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Jin Med(ZJYL) - 2024 Q4 - Annual Report
ZJYLJin Med(ZJYL)2025-01-24 21:10

VIE Structure and Regulatory Risks - The company's operations are conducted in China through a variable interest entity (VIE), Changzhou Zhongjin Medical Equipment Co. Ltd., with no direct equity ownership but control through contractual arrangements[26][27] - The VIE structure is subject to legal and regulatory risks in China, including potential government disallowance, which could significantly impact operations and share value[28] - The company operates through a VIE structure, and any changes in PRC regulations or interpretations could result in severe penalties, including the potential devaluation or loss of value of its Ordinary Shares[102] - The company's PRC legal counsel has advised that there are substantial uncertainties regarding the interpretation and application of current or future PRC laws and regulations, which could lead to adverse actions by PRC regulatory authorities[103] - The company relies on contractual arrangements with its VIE, Changzhou Zhongjin, which may not be as effective as direct ownership in providing operational control or economic benefits[106] - If the PRC tax authorities determine that the company's contractual arrangements with its VIE are not at arm's length, it could result in additional taxes, penalties, and increased tax liabilities for Changzhou Zhongjin[114] - The company may face substantial costs and tax liabilities if it exercises the option to acquire equity ownership of Changzhou Zhongjin[115] - The company may lose control over assets held by Changzhou Zhongjin if it becomes bankrupt or undergoes liquidation, which could materially and adversely affect its business operations[116] - The company may face difficulties in enforcing contractual arrangements with Changzhou Zhongjin due to uncertainties in the PRC legal system[161] Financial and Tax Risks - The company transferred 1.3milliontoitswhollyownedsubsidiaryinChina,AnhuiZhongjin,forcapitalinjectionduringthefiscalyearendedSeptember30,2024[33]−MainlandChinasubsidiariesarerequiredtosetasideatleast101.3 million to its wholly owned subsidiary in China, Anhui Zhongjin, for capital injection during the fiscal year ended September 30, 2024[33] - Mainland China subsidiaries are required to set aside at least 10% of after-tax profits annually for reserve funds, limiting distributable cash dividends[34] - The company is subject to restrictions on foreign exchange and cross-border cash transfers, which may limit the ability to distribute earnings to shareholders[34] - The company's ability to pay dividends to U.S. investors depends on the VIE's payments to its wholly owned subsidiary, Erhua Medical Technology, under the VIE Agreements[31] - The company may be classified as a "Resident Enterprise" in China, subjecting it to a 25% enterprise income tax on worldwide income and potential withholding taxes on dividends[130][132] - The company may be classified as a "resident enterprise" under PRC tax laws, potentially subjecting it to a 25% worldwide income tax rate and affecting dividends to non-PRC shareholders[166][169] - Fluctuations in the RMB exchange rate could adversely affect the company's revenues, financial condition, and the value of its securities[172] - The PRC government imposes controls on currency conversion, which may restrict the company's ability to remit dividends and meet foreign exchange requirements[174][175] - The company's ability to transfer funds and assets among its subsidiaries and the VIE is subject to governmental control and restriction, potentially limiting its operational flexibility[178] - Cash or assets in mainland China or Hong Kong may not be available for operations outside these regions due to government restrictions[180] - The company does not intend to pay dividends in the foreseeable future, retaining earnings for business operations and expansion[222] Market and Customer Concentration Risks - The company's largest customer, Nissin, represented 57.3%, 78.2%, and 80.5% of total sales for the fiscal years ended September 30, 2024, 2023, and 2022, respectively[58] - The company relies heavily on Nissin, with no long-term agreement in place, and a loss of this customer would materially impact operations[58] - The company's dealer network, especially Nissin, is critical, with Nissin representing 57.3%, 78.2%, and 80.5% of revenues for fiscal years 2024, 2023, and 2022, respectively[67] - The company faces intense competition in the wheelchair and living aids markets, with competitors having advantages in brand recognition, resources, and market reach[54][57] - The company's reliance on a limited number of suppliers for critical components poses risks to manufacturing and sales if disruptions occur[59] - The company's exposure to foreign currency fluctuations, particularly in Japan, could impact competitiveness and financial results[65] - Adverse macroeconomic conditions in Japan, such as inflation and unemployment, could negatively affect demand for the company's products[193] Operational and Supply Chain Risks - Raw material price fluctuations, particularly in steel and aluminum, have adversely affected the company's results[64] - The company's operations in China were significantly impacted by COVID-19, with revenues materially affected in 2020, but operations have since recovered to pre-pandemic levels[61] - The company's business operations are still impacted by the uncertainty of COVID-19, particularly in China and Japan, its major international market[99] - The company relies on third-party logistics service providers for product delivery, and disruptions in logistics could result in delayed deliveries, increased costs, or damage to the company’s brand image[96] - The company sources raw materials from a limited number of suppliers, and the loss of suppliers could disrupt operations and increase costs[81] - The average utilization rate of the company's production lines was 70%, 75%, and 77% for the fiscal years ended September 30, 2024, 2023, and 2022, respectively[98] - Labor costs in China are expected to continue increasing, potentially impacting financial conditions if costs cannot be passed on to customers[183] - Additional social security and housing fund contributions based on actual wages amounted to 262,365, 257,478,and257,478, and 467,246 for fiscal years 2024, 2023, and 2022, respectively[187] - The company may face penalties if found non-compliant with PRC regulations on social insurance and housing funds, potentially requiring additional contributions and fines[187] Product and Liability Risks - The company does not carry product liability insurance in Japan and China, its two largest markets, exposing it to significant financial risks[69] - The company’s warranty costs for the fiscal years ended September 30, 2024, 2023, and 2022 were nil,butmayincreaseinthefuturewiththesaleofmorecomplexproductslikeelectricwheelchairs[93]−Thecompany’selectricwheelchairsandlivingaidsproductsarecurrentlysoldtoalimitednumberofcustomersformarkettesting,withchallengesinmeetingregulatoryrequirementsandanticipatinguserdemand[89]−Thecompany′sexpansionintonewproductcategories,suchaselectricwheelchairsandoxygenconcentrators,exposesittorisksincludinginventorybuildup,higherreturnrates,andpotentialproductliabilityclaims[91]−Thecompany′smedicaldevices,classifiedasClassII,aresubjecttosafetyandtechnicalinspections,witharecentproductfailureresultinginaRMB20,000fine[137]−ThecompanyfacesrisksundertheForeignCorruptPracticesActandChineseanti−corruptionlaws,withpotentialliabilitiesforunauthorizedpaymentsbyemployeesorthirdparties[134][135]LegalandComplianceRisks−Thecompany′slistingiscurrentlynotaffectedbytheHoldingForeignCompaniesAccountableAct(HFCAA),butfutureuncertaintiesremainregardingPCAOBinspectionsandpotentialdelistingrisks[43]−Thecompanychangedauditorsmultipletimes,withthecurrentauditorbeingAuditAllianceLLP,aPCAOB−registeredfirm,tocomplywithU.S.regulations[43]−ThecompanyisnotsubjecttocybersecurityreviewbytheCyberspaceAdministrationofChina(CAC)asitdoesnotpossesspersonalinformationofoveronemillionusers[30]−ThecompanyfacesrisksrelatedtotheinterpretationandenforcementofnewChineselawsandregulations,whichcouldimpactitsabilitytoconductbusinessandacceptforeigninvestments[30]−Thecompany′sabilitytolistonU.S.exchangesmaybehinderediffutureChineseregulationsrequireadditionalpermissionsorapprovals[129]−PRClegalsystemuncertaintiesmayadverselyaffectthecompany′soperationsandcompliance,particularlyduetothelimitedprecedentialvalueofcourtdecisionsandpotentialretroactiveeffectsofunpublishedgovernmentpolicies[138][139]−PRCregulationsonloansanddirectinvestmentbyoffshoreholdingcompaniescoulddelayorpreventthecompanyfromusingofferingproceedstofunditsPRCsubsidiary,impactingliquidityandbusinessexpansion[140][141]−SAFECircular21,effectiveMay13,2013,simplifiesforeignexchangeproceduresbutmaylimitthecompany′sabilitytoconvert,transfer,andusenetproceedsfromofferingsinChina,affectingliquidityandbusinessfunding[143][144]−CapitalcontributionstoPRCsubsidiariesrequireMOFCOMapproval,whichmaytakeupto30workingdays,anddelaysordenialscouldadverselyaffectthecompany′sliquidityandexpansionplans[145]−TheCybersecurityReviewMeasures,effectiveFebruary15,2022,requiredataprocessingoperatorswithover1millionuserstoundergocybersecurityreviewbeforeforeignlistings,potentiallyimpactingthecompany′sbusinessandofferings[146]−TheSecurityAdministrationDraft,publishedNovember14,2021,mandatesnetworkdatasecurityreviewsfordataprocessingoperatorswithover1millionusersordataaffectingnationalsecurity,addingregulatoryuncertainty[147]−Thecompany′sproposedU.S.listingmayfacefutureregulatoryrisksifPRCauthoritiesadoptnewlawsorinterpretationsundertheCybersecurityReviewMeasuresorSecurityAdministrationDraft[148]−PRCgovernmentoversightandpotentialpolicychangescouldsignificantlyimpactthecompany′soperations,securitiesofferings,andsharevalue,particularlyregardingoverseaslistings[150][152]−TheTrialMeasures,effectiveMarch31,2023,requiredomesticcompaniestofilewiththeCSRCforoverseasofferings,withnon−compliancepotentiallyleadingtoadministrativepenalties[158]−RevisedProvisions,effectiveMarch31,2023,expandconfidentialityandarchivesadministrationrequirementsforoverseasofferings,withnon−compliancepotentiallyresultinginlegalliability[159]−ThecompanyregainedcompliancewithNasdaqListingRule5550(a)(3)afterahearingdecisiononMarch28,2024,andfileditsannualreportonForm20−Fforfiscalyear2023onApril26,2024[194]−ThecompanyfacesrisksofdelistingfromNasdaqifitfailstocomplywithlistingrules,whichcouldreduceliquidityandmakefuturefinancingmoredifficult[195]−HoldingForeignCompaniesAccountableActcouldadduncertaintiestocompany′slistingonNasdaq[203]−PCAOBdetermineditwasabletoinspectandinvestigateregisteredpublicaccountingfirmsinmainlandChinaandHongKong[213]−AcceleratingHoldingForeignCompaniesAccountableActreducesnon−inspectionyearsforcompliancefromthreetotwo[214]−ThecompanymayloseitsforeignprivateissuerstatusonMarch31,2024,potentiallyleadingtosignificantadditionallegal,accounting,andreportingexpenses[221]IntellectualPropertyandInnovationRisks−Thecompanyownsapproximately119patentsandhasfiled13additionalpatentapplicationswiththePatentAdministrationDepartmentofthePRC,butthereisnoassurancethattheseapplicationswillbegranted[84]−IntellectualpropertyprotectioninChinaischallenging,andunauthorizeduseofIPcouldharmthecompany′scompetitiveposition[191]CorporateGovernanceandControlRisks−Thecompany′sCEOownsover50nil, but may increase in the future with the sale of more complex products like electric wheelchairs[93] - The company’s electric wheelchairs and living aids products are currently sold to a limited number of customers for market testing, with challenges in meeting regulatory requirements and anticipating user demand[89] - The company's expansion into new product categories, such as electric wheelchairs and oxygen concentrators, exposes it to risks including inventory buildup, higher return rates, and potential product liability claims[91] - The company's medical devices, classified as Class II, are subject to safety and technical inspections, with a recent product failure resulting in a RMB20,000 fine[137] - The company faces risks under the Foreign Corrupt Practices Act and Chinese anti-corruption laws, with potential liabilities for unauthorized payments by employees or third parties[134][135] Legal and Compliance Risks - The company's listing is currently not affected by the Holding Foreign Companies Accountable Act (HFCAA), but future uncertainties remain regarding PCAOB inspections and potential delisting risks[43] - The company changed auditors multiple times, with the current auditor being Audit Alliance LLP, a PCAOB-registered firm, to comply with U.S. regulations[43] - The company is not subject to cybersecurity review by the Cyberspace Administration of China (CAC) as it does not possess personal information of over one million users[30] - The company faces risks related to the interpretation and enforcement of new Chinese laws and regulations, which could impact its ability to conduct business and accept foreign investments[30] - The company's ability to list on U.S. exchanges may be hindered if future Chinese regulations require additional permissions or approvals[129] - PRC legal system uncertainties may adversely affect the company's operations and compliance, particularly due to the limited precedential value of court decisions and potential retroactive effects of unpublished government policies[138][139] - PRC regulations on loans and direct investment by offshore holding companies could delay or prevent the company from using offering proceeds to fund its PRC subsidiary, impacting liquidity and business expansion[140][141] - SAFE Circular 21, effective May 13, 2013, simplifies foreign exchange procedures but may limit the company's ability to convert, transfer, and use net proceeds from offerings in China, affecting liquidity and business funding[143][144] - Capital contributions to PRC subsidiaries require MOFCOM approval, which may take up to 30 working days, and delays or denials could adversely affect the company's liquidity and expansion plans[145] - The Cybersecurity Review Measures, effective February 15, 2022, require data processing operators with over 1 million users to undergo cybersecurity review before foreign listings, potentially impacting the company's business and offerings[146] - The Security Administration Draft, published November 14, 2021, mandates network data security reviews for data processing operators with over 1 million users or data affecting national security, adding regulatory uncertainty[147] - The company's proposed U.S. listing may face future regulatory risks if PRC authorities adopt new laws or interpretations under the Cybersecurity Review Measures or Security Administration Draft[148] - PRC government oversight and potential policy changes could significantly impact the company's operations, securities offerings, and share value, particularly regarding overseas listings[150][152] - The Trial Measures, effective March 31, 2023, require domestic companies to file with the CSRC for overseas offerings, with non-compliance potentially leading to administrative penalties[158] - Revised Provisions, effective March 31, 2023, expand confidentiality and archives administration requirements for overseas offerings, with non-compliance potentially resulting in legal liability[159] - The company regained compliance with Nasdaq Listing Rule 5550(a)(3) after a hearing decision on March 28, 2024, and filed its annual report on Form 20-F for fiscal year 2023 on April 26, 2024[194] - The company faces risks of delisting from Nasdaq if it fails to comply with listing rules, which could reduce liquidity and make future financing more difficult[195] - Holding Foreign Companies Accountable Act could add uncertainties to company's listing on Nasdaq[203] - PCAOB determined it was able to inspect and investigate registered public accounting firms in mainland China and Hong Kong[213] - Accelerating Holding Foreign Companies Accountable Act reduces non-inspection years for compliance from three to two[214] - The company may lose its foreign private issuer status on March 31, 2024, potentially leading to significant additional legal, accounting, and reporting expenses[221] Intellectual Property and Innovation Risks - The company owns approximately 119 patents and has filed 13 additional patent applications with the Patent Administration Department of the PRC, but there is no assurance that these applications will be granted[84] - Intellectual property protection in China is challenging, and unauthorized use of IP could harm the company's competitive position[191] Corporate Governance and Control Risks - The company's CEO owns over 50% of Ordinary Shares, giving him significant control over director elections and shareholder resolutions[197] - Shareholders holding at least 10% of voting share capital can requisition a general meeting, with specific notice requirements for convening meetings[229] - Shareholders may face challenges in protecting their interests under Cayman Islands law, which has a less developed body of securities laws compared to the U.S.[225] - Legal and regulatory obstacles may limit the ability of U.S. authorities to investigate or enforce actions against the company or its directors in China[228] - The market price of Ordinary Shares may vary significantly, and shareholders could lose a substantial part or all of their investment[230] Internal Control and Financial Reporting Risks - Material weaknesses identified in internal control over financial reporting include lack of accounting staff, formal internal controls, and independent directors[198] - Company took remedial measures by appointing independent directors and establishing an audit committee[198] - Company plans to hire more qualified accounting personnel and implement U.S. GAAP training programs[198] - Failure to correct material weaknesses could result in inaccuracies in financial statements and impair compliance with reporting requirements[198] - Company is subject to Sarbanes-Oxley Act Section 404 but not required to include an attestation report while an emerging growth company[199] - Presence of material weaknesses could lead to financial statement errors and delays in financial reporting[199] - Company is a foreign private issuer and not subject to certain U.S. securities law disclosure requirements[202] Economic and Geopolitical Risks - The Chinese economy's growth has slowed since 2012, and global economic uncertainties, including geopolitical tensions, may adversely affect the company's business and financial condition[119] - Changes in China's economic, political, or social conditions, including government policies and regulations, could materially affect the company's business and operations[126][127] - The company's operations are sensitive to global and domestic economic conditions, including potential conflicts in Asia and volatility in oil markets[119] Liquidity and Funding Risks - The company had cash of approximately 8.1 million and short-term investments of 18.6millionasofSeptember30,2024,withtotalcurrentassetsof18.6 million as of September 30, 2024, with total current assets of 42.8 million and total current liabilities of $17.2 million[79] - The company’s inability to secure sufficient additional financing could lead to delays in business plans, reduced scope of operations, or potential cessation of activities[77] - Remitting offering proceeds to China may take up to six months, and delays in government approvals could negatively impact the company's liquidity and expansion plans[122][124] - Offshore holding companies face regulatory challenges in transferring funds to PRC subsidiaries, including statutory limits on loans and registration requirements with SAFE and MOFCOM[121] - The company relies on dividend payments from PRC operating entities, which are subject to restrictions under PRC laws, potentially impacting its ability to pay dividends and service debt[162] - If any PRC operating entity undergoes liquidation, third-party creditors may claim rights to important assets, adversely affecting the company's business operations[164] Shareholder and Market Risks - An active trading market for the company's Ordinary Shares may not develop or be sustained, potentially limiting shareholders' ability to sell shares at market price[223] - Sales of 156,547,100 outstanding Ordinary Shares, including restricted securities, could adversely affect the market price of the shares[224]