Risk Factors Update Summary

• Expanded to 20 countries outside the US, including the EU, Australia, Canada, and Hong Kong.
• The IRA's impact on business and pharmaceutical industry is significant, although not fully determined.
• The company added two new countries for NERLYNX approval, increasing the total to 20 countries.
• Sales specialists decreased from 40 to 38, impacting the direct specialty sales force.
• Legislative and regulatory initiatives aim to bring transparency to product pricing and reimbursement methodologies.
• Total revenue for NERLYNX was $253.2 million in 2022 and $235.6 million in 2023.
• Accumulated deficit decreased from approximately $1,366 million to $1,345 million.
• EU Regulation phased implementation will impact cooperation, clinical assessments, and reimbursement for products.
• The company initiated a Phase II trial for alisertib in small cell lung cancer in February 2024.
• Full-time employees decreased from 192 to 185 as of December 31, 2023.
• EU Regulation allows joint scientific consultations for innovative health technologies with the highest impact.
• The company plans to meet with the FDA in 2024 to discuss the ALI-4201 clinical trial.
• The company plans to initiate a Phase II trial of alisertib in combination with endocrine treatment in the second half of 2024.
• Changes in EU Regulation could limit coverage and reimbursement for approved drug candidates.
• Revenue from sub-license agreements decreased from 14% to 12% of total revenue in 2023.
• Revenue from sub-licensees increased to $32.5 million in 2023 from $28.0 million in 2022.
• The company entered into agreements with various parties for the development and commercialization of NERLYNX.
• Clinical trials may be adversely affected by disruptions, impacting business operations and financial results.
• The company faces oppositions and patent challenges related to its products in various territories.