Corporate Structure and Regulatory Environment - The company operates through its PRC subsidiaries, which include Work (Hangzhou) Medical Treatment Technology Co., Ltd. and several others, affecting its overall business operations[20]. - Investors hold equity in WORK Medical Technology Group LTD, a Cayman Islands holding company, which indirectly owns a majority of the equity interests in its PRC subsidiaries[21]. - The company is not currently using a variable interest entity (VIE) structure, which could mitigate certain regulatory risks[21]. - Recent regulatory actions by the PRC government may impact the company's operations and ability to accept foreign investments, although the company believes it is not directly subject to these actions[22]. - The company has not received any denial to list on a U.S. exchange, but future regulatory changes could adversely affect its ability to offer securities[25]. - The company’s Hong Kong subsidiary, Work Medical Technology, is expected to operate as an investment holding company without substantive operations, limiting its exposure to regulatory risks in Hong Kong[28]. - The company’s securities may face delisting risks under the Holding Foreign Companies Accountable Act if the PCAOB cannot inspect its auditors for two consecutive years[31]. - The PCAOB has recently secured access to inspect registered public accounting firms in mainland China and Hong Kong, which may alleviate some concerns regarding audit inspections[31]. - The company has appointed HTL International, LLC as its independent registered public accounting firm, effective July 30, 2025[31]. - The company is subject to legal and operational risks associated with being based in China, which could materially affect its operations and the value of its securities[22]. Financial Operations and Currency Risks - The Company transferred a total of $7,373,839 from its IPO proceeds through Work BVI to Work Medical Technology in the fiscal year ended September 30, 2024, with $5,404,654 remaining available after reimbursing PRC subsidiaries for IPO-related expenses[33]. - The aggregate principal amounts of funds transferred among the PRC subsidiaries were $22,069,242, $2,459,263, and $8,262,606 for the fiscal years ended September 30, 2025, 2024, and 2023, respectively[33]. - As of the date of the annual report, no dividends or distributions have been made from the PRC subsidiaries to the Company or U.S. investors[33]. - Current PRC regulations allow indirect PRC subsidiaries to pay dividends to Work Medical Technology only from their accumulated profits, which must be determined according to Chinese accounting standards[34]. - Each PRC subsidiary is required to set aside at least 10% of its after-tax profits to fund a statutory reserve until it reaches 50% of its registered capital[34]. - The Company may face difficulties in obtaining and remitting foreign currency for dividend payments due to PRC government controls on currency conversion[36]. - Cash dividends on Class A Ordinary Shares will be paid in U.S. dollars, and payments from PRC subsidiaries to Work Medical Technology are subject to a 25% PRC enterprise income tax[37]. - The withholding tax rate on dividends may be reduced to 5% under the Double Tax Avoidance Arrangement if certain conditions are met, but the Company has not yet applied for the tax resident certificate necessary for this[38]. - Cash located in the PRC may not be available for funding operations outside of the PRC due to government restrictions[39]. - The Company has not established other cash management policies or procedures for fund transfers beyond those described[33]. Operational and Compliance Risks - The PRC subsidiaries face significant risks related to compliance with various environmental, fire protection, and construction laws, which could adversely affect operations and financial condition[46]. - Failure to renew medical device licenses or registration certificates in a timely manner could negatively impact the reputation and financial results of the PRC subsidiaries[46]. - The PRC subsidiaries' growth rates may decline due to factors such as decreasing customer demand and increasing competition, which could adversely affect investor perceptions and share price[50]. - Maintaining product quality and safety is critical, as any failure could lead to liability claims and negatively impact the financial condition and reputation of the PRC subsidiaries[51]. - The PRC subsidiaries rely on third-party distributors, which may limit control over product placement and sales[46]. - Regulatory approval requirements for acquisitions may hinder growth strategies for the PRC subsidiaries[47]. - The PRC subsidiaries may face challenges in collecting timely payments from customers, impacting overall financial health[46]. - The company may incur substantial costs as a public entity, affecting profitability and shareholder returns[49]. - Fluctuations in exchange rates could result in foreign currency losses, impacting the value of dividends payable to shareholders[47]. - The dual class share structure may limit the influence of Class A shareholders on corporate matters, potentially affecting share value[49]. Revenue and Market Dynamics - The net revenue from sales of masks decreased from $5,091,331 (approximately 37.53% of total net revenue) for the fiscal year ended September 30, 2023, to $1,559,750 (approximately 13.56% of total net revenue) for the fiscal year ended September 30, 2024[64]. - The net revenue from sales of masks is projected to further decrease to $640,428 (approximately 6.50% of total net revenue) for the fiscal year ended September 30, 2025[64]. - The PRC subsidiaries face risks related to fluctuations in the cost, availability, and quality of raw materials, which could adversely affect their results of operations[66]. - The PRC subsidiaries do not have long-term contracts with suppliers, which allows suppliers to reduce order quantities or terminate sales at any time, potentially impacting revenue and financial condition[71]. - The overall tightening of the labor market and increases in labor costs may adversely affect the PRC subsidiaries' business operations and financial performance[72]. - The medical device industry is intensely competitive, and the PRC subsidiaries may struggle to compete against companies with greater resources, which could negatively impact their market share and profitability[73]. - The PRC subsidiaries intend to develop and commercialize additional products through research and development or by acquiring technologies and patents, which is critical for their growth strategy[78]. - Changes in payment terms with customers and suppliers may materially affect the PRC subsidiaries' operating cash flows, posing a risk to their financial condition[85]. - The PRC subsidiaries' products may be subject to recalls if they fail to meet quality requirements, which could lead to significant costs and harm their financial condition[59]. - The impact of geopolitical conflicts on the global economy and the PRC subsidiaries' financial condition remains indeterminate, despite stable supply chains for raw materials[70]. Legal and Compliance Challenges - The company may incur significant liabilities if its products are found to infringe upon third-party rights, which could adversely affect operations and financial condition[89]. - Economic recessions could significantly impact the PRC subsidiaries' business, affecting discretionary spending and order volumes[94]. - Changes in U.S. and international trade policies, including tariffs, may adversely affect the PRC subsidiaries' business and operating results[95]. - The company is vulnerable to disruptions from pandemics, natural disasters, and geopolitical uncertainties, which could materially affect operations and financial results[99]. - The company requires substantial additional financing for business expansion and development, which may not be available on favorable terms[98]. - The PRC subsidiaries are subject to various environmental laws, and failure to comply could result in fines and liabilities, adversely affecting the Group[104]. - Hangzhou Shanyou failed to obtain the necessary Environmental Impact Statement approval before construction, risking penalties between RMB0.2 million and RMB2 million[108]. - The company has not provided fire protection design drawings or prepared Inspection and Acceptance Reports of Fire Protection, which could lead to fines between RMB30,000 and RMB300,000[111]. - Hangzhou Shanyou did not obtain a construction license prior to construction, potentially incurring fines of approximately $77,500 to $169,100 for various compliance failures[114]. - The PRC subsidiaries have leased properties without valid property ownership certificates, posing risks of dispossession and operational disruptions[117]. Revenue and Supplier Relationships - The leased land for warehouses requires approval from collective members, and non-compliance could lead to lease termination and operational disruptions[118]. - The PRC subsidiaries could face fines of up to RMB10,000 for each unregistered property lease if compliance is not rectified[119]. - Total revenues for the Group were $9,848,715, $11,506,440, and $13,565,951 for the fiscal years ended September 30, 2025, 2024, and 2023, respectively[124]. - Revenues from related party sales accounted for 0.4%, 5%, and 8% of total revenues for the fiscal years ended September 30, 2025, 2024, and 2023, respectively[124]. - The Group made a significantly greater amount of bad debt provision in the fiscal year ended September 30, 2022, due to customers' lack of working capital[126]. - The company cannot assure timely collection of payments from customers, which could adversely affect its financial condition and results of operations[126]. - As of September 30, 2025, the PRC subsidiaries had approximately 1,026 domestic distributors, an increase from 953 in 2024 and 892 in 2023[127]. - The top three significant suppliers represented approximately 16%, 11%, and 8% of total supplies purchased for the fiscal year ended September 30, 2025, compared to 15%, 10%, and 7% in 2024, and 13%, 11%, and 9% in 2023[129]. - The PRC subsidiaries' ability to maintain relationships with existing suppliers and establish new supplier agreements is critical for production[129]. - The PRC subsidiaries face risks from potential non-compliance by distributors, which could negatively affect brand demand and relationships with other distributors[128]. Governmental Influence and Regulatory Compliance - The PRC government exerts substantial influence over business operations, which may change rapidly and impact the subsidiaries' financial performance[145]. - The New Administrative Rules Regarding Overseas Listings require Chinese domestic companies to complete filing procedures with the CSRC within three working days of IPO or subsequent offerings[141]. - The PRC subsidiaries had 169, 141, and 143 suppliers for the fiscal years ended September 30, 2025, 2024, and 2023, respectively[129]. - The PRC subsidiaries' revenue is significantly affected by economic, political, and legal developments in China, as well as U.S.-China relations[131]. - The PRC government may impose new regulations that could require additional compliance efforts and expenditures[147]. - The PRC subsidiaries' operations and ability to raise capital may be materially affected by changes in laws and regulations governing foreign investment[145]. - The PRC subsidiaries are subject to various government and regulatory interferences, which may increase compliance costs and penalties for non-compliance[148]. - As of December 21, 2023, the company completed all required filing procedures with the CSRC regarding its IPO, and is currently not required to obtain further approvals from PRC authorities[151]. - The New Administrative Rules Regarding Overseas Listings, effective March 31, 2023, require Chinese companies to complete filing procedures with the CSRC within three working days of submitting IPO or listing applications[151]. - The company believes it is not classified as a special purpose vehicle (SPV) under the M&A Rules, thus not requiring CSRC approval for securities offerings[159]. Legal Challenges and Compliance Costs - The PRC subsidiaries have obtained necessary licenses and permissions to operate, including Medical Device Registration Certificates and Business Licenses[162]. - The PRC government may impose additional oversight on overseas offerings, potentially hindering the company's ability to offer securities outside China[162]. - The company may face difficulties in enforcing foreign judgments or legal processes in China due to the lack of reciprocal recognition treaties[152]. - Shareholder claims related to securities law in the U.S. are challenging to pursue in China due to significant legal obstacles[153]. - The M&A safety review rules require foreign investors to file applications for M&A safety reviews in specific sensitive sectors, which could impact future acquisitions[160]. - The company may incur additional costs and face procedural obstacles in enforcing judgments in Hong Kong, as U.S. judgments are not directly enforceable there[155]. - PRC subsidiaries may face significant regulatory hurdles in pursuing acquisitions, including potential delays from MOFCOM and scrutiny from national security reviews[163]. - The PRC subsidiaries' ability to expand through acquisitions could be materially affected by compliance with anti-monopoly laws, particularly if target companies have revenues exceeding RMB400 million[172]. - As of the latest report, the PRC subsidiaries have not been involved in any cybersecurity reviews or received sanctions, but future regulations may impose new compliance requirements[166]. - The Cyberspace Administration of China has established that operators with personal data of over one million users must undergo cybersecurity reviews for foreign listings, but the company does not currently meet this threshold[166]. Regulatory Uncertainties and Compliance Obligations - The new administrative rules regarding overseas listings require domestic companies to file with the CSRC within three working days after submitting applications overseas, which could impact future capital raising efforts[166]. - Regulatory uncertainties regarding approvals for overseas listings may significantly hinder the company's ability to offer securities to investors[167]. - The company has notified PRC-resident beneficial owners of their filing obligations under SAFE Circular 37, but compliance cannot be guaranteed for all[175]. - PRC regulations may limit the company's ability to inject capital into PRC subsidiaries or distribute profits, potentially affecting liquidity and expansion plans[173]. - The company is subject to governmental control over currency conversion, which may delay the use of IPO proceeds for loans or capital contributions to PRC subsidiaries[176]. - The regulatory landscape in China is evolving, with potential implications for data security and overseas listings that could materially affect the company's operations and financial condition[164]. - Loans to the WFOE in China are subject to PRC regulations and cannot exceed statutory limits, requiring registration with SAFE[177]. - As of September 30, 2025, restricted assets in PRC subsidiaries amounted to $3,235,308, up from $972,494 in 2024[184]. - PRC regulations require subsidiaries to set aside at least 10% of after-tax profits for statutory reserves until reaching 50% of registered capital[184]. - A 10% PRC withholding tax applies to dividends payable to non-resident investors, which may affect the value of investments in Class A Ordinary Shares[188]. Currency and Taxation Risks - Fluctuations in the RMB against the U.S. dollar can impact the value of dividends payable and may result in foreign currency exchange losses[194]. - SAFE Circular 28 allows foreign-invested enterprises to use capital funds for equity investments in China, but its practical implementation remains uncertain[181]. - Restrictions on currency exchange may limit the ability to utilize revenue effectively, particularly for funding business activities outside of China[193]. - The PRC government may impose limitations on foreign currency purchases for current account transactions, affecting liquidity and funding capabilities[180]. - If deemed a PRC resident enterprise, the company could be subject to a 25% income tax on global income, impacting profitability[187]. - Indirect transfers of equity interests may be subject to PRC enterprise income tax, introducing additional compliance challenges[189]. - PRC subsidiaries failed to make required contributions to social insurance and housing provident funds, with unmade contributions of $227,789, $300,945, and $287,629 for the fiscal years 2025, 2024, and 2023 respectively[196]. - Contributions for the housing provident fund that should have been made but were not total $99,552, $94,815, and $90,620 for the fiscal years 2025, 2024, and 2023 respectively[196]. - The company may incur additional costs to comply with PRC laws and regulations regarding employee benefits, which could adversely affect its financial condition and results of operations[197]. Market Compliance and Listing Risks - The Class A Ordinary Shares may face delisting under the Holding Foreign Companies Accountable Act if the PCAOB cannot inspect the auditors, which could materially affect investment value[198]. - The SEC has proposed rules that could impact the company if its auditor is not subject to PCAOB inspection, potentially leading to earlier delisting than required by the HFCA Act[207]. - The trading price of Class A Ordinary Shares is likely to be volatile due to factors including performance of other Chinese companies listed in the U.S. and general market conditions[211]. - A decline in the closing price of Class A Ordinary Shares could breach Nasdaq's continued listing requirements, leading to potential suspension or delisting[213]. - The company’s former auditor was replaced by HTL, which is currently subject to PCAOB inspection, adding uncertainties to the company's offerings[204]. - New laws and regulations in the U.S. and China could affect the company's ability to maintain its Nasdaq listing, impacting market price and trading[208]. - The enactment of the Hong Kong National Security Law and the U.S. Hong Kong Autonomy Act could materially affect the operations and financial position of the company's Hong Kong subsidiary[209]. - The Company received a notification from Nasdaq on April 7, 2025, indicating non-compliance with the minimum bid price requirement, needing to maintain a closing bid price of at least $1.00 for 10 consecutive business days[216]. - The compliance deadline was initially set for October 6, 2025, with a potential extension of an additional 180 days until April 6, 2026, if necessary[216]. - The Company regained compliance on November 4, 2025, by maintaining a minimum closing bid price of $1.00 or greater from October 10, 2025, to November 3, 2025[217]. - Future compliance issues may arise, and if delisted, the Company could face significant consequences under the Nasdaq Excessive Reverse Share Split Rule[218]. - Under the Nasdaq Excessive Reverse Share Split Rule, companies are limited in the number of reverse share splits they can perform within a year to regain compliance[218]. - If the Class A Ordinary Shares fall out of compliance within a year after a reverse share split, the Company may receive a delisting determination without a compliance period[218]. - The Company has previously faced compliance challenges, highlighting the importance of maintaining stockholder equity and share price[215]. - The Nasdaq rules require ongoing adherence to various listing standards, including minimum market value of publicly held shares[215]. - The Company must remain vigilant to avoid potential delisting, which could negatively impact the securities' market price[215]. - The appeal process is available if a delisting determination is issued, allowing for a stay on any suspension or delisting actions[218].
WORK Medical Technology Group Ltd(WOK) - 2025 Q4 - Annual Report