Financial Overview - Qilian International Holding Group Limited raised approximately US1.00, subject to PRC law[295]. - The Shareholders' Voting Rights Proxy Agreement grants WFOE exclusive rights to act on behalf of Gansu QLS Shareholders, including voting and appointing management[296]. Regulatory Environment - The company faces potential delisting risks under the HFCA Act if the PCAOB cannot inspect its auditors, which could significantly affect the value of its Ordinary Shares[303]. - The company is subject to uncertainties regarding PRC government regulations, which could materially impact its business operations and financial performance[300]. - Recent regulatory developments may impact the company's ability to conduct future offerings or maintain its listing on U.S. exchanges[309]. - The pharmaceutical industry in China is highly regulated, with oversight from the NMPA and other governmental bodies, affecting all aspects of production and sale[402]. - The NMPA has the authority to enforce regulations through various actions, including fines, product recalls, and operational restrictions[414]. - The company is subject to periodic inspections and safety monitoring by the NMPA to ensure compliance with regulatory requirements[411]. - All marketed pharmaceutical products meet the packaging requirements as per PRC regulations[417]. Product Development and Innovation - Gansu QLS's business scope includes the development, manufacture, marketing, and sale of its products, distinct from the consulting services provided by WFOE[274]. - The VIE and its subsidiaries operate a pharmaceutical and chemical company focusing on oxytetracycline products, licorice products, TCMD products, heparin products, sausage casings, and fertilizers[312]. - The innovative antitussive and expectorant medicine Gan Di Xin® is developed by the VIE and its subsidiaries[312]. - Gansu QLS has invested approximately RMB 1,000,000 in mutational breeding experiments, increasing the average fermentation unit of oxytetracycline from 32,000 U/ml to 35,000 U/ml, significantly improving product yield and reducing production costs[392]. - Gansu QLS is focusing on developing new products, including nitrofurantoin enteric-coated tablets and vitacoenzyme, to meet unmet market demands[393]. - The company has established a TCMD research project leading to the Ahan® antibacterial paste, which has been on the market since November 2017[392]. - Ahan® antibacterial paste will be further developed to cater to different skin types and cultural regions in China, with additional product variants under research and development[394]. - Gansu QLS has initiated a "Quality Improvement Process for Oxytetracycline Injections" project to enhance product quality and reduce production costs, which includes research on various pharmaceutical products[394]. Intellectual Property - The company has a strong focus on protecting intellectual property as a strategic priority[381]. - The company does not rely on third-party licenses for intellectual property, utilizing a combination of patents, trademarks, and trade secrets[381]. - Gansu QLS holds 14 Chinese patents, with expiration dates ranging from 2026 to 2029[382]. - Chengdu QLS has eight Chinese patents, all expiring in 2029[382]. - The company has filed for record with the Drug-related Information Filing Platform, which has streamlined the re-registration process for its products[320]. - The company’s current patents and applications are crucial for maintaining competitive advantages in the market[382]. - The company has multiple effective patents related to various technologies, including oxytetracycline residue neutralizers and traditional Chinese medicine extraction devices[385]. - The company currently holds ten Chinese trademarks, with expiration dates ranging from 2020 to 2030[388]. - Gansu QLS has obtained the National New Drug Certificate for Gan Di Xin® (No. H20040463) on April 30, 2004, indicating compliance with national medicine quality standards[318]. Market Performance and Recognition - Gan Di Xin® sold approximately 674 million pieces for the year ended September 30, 2021, showing significant growth from 213 million pieces in 2020[320]. - Gansu QLS's oxytetracycline products are certified for both veterinary and human consumption, providing a competitive edge over domestic competitors[324]. - Gansu QLS was recognized as a Strategic Emerging Growth Exemplar Enterprise, indicating its market competitiveness and future development potential[361]. - Gansu QLS received the Gansu Provincial Excellent Engineering Consulting Award for its "Gan Di Xin Industrialization Project," recognized for its high level of ingenuity and economic potential[356]. - The company was awarded the Gansu Province's Famous Brand title, evaluated based on product quality control, market share, and customer satisfaction[357]. - Gansu QLS's trademark Qilian Shan® was awarded the Famous Trademark of Gansu Province, reflecting its high reputation and customer service satisfaction[360]. - Gansu QLS was recognized as a "Specialized New Technology" Enterprise by Gansu Province, reflecting its technological innovation and product development capabilities[364]. - Gansu QLS achieved the status of a Nationally Recognized Enterprise Technology Center, based on criteria including annual sales revenue and research and development capabilities[363]. Operational Insights - The company’s financial management system is complete and organized, contributing to its operational success[366]. - The company has a high average annual growth rate of net profit, with a target of no less than 10%[366]. - The company has well-qualified employees for manufacturing and quality control procedures to ensure product compliance[345]. - The prices for raw materials used by the WFOE and its subsidiaries are subject to market forces and have varied significantly in the past[350]. - For the fiscal year ended September 30, 2022, two customers represented approximately 11% of the sales of the WFOE and its subsidiaries[348]. - One vendor accounted for 14% of total purchases for the fiscal year ended September 30, 2022[351]. - Chengdu QLS has 54 corporate customers for its heparin products and 39 for its sausage casings throughout China[346]. - The WFOE and its subsidiaries intend to engage more qualified distributors and dealers to strengthen their distribution network[346]. - The manufacturing process for heparin sodium involves collecting and processing cleaned pigs' intestines[340]. - Moshangfa's organic fertilizer is designed to improve crop yield and reduce soil compaction[330]. - The company leases a production facility of approximately 6,000 square meters for an annual rent of RMB200,000 (US$30,969), which is sublet to Rugao for the same amount[399].
Qilian International(QLI) - 2022 Q4 - Annual Report