Risk Factors Update Summary
- Not pursuing further clinical development of mavodelpar could impact revenue streams significantly.
- Plaintiffs increasingly bring privacy-related claims, potentially leading to monumental statutory damages.
- Anticipate continued net losses for the foreseeable future. Reported net loss: $77.4 million in 2023.
- The company may face fines up to $7,500 per intentional violation for data privacy breaches.
- The company's common stock may be delisted from Nasdaq, impacting liquidity and financing options.
- Pursuing strategic alternatives due to suspension of product candidate. Reduction in workforce costs: $4.1 million.
- The Budget Control Act of 2011 resulted in aggregate reductions, effective until 2032.
- The company may rely on third parties for manufacturing, facing risks of delays and quality issues.
- Loss of clinical trial data could hinder commercialization efforts and delay product candidates.
- The company maintains up to $7.0 million in product liability insurance, now noted in Note 11.
- The company may need significant additional capital for future operations, up to $100 million.
- The IRA eliminates the Medicare Part D donut hole starting in 2024.
- Cash, cash equivalents, and short-term investments: $103.0 million as of December 31, 2023, expected $82.0 million by March 31, 2024.
- Increased risk of cyber threats, including ransomware and social engineering attacks, poses operational disruptions.
- The company's ability to protect intellectual property is crucial for future product commercialization.
- The company moved cash deposits from SVB to other institutions, avoiding material impact.
- The Affordable Care Act established an annual fee on entities manufacturing specified drugs.
- The Biden administration's Comprehensive Plan includes price negotiations for the first ten drugs.
- The Biden administration's executive order directs testing of new models for lowering drug costs.
- The company may face fines up to $20 million or 4% of annual global revenue for data privacy violations.
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=1637715&owner=exclude
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