GEN-1042

TEPKINLY (epcoritamab) is the first and only subcutaneous bispecific antibody conditionally approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of prior therapy FL is an incurable form of non-Hodgkin's lymphoma (NHL), with about 13,000 estimated cases in Western Europe alone each year1NORTH CHICAGO, Ill., Aug. 19, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland."The European approval of TEPKINLY for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop TEPKINLY as a potential core therapy across multiple B-cell malignancies. First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a hematological cancer treatment," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "Together with our partner, Genmab, we are thrilled with today's approval which advances our commitment to elevating care for people living with cancer."FL is typically a slow-growing form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30% of all cases.2 FL is considered incurable, and there is no standard of care treatment for third-line or later FL.2,3 Patients often relapse and with each relapse, the remission and time to next treatment is shorter.4 Over time, transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.5"The approval of epcoritamab by the European Commission is a promising update for the lymphoma community," said Kate Rogers, CEO of the Follicular Lymphoma Foundation. "Given that relapsed or refractory follicular lymphoma is a very challenging form of cancer to treat, especially in later lines of therapy, it is critical that patients and physicians have additional options when it comes to treating this type of cancer."The conditional marketing authorization is supported by data from Phase 1/2 EPCORE® NHL-1 clinical trial: an open-label, multi-cohort, multicenter, single-arm trial that evaluated TEPKINLY as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy. The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent (70% having double refractory disease), patients who were refractory to last prior treatment (82%), and patients whose disease progressed within two years of initiating any first systemic therapy (52%). The results published in the Lancet Haematology showed that patients treated with TEPKINLY (n=128) had an overall response rate (ORR) of 83% and a complete response (CR) rate of 63%. At a median follow-up of 16.2 months, the median duration of response was 21.4 months (13.7, NR). Duration of complete response (DOCR) was not reached.The study included a planned separate optimization cohort, which evaluated 86 patients with the recommended 3-step-up doses for cytokine release syndrome (CRS) mitigation. Hospitalization was not mandatory in the cycle 1 optimization cohort. With the optimized regimen, 40% of patients experienced Grade 1 CRS and 9% experienced Grade 2 (no Grade 3 or higher CRS were reported). No immune effector cell-associated neurotoxicity syndrome (ICANS) cases were reported in this cohort.The safety profile of epcoritamab in the pivotal cohort was similar to reports of epcoritamab monotherapy in the pivotal EPCORE NHL-1 DLBCL cohort.6 In the pooled safety population (n=382), the most common adverse reactions (≥ 20%) with TEPKINLY were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhea. The most frequent serious adverse reaction (≥ 10%) was CRS (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction [pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient].About the Phase 1/2 EPCORE® NHL-1 TrialEPCORE® NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The optimization part evaluates the potential for alternative step-up dosing regimens to help minimize overall rates and severity of cytokine release syndrome (CRS). The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.More information can be found on www.clinicaltrials.gov (NCT03625037).About EpcoritamabEpcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.Epcoritamab (approved under the brand name EPKINLY® in the United States and TEPKINLY® in the European Union) has received regulatory approval in certain lymphoma indications in several countries.Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the R/R FL indication and the R/R DLBCL indication.AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets. Both Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy and in combination across lines of therapy in a range of hematologic malignancies. Please visit clinicaltrials.gov for more information.EU Indications and Important Safety Information about Tepkinly®▼(epcoritamab)IndicationsTepkinly (epcoritamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Important Safety InformationContraindicationsHypersensitivity to the active substance or to any of the excipients.Special warnings and precautions for useCytokine release syndrome (CRS)CRS, which may be life-threatening or fatal, occurred in patients receiving Tepkinly. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea.Most CRS events occurred in Cycle 1 and were associated with the first full dose of Tepkinly. Administer prophylactic corticosteroids to mitigate the risk of CRS. Patients should be monitored for signs and symptoms of CRS following Tepkinly administration.  At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as appropriate. Patients should be counselled on the signs and symptoms associated with CRS and patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of Tepkinly based on the severity of CRS. Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of CRS.Immune effector cell-associated neurotoxicity syndrome (ICANS)ICANS, including a fatal event, have occurred in patients receiving Tepkinly. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema. The majority of cases of ICANS occurred within Cycle 1 of Tepkinly treatment, however some occurred with delayed onset. Patients should be monitored for signs and symptoms of ICANS following Tepkinly administration. At the first signs or symptoms of ICANS treatment with corticosteroids and non-sedating-anti-seizure medicinal products should be instituted as appropriate. Patients should be counselled on the signs and symptoms of ICANS and that the onset of events may be delayed. Patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Tepkinly should be delayed or discontinued as recommended. Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of ICANS. Serious infectionsTreatment with Tepkinly may lead to an increased risk of infections. Serious or fatal infections were observed in patients treated with Tepkinly in clinical studies. Administration of Tepkinly should be avoided in patients with clinically significant active systemic infections. As appropriate, prophylactic antimicrobials should be administered prior to and during treatment with Tepkinly. Patients should be monitored for signs and symptoms of infection, before and after Tepkinly administration, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.Tumour Lysis Syndrome (TLS)TLS has been reported in patients receiving Tepkinly. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.Tumour flareTumour flare has been reported in patients treated with Tepkinly. Manifestations could include localized pain and swelling.  Consistent with the mechanism of action of Tepkinly, tumour flare is likely due to the influx of T-cells into tumour sites following Tepkinly administration.  There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ. Patients treated with Tepkinly should be monitored and evaluated for tumour flare at critical anatomical sites.CD20-negative diseaseThere are limited data available on patients with CD20-negative DLBCL and patients with CD20-negative FL treated with Tepkinly, and it is possible that patients with CD20-negative DLBCL and CD20-negative FL may have less benefit compared to patients with CD20-positive DLBCL and patients with CD20-postitive FL, respectively. The potential risks and benefits associated with treatment of patients with CD20-negative DLBCL and FL with Tepkinly should be considered.ImmunisationLive and/or live-attenuated vaccines should not be given during Tepkinly therapy. Studies have not been conducted in patients who received live vaccines.Fertility, pregnancy and lactationTepkinly is not recommended during pregnancy and in women of childbearing potential not using contraception. Effects on ability to drive and use machinesTepkinly has minor influence on the ability to drive and use machines. Due to the potential for ICANS, patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.Undesirable effectsSummary of the safety profileThe safety of Tepkinly was evaluated in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), FL (N=129) and FL (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of TEPKINLY. The most common adverse reactions (≥ 20%) were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhoea.Serious adverse reactions occurred in 50% of patients. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction (pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient). Adverse reactions that led to discontinuation occurred in 6.8% of patients. Discontinuation of Tepkinly due to pneumonia occurred in 14 (3.7%) patients, viral infection in 8 (2.1%) patients, fatigue in 2 (0.5%) patients, and CRS, ICANS, or diarrhoea, in 1 (0.3%) patient each.Dose delays due to adverse reactions occurred in 42% of patients. Adverse reactions leading to dose delays (≥ 3%) were viral infections (17%), CRS (11%), neutropenia (5.2%), pneumonia (4.7%), upper respiratory tract infection (4.2%), and pyrexia (3.7%).This is not a complete summary of all safety information.See Tepkinly® full Summary of Product Characteristics (SmPC) at www.ema.europa.euGlobally, prescribing information varies; refer to the individual country product label for complete information.About AbbVie in OncologyAt AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities including Antibody Drug Conjugates (ADCs), Immuno-Oncology, and bi-specific and CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at http://www.abbvie.com/oncology.About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.AbbVie Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63 2 Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed February 2024. 3 Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421. 4 Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708. 5 Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. 6 Linton Kim, Vitolo Umberto, Jurczak Wojciech, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024. https://doi.org/10.1016/ S2352-3026(24)00166-2. SOURCE AbbVieFor further information: Contacts: Global Media: Anisha Manix, Email: anisha.manix@abbvie.com; US Media: Ilke Limoncu, Email: ilke.limoncu@abbvie.com; Investors: Todd Bosse, Email: todd.bosse@abbvie.comThe information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on AbbVie's website for historical purposes only. AbbVie assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.For more informationContact us »Subscribe for email alertsSign upSubscription managementAbbVie social media twitter facebook linkedin Instagram youtubeWe also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. Before engaging, please read and adhere to our established community guidelines for each channel.View our social media channel guidelines »AbbVie.com | Site Map | Terms of Use | Privacy Notice | Consumer Health Data Privacy Notice | Cookie Settings | Your Privacy ChoicesCopyright © 2024 AbbVie Inc. North Chicago, Illinois, U.S.A.Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. 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– Net revenue of $65.0 million in Q2 2024 – – CHS-114 Phase 1 Study Recruitment Continues into Expansion Cohorts in Head and Neck Cancer in Combination with LOQTORZI – – Bryan McMichael Appointed as Chief Financial Officer – – Conference call today at 5:00 p.m. Eastern Time – REDWOOD CITY, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended June 30, 2024 and recent business highlights: RECENT BUSINESS HIGHLIGHTS UDENYCA® RESULTS UDENYCA net product sales were $50.9 million in Q2 2024, an increase of 19% compared to $42.7 million in Q1 2024 and a 60% increase compared to $31.7 million in Q2 2023. Total unit demand increased 25% in Q2 2024 compared to Q1 2024, and 138% compared to Q2 2023.Based on data from IQVIA, UDENYCA franchise market share for Q2 2024 was 29.0%, an increase of 4 market share points from Q1 2024. LOQTORZI® LAUNCH UPDATE LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), commercially launched on January 2, 2024.LOQTORZI net sales in Q2 2024 of $3.8 million, with new patient uptake primarily in relapsed locally advanced and 1L metastatic disease, a potential driver of long-term revenue growth.LOQTORZI can now be ordered in all 33 National Comprehensive Cancer Network (NCCN) institutions.The Centers for Medicare and Medicaid Services granted LOQTORZI a product-specific, permanent J Code, which was implemented on July 1, 2024. ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE Clinical data from the dose escalation stage of the Phase 1 study of CHS-114, a highly selective cytolytic anti-CCR8 antibody, was presented at the 2024 ASCO Annual Meeting in June. These data showed selective depletion of peripheral CCR8+ regulatory T cells, establishing proof of mechanism for CHS-114, and an acceptable safety profile with no dose-limiting toxicities, and a disease control rate of 47% in heavily pretreated patients with solid tumors. Expansion cohorts evaluating CHS-114 as monotherapy and in combination with toripalimab are currently enrolling patients with advanced/metastatic head and neck squamous cell carcinoma (HNSCC).A Phase 2 study evaluating casdozokitug, an immune regulatory IL-27 antagonizing antibody, in combination with toripalimab and bevacizumab in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma is expected to begin enrolling patients in Q4 2024.An Investigational New Drug (IND) application for CHS-1000, a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2), was filed with the U.S. Food and Drug Administration (FDA) in Q2 2024 and received clearance. Coherus plans to initiate a Phase 1 study in the coming months. “The first half of 2024 has been a period of disciplined execution of our strategy, which included improving our capital structure, advancing our innovative oncology pipeline and driving increasing sales of our commercial portfolio. We continue to streamline our operations, solidifying our focus on our oncology business,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. “Bryan McMichael, our newly appointed Chief Financial Officer, will play a key role on our management team as we further translate this oncology focus into shareholder value.” “I am honored to carry forward my work at Coherus in the role of Chief Financial Officer. The strength of the team, commercial portfolio, and pipeline gives me great confidence in the Company’s future,” said Bryan McMichael, Coherus’ Chief Financial Officer. “I look forward to continuing in my partnership with Denny, the Board, and other members of management to execute our strategy and bring value to shareholders.” SECOND QUARTER 2024 FINANCIAL RESULTS Net revenue was $65.0 million during the three months ended June 30, 2024, and included $50.9 million of net sales of UDENYCA, $3.8 million of net sales of LOQTORZI, which was launched on January 2, 2024, $3.8 million of net sales of YUSIMRY, which was divested to Hong Kong King-Friend Industrial Company Ltd. (“HKF”) on June 26, 2024, and other revenue of $6.5 million which included the $6.3 million up-front cash payment received for the outlicense to Apotex, Inc. of the Canadian rights to LOQTORZI on June 27, 2024. Net revenue was $58.7 million during the three months ended June 30, 2023 and included $26.7 million in revenues for CIMERLI, which was divested on March 1, 2024. Net revenue was $142.0 million and $91.2 million for the six months ended June 30, 2024 and 2023, respectively. Total net revenues attributable to the Company’s divested products, CIMERLI and YUSIMRY, during the first half of 2024 and 2023 were $35.9 million and $32.9 million, respectively. Cost of goods sold (COGS) was $28.4 million and $24.8 million during the three months ended June 30, 2024 and 2023, respectively, and $63.0 million and $41.7 million during the six months ended June 30, 2024 and 2023, respectively. UDENYCA COGS included a mid-single digit royalty on net sales which expired on July 1, 2024. The increases in COGS in both 2024 periods were primarily driven by increased unit volumes, and in the second quarter of 2024, a $4.5 million fee for a contract change with a CMO, partially offset by a $9.7 million decrease in royalty costs in the second quarter of 2024, due to the CIMERLI divestiture on March 1, 2024. Research and development (R&D) expenses were $22.0 million and $23.3 million for the three months ended June 30, 2024 and 2023, respectively, and $50.4 million and $57.4 million for the six months ended June 30, 2024 and 2023, respectively. The decreases were primarily due to savings from reduced headcount and lower costs related to biosimilar products, partially offset by increased costs for development of casdozokitug and CHS-114. Selling, general and administrative (SG&A) expenses were $35.2 million and $45.1 million during the three months ended June 30, 2024 and 2023, respectively, and $91.7 million and $94.3 million during the six months ended June 30, 2024 and 2023, respectively. The declines in SG&A compared to the prior year periods were driven primarily by lower headcount. The decrease for the six-month period was partially offset by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, obtained in the Surface Oncology, Inc. acquisition. Gain on Sale Transactions, Net which included the divestiture of the YUSIMRY franchise, which closed during the three months ended June 30, 2024, was $22.9 million, and reflects total cash proceeds of $40.0 million, net of assets transferred to HKF, liabilities derecognized, and transactions costs of $0.9 million. Gain on Sale Transactions, net for the first half of 2024 was $177.7 million and included a $154.8 million gain on the divestiture of the CIMERLI franchise, which closed during the three months ended March 31, 2024. There was no gain on Sale Transactions in the first half of 2023. Interest expense was $5.3 million and $9.9 million during the three months ended June 30, 2024 and 2023, respectively, and $16.5 million and $19.7 million during the six months ended June 30, 2024 and 2023, respectively. The declines in both periods were primarily due to prepaying $175.0 million of the principal amount of the senior secured term loan facility that was entered into on January 5, 2022 on April 1, 2024 and prepaying the remaining $75.0 million principal amount on May 8, 2024. This was offset by interest on the $38.7 million principal amount of the new term loan facility and the revenue participation right purchase and sale agreement, both commencing May 8, 2024, as well as an average higher variable rate in the first half of 2024 compared to the first half of 2023. Net loss for the second quarter of 2024 was $12.9 million, or $(0.11) per share on a diluted basis, compared to a net loss of $42.9 million, or $(0.49) per share on a diluted basis for the same period in 2023. Net income for the first half of 2024 was $90.0 million, or $0.73 per share on a diluted basis, compared to a net loss of $118.6 million, or $(1.42) per share on a diluted basis for the first half of 2023. Non-GAAP net loss for the second quarter of 2024 was $16.4 million, or $(0.14) per share on a diluted basis, compared to $32.8 million, or $(0.38) per share for the same period in 2023. Non-GAAP net loss for the first half of 2024 was $52.2 million, or $(0.46) per share on a diluted basis, compared to $92.3 million, or $(1.11) per share for the first half of 2023. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures. Cash, cash equivalents and investments in marketable securities were $159.2 million as of June 30, 2024, compared to $117.7 million as of December 31, 2023. 2024 R&D and SG&A Expense Guidance Coherus projects combined R&D and SG&A expenses for 2024 to be in the range of $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of acquisitions, collaborations, investments, divestitures including expenses incurred on behalf of and reimbursed by Sandoz and HKF to satisfy Coherus’ obligations under the transition services agreements with those entities, restructuring, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below. Conference Call Information When: Thursday, August 8, 2024, starting at 5:00 p.m. Eastern Daylight Time To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI9dd3f986eeb7428485a66ce1fb34999fPlease dial in 15 minutes early to ensure a timely connection to the call. Webcast: https://edge.media-server.com/mmc/p/kguryzuk An archived webcast will be available on the “Investors” section of the Coherus website at https://investors.coherus.com/events-presentations. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1 study as a monotherapy in patients with advanced solid tumors. CHS-1000 is a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2). An IND application has been accepted by the FDA and Coherus plans to initiate a Phase 1 study in the coming months. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®. Neulasta® is a registered trademark of Amgen Inc. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ expectations about identifying synergies between its I-O pipeline and its commercial operations; Coherus’ expected timing for the start of a Phase 1 study for CHS-1000; Coherus’ expected timing for enrolling patients in a Phase 2 study evaluating casdozokitug; Coherus’ future projections for R&D and SG&A expenses; and Coherus’ expectations about long term revenue growth. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ products and product candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ quarterly filing on Form 10-Q for the fiscal quarter ended June 30, 2024 filed with the Securities and Exchange Commission on or about the date of this press release, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission. Coherus’ results for the fiscal quarter ended June 30, 2024 are not necessarily indicative of its operating results for any future periods. UDENYCA®, UDENYCA® ONBODY™, and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information:For Investors:Jami TaylorHead of Investor RelationsIR@coherus.com For Media:Jodi SieversVP, Corporate Communicationsmedia@coherus.com Coherus BioSciences, Inc.Condensed Consolidated Statements of Operations(in thousands, except share and per share data)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023Net revenue$64,979 $58,716 $142,042 $91,152 Costs and expenses: Cost of goods sold 28,368 24,848 62,954 41,722 Research and development 21,955 23,267 50,425 57,421 Selling, general and administrative 35,165 45,144 91,697 94,297 Total costs and expenses 85,488 93,259 205,076 193,440 Loss from operations (20,509) (34,543) (63,034) (102,288)Interest expense (5,334) (9,943) (16,450) (19,655)Gain on Sale Transactions, net 24,085 — 177,732 — Loss on debt extinguishment (12,630) — (12,630) — Other income (expense), net 1,467 1,617 4,336 3,345 Income (loss) before income taxes (12,921) (42,869) 89,954 (118,598)Income tax provision — — — — Net income (loss)$(12,921) $(42,869) $89,954 $(118,598) Net income (loss) per share: Basic$(0.11) $(0.49) $0.79 $(1.42)Diluted$(0.11) $(0.49) $0.73 $(1.42) Weighted-average number of shares used in computing net income (loss) per share: Basic 114,819,965 87,269,614 113,784,636 83,469,247 Diluted 114,819,965 87,269,614 126,174,802 83,469,247 Coherus BioSciences, Inc.Condensed Consolidated Balance Sheets(in thousands)(unaudited) June 30, December 31, 2024 2023Assets Cash and cash equivalents$159,240 $102,891 Investments in marketable securities — 14,857 Trade receivables, net 175,251 260,522 TSA receivables, net 138,317 — Inventory 112,041 130,100 Intangible assets, net 55,455 71,673 Other assets 34,551 49,561 Total assets$674,855 $629,604 Liabilities and Stockholders’ Deficit Accrued rebates, fees and reserve$177,455 $169,645 TSA payables and other accrued liabilities 133,536 — Term loans 36,541 246,481 Convertible notes 227,555 226,888 Other liabilities 183,876 180,015 Total stockholders' deficit (84,108) (193,425)Total liabilities and stockholders’ deficit$674,855 $629,604 Coherus BioSciences, Inc.Condensed Consolidated Statements of Cash Flows(in thousands)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023Cash, cash equivalents and restricted cash at beginning of the period$260,227 $16,585 $103,343 $63,987 Net cash provided by (used in) operating activities 59,734 (38,915) 12,968 (107,647) Proceeds from maturities of investments in marketable securities — 47,250 6,200 64,750 Proceeds from sale of investments in marketable securities — 13,282 8,688 13,282 Cash received from CIMERLI sale — — 187,823 — Cash received from YUSIMRY sale 40,000 — 40,000 — Milestone based license fee payment to Junshi Biosciences (12,500) — (12,500) — Purchases of investments in marketable securities — (19,507) — (19,507)Other investing activities, net 156 340 208 366 Net cash provided by investing activities 27,656 41,365 230,419 58,891 Proceeds from 2029 Term Loan, net of debt discount & issuance costs 37,120 — 37,120 — Proceeds from Revenue Purchase and Sale Agreement, net of issuance costs 36,495 — 36,495 — Proceeds from issuance of common stock under ATM Offering, net of issuance costs (52) (74) 1,455 6,761 Proceeds from issuance of common stock under Public Offering, net of issuance costs — 53,625 — 53,625 Proceeds from issuance of common stock upon exercise of stock options — 14 291 117 Proceeds from purchase under the employee stock purchase plan 685 1,337 685 1,337 Repayment of 2027 Term Loans, premiums and fees (260,387) — (260,387) — Taxes paid related to net share settlement (1,711) (305) (2,456) (3,086)Other financing activities (75) (272) (241) (625)Net cash (used in) provided by financing activities (187,925) 54,325 (187,038) 58,129 Net increase (decrease) in cash, cash equivalents and restricted cash (100,535) 56,775 56,349 9,373 Cash, cash equivalents and restricted cash at end of the period$159,692 $73,360 $159,692 $73,360 Reconciliation of cash, cash equivalents, and restricted cash Cash and cash equivalents$159,240 $72,920 $159,240 $72,920 Restricted cash balance 452 440 452 440 Cash, cash equivalents and restricted cash$159,692 $73,360 $159,692 $73,360 Non-GAAP Financial Measures To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net loss, and the related per share measures, which exclude from net income (loss), and the related per share measures, stock-based compensation expense, certain acquisition-related expenses, amortization of intangible assets, gain on divestiture, impairments of intangible assets, contingent consideration, loss on debt extinguishment and restructuring charges related to our reduction in workforce. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business. Coherus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. Coherus BioSciences, Inc.Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss(in thousands, except share and per share data)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023GAAP net income (loss)$(12,921) $(42,869) $89,954 $(118,598)Adjustments: Stock-based compensation expense(1) 7,231 10,077 14,550 21,410 Gain on Sale Transactions, net (24,085) — (177,732) — Loss on debt extinguishment 12,630 — 12,630 — Impairment of out-license asset and remeasurement of CVR liability, net — — 6,772 — Restructuring charges related to reduction in workforce(1) — — — 4,876 Amortization of intangible assets 704 — 1,634 — Non-GAAP net loss$(16,441) $(32,792) $(52,192) $(92,312) GAAP Net income (loss) per share, basic$(0.11) $(0.49) $0.79 $(1.42)Net income (loss) per share, diluted$(0.11) $(0.49) $0.73 $(1.42)Shares used in computing basic net income (loss) per share 114,819,965 87,269,614 113,784,636 83,469,247 Shares used in computing diluted net income (loss) per share 114,819,965 87,269,614 126,174,802 83,469,247 Non-GAAP Net loss per share, basic and diluted$(0.14) $(0.38) $(0.46) $(1.11)Shares used in computing basic and diluted net loss per share 114,819,965 87,269,614 113,784,636 83,469,247 (1) In the six months ended June 30, 2023, stock-based compensation of $1.0 million was classified within Restructuring charges related to reduction in workforce.