Core Viewpoint - Coherus BioSciences is repurchasing approximately $170 million of its outstanding 1.500% Convertible Senior Subordinated Notes due 2026, contingent upon the closing of the divestiture of its UDENYCA franchise to Intas Pharmaceuticals [1][2][4] Group 1: Repurchase Details - The repurchase will occur at a cash price equal to 100% of the principal amount plus accrued interest [1] - After the repurchase, approximately $60 million of Convertible Notes will remain outstanding, which the company plans to repurchase following the divestiture [3] - The majority of the holders of the Convertible Notes have consented to amendments in the Indenture to facilitate the divestiture transaction [4] Group 2: Company Overview - Coherus BioSciences is a commercial-stage oncology company with an approved PD-1 inhibitor, LOQTORZI, and a promising pipeline targeting various cancers [5][6] - The company is focused on enhancing immune responses through its immuno-oncology pipeline, which includes multiple antibody candidates [6] - Coherus markets LOQTORZI and UDENYCA, with the latter being a biosimilar of Neulasta, and plans to close the divestiture transaction in early Q2 2025 [7]

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 Data and Key Metrics Changes - UDENYCA net product sales for Q4 were $46.3 million, an increase of 28% compared to $36.2 million for Q4 2023. For fiscal year 2024, UDENYCA net sales were $206 million, an increase of 62% compared to $127.1 million for fiscal year 2023 [24][10]. - Cost of goods sold (COGS) decreased to $118 million in 2024 from $159 million in 2023, primarily driven by lower COGS from divested products and reduced inventory write-offs [53]. - Total GAAP R&D and SG&A expenses for 2024 were $261 million, reflecting decreases in both R&D and SG&A due to lower headcount and cost savings from biosimilar divestitures [54]. Business Line Data and Key Metrics Changes - 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]. - UDENYCA market share in Q4 was 15% with an exit share of 22%, with expectations for continued market share growth in 2025 [26]. Market Data and Key Metrics Changes - The company reported that nearly 80% of all NCCN institutions have used LOQTORZI for at least one patient, with a 37% increase in new accounts purchasing LOQTORZI in Q4 [30]. - The NCCN updated MPC guidelines in November 2024, placing LOQTORZI in a preferred position for metastatic and locally recurrent MPC patients [34]. Company Strategy and Development Direction - The company aims to maximize revenues with LOQTORZI, expand its indications, and advance its proprietary pipeline in innovative oncology [8]. - The divestiture of the UDENYCA franchise is a significant strategic change, expected to close in late Q1 or early Q2, which will enhance the company's focus on oncology [10][11]. - The company has divested at least $800 million in assets or commitments, paying off $480 million in debt, positioning itself with $250 million in cash post-transaction [17]. Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the divestiture process, stating there are no expected obstacles and that investor support is strong [64]. - The company is focused on enhancing investor appreciation of its value proposition post-transaction, with a strong balance sheet and promising data expected in the future [12]. Other Important Information - The company has made substantial progress in its strategic transformation, including the acquisition of Surface Oncology for $40 million, which adds promising oncology candidates to its pipeline [15]. - The company expects to reduce headcount by 30% post-transaction, with a significant portion of off-balance sheet commitments transitioning to the buyer [57]. 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][65]. Question: Does the $250 million cash projection include cost savings from headcount reduction? - The $250 million represents expected cash after the transaction, net of payoffs and other cash flows, and does not specifically account for headcount reduction savings [67][68]. Question: Where is LOQTORZI currently being used now that it has both front line and second line in guidelines? - LOQTORZI is being used in a mix of recurrent locally advanced and metastatic first-line patients, with expectations for increased use due to updated guidelines [73][76]. 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 [81][82]. Question: What are the expectations for the head and neck cancer data in the first half of this year? - The company anticipates reporting data from around 30-35 patients, focusing on safety, early efficacy, and biomarker data [100]. Question: How much continued use is there of off-label IO agents 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 and the NCCN guidelines [131][134].

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]

Core Viewpoint - Coherus BioSciences, Inc. is set to release its fourth quarter and full year 2024 financial results on March 10, 2025, followed by a conference call to discuss these results and provide a business update [1]. Financial Results Announcement - The financial results will be released after market close on March 10, 2025 [1]. - A conference call and webcast will begin at 5:00 p.m. ET on the same day [2]. Conference Call Details - Participants must pre-register to receive dial-in information and a personal PIN for the live call [2]. - A live and archived webcast will be available on the Coherus website after the conference call [3]. - Attendees are advised to dial in 15 minutes early for a timely connection [3]. Company Overview - Coherus is a commercial-stage biopharmaceutical company focused on innovative immunotherapies for cancer treatment [5]. - The company markets LOQTORZI® (toripalimab-tpzi), a next-generation PD-1 inhibitor, and is developing a robust immuno-oncology pipeline [5]. Immuno-Oncology Pipeline - Coherus' pipeline includes multiple antibody immunotherapy candidates aimed at enhancing immune responses against tumors [6]. - Casdozokitug, an IL-27 antagonistic antibody, is currently in three clinical studies, including a Phase 1/2 study for advanced solid tumors [6]. - CHS-114, a selective anti-CCR8 antibody, is in a Phase 1 study for advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC) [6].

Core Insights - Coherus BioSciences, Inc. will participate in a fireside chat presentation at the 45th Annual TD Cowen Health Care Conference on March 4, 2025 [1] - The presentation is scheduled for 11:50 a.m. Eastern time and will be accessible via a live audio webcast [1] - A replay of the presentation will be available on the Coherus investor website for approximately 90 days [1] Company Information - Coherus BioSciences, Inc. is listed on NASDAQ under the ticker CHRS [1] - The company has provided contact information for investor relations, specifically Jodi Sievers, VP of Investor Relations & Corporate Communications [2]

Core Insights - Coherus BioSciences announced final data from a Phase 2 trial of casdozokitug in combination with atezolizumab and bevacizumab for treating unresectable hepatocellular carcinoma (HCC), showing a complete response rate of 17.2% and an overall response rate of 38% [1][2][4] Group 1: Clinical Trial Results - The Phase 2 trial demonstrated an increase in overall response rate from an initially reported 27% to 38%, with complete responses rising from 10.3% to 17.2% [2][5] - The trial involved 30 treatment-naïve patients, with a primary endpoint focused on safety and tolerability, and secondary endpoints including progression-free survival (PFS) and overall response rate (ORR) [5][6] - The triplet combination of casdozokitug, atezolizumab, and bevacizumab showed promising antitumor activity and an acceptable safety profile, consistent with known adverse event profiles of the individual drugs [6][7] Group 2: Future Developments - Coherus has initiated a new randomized Phase 2 trial evaluating casdozokitug in combination with toripalimab and bevacizumab, aimed at further assessing safety and efficacy [3][8] - The new trial is expected to enroll up to 72 patients and will compare two biologically active doses of casdozokitug [8] Group 3: Mechanism and Significance - Casdozokitug is a first-in-class antibody targeting IL-27, which plays a role in suppressing anti-tumor immune responses, making it a novel target for cancer treatment [3][11] - The data from the trial support the ongoing development of IL-27 as a promising target for advanced solid tumors, addressing significant unmet needs in the treatment landscape for liver cancer [4][10]