ADDED
Excludes shares of the registrant s common stock held by persons who were directors and/or executive officers of the registrant at July 4, 2025 on the basis that such persons may be deemed to have been affiliates of the registrant at such date.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 118 Item 9A.
Our ability to grow our company is dependent upon the commercial success of CABOMETYX in its approved indications and, to a lesser degree, the continued clinical development, regulatory approval, clinical acceptance and commercial success of the cabozantinib franchise.
Current healthcare laws, policies, and regulations in the U.S.
healthcare system, including those related to drug pricing, may affect our ability to commercialize our marketed products profitably.
has come under increasing attention and scrutiny by federal and state governments, legislative bodies and enforcement agencies.
Clinical testing of our product candidates is a lengthy, costly, complex and uncertain process that may ultimately fail to demonstrate sufficiently differentiated safety and efficacy data for those products to compete in our highly competitive market environment.
For example, we rely on Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) for the commercial success of CABOMETYX in its approved indications outside of the U.S., and we are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S.
Fiscal year 2025, which was a 52-week fiscal year, ended on January 2, 2026; fiscal year 2024, which was a 53-week fiscal year, ended on January 3, 2025; and fiscal year 2023, which was a 52-week fiscal year, ended on December 29, 2023.
For convenience, references in this report as of and for the fiscal years ended January 2, 2026, January 3, 2025 and December 29, 2023, are indicated as being as of and for the years ended December 31, 2025, 2024 and 2023, respectively.
REMOVED
Excludes shares of the registrant s common stock held by persons who were directors and/or executive officers of the registrant at June 28, 2024 on the basis that such persons may be deemed to have been affiliates of the registrant at such date.
Changes in and Disagreements Wi th Accountants on Accounting and Financial Disclosure 119 Item 9A.
Form 10-K Summary 128 SIGNATURES 129 1 Table of C o n t e n t s SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS Some of the statements under the captions Risk Factors, Management s Discussion and Analysis of Financial Condition and Results of Operations and Business and elsewhere in this Annual Report on Form 10-K are forward-looking statements.
Our ability to grow our company is dependent upon the commercial success of CABOMETYX in its approved indications and the continued clinical development, regulatory approval, clinical acceptance and commercial success of the cabozantinib franchise in additional indications.
and in foreign countries, has come under increasing attention and scrutiny by federal, state and foreign national governments, legislative bodies and enforcement agencies.
Clinical testing of cabozantinib for new indications, or of our other new product candidates, such as zanzalintinib, is a lengthy, costly, complex and uncertain process that may ultimately fail to demonstrate sufficiently differentiated safety and efficacy data for those products to compete in our highly competitive market environment.
Our clinical, regulatory and commercial collaborations with major companies make us reliant on those companies for their continued performance and investments, which subjects us to a number of risks.
For example, we rely on 2 Table of C o n t e n t s Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) for the commercial success of CABOMETYX in its approved indications outside of the U.S., and we are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S.
Fiscal year 2024, which was a 53-week fiscal year, ended on January 3, 2025; fiscal year 2023, which was a 52-week fiscal year, ended on December 29, 2023; and fiscal year 2022, which was a 52-week fiscal year, ended on December 30, 2022.
For convenience, references in this report as of and for the fiscal years ended January 3, 2025, December 29, 2023 and December 30, 2022, are indicated as being as of and for the years ended December 31, 2024, 2023 and 2022, respectively.