−Removed: We are a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer.
−Removed: Our commercial portfolio includes our first product, UDENYCA® (pegfilgrastim-cbqv), a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor (“G-CSF”) and LOQTORZI® (toripalimab-tpzi), a novel next-generation programmed death receptor-1 (“PD-1”) inhibitor.
−Removed: We are developing an innovative immuno-oncology pipeline that we expect to bring forward new potential indications for LOQTORZI in the U.S.
−Removed: and the development of new product candidates.
−Removed: UDENYCA 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.
−Removed: On December 2, 2024, we and Intas Pharmaceuticals Ltd.
−Removed: (“Intas”), entered into an Asset Purchase Agreement (the “UDENYCA Purchase Agreement”), pursuant to which, and upon the terms and subject to the conditions thereof, we have agreed to divest the UDENYCA franchise (the “UDENYCA Business”) to Intas (the “UDENYCA Sale”).
−Removed: As consideration for the UDENYCA Sale, Intas has agreed to pay us $483.4 million in cash, inclusive of $118.4 million of UDENYCA product inventory (the “Inventory Target”), subject to downward adjustment by the amount of inventory delivered at the closing of the UDENYCA Sale less than the Inventory Target (the “Closing Consideration”).
−Removed: Intas has designated Accord BioPharma, Inc., an indirect wholly owned subsidiary of Intas (“Accord” and, together with Intas, the “Intas Parties”) to purchase the physical assets, including product inventory.
−Removed: In addition, the Company is also eligible to receive two additional payments of $37.5 million each (the “Earnout Payments,” together with the Closing Consideration, the “Consideration”), provided that certain minimum UDENYCA net sales (as defined in the UDENYCA Purchase Agreement, “Net Sales”) thresholds are met during specified periods after the closing of the UDENYCA Sale.
−Removed: We anticipate the transactions contemplated by the UDENYCA Purchase Agreement to close late in the first quarter or early in the second quarter of 2025.
−Removed: We expect to use proceeds from the UDENYCA Sale (a) to fully repay our outstanding $230.0 million in aggregate principal amount of 1.5% Convertible Senior Subordinated Notes due 2026 (the “2026 Convertible Notes”) and (b) to pay $47.7 million, assuming a closing late in the first quarter or early in the second quarter of 2025, to buy out the right to receive royalties on net sales of UDENYCA in accordance with our Revenue Purchase and Sale Agreement (the “Revenue Purchase and Sale Agreement”) with Coduet Royalty Holdings, LLC and each buyer named in an annex thereto (collectively, the “Purchaser Group”), dated May 8, 2024.
−Removed: In addition, we will use the proceeds for working capital and general corporate purposes, in connection with our continued business.
+Added: We are a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 (“PD-1”) inhibitor, LOQTORZI® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, head and neck, colorectal and other cancers.
+Added: Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma (“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.
+Added: 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.
On October 27, 2023, we announced that LOQTORZI was approved by the U.S.
−Removed: Food and Drug Administration (“FDA”) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (“NPC"), and as monotherapy for the treatment of adults with recurrent unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
+Added: Food and Drug Administration (“FDA”) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma, 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 Co., Ltd.
−Removed: (“Junshi Biosciences”) that is currently the only immune checkpoint inhibitor approved by the FDA for the treatment of these indications.
+Added: (“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.
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Further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by us, Junshi Biosciences and our biopharma partners.
−Removed: Our pipeline is comprised of earlier stage clinical and preclinical immuno-oncology programs that we plan to develop in combination with LOQTORZI as well as in partnership with other companies with immune activating or cancer agents.
−Removed: Our lead clinical stage product candidate is casdozokitug (CHS-388, formerly SRF388), an investigational antagonist antibody targeting IL-27, an immune regulatory cytokine, that is overexpressed in certain cancers, including hepatocellular, lung and renal cell carcinoma.
−Removed: Casdozokitug received orphan drug designation from the FDA for the treatment of hepatocellular carcinoma (“HCC”) in October 2020 and fast track designation from the FDA for the treatment of patients with HCC previously treated with standard therapies in November 2020.
−Removed: Casdozokitug is currently in three on-going clinical studies, including a Phase 1/2 study in patients with advanced solid tumors, including combination with toripalimab in non-small cell lung cancer (clinicaltrials.gov identifier# NCT04374877), and a Phase 2 study in HCC (clinicaltrials.gov identifier# NCT05359861).
−Removed: We initiated a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab in the fourth quarter of 2024 (clinicaltrials.gov identifier# NCT06679985).
−Removed: Our second clinical-stage product candidate, CHS-114 (formerly SRF114), is an investigational IgG1 antibody targeting CCR8, a chemokine receptor highly expressed on regulatory T cells (“Treg cells”) in the tumor microenvironment (“TME”).
−Removed: We are enrolling patients with advanced solid tumors and head and neck squamous cell carcinoma (“HNSCC”) in the U.S.
−Removed: in a clinical trial evaluating safety and pharmacokinetics of CHS-114 with and without LOQTORZI (clinicaltrials.gov identifier# NCT05635643).
−Removed: We plan to initiate a Phase 1b clinical study of CHS-114 in combination with toripalimab in second-line HNSCC (clinicaltrials.gov identifier# NCT05635643) and to initiate
−Removed: a Phase 1b clinical study of CHS-114 in combination with toripalimab and/or other treatments in participants with advanced solid tumors with the first cohort evaluating gastric cancer (clinicaltrials.gov identifier# NCT06657144), each in the first quarter of 2025.
−Removed: We also have an early-stage development candidate, CHS-1000, an investigational antibody targeting human ILT4, designed to improve anti-PD-1 clinical benefit by transforming an unfavorable TME to a more favorable TME.
−Removed: Our investigational new drug application (“IND”) for CHS-1000 was allowed to proceed by the FDA in the second quarter of 2024 and initiating the first-in-human clinical study remains subject to further evaluation in our portfolio prioritization process.
−Removed: In addition, we have a product candidate, GSK4381562, which is exclusively licensed to GlaxoSmithKline Intellectual Property No.
−Removed: 4 Limited (“GSK”).
−Removed: Through September 2033, we have an obligation to pay 70% of all milestone- and royalty-based payments that we or our affiliates receive from GSK4381562 to the holders of contingent value rights (“CVRs”).
−Removed: 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.
−Removed: We expect to further leverage these capabilities as we continue to advance our immuno-oncology franchise.
−Removed: We primarily operate in the United States and partner with companies that operate in other countries.
−Removed: Products and Product Candidates
−Removed: Our portfolio includes the following products and product candidates:
−Removed: ● UDENYCA 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.
−Removed: On December 2, 2024, we and Intas entered into the UDENYCA Purchase Agreement, pursuant to which, and upon the terms and subject to the conditions thereof, we have agreed to divest the UDENYCA Business to Intas.
−Removed: We anticipate the transactions contemplated by the UDENYCA Purchase Agreement to close late in the first quarter or early in the second quarter of 2025.
+Added: Our pipeline comprises two mid-stage clinical candidates aimed at overcoming immune resistance in cancer.
+Added: We plan to develop each of them in combination with LOQTORZI as well as in partnership with other companies with immune activating or cancer agents.
+Added: Our clinical stage product candidate casdozokitug (CHS-388, formerly SRF388) is an investigational antagonist antibody targeting IL-27, an immune regulatory cytokine, that is overexpressed in certain cancers, including hepatocellular, lung and renal cell carcinoma.
+Added: Casdozokitug received orphan drug designation from the FDA for the treatment of hepatocellular carcinoma (“HCC”) in October 2020.
+Added: The lead indication for casdozokitug is 1L HCC, and it is currently being studied in a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab (clinicaltrials.gov identifier# NCT06679985).
+Added: Our second clinical-stage product candidate, tagmokitug (CHS-114, formerly SRF114), is an investigational afucosylated IgG1 antibody targeting CCR8, a chemokine receptor highly expressed on regulatory T cells (“Treg cells”) in the tumor microenvironment (“TME”).
+Added: We are enrolling patients with head and neck squamous cell carcinoma (“HNSCC”) in the U.S.
+Added: in a clinical trial evaluating safety and pharmacokinetics of tagmokitug with and without LOQTORZI (clinicaltrials.gov identifier# NCT05635643).
+Added: We have also initiated a multiregional Phase 1b clinical study of tagmokitug in combination with toripalimab and/or other treatments in participants with advanced solid tumors including several cohorts including 2L upper GI adenocarcinoma, 2L esophageal squamous cell carcinoma (“ESCC”), 1LESCC, and Phase 2a cohort evaluating 4L+ colorectal cancer (clinicaltrials.gov identifier# NCT06657144).
+Added: We have planned a clinical study evaluating tagmokitug in combination with pasritamig (a T cell engaging bispecific antibody targeting KLK2) in metastatic castrate resistant prostate cancer.
+Added: Coherus is executing a coordinated initiative to onshore the biomanufacturing process for LOQTORZI, casdozokitug and tagmokitug to the United States.
+Added: We have scientific expertise, manufacturing capabilities, and U.S.-based experience across oncology clinical development, regulatory affairs, sales, and medical affairs, which have supported the commercialization of LOQTORZI.
+Added: We expect to leverage these capabilities as we continue to advance our immuno-oncology franchise.
+Added: We commercialize LOQTORZI in the United States, and we have global rights to develop and commercialize casdozokitug and tagmokitug.
+Added: Product and Product Candidates
+Added: 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.
−Removed: 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.
+Added: We believe blocking PD-1 interactions with PD-L1 and PD-L2 can help to promote the immune system’s
+Added: 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.
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on January 2, 2024.
−Removed: On December 11, 2023 we announced that the National Comprehensive Cancer Network (“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.
+Added: 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.
−Removed: The guidelines also recommend LOQTORZI monotherapy as the only preferred treatment in subsequent lines of therapy if disease progression on or after a platinum-containing therapy.
+Added: 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.
−Removed: We have a postmarketing commitment study active and enrolling patients in locations in the U.S.
−Removed: and Canada in order to further evaluate the efficacy of toripalimab in combination with chemotherapy (cisplatin and gemcitabine) in patients with advanced NPC (clinicaltrials.gov identifier NCT06457503).
−Removed: Junshi Biosciences is currently enrolling in a multiregional Phase 3 clinical study evaluating the treatment of LOQTORZI with its investigational anti-BTLA antibody in limited-stage small cell lung cancer (“LS-SCLC”) (clinicaltrials.gov identifier NCT06095583).
+Added: We have a post marketing commitment study active and enrolling patients in locations in the U.S.
+Added: 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).
+Added: 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.
−Removed: Cancer Research Institute (“CRI”) plans to evaluate toripalimab in combination with ENB Therapeutics’ investigational agent ENB-003 in its
−Removed: 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 (“CCTG”).
−Removed: On June 27, 2024, we entered into an exclusive license and distribution agreement (the “Canada License Agreement”) with Apotex, Inc.
−Removed: (“Apotex”), pursuant to which, we granted to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada.
+Added: 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.
+Added: STORM Therapeutics, Ltd.
+Added: 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.
+Added: On June 27, 2024, we entered into a license Agreement with Apotex, Inc.
+Added: (“Apotex”), pursuant to which, we granted to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada (“Canada License Agreement”).
+Added: 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.
−Removed: IL-27 is a cytokine secreted by macrophages and antigen presenting cells that plays an important physiologic role in suppressing the immune system, as evidenced by its ability to resolve tissue inflammation.
+Added: 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.
−Removed: Casdozokitug received orphan drug designation from the FDA for the treatment of HCC in October 2020 and fast track designation from the FDA for the treatment of patients with HCC previously treated with standard therapies in November 2020.
−Removed: Casdozokitug is currently in three on-going clinical studies, including a Phase 1/2 study in advanced solid tumors (clinicaltrials.gov identifier# NCT04374877), a Phase 2 study in HCC (clinicaltrials.gov identifier# NCT05359861) and a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab (clinicaltrials.gov identifier# NCT06679985).
−Removed: ● CHS-114 (formerly SRF114), is an investigational highly specific human afucosylated IgG1 monoclonal antibody selectively targeting CCR8, a chemokine receptor highly expressed on Treg cells in the TME.
−Removed: CHS-114 is 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.
−Removed: CHS-114 has shown anti-tumor activity as monotherapy or in combination with anti-PD-1 antibodies in preclinical models.
−Removed: We are enrolling patients with advanced solid tumors and HNSCC in the U.S.
−Removed: in a clinical trial evaluating safety and pharmacokinetics of CHS-114 with and without LOQTORZI (clinicaltrials.gov identifier# NCT05635643).
−Removed: We plan to initiate a Phase 1b clinical study of CHS-114 in combination with toripalimab in second-line HNSCC (clinicaltrials.gov identifier# NCT05635643) and to initiate a Phase 1b clinical study of CHS-114 in combination with toripalimab and/or other treatments in participants with advanced solid tumors with the first cohort evaluating gastric cancer (clinicaltrials.gov identifier# NCT06657144), each in the first quarter of 2025.
−Removed: ● CHS-1000 is an investigational antibody targeting human ILT4, designed to improve anti-PD-1 clinical benefit by transforming an unfavorable TME to a more favorable TME.
−Removed: Our IND for CHS-1000 was allowed to proceed by the FDA in the second quarter of 2024 and initiating the first-in-human clinical study remains subject to further evaluation in our portfolio prioritization process.
−Removed: ● In addition, we have a product candidate, GSK4381562, which is exclusively licensed to GSK.
−Removed: GSK4381562 is an investigational antibody targeting CD112R (“PVRIG”), an inhibitory protein expressed on natural killer (“NK”) and T cells.
−Removed: GSK4381562 is designed to block the interaction of PVRIG with CD112, its binding partner that is expressed on tumor cells.
−Removed: GSK4381562 is designed to promote the activation of both NK and T cells, with potential to elicit a strong anti-tumor response and promote immunological memory.
−Removed: Through September 2033, we have an obligation to pay 70% of all milestone- and royalty-based payments that we or our affiliates receive from GSK4381562 to the holders of CVRs.
−Removed: Immunology – Sold to Hong Kong King-Friend Industrial Company Ltd.
−Removed: (“HKF”) pursuant to the sale of our YUSIMRY franchise (the “YUSIMRY Sale”)
−Removed: ● YUSIMRY (adalimumab-aqvh), a biosimilar of Humira (adalimumab), is a monoclonal antibody that can bind to tumor necrosis factor (“TNF”).
−Removed: YUSIMRY provides certain therapeutic benefits for treatment of patients with certain inflammatory diseases characterized by increased production of TNF in the body, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
−Removed: In December 2021, the FDA approved YUSIMRY, which we launched in the United States in July 2023.
−Removed: On June 26, 2024, we entered into an Asset Purchase Agreement (the “YUSIMRY Purchase Agreement”) with HKF, and we completed the sale of our YUSIMRY franchise for upfront, cash consideration of $40.0 million and the assumption of $17.0 million of inventory purchase commitments by HKF.
−Removed: We retained the rights to certain patents that were licensed to Pfizer
−Removed: (“Pfizer”) under the License and Settlement Agreement, dated as of October 21, 2019, between us and Pfizer (the “Pfizer License Agreement”).
−Removed: Ophthalmology – Sold to Sandoz Inc.
−Removed: (“Sandoz”) pursuant to the sale of our CIMERLI ophthalmology franchise (the “CIMERLI Sale” and, together with the YUSIMRY Sale, the “Sale Transactions”)
−Removed: ● CIMERLI (ranibizumab-eqrn), a Lucentis biosimilar, was approved by the FDA on August 2, 2022 for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization and we launched CIMERLI commercially in the United States on October 3, 2022.
−Removed: On January 19, 2024, we entered into a Purchase and Sale Agreement (the “CIMERLI Purchase Agreement”) by and between us and Sandoz.
−Removed: Pursuant to the terms and subject to the conditions set forth in the CIMERLI Purchase Agreement, on March 1, 2024, we completed the divestiture of our CIMERLI ophthalmology franchise through the sale of our subsidiary, Coherus Ophthalmology LLC (“Coherus Ophthalmology”), to Sandoz for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets.
+Added: Casdozokitug received orphan drug designation from the FDA for the treatment of HCC in October 2020.
+Added: 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).
+Added: ● 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.
+Added: T agmokitug is designed as a cytolytic antibody to cause depletion of intra-tumoral Treg cells, important regulators of immune suppression and tolerance, through antibody-dependent cellular cytotoxicity (“ADCC”), or antibody-dependent cellular phagocytosis (“ADCP”), or both.
+Added: T agmokitug has shown anti-tumor activity as monotherapy and in combination with anti-PD-1 antibodies in preclinical models.
+Added: We are currently evaluating t agmokitug in combination with toripalimab in a Phase 1b clinical study in second-line HNSCC (clinicaltrials.gov identifier# NCT05635643).
+Added: We also have an ongoing Phase 1b/2a clinical study of t agmokitug in 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 (“MSS”) colorectal cancer (clinicaltrials.gov identifier# NCT06657144).
+Added: On February 4, 2026, we announced a clinical supply agreement with Janssen Research & Development, LLC (“Janssen”), 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 (“mCRPC”).
+Added: Under the terms of the clinical supply agreement,
+Added: Janssen will provide pasritamig to us, and we will be the sponsor of the Phase 1b clinical trial.
+Added: Janssen and us each retain all commercial rights to our respective compounds, including as monotherapy or as combination treatments.
Oncology Franchise Market Opportunity
LOQTORZI Opportunity
−Removed: According to Clarivate/Decision Resource Group, the HNSCC therapy market was expected to increase 10.6% annually over the 2023-2033 forecast period.
−Removed: In 2023, sales of HNSCC therapies in the major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) totaled $1.4 billion, and sales were expected to increase to almost $4.8 billion in 2033.
−Removed: Fueling this growth is the label expansion of pembrolizumab in the locoregionally advanced setting, and the expected approval of four new therapies.
−Removed: PD-1 inhibitors are expected by the Clarivate/Decision Resource Group to be the sales-leading drug class in 2033, garnering major-market sales of over $1.4 billion, and we expect these agents to be approved for both non-nasopharyngeal and nasopharyngeal drug-treatable patient populations.
−Removed: By the end of 2033, we expect them to be prescribed mostly in the large and commercially lucrative locoregionally advanced and recurrent or metastatic first-line setting.
Immuno-oncology agents, and the PD-1/PD-L1 class in particular, have shifted the treatment paradigm across a broad range of tumors, and across the continuum of cancer settings (metastatic to early stage).
1 unchanged sentence
The improved safety profile observed for approved PD-L1 therapies versus chemotherapy enables these therapies to be used as a backbone therapy in a broad array of combination regimens.
−Removed: 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.
+Added: 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 (“RM-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.
10 unchanged sentences
and low median overall survival (“OS”) of 29 months.
−Removed: Based on SEER and DRG models, we estimate that the annual drug-treatable population in the United States for NPC is approximately 2,000 patients annually.
−Removed: Of this group, 60% have relapsed/metastatic disease and would be candidates for LOQTORZI.
−Removed: 40% have localized disease that can progress to relapsed/metastatic within a 12-24 month timeframe.
+Added: We estimate that there are up to 2,000 RM-NPC patients who are eligible for LOQTORZI, which translates into a $250 million market opportunity.
+Added: LOQTORZI is the first FDA-approved therapy for RM-NPC.
+Added: It represents a new standard of care for treating the disease when used in combination with cisplatin and gemcitabine in the first line setting or as monotherapy in the second line or greater setting.
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.
3 unchanged sentences
In the JUPITER-02 Phase 3 study, LOQTORZI combined with chemotherapy significantly improved progression-free survival, reducing the risk of disease progression or death by 48% compared to chemotherapy alone.
−Removed: LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in OS, with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
−Removed: In the POLARIS-02 clinical study, LOQTORZI demonstrated durable anti-tumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate of 20.5%, a disease control rate of 40%, and a median OS of 17.4 months with an acceptable safety profile.
−Removed: LOQTORZI is the first FDA-approved therapy for NPC, and we believe could represent a new standard of care for treating the disease when used in combination with cisplatin and gemcitabine in the first line setting or as monotherapy in the second line or greater setting.
−Removed: UDENYCA Biosimilar
−Removed: We initiated United States sales of UDENYCA in January 2019, and in 2024 we recorded UDENYCA net product sales of $206.0 million.
−Removed: UDENYCA is currently approved by the FDA in three presentations:
−Removed: pre-filled syringe (“PFS”), autoinjector (“AI”) and UDENYCA ONBODY.
−Removed: On December 2, 2024, we and Intas entered into the UDENYCA Purchase Agreement, pursuant to which, and upon the terms and subject to the conditions thereof, we have agreed to divest the UDENYCA Business to Intas.
−Removed: We anticipate the transactions contemplated by the UDENYCA Purchase Agreement to close late in the first quarter or early in the second quarter of 2025.
+Added: LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival, with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
+Added: In the POLARIS-02 clinical study, LOQTORZI demonstrated durable anti-tumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate of 20.5%, a disease control rate of 40%, and a median overall survival of 17.4 months with an acceptable safety profile.
+Added: In December 2025, six-year overall survival follow-up results from the JUPITER-02 trial were presented at the European Society of Medical Oncology (“ESMO”) Asia.
+Added: These findings reveal a durable survival advantage for LOQTORZI plus gemcitabine+cisplatin over chemotherapy alone as a first line treatment for RM-NPC.
+Added: In this exploratory post-hoc analysis, patients receiving LOQTORZI plus gemcitabine and cisplatin achieved a median overall survival of 64.8 months, nearly double that of chemotherapy alone (33.7 months), representing a 31-month improvement and an observed 38% reduction in risk of death (HR 0.62;
+Added: 95% CI, 0.45-0.85).
Sales and Marketing
−Removed: Our strategy, following the closing of the UDENYCA Sale, is to focus our research, development and commercial resources on our innovative immuno-oncology portfolio in combination with our commercial product LOQTORZI.
−Removed: Following the FDA approval of LOQTORZI for NPC, the commercial launch commenced in January 2024 with our existing Oncology commercial and medical affairs teams.
−Removed: As the UDENYCA transaction process unfolds, we plan to focus on maintaining business continuity for both our UDENYCA and LOQTORZI customers and ensure patients continue to access our products without disruption.
−Removed: Post-UDENYCA Sale, we will maintain a more focused commercial team fully enabled to continue momentum of our LOQTORZI launch and to maximize the commercial opportunity for LOQTORZI along with meeting the requirements of the transition services agreement that we are required to enter into with Intas (the “UDENYCA TSA”).
−Removed: Our overarching strategy with LOQTORZI is to establish a new standard of care for eligible patients with NPC and our execution plan is anchored on three growth drivers:
−Removed: accelerating new patient share through strong healthcare professional and patient identification, ensuring LOQTORZI messaging is delivered at the time of treatment decision, and optimizing the duration of LOQTORZI treatment.
−Removed: After the closing of the UDENYCA Sale, we will maintain an experienced sales force for LOQTORZI.
−Removed: An experienced set of Sales and Marketing personnel will transfer to Accord.
−Removed: We will maintain a focused set of field facing sales representatives and strategic account managers to support LOQTORZI and work directly with the largest accounts including group purchasing organizations, integrated delivery networks, and large clinic customers.
−Removed: We have an experienced market access and patient services team that will continue to support LOQTORZI and a set of personnel will also transfer to Accord to ensure the continued success of UDENYCA.
−Removed: This team is responsible for negotiating payer coverage with national and regional health plans and pension benefit managers (via a team of National Account Directors), servicing account specific questions regarding the billing, coding and reimbursement of our products (via a team of Field Reimbursement Managers), and managing our Coherus Solutions patient services hub which provides product specific coverage, reimbursement and co-pay support for patients and providers.
−Removed: For a discussion of risks related to sales and marketing, please see “Risk Factors—Risks Related to Launch and Commercialization of our Products and our Product Candidates.”
+Added: Our current overarching commercial strategy with LOQTORZI is to establish a new standard of care for eligible patients with RM-NPC.
+Added: Our execution plan is anchored on three growth drivers:
+Added: accelerating new patient share through strong healthcare professional engagement and patient identification, ensuring LOQTORZI educational messaging is delivered at the time of treatment decision, and optimizing the duration of LOQTORZI treatment.
+Added: Our educational efforts are focused on communicating the proven superior overall survival benefit of LOQTORZI to physicians that still treat RM-NPC with chemotherapy alone and, reinforcing LOQTORZI’s position as the only approved and available IO treatment for these patients.
+Added: We sell and distribute LOQTORZI in the U.S.
+Added: and Puerto Rico, exclusively through the wholesale (Specialty Distribution) channel.
+Added: During the year ended December 31, 2025, approximately 99% of LOQTORZI revenues were from three large wholesale distributors:
+Added: McKesson Corporation , Cencora, Inc., and Cardinal Health, Inc.
+Added: For a discussion of risks related to sales and marketing, see “Risk Factors—Risks Related to Launch and Commercialization of our Product and our Product Candidates.”
Scientific, Clinical and Regulatory
−Removed: The Company has a depth of scientific, oncology clinical and regulatory expertise in the United States, which has supported the commercialization of LOQTORZI.
−Removed: The Company expects to further leverage these capabilities as it continues to advance its immuno-oncology franchise.
+Added: We have a depth of scientific, oncology clinical and regulatory expertise in the United States, which has supported the commercialization of LOQTORZI.
+Added: We expect to further leverage these capabilities as we continue to advance our immuno-oncology pipeline.
+Added: For a discussion of risks related to scientific, clinical and regulatory matters, see “Risk Factors— Risks Related to Launch and Commercialization of our Product and our Product Candidates, and Risks Related to Reliance on Third Parties, and Risks Related to the Discovery and Development of Our Product Candidates.”
Manufacturing
−Removed: We have entered into agreements with several contract manufacturing organizations (“CMOs”) for the manufacture and clinical drug supply of our commercial products and product candidates.
+Added: We have entered into agreements with several contract manufacturing organizations (“CMOs”) for the manufacture and clinical drug supply of our commercial product and product candidates.
We continue to screen other contract manufacturers to meet our clinical, commercial and regulatory supply requirements on a product-by-product basis.
−Removed: On September 13, 2024, we announced that our third-party labeling and packaging CMO for UDENYCA delayed production of UDENYCA due to over-commitments and capacity constraints.
−Removed: These delays caused a temporary UDENYCA supply interruption that quickly took away our ability to sell our product UDENYCA, that makes up a large percentage of our total revenue, for a significant period of time.
−Removed: Production resumed in November 2024.
−Removed: We have made significant progress in our efforts to diversify our labeling and packaging resources.
−Removed: An additional final packaging and labeling CMO started production testing and manufacturing saleable product.
−Removed: Commercial supply from that CMO is expected to commence late in the first quarter or early in the second quarter of 2025, subject to FDA authorization.
−Removed: For a discussion of risks related to manufacturing our products and our reliance on third parties, please see “Risk Factors— Risks Related to Manufacturing and Supply Chain” and “Risk Factors—Risks Related to Reliance on Third Parties.”
+Added: We are executing a coordinated initiative to onshore the biomanufacturing process for LOQTORZI, casdozokitug and tagmokitug to the United States.
+Added: For a discussion of risks related to manufacturing our product and our reliance on third parties, see “Risk Factors— Risks Related to Manufacturing and Supply Chain” and “Risk Factors—Risks Related to Reliance on Third Parties.”
While we believe that our knowledge, experience and scientific resources provide us with competitive advantages, we face competition from many different sources.
We operate in a highly competitive environment.
−Removed: Such competition includes larger and better-funded pharmaceutical, generic pharmaceutical, specialty pharmaceutical and biotechnology companies commercializing and developing immuno-oncology and biosimilar products that would compete with our products and the product candidates in our pipeline.
−Removed: LOQTORZI faces a competitive market in the United States where a number of anti-PD-1 or PD-L1 antibody drugs have been approved by the FDA, although not in NPC, including the following marketed products from several competitors:
+Added: Such competition includes larger and better-funded pharmaceutical, generic pharmaceutical, specialty pharmaceutical and biotechnology companies commercializing and developing immuno-oncology and biosimilar products that would compete with our product and the product candidates in our pipeline.
+Added: LOQTORZI faces a competitive market in the United States where a number of anti-PD-1 or PD-L1 antibody drugs have been approved by the FDA, including the following marketed products from several competitors:
Keytruda® (pembrolizumab) from Merck & Co., Inc.
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(in collaboration with Jiangsu Hengrui Pharmaceuticals Co., Ltd.).
−Removed: As the only immunotherapy approved by the FDA for the treatment of NPC, we believe LOQTORZI addresses a potentially high unmet need.
−Removed: UDENYCA faces competition in the United States from Amgen, Biocon Biologics Inc.
−Removed: (“Biocon”), Sandoz International GmbH, Pfizer, Spectrum Pharmaceuticals, Inc.
−Removed: (“Spectrum”), Amneal Pharmaceuticals, Inc.
−Removed: (“Amneal”) and Fresenius Medical Care AG & Co.
−Removed: KGaA (“Fresenius”).
+Added: On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx, manufactured by Akeso Biopharma Co., Ltd.
+Added: (“Akeso”) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
+Added: FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
+Added: To date, Akeso has not launched penpulimab in the United States.
+Added: As the only immunotherapy approved by the FDA for the treatment of NPC that is available in the United States, we believe LOQTORZI addresses a potentially high unmet need.
Casdozokitug is in development and is the only antagonist antibody in development known to us that is targeting the immune regulatory cytokine IL-27.
−Removed: CHS-114 is in development and, if approved, faces competition from programs in development specifically targeting CCR8, including those by BMS, Gilead Sciences, Inc.
−Removed: / Jounce Therapeutics, Inc., Shionogi Inc., AbbVie Inc.
+Added: If approved, it faces competition from other immuno-oncology products that are currently approved and that may be approved in the future.
+Added: T agmokitug is in development and, if approved, faces competition from programs in development specifically targeting CCR8, including those by BMS, Gilead Sciences, Inc.
+Added: (“Gilead”) / Jounce Therapeutics, Inc.
+Added: (“Jounce”), Shionogi Inc.
+Added: (“Shinogi”), AbbVie Inc.
(“AbbVie”), Bayer AG, F.
−Removed: Hoffmann-La Roche Ltd, Amgen Inc.
+Added: Hoffmann-La Roche Ltd.
+Added: (“Bayer”), Amgen Inc.
(“Amgen”), LaNova Medicines Ltd.
−Removed: and Nanjing Immunophage Biotech Co., Ltd.
−Removed: We expect any products that we develop and commercialize directly or with partners to compete on the basis of, among other things, price and the availability of reimbursement from government and other third-party payers.
+Added: (“LaNova”) and Nanjing Immunophage Biotech Co., Ltd.
+Added: (“Nanjing”) in addition to competition from other immuno-oncology products that are currently approved and that may be approved in the future.
+Added: We expect any products that we develop and commercialize directly or with partners to compete on the basis of, among other things, the strength of clinical efficacy and safety data, price and the availability of reimbursement from government and other third-party payers.
Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.
−Removed: For a discussion of risks related to our competition, please see “Risk Factors— Risks Related to Competitive Activity.”
+Added: For a discussion of risks related to our competition, see “Risk Factors— Risks Related to Competitive Activity.”
Collaboration and License Agreements
−Removed: Distribution Agreement with Orox Pharmaceuticals B.V.
−Removed: (“Orox”) / Laboratorio Gador S.A.
−Removed: In December 2012, we entered into a distribution agreement with Orox / Gador, for the commercialization of biosimilar versions of our internally developed biosimilars.
−Removed: Under this agreement, we granted to Orox / Gador an exclusive license to commercialize UDENYCA in Latin America, except Brazil and Argentina, and YUSIMRY (which we sold in 2024) and CHS-0214 (which we discontinued development in 2020) in Latin America, except Brazil.
−Removed: Under this agreement, Orox / Gador has an option, exercisable within a defined time period, to obtain an exclusive license to commercialize certain additional biosimilar products in the same field and territory.
−Removed: We are obligated to manufacture and supply licensed products to Orox / Gador.
−Removed: We are obligated to develop licensed products and achieve regulatory approval for such products outside of the Caribbean and Latin American countries covered by the agreement by specified dates in order to support Orox / Gador’s activities under the agreement in its licensed territory.
−Removed: We are eligible to receive from Orox / Gador a share of gross profits in the low twenty percent range from the sale of licensed products, on a product-by-product basis.
−Removed: Our agreement with Orox / Gador will expire on a product-by-product and country-by-country basis ten years after regulatory approval of such product in such country, subject to automatic three-year extensions unless Orox notifies us in writing at least 18 months in advance of the date upon which the term would otherwise expire that it does not wish to extend the term for such product in such country.
−Removed: Either party may terminate the agreement for material breach by the other party that is not cured within a specified time period.
−Removed: Orox / Gador may terminate the agreement for convenience on a product-by-product basis at any time upon 12-months prior written notice.
−Removed: Each party may terminate the agreement upon bankruptcy or insolvency of the other party, and we may terminate the agreement immediately upon written notice to Orox / Gador if Orox / Gador challenges the licensed patents or commits a breach of specified provisions of the agreement.
−Removed: Upon the closing of the UDENYCA Sale, all rights and benefits under our agreement with Orox / Gador will be assigned, conveyed, transferred and delivered to Intas.
Settlement and License Agreements with Pfizer
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Under the terms of the Collaboration Agreement, we paid $150.0 million upfront for exclusive rights to LOQTORZI in the United States and Canada, an option in these territories to Junshi Biosciences’ anti-TIGIT antibody CHS-006, an option in these territories to a next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates.
−Removed: We obtained the right to conduct all commercial activities of LOQTORZI in the United States and Canada.
−Removed: We are obligated to pay Junshi Biosciences up to an aggregate $380.0 million in one-time payments for the achievement of various regulatory and sales milestones, of which $12.5 million was paid as of December 31, 2024 and another $12.5 million was paid in January 2025, and a royalty in the low twenty
−Removed: percent range on net sales of LOQTORZI.
−Removed: 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.
−Removed: In March 2022, we paid $35.0 million for the exercise of our option to license CHS-006.
+Added: We are obligated to pay Junshi Biosciences a royalty in the low twenty percent range on net sales of LOQTORZI and up to an aggregate $380.0 million in one-time payments for the achievement of various regulatory and sales milestones, of which $12.5 million was paid as of December 31, 2024 and another $12.5 million was paid in January 2025.
+Added: In March 2022, we paid $35.0 million to exercise our option to license CHS-006.
Subsequent joint development consistent with the Collaboration Agreement commenced.
On January 10, 2024, we announced that we had delivered a notice of termination of the TIGIT Program (as defined in the Collaboration Agreement) to Junshi Biosciences pursuant to the Collaboration Agreement.
−Removed: Under the Collaboration Agreement, we retain the right to collaborate in the development of LOQTORZI and the other licensed compounds and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year.
+Added: Under the Collaboration Agreement, we retain the right to collaborate in the development of LOQTORZI and the other licensed compounds and will pay for a portion of these co-development activities.
Additionally, we are responsible for certain associated regulatory and technology transfer costs for LOQTORZI and other licensed compounds and will reimburse Junshi Biosciences for such costs.
−Removed: We accounted for the licensing transaction as an asset acquisition under the relevant accounting rules.
−Removed: The $35.0 million payment for the option to license CHS-006 was reflected in our first quarter of 2022 financial statements.
−Removed: As of December 31, 2023, we accrued a $25.0 million milestone payment to Junshi Biosciences, of which we paid $12.5 million in the second quarter of 2024 and $12.5 million in January of 2025.
−Removed: The accrued royalty obligation to Junshi Biosciences was $1.5 million as of December 31, 2024 and immaterial at December 31, 2023.
−Removed: The additional milestone payments and royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are incurred.
+Added: 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.
+Added: We made milestone payments to Junshi Biosciences of $12.5 million in the second quarter of 2024 and another $12.5 million in January of 2025.
+Added: The accrued royalty obligation to Junshi Biosciences was $4.7 million and $1.5 million as of December 31, 2025 and 2024, respectively.
+Added: Additional milestone payments and royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are contractually payable.
Adimab Development and Option Agreement
In October 2018, Surface Oncology, Inc.
−Removed: (“Surface”), which we acquired in September 2023, and Adimab LLC (“Adimab”), entered into an amended and restated development and option agreement, (as amended by the amendments dated as of December 16, 2020, June 1, 2022 and July 18, 2022, the “A&R Adimab Agreement”), which amended and restated the development and option agreement with Adimab dated July 2014, as amended, (the “Original Adimab Agreement”), for the discovery and optimization of proprietary antibodies as potential therapeutic product candidates.
+Added: (“Surface”), which we acquired in September 2023 (the “Surface Acquisition”), and Adimab LLC (“Adimab”), entered into an amended and restated development and option agreement, which was subsequently amended on December 16, 2020, June 1, 2022 and July 18, 2022 (the “A&R Adimab Agreement”), for the discovery and optimization of proprietary
+Added: antibodies as potential therapeutic product candidates.
Under the A&R Adimab Agreement, we will select biological targets against which Adimab will use its proprietary platform technology to research and develop antibody proteins using a mutually agreed upon research plan.
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Upon exercise of a Research Option, we are obligated to pay a nominal research maintenance fee on each of the next four anniversaries of the exercise.
−Removed: Upon the exercise of each Commercialization Option, we will be required to pay an option exercise fee of a low seven-digit dollar amount, and we may be responsible for milestone payments of up to an aggregate of $13.0 million for each licensed product that receives marketing approval.
+Added: Upon the exercise of each Commercialization Option, we will be required to pay an option exercise fee of a low seven-digit dollar amount, and we may be responsible for remaining potential milestone payments up to an aggregate of $10.5 million for each licensed product that receives marketing approval.
For any licensed product that is commercialized, we are obligated to pay Adimab tiered royalties of a low to mid single-digit percentage on worldwide net sales of such product.
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No additional payment is due with respect to any companion diagnostic or any diagnostic product that does not contain any licensed antibody.
−Removed: Any payments payable to Adimab as a result of any product candidates being developed pursuant to the license agreement between Surface and GSK, dated December 16, 2020, which was subsequently amended in August 2021 (as amended, the “GSK Agreement”), will be payable to Adimab directly by GSK.
−Removed: GSK Out-licensing Agreement
−Removed: In December 2020, Surface entered into the GSK Agreement.
−Removed: Pursuant to the GSK Agreement, Surface granted GSK a worldwide exclusive, sublicensable license to develop, manufacture and commercialize antibodies that target PVRIG, including the antibody GSK4381562 (the “Licensed Antibodies”).
−Removed: GSK is responsible for the development, manufacturing and commercialization of the Licensed Antibodies and a joint development committee was formed to facilitate information sharing.
−Removed: GSK is responsible for all costs and expenses of such development, manufacturing and commercialization and is obligated to provide us with updates on its development, manufacturing and commercialization activities through the joint development committee.
−Removed: In March 2022, Surface earned a $30.0 million milestone payment from GSK upon the dosing of the first patient in the Phase 1 trial of GSK4381562.
−Removed: We are eligible to receive up to $60.0 million in additional clinical milestones and $155.0 million in regulatory milestones.
−Removed: In addition, we may receive up to $485.0 million in sales milestone payments.
−Removed: We are also eligible to receive royalties on global net sales of any approved products based on the Licensed Antibodies, ranging in percentages from high single digits to mid-teens.
−Removed: Due to the uncertainty of pharmaceutical development and the historical failure rates generally associated with drug development, we may not receive any milestone payments or any royalty payments under the GSK Agreement.
−Removed: We have not recognized license-related revenue under the GSK Agreement to date.
−Removed: Unless terminated earlier, the GSK Agreement expires on a licensed product-by-licensed product and country-by-country basis on the later of ten years from the date of first commercial sale or when there is no longer a valid patent claim or regulatory exclusivity covering such licensed product in such country.
−Removed: Either party may terminate the GSK Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party.
−Removed: GSK may terminate the GSK Agreement for its convenience.
−Removed: We may terminate the GSK Agreement if GSK institutes certain actions related to the licensed patents or if GSK ceases development activities, other than for certain specified technical or safety reasons.
−Removed: In the event of termination, we would regain worldwide rights to the terminated program.
License Agreement with Vaccinex
On March 23, 2021, Surface and Vaccinex, Inc.
−Removed: (“Vaccinex”) entered into an exclusive product license agreement (the “Vaccinex License Agreement”) to exclusively license certain antibodies, including CHS-114.
−Removed: Pursuant to the terms of the Vaccinex License Agreement, we have a worldwide, exclusive, sublicensable license to make, have made, use, sell, offer to sell, have sold, import and otherwise exploit licensed products that incorporate certain Vaccinex intellectual property which covers certain antibodies (each, a “Vaccinex Licensed Product”), including the antibody CHS-114 targeting CCR8.
+Added: (“Vaccinex”) entered into an exclusive product license agreement (the “Vaccinex License Agreement”) to exclusively license certain antibodies, including t agmokitug.
+Added: Pursuant to the terms of the Vaccinex License Agreement, we have a worldwide, exclusive, sublicensable license to make, have made, use, sell, offer to sell, have sold, import and otherwise exploit licensed products that incorporate certain Vaccinex intellectual property which covers certain antibodies (each, a “Vaccinex Licensed Product”), including the antibody t agmokitug targeting CCR8.
Under the Vaccinex License Agreement, we are obligated to use commercially reasonable efforts to develop, clinically test, achieve regulatory approval, manufacture, market and commercialize at least one Vaccinex Licensed Product and have the sole right to develop, manufacture and commercialize the licensed products worldwide.
We are responsible for all costs and expenses of such development, manufacturing and commercialization.
−Removed: Pursuant to the Vaccinex License Agreement, Surface paid Vaccinex a one-time fee of $0.9 million.
−Removed: Vaccinex is eligible to receive up to an aggregate of $3.5 million based on achievement of certain clinical milestones and up to an aggregate of $11.5 million based on achievement of certain regulatory milestones per Vaccinex Licensed Product.
+Added: Vaccinex is eligible to receive potential remaining milestones up to $2.0 million based on the achievement of certain clinical milestones, excluding a $1.0 million milestone payment accrued at December 31, 2025, and up to $11.5 million based on the achievement of certain regulatory milestones per Vaccinex Licensed Product.
We also owe low single-digit royalties on global net sales of any approved licensed products.
−Removed: Commencing on the third anniversary of the date of the Vaccinex License Agreement and continuing until the first dosing of a Vaccinex Licensed Product in a clinical trial, we will be required to pay Vaccinex a nominal yearly maintenance fee.
−Removed: Since a patient was dosed with a Vaccinex Licensed Product, CHS-114, in January 2023, no yearly maintenance fees are due under the Vaccinex License Agreement.
+Added: As of December 31, 2025, we accrued a $1.0 million milestone payment to Vaccinex related to the achievement of a clinical milestone, which was paid in January 2026.
+Added: Any additional milestone payments and royalties under the Vaccinex License Agreement are contingent upon the achievement of future development, regulatory, or commercial events and will be recorded if and when it becomes probable that a milestone will be achieved, or when royalties are contractually payable.
+Added: GSK Out-licensing Agreement
+Added: In December 2020, Surface entered into the GSK Agreement.
+Added: Pursuant to the GSK Agreement, Surface granted GSK a worldwide exclusive, sublicensable license to develop, manufacture and commercialize antibodies that target PVRIG, including the antibody GSK4381562 (the “Licensed Antibodies”).
+Added: GSK was responsible for the development, manufacturing and commercialization of the Licensed Antibodies and a joint development committee was formed to facilitate information sharing.
+Added: GSK was responsible for all costs and expenses of such development, manufacturing and commercialization and was obligated to provide us with updates on its development, manufacturing and commercialization activities through the joint development committee.
+Added: In March 2022, Surface earned a $30.0 million
+Added: milestone payment from GSK upon the dosing of the first patient in the Phase 1 trial of GSK4381562.
+Added: GSK terminated the GSK Agreement effective December 16, 2025.
+Added: Coherus has elected not to pursue further development of the Licensed Antibodies.
+Added: License Agreement with Apotex
+Added: 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.
+Added: Pursuant to the Canada License Agreement, Apotex paid the Company an upfront payment of $6.3 million United States Dollars.
+Added: In addition, Apotex agreed to pay the Company up to an aggregate of $51.5 million Canadian Dollars in milestone payments in connection with the achievement of certain regulatory and sales milestones with respect to toripalimab in Canada.
+Added: Apotex also agreed to pay the Company a low twenty percent range on future net sales of toripalimab in Canada as running royalties, which the Company subsequently pays through to Junshi Biosciences pursuant to the Collaboration Agreement.
+Added: Apotex received Health Canada approval for LOQTORZI for the treatment of recurrent unresectable or metastatic nasopharyngeal cancer in October 2025.
+Added: The Canada License Agreement term continues until the tenth year after the first commercial sales of toripalimab in Canada, which occurred in January 2026, subject to an extension for a subsequent ten-year term at the option of Apotex.
+Added: Apotex may terminate the Canada License Agreement for any reason after a specified notice period.
+Added: The Canada License Agreement will terminate automatically if the rights granted to the Company by the Collaboration Agreement are terminated, if there is a material breach that is not cured, if there are certain challenges to licensed patents by Apotex and in the case of certain insolvency events.
Intellectual Property
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In most countries, including the United States, the patent term is generally 20 years from the earliest date of filing a non-provisional patent application in the applicable country.
−Removed: In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office (“USPTO”) in examining and
−Removed: granting a patent or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date.
+Added: In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office (“USPTO”) in examining and granting a patent or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date.
In the normal course of business, we pursue patent protection for inventions related to our product candidates.
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Our patent portfolio includes issued or pending claims directed to formulations, methods of manufacturing biological proteins, and drug products and devices, including their methods of use and methods of manufacture.
−Removed: For a discussion of risks related to our proprietary technology and processes, please see “Risk Factors — Risks Related to Intellectual Property.”
+Added: For a discussion of risks related to our proprietary technology and processes, see “Risk Factors — Risks Related to Intellectual Property.”
Government Regulation
−Removed: Our operations and activities are subject to extensive regulation by numerous government authorities in the United States, the European Union (the “E.U.”) and other countries, including laws and regulations governing the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of our products.
+Added: Our operations and activities are subject to extensive regulation by numerous government authorities in the United States, the European Union (the “E.U.”) and other countries, including laws and regulations governing the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of our product.
As a result of these regulations, product development and product approval processes are very expensive and time consuming.
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A country’s regulatory agency, such as the FDA in the United States, must approve a drug before it can be sold in the respective country or countries.
−Removed: The general process for biosimilar approval in the United States is summarized below.
+Added: The general process for drugs and biologics approval in the United States is summarized below.
Many other countries, including countries in the E.U., have similar regulatory structures.
FDA Approval Process for Drugs and Biologics
−Removed: Our products and product candidates are subject to regulation in the United States by the FDA as biological products or as drug product candidates.
+Added: Our product and product candidates are subject to regulation in the United States by the FDA as biological products or as drug product candidates.
The FDA subjects drugs and biologics to extensive pre- and post-market regulation pursuant to the Federal Food, Drug and Cosmetic Act (“FFDCA”) and its implementing regulations, and in the case of biologics, the FFDCA and the Public Health Service Act (“PHSA”) and their implementing regulations.
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A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans.
−Removed: If during the 30-day waiting period the FDA raises concerns or
−Removed: questions related to the proposed clinical studies, the sponsor and the FDA must resolve any outstanding concerns or questions before clinical studies can begin.
+Added: If during the 30-day waiting period the FDA raises concerns or questions related to the proposed clinical studies, the sponsor and the FDA must resolve any outstanding concerns or questions before clinical studies can begin.
If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.
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Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of a use of the product, or from a number of alternative sources, including studies initiated by investigators.
−Removed: Under the PDUFA as amended, each original BLA or NDA must be accompanied by a significant user fee.
+Added: Under the Prescription Drug User Fee Act (the “PDUFA”) as amended, each original BLA or NDA must be accompanied by a significant user fee.
Fee waivers or reductions are available in certain circumstances, such as where a waiver is necessary to protect the public health, where the fee would present a significant barrier to innovation, where the product candidate has received orphan drug designations for the sought indication or where the applicant is a small business submitting its first human therapeutic application for review.
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The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
−Removed: The FDA’s goal is to review standard applications within ten months after the filing date, or, if the application qualifies for Priority Review, six months after the FDA accepts the application for filing.
−Removed: A BLA or NDA is eligible for Priority Review if the product or the product candidate has the potential to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition compared to marketed products.
+Added: The FDA’s goal is to review standard applications within ten months after the filing date, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing (“Priority Review”).
+Added: A BLA or NDA is eligible for Priority Review if the product or the product candidate has the potential to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or
+Added: condition compared to marketed products.
In both standard and Priority Reviews, the review process may also be extended for a three-month period by the FDA to review additional information deemed a major amendment to the application.
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The FDA will not approve the application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
−Removed: Additionally, before approving an original BLA or NDA, the FDA will typically inspect one or more clinical sites to ensure compliance with cGCP.
+Added: Additionally, before approving an original BLA or NDA, the FDA will typically inspect one or more clinical sites to ensure compliance with GCP.
After the FDA evaluates an original BLA or NDA and conducts any inspections in the U.S.
−Removed: or internationally that it deems necessary, the FDA may issue an approval letter or a CRL.
+Added: or internationally that it deems necessary, the FDA may issue an approval letter or a Complete Response Letter (“CRL”).
An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
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Orphan designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.
−Removed: If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications –including full NDAs or BLAs– to market the same drug for the same disease or condition for seven years, except in limited circumstances,
−Removed: such as a showing of clinical superiority to the product with orphan exclusivity or inability to manufacture the product in sufficient quantities.
+Added: If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications –including full NDAs or BLAs– to market the same drug for the same approved indication or use within such disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity in the relevant indication or inability to manufacture the product in sufficient quantities.
The designation of such drug or biologic also entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.
−Removed: However, competitors, may receive approval of different products for the disease or condition for which the orphan product has exclusivity, or obtain approval for the same product but for a different disease or condition for which the orphan product has exclusivity.
−Removed: Orphan exclusivity also could block the approval of a competing product for seven years if a competitor obtains approval of the “same drug,” as defined by the FDA, or if the active ingredient of the product candidate is determined to be contained within the competitor’s product for the same disease or condition.
+Added: However, competitors, may receive approval of different products for the indication or use for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication or use for which the orphan product has exclusivity.
+Added: Orphan exclusivity also could block the approval of a competing product for seven years within the relevant indication or use if a competitor obtains approval of the “same drug,” as defined by the FDA, or if the active ingredient of the product candidate is determined to be contained within the competitor’s product.
In addition, if an orphan designated product receives marketing approval for a disease or condition broader than what is designated, it may not be entitled to orphan exclusivity.
−Removed: Abbreviated Licensure Pathway of Biological Products as Biosimilar under Section 351(k)
−Removed: The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended the PHSA and created an abbreviated approval pathway for biological products shown to be highly similar to an FDA-licensed reference biological product.
−Removed: The BPCIA attempts to minimize duplicative testing and thereby lower development costs and increase patient access to affordable treatments.
−Removed: Thus, an application for licensure of a biosimilar product pursuant to a Section 351(k) BLA must include information demonstrating biosimilarity based upon the following, unless the FDA determines otherwise:
−Removed: ● analytical studies demonstrating that the proposed biosimilar product is highly similar to the approved product notwithstanding minor differences in clinically inactive components;
−Removed: ● animal studies (including the assessment of toxicity);
−Removed: ● two clinical study phases:
−Removed: first, a clinical study or studies (generally termed “Phase 1”) that demonstrate the PK and PD similarity (e.g., bioequivalence study) of the proposed biosimilar to the originator molecule, and second, a clinical study or studies (generally termed “Phase 3”) that demonstrate the safety (including immunogenicity), purity and that potency is statistically not inferior to that of the originator in one or more conditions for which the reference product is licensed and intended to be used.
−Removed: In addition, an application submitted under the Section 351(k) pathway must include information demonstrating that:
−Removed: ● the proposed biosimilar product and reference product utilize the same mechanism of action for the condition(s) of use prescribed, recommended or suggested in the proposed labeling, but only to the extent the mechanism(s) of action are known for the reference product;
−Removed: ● the condition or conditions of use prescribed, recommended or suggested in the labeling for the proposed biosimilar product have been previously approved for the reference product;
−Removed: ● the route of administration, the dosage form and the strength of the proposed biosimilar product are the same as those for the reference product;
−Removed: ● the facility in which the biological product is manufactured, processed, packed or held meets standards designed to assure that the biological product continues to be safe, pure and potent.
−Removed: Biosimilarity is defined to mean that the proposed biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product.
−Removed: In addition, a biosimilar may also be determined to be “interchangeable” with the reference products, whereby the biosimilar may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
−Removed: The higher standard of interchangeability must be demonstrated by information sufficient to show that:
−Removed: ● the proposed product is biosimilar to the reference product;
−Removed: ● the proposed product is expected to produce the same clinical result as the reference product in any given patient;
−Removed: ● for a product that is administered more than once to an individual, the risk to the patient in terms of safety or diminished efficacy of alternating or switching between the biosimilar and the reference product is no greater than the risk of using the reference product without such alternation or switch.
−Removed: FDA approval is required before a biosimilar may be marketed in the United States.
−Removed: The FDA has discretion over the kind and amount of scientific evidence — laboratory, preclinical and/or clinical — required to demonstrate biosimilarity to a licensed biological product.
−Removed: The FDA intends to consider the totality of the evidence provided by a sponsor to support a demonstration of biosimilarity, and recommends that sponsors use a stepwise approach in the development of their biosimilar products.
−Removed: Biosimilar product applications thus may not be required to duplicate the entirety of preclinical and clinical testing used to establish the underlying safety and effectiveness of the reference product.
−Removed: However, the FDA may refuse to approve a biosimilar application if there is insufficient information to show that the active ingredients are the same or to demonstrate that any impurities or differences in active ingredients do not affect the safety, purity or potency of the biosimilar product.
−Removed: In addition, as with original BLAs, biosimilar product applications will not be approved unless the product is manufactured in facilities designed to assure and preserve the biological product’s safety, purity and potency.
−Removed: The submission of an application via the Section 351(k) pathway does not guarantee that the FDA will accept the application for filing and review, as the FDA may refuse to accept applications that it finds are incomplete.
−Removed: The FDA will treat a biosimilar application or supplement as incomplete if, among other reasons, any applicable user fees have not been paid.
−Removed: In addition, the FDA may accept an application for filing but deny approval on the basis that the sponsor has not demonstrated biosimilarity, in which case the sponsor may choose to conduct further analytical, preclinical or clinical studies to demonstrate such biosimilarity under Section 351(k) or submit an original BLA for licensure as a new biological product under Section 351(a) of the PHSA.
−Removed: The timing of final FDA approval of a biosimilar for commercial distribution depends on a variety of factors, including whether the manufacturer of the branded product is entitled to one or more statutory exclusivity periods, during which time the FDA is prohibited from approving any products that are biosimilar to the branded product.
−Removed: The FDA cannot approve a biosimilar application for 12 years from the date of first licensure of the reference product.
−Removed: Additionally, a biosimilar product sponsor may not submit an application under the Section 351(k) pathway for four years from the date of first licensure of the reference product.
−Removed: In certain circumstances, a regulatory exclusivity period can extend beyond the life of a patent and thus block the Section 351(k) BLA from being approved on or after the patent expiration date.
−Removed: In addition, the FDA may under certain circumstances extend the exclusivity period for the reference product by an additional six months if the FDA requests, and the manufacturer undertakes, studies on the effect of its product in children, a so-called pediatric extension.
−Removed: The first biological product determined to be interchangeable with a branded product for any condition of use is also entitled to a period of exclusivity, during which time the FDA may not determine that another product is interchangeable with the reference product for any condition of use.
−Removed: This exclusivity period extends until the earlier of:
−Removed: (1) one year after the first commercial marketing of the first interchangeable product;
−Removed: (2) 18 months after resolution of a patent infringement suit instituted under 42 U.S.C.
−Removed: § 262(l)(6) against the applicant that submitted the application for the first interchangeable product, based on a final court decision regarding all of the patents in the litigation or dismissal of the litigation with or without prejudice;
−Removed: (3) 42 months after approval of the first interchangeable product, if a patent infringement suit instituted under 42 U.S.C.
−Removed: § 262(l)(6) against the applicant that submitted the application for the first interchangeable product is still ongoing;
−Removed: or (4) 18 months after approval of the first interchangeable product if the applicant that submitted the application for the first interchangeable product has not been sued under 42 U.S.C.
−Removed: FDA Regulation of Combination Products
−Removed: Certain products or product candidates, such as the OBI presentation of UDENYCA we developed, may be composed of components, such as drug components and device components that would normally be regulated under different types of regulatory authorities, and frequently by different centers at the FDA.
−Removed: These products are known as combination products.
−Removed: Specifically, under regulations issued by the FDA, a combination product may be:
−Removed: ● a product composed of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
−Removed: ● two or more separate products packaged together in a single package or as a unit and composed of drug and device products, device and biological products, or biological and drug products;
−Removed: ● a drug, or device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, or device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose;
−Removed: ● any investigational drug, or device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
−Removed: Under the FFDCA and its implementing regulations, the FDA is charged with assigning a center with primary jurisdiction, or a lead center, for review of a combination product.
−Removed: The designation of a lead center generally eliminates the need to receive approvals from more than one FDA component for combination products, although it does not preclude consultations by the lead center with other components of the FDA.
−Removed: The determination of which center will be the lead center is based on the “primary mode of action” of the combination product.
−Removed: Thus, if the primary mode of action of a drug-device combination product is attributable to the drug product, the FDA center responsible for premarket review of the drug product would have primary jurisdiction for the combination product.
−Removed: The FDA has also established an Office of Combination Products to address issues surrounding combination products and provide more certainty to the regulatory review process.
−Removed: That office serves as a focal point for combination product issues for agency reviewers and industry.
−Removed: It is also responsible for developing guidance and regulations to clarify the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute.
−Removed: A combination product with a biologic primary mode of action generally would be reviewed and approved pursuant to the biologic licensure processes under the PHSA.
−Removed: In reviewing the BLA or Section 351(k) BLA for such a product, however, FDA reviewers in the drug center could consult with their counterparts in the device center to ensure that the device component of the combination product met applicable requirements regarding safety, purity, potency, durability and performance.
−Removed: In addition, under FDA regulations, combination products are subject to cGMP requirements applicable to both drugs and devices, including the Quality System regulations applicable to medical devices.
Advertising and Promotion
−Removed: Once an NDA, original BLA, or Section 351(k) BLA is approved, a product will be subject to continuing post-approval regulatory requirements, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product.
+Added: Once an NDA or BLA is approved, the product will be subject to continuing post-approval regulatory requirements, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product.
For instance, the FDA closely regulates the post-approval marketing and promotion of biologics, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet.
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Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with cGMPs.
−Removed: Regulatory authorities may withdraw product approvals,
−Removed: request product recalls or impose marketing restrictions through labeling changes or product removals if a company fails to comply with regulatory standards, if it encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.
+Added: Regulatory authorities may withdraw product approvals, request product recalls or impose marketing restrictions through labeling changes or product removals if a company fails to comply with regulatory standards, if it encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.
The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
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The federal government is using the False Claims Act, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, for example, in connection with the promotion of products for unapproved uses and other sales and marketing practices.
−Removed: The government has obtained multi-million and multi-billion dollar settlements under the False Claims Act in addition to individual criminal convictions under applicable criminal statutes.
+Added: The government has obtained multi-million and multi-billion dollar settlements under the False Claims Act in addition to individual criminal convictions
+Added: under applicable criminal statutes.
Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.
The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.
−Removed: Noncompliance with such beneficiary inducement provision of the federal Civil Monetary
−Removed: Penalties Law can result in civil money penalties for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from the federal healthcare programs.
+Added: Noncompliance with such beneficiary inducement provision of the federal Civil Monetary Penalties Law can result in civil money penalties for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from the federal healthcare programs.
Federal and state government price reporting laws require manufacturers to calculate and report complex pricing metrics to government programs.
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In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers.
−Removed: The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), among other things, imposed new reporting requirements on drug manufacturers for payments made by them to physicians (defined to include doctors, dentists, optometrists, podiatrists, chiropractors, certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by such physicians and their immediate family members.
+Added: The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), among other things, imposed reporting requirements on drug manufacturers for payments made by them to physicians (defined to include doctors, dentists, optometrists, podiatrists, chiropractors, certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse midwives)) and teaching hospitals, as well as ownership and investment interests held by such physicians and their immediate family members.
Failure to submit required information may result in significant civil monetary penalties for any payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission, and additional penalties for “knowing failures.” Certain states also mandate implementation of commercial compliance programs, impose restrictions on pharmaceutical manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians.
−Removed: The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created new federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third ‑ party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
+Added: The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations (“HIPAA”) created new federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third ‑ party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
Similar to the federal Anti ‑ Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
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In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
−Removed: Privacy and security laws, regulations and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts and can result in investigations, proceedings or actions that lead to significant civil or criminal penalties or both and restrictions on data processing.
+Added: Privacy and security laws, regulations and other obligations are constantly evolving, may conflict with each other to
+Added: complicate compliance efforts and can result in investigations, proceedings or actions that lead to significant civil or criminal penalties or both and restrictions on data processing.
Pharmaceutical Coverage, Pricing and Reimbursement
−Removed: In the United States and other countries, sales of UDENYCA and LOQTORZI and any other products for which we receive regulatory approval for commercial sale will depend in part on the availability of coverage and reimbursement from third-party payers, including government health administrative authorities, managed care providers, private health insurers and other organizations.
−Removed: Third-party payers
−Removed: are increasingly examining the medical necessity and cost effectiveness of medical products and services in addition to safety and efficacy and, accordingly, significant uncertainty exists as to the reimbursement status of newly approved therapeutics.
+Added: In the United States and other countries, sales of LOQTORZI and any other products for which we receive regulatory approval for commercial sale will depend in part on the availability of coverage and reimbursement from third-party payers, including government health administrative authorities, managed care providers, private health insurers and other organizations.
+Added: Third-party payers are increasingly examining the medical necessity and cost effectiveness of medical products and services in addition to safety and efficacy and, accordingly, significant uncertainty exists as to the reimbursement status of newly approved therapeutics.
In addition, the United States government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products.
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A significant portion of our sales are subject to substantial discounts to list price, including rebates we may be required to pay to Medicaid agencies or discounts we may be required to pay to 340B covered entities.
−Removed: Decreases in third-party reimbursement for UDENYCA and LOQTORZI or other products for which we receive regulatory approval or a decision by a third-party payer to not cover our products could reduce physician utilization of our products and have a material adverse effect on our sales, results of operations and financial condition.
+Added: Decreases in third-party reimbursement for LOQTORZI or other products for which we receive regulatory approval or a decision by a third-party payer to not cover our products could reduce physician utilization of our products and have a material adverse effect on our sales, results of operations and financial condition.
Government Price Reporting
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Public Health Service (including the Indian Health Service).
−Removed: We must also pay rebates on products purchased by military personnel and dependents through the TRICARE retail pharmacy program.
+Added: We must also pay rebates on products purchased by military personnel
+Added: and dependents through the TRICARE retail pharmacy program.
If a manufacturer participating in the FSS program fails to provide timely information or is found to have knowingly submitted false information, the manufacturer may be subject to civil monetary penalties.
1 unchanged sentence
A number of states have either implemented or are considering implementation of drug price transparency legislation.
−Removed: Requirements under such laws include advance notice of planned price increases, reporting price increase amounts and factors considered in taking such increases, wholesale acquisition cost information disclosure to prescribers, purchasers, and
−Removed: state agencies, and new product notice and reporting.
+Added: Requirements under such laws include advance notice of planned price increases, reporting price increase amounts and factors considered in taking such increases, wholesale acquisition cost information disclosure to prescribers, purchasers, and state agencies, and new product notice and reporting.
Such legislation could limit the price or payment for certain drugs, and a number of states are authorized to impose civil monetary penalties or pursue other enforcement mechanisms against manufacturers for the untimely, inaccurate, or incomplete reporting of drug pricing information or for otherwise failing to comply with drug price transparency requirements.
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Most significantly, on August 16, 2022, the IRA was signed into law.
−Removed: Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;
+Added: Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap;
imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);
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HHS has issued and will continue to issue guidance implementing the IRA.
−Removed: CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and the list of the subsequent 15 drugs that will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges.
+Added: CMS has published the negotiated prices for the initial ten drugs, which went into effect in 2026, and the subsequent 15 drugs, which will first be effective in 2027, as well as the next set of 15 drugs that will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges.
While the impact of the IRA on our business and the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.
In particular, if a product becomes subject to the IRA negotiation provision and related price cap, that may significantly alter the economic rationale for developing and commercializing a biosimilar.
+Added: The One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program.
+Added: Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our sales of LOQTORZI® or any other product candidate that we commercialize.
+Added: The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S.
+Added: President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S.
+Added: to the lowest price in a group of other countries.
+Added: In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government.
+Added: The Trump administration is also pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard.
+Added: If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing.
+Added: While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant.
+Added: Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S.
+Added: pharmaceutical sector and our business.
+Added: In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.
+Added: Moreover, the individual states in the United States have become increasingly active in developing proposals, passing legislation and implementing regulations designed to control drug pricing, including price or patient reimbursement constraints, discounts, formulary flexibility, marketing cost disclosure, drug price reporting and other transparency measures.
+Added: Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states, and at least one state board is imposing an upper payment limit.
+Added: States are also seeking to implement general, across the board price caps for pharmaceuticals, or are seeking to regulate drug distribution.
+Added: Some measures are designed to encourage importation from other countries.
+Added: These new laws and the regulations and policies implementing them, as well as other healthcare-related measures that may be adopted in the future, could materially reduce our ability to develop and commercialize LOQTORZI® and our product candidates, if approved.
We are subject to a number of laws and regulations that require compliance with federal, state, and local regulations for the protection of the environment.
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Human Capital Management
−Removed: As of December 31, 2023, we had 306 full-time and part-time employees.
−Removed: In addition to our 35 former employees who transferred to Sandoz in connection with the closing of the CIMERLI Sale, on March 11, 2024 we committed to a plan to reduce our workforce (the “Plan”) by approximately 26 employees effective March 18, 2024 to focus resources on strategic priorities including the research, development and commercialization of innovative cancer treatments and the commercialization of our portfolio of FDA-approved oncology products.
−Removed: The Plan was completed in 2024.
−Removed: As of December 31, 2024, we had 228 full-time and part-time employees.
−Removed: All were located in the United States and none of our employees were represented by a labor union.
+Added: As of December 31, 2025, we had 147 full-time and part-time employees, which represented a decrease of 81 full-time and part-time employees since December 31, 2024.
+Added: All employees were located in the United States and none were represented by a labor union.
We have not experienced any work stoppages and believe we have good relations with our employees and contractors.
Our guiding principles are anchored on the goals of being able to recruit, incentivize, retain and integrate talented employees who can develop, implement, and drive long-term value creation strategies.
−Removed: Pursuant to the UDENYCA Purchase Agreement, approximately 50 of our employees are expected to transfer employment to Accord, with the transfer of employment effective at the closing of the UDENYCA Sale, which we expect to occur late in the first quarter or early in the second quarter of 2025.
−Removed: None of our executive officers are expected to transfer to Intas.
+Added: As our development and commercialization plans and strategies evolve and because of reductions in force and turnover, from time to time we experience changes in our number of employees.
+Added: On December 2, 2024, we and Intas Pharmaceuticals Ltd.
+Added: (“Intas”) entered into an asset purchase agreement (the “UDENYCA Purchase Agreement”), pursuant to which the Company agreed to divest the UDENYCA franchise (the “UDENYCA Business”) to Intas (the “UDENYCA Sale”).
+Added: On April 11, 2025 (the “UDENYCA Closing Date”), we completed the divestiture of the UDENYCA Business to Intas.
+Added: Intas has designated Accord BioPharma, Inc., an indirect wholly owned subsidiary of Intas (“Accord” and, together with Intas, the “Intas Parties”) to purchase the physical assets, including product inventory.
+Added: Pursuant to the UDENYCA Purchase Agreement, 43 of our employees transferred employment to Accord at the closing of the UDENYCA Sale.
+Added: None of our executive officers transferred to Accord.
Compensation and Benefits
−Removed: We believe our base salaries are fair and competitive with the external labor markets in which our employees work and are reviewed on a regular basis.
+Added: We review our base salaries on a regular basis and believe they are fair and competitive with the external labor markets in which our employees work.
We offer incentive programs that provide bonus opportunities to encourage and reward participants for our achievement of financial and other key performance metrics and strengthen the connection between pay and performance.
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Additionally, we offer an Employee Assistance Program that includes professional support for employees to balance the stress of personal and professional demands.
−Removed: Inclusion and Diversity
−Removed: People are a critical component of our efforts to drive growth and deliver value for stockholders.
−Removed: One of the ways we have put people at the center of our business is by continuing to work toward a more inclusive and diverse workplace where each person feels respected, valued and seen and can be the best version of themselves.
−Removed: We believe that having a truly diverse workplace helps our company to achieve the best results, including by valuing diversity in terms of gender, ethnicity, nationality, disability status, veteran status and other factors.
−Removed: We donate to non-profit organizations such as Life Science Cares, an organization focused on eliminating the impact of poverty on our neighbors.
−Removed: Our Chief Executive Officer also serves on the Board of Advisors of Life Science Cares.
Health and Safety
We are committed to a safe workplace for our employees and have implemented health and safety management processes, including training and awareness, into our operations.
−Removed: In response to the COVID-19 pandemic, we implemented additional safety measures for the protection of our employees, including work-from-home measures for applicable employees and additional cleaning and protective measures.
We have an incident reporting plan to respond to injuries and emergencies on an ongoing basis to protect our employees and comply with all Occupational Safety and Health Administration requirements.
Training, Development and Engagement
−Removed: Through our online learning platform, we deliver a variety of required learning modules, including those modules tied to our Code of Business Conduct, cybersecurity, unlawful harassment, workplace violence prevention and anti-corruption policies, which are completed periodically by all team members.
−Removed: We also have Performance Management, Leadership and Interview Training programs for our managers.
+Added: Through our online learning platform, we deliver a variety of required learning modules, including those modules tied to our Code of Business Conduct, healthcare compliance, cybersecurity, unlawful harassment, workplace violence prevention and anti-corruption policies, which are completed periodically by all team members.
We have a highly collaborative, engaging company environment.
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You may find electronic copies of our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 on our website at https://www.coherus.com free of charge.
−Removed: We also periodically release and publicize press releases to the public that are also available on our website’s section entitled “News” which we use as a recognized channel of distribution for our investors and other people interested in our company.
+Added: We also periodically release and publicize press releases to the public that are also available on our website’s section entitled “Investors & Media” which we use as a recognized channel of distribution for our investors and other people interested in our company.
The SEC maintains a website (https://www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.