 | (3%) | | Total Net Revenue | $103,892 | $96,493 | 8% | Net Revenue by Geographic Region (in thousands) | Region | Q1 FY24 (2023) | Q1 FY23 (2022) | Percent Change | |:----------------------------|---------------:|---------------:|---------------:|\n| Americas | $20,557 | $27,285 | (25%) | | EIMEA | $39,533 | $36,746 | 8% | | China | $26,215 | $13,000 | 102% | | Japan | $12,592 | $11,488 | 10% | | Asia Pacific, excluding China | $4,995 | $7,974 | (37%) | | Total | $103,892 | $96,493 | 8% | Operating Expenses (in thousands) | Operating Expense | Q1 FY24 (2023) | Q1 FY23 (2022) | Percent Change | |:---------------------------|---------------:|---------------:|---------------:|\n| Research and development | $14,013 | $14,092 | (1%) | | Selling and marketing | $10,244 | $10,795 | (5%) | | General and administrative | $13,023 | $11,892 | 10% | | Total Operating Expenses | $37,280 | $36,779 | 1% | - Income from equity method investment increased by $0.8 million, primarily due to higher product and service revenues and gross profit from the JV[146] - Other expense, net, increased by $1.1 million, driven by higher interest expense due to increased interest rates and increased foreign currency transaction losses[147] - Provision for income taxes increased by $1.6 million, mainly due to higher foreign earnings and deferred tax liability on unremitted foreign earnings[148] Liquidity and Capital Resources Accuray had $76.9 million in cash at September 30, 2023, with sufficient liquidity for 12 months, despite Q1 FY24 operating cash outflows and $178.5 million in total debt - Accuray had $76.9 million in cash and cash equivalents at September 30, 2023, and expects sufficient cash resources for the next 12 months[149] - The 2024 restructuring initiative is estimated to cost $2.5 million in employee-related cash expenditures, to be recorded in Q2 FY24[150] - Net cash used in operating activities was $8.6 million in Q1 FY24, primarily due to increased inventories ($8.9 million) and accounts receivable ($5.2 million), and decreased customer advances ($1.3 million)[156][157] - Outstanding debt includes $100.0 million in 3.75% Convertible Senior Notes due 2026 and $78.5 million outstanding under the Term Loan Facility and Revolving Credit Facility[153] Critical Accounting Policies and Estimates No material changes occurred in Accuray's critical accounting policies and estimates during Q1 FY24 compared to the prior fiscal year - No material changes to critical accounting policies and estimates during the three months ended September 30, 2023[166] Item 3. Quantitative and Qualitative Disclosures About Market Risk Accuray is exposed to market risks from credit, foreign currency, interest rates, and equity prices, managed through forward contracts and monitoring variable-rate debt and convertible note features Concentration of Credit and Other Risks Accuray's cash is held with major financial institutions, one customer accounts for 10%+ of revenue/receivables, and Accuray relies on single-source suppliers - Cash and cash equivalents are deposited with several major financial institutions, with deposits sometimes exceeding insurance limits, but no significant risk of loss is believed[168] - One customer represented 10% or more of total net revenue and accounts receivable for the three months ended September 30, 2023[168] - Accuray depends on single-source suppliers for several critical components of its products[169] Foreign Currency Exchange Rate Risk A majority of Accuray's sales are in foreign currencies, exposing Accuray to exchange rate fluctuations, which are mitigated by $59.5 million in foreign currency forward contracts - A majority of sales are denominated in foreign currencies (Euro, Japanese Yen), making Accuray vulnerable to U.S. Dollar fluctuations[170] - A strengthening U.S. Dollar negatively impacts revenue and can cause sales and margins outside the U.S. to decline[170] - Accuray uses foreign currency forward contracts with a notional value of approximately $59.5 million to manage this risk, with gains/losses recorded in other expense, net[171] Interest Rate Risk Accuray's $78.5 million variable-rate debt is tied to SOFR; a 50 basis point change would impact annual interest expense by approximately $0.4 million - Debt obligations, including the Term Loan Facility ($68.5 million) and Revolving Credit Facility ($10.0 million), are subject to variable interest rates tied to SOFR[173] - A 50 basis point change in interest rates would increase or decrease annual interest expense by approximately $0.4 million[173] Equity Price Risk Accuray's convertible notes expose Accuray to equity price risk if its common stock exceeds the $5.86 conversion price, potentially requiring $17.1 million in cash or shares - The 3.75% Convertible Notes due 2026 have an initial conversion rate equivalent to approximately $5.86 per share[174] - If the common stock price exceeds $5.86 upon conversion, Accuray expects to issue an additional $17.1 million in cash or shares if all notes are converted[174] Item 4. Controls and Procedures Accuray's disclosure controls were effective as of September 30, 2023, with a new ERP system (SAP) implemented to strengthen internal financial controls - Management concluded that disclosure controls and procedures were effective as of September 30, 2023, providing reasonable assurance for timely and accurate reporting[176] - Accuray implemented a new enterprise resource planning (ERP) system, SAP, in August 2023, which is expected to strengthen internal financial controls by automating processes and standardizing reporting[177] - No other significant changes in internal control over financial reporting occurred during the three months ended September 30, 2023[177] PART II. OTHER INFORMATION Item 1. Legal Proceedings Accuray is involved in various legal proceedings but does not anticipate any probable and reasonably estimable material losses - Accuray is involved in legal proceedings but does not believe any current claims would materially and adversely affect its financial condition or operating results[80][180] Item 1A. RISK FACTORS This section outlines numerous risks including global economic instability, market acceptance, profitability, indebtedness, competition, international operations, supply chain, and regulatory compliance Risk Factors Summary Accuray's business faces significant risks including global economic instability, market acceptance, profitability, indebtedness, competition, international operations, supply chain, and regulatory compliance - Risks related to business and results of operations include global economic environment, market acceptance, gross margins, indebtedness, operating result fluctuations, intense competition, international operations, foreign currency exchange rates, COVID-19 pandemic effects, manufacturing problems, new product development, growth management, product liability, single-source suppliers, key employee dependence, and IT system disruptions[181][182][183][185][186] - Regulatory risks involve new FDA clearances for product modifications, compliance with federal, state, and foreign laws, and obtaining necessary regulatory approvals in specific countries[187][188] - Risks related to common stock include price volatility, future equity issuances causing dilution, conditional conversion features of notes, and provisions that could discourage takeovers[189] Risks Related to Our Business and Results of Operations Accuray's business is highly susceptible to global economic conditions, market acceptance, profitability challenges, substantial indebtedness, intense competition, supply chain disruptions, and cybersecurity threats - Global economic environment, including inflation, increased interest rates, and geopolitical conflicts, significantly impacts Accuray's business, potentially reducing demand, increasing costs, and affecting gross margins[192][193][194][197] - Achieving widespread market acceptance for CyberKnife and TomoTherapy platforms is crucial, requiring extensive physician education, clinical data, and favorable third-party reimbursement, which are uncertain[198][199][202] - Profitability depends on maintaining or increasing gross margins, which are vulnerable to manufacturing yields, production volume, selling prices, increased labor/material costs, supply chain disruptions, and price competition[203][204][205] - Outstanding debt ($100M convertible notes, $78.5M credit facilities) poses risks by dedicating cash flow to payments, limiting future financing, and increasing vulnerability to economic downturns[207][208][209][210][211] - Operating results fluctuate due to long sales and implementation cycles, high unit prices, timing of orders/installations, cancellations, age-outs, and macroeconomic factors like COVID-19, making future performance unpredictable[213][214][215][216][218][219][296][297][298][300][303][304] - Intense competition from larger, well-capitalized companies (Varian, Elekta) and rapid technological change threaten to render Accuray's products obsolete or less useful[220][221][222][223][224] - International operations (majority of revenue) expose Accuray to economic, regulatory, social, and political risks, including import delays, foreign laws, trade policies, and currency fluctuations[225][226][227][228][229][231][232][233][234] - Supply chain disruptions, reliance on single-source suppliers for critical components, and manufacturing problems can lead to delays, increased costs, inability to meet demand, and adverse impact on financial results[239][243][253][254][255] - Dependence on key employees and challenges in attracting/retaining qualified personnel, exacerbated by workforce reductions, could adversely affect business growth[256][257] - Disruption of IT systems, cyberattacks, and security breaches pose risks of data loss, operational inefficiencies, legal liabilities, and reputational harm[258][259][260][261][262] - Failure to comply with evolving global privacy, cybersecurity, and data protection laws (e.g., GDPR, CCPA, PIPL) could result in significant fines, litigation, and reputational damage[263][264][265][266][267][268][269][270] - Third-party claims of intellectual property infringement or violation of license agreements could lead to costly litigation, licensing expenses, supply disruptions, or inability to sell products[280][281][282][283][284][285] - Difficulty and cost in protecting intellectual property (patents, trade secrets) against third-party challenges, design-arounds, and varying international protections could reduce competitive advantage[287][288][289][290][291][292][294] - Reliance on third-party distributors in international markets introduces risks related to their marketing efforts, regulatory compliance, financial stability, and potential termination of relationships[301][302] - Extended payment terms offered to customers may increase days sales outstanding, reduce cash flows, and lead to greater payment defaults[305] - Collaborations, partnerships, and joint ventures (like the China JV) are subject to risks such as capital contributions, failure to meet expectations, regulatory delays, and inconsistent interests with partners[307][308] - Acquisitions of new businesses, products, or technologies carry risks of integration difficulties, failure to realize expected benefits, dilution, and increased litigation risk[309][310] - Limited ability to raise capital or obtain future financing, especially during economic downturns or banking instability, could hinder growth strategy[311][312] - Uncertainty regarding the full utilization of tax loss carryforwards ($294.1M federal, $125.1M state) due to limitations from Section 382 and changes in tax laws[313][314][316] - Failure to maintain an effective system of internal control over financial reporting, especially with the new ERP system, could impair financial reporting accuracy and investor confidence[318][319][320] Risks Related to the Regulation of our Products and Business Accuray's products are subject to extensive FDA and international regulations, requiring new clearances and compliance with healthcare, anti-corruption, and privacy laws, with healthcare reform posing additional risks - Modifications, upgrades, and new products require new FDA 510(k) clearances or premarket approvals and similar international licensing, which can be expensive, lengthy, and unpredictable[321][323][324] - Failure to comply with manufacturing standards (FDA QSR, ISO), medical device reporting, and advertising regulations can lead to enforcement actions, recalls, and significant penalties[240][241][242][322][325][326] - Operations are subject to federal, state, and foreign laws, including anti-kickback, false claims, self-referral, and anti-corruption (FCPA) laws, with violations potentially resulting in substantial civil and criminal penalties[327][328][329][330][331][332] - Compliance with patient health information privacy laws (HIPAA) and transparency laws (Sunshine Act) is mandatory, with non-compliance risking civil and criminal liability, and penalties[333][334] - Failure to obtain and maintain necessary regulatory approvals in specific countries (e.g., CE mark in EU, Shonin in Japan) or comply with environmental laws can prevent market access and harm revenue[337][338][339][340][341] - Healthcare reform legislation (e.g., ACA, RO-APM) could adversely affect demand for products, revenue, and financial condition through changes in reimbursement rates and payment models[343][344][345][346][347] Risks Related to Our Common Stock Accuray's common stock price is volatile, with future equity issuances potentially diluting ownership, and conditional conversion features impacting liquidity, while corporate provisions could deter takeovers - The price of Accuray's common stock is volatile and can fluctuate significantly due to macroeconomic factors, operating results, and market perceptions[349][350][351] - Future issuances of equity securities, including common stock upon conversion of convertible notes, could dilute the ownership interests of existing stockholders[352][353] - Conditional conversion features of the Notes, if triggered, may require cash payments or reclassification of debt as current liability, adversely affecting liquidity and working capital[354][355] - Provisions in Accuray's certificate of incorporation, bylaws, and debt agreements (Notes indenture, Credit Facilities) could discourage or prevent a takeover, even if beneficial to stockholders[356][357][358][359] General Risks Accuray's liquidity is vulnerable to adverse financial market conditions, operations are exposed to interruptions, changes in accounting principles may affect results, and no dividends are expected - Liquidity could be adversely impacted by adverse conditions in financial markets, including reduced liquidity, defaults, and instability in the banking sector[360][361][362] - Operations are vulnerable to interruptions from natural disasters, global health pandemics (e.g., COVID-19), terrorist acts, and equipment failures, which could disrupt manufacturing and IT systems[362][363] - Changes in the interpretation or application of U.S. GAAP can significantly affect reported results and cause fluctuations in operating results[364] - Accuray has never paid and does not expect to pay cash dividends in the foreseeable future, retaining earnings for business operations and expansion[365] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds to report[367] Item 3. Defaults Upon Senior Securities No defaults upon senior securities were reported for the period - No defaults upon senior securities to report[367] Item 4. Mine Safety Disclosures Mine Safety Disclosures are not applicable to Accuray - Mine Safety Disclosures are not applicable[367] Item 5. Other Information No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 FY24 - No director or officer adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the first quarter of fiscal 2024[367] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including amended bylaws, CEO and CFO certifications, and Inline XBRL documents - Exhibits include Amended and Restated Bylaws, CEO and CFO certifications (Rule 13a-14(a) and 13a-14(b)), and various Inline XBRL documents[370][371][372][373][374][375][376][377] SIGNATURES The report is duly signed by Suzanne Winter, President & CEO, and Ali Pervaiz, SVP & CFO, on behalf of Accuray as of November 7, 2023 - The report is signed by Suzanne Winter, President & Chief Executive Officer, and Ali Pervaiz, Senior Vice President & Chief Financial Officer[379] - The signing date for the report is November 7, 2023[379]