Risk Factors Update Summary

• We currently have two commercial products, ZTlido and ELYXYB, with GLOPERBA expected to launch in the first half of 2024. This addition highlights the company's product portfolio expansion.
• Issuance of additional equity securities totaling 20,167,587 shares may dilute existing stockholders.
• The company filed a complaint against Aveva Drug Delivery Systems, Inc. in 2022 regarding ZTlido patents.
• The terms of the Oramed Note place restrictions on operating and financial flexibility, with a principal amount of $101,875,000 due in six installments. This impacts the company's financial obligations significantly.
• Authorization to grant equity awards under various plans may lead to additional dilution.
• The U.S. Department of Health and Human Services announced negotiations for certain high spend single-source drugs under Medicare.
• The closure of any additional national or regional commercial banks could lead to further economic instability.
• The IRA seeks to limit manufacturers' price increases for Medicare drugs to not more than the rate of inflation.
• The company entered into the Romeg Agreement on June 14, 2022, for the exclusive development and commercialization in the Romeg Territory.
• The company's accumulated deficit increased from approximately $375.9 million in 2022 to approximately $490.2 million in 2023. This change indicates a significant financial challenge for the company.
• Changes in corporate governance standards may impact compliance and board composition.
• Takeda filed GLOPERBA Patent Litigation against the company, impacting the sale of GLOPERBA under a revised label.
• The Eastern District of California ruled AB 979 unconstitutional, impacting litigation and financial penalties.
• The company expects to incur substantial expenses related to the commercialization of ZTlido, GLOPERBA, and ELYXYB, as well as the development of product candidates. This highlights the company's financial burden and investment requirements.
• The company's net losses increased from $23.4 million in 2022 to $114.3 million in 2023, indicating a significant negative financial trend.
• The company's full-time employees increased from approximately 90 in 2022 to approximately 105 in 2023, reflecting potential growth and increased operational capacity.
• The company may need to make milestone payments for the approval of Semnur products, including SEMDEXA, with the first approval triggering payments. This indicates potential additional financial obligations for the company.