Presentation Operator Welcome to the UBS Virtual Event. David Dai, you may begin. Xiaochuan DaiUBS Investment Bank, Research Division Great. Thank you, operator. Hi, everyone. I'm David Dai, I'm a biotech analyst here at UBS. Thanks for joining our inaugural Virtual Oncology day today. We continue our session with Coherus. It's our great pleasure to welcome Dennis Lanfear, Chief Executive Officer; Theresa Lavallee, Chief Development and Scientific Officer; and Rosh Dias, Chief Medical Officer. Thank you f ...

Coherus BioSciences Conference Call Summary Company Overview - **Company**: Coherus BioSciences (NasdaqGM:CHRS) - **Focus**: Enhancing the lives of cancer patients and improving survival rates through innovative therapies [5][6] Pipeline and Strategy - **Key Products**: - **LOQTORZI**: Next-generation PD-1 inhibitor - **CHS-114**: Anti-CCR8 antibody T-reg depletor - **Casdozokitug**: Anti-IL-27 antibody - **Development Programs**: - Data expected around mid-2026 for CHS-114 in various cancers including head and neck, gastric, esophageal, and colorectal [6][12] - Active in liver cancer with casdozokitug, showing promising results [6][12] - **Partnerships**: Seeking ex-US partners for pipeline validation and monetary support [6][12] Market Dynamics - **LOQTORZI**: - Approved for frontline and second-line nasopharyngeal carcinoma - Generated approximately $10 million in revenue last quarter, with expectations of substantial market growth [11][12] - Anticipated peak sales between $150 million and $200 million by mid-2028, with a growth rate of 10% to 15% per quarter [12] - **Market Size**: The nasopharyngeal market is estimated at $250 million [12] Competitive Advantages - **LOQTORZI**: - Higher binding affinity (>10x) compared to other PD-1 inhibitors, with unique epitope binding [9][10] - Approved irrespective of PD-L1 status, unlike competitors [9][10] - **CHS-114**: - Selective targeting of CCR8, a key marker in regulatory T cells, with a mechanism that enhances immune response [19][20] - Potential to be a best-in-class asset in immuno-oncology [22][30] Clinical Data and Expectations - **CHS-114**: - Ongoing studies in head and neck cancer, gastric cancer, and esophageal squamous cell carcinoma [25][26] - Early data shows promise with partial responses in late-line patients [24] - **Casdozokitug**: - Demonstrated a 38% overall response rate and a 17% complete response rate in combination with atezolizumab and bevacizumab for hepatocellular carcinoma [39] - Ongoing study with LOQTORZI, aiming to further characterize efficacy and safety [40] Future Outlook - **Data Readouts**: Anticipated results for various studies in mid-2026, with a focus on combination therapies and their contributions to overall efficacy [32][40] - **Strategic Positioning**: Coherus aims to leverage its unique product offerings and partnerships to drive growth and improve patient outcomes [45] Conclusion - Coherus BioSciences is positioned uniquely in the oncology space with a strong pipeline and strategic focus on combination therapies, aiming to deliver significant advancements in cancer treatment and patient survival [45]

Coherus BioSciences FY Conference Summary Company Overview - Coherus BioSciences has transitioned from a biosimilar company to a full immuno-oncology (IO) company, divesting its biosimilar business over the past year and acquiring Surface Oncology in 2023, which added key assets CHS-114 and Casdozokitug to its pipeline [4][6] Core Strategies and Differentiation - The company focuses on combining its PD-1 agent, Toripalimab, with other agents like CHS-114 and Casdozokitug to enhance patient outcomes in various cancers [5][6] - Coherus emphasizes partnerships and collaborations, aiming to validate its platform, generate income, and share costs for pivotal trials [6][7] - The company plans to focus on ex-U.S. partnerships and licensing, with global rights to its assets acquired through recent acquisitions [6][8] Product Performance and Market Position - LOQTORZI, the company's product, has been positioned at the top of NCCN guidelines, leading to a 36% increase in utilization from Q1 to Q2 2025 [12] - The company anticipates reaching $150 to $200 million in revenue by mid-2028, although early adoption may be uneven due to the nature of the patient population [12][13] - 90% of NCCN institutions have ordered LOQTORZI, indicating strong performance in academic centers, while community settings require more educational efforts [14][15] Pipeline Developments - Casdozokitug, an IL-27 antagonist, is in a phase 2 study for first-line HCC, showing promising early responses and safety profiles [16][18] - CHS-114, a CCR8 antibody, is in several phase 1 studies, targeting T-regs in solid tumors, with early data showing immune activation and robust T-reg depletion [22][23] Competitive Landscape and Market Dynamics - The company does not foresee significant impact from the potential loss of exclusivity for Keytruda, as its products are differentiated and will not be directly affected by biosimilars [25][26] - Coherus is positioned to collaborate with other biotechs, especially in underserved tumor types, enhancing its development capabilities [28] Future Milestones - Upcoming milestones include top-line results from the HCC study on Casdozokitug and further progression of CHS-114 in head and neck and gastric cancers [33] - The company expects to pursue transactions to offset development costs and anticipates earnout payments from its partner Accord Healthcare, which has gained significant market share [34]

Core Insights - Coherus Oncology reported a net revenue of $10.0 million for LOQTORZI, marking a 36% increase from Q1 2025, driven by higher patient demand and inventory restocking [1][6][11] - The company has a cash position of $238 million as of Q2 2025, providing a runway through 2026 for ongoing clinical programs [1][22] - Upcoming data readouts for CHS-114 and casdozokitug are expected in the first half of 2026, indicating progress in the oncology pipeline [1][2][7] Financial Performance - LOQTORZI net revenue increased from $7.3 million in Q1 2025 to $10.0 million in Q2 2025, compared to $3.8 million in Q2 2024 [6][11] - Total net revenue from continuing operations was approximately $10.3 million for Q2 2025, consistent with Q2 2024 [11] - The net loss from continuing operations for Q2 2025 was $44.9 million, a reduction from a net loss of $54.9 million in Q2 2024 [16] Pipeline Development - CHS-114, a cytolytic CCR8 antibody, is in Phase 1b studies, with initial data readouts expected in 1H 2026 [2][7] - Casdozokitug, an IL-27 antagonist, is being evaluated in multiple studies, with a focus on solid tumors [5][25] - The combination of LOQTORZI with internal pipeline candidates is aimed at expanding treatment indications [4][24] Recent Business Highlights - The divestiture of UDENYCA was completed in April 2025, generating $483.4 million in cash, which has been used to pay off significant financial obligations [9][10] - The company is focusing on maximizing LOQTORZI's potential in nasopharyngeal carcinoma, supported by a recent revision in NCCN guidelines granting it preferred status [6][24] Cash Position and Financial Obligations - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $237.6 million, up from $126.0 million at the end of 2024 [22][33] - The company has settled a majority of UDENYCA-related obligations, which are expected to be resolved in a front-loaded manner over the remainder of 2025 and into 2026 [22]

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]

Core Insights - Coherus BioSciences announced promising clinical data for CHS-114, a selective anti-CCR8 antibody, demonstrating efficacy in combination with toripalimab for treating head and neck squamous cell carcinoma (HNSCC) and gastric cancer [1][2][4] - A confirmed partial response was observed in a heavily pretreated PD-1 refractory patient, indicating potential for overcoming PD-1 resistance [2][13] - The ongoing Phase 1b trial aims to optimize dosing and evaluate safety and efficacy, with results expected in the first half of 2026 [1][8] Company Overview - Coherus BioSciences is focused on developing innovative oncology treatments, including the next-generation PD-1 inhibitor, LOQTORZI (toripalimab), and has a pipeline targeting various cancers [16][17] - The company is advancing CHS-114 in combination with toripalimab in two Phase 1b clinical trials for advanced solid tumors, including HNSCC and gastric cancer [15][17] Clinical Trial Details - The Phase 1b trial evaluated CHS-114 as a monotherapy and in combination with toripalimab in 21 patients, focusing on dose-limiting toxicities and treatment-emergent adverse events [5][12] - Key findings include a significant depletion of CCR8+ Treg cells (52-97%) and an increase in CD8+ T cells, supporting the mechanism of action for CHS-114 [6][13] Future Directions - The company plans to continue exploring CHS-114's potential in various solid tumors, with a strategic focus on HNSCC and gastric cancer [4][8] - Upcoming data presentations are expected to provide further insights into the efficacy and safety of CHS-114 in combination therapies [1][9]

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]

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].