Core Insights - Coherus BioSciences, Inc. will be webcasting its participation in several upcoming conferences, providing access to presentations via its Investor Events section on the company website [1][2] - The company is a fully integrated commercial-stage innovative oncology firm with an approved PD-1 inhibitor, LOQTORZI®, and a promising pipeline of mid-stage clinical candidates targeting various cancers [4] - Coherus' immuno-oncology pipeline includes multiple antibody immunotherapy candidates aimed at enhancing immune responses against tumors, with ongoing studies for novel treatments [5] Company Overview - Coherus is focused on growing sales of LOQTORZI in nasopharyngeal carcinoma and advancing new indications in combination with pipeline candidates and partners [4] - The company has a robust immuno-oncology pipeline, including Casdozokitug, an IL-27 antagonistic antibody, and CHS-114, a selective anti-CCR8 antibody, both in various stages of clinical trials [5] Upcoming Events - Coherus will participate in the Citizens Life Science Conference on May 8, 2025, at 9:00 a.m. EDT [6] - The company will also present at the HCW BioConnect @ Nasdaq NYC 2025 on May 20, 2025, at 12:00 p.m. EDT [6] - Additional participation includes the TD Cowen 6th Annual Oncology Innovation Summit on May 27, 2025, and the Jefferies Global Healthcare Conference on June 4, 2025 [6]

– CHS-114 demonstrates clinical efficacy and proof of mechanism in HNSCC in combination with toripalimab – – Confirmed partial response in heavily pretreated PD-1 refractory patient supports expansion in HNSCC and gastric cancer in combination with toripalimab – – A second-line Phase 1 dose optimization study in HNSCC and gastric cancer is ongoing; results expected in the first half of 2026– – Coherus to host investor and analyst call with study investigator, Dr. Douglas Adkins, Washington University, today ...

Coherus BioSciences (NASDAQ: CHRS ) has shed its marketed biosimilar drugs, now only markets the branded drug Loqtorzi (toripalimab), and is focusing on development of its clinical pipeline. When I last covered the name in May 2024, I rated CHRS aScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Di ...

Core Insights - Coherus BioSciences has completed the divestiture of its UDENYCA franchise to Intas Pharmaceuticals for a deal valued at up to $558.4 million, receiving an upfront payment of $483.4 million [1][3] - The company now has a post-close cash balance of $250 million, extending its cash runway into 2027, which will support the development of its oncology pipeline [1][2] - Coherus is focusing on its innovative oncology programs, particularly the growth of LOQTORZI revenues and advancing its immuno-oncology candidates [2][5] Transaction Details - The transaction closed on April 11, 2025, with Coherus receiving $483.4 million upfront, including $118.4 million for UDENYCA inventory, and potential milestone payments of up to $75 million based on net sales [1][3] - Intas received assets related to the UDENYCA franchise, including pre-filled syringes and autoinjectors, and assumed certain liabilities [3] Company Overview - Coherus is a commercial-stage innovative oncology company with an approved PD-1 inhibitor, LOQTORZI, and a promising pipeline targeting various cancers [5] - The company aims to grow LOQTORZI sales in nasopharyngeal carcinoma and develop new indications in combination with its pipeline candidates [5] Pipeline Information - Coherus' immuno-oncology pipeline includes multiple antibody candidates, such as Casdozokitug, an IL-27 antagonist, and CHS-114, a selective anti-CCR8 antibody, currently in various clinical studies [6][9]

– Remaining $60 Million of outstanding convertible notes to be repurchased post-close of pending UDENYCA divestiture – REDWOOD CITY, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company, NASDAQ:CHRS) announced today that it has entered into privately negotiated transactions (the "Repurchases") with certain holders (the "Holders") of its 1.500% Convertible Senior Subordinated Notes due 2026 (the "Convertible Notes"), pursuant to which the Company agreed to repurcha ...

Core Insights - Coherus BioSciences announced interim data from its Phase 1 clinical trial of CHS-114, a selective anti-CCR8 antibody, which will be presented at the 2025 AACR Annual Meeting [1][2] - The trial evaluates CHS-114 both as a monotherapy and in combination with toripalimab for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] Company Overview - Coherus BioSciences is a commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI, and a growing revenue stream [4] - The company is focused on expanding the use of LOQTORZI in nasopharyngeal carcinoma and developing new indications in combination with its pipeline candidates [4] Clinical Trial Details - The Phase 1 study (NCT05635643) is designed to optimize the dosing of CHS-114 and assess its safety in advanced solid tumors, including HNSCC [2][3] - The study includes multiple cohorts, with Cohort 1a enrolling 20 patients and evaluating various doses of CHS-114, while Cohort 1b focuses on HNSCC patients with paired tumor biopsies [2] Product Information - CHS-114 is an afucosylated, cytolytic CCR8 monoclonal antibody that targets CCR8+ Tregs in the tumor microenvironment, aiming to enhance the immune response against tumors [3] - Preclinical studies have shown that CHS-114 can reduce tumor growth and improve antitumor activity when combined with anti-PD-1 treatment [3] Pipeline and Future Directions - Coherus has a robust immuno-oncology pipeline, including candidates like casdozokitug, which is being evaluated in multiple clinical studies [5] - The company is also planning to divest its UDENYCA franchise, with the transaction expected to close in early to mid-2025 [6]

Sales and Revenue - UDENYCA Sale to Intas for $483.4 million, including $118.4 million in product inventory, with potential earnout payments of $75 million based on sales thresholds [491] - Total net revenues for the company were $267.0 million in 2024, compared to $257.2 million in 2023, reflecting a growth of approximately 3.1% [519] - Total net revenue for 2024 was $266.96 million, an increase of $9.72 million compared to $257.24 million in 2023 [534] - UDENYCA net revenue increased by $78.89 million to $205.95 million, primarily due to increased market share from the launch of UDENYCA ONBODY [535] - CIMERLI revenue decreased by $98.31 million to $27.08 million due to its divestiture in March 2024 [534] - The company anticipates an increase in LOQTORZI's net product revenue in 2025 compared to 2024 [536] - The company reported a net income of $28.51 million in 2024, a significant recovery from a net loss of $237.89 million in 2023 [607] - Basic and diluted net income per share improved to $0.25 in 2024, compared to a loss of $2.53 per share in 2023 [604] - Comprehensive income for 2024 was $28.48 million, compared to a comprehensive loss of $237.89 million in 2023 [607] Clinical Developments - LOQTORZI approved by the FDA for first-line treatment of metastatic NPC, launched in the U.S. on January 2, 2024 [492] - Casdozokitug, targeting IL-27, is in three ongoing clinical studies, including a Phase 1/2 study in advanced solid tumors [493] - CHS-114, targeting CCR8, is enrolling patients in a clinical trial and plans to initiate additional studies in 2025 [494] - LOQTORZI is being evaluated in multiple clinical studies in collaboration with partners, including Junshi Biosciences [507] - The company plans to initiate a Phase 1b clinical study of CHS-114 in combination with toripalimab in advanced solid tumors in Q1 2025 [619] Financial Performance - Research and development expenses totaled $93.3 million in 2024, down from $109.4 million in 2023, indicating a reduction of approximately 14.7% [525] - Selling, general and administrative expenses decreased by $24.28 million to $167.74 million, primarily due to lower headcount and operating costs [541] - Interest expense decreased by $13.38 million to $27.16 million, mainly due to the payoff of $250 million in senior secured term loans [543] - Total costs and expenses decreased to $378.63 million in 2024 from $460.44 million in 2023, representing a 17.8% reduction [604] - The company achieved a gain on sale transactions of $176.59 million in 2024, which was not present in 2023 [604] Asset Management - Cash used in operating activities was $20.4 million in 2024, a significant improvement compared to $174.9 million in 2023 [566][568] - Cash provided by investing activities in 2024 was $230.3 million, mainly from the CIMERLI Sale ($187.8 million) and YUSIMRY Sale ($40.0 million) [569] - The company’s cash, cash equivalents, and restricted cash at the end of 2024 totaled $126.3 million, up from $103.3 million at the end of 2023 [626] - The company recorded interest income of $4.5 million, $2.8 million, and $1.9 million for the years 2024, 2023, and 2022, respectively [630] Liabilities and Obligations - Total financial liabilities decreased to $293.67 million in 2024 from $473.37 million in 2023, primarily due to the repayment of the 2027 Term Loans [551] - The company has an obligation to pay up to $380.0 million in milestone payments to Junshi Biosciences for LOQTORZI, of which $25.0 million has already been paid [516] - The company has contingent milestone obligations totaling $355.0 million related to LOQTORZI, with no other milestones accrued as of December 31, 2024 [559] - Non-cancelable purchase commitments as of December 31, 2024, were $86.5 million, primarily expected to transfer to the Intas Parties upon closing of the UDENYCA Sale [564] Inventory and Production - UDENYCA experienced a temporary supply interruption due to production delays, with resumed production in November 2024 [503] - Inventory write-downs amounted to $14.1 million in 2024, $52.6 million in 2023, and $26.0 million in 2022, primarily due to slow-moving inventory and competitive pressures [639] - The company capitalized inventory costs associated with UDENYCA, CIMERLI, and LOQTORZI after receiving regulatory approvals in November 2018, August 2022, and October 2023, respectively [641] Regulatory and Compliance - NCCN updated guidelines to include LOQTORZI as the only preferred category 1 first-line treatment for NPC [506] - The company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit [675] - The company has entered into license agreements that may be recorded as asset acquisitions if they do not meet the definition of a business [671] Market and Sales Dynamics - Total sales deductions to gross product sales were 83% in 2024, 77% in 2023, and 73% in 2022 [578] - A 10% change in total provisions for product sales discounts and allowances as of December 31, 2024, would have resulted in a change of approximately $27.6 million in pre-tax earnings [578] - The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer [657] - Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration such as chargebacks, rebates, and discounts [655]

Financial Data and Key Metrics Changes - Coherus reported Q4 2024 net product sales for UDENYCA at $46.3 million, a 28% increase from $36.2 million in Q4 2023. For the fiscal year 2024, UDENYCA net sales were $206 million, a 62% increase from $127.1 million in 2023 [24][10]. - LOQTORZI net revenue was $7.5 million in Q4, a 29% increase quarter-over-quarter, with fiscal year 2024 revenue at $19.1 million [28][10]. - Cost of goods sold (COGS) decreased from $159 million in 2023 to $118 million in 2024, primarily due to lower COGS from divested products and reduced inventory write-offs [53][54]. - Total GAAP R&D and SG&A expenses for 2024 were $261 million, reflecting decreases in both categories compared to 2023 [54][55]. Business Line Data and Key Metrics Changes - UDENYCA's market share in Q4 was 15%, with an exit share of 22%, and the company expects continued market share growth in 2025 [26][10]. - LOQTORZI's eligible patient population is approximately 2,000 annually, with a focus on relapsed locally advanced and first-time metastatic patients [29][10]. - The number of new accounts purchasing LOQTORZI grew by 37% in Q4, indicating strong market penetration [31][10]. Market Data and Key Metrics Changes - The company anticipates that LOQTORZI will achieve a dominant market share position in the MPC market, estimated to be valued at $150 million to $200 million [37][10]. - The NCCN updated guidelines in November 2024 placed LOQTORZI in a preferred position for metastatic and locally recurrent MPC patients, which is expected to drive increased usage [34][10]. Company Strategy and Development Direction - Coherus aims to maximize revenues with LOQTORZI, expand its indications, and advance its proprietary pipeline [8][10]. - The company has successfully addressed its balance sheet debt issue and expects to have $250 million in cash post-transaction close, which will support development efforts through key data milestones in 2025 and 2026 [10][12]. - The divestiture of the UDENYCA franchise is a significant strategic change, with expectations to complete the transaction in late Q1 or early Q2 2025 [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the divestiture of UDENYCA, stating that there are no anticipated obstacles to its completion [64][10]. - The company is focused on enhancing investor appreciation of its value proposition post-transaction, particularly with a strong balance sheet and promising data on the horizon [12][10]. Other Important Information - The company has divested at least $800 million in assets or commitments, paying off $480 million in debt, and expects to maintain a strong financial position moving forward [17][10]. - The FDA authorization for selling final packaged products from a new contract manufacturer is the primary remaining condition for the UDENYCA divestiture [13][10]. Q&A Session Summary Question: Are there any hurdles expected with the UDENYCA divestiture? - Management sees no obstacles and believes the divestiture will proceed as planned, with all necessary reviews completed [64][10]. Question: Does the $250 million cash projection include cost savings from headcount reduction? - The $250 million projection is based on cash after the transaction, with a headcount reduction expected to decrease from 225 to 155 employees [67][70]. Question: Where is LOQTORZI currently being used? - LOQTORZI is being used in a mix of recurrent locally advanced and metastatic first-line patients, with expectations for increased usage due to updated guidelines [77][10]. Question: What is the FDA looking for regarding the second supplier's labeling and packaging? - The FDA requires validation runs and data review from the new contract manufacturer, which has been completed [82][10]. Question: What are the expectations for the CCR8-tori combo data? - The company anticipates robust data on immune cell ratios and T-reg depletion, which are critical for efficacy [122][10]. Question: How much off-label use of other PD-1s exists in the MPC market? - There is ongoing off-label use, particularly in community settings, and the company is actively working to increase awareness of LOQTORZI [131][10].

Financial Performance - Coherus BioSciences, Inc. will present preliminary unaudited net revenues for Q4 2024 and the fiscal year ended December 31, 2024 at the 42nd Annual J.P. Morgan Healthcare Conference[4] - The financial closing procedures for Q4 2024 are not yet complete, which may lead to significant changes in the preliminary unaudited results[5] Product Demand - Due to strong demand in Q4 2024 and into Q1 2025, all three presentations of UDENYCA are being temporarily allocated[6]

Core Insights - Coherus BioSciences reported a 4% increase in annual net revenue to $267.0 million for 2024, despite significant divestitures [1][12] - The company is focused on maximizing revenue potential for LOQTORZI and advancing its oncology pipeline, including casdozokitug and CHS-114 [3][8] - The divestiture of UDENYCA is on track, with expected cash of approximately $250 million post-transaction, providing a cash runway exceeding two years [1][24] Financial Performance - UDENYCA net revenue increased by 62% year-over-year, reaching $206.0 million for FY 2024 [1][14] - LOQTORZI net revenue for Q4 2024 was $7.5 million, a 29% increase from Q3 2024, with total FY 2024 sales of $19.1 million [1][7] - Total net product revenue for FY 2024 was $259.7 million, a slight increase from $256.6 million in FY 2023 [10][12] Divestiture and Strategic Focus - The UDENYCA divestiture is expected to close late in Q1 or early in Q2 2025, with a special meeting of shareholders scheduled for March 11, 2025 [1][4] - Following the divestiture, the company plans to reduce its headcount by approximately 30% [1][24] - The company aims to leverage its innovative oncology pipeline, with multiple clinical data readouts anticipated in 2025 and 2026 [1][3] Cost Management - Cost of goods sold (COGS) decreased significantly, from $159.0 million in 2023 to $117.6 million in 2024, primarily due to divestitures [15][16] - Research and development (R&D) expenses decreased to $93.3 million in 2024 from $109.4 million in 2023, attributed to reduced headcount and lower costs from divestitures [17] - Selling, general and administrative (SG&A) expenses also declined to $167.7 million in 2024 from $192.0 million in 2023, driven by lower operating costs [18] Cash Position and Outlook - As of December 31, 2024, cash, cash equivalents, and investments totaled $126.0 million, up from $117.7 million in 2023 [23] - The company projects a cash position of approximately $250 million post-UDENYCA divestiture, with a cash runway exceeding two years [1][24] - Coherus is focused on advancing its pipeline and exploring external partnerships for additional label expansions in 2025 [13][24]