Risk Factors Update Summary

• Drug pricing legislation eliminated statutory cap on rebates, reducing profitability by $20 million annually.
• Addition of drug product candidates AJ201 and BAER-101. This expands product pipeline.
• Disclosure of FDA interactions and NDA submissions for IV tramadol. Indicates progress in regulatory approval.
• Legislative challenges may delay IV Tramadol approval, impacting revenue generation significantly.
• Added caution against interpreting risk disclosure as risk not materialized. This clarifies investor perception.
• Mention of potential delays or prevention of regulatory approval for IV tramadol. Highlights approval risks.
• Competition increased with new products, potentially rendering current product candidates obsolete or noncompetitive.
• Inclusion of potential adverse events for IV tramadol and BAER-101. This highlights safety concerns.
• Inclusion of risks related to controlled substances regulations. Highlights regulatory challenges for product candidates.
• Late-stage pain development pipeline includes new formulations and fixed-dose combination products.
• Emphasis on regulatory compliance for product development and commercialization. Ensures adherence to laws.
• Potential commercial opportunity may be harmed if competitors develop more effective products.
• Failure to establish sales and marketing capabilities may hinder commercialization of product candidates.
• Limited product liability insurance coverage may adversely affect financial condition and results of operations.