What the changes say
- Accuray faces heavy debt and covenant compliance issues tied to its credit facilities and convertible notes.
- New disclosures highlight risks from data protection laws, FDA scrutiny on device modifications, and warrant dilution.
- Tax loss carryforwards decreased, shifting expiration timelines for federal and state credits.
What changed since the prior 10-K
New
- NewRisks Related to Our Business and Results of Operations
If we are unable to maintain or increase our gross margins on product sales and service, our results of operations could be adversely impacted, we may not achieve profitability and our stock price could decline
We carry $150 million in term loans, $18 million in 2026 notes, and past covenant waivers threaten our financial stability.
- NewRisks Related to Our Business and Results of Operations
developments. As a result, we may be subject to significant consequences, including penalties and fines, for any failure to comply with such laws, regulations and directives
Strict privacy and cybersecurity enforcement could limit product adoption, increase costs, and trigger costly legal proceedings.
- NewRisks Related to Our Business and Results of Operations
management’s considerations of the Company’s disclosure controls and procedures, internal control over financial reporting, and the material weaknesses identified, refer to Controls and Procedures in Part I, Item 4
Remediating past material weaknesses was costly, and future internal control failures remain a risk.
- NewRisks Related to the Regulation of our Products and Business
modifications or that we will be successful in obtaining premarket approvals or 510(k) clearances for modifications in a timely fashion, if at all
FDA disagreements over modifications to the CyberKnife or TomoTherapy platforms could force product recalls or halts.
- NewRisks Related to the Regulation of our Products and Business
medical device regulation similar to the EU MDR, which will require additional registrations for economic operators and products within Switzerland for our devices
MHLW approval delays in Japan or global environmental hazardous material regulations could harm our revenue and operations.
- NewRisks Related to Our Common Stock
The exercise of outstanding warrants for our common stock would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders
Exercising 17.1 million Premium Warrants and 6.2 million Penny Warrants will dilute stockholders and depress our stock price.
Dropped
- DroppedRisks Related to Our Business and Results of Operations
system, trade, fiscal or tax policies, customer demand may not materialize to levels we require to achieve our anticipated financial results, which could have a material adverse effect on our business, financial condition and results of operations
Inflation and supply chain logistics costs adversely affecting gross margins and net income.
- DroppedRisks Related to Our Business and Results of Operations
We have outstanding indebtedness in the form of Convertible Senior Notes and a credit facility and may incur other debt in the future, which may adversely affect our financial condition and future financial results
- DroppedRisks Related to Our Business and Results of Operations
In May 2021, we entered into a credit agreement that provided us with a five-year $80.0 million term loan (the “Term Loan Facility”) and $40.0 million revolving credit facility (the “Revolving Credit Facility” and together with the “Term Loan Facility”, the “Credit Facilities”)
- DroppedRisks Related to Our Business and Results of Operations
Enhanced international tariffs, including tariffs imposed by the United States and China that affect our products or components within our products, other trade barriers or a global trade war could increase our costs and materially and adversely affect our business operations and financial condition
- DroppedRisks Related to Our Business and Results of Operations
Russia or other countries, could adversely affect the global economy and financial markets, as well as our business, financial condition and results of operations, which may also magnify the impact of other risks described in this “Risk Factors” section
May 2021 convertible senior notes maturity and refinancing obligations.
- DroppedRisks Related to Our Business and Results of Operations
some of the AI features involve the processing of personal data and may be subject to laws, policies, legal obligations, and codes of conduct related to privacy and data protection
Consolidated liabilities of $423.5 million as of June 30, 2024.
- DroppedRisks Related to Our Business and Results of Operations
competing platforms. Future patient studies or clinical experience may indicate that treatment with the CyberKnife platform does not improve patient survival or outcomes relative to other platforms
- DroppedRisks Related to Our Business and Results of Operations
carryforwards of approximately $28.4 million and $22.8 million, respectively. The California research credits have no expiration date, but if not utilized, the federal research credits and other non-California state research credits will begin to expire in 2025
- DroppedRisks Related to the Regulation of our Products and Business
may include significant civil and criminal penalties, damages, fines, imprisonment and exclusion from healthcare programs. The impact of any such violations may lead to curtailment or restructuring of our operations, which could adversely affect our ability to operate our business and our financial results
Reworded
- 91% rewrittenRisks Related to Our Business and Results of Operations
We may not be able to fully utilize certain tax loss carryforwards
Updated federal and state net operating loss carryforwards to $260.9 million and $119.9 million as of June 30, 2025, with revised expiration dates.
- 80% rewrittenRisks Related to Our Business and Results of Operations
increasing our vulnerability to downturns in our business, our industry or the economy in general
Replaced restrictive covenant details with specific terms of the Financing Agreement and the issuance of 17,180,710 Premium Warrants and 6,247,531 Penny Warrants.
- 75% rewrittenRisks Related to Our Business and Results of Operations
The safety and efficacy of our products for certain uses is not yet supported by long‑term clinical data, and our products may therefore prove to be less safe and effective than initially thought
Added explicit warnings that future patient studies may show CyberKnife does not improve outcomes relative to competing platforms.
- 53% rewrittenRisks Related to Our Business and Results of Operations
We may attempt to acquire new businesses, products or technologies, including forming joint ventures, and if we are unable to successfully complete these acquisitions or to integrate acquired businesses, products, technologies or employees, we may fail to realize expected benefits or harm our existing business
Retained the risk regarding difficulties in acquiring and integrating new businesses, products, or technologies without textual changes.
- 52% rewrittenRisks Related to the Regulation of our Products and Business
We are subject to federal, state and foreign laws and regulations applicable to our operations, the violation of which could result in substantial penalties and harm our business
Retained the risk regarding regulatory compliance violations and penalties without textual changes.
- 45% rewrittenRisks Related to Our Common Stock
Future issuances of shares of our common stock could dilute the ownership interests of our stockholders
Added dilution warnings specifically regarding the conversion of outstanding 2026 Notes into common stock.
- 44% rewrittenRisks Related to Our Common Stock
The conditional conversion features of the 2026 Notes, if triggered, may adversely affect our financial condition and operating results
Updated references from general Notes to specifically name the 2026 Notes and their conditional conversion features.
Was: The conditional conversion features of the Notes, if triggered, may adversely affect our financial condition and operating results
- 40% rewrittenRisks Related to the Regulation of our Products and Business
If we or our distributors do not obtain and maintain the necessary regulatory approvals in a specific country, we will not be able to market and sell our products in that country
Retained the risk regarding country-specific regulatory approvals and distributor dependencies without textual changes.
- 36% rewrittenRisks Related to Our Business and Results of Operations
Any actual or perceived failure by us to comply with legal or regulatory requirements related to privacy, cybersecurity and data protection in one or multiple jurisdictions could result in proceedings, actions or penalties against us
- 29% rewrittenRisks Related to Our Business and Results of Operations
We have entered into certain relationships with collaborators, partnerships, strategic alliances, joint venture partners and other third parties, which are outside of our full control and may harm our existing business if we fail to realize the expected benefits of such relationships
- 29% rewrittenGeneral Risks
Our operations are vulnerable to interruption or loss because of climate change, natural disasters, global or regional health pandemics or epidemics, terrorist acts and other events beyond our control, which has impacted and could in the future adversely affect our business
- 28% rewrittenRisks Related to Our Business and Results of Operations
We are subject to the tax laws of various foreign jurisdictions, as well as within the United States, which are subject to unanticipated changes and interpretation and could harm our future results
- 26% rewrittenRisks Related to Our Business and Results of Operations
the proportion of revenue attributable to orders placed by our distributors, which may be more difficult to forecast due to factors outside our control
- 26% rewrittenRisks Related to Our Business and Results of Operations
We derive most of our revenue from our international operations, and we plan to continue expanding our business in international markets in the future. In addition, we have employees engaged in R&D, manufacturing, administration, manufacturing, support and sales and marketing activities
- 25% rewrittenRisks Related to Our Business and Results of Operations
Our results have been and may continue to be impacted by changes in foreign currency exchange rates
- 25% rewrittenRisks Related to Our Business and Results of Operations
Our ability to achieve profitability depends in part on maintaining or increasing our gross margins on product sales and services, which we may not be able to achieve
- 21% rewrittenRisks Related to Our Business and Results of Operations
Our ability to raise capital or obtain financing in the future may be limited, and our failure to raise capital when needed could prevent us from executing our growth strategy
- 20% rewrittenRisks Related to Our Business and Results of Operations
As a strategy to assist our sales efforts, we may offer extended payment terms, which may potentially result in higher days sales outstanding, reduced cash flows in a particular period and greater payment defaults
All 55 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business and Results of Operations
- 01If the CyberKnife or TomoTherapy platforms do not achieve widespread market acceptance, we will not be able to generate the revenue necessary to support our business
- 02development of new products and technologies by our competitors or new treatment alternatives
- 03Our ability to achieve profitability depends in part on maintaining or increasing our gross margins on product sales and services, which we may not be able to achieve25% rewritten
- 04If we are unable to maintain or increase our gross margins on product sales and service, our results of operations could be adversely impacted, we may not achieve profitability and our stock price could declineNew
- 05increasing our vulnerability to downturns in our business, our industry or the economy in general80% rewritten
- 06Our operating results, including our cash flows, quarterly orders, revenues and margins fluctuate from quarter to quarter and may be unpredictable
- 07the proportion of revenue attributable to orders placed by our distributors, which may be more difficult to forecast due to factors outside our control26% rewritten
- 08changes in accounting principles, such as those related to revenue recognition, or in the interpretation or the application thereof; and
- 09We derive most of our revenue from our international operations, and we plan to continue expanding our business in international markets in the future. In addition, we have employees engaged in R&D, manufacturing, administration, manufacturing, support and sales and marketing activities26% rewritten
- 10contractual provisions governed by foreign laws; and
- 11Our inability to overcome these obstacles could harm our business, financial condition and operating results. Even if we are successful in managing these obstacles, our partners internationally are subject to these same risks and may not be able to manage these obstacles effectively
- 12Our results have been and may continue to be impacted by changes in foreign currency exchange rates25% rewritten
- 13If we encounter manufacturing problems, or if our manufacturing facilities do not continue to meet federal, state or foreign manufacturing standards, we may be required to temporarily cease all or part of our manufacturing operations, which would result in delays and lost revenue
- 14If we are unable to develop new products or enhance existing products to meet our customers’ needs and compete favorably in the market, we may be unable to attract or retain customers
- 15Even if customers accept new products or product enhancements, the revenues from these products may not be sufficient to offset the significant costs associated with making them available to customers
- 16If we do not effectively manage our growth, our business may be significantly harmed
- 17We could become subject to product liability claims, product recalls, other field actions and warranty claims that could be expensive, divert management’s attention and harm our business
- 18Our reliance on single‑source suppliers for critical components of the CyberKnife and TomoTherapy platforms could harm our ability to meet demand for our products in a timely and cost effective manner
- 19We depend on key employees, the loss of whom would adversely affect our business. If we fail to attract and retain employees with the expertise required for our business, we may be unable to continue to grow our business
- 20Disruption of critical information technology systems, infrastructure and data or cyberattacks or other security breaches or incidents could harm our business and financial condition
- 21Any actual or perceived failure by us to comply with legal or regulatory requirements related to privacy, cybersecurity and data protection in one or multiple jurisdictions could result in proceedings, actions or penalties against us36% rewritten
- 22developments. As a result, we may be subject to significant consequences, including penalties and fines, for any failure to comply with such laws, regulations and directivesNew
- 23Continued consolidation in the healthcare industry could have an adverse effect on our business, financial condition, or results of operations
- 24If third‑party payors do not provide sufficient coverage and reimbursement to healthcare providers for use of the CyberKnife and TomoTherapy platforms or if the number of patients covered by health insurance reduces, demand for our products and our revenue could be adversely affected
- 25The safety and efficacy of our products for certain uses is not yet supported by long‑term clinical data, and our products may therefore prove to be less safe and effective than initially thought75% rewritten
- 26We rely on third parties to perform shipping and logistics functions on our behalf. Failures or disruptions at our logistics providers have occurred and could occur in the future, which could adversely impact our business
- 27We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
- 28It is difficult and costly to protect our intellectual property and our proprietary technologies and we may not be able to ensure their protection
- 29Unfavorable results of legal proceedings could materially and adversely affect our financial condition
- 30Because the majority of our product revenue is derived from sales of the CyberKnife and TomoTherapy platforms, which have a long and variable sales and installation cycle, our revenues and cash flows may be volatile and difficult to predict
- 31We depend on third‑party distributors to market and distribute our products in international markets. If our distributors fail to successfully market and distribute our products, our business will be materially harmed
- 32The high unit price of the CyberKnife and TomoTherapy platforms, as well as other factors, may contribute to substantial fluctuations in our operating results, which could adversely affect our stock price
- 33As a strategy to assist our sales efforts, we may offer extended payment terms, which may potentially result in higher days sales outstanding, reduced cash flows in a particular period and greater payment defaults20% rewritten
- 34We have entered into certain relationships with collaborators, partnerships, strategic alliances, joint venture partners and other third parties, which are outside of our full control and may harm our existing business if we fail to realize the expected benefits of such relationships29% rewritten
- 35We may attempt to acquire new businesses, products or technologies, including forming joint ventures, and if we are unable to successfully complete these acquisitions or to integrate acquired businesses, products, technologies or employees, we may fail to realize expected benefits or harm our existing business53% rewritten
- 36management’s considerations of the Company’s disclosure controls and procedures, internal control over financial reporting, and the material weaknesses identified, refer to Controls and Procedures in Part I, Item 4New
- 37Our ability to raise capital or obtain financing in the future may be limited, and our failure to raise capital when needed could prevent us from executing our growth strategy21% rewritten
- 38We may not be able to fully utilize certain tax loss carryforwards91% rewritten
- 39We are subject to the tax laws of various foreign jurisdictions, as well as within the United States, which are subject to unanticipated changes and interpretation and could harm our future results28% rewritten
Risks Related to the Regulation of our Products and Business
- 40modifications or that we will be successful in obtaining premarket approvals or 510(k) clearances for modifications in a timely fashion, if at allNew
- 41We are subject to federal, state and foreign laws and regulations applicable to our operations, the violation of which could result in substantial penalties and harm our business52% rewritten
- 42If we or our distributors do not obtain and maintain the necessary regulatory approvals in a specific country, we will not be able to market and sell our products in that country40% rewritten
- 43medical device regulation similar to the EU MDR, which will require additional registrations for economic operators and products within Switzerland for our devicesNew
- 44Healthcare reform legislation could adversely affect demand for our products, our revenue and our financial condition
Risks Related to Our Common Stock
- 45The price of our common stock is volatile and may continue to fluctuate significantly, which could lead to losses for stockholders
- 46announcement of strategic transactions or capital raising activities; and
- 47Future issuances of shares of our common stock could dilute the ownership interests of our stockholders45% rewritten
- 48The exercise of outstanding warrants for our common stock would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholdersNew
- 49The conditional conversion features of the 2026 Notes, if triggered, may adversely affect our financial condition and operating results44% rewritten
- 50Provisions in the indenture for the 2026 Notes, the Financing Agreement for our Credit Facilities, our certificate of incorporation and our bylaws could discourage or prevent a takeover, even if an acquisition would be beneficial in the opinion of our stockholders
- 51establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings
General Risks
- 52Our liquidity could be adversely impacted by adverse conditions in the financial markets
- 53Our operations are vulnerable to interruption or loss because of climate change, natural disasters, global or regional health pandemics or epidemics, terrorist acts and other events beyond our control, which has impacted and could in the future adversely affect our business29% rewritten
- 54Changes in interpretation or application of generally accepted accounting principles may adversely affect our operating results
- 55We have not paid dividends in the past and do not expect to pay dividends in the foreseeable future
Other Accuray 10-Ks
- FY2026 10-K risk factors51 risks5 new9 dropped15 reworded
A $55.0 million preferred-stock financing could convert $40.0 million of debt and materially change ownership.
Filed Aug 27, 2026 - FY2024 10-K risk factors58 risks
Accuray relies heavily on sales of the CyberKnife and TomoTherapy platforms, which face market acceptance hurdles. The company carries significant debt, including $100.0 million in convertible notes and credit facilities. International operations and single-source component suppliers expose the business to supply chain disruptions.
Filed Sep 19, 2024
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.