Coherus Oncology Inc.

03/09/2026 | Press release | Distributed by Public on 03/09/2026 14:58

Annual Report for Fiscal Year Ending 12-31, 2025 (Form 10-K)

Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the consolidated financial statements and notes thereto included elsewhere in this Annual Report on Form 10-K ("Form 10-K"). This Form 10-K, including the following sections, contains forward-looking statements within the meaning of the federal securities laws. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see the "Risk Factors" section in Item 1A of this Form 10-K. We caution the reader not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this Form 10-K. We undertake no obligation to update forward-looking statements, which reflect events or circumstances occurring after the date of this Form 10-K.

As described below, on April 11, 2025, we sold the UDENYCA Business, which represented the last and most significant divestiture of the Company's biosimilar businesses, which comprised the UDENYCA, YUSIMRY and CIMERLI franchises; therefore, the strategic shift criteria had been met. As a result, the assets, liabilities, and results of the biosimilar businesses were classified to discontinued operations in our Form 10-K herein. As such, we have retrospectively reclassified all assets, liabilities, and results of the biosimilar businesses as discontinued operations in the following discussion and adjusted all references to the assets, liabilities, and results of our biosimilar businesses accordingly.

Overview

We are a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 inhibitor, LOQTORZI® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, head and neck, colorectal and other cancers. Our strategy is to grow sales of LOQTORZI in NPC and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners, driving sales multiples and synergies from proprietary combinations. On May 29, 2025, we changed our corporate name from "Coherus BioSciences, Inc." to "Coherus Oncology, Inc." to better align with our exclusive focus on proprietary innovative immuno-oncology medicines following the completion of the recent divestitures of our biosimilar businesses and the transition to an exclusive focus on overcoming immune resistance in cancer with novel drugs.

We previously owned UDENYCA (pegfilgrastim-cbqv), which was launched commercially in a pre-filled syringe presentation in the United States in January 2019, followed by the launch of UDENYCA in an autoinjector presentation in May 2023 and the launch of UDENYCA ONBODY in February 2024. On December 2, 2024, we entered into the UDENYCA Purchase Agreement, pursuant to which the Company agreed to divest the UDENYCA Business to Intas. On April 11, 2025, we completed the divestiture of the UDENYCA Business to Intas for upfront, all-cash consideration of $483.4 million, inclusive of $118.4 million for UDENYCA product inventory. Intas has designated Accord to purchase the physical assets, including product inventory. We are eligible to receive two additional payments of $37.5 million each (together, the "Earnout Payments"). The first such payment is payable by Intas to us if net sales (as defined in the UDENYCA Purchase Agreement, "Net Sales") of UDENYCA for four consecutive fiscal quarters from July 1, 2025 through September 30, 2026 are equal to or greater than $300 million, and the second such payment is payable by Intas to us if Net Sales of UDENYCA for four consecutive fiscal quarters from July 1, 2025 through March 31, 2027 are equal to or greater than $350 million.

The UDENYCA Sale represented the last and most significant divestiture of our biosimilar businesses, which comprised the UDENYCA, YUSIMRY and CIMERLI franchises; therefore, the strategic shift criteria had been met and discontinued operations presentation has been included in the consolidated financial statements for all periods presented.

On October 27, 2023, we announced that LOQTORZI was approved by the FDA in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is an anti-PD-1 antibody that we developed in collaboration with Junshi Biosciences that is currently the only immune checkpoint inhibitor approved by the FDA for the treatment of these indications that is commercially available in the United States. We announced the launch of LOQTORZI in the U.S. on January 2, 2024. Further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by us, Junshi Biosciences and our biopharma partners.

We have a depth of scientific expertise, an experienced and robust manufacturing know-how and oncology clinical, regulatory, market access, sales, key account management and medical affairs capabilities in the United States, which has supported the commercialization of LOQTORZI. We expect to further leverage these capabilities as we continue to advance our immuno-oncology franchise.

We primarily operate in the United States and partner with companies that operate in other countries.

UDENYCA Sale

On December 2, 2024, we entered into the UDENYCA Purchase Agreement by and between us and Intas. Pursuant to the terms and subject to the conditions set forth in the UDENYCA Purchase Agreement, we agreed to divest the UDENYCA Business to Intas for $483.4 million in cash, inclusive of $118.4 million of UDENYCA product inventory, subject to downward adjustment by the amount of inventory delivered at the closing of the UDENYCA Sale less than the Inventory Target. In addition, we are also eligible to receive two additional Earnout Payments of $37.5 million each, provided that certain minimum UDENYCA Net Sales thresholds are met during specified periods after the closing of the UDENYCA Sale. The first such payment is payable by Intas to us if net sales of UDENYCA for four consecutive fiscal quarters within the first five full fiscal quarters following the consummation of the UDENYCA Sale are equal to or greater than $300 million, and the second such payment is payable by Intas to us if net sales of UDENYCA for four consecutive fiscal quarters within the first seven full fiscal quarters following the consummation of the UDENYCA Sale are equal to or greater than $350 million.

Our board of directors unanimously approved and declared the UDENYCA Purchase Agreement and the transactions contemplated thereby, including the UDENYCA Sale, to be in the best interest of the Company and its stockholders, and resolved to recommend that the our stockholders adopt the UDENYCA Purchase Agreement. There was a vote of our stockholders at a special stockholder meeting on March 11, 2025 where our stockholders approved the UDENYCA Sale, the UDENYCA Purchase Agreement and the other transactions and ancillary documents contemplated by the Asset Purchase Agreement. The transactions contemplated thereby closed on April 11, 2025.

Product and Product Candidates

Our portfolio includes the following product and product candidates:

LOQTORZI was developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, by binding to the FG loop on the PD-1 receptor. We believe blocking PD-1 interactions with PD-L1 and PD-L2 can help to promote the immune system's ability to attack and kill tumor cells. On October 27, 2023, we announced that LOQTORZI was approved by the FDA in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is an anti-PD-1 antibody that we developed in collaboration with Junshi Biosciences. We announced the launch of LOQTORZI in the U.S. on January 2, 2024.

On December 11, 2023 we announced that NCCN updated the clinical practice guidelines for NPC to include LOQTORZI as a preferred, category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine. On November 26, 2024, NCCN made a further update to the clinical practice guidelines for NPC to specify that LOQTORZI is the only preferred category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine. The guidelines also recommend LOQTORZI monotherapy as the only preferred treatment in subsequent lines of therapy with disease progression on or after a platinum-containing therapy.

Further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by us and our partners. We have a post marketing commitment study active and enrolling patients in locations in the U.S. and Canada in order to further evaluate the safety and efficacy of toripalimab in combination with chemotherapy (cisplatin and gemcitabine) in patients with advanced NPC (clinicaltrials.gov identifier# NCT06457503). Junshi Biosciences has an active multiregional Phase 3 clinical study evaluating the treatment of LOQTORZI with its investigational anti-BTLA antibody in LS-SCLC (clinicaltrials.gov identifier# NCT06095583). INOVIO Pharmaceuticals, Inc. plans a randomized Phase 3 study of INO-3112 and toripalimab in locally advanced, high risk HPV16/18+ oropharyngeal squamous cell carcinoma. Cancer Research Institute is evaluating toripalimab in combination with ENB Therapeutics' investigational agent ENB-003 in its Phase 2 trial titled, "Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC)" (clinicaltrials.gov identifier# NCT04918186) that is being performed in collaboration with Canadian Cancer Trials Group. STORM Therapeutics, Ltd. is evaluating its METTL3 inhibitor STC-15 in combination with LOQTORZI in a Phase 1b/2 study (clinicaltrials.gov identifier# NCT06975293) for the treatment of non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma, and endometrial cancer. On June 27, 2024, we entered into a license Agreement with Apotex, pursuant to which, we granted to Apotex the Canada License Agreement. On October 23, 2025, Health Canada approved LOQTORZI for the treatment of recurrent unresectable or metastatic NPC.

Casdozokitug (CHS-388, formerly SRF388), is an investigational recombinant human IgG1 monoclonal antibody targeting IL-27, an immune regulatory cytokine, or protein that is overexpressed in certain cancers, including hepatocellular, lung and renal cell carcinoma. IL-27 is a cytokine secreted by macrophages and antigen presenting cells that plays an important
physiological role in suppressing the immune system, as evidenced by its ability to resolve tissue inflammation. In addition, IL-27 is highly expressed during pregnancy and its expression is correlated with maternal-fetal tolerance. Due to its immune regulatory nature, there is a rationale for inhibiting IL-27 to treat cancer, as this approach will influence the activity of multiple types of immune cells that are necessary to recognize and attack a tumor. Casdozokitug received orphan drug designation from the FDA for the treatment of HCC in October 2020. Casdozokitug is currently being evaluated in an ongoing randomized Phase 2 clinical study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab (clinicaltrials.gov identifier# NCT06679985).
Tagmokitug (CHS-114, formerly SRF114), is an investigational human afucosylated IgG1 monoclonal antibody selectively targeting CCR8, a chemokine receptor highly expressed on regulatory T cells ("Treg cells") in the tumor microenvironment. Tagmokitugis designed as a cytolytic antibody to cause depletion of intra-tumoral Treg cells, important regulators of immune suppression and tolerance, through ADCC, or ADCP or both. Tagmokitughas shown anti-tumor activity as monotherapy and in combination with anti-PD-1 antibodies in preclinical models. We are currently evaluating tagmokitugin combination with toripalimab in a Phase 1b clinical study in second-line HNSCC (clinicaltrials.gov identifier# NCT05635643). We also have an ongoing Phase 1b/2a clinical study of tagmokitugin combination with toripalimab and/or other treatments in participants with advanced solid tumors with the first cohorts evaluating upper GI adenocarcinoma, esophageal squamous cell cancer and microsatellite stable colorectal cancer (clinicaltrials.gov identifier# NCT06657144).

On February 4, 2026, we announced a clinical supply agreement with Janssen Research & Development, LLC, to evaluate tagmokitug in combination with pasritamig, a T-cell engaging bispecific antibody, in a Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer. Under the terms of the clinical supply agreement, Janssen will provide pasritamig to us, and we will be the sponsor of the Phase 1b clinical trial. Janssen and us each retain all commercial rights to our respective compounds, including as monotherapy or as combination treatments.

License Agreement with Junshi Biosciences

On February 1, 2021, we entered into the Collaboration Agreement with Junshi Biosciences for the co-development and commercialization of LOQTORZI, Junshi Biosciences' anti-PD-1 antibody in the United States and Canada.

Under the terms of the Collaboration Agreement, we paid $150.0 million upfront for exclusive rights to LOQTORZI in the United States and Canada. We obtained the right to conduct all commercial activities of LOQTORZI in the United States and Canada. We have paid $25.0 million for the achievement of certain milestones, and we pay a royalty in the low twenty percent range on net sales of LOQTORZI. On June 27, 2024, we entered into the Canada License Agreement pursuant to which, we granted to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada. Apotex received Health Canada approval for LOQTORZI for the treatment of recurrent unresectable or metastatic nasopharyngeal cancer in October 2025.

Financial Operations Overview

Discontinued Operations

The UDENYCA Sale represented the last and most significant divestiture of the Company's biosimilar businesses, which comprised the UDENYCA, YUSIMRY and CIMERLI franchises; therefore, the strategic shift criteria had been met and discontinued operations presentation has been included in the consolidated financial statements for all periods presented.

Revenue

LOQTORZI was approved in October 2023 and was launched in the United States in January 2024.

Cost of Goods Sold

Cost of goods sold consists primarily of third-party manufacturing, distribution, royalties and certain overhead costs. Cost of goods sold includes a royalty in the low twenty percent range on net sales of LOQTORZI.

Research and Development Expense

Research and development expense represents costs incurred to conduct research, such as the discovery and development of our product candidates. We recognize all research and development costs as they are incurred. We currently track research and development costs incurred on a product candidate basis only for external research and development expenses. Our external research and development expense consists primarily of:

expense incurred under agreements with collaborators, consultants, third-party CROs, and investigative sites where a substantial portion of our preclinical studies and all of our clinical trials are conducted;
costs of manufacturing preclinical study and clinical trial supplies and other materials from CMOs, and related costs associated with release and stability testing;
costs associated with manufacturing process development activities, analytical activities and pre-launch inventory manufactured prior to regulatory approval being obtained or deemed to be probable; and
upfront and certain milestone payments related to licensing and collaboration agreements.

Internal costs are associated with activities performed by our research and development organization and generally benefit multiple programs. These costs are not separately allocated by product candidate. Unallocated, internal research and development costs consist primarily of:

personnel-related expense, which include salaries, benefits and stock-based compensation; and
facilities and other allocated expense, which include direct and allocated expense for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment, laboratory and other supplies.

The process of conducting the necessary clinical research to obtain regulatory approval is costly and time consuming. Furthermore, in the past, we have entered into collaborations with third parties to participate in the development and commercialization of our product candidates, and we may enter into additional collaborations in the future. In situations in which third parties have substantial influence over the development activities for product candidates, the estimated completion dates are not fully under our control. For example, our partners in licensed territories may exert considerable influence on the regulatory filing process globally. Therefore, we cannot forecast with any degree of certainty the duration and completion costs of these or other current or future clinical trials of our product candidates. We may never succeed in achieving regulatory approval for any of our pipeline product candidates. In addition, we may enter into other collaboration arrangements for our other product candidates, which could affect our development plans or capital requirements.

The following table summarizes our research and development expense from continuing operations incurred during the respective periods:

Clinical Stage as of

Year Ended December 31,

(in thousands)

​ ​

December 31, 2025

​ ​

2025

​ ​

2024

External costs incurred by product candidate:

Casdozokitug

Clinical trials

$

31,098

$

16,588

Tagmokitug

Clinical trials

27,773

7,847

LOQTORZI

Approved (1)

7,470

13,290

Other discontinued projects

Discontinued (2)

2,454

2,305

Other research and development expenses

25

7,556

Internal costs

40,068

44,247

Total research and development expenses from continuing operations

$

108,888

$

91,833

(1) In October 2023, LOQTORZI was approved by the FDA in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for LOQTORZI as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
(2) In 2025, this primarily includes $2.5 million for the net write down of an intangible asset not related to our current pipeline. The 2024 expenses primarily related to the TIGIT Program, which we terminated in January 2024.

Selling, General and Administrative Expense

Selling, general and administrative expense consists primarily of personnel costs, allocated facilities costs and other expense for outside professional services, including legal, insurance, human resources, outside marketing, advertising, audit and accounting services, acquisition-related costs, and costs associated with establishing commercial capabilities in support of the commercialization of LOQTORZI. Personnel costs consist of salaries, benefits and stock-based compensation. Reimbursement of expenses from counterparties to the Transition Service Agreements ("TSAs") are recorded as reductions to selling, general and administrative expense.

Interest Expense

Interest expense consists primarily of interest incurred on our outstanding indebtedness, our Revenue Purchase and Sale Agreement, and non-cash interest related to the amortization of debt discount and debt issuance costs.

Loss on Debt Extinguishment

Loss on debt extinguishment consists of losses incurred related to the early repayment of debt obligations.

Other Income (Expense), Net

Other income (expense), net consists primarily of interest earned on our cash and cash equivalents, non-cash accretion of discount on our investments in marketable securities, foreign exchange gains (losses) resulting from currency fluctuations, gains (losses) from financial instruments including the change in fair value of the Royalty Fee Derivative Liability, gains (losses) from disposal of long-lived assets, and income related to certain services provided under transition service agreements.

Net Income from Discontinued Operations, Net of Tax

Net income from discontinued operations, net of tax represents the activities of the divested biosimilar businesses, which comprised the UDENYCA, YUSIMRY and CIMERLI franchises, including gains recognized upon divestiture, interest expense and loss on debt extinguishment associated with debt and financial liabilities repaid in connection with divestitures, the change in fair value for the UDENYCA portion of the Royalty Fee Derivative Liability, and the tax provision for discontinued operations.

Results of Operations

Comparison of Years Ended December 31, 2025 and 2024

Revenue

Year Ended December 31,

(in thousands)

​ ​ ​

2025

​ ​ ​

2024

​ ​ ​

Change

LOQTORZI

$

40,836

$

19,131

$

21,705

Other revenue

1,336

7,258

(5,922)

Total net revenue

$

42,172

$

26,389

$

15,783

The increase in LOQTORZI net revenue for the year 2025 compared to 2024 was driven primarily by volume growth of LOQTORZI, which launched in January 2024. Other revenue in 2024 includes $6.3 million for the out-license of rights to commercialize toripalimab within Canada.

We expect net revenue from continuing operations in 2026 to be higher than in 2025 because of continued growth of LOQTORZI.

Cost of Goods Sold

Year Ended December 31,

(in thousands)

2025

​ ​ ​

2024

​ ​ ​

Change

Cost of goods sold

$

13,814

$

8,727

$

5,087

Gross margin

67

%

67

%

The increase in cost of goods sold from continuing operations for 2025 compared to 2024 was primarily due to volume growth of LOQTORZI, which launched in January 2024.

We expect cost of goods sold from continuing operations for 2026 to be higher than 2025 because of continued growth of LOQTORZI.

Research and Development Expense

Year Ended December 31,

(in thousands)

2025

​ ​ ​

2024

​ ​ ​

Change

Research and development

$

108,888

$

91,833

$

17,055

The increase in research and development expense from continuing operations in 2025 compared to the prior period was primarily due to the following:

an increase of $19.9 million for the development of tagmokitug, including $1.1 million in milestones;
an increase of $14.5 million for the development of casdozokitug; and
an increase of $2.5 million for the net write-down of an intangible asset unrelated to our current active pipeline.

The increase was partially offset by the following:

a decrease of $5.8 million in development costs for single agent toripalimab in the United States;
a decrease of $5.8 million in facilities, supplies and materials and other infrastructure related expenses to support our research and development programs;
a decrease of $5.7 million related to programs that are no longer being developed; and
a decrease of $1.7 million in employee-related costs including stock-based compensation.

We expect our fixed research and development expenses in 2026 to be lower than in 2025 primarily due to rebalancing manufacturing-related development activities and reduced headcount. Total overall research and development expenses, which includes external clinical costs, will be a function of data readouts and our ongoing portfolio prioritization process.

Selling, General and Administrative Expense

Year Ended December 31,

(in thousands)

2025

​ ​ ​

2024

​ ​ ​

Change

Selling, general and administrative

$

100,604

$

125,482

$

(24,878)

The decrease in selling, general and administrative expense from continuing operations in 2025 was primarily due to a lower average headcount resulting in reductions of $11.9 million in employee-related costs including stock-based compensation, the $6.8 million net impairment charge in the first quarter of 2024 relating to the write-off of the net carrying value of the out-license intangible asset of $10.6 million and the final remeasurement of the contingent value right ("CVR") liability of $3.8 million related to NZV930 to its fair value of zero, lower professional fees of $5.4 million and a reduction of $2.6 million in facilities, supplies and materials and other related expenses to support our commercial infrastructure. These reductions were offset by the $1.6 million net impairment charge in the third quarter of 2025 relating to the write-off of the net carrying value of the out-license intangible asset and the final remeasurement of the CVR liability related to GSK4381562 to its fair value of zero (see Note 5. Balance Sheet Components).

We expect our selling, general and administrative expense from continuing operations for the full year 2026 to be lower than the full year 2025 primarily as a result of decreased operating costs and headcount.

Interest Expense

Year Ended December 31,

(in thousands)

2025

​ ​ ​

2024

​ ​ ​

Change

Interest expense

$

9,001

$

10,734

$

(1,733)

The decrease in interest expense from continuing operations in 2025 was primarily due to prepaying the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest expense on the $38.7 million of

outstanding 2029 Term Loan principal and the LOQTORZI portion of the Revenue Purchase and Sale Agreement, both of which commenced on May 8, 2024 and incurred twelve months of interest during the year ended December 31, 2025.

Interest expense from discontinued operations was $3.5 million and $16.4 million in 2025 and 2024, respectively, and was related to the 2026 Convertible Notes, the UDENYCA portion of the Revenue Purchase and Sale Agreement, and $175.0 million of the $250.0 million principal amount due under the 2027 Term Loans.

We expect interest expense from continuing operations to be slightly lower in 2026 than in 2025, primarily as a result of the downward trend in market interest rates relative to the 2025 period.

Loss on Debt Extinguishment

Year Ended December 31,

(in thousands)

​ ​ ​

2025

​ ​ ​

2024

​ ​ ​

Change

Loss on debt extinguishment

$

-

$

12,630

$

(12,630)

The $12.6 million loss on debt extinguishment in 2024 resulted from the payoff of the 2027 Term Loans in May 2024, and the charge included the write-off of the remaining debt discount and debt issuance costs, the prepayment premium fee, the make-whole interest payment, and lender fees.

Other Income (Expense), Net

Year Ended December 31,

(in thousands)

​ ​ ​

2025

​ ​ ​

2024

​ ​ ​

Change

Other income (expense), net

$

7,011

$

7,623

$

(612)

Other income (expense), net from continuing operations in 2025 changed unfavorably compared to the prior year primarily due to a reduction of certain TSA reimbursements classified in other income of $2.2 million, a decrease in foreign exchange gains of $1.1 million, and the change in fair value of the LOQTORZI Royalty Fee Derivative Liability of $0.8 million, partially offset by an increase in interest and investment income of $3.3 million.

Net Income from Discontinued Operations, net of tax

Year ended December 31, 2025

(in thousands)

2025

​ ​ ​

2024

​ ​ ​

Change

Net income from discontinued operations, net of tax

$

351,148

$

243,901

$

107,247

The increase in net income from discontinued operations, net of tax in 2025 was primarily driven by the $161.7 million favorable change in gain on Sale Transactions, which included the UDENYCA Sale gain of $338.3 million in 2025 as compared to the CIMERLI Sale gain of $153.8 million and YUSIMRY Sale gain of $22.8 million in 2024; lower cost of goods sold of $82.1 million; lower selling, general and administrative expense of $31.2 million; and lower interest expense of $12.9 million. These favorable items were partially offset by lower net revenue of $164.0 million, $10.3 million of loss on debt extinguishment in 2025 related to the 2026 Convertible Notes, and an unfavorable impact of $7.4 million from the change in fair value of the Royalty Fee Derivative Liability related to UDENYCA. Total net revenues attributable to our divested products, UDENYCA, CIMERLI and YUSIMRY, which are reflected in discontinued operations, were $76.6 million and $240.6 million for the years ended December 31, 2025 and 2024, respectively.

Liquidity and Capital Resources

Certain relevant measures of our liquidity and capital resources are summarized as follows:

December 31,

(in thousands)

​ ​ ​

2025

​ ​ ​

2024

Financial assets

Total Cash, cash equivalents and marketable securities

$

172,125

$

125,987

Financial liabilities(1):

2029 Term Loan

$

37,051

$

36,698

Revenue Purchase and Sale Agreement

14,028

(2)

28,743

2026 Convertible Notes

121

(2)

228,229

Total Financial liabilities

$

51,200

$

293,670

(1) See "Note 8. Financial Liabilities" in the Notes to Consolidated Financial Statements contained in Part II, Item 8 of this Annual Report on Form 10-K.
(2) We used a portion of the proceeds of the Udenyca Sale, which closed on April 11, 2025, to repay substantially all of the outstanding 2026 Convertible Notes and to buy out the right to receive royalties on the net sales of UDENYCA in accordance with the Revenue Purchase and Sale Agreement.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $172.1 million and an accumulated deficit of $1.4 billion. We have generated significant operating losses in all the years since our inception, except for certain periods that had gains from divestitures and 2020 and 2019. We currently have one commercial product, LOQTORZI, which generated $40.8 million in net revenues during 2025. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. As of December 31, 2025, our investment in cash, cash equivalents and investments in marketable securities are primarily held in money market accounts, commercial paper and corporate notes, U.S. Treasury securities, and U.S. government agency securities. We have funded our operations primarily through sales of our common stock, issuance and incurrence of debt, the Revenue Purchase and Sale Agreement, the Sale Transactions and sales of our products.

The following is a summary of recent key liquidity events and financing transactions:

On February 12, 2026, we entered into an underwriting agreement (the "Underwriting Agreement") with TD Securities (USA) LLC, Guggenheim Securities, LLC and Oppenheimer & Co. Inc. as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which we agreed to issue and sell an aggregate of 28,600,000 shares of our common stock to the Underwriters (the "Offering"). The price to the public in the Offering was $1.75 per share. The Underwriters agreed to purchase the shares from us pursuant to the Underwriting Agreement at a price of $1.645 per share. On February 17, 2026, we completed the sale and received net proceeds of approximately $47.0 million, after deducting the Underwriters' discounts and commissions but before estimated offering expenses payable by the Company.
On October 21, 2025, we sold to certain unaffiliated third-party investors (i) an aggregate of 4,634,995 shares of our common stock and (ii) the PIPE Warrants to purchase an aggregate of 463,498 shares of common stock, each for an exercise price of $0.01 per share, for an aggregate purchase price of $8.0 million. The PIPE Warrants are subject to appropriate adjustment in the event of share dividends, stock splits, reorganizations or similar events affecting our common stock.
On April 11, 2025, we completed the UDENYCA Sale and received $483.4 million in cash, inclusive of $118.4 million for UDENYCA product inventory. We are eligible to receive two additional Earnout Payments of $37.5 million each, provided that certain minimum UDENYCA Net Sales thresholds are met during specified periods after the closing of the UDENYCA Sale.
During the second quarter of 2025, we used a portion of the proceeds from the UDENYCA Sale to: (1) repay substantially all of the $230 million aggregate principal amount of the outstanding 2026 Convertible Notes, and (2) buy out the royalty rights on the net salesof UDENYCA, in accordance with the Revenue Purchase and Sale Agreement, resulting in a $47.7 million payment.

We are party to a sales agreement with TD Cowen, pursuant to which (and subject to applicable law) we may sell shares of our common stock in an at-the-market offering. As of December 31, 2025, we had approximately $64.9 million of our common stock remaining available for sales under the Sales Agreement.

We believe that our available cash, cash equivalents and marketable securities, and product sales will be sufficient to fund our planned expenditures and meet our obligations for at least the twelve months following our financial statement issuance date. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital

requirements for product development and commercialization sooner than planned. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates and the extent to which we may enter into additional agreements with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated research and development activities, and on-going and future licensing and collaboration obligations. We may need to raise additional funds in the future; however, there can be no assurance that such efforts will be successful or that, if they are successful, the terms and conditions of such financing will be favorable. Our future funding requirements will depend on many factors, including the following:

cash proceeds from product sales;
the payment of interest, principal and royalties related to our financial liabilities;
the costs of manufacturing, distributing and marketing our product;
the cost of manufacturing clinical drug supplies and establishing commercial supplies of our product candidates and product;
the percentage of customers that continue to purchase our product and that do not switch to products made by our competitors;
the terms and timing of any other collaborative, licensing and other arrangements that we have established or may establish;
the timing, receipt and amount of sales, profit sharing or royalties, if any, from any product candidates that are approved in the future;
the number and characteristics of product candidates that we pursue;
the scope, rate of progress, results and cost of our clinical trials, preclinical testing and other related activities;
scope, rate of progress, results and cost of our clinical trials, preclinical testing and other related activities;
the costs of manufacturing preclinical study and clinical trial supplies and other materials from CMOs and related costs associated with release and stability testing;
whether we receive either of the Earnout Payments from the sale of the UDENYCA Business;
the cost, timing and outcomes of regulatory approvals; and
the extent to which we divest, acquire or invest in businesses, products or technologies.

For further discussion of risks related to our financial condition and capital requirements, see "Risk Factors- Risks Related to Our Financial Condition and Capital Requirements."

Contingent Milestones

We have obligations to make future payments to third parties that become due and payable upon the achievement of certain development, regulatory and commercial milestones (such as clinical trial achievements, the filing of a BLA, approval by the FDA or product launch). These milestone payments and other similar fees are contingent upon future events and therefore are only recorded when it becomes probable that a milestonewill be achieved or other applicable criteria will be met. With the exception of $1.1 million recorded as a liability as of December 31, 2025, no other milestones were accrued because the probability of achievement had not reached the threshold for recognition.

The following presents a summary of our active partnerships and collaborations that have contingent regulatory and sales milestones as of December 31, 2025:

Counterparty

Description

Remaining Potential Aggregate Milestone Amount

Junshi Biosciences

LOQTORZI

$355.0 million (1)

Adimab LLC

Casdozokitug

$10.5 million

Vaccinex, Inc.

Tagmokitug

$13.5 million

Memorial Sloan Kettering Cancer Center

Tagmokitug

$7.2 million

(1) $65.0 million relates to regulatory milestones for indications that are not currently the subject of our clinical trials and $290.0 million relates to sales milestones.

Contingent Value Rights

In connection with the Surface Acquisition, we entered into the Contingent Value Rights Agreement, dated September 8, 2023, by and among us and Computershare Inc. and its affiliate Computershare Trust Company, N.A., together, as the rights agent thereunder (the "CVR Agreement"). As of December 31, 2025, the remaining CVRs in connection with the Surface Acquisition consisted of the CVRs associated with the receipt by us of any upfront payments pursuant to ex-U.S. licensing agreements related to casdozokitug or tagmokitug. The potential payments are only due if we first receive upfront payments pursuant to ex-U.S. licensing agreements, less any permitted deductions in accordance with the CVR Agreement. Payments to CVR holders can be in the form of cash, stock or a combination of cash and stock. For further details, see "Note 1. Organization and Significant Accounting Policies" in the Notes to Consolidated Financial Statements contained in Part II, Item 8 of this Annual Report on Form 10-K.

Other Commitments

Transition service agreements

Since certain contracts with third parties related to the divested biosimilar businesses could not immediately be transitioned to the buyers in the Sale Transactions at the respective divestiture dates, generally because the contracts did not allow for assignment, we remained a legal party to transactions occurring after the closings, often functioning as an agent on behalf of the buyer. These transactions are presented within TSA receivables, net and TSA payables and accrued liabilities in the consolidated balance sheets, and they generally do not have a net effect the consolidated statements of operations. The use of cash to settle TSA payables and accrued liabilities is expected to occur in a front-loaded fashion over the remainder of 2026. The CIMERLI and YUSIMRY TSAs were substantially completed as of December 31, 2025.

In addition, in connection with the divestiture of the UDENYCA Business, we retained certain contractual obligations related to inventory replacement under a legacy customer agreement. Pursuant to the terms of that agreement, we may be required to reimburse Accord for the cost of replacing certain inventory in specified circumstances. Our maximum potential exposure under this obligation is approximately $5.9 million. As of December 31, 2025, no amounts have been recorded in the consolidated financial statements related to this matter, as the likelihood of incurring a loss was not considered probable. We will continue to evaluate this matter each reporting period and record a liability if and when it becomes probable that a loss has been incurred and the amount can be reasonably estimated.

Non-cancelable purchase commitments

We enter into contracts in the normal course of business with CROs for preclinical research studies and clinical trials, research supplies and other services and products for operating purposes. We have also entered into agreements with several CMOs for the manufacture and clinical drug supply of our commercial and product candidates. Our non-cancelable purchase commitments as of December 31, 2025 were $8.1 million, as outlined in Note 9. Commitments and Contingencies in the Notes to Consolidated Financial Statements contained in Part I, Item 1 of this Annual Report on Form 10-K.

Leases

We lease office and laboratory facilities through arrangements treated as operating leases. Refer to Note 10. Leases in the Notes to Consolidated Financial Statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information related to our leases. Our total non-cancelable contractual obligations arising from these agreements as of December 31, 2025 was $3.7 million, with $2.1 million of these obligations due within twelve months.

Summary Statement of Cash Flows

The following table summarizes our cash flows for discontinued and continuing operations on a combined basis as follows for the periods presented:

Year Ended December 31,

(in thousands)

2025

​ ​ ​

2024

Net cash used in operating activities

$

(138,513)

$

(20,440)

Net cash provided by investing activities

375,087

230,321

Net cash used in financing activities

(273,705)

(186,974)

Net increase (decrease) in cash, cash equivalents and restricted cash

$

(37,131)

$

22,907

Net cash used in operating activities

Net cash used in operating activities of $138.5 million and $20.4 million for 2025 and 2024, respectively, was primarily due to ongoing commercial activity, research and development activities and selling, general and administrative expenses to support those activities. Net income for 2025 and 2024 included, among other items: adjustments for gain on Sale Transactions, non-cash stock-based compensation expense, non-cash inventory write-downs, non-cash intangible asset write-downs net of contingent consideration, non-cash changes in fair values related to derivative liabilities, loss on debt extinguishment, and non-cash interest expense on financial liabilities related to revenue participation right purchase agreements and debt.

Net cash provided by investing activities

Cash provided by investing activities of $375.1 million in 2025 was primarily due to $470.3 million net cash received related to the Sale Transactions which primarily comprised the UDENYCA Sale, partially offset by $103.8 million in purchases of investments in marketable securities, the second out of two $12.5 million milestone payments to Junshi Biosciences and $4.7 million in retention bonus payments in connection with the CIMERLI Sale.

Cash provided by investing activities of $230.3 million in 2024 was primarily due to a total of $227.8 million cash acquired from the CIMERLI Sale and YUSIMRY Sale, proceeds from the sale of investments in marketable securities of $8.7 million and proceeds from maturities of investments in marketable securities of $6.2 million, partially offset by the milestone payment to Junshi Biosciences of $12.5 million.

Net cash (used in) provided by financing activities

Cash used in financing activities of $273.7 million in 2025 was due to $233.2 million for repayment of substantially all the 2026 Convertible Notes and $47.7 million to buy out the right to receive royalties on net sales of UDENYCA in accordance with the Revenue Purchase and Sale Agreement.

Cash used in financing activities of $187.0 million in 2024 was primarily due to $260.4 million in payments to fully repay the 2027 Term Loans (excluding interest which is presented as an operating activity) and $2.5 million in tax payments related to net share settlement of RSUs. These payments were partially offset by $37.0 million of proceeds on the 2029 Term Loan, net of debt discount and issuance costs, $36.5 million of proceeds from the Revenue Purchase and Sale Agreement, net of issuance costs, and $1.5 million in proceeds from sales under the Sales Agreement, net of issuance costs.

Discontinued operations

Cash flows from continuing operations and discontinued operations have been presented together in the consolidated statements of cash flows. During the year ended December 31, 2025, operating cash flows of discontinued operations were primarily related to the adjustment for the net gain on UDENYCA Sale of $338.3 million, partially offset by the $11.8 million change in fair value for the UDENYCA portion of the Royalty Fee Derivative Liability and a loss on debt extinguishment of $10.3 million.During the year ended December 31, 2024, operating cash flows of discontinued operations were primarily related to the adjustment for the net gain on Sale Transactions of $176.6 million and an increase in UDENYCA inventory which resulted in a net cash outflow of $15.5 million.

Critical Accounting Estimates

The preparation of our consolidated financial statements in accordance with United States generally accepted accounting principles ("U.S. GAAP") requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenue generated and expense incurred during the reporting periods. "Note 1. Organization and Significant Accounting Policies" in the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K describes the significant accounting policies and methods used in the preparation of our consolidated financial statements. Our estimates are based on our historical experience and on various other factors that we believe to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Product Sales Discounts and Allowances

We recognize revenue when a customer obtains control of the product, which generally occurs upon delivery to the customer. The amount recognized in net revenue reflects the consideration which we expect to receive in exchange for product sold, which includes

adjustments to gross sales amounts for estimated chargebacks, rebates, discounts for prompt payment, co-payment assistance, product returns and other allowances. The actual amount of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, the estimates will be adjusted, which will affect net product revenue in the period that such variances become known.

The most judgmental gross to net revenue adjustments are for chargebacks and rebates we provide to customers, hospitals, clinics, and payers under commercial and government programs. Amounts payable are provided for under various programs and vary by payer and individual payer plans. In developing our estimates of chargebacks and rebates, we use our historical claims experience and also consider payer mix, statutory discount rates and expected utilization, contractual terms, market events and trends, customer and commercially available payer data, as well as data collected from the healthcare providers, channel inventory data obtained from our customers and other relevant information.

In 2025 and 2024, total sales deductions to gross product sales for our continuing operations were 24% and 20%, respectively. Adjustments to provisions for rebates and chargebacks related to sales made in prior periods were less than 2% of the actual payments and customer credits issued in each respective year. A change of 10% in our total provisions for product sales discounts and allowances as of December 31, 2025, would have resulted in a change of our pre-tax loss from continuing operations in 2025 by approximately $0.4 million. A summary of the activities and ending reserve balances for each significant category of discounts and allowances, can be found in "Note 2. Revenue" in the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.

Recent Accounting Pronouncements

For a description of the impact of recent accounting pronouncements, see "Note 1. Organization and Significant Accounting Policies" in the Notes to Consolidated Financial Statements contained in Part II, Item 8 of this Annual Report on Form 10-K.

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