Risk Factors Update Summary
- The European Union's Health Technology Assessment (HTA) regulation will apply from January 2025 onwards.
- The Department of Health and Human Services (HHS) published a final rule allowing drug importation.
- Merck & Co., Inc., filed a lawsuit against HHS and CMS regarding the IRA's Drug Price Negotiation Program.
- Net income increased significantly from $26.6 million in 2022 to $40.7 million in 2023.
- The FDA authorized the importation of mass medications from Canada into Florida.
- The EU-U.S. Data Privacy Framework was adopted, allowing valid data transfers from the EU to the U.S.
- Accumulated deficit decreased from $379 million to $338 million as of December 31, 2023.
- Federal NOLs decreased from approximately $270 million to $179 million as of December 31, 2023.
- The Inflation Reduction Act has been delayed until January 1, 2032 by Congress.
- The United Kingdom and the United States implemented a US-UK "data bridge" for data transfers.
- Total revenues increased by 20% from $181.0 million in 2022 to $216.7 million in 2023.
- State NOLs decreased from approximately $170 million to $98 million as of December 31, 2023.
- Revenue growth fluctuated, with a 31% increase in 2023 compared to 28% in 2022.
- Federal research and development tax credit carryforwards decreased from approximately $19 million to $23 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.
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=1490978&owner=exclude
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