Risk Factors Update Summary
- Wholesale acquisition cost for XHANCE increased from $626.82 to $626.82 as of January 1, 2024.
- Reduction in foreign NOL carry forwards from $9 million to $3 million for the Norwegian subsidiary.
- The FDA extended the final report submission deadline for XHANCE from April 2023 to September 2026.
- Operating strategy revised in 2023 to focus on efficiency, reducing expenses by $38 million.
- Reduction in foreign NOL carry forwards from $9 million to $3 million for the UK subsidiary.
- Failure to timely pay a Part D inflation rebate now incurs a civil monetary penalty.
- Sales force reduced from 77 to 75 territory managers targeting 7,000 primary care physicians.
- Reduction in U.S. federal net operating loss carry forwards from approximately $335 million to $360 million.
- The coverage gap program will be replaced by a new manufacturer discount program starting in 2025.
- Reduction in full-time employees from 141 to 132, all in the U.S., with 70% in customer-facing roles.
- The European Commission proposed reforms that may reduce regulatory data exclusivity, impacting XHANCE.
- The FDA extended the PDUFA goal date for XHANCE sNDA from December 2023 to March 2024.
- The FTC initiated actions against improper patent listings in the FDA's Orange Book.
- OptiNose AS was dissolved in October 2023, impacting the company's operations and products.
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=1494650&owner=exclude
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