Risk Factors Update Summary

• The company entered into an agreement with Alimera for the sale of YUTIQ franchise for $82.5 million.
• The FDA approved EYLEA HD for wet AMD, DME, and DR in August 2023 based on clinically equivalent vision gains.
• YUTIQ was approved in China in 2022 and we are entitled to royalties on product sales by Ocumension.
• The future sales of YUTIQ and DEXYCU may be impacted by FDA regulations and product liability exposure.
• The Company received $82.5 million plus royalties for the sale of YUTIQ® to Alimera.
• The company received a $75 million upfront payment from Alimera for the YUTIQ franchise.
• Several companies are developing gene therapy treatments for retinal diseases, potentially impacting the market.
• The IRA requires negotiation of drug prices, potentially impacting the company's Medicare revenue and Medicaid rebate liability.
• The company's U.S. net operating loss carryforwards were approximately $296 million for federal income tax purposes.
• The last expiring patent covering DEXYCU expires in July 2023, with additional patents extending coverage until at least May 2034.
• The IRA includes provisions penalizing manufacturers for price increases above inflation, affecting the company's pricing strategies.
• The IRA sunsets the coverage gap program and introduces a new manufacturer discount program effective 2025.
• The loss of the license from Equinox could prevent the development of EYP-1901.
• EYP-1901 Phase 3 trials for wet AMD are expected to start in the second half of 2024.
• The last expiring patent covering the vorolanib compound used in EYP-1901 expires in September 2037.
• The IRA imposes penalties for non-compliance with drug price negotiation programs, potentially impacting the company's financial condition.
• The new standalone manufacturing facility is expected to be operational in the second half of 2024.
• Positive topline data from the DAVIO 2 trial showed EYP-1901 achieved primary and secondary endpoints.UT:53% of patients went six months without needing a supplemental anti-VEGF injection.UT:80% reduction in treatment burden.UT:65% of eyes were supplement-free up to six months.UT:Strong anatomical control with OCT.UT:Patient discontinuation was low at 4%.UT:Sub-group patients showed numerical superiority in BCVA change compared to aflibercept.UT:Topline results at week 32 released on December 4, 2023.UT:DAVIO 2 study ongoing with continued patient follow-up through week 56.UT:PAVIA NPDR Phase 2 trial completed enrollment of 77 patients.UT:VERONA DME Phase 2 trial enrolled its first patient on Jan 9, 2024.UT:Topline results anticipated in the second quarter of 2024 for PAVIA and in the first quarter of 2025 for VERONA.UT:EYP-1901 Phase 2 clinical trials for wet AMD, NPDR, and DME ongoing.UT:EYP-2301 advancing into pre-clinical development.UT:Market opportunities for wet AMD, NPDR, and DME being explored.UT:Focus on improving treatment for VEGF-mediated diseases.
• The company's U.S. net operating loss carryforwards were approximately $254 million for state income tax purposes.
• The latest expiring U.S. patent covering ILUVIEN and YUTIQ expires in August 2027.
• The Company is constructing a 40,000-square-foot manufacturing facility in Northbridge, MA, expected to be operational in the second half of 2024.
• The commercial alliance agreement with ImprimisRx for DEXYCU was expanded until at least six months.
• Ocumension has the right to nominate individuals to the board and participate in private placements.
• Provisions in the charter documents could prevent or delay stockholders' attempts to take over the company.
• Data protection laws in various states and countries may impose limitations on activities.