What changed in this filing

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Item 1. Business

2025-03-17 compared with 2024-03-15 · 206 added, 241 removed, 409 unchanged (52% of the section changed)

We are a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative cancer treatments and the commercialization of our portfolio of United States Food and Drug Administration (“FDA”)-approved oncology products, including LOQTORZI® (toripalimab-tpzi).

Our strategy is to build a leading immuno-oncology business funded with cash generated from our diversified portfolio of FDA-approved therapeutics.

As of March 15, 2024, our commercial portfolio includes two FDA-approved biosimilar products.

Our first product, UDENYCA®, a biosimilar to Neulasta, a long-acting G-CSF, was launched commercially in the United States in January 2019.

The FDA approved the prior approval supplement (“PAS”) for an autoinjector (“AI”) presentation of UDENYCA on March 3, 2023, and on May 22, 2023 we announced the availability of UDENYCA AI for commercial sale.

On December 26, 2023 we announced that the FDA approved the PAS for our third pegfilgrastim presentation, the UDENYCA® on-body injector (“UDENYCA ONBODY”).

UDENYCA ONBODY became commercially available in the first quarter of 2024.

Our second product, YUSIMRY® (adalimumab-aqvh), a biosimilar to Humira (adalimumab), was launched in the United States in July 2023.

Another product, CIMERLI® (ranibizumab-eqrn), was approved by the FDA in August 2022 as a biosimilar product interchangeable with Lucentis (ranibizumab injection) 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.

We launched CIMERLI commercially in the United States in October 2022.

On January 19, 2024, we entered into a Purchase and Sale Agreement (the “Purchase Agreement”) by and between us and Sandoz Inc., a Delaware corporation (“Sandoz”).

Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024, we completed the divestiture of our CIMERLI ophthalmology franchise through the sale of our subsidiary, Coherus Ophthalmology LLC, to Sandoz (the “Sale Transaction”) for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets.

Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the Purchase Agreement.

Our commercial portfolio includes LOQTORZI, a novel PD-1 inhibitor that we developed in collaboration with Shanghai Junshi Biosciences Co., Ltd.

(“Junshi Biosciences”).

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 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.

We are a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer.

Our commercial portfolio includes our first product, UDENYCA® (pegfilgrastim-cbqv), a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor (“G-CSF”) and LOQTORZI® (toripalimab-tpzi), a novel next-generation programmed death receptor-1 (“PD-1”) inhibitor.

We are developing an innovative immuno-oncology pipeline that we expect to bring forward new potential indications for LOQTORZI in the U.S.

and the development of new product candidates.

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.

On December 2, 2024, we and Intas Pharmaceuticals Ltd.

(“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”).

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”).

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.

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.

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.

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.

In addition, we will use the proceeds for working capital and general corporate purposes, in connection with our continued business.

On October 27, 2023, we announced that LOQTORZI was approved by the U.S.

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.

LOQTORZI is an anti-PD-1 antibody that we developed in collaboration with Junshi Biosciences Co., Ltd.

(“Junshi Biosciences”) that is currently the only immune checkpoint inhibitor approved by the FDA for the treatment of these indications.

We announced the launch of LOQTORZI in the U.S.

on January 2, 2024.

We also have a pipeline of earlier stage clinical and preclinical immuno-oncology programs.

On September 8, 2023, we acquired Surface Oncology, Inc.

(“Surface”) and took ownership of its assets, including its portfolio of product candidates.

The lead clinical stage product candidate from our acquisition of Surface (the “Surface Acquisition”) is casdozokitug (CHS-388, formerly SRF388), an investigational antibody targeting interleukin 27 (“IL-27”) , an immune regulatory cytokine, or protein that is overexpressed in certain cancers, including hepatocellular, lung and renal cell carcinoma.

IL-27 is a cytokine secreted by macrophages and antigen presenting cells that plays an important physiologic role in suppressing the immune system, as evidenced by its ability to resolve tissue inflammation.

In addition, both IL-27 subunits, EBI3 and p28, are highly expressed during pregnancy in the placenta and their expression is associated with maternal-fetal tolerance.

Due to its immunosuppressive nature, there is a rationale for inhibiting IL-27 to treat cancer, as this approach will influence the activity of multiple types of immune cells that are necessary to recognize and attack a tumor.

Casdozokitug received orphan drug designation and fast track designation from the FDA for the treatment of hepatocellular carcinoma (“HCC”) in November 2020.

Casdozokitug is currently in two on-going clinical studies, a Phase 1/2 study in patients with advanced solid tumors (clinicaltrials.gov identifier# NCT04374877) and a Phase 2 study in HCC (clinicaltrials.gov identifier# NCT05359861).

Our second clinical-stage product candidate from the Surface Acquisition, CHS-114 (formerly SRF114), is an investigational afucosylated immunoglobulin isotype G1 (“ IgG1”) antibody targeting CCR8, a chemokine receptor highly expressed on regulatory T cells (“Treg cells”) in the tumor microenvironment (“TME”).

CHS-114 is designed to cause depletion of intra-tumoral CCR8 expressing Treg cells, important regulators of immune suppression, through antibody-dependent cellular cytotoxicity (“ADCC”), or antibody-dependent cellular phagocytosis (“ADCP”), or both, and CCR8 cytolytic antibodies have shown anti-tumor activity in preclinical cancer models.

We are enrolling patients with advanced solid tumors in North America in a clinical trial evaluating safety and pharmacokinetics of CHS-114 (clinicaltrials.gov identifier# NCT05635643).

We are also pursuing an early-stage development candidate that is in investigational new drug application-enabling studies, CHS-1000, an antibody targeting human ILT4, designed to improve anti-PD-1 clinical benefit by transforming an unfavorable TME to a more favorable TME.

In addition to our internally developed portfolio of product candidates that we obtained in the Surface Acquisition, we also own two product candidates, NZV930 and GSK4381562, which are exclusively licensed to Novartis Institutes for Biomedical Research, Inc.

(“Novartis Institutes”) and GlaxoSmithKline Intellectual Property No.

4 Limited (“GSK”), respectively .

We will pay 70% of all milestone- and royalty-based payments that we or our affiliates actually receive from the product candidates licensed to Novartis Institutes and GSK during the ten-year period following the entry into the Contingent Value Rights Agreement, dated September 8, 2023, by and among us and Computershare Inc.

and its affiliate Computershare Trust Company, N.A., together, as the rights agent thereunder (the “CVR Agreement”) to the holders of contingent value rights (“CVRs”).

Further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by us, Junshi Biosciences and our biopharma partners.

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.

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.

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.

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).

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).

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”).

We are enrolling patients with advanced solid tumors and head and neck squamous cell carcinoma (“HNSCC”) in the U.S.

in a clinical trial evaluating safety and pharmacokinetics of CHS-114 with and without LOQTORZI (clinicaltrials.gov identifier# NCT05635643).

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.

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.

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.

In addition, we have a product candidate, GSK4381562, which is exclusively licensed to GlaxoSmithKline Intellectual Property No.

4 Limited (“GSK”).

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”).

We have a depth of scientific expertise, an experienced and robust manufacturing know-how and oncology clinical, regulatory, market access, sales, key account management and medical affairs capabilities in the United States, which has supported the commercialization of LOQTORZI.

We expect to further leverage these capabilities as we continue to advance our immuno-oncology franchise.

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

Products and Product Candidates

Our portfolio includes the following products and product candidates:

● UDENYCA, a biosimilar to Neulasta, a long-acting G-CSF, was launched commercially in the United States in January 2019.

The FDA approved the PAS for an AI presentation of UDENYCA on March 3, 2023, and on May 22, 2023 we announced the availability of UDENYCA AI for commercial sale.

We announced on December 26, 2023 that the FDA approved the PAS for our third pegfilgrastim presentation, UDENYCA ONBODY ™, the first and only pegfilgrastim biosimilar on-body injector novel in its design .

UDENYCA ONBODY became commercially available in the first quarter of 2024.

● 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.

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.

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.

● 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.

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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.

On November 26, 2024, NCCN made a further update to the clinical practice guidelines for NPC to specify that LOQTORZI is the only preferred category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine.

The guidelines also recommend LOQTORZI monotherapy as the only preferred treatment in subsequent lines of therapy if disease progression on or after a platinum-containing therapy.

Further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by us and our partners.

We have a postmarketing commitment study active and enrolling patients in locations in the U.S.

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).

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).

INOVIO Pharmaceuticals, Inc.

plans a randomized Phase 3 study of INO-3112 and toripalimab in locally advanced, high risk HPV16/18+ oropharyngeal squamous cell carcinoma.

Cancer Research Institute (“CRI”) plans to evaluate 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 (“CCTG”).

On June 27, 2024, we entered into an exclusive license and distribution agreement (the “Canada License Agreement”) with Apotex, Inc.

(“Apotex”), pursuant to which, we granted to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada.

● 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.

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Due to its immune regulatory nature, there is a rationale for inhibiting IL-27 to treat cancer, as this approach will influence the activity of multiple types of immune cells that are necessary to recognize and attack a tumor.

Casdozokitug received orphan drug designation and fast track designation from the FDA for the treatment of HCC in November 2020.

Casdozokitug is currently in two on-going clinical studies, a Phase 1/2 study in advanced solid tumors (clinicaltrials.gov identifier# NCT04374877) and a Phase 2 study in HCC (clinicaltrials.gov identifier# NCT05359861).

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.

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).

● 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.

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CHS-114 has shown anti-tumor activity as monotherapy or in combination with anti-PD-1 antibodies in preclinical models.

We are enrolling patients with advanced solid tumors in North America in a clinical trial evaluating safety and pharmacokinetics of CHS-114 (clinicaltrials.gov identifier# NCT05635643).

● We are pursuing a development candidate, CHS-1000, an antibody targeting human ILT4, designed to improve anti-PD-1 clinical benefit by transforming an unfavorable TME to a more favorable TME.

We plan to submit an investigational new drug application (“IND”) to the FDA in the second quarter of 2024 for CHS-1000.

● In addition to our internally developed portfolio of product candidates that we obtained in the Surface Acquisition, we also own NZV930 and GSK4381562, which are exclusively licensed to Novartis Institutes and GSK, respectively.

NZV930 is an antibody designed to inhibit CD73, which is a critical enzyme involved in the production of extracellular adenosine, a key metabolite with strong immunosuppressive properties within the TME.

NZV930 aims to reduce the production of immunosuppressive adenosine within the TME.

GSK4381562 is an antibody targeting CD112R, also known as PVRIG, an inhibitory protein expressed on natural killer (“NK”) and T cells.

GSK4381562 is designed to block the interaction of CD112R with CD112, its binding partner that is expressed on tumor cells.

We are enrolling patients with advanced solid tumors and HNSCC in the U.S.

in a clinical trial evaluating safety and pharmacokinetics of CHS-114 with and without LOQTORZI (clinicaltrials.gov identifier# NCT05635643).

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.

● 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.

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.

● In addition, we have a product candidate, GSK4381562, which is exclusively licensed to GSK.

GSK4381562 is an investigational antibody targeting CD112R (“PVRIG”), an inhibitory protein expressed on natural killer (“NK”) and T cells.

GSK4381562 is designed to block the interaction of PVRIG with CD112, its binding partner that is expressed on tumor cells.

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.

We will pay 70% of all milestone- and royalty-based payments that we or our affiliates receive from the product candidates licensed to Novartis Institutes and GSK during the ten-year period following the entry into the CVR Agreement to the holders of the CVRs.

● YUSIMRY, a biosimilar of Humira (adalimumab), is a monoclonal antibody that can bind to tumor necrosis factor (“TNF”).

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.

Immunology – Sold to Hong Kong King-Friend Industrial Company Ltd.

(“HKF”) pursuant to the sale of our YUSIMRY franchise (the “YUSIMRY Sale”)

● YUSIMRY (adalimumab-aqvh), a biosimilar of Humira (adalimumab), is a monoclonal antibody that can bind to tumor necrosis factor (“TNF”).

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.

In December 2021, the FDA approved YUSIMRY, which we launched in the United States in July 2023.

The list price of YUSIMRY at launch represented an approximately 85% discount to the list price of Humira.

YUSIMRY is now available for sale nationwide through select retail, mail order, and specialty pharmacy channels, including Mark Cuban Cost Plus Drug Company, PBC.

Ophthalmology – Sold to Sandoz pursuant to the Sale Transaction

● CIMERLI is a Lucentis biosimilar.

On November 4, 2019, we entered into a license agreement (the “Bioeq Agreement”) with Bioeq IP AG (“Bioeq”) for the commercialization of CIMERLI in certain dosage forms in both a vial and pre-filled syringe (“PFS”) presentation.

Under the Bioeq Agreement, Bioeq granted to us an exclusive royalty-bearing license to commercialize CIMERLI in the field of ophthalmology (and any other approved labelled indication) in the United States.

On August 2, 2022, the FDA approved CIMERLI as a biosimilar product interchangeable with Lucentis 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.

The FDA also granted CIMERLI 12 months of first interchangeable exclusivity.

On October 3, 2022, we launched CIMERLI commercially in the United States in both 0.3 mg and 0.5 mg dosage forms.

On January 19, 2024, we entered into the Purchase Agreement by and between us and Sandoz.

Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024, we completed the divestiture of our CIMERLI ophthalmology franchise through the sale of our subsidiary, Coherus Ophthalmology LLC, 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.

Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the Purchase Agreement.

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.

We retained the rights to certain patents that were licensed to Pfizer

(“Pfizer”) under the License and Settlement Agreement, dated as of October 21, 2019, between us and Pfizer (the “Pfizer License Agreement”).

Ophthalmology – Sold to Sandoz Inc.

(“Sandoz”) pursuant to the sale of our CIMERLI ophthalmology franchise (the “CIMERLI Sale” and, together with the YUSIMRY Sale, the “Sale Transactions”)

● 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.

On January 19, 2024, we entered into a Purchase and Sale Agreement (the “CIMERLI Purchase Agreement”) by and between us and Sandoz.

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.

Oncology Franchise Market Opportunity

LOQTORZI Opportunity

According to Clarivate/Decision Resource Group, the Squamous Cell Carcinoma of the Head and Neck (“SCCHN”) therapy market was expected to increase 9% annually over the 2022-2032 forecast period.

In 2022, sales of SCCHN therapies in the major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) totaled $1.5 billion, and sales were expected to increase to almost $3.5 billion in 2032.

Fueling this growth are the continued uptake of pembrolizumab in the recurrent or metastatic first-line setting, its label expansion into the locoregionally advanced setting, and the expected approval of four new therapies.

PD-1 inhibitors are expected to be the sales-leading drug class in 2032, garnering major-market sales of over $1.7 billion, and we expect these agents to be approved for both non-nasopharyngeal and nasopharyngeal drug-treatable patient populations.

According to Clarivate/Decision Resource Group, the HNSCC therapy market was expected to increase 10.6% annually over the 2023-2033 forecast period.

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.

Fueling this growth is the label expansion of pembrolizumab in the locoregionally advanced setting, and the expected approval of four new therapies.

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.

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.

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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.

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 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.

On October 27, 2023, we announced that LOQTORZI was approved by the FDA in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

LOQTORZI is an anti-PD-1 antibody that we developed in collaboration with Junshi Biosciences.

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on January 2, 2024.

LOQTORZI is a next-generation programmed death receptor-1 (“PD-1”) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.

LOQTORZI is a novel next-generation PD-1 monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.

NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of the skull.

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40% have localized disease that can progress to relapsed/metastatic within a 12-24 month timeframe.

11, 2023 we announced that the 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 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.

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.

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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.

On November 27, 2023, we announced that we established a wholesale acquisition cost for LOQTORZI of $8,892.03 per single-use vial.

UDENYCA Biosimilar

We initiated United States sales of UDENYCA in January 2019, and in 2024 we recorded UDENYCA net product sales of $206.0 million.

UDENYCA is currently approved by the FDA in both PFS and AI presentation, and as we announced on December 26, 2023, the FDA approved the PAS for our third pegfilgrastim presentation, UDENYCA ONBODY.

UDENYCA ONBODY became commercially available in the first quarter of 2024.

PFS products currently account for approximately 56% of the overall pegfilgrastim market, which annually comprises sales of approximately 1.4 million units.

Prior to the launch of UDENYCA ONBODY, approximately 43% of the remaining market was held by Neulasta Onpro®, an on-body presentation of pegfilgrastim owned by Amgen Inc.

and Amgen USA Inc.

(collectively “Amgen”).

UDENYCA ONBODY could potentially expand the UDENYCA market opportunity into a portion of the market held by Neulasta Onpro.

Immunology Franchise Market Opportunity

In 2023, Humira revenue in the United States was approximately $12.2 billion.

In December 2021, the FDA approved YUSIMRY, which we launched in the United States in July 2023.

The list price of YUSIMRY at launch represented an approximately 85% discount to the list price of Humira.

This pricing strategy provides physicians, patients, payers, and employers with access to low-cost, high-quality, safe and effective treatment.

YUSIMRY Solutions™—our patient services platform—facilitates improved access and fast and seamless experience as patients start or switch to YUSIMRY based on a determination by their healthcare provider.

YUSIMRY is now available for sale nationwide through select retail, mail order, and specialty pharmacy channels and was the first biologic offered by Mark Cuban Cost Plus Drug Company, PBC.

For our commercial strategy with YUSIMRY, we believe that payor coverage policies and formularies dictate provider access to both Humira and adalimumab biosimilars and that a combination of factors influence formulary decision making.

With the implementation of the Inflation Reduction Act of 2022 (the “IRA”), in 2025 the Part D benefit will be restructured and liability for all Part D plans will significantly increase.

This change in liability will shift plan costs into Part D plan bids, as opposed to costs being primarily paid through reinsurance, as is the case under the benefit today.

Therefore, Part D plans may re-structure formularies to include products with low WAC prices, creating potential opportunity for YUSIMRY in 2025 to achieve broader payer coverage.

Ophthalmology Franchise – Sold to Sandoz pursuant to the Sale Transaction

On October 3, 2022, we launched CIMERLI commercially in the United States in both 0.3 mg and 0.5 mg dosage forms.

On January 19, 2024, we entered into the Purchase Agreement by and between us and Sandoz.

Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024, we completed the divestiture of our CIMERLI ophthalmology franchise through the sale of our subsidiary, Coherus Ophthalmology LLC, 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.

Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the Purchase Agreement.

UDENYCA is currently approved by the FDA in three presentations:

pre-filled syringe (“PFS”), autoinjector (“AI”) and UDENYCA ONBODY.

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.

Sales and Marketing

Our strategy is to build a leading immuno-oncology franchise funded with cash generated from our diversified portfolio of FDA-approved therapeutics.

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.

Following the FDA approval of LOQTORZI for NPC, the commercial launch commenced in January 2024 with our existing Oncology commercial and medical affairs teams.

There are approximately 2,200 Oncologists that treat 80% of patients in the United States with NPC and 90% of these physicians practice in existing UDENYCA accounts creating significant synergies in our commercial execution.

Oncology commercial team was built to scale and meet the needs of our existing Oncology portfolio, as well as new indications for LOQTORZI that could come in the future, pending FDA approval.

In addition to the field facing teams, Coherus has a team of strategic account managers that support the portfolio of products and work directly with the largest accounts including group purchasing organizations, integrated delivery networks, and large clinic customers.

We have an experienced market access and patient services team that support the portfolio of Coherus’ products.

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 Coherus’ 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.

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.

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”).

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:

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.

After the closing of the UDENYCA Sale, we will maintain an experienced sales force for LOQTORZI.

An experienced set of Sales and Marketing personnel will transfer to Accord.

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.

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.

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.

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.”

Scientific, Clinical and Regulatory

The Company has a depth of scientific, oncology clinical and regulatory expertise in the United States, which has supported the commercialization of LOQTORZI.

The Company expects to further leverage these capabilities as it continues to advance its immuno-oncology franchise.

Manufacturing

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We continue to screen other contract manufacturers to meet our clinical, commercial and regulatory supply requirements on a product-by-product basis.

We have and may be required again to take inventory write-downs and incur other charges and expenses for products that are manufactured in reliance on a forecast that proves to be inaccurate because we do not sell as many units as forecasted.

For example, during the fourth quarter of 2023, we recorded a $47.0 million charge for the write-down of slow moving YUSIMRY inventory and the related partial recognition of certain firm purchase commitments.

For a discussion of risks related to our sources and availability of supplies, please see “Risk Factors—Risks Related to Our Ability to Hire and Retain Highly Qualified Personnel” and “Risk Factors—Risks Related to Manufacturing and Supply Chain.”

While we believe that our biologics platform, knowledge, experience and scientific resources provide us with competitive advantages, we face competition from many different sources.

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.

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.

Production resumed in November 2024.

We have made significant progress in our efforts to diversify our labeling and packaging resources.

An additional final packaging and labeling CMO started production testing and manufacturing saleable product.

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.

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.”

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.

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.

LOQTORZI, following its recent launch, 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 & Company, Inc.

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:

Keytruda® (pembrolizumab) from Merck & Co., Inc.

(“Merck”), Opdivo® (nivolumab) from Bristol-Myers Squibb Company (“BMS”), Tecentriq® (atezolizumab) from Genentech, Inc.

(“Genentech”), Imfinzi® (durvalumab) from AstraZeneca plc (“AstraZeneca”), Bavencio® (avelumab) from EMD Serono Inc.

and Pfizer Inc.

(“Pfizer”), Libtayo® (cemiplimab-rwlc) from Regeneron Pharmaceuticals, Inc.

(“Regeneron”) and Sanofi S.A.

(“Sanofi”), and Jemperli (dostarlimab-gxly) from GlaxoSmithKline plc (“GlaxoSmithKline”).

In addition to LOQTORZI, multiple other competitors are seeking to develop and approve novel anti-PD-1 or PD-L1 antibody drugs in the United States in the coming years, including but not limited to BeiGene, Ltd.

(in collaboration with Novartis International AG (“Novartis”)).

and Pfizer, Libtayo® (cemiplimab-rwlc) from Regeneron Pharmaceuticals, Inc.

(“Regeneron”), Jemperli (dostarlimab-gxly) from GlaxoSmithKline plc (“GlaxoSmithKline”) and TEVIMBRA® (tislelizumab-jsgr) from BeiGene, Ltd.

(in collaboration with Jiangsu Hengrui Pharmaceuticals Co., Ltd.).

As the only immunotherapy approved by the FDA for the treatment of NPC, we believe LOQTORZI addresses a potentially high unmet need.

CHS-114, if approved, faces competition from programs in development specifically targeting CCR8, including those by BMS, Gilead/Jounce, Shionogi, AbbVie, Bayer, LaNova and Immunophage.

UDENYCA faces competition in the United States from Amgen, Viatris Inc.

(“Viatris”), Sandoz, Pfizer and Spectrum Pharmaceuticals, Inc.

(“Spectrum”), and also faces competition from Amneal Pharmaceuticals, Inc.

UDENYCA faces competition in the United States from Amgen, Biocon Biologics Inc.

(“Biocon”), Sandoz International GmbH, Pfizer, Spectrum Pharmaceuticals, Inc.

(“Spectrum”), Amneal Pharmaceuticals, Inc.

(“Amneal”) and Fresenius Medical Care AG & Co.

KGaA (“Fresenius”), each of which has announced the approval of a pegfilgrastim biosimilar and have launched their products for sale in the United States.

YUSIMRY faces competition in the United States from AbbVie (the holder of rights to Humira), Amgen (Amjevita TM (adalimumab-atto)), Sandoz (Hyrimoz TM (adalimumab-adaz)), Samsung Bioepis (Hadlima TM (adalimumab-bwwd)), Pfizer (Abrilada TM (adalimumab-afzb)), Boehringer Ingelheim GmbH (“Boehringer Ingelheim”) (Cyltezo TM (adalimumab-adbm)) as well as Viatris / Biocon (“Biocon”) (Hulio ® (adalimumab-fkjp)), Alvotech Holdings S.A.

and Fresenius, each a company that has disclosed development plans for a Humira biosimilar

As a result of continued expected competition from Humira and a large number of potential adalimumab (Humira) biosimilar competitors, we may not be able to achieve substantial topline sales for YUSIMRY in the United States.

KGaA (“Fresenius”).

Casdozokitug is in development and is the only antagonist antibody in development known to us that is targeting the immune regulatory cytokine IL-27.

CHS-114 is in development and, if approved, faces competition from programs in development specifically targeting CCR8, including those by BMS, Gilead Sciences, Inc.

/ Jounce Therapeutics, Inc., Shionogi Inc., AbbVie Inc.

(“AbbVie”), Bayer AG, F.

Hoffmann-La Roche Ltd, Amgen Inc.

(“Amgen”), LaNova Medicines Ltd.

and Nanjing Immunophage Biotech Co., Ltd.

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.

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Distribution Agreement with Orox Pharmaceuticals B.V.

In December 2012, we entered into a distribution agreement with Orox, for the commercialization of biosimilar versions of our internally developed biosimilars.

Under this agreement, we granted to Orox an exclusive license to commercialize UDENYCA in Latin America, except Brazil and Argentina, and YUSIMRY and CHS-0214 (our etanercept (Enbrel ® ) biosimilar candidate, for which we discontinued development in 2020) in Latin America, except Brazil.

Under this agreement, Orox 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.

We are obligated to manufacture and supply licensed products to Orox.

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’s activities under the agreement in its licensed territory.

We are eligible to receive from Orox a share of gross profits in the low twenty percent range from the sale of licensed products, on a product-by-product basis.

Our agreement with Orox 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.

(“Orox”) / Laboratorio Gador S.A.

In December 2012, we entered into a distribution agreement with Orox / Gador, for the commercialization of biosimilar versions of our internally developed biosimilars.

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.

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.

We are obligated to manufacture and supply licensed products to Orox / Gador.

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.

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.

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.

Either party may terminate the agreement for material breach by the other party that is not cured within a specified time period.

Orox may terminate the Agreement for convenience on a product-by-product basis at any time upon 12-months prior written notice.

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 if Orox challenges the licensed patents or commits a breach of specified provisions of the agreement.

Settlement and License Agreements with AbbVie

In January 2019, we entered into three settlement and license agreements with AbbVie that grant Coherus global, royalty-bearing, non-exclusive license rights under AbbVie’s intellectual property to commercialize YUSIMRY.

The global settlements resolve all pending disputes between the parties related to YUSIMRY.

Under the United States settlement, our license period in the United States commenced on July 1, 2023.

Orox / Gador may terminate the agreement for convenience on a product-by-product basis at any time upon 12-months prior written notice.

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.

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

In October 2019, we entered into a license and settlement agreement with Pfizer relating to Coherus’ patents and applications for patents directed to Humira (adalimumab) formulations.

License Agreement with Bioeq

In November 2019, we entered into the Bioeq Agreement with Bioeq for the commercialization of a biosimilar version of ranibizumab (Lucentis) in certain dosage forms in both a vial and pre-filled syringe presentation (the “Bioeq Licensed Products”).

Under this agreement, Bioeq granted to us an exclusive, royalty-bearing license to commercialize the Bioeq Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States.

Bioeq will supply us the Bioeq Licensed Products in accordance with terms and conditions specified in the agreement and a manufacturing and supply agreement to be executed by the parties in accordance therewith.

Under the Bioeq Agreement, Bioeq must use commercially reasonable efforts to develop and obtain regulatory approval of the Bioeq Licensed Products in the United States in accordance with a development and manufacturing plan, and we must use commercially

reasonable efforts to commercialize the Bioeq Licensed Products in accordance with a commercialization plan.

Bioeq will manufacture and supply the Bioeq Licensed Products to us in accordance with terms and conditions specified in the Bioeq Agreement and a manufacturing and supply agreement between us and Bioeq dated as of September 29, 2022 (the “Bioeq Manufacturing Agreement”).

The Bioeq Manufacturing Agreement will remain in force until the first to occur of the following:

(1) the termination of the Bioeq Agreement;

(2) the exercise of a right to termination by us or Bioeq for a material breach of the other party that is not cured in accordance with the Bioeq Manufacturing Agreement;

and (3) the exercise of a right to termination by Bioeq if invoices are not paid in full in accordance with the Bioeq Manufacturing Agreement.

Additionally, we must commit certain post-launch resources to the commercialization of the Bioeq Licensed Products for a limited time as specified in the Bioeq Agreement.

The development, manufacturing, and commercialization of the Bioeq Licensed Products in the United States is governed by a governance committee as described in more detail in the Bioeq Agreement.

We paid Bioeq an upfront payment of €5.0 million and a milestone payment of €5.0 million in 2019.

In 2022, we paid Bioeq a €2.5 million milestone payment related to the FDA approval of the CIMERLI Section 351(k) BLA.

We share a percentage of gross profits on sales of Bioeq Licensed Products in the United States with Bioeq in the low- to mid-fifty percent range.

The Bioeq Agreement’s initial term continues in effect for ten years after the first commercial sale of a Bioeq Licensed Product in the United States, which occurred on October 3, 2022, and thereafter renews for an unlimited period of time unless otherwise terminated in accordance with its terms.

Either party may terminate the Bioeq Agreement for the other party’s material breach which is not cured within a specified time period or for the other party’s bankruptcy or insolvency-related events.

Bioeq may terminate the Bioeq Agreement in certain limited circumstances for failure to obtain specified minimum market share requirements during certain windows of time, if we conduct certain commercial or advanced pre-commercial activities with respect to certain competitive products, if we challenge the validity or enforceability of the patent rights licensed to us under the Bioeq Agreement, or if we undergo a change of control with a competitor of Bioeq and do not divest certain competitive products in connection therewith.

We may terminate the Bioeq Agreement if Bioeq receives certain adverse regulatory feedback from the FDA for the Bioeq Licensed Products.

The FDA approval of CIMERLI occurred on August 2, 2022, and we commercially launched CIMERLI in the United States on October 3, 2022.

Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024, we completed the divestiture of our CIMERLI ophthalmology franchise through the sale of our subsidiary, Coherus Ophthalmology LLC, 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.

Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the Purchase Agreement.

License Agreement with Bioeq and Genentech

On June 22, 2022, we entered into a license agreement with Genentech, Inc.

(“Genentech”) and our partner Bioeq (the “Genentech Agreement”).

Under the agreement, Genentech granted us and Bioeq a non-exclusive, royalty-bearing, license under certain of its patent rights to commercially launch and sell CIMERLI in the United States which started on the launch date on October 3, 2022.

Pursuant to the terms of the Genentech Agreement, the royalty is a low single-digit percentage of net sales of CIMERLI that must be paid through the end of 2023.

In addition, we obtained the right to make non-binding offers to sell and engage in manufacturing and stockpiling activities during specified time periods prior to the launch date pursuant to the terms of the Genentech Agreement.

The term of the Genentech Agreement will expire when all of the valid claims in the patent rights licensed under the agreement expire.

The agreement may be terminated by either party if a party materially breaches one or more of its material obligations, subject to customary cure period.

If we, Bioeq or either party’s respective affiliates initiate, participate, or assist any other person in bringing or prosecuting any challenge to the validity of any patent rights licensed under the Genentech Agreement, Genentech may terminate the licenses granted under such licensed patent rights or terminate the Genentech Agreement in its entirety, unless we, Bioeq, or the applicable affiliates withdraw all such challenges or stop assisting in any such challenges.

Genentech may also terminate the agreement in the event of our insolvency.

Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024, we completed the divestiture of our CIMERLI ophthalmology franchise through the sale of our subsidiary, Coherus Ophthalmology LLC, 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.

Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the Purchase Agreement.

License Agreement with Junshi Biosciences

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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.

We have the right to conduct all commercial activities of LOQTORZI in the United States and Canada.

We are obligated to pay Junshi Biosciences up to a 20% royalty 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.

In March 2022, we paid $35.0 million for the exercise of our option to license the TIGIT Program (as defined in the Collaboration Agreement).

We obtained the right to conduct all commercial activities of LOQTORZI in the United States and Canada.

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

percent range on net sales of LOQTORZI.

On June 27, 2024, we entered into the Canada License Agreement pursuant to which, we granted to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada.

In March 2022, we paid $35.0 million for the exercise of 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 to Junshi Biosciences pursuant to the Collaboration Agreement.

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.

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.

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The $35.0 million payment for the option to license CHS-006 was reflected in our first quarter of 2022 financial statements.

We recorded research and development expense of $145.0 million during the first quarter of 2021, related to an upfront payment for exclusive rights to LOQTORZI in the United States and Canada.

We had entered into a Right of First Negotiation agreement with Junshi Biosciences and paid a fee of $5.0 million which was expensed as research and development expense in the fourth quarter of 2020.

The Right of First Negotiation fee was fully credited against the total upfront license fee obligation under the Collaboration Agreement.

As of December 31, 2023, we recorded $26.3 million in accrued and other current liabilities, inclusive of the $25.0 million milestone payment to Junshi Biosciences.

Additionally, we recorded $6.3 million in accounts payable related to the co-development, regulatory and technology transfer costs related to these programs, as well as an immaterial royalty obligation.

The additional milestone payments, option fee for the IL-2 cytokine 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.

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.

The accrued royalty obligation to Junshi Biosciences was $1.5 million as of December 31, 2024 and immaterial at December 31, 2023.

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.

Adimab Development and Option Agreement

In October 2018, Surface 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.

In October 2018, Surface Oncology, Inc.

(“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.

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.

The A&R Adimab Agreement, among other things, extended the discovery term of the Original Adimab Agreement, provided access to additional antibodies, and expanded our right to evaluate and use antibodies that were modified or derived using Adimab technology for diagnostic purposes.

Upon our selection of a target, we and Adimab will initiate a research plan and the discovery term begins.

During the discovery term, Adimab will grant us a non-exclusive, non-sublicensable license under its technology with respect to the target, to research, design and preclinically develop and use antibodies that were modified or derived using Adimab technology, solely to evaluate such antibodies, perform our responsibilities under the research plan, and use such antibodies for certain diagnostic purposes.

We also will grant Adimab a non-exclusive, nontransferable license with respect to the target under our technology that covers or relates to such target, solely to perform its responsibilities under the research plan during the discovery period.

We are required to pay Adimab at an agreed upon rate for its full-time employees during the discovery period while Adimab performs research on each target under the applicable research plan.

The A&R Adimab Agreement, among other things, provided access to additional antibodies and expanded our right to evaluate and use antibodies that were modified or derived using Adimab technology for diagnostic purposes.

Adimab granted us an exclusive option to obtain a non-exclusive, worldwide, fully paid-up, sublicensable license under Adimab’s platform patents and other Adimab technology solely to research up to ten antibodies, chosen by us against a specific biological target for a specified period of time (the “Research Option”).

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Under the A&R Adimab Agreement, we are obligated to make milestone payments and to pay specified fees upon the exercise of the Research Option or Commercialization Option.

During the discovery term, we may be obligated to pay Adimab up to $0.3 million for technical milestones achieved against each biological target.

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.

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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.

The A&R Adimab Agreement will remain in effect until (a) the earlier of (i) the expiration of the Research and Commercialization Options (if they expire without exercise) and (ii) 12 months from the effective date without us providing materials that pass Adimab’s quality control;

or (b) if a Research Option is exercised but the Commercialization Option is not, then upon the expiration of the last to expire research license term;

or (c) upon commercialization of a product, until the end of the royalty term, which will vary on a product-by-product and country-by-country basis, ending on the later of (y) the expiration of the last valid claim covering the licensed product in such country as the product is manufactured or sold, or (z) ten years after the first commercial sale of the licensed product in such country.

Either party may terminate the A&R Adimab Agreement for material breach if such breach remains uncured for a specified period of time, however, if a Research Option or Commercialization Option has been exercised and the breach only applies to the applicable target of such Research Option or Commercialization Option, then the termination right will only apply to such target.

We may also terminate the A&R Adimab Agreement for any reason with prior notice to Adimab.

If Adimab is bankrupt, we will be entitled to a complete duplicate of, or complete access to, all rights and licenses granted under or pursuant to the A&R Adimab Agreement.

Novartis Institutes Out-licensing Agreement

In January 2016, Surface entered into the collaboration agreement between Surface and Novartis Institutes dated January 9, 2016 which was subsequently amended in May 2016, July 2017, September 2017, and October 2018 (as amended, the “Novartis Agreement”).

Pursuant to the Novartis Agreement, Surface granted Novartis Institutes a worldwide exclusive license to research, develop, manufacture and commercialize antibodies that target cluster of differentiation 73 (“CD73”).

Under the Novartis Agreement, we are currently entitled to potential development milestones of $325.0 million and sales milestones of $200.0 million, as well as tiered royalties on annual net sales by Novartis Institutes ranging from high single-digit to mid-teens percentages upon the successful commercialization of NZV930.

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 Novartis Agreement.

We did not recognize any revenue relating to the Novartis Agreement from September 8, 2023 through December 31, 2023.

Unless terminated earlier, the Novartis Agreement will continue in effect until neither us nor Novartis Institutes is researching, developing, manufacturing or commercializing NZV930.

Novartis Institutes may terminate the Novartis Agreement for any or no reason upon prior notice to the Company within a specified time period.

Either party may terminate the Novartis Agreement in full if an undisputed material breach is not cured within a certain period of time or upon notice of insolvency of the other party.

To the extent Novartis Institutes terminates for convenience, or we terminate for Novartis Institutes’ uncured material breach, Novartis Institutes will grant us, on mutually agreeable financial terms, an exclusive, worldwide, irrevocable, perpetual and royalty-bearing license with respect to intellectual property controlled by Novartis Institutes that is reasonably necessary to research, develop, manufacture or commercialize NZV930.

GSK Out-licensing Agreement

In December 2020, Surface entered into the GSK Agreement.

Pursuant to the GSK Agreement, Surface granted GSK a worldwide exclusive, sublicensable license to develop, manufacture and commercialize antibodies that target CD112R, also known as PVRIG, including the antibody GSK4381562 (the “Licensed Antibodies”).

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”).

GSK is responsible for the development, manufacturing and commercialization of the Licensed Antibodies and a joint development committee was formed to facilitate information sharing.

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.

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.

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.

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We did not recognize license-related revenue under the GSK Agreement from September 8, 2023 through December 31, 2023.

We have not recognized license-related revenue under the GSK Agreement to date.

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.

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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.

We may terminate the Vaccinex License Agreement for convenience upon the notice period specified in the Vaccinex License Agreement.

Either party may terminate the agreement for an uncured material breach by the other party.

Vaccinex may terminate the Vaccinex License Agreement if we default on any payments owed to Vaccinex under the agreement, if we are in material breach of, and fail to cure, our development obligations, or institute certain actions related to the licensed patents.

In the event of termination, all rights in the licensed intellectual property would revert to Vaccinex.

Term Sheet with Klinge Biopharma

On January 9, 2023, we announced that we entered into a term sheet (the “Term Sheet”) with Klinge Biopharma GmbH (“Klinge Biopharma”) for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States.

We notified Klinge Biopharma that we do not intend to pursue the transaction contemplated by the Term Sheet.

Intellectual Property

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Additionally, our commercial success may depend on our ability to obtain and maintain proprietary protection for our technologies where applicable and to prevent others from infringing our proprietary rights.

We seek to protect our proprietary technologies by, among other methods, filing United States and international patent applications on these technologies, inventions and improvements that are important to our

We also rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary position.

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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.

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.

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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An IND is a request for allowance from the FDA to administer an investigational drug or biologic to humans.

The central focus of an IND submission is on the general investigational plan and the protocol(s) for human studies,

although the IND must also include the results of preclinical testing and animal testing assessing the toxicology, pharmacokinetic, pharmacology and pharmacodynamic characteristics of the product along with other information, including information about product chemistry, manufacturing and controls and a proposed clinical trial protocol.

The central focus of an IND submission is on the general investigational plan and the protocol(s) for human studies, although the IND must also include the results of preclinical testing and animal testing assessing the toxicology, pharmacokinetic, pharmacology and pharmacodynamic characteristics of the product along with other information, including information about product chemistry, manufacturing and controls and a proposed clinical trial protocol.

Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

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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.

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 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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Human clinical trials for novel drugs and biologics are typically conducted in three sequential phases that may overlap or be combined.

● Phase 1—The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and elimination.

● Phase 1—The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, optimal dosage, absorption, metabolism, distribution and elimination.

In the case of some therapeutic candidates for severe or life-threatening diseases, such as cancer, especially when the product candidate may be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

● Phase 2—Clinical trials are performed on a limited patient population intended to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

● Phase 2—Clinical trials are performed on a limited patient population intended to identify possible adverse effects and safety risks and to preliminarily evaluate the efficacy of the product for specific targeted diseases.

● Phase 3—Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites.

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The manufacturing process must be capable of consistently producing quality batches of the product candidate and the manufacturer must develop methods for testing the quality, purity and potency of the product candidate.

To help reduce the risk of the introduction of adventitious agents with use of

biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.

To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.

The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other criteria, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product.

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In addition, the FDA may require post marketing clinical trials, sometimes referred to as “Phase 4” clinical trials, designed to further assess a biological product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

Expedited Development and Review Programs

The FDA has a number of programs intended to expedite the development or review of a marketing application for an investigational drug or biologic.

For example, the fast track designation program is intended to expedite or facilitate the process for developing and reviewing product candidates that meet certain criteria.

Specifically, investigational drugs and biologics are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

The sponsor of a fast track product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, with regard to a fast track product candidate, the FDA may consider for review sections of the NDA or original BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA or original BLA, the FDA agrees to accept sections of the NDA or original BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA or original BLA.

A product candidate can also receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers.

Separately, an NDA or original BLA is eligible for priority review if the product candidate is designed to treat a serious condition, and if approved, would provide a significant improvement in safety or efficacy compared to available therapies.

The FDA will attempt to direct additional resources to the evaluation of a NDA or original BLA designated for priority review in an effort to facilitate the review.

The FDA endeavors to review applications with priority review designations within six months of the filing date as compared to ten months for review of new molecular entity NDAs and original BLAs under its current PDUFA review goals.

In addition, depending on the design of the applicable clinical trials, a product candidate may be eligible for accelerated approval.

Specifically, drugs and biologics intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

As a condition of approval, the FDA generally requires that a sponsor of a drug or biologic receiving accelerated approval perform adequate and well-controlled confirmatory clinical trials, and may require that such confirmatory trials be underway prior to granting accelerated approval.

Drugs or biologics receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required confirmatory trials in a timely manner or if such trials fail to verify the predicted clinical benefit.

In addition, the FDA requires as a condition of accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for approval but may expedite the development or approval process.

Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Orphan drug designation

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States or, if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the cost of developing and making the product available in the United States for this type of disease or condition will be recovered from sales of the product.

Orphan designation must be requested before submitting an NDA or BLA.

After the FDA grants orphan designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.

Orphan designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

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,

such as a showing of clinical superiority to the product with orphan exclusivity 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.

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.

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.

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.

Abbreviated Licensure Pathway of Biological Products as Biosimilar under Section 351(k)

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Pharmaceutical Coverage, Pricing and Reimbursement

In the United States and other countries, sales of UDENYCA, YUSIMRY, 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.

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 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.

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.

Decreases in third-party reimbursement for UDENYCA, YUSIMRY, 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.

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.

Government Price Reporting

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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.

Healthcare Reform, including the IRA

Healthcare Reform, including the Inflation Reduction Act of 2022 (the “IRA”)

The United States federal and state governments continue to propose and pass legislation designed to regulate the healthcare industry, including legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing.

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imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

and replaces the Part D coverage gap discount program with a new manufacturer discounting program (which began in 2025).

The IRA permits the Secretary of the Department of Health and Human Services (“HHS”) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations.

HHS has issued and will continue to issue guidance implementing the IRA, although the Medicare drug price negotiation program is currently subject to legal challenges.

HHS has issued and will continue to issue guidance implementing the IRA.

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.

While the impact of the IRA on our business and the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.

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Human Capital Management

On March 3, 2023, we committed to a plan to reduce our workforce to focus resources on strategic priorities including the commercialization of our diversified product portfolio and development of innovative immuno-oncology product candidates.

We initiated a reduction in force impacting approximately 50 full-time and part-time employees effective March 10, 2023 for most of these employees.

As of December 31, 2023, we had 306 full-time and part-time employees.

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.

The Plan was completed in 2024.

As of December 31, 2024, we had 228 full-time and part-time employees.

All were located in the United States and none of our employees were represented by a labor union.

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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.

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.

None of our executive officers are expected to transfer to Intas.

Compensation and Benefits

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We also offer competitive benefits to our employees, including paid vacation and holidays, family leave, disability insurance, life insurance, healthcare, dental and vision coverage, dependent care flexible spending accounts, a 401(k) plan with a company match, and an Employee Stock Purchase Plan.

Additionally, we offer an Employee Assistance Program (“EAP”) that includes professional support for employees to balance the stress of personal and professional demands.

Additionally, we offer an Employee Assistance Program that includes professional support for employees to balance the stress of personal and professional demands.

Inclusion and Diversity

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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.

We believe that having a truly diverse workplace helps our company to achieve the best results, including by striving for diversity in terms of gender, ethnicity, nationality, disability status, veteran status and other factors.

We launched our Diversity and Inclusion Program to our employees in 2020 and intend to continue implementation of the program in 2024.

As of December 31, 2023, ethnically diverse employees represented approximately 37% of our employees and women composed 49% of our employees.

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.

We donate to non-profit organizations such as Life Science Cares, an organization focused on eliminating the impact of poverty on our neighbors.

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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 require that all employees are fully vaccinated for COVID-19 and recommend they get all booster shots recommended by the United States Centers of Disease Control and Prevention.

We react to emergencies on an ongoing basis to protect our employees.

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

Through our online learning platform, we deliver a variety of required learning modules, including those modules tied to our Code of Business Conduct, unlawful harassment and anti-corruption policies, which are completed periodically by all team members.

We also have Performance Management Training and Interview Training programs for our managers.

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.

We also have Performance Management, Leadership and Interview Training programs for our managers.

We have a highly collaborative, engaging company environment.

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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.

The SEC maintains a website (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC.

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.

Such filings are placed on our website as soon as reasonably possible after they are filed with the SEC.

Our most recent charter for our audit, compensation, and nominating and corporate governance committees and our Code of Business Conduct and Ethics are available on our website as well.

Any waiver of our Code of Business Conduct and Ethics may be made only by our board of directors.

Our most recent charter for our audit, compensation, and nominating and corporate governance committees and our Code of Business Conduct and Ethics are available on our website as well at https://www.coherus.com.

Any waiver of our Code of Business Conduct and Ethics may be made only by our board of directors (“Board”).

Any waiver of our Code of Business Conduct and Ethics for any of our directors or executive officers must be disclosed on a Current Report on Form 8-K within four business days, or such shorter period as may be required under applicable law.

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What changed 10-K

Item 1. Business