Coherus Oncology (NasdaqGM:CHRS) 2025 Conference November 18, 2025 05:30 AM ET Company ParticipantsDennis Lanfear - CEOOperatorIt is now my pleasure to introduce Dennis Lanfear, CEO of Coherus Oncology.Dennis LanfearThank you. Thank you to the organizers for the opportunity to talk to you about Coherus Oncology, an emerging innovative oncology company based in the Bay Area in Northern California. Let me first apprise you of the company's forward-looking statements and direct you to the requisite SEC filings ...

Coherus Oncology Conference Call Summary Company Overview - Coherus Oncology transitioned to being solely an innovative oncology company after divesting its biosimilar business in Q2 2025, marking Q3 2025 as its first quarter focused exclusively on oncology [6][13] - The company reported $198 million in cash on its balance sheet at the end of Q3 2025, indicating strong financial management [13] Pipeline Programs Toripalimab (LOQTORZI) - Toripalimab is a next-generation PD-1 inhibitor with unique binding sites, demonstrating activity in low PD-L1 states [7] - Approved for front-line and second-line nasopharyngeal carcinoma in 2023, generating $11 million in revenue in Q3 2025, a 12% increase from Q2 2025 [17][19] - The drug has shown a strong hazard ratio, extending survival from 22 months to over 48 months in nasopharyngeal cancer patients [18] - The company aims for 10-15% revenue growth, targeting $150-$200 million by 2028 [20] - Adoption is strong among academic physicians, but community physicians require more education about the drug [21][22] - Combination strategies with other therapeutics are being explored to enhance treatment efficacy [15][16] CHS-114 (CCR8 Targeting) - CHS-114 is a highly selective molecule targeting CCR8, which plays a significant role in Treg cells within the tumor microenvironment [26][28] - The drug is designed to deplete Tregs, potentially allowing CD8 positive T cells to infiltrate tumors, which is crucial for effective immunotherapy [30][34] - The clinical program is strategically designed to evaluate efficacy across various cancers, including head and neck, gastric, and colorectal cancers [32][35] - The company is optimistic about the potential for CHS-114 to show significant activity in underserved tumor types [32] Casdozokitug - Casdozokitug is an anti-IL-27 molecule showing promising efficacy in liver cancer, with a focus on improving overall response rates and progression-free survival [50][51] - The company anticipates data from ongoing studies in the first half of 2026, which will inform the design of future phase two and three trials [47][48] Strategic Partnerships and Deals - Coherus has global rights to its products, allowing for flexibility in forming partnerships, particularly in Asian markets for liver cancer treatments [12][53] - The company is open to collaborations with other biotech firms to enhance the development of its products [40][41] - Upcoming deals are expected to validate the value of its assets and provide upfront funding to offset clinical costs [53][54] Key Catalysts and Future Outlook - The company is focused on delivering data in 2026 that will support the advancement of its pipeline products [34][46] - Coherus is positioned to leverage its scientific leadership and partnerships to enhance patient outcomes and drive growth [45][46] - The next 12-18 months are expected to be pivotal for the company, with significant updates anticipated from ongoing studies and potential partnerships [52][55]

Core Insights - Coherus Oncology has expanded its clinical program for CHS-114, a selective Treg depleter, to include colorectal cancer, addressing a significant unmet medical need [1][2] - The company reported a net revenue of $11.2 million for LOQTORZI in Q3 2025, marking a 12% increase from Q2 2025 and a 92% increase from Q3 2024 [5][8] - As of September 30, 2025, Coherus had cash, cash equivalents, and marketable securities totaling $191.7 million [16] Recent Business Highlights - LOQTORZI is the only FDA-approved treatment for recurrent, locally advanced, or metastatic nasopharyngeal carcinoma in the U.S. [5] - The growth in LOQTORZI's revenue is attributed to increased patient demand and awareness of updated NCCN guidelines [5] - The company is focusing on expanding its oncology pipeline, including combining LOQTORZI with internal candidates like CHS-114 and casdozokitug [4][19] Financial Performance - For Q3 2025, net revenue from continuing operations was $11.6 million, compared to $6.1 million in Q3 2024, and $29.4 million for the nine months ended September 30, 2025, compared to $18.7 million in the same period of 2024 [8][14] - Research and development expenses increased to $27.3 million in Q3 2025 from $22.1 million in Q3 2024, driven by the development of casdozokitug and CHS-114 [10] - The net loss from continuing operations for Q3 2025 was $44.5 million, a slight improvement from a net loss of $47.6 million in Q3 2024 [14][15] Pipeline Developments - CHS-114 is currently in Phase 1b/2a studies targeting various cancers, including head and neck squamous cell carcinoma and colorectal cancer [21] - Casdozokitug is being evaluated in a Phase 2 study for first-line hepatocellular carcinoma, showing promising monotherapy activity in treatment-refractory non-small cell lung cancer [7][21] - Initial data readouts for ongoing studies are expected throughout 2026, indicating a robust pipeline for the company [2][11]

Core Insights - Coherus Oncology has appointed Arvind Sood as Chief Strategy and Corporate Affairs Officer to enhance its strategic functions and investor relations [1][2] - The company is focused on advancing its innovative cancer therapeutics, particularly LOQTORZI® and its pipeline candidates, which target various cancers [2][3] - Coherus holds global rights to key products, CHS-114 and casdozokitug, which presents potential business development opportunities [2][4] Company Overview - Coherus Oncology is a commercial-stage innovative oncology company with an approved PD-1 inhibitor, LOQTORZI®, and a pipeline that includes mid-stage clinical candidates targeting multiple cancers [3] - The company's strategy includes growing LOQTORZI sales in nasopharyngeal carcinoma and developing new indications in combination with pipeline candidates [3] Pipeline Development - Coherus' pipeline features multiple antibody immunotherapy candidates aimed at enhancing immune responses against cancer [4] - CHS-114 is currently in Phase 1b/2a studies for advanced solid tumors, while casdozokitug is being evaluated in a Phase 2 study for hepatocellular carcinoma [4]

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]

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 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].