Risk Factors Update Summary
- Received approval from the European Commission and Medicines and Healthcare products Regulatory Agency for BRIUMVI in 2023.
- The number of full-time employees increased from 226 to 264, indicating significant growth.
- Approval for BRIUMVI is subject to post-marketing testing, including Phase 4 clinical trials.
- Entered into a commercialization agreement with Neuraxpharm Pharmaceuticals for BRIUMVI in certain markets.
- The federal net operating loss carryforwards were updated from December 31, 2022, to 2023.
- Obtained a product-specific J-Code for BRIUMVI, effective July 1, 2023, to address reimbursement concerns.
- Increased the aggregate principal amount for loan advances under the First Amendment to $85.0 million.
- The risks section expanded to include ESG practices, emphasizing the importance of environmental stewardship.
- Commenced a trial evaluating azer-cel in autoimmune disease in 2024.
- Entered into a commercialization agreement with Neuraxpharm Pharmaceuticals for BRIUMVI in certain markets.
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=1001316&owner=exclude
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