Risk Factors Update Summary
- Net losses increased from $282.5 million to $367.3 million for the year ended December 31, 2022.
- Nine states have passed laws allowing drug importation from Canada, with FDA approvals pending.
- Cybersecurity risks have increased in frequency, sophistication, and intensity, potentially disrupting operations.
- Accumulated deficit increased from $965 million to $1.332 billion as of December 31, 2023.
- Several states have passed or are considering health privacy laws, impacting compliance risk.
- Litigation challenges to the IRA's Drug Price Negotiation Program could have uncertain outcomes.
- Cash, cash equivalents, and marketable securities increased from $1.2 billion to $1.3 billion as of December 31, 2023.
- The Consolidated Appropriations Act delays the 4% PAYGO sequester through 2024, affecting Medicare.
- The final rule on Medicare drug rebates was delayed to January 1, 2023, impacting pricing.
- The Consolidated Appropriations Act extends the Medicare sequester into fiscal year 2032.
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.
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