Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Failure to achieve commercial success of iDose TR could materially impact business. Downturns in general economic conditions could harm business.
  • Changes in Medicare payment rates for procedures involving iStent products were significant, impacting physician and facility fees.
  • Research programs may fail to yield product candidates, affecting business prospects materially.
  • Cybersecurity threats and incidents pose risks to information technology systems, potentially impacting operations.
  • The company's ability to manufacture and ship products may be impacted by disruptions at its manufacturing locations, affecting revenue.
  • Products may not receive regulatory approval, be profitable, or face competition with superior technologies.
  • Supply/manufacturing disruptions impacting principal revenue-producing products could reduce gross margins and negatively impact operating results.
  • Changes in foreign currency fluctuations may negatively impact revenue, gross margins, and operating income.
  • The company's NDA submission for iDose TR was impacted, affecting future pipeline products. This change may delay approval.
  • Products classified as drug-led drug-device combinations will require coordination by FDA's drug and device centers, potentially delaying approval.
  • Failure to comply with data privacy laws could have a material adverse effect on business.
  • The company faces risks related to unfavorable global and regional macroeconomic conditions, including inflation and labor shortages.
  • Orphan drug exclusivity for Photrexa therapy expired in April 2023, impacting market competitiveness.
  • Difficulty in scaling up manufacturing to meet increased demand may result in significant costs or lost revenue.
  • Laws and regulations governing the company's U.S. operations were expanded, including the federal health care Anti-Kickback Statute.
  • Global growth strategy faces challenges in managing foreign operations, impacting sales and operations.
  • Cybersecurity incidents, service interruptions, or data corruption could disrupt operations and adversely affect business.
  • The company's accumulated deficit was approximately $464 million as of December 31, 2023, impacting its financial condition and operations.
  • Debt service obligations could limit cash flow, affecting the ability to pay debt obligations.
  • Failure to raise funds to settle conversions of Convertible Notes may adversely affect financial condition.
  • Failure to protect intellectual property could impair ability to compete effectively.

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=1192448&owner=exclude

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