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].

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q4 2024 Earnings Conference Call March 10, 2025 5:00 PM ET Company Participants Jodi Sievers - Head of IR Denny Lanfear - CEO Paul Reider - CCO Sameer Goregaoker - SVP, Immuno-Oncology Marketing Theresa LaVallee - CDO Rosh Dias - CMO Bryan McMichael - CFO Conference Call Participants Srikripa Devarakonda - Truist Securities Yigal Nochomovitz - Citigroup Colleen Kusy - Baird Michael Nedelcovych - TD Cowen Brian Cheng - JPMorgan Douglas Tsao - H.C. Wainwright Operator H ...

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]

Core Points - Coherus BioSciences, Inc. will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 5:15 p.m. Pacific Time [1] - The presentation will include a Q&A session and will be accessible via Webcast on the Coherus website [1] - The Webcast will be available for replay until February 10, 2025 [1]

Core Insights - Coherus BioSciences has initiated a randomized Phase 2 study evaluating the combination of casdozokitug, toripalimab, and bevacizumab in patients with liver cancer, specifically unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) [1][2][3] Company Developments - The Phase 2 study (NCT06679985) aims to assess the safety, efficacy, and dosing of the triplet combination in first-line HCC patients, with an expected enrollment of up to 72 patients [2][3] - Casdozokitug is a first-in-class IL-27 antagonist that has shown promising responses in combination with standard care therapies [2][3] - The upcoming ASCO GI Annual Meeting will feature a poster presentation of final clinical and biomarker data from the Phase 2 trial [1][4] Clinical Data and Efficacy - Previous studies, such as the Phase 3 HEPATORCH study, demonstrated that toripalimab combined with bevacizumab significantly outperformed sorafenib monotherapy, with an objective response rate of 25.3% compared to 6.1% and median overall survival of 20 months versus 14.5 months [3][4] - The combination of toripalimab and bevacizumab was well tolerated, with no new safety signals identified, supporting its use as a first-line treatment option for advanced HCC [3][4] Market Context - Hepatocellular carcinoma (HCC) accounts for approximately 90% of primary liver cancers and is the third leading cause of cancer-related deaths globally, with an estimated 41,630 new cases and 29,840 deaths in the U.S. in 2024 [4][5] - The treatment landscape for liver cancer is evolving with the introduction of immunotherapy combinations, which are expected to improve outcomes for patients [5]

Company Overview - Coherus BioSciences (NASDAQ: CHRS) is focused on immunotherapy and aims to expand the market for their PD-1 antibody while developing novel treatment options for solid tumors [1] Recent Performance - The company has recently experienced a recovery, indicating potential positive momentum in its operations and market position [1]