Risk Factors Update Summary
- Reported net loss decreased significantly from $94.7 million in 2022 to $62.3 million in 2023.
- Major customers accounted for over 90% of gross product revenue in 2023, similar to 2022.
- Federal net operating loss carryforwards decreased from $501 million to $494 million as of December 31, 2023.
- Accumulated deficit increased from $554 million to $617 million as of December 31, 2023.
- Received untitled letter from FDA regarding Recorlev website, addressed concerns, and received close-out letter.
- Legislation enacted in 2019 requires providing product samples to eligible entities developing generic drugs and biosimilar biological products.
- Federal income tax credits decreased from $6.7 million to $3.1 million as of December 31, 2023.
- Completed exchange of $31,975,000 in 2025 Convertible Notes for $33,574,000 in 2028 Convertible Notes.
- Outstanding balance of 2028 Convertible Notes was $33.6 million as of December 31, 2023.
- A performance milestone worth $0.25 has been achieved, with $0.50 milestones outstanding as of December 31, 2023.
- State net operating loss carryforwards decreased from $345 million to $352 million as of December 31, 2023.
- Outstanding balance of 2025 Convertible Notes decreased from $47.2 million to $15.2 million.
- The outstanding balance of Convertible Notes increased from $47 million to $48 million as of December 31, 2023.
- State economic development and research and development credits decreased from $5.6 million to $4.9 million as of December 31, 2023.
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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