Core Insights - Coherus BioSciences has completed its strategic transformation to focus on innovative oncology, particularly through the commercialization of LOQTORZI and the advancement of its immuno-oncology pipeline [1][2] Recent Business Highlights - The divestiture of UDENYCA in April 2025 allows Coherus to concentrate on its oncology portfolio, with LOQTORZI revenues expected to be maximized [2] - LOQTORZI net revenue for Q1 2025 was $7.3 million, with patient demand increasing over 15% compared to Q4 2024 [5][9] - The National Comprehensive Cancer Network (NCCN) has designated LOQTORZI as the only treatment with Preferred status for nasopharyngeal carcinoma (NPC) [5] Financial Performance - Net revenue from continuing operations for Q1 2025 was $7.6 million, up from $2.3 million in Q1 2024, primarily due to higher LOQTORZI sales [9] - Research and development expenses decreased to $24.4 million in Q1 2025 from $28.4 million in Q1 2024, attributed to reduced co-development costs and personnel savings [11] - The company reported a net loss from continuing operations of $47.4 million, or $(0.41) per share, compared to a loss of $68.0 million, or $(0.60) per share, in the same period last year [15][16] Pipeline Development - Coherus is advancing its next-generation immuno-oncology pipeline, including CHS-114, which is currently in Phase 1 clinical trials [4][12] - Promising early clinical data for CHS-114 was presented at the AACR Annual Meeting, showing potential for treating various solid tumors [12] - Enrollment is ongoing for a Phase 2 trial of casdozokitug in combination with toripalimab and bevacizumab for first-line hepatocellular carcinoma (HCC), with data readout expected in 1H 2026 [4][12] Cash Position - As of March 31, 2025, cash and cash equivalents totaled $82.4 million, down from $126.0 million at the end of 2024 [18] - The company received an upfront payment of $483.4 million from the divestiture of the UDENYCA franchise, which will be reflected in Q2 2025 financials [18]

Core Insights - Coherus BioSciences has completed its strategic transformation to focus on innovative oncology, with significant advancements in its product pipeline and financial performance [1][3][24] Recent Business Highlights - The company reported positive Phase 1b data for CHS-114, an anti-CCR8 antibody, at the 2025 AACR Annual Meeting, indicating potential for treating various solid tumors [1][3] - LOQTORZI, a next-generation PD-1 inhibitor, generated net revenues of $7.3 million in Q1 2025, with patient demand increasing over 15% compared to Q4 2024 [5][11] - The divestiture of UDENYCA was completed in April 2025, allowing the company to concentrate on its oncology portfolio [3][10] Financial Performance - Net revenue from continuing operations for Q1 2025 was $7.6 million, up from $2.3 million in Q1 2024, primarily driven by higher LOQTORZI sales [11] - The company reported a net loss from continuing operations of $47.4 million, or $(0.41) per share, compared to a loss of $68.0 million, or $(0.60) per share, in the same period last year [17][18] - Cash and cash equivalents decreased to $82.4 million as of March 31, 2025, down from $126.0 million at the end of 2024 [20] Pipeline Development - Ongoing studies for CHS-114 include Phase 1b trials in second-line gastric cancer and head and neck squamous cell carcinoma (HNSCC), with data readouts expected in 2026 [1][13] - Enrollment is ongoing in a Phase 2 trial of casdozokitug in combination with toripalimab and bevacizumab for first-line hepatocellular carcinoma (HCC), with initial data expected in the first half of 2026 [1][13] Strategic Focus - The company aims to maximize LOQTORZI revenues and advance its immuno-oncology candidates, including CHS-114 and casdozokitug, through strategic partnerships and label expansions [3][6][24] - Coherus is positioned to leverage its innovative oncology pipeline to enhance treatment options for cancer patients and drive future growth [3][25]

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].