Overview

We are a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer. Our commercial portfolio includes our first product, UDENYCA (pegfilgrastim-cbqv), a biosimilar to Neulasta, and LOQTORZI, a novel next-generation PD-1 inhibitor. We are also developing an innovative immuno-oncology pipeline, including casdozokitug and CHS-114.

On December 2, 2024, we entered into an agreement to divest the UDENYCA business to Intas for $483.4 million in cash, plus potential additional earnout payments. We anticipate this transaction to close late in the first quarter or early in the second quarter of 2025. We plan to use the proceeds to fully repay our outstanding convertible notes, buy out certain royalty obligations, and for general corporate purposes.

LOQTORZI was approved by the FDA in October 2023 for the treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). We launched LOQTORZI in the U.S. in January 2024 and are evaluating it through multiple clinical studies. Our pipeline also includes earlier-stage immuno-oncology programs, such as casdozokitug and CHS-114, that we plan to develop in combination with LOQTORZI.

Business Update

UDENYCA Sale On December 2, 2024, we entered into an agreement to divest the UDENYCA business to Intas for $483.4 million in cash, inclusive of $118.4 million of UDENYCA product inventory. We are also eligible for two additional earnout payments of $37.5 million each if certain UDENYCA net sales thresholds are met. The transaction is expected to close late in the first quarter or early in the second quarter of 2025.

UDENYCA Supply Interruption In September 2024, we experienced a temporary UDENYCA supply interruption due to production delays at one of our third-party packaging and labeling CMOs. This disruption temporarily impacted our ability to sell UDENYCA, which makes up a large percentage of our total revenue. Production resumed in November 2024, but we have since implemented measures to diversify our labeling and packaging resources.

Products and Product Candidates

Oncology

• UDENYCA was launched in 2019 and is being divested to Intas.
• LOQTORZI was approved in October 2023 for the treatment of NPC and launched in the U.S. in January 2024. It is being evaluated in multiple clinical studies.
• Casdozokitug is in Phase ¹⁄₂ and Phase 2 studies for advanced solid tumors and hepatocellular carcinoma.
• CHS-114 is in clinical trials for advanced solid tumors and head and neck squamous cell carcinoma.
• CHS-1000 is an early-stage antibody targeting ILT4 that is being evaluated for potential clinical development.
• GSK4381562 is exclusively licensed to GSK.

Immunology - Sold

• YUSIMRY (adalimumab-aqvh), a Humira biosimilar, was sold to HKF in June 2024.

Ophthalmology - Sold

• CIMERLI (ranibizumab-eqrn), a Lucentis biosimilar, was sold to Sandoz in March 2024.

Financial Operations Overview

Revenue Our total net revenues were $267.0 million and $257.2 million in 2024 and 2023, respectively. UDENYCA net revenue increased in 2024 due to higher market share, partially offset by the supply interruption. LOQTORZI contributed $19.1 million in net revenue following its launch in January 2024.

Cost of Goods Sold Cost of goods sold decreased in 2024 compared to 2023, primarily due to the divestitures of CIMERLI and YUSIMRY, partially offset by higher UDENYCA and LOQTORZI volumes and inventory write-downs.

Research and Development Expense Research and development expense decreased in 2024 compared to 2023, primarily due to lower personnel costs, reduced co-development costs for toripalimab and CHS-006, and fewer expenditures for CHS-1000. This was partially offset by increased spending on casdozokitug and CHS-114.

Selling, General and Administrative Expense Selling, general and administrative expense decreased in 2024 compared to 2023, primarily due to lower headcount and operating costs, partially offset by a net impairment charge related to an out-license intangible asset.

Interest Expense Interest expense decreased in 2024 compared to 2023, primarily due to the payoff of the 2027 Term Loans in the second quarter of 2024.

Gain on Sale Transactions, Net We recognized a net gain of $176.6 million in 2024 from the sales of the CIMERLI and YUSIMRY franchises.

Loss on Debt Extinguishment We recognized a $12.6 million loss in 2024 related to the early repayment of the 2027 Term Loans.

Liquidity and Capital Resources

As of December 31, 2024, we had $126.0 million in cash, cash equivalents, and marketable securities, and $293.7 million in total financial liabilities. We have funded our operations primarily through product sales, debt financing, and the recent sale transactions.

Key liquidity events in 2024 included:

• $187.8 million in cash proceeds from the CIMERLI sale
• $40.0 million in cash proceeds from the YUSIMRY sale
• $37.5 million in proceeds from the Revenue Purchase and Sale Agreement
• $37.5 million in proceeds from the 2029 Term Loan

We anticipate using a portion of the proceeds from the planned UDENYCA sale to fully repay our outstanding convertible notes and buy out certain royalty obligations. We believe our available cash and cash from operations will be sufficient to fund our planned expenditures for at least the next 12 months.

Outlook

Following the anticipated close of the UDENYCA sale, our business will be focused on the continued development and commercialization of our immuno-oncology portfolio, led by LOQTORZI. We expect LOQTORZI net revenue to increase in 2025 compared to 2024 as we further leverage our commercial capabilities. At the same time, we plan to advance our earlier-stage pipeline assets, such as casdozokitug and CHS-114, through ongoing and planned clinical studies. Overall, we are well-positioned to execute on our strategic priorities and drive value for shareholders.