Risk Factors Update Summary
- Became a commercial-stage company by commercializing three approved cancer therapies, generating substantial product sales revenue.
- The Implementing Rules for the HGR Regulation and additional issued guidance have clarified many areas of the HGR Regulation.
- Increased investment in employees, with a rise from 9,000 to close to 10,500 employees, a 15% increase.
- The Overseas Listing Trial Measures will take effect on March 31, 2023, impacting Chinese companies.
- Material changes in intellectual property risks, including potential patent challenges and regulatory exclusivities.
- Increased accumulated deficit from $7.8 billion to $8.1 billion, expecting continued losses.
- The Cyberspace Administration of China released the final Measures of Cross-Border Data Transfer Security Assessment, effective as of September 1, 2022, triggering a security assessment for any transfer of important data out of China.
- Strategic collaborations terminated with Amgen and Novartis, regaining full rights to develop and commercialize certain products.
- The Chinese government enhanced the administration of China HGR by amending the Criminal Code in 2021.
- The PRC government may strengthen oversight of capital controls, impacting cross-border transactions.
- The company may need to go through the filing process for follow-on offerings on NASDAQ.
- Operating activities used $1.2 billion, $1.3 billion, and $1.3 billion of net cash during 2023, 2022, and 2021, respectively.
- The company's PFIC status for the taxable year ended December 31, 2023, may impact U.S. shareholders.
- The company's ordinary shares outstanding decreased from 359 million to 312 million as of February 14, 2024.
- The Biosecurity Law became effective in April 2021, establishing an integrated system to regulate biosecurity-related activities.
- The company's restricted assets increased from $3 billion to $4 billion as of December 31, 2023.
- Risks related to manufacturing interruptions or contamination, impacting product availability and regulatory compliance.
- Shareholders beneficially owned approximately 53% of outstanding ordinary shares as of February 14, 2024.
- The Provisions on Thresholds for Prior Notification of Concentrations of Undertakings issued by the State Council require notification for concentrations of business undertakings.
- Potential delays in clinical trials due to regulatory inspections and approvals, affecting drug development timelines.
- The Anti-Monopoly Law of the PRC was amended in June 2022, impacting transactions involving mergers and acquisitions.
- Risks associated with third-party distributors, including potential interruptions impacting sales volumes and business prospects.
- The Overseas Listing Trial Measures and guidelines released by the CSRC will take effect as of March 31, 2023.
- Increased focus on ESG matters, with potential risks related to failure to meet ESG goals and compliance with emerging regulations.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1651308&owner=exclude
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