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 ...

Group 1 - The meeting is officially opened with a quorum of shareholders confirmed [3] - The Chair of the Board, Justine Smyth, and the CEO, Jolie Hodson, will present during the meeting [3] - Shareholders participating virtually can vote and submit questions throughout the meeting [4] Group 2 - The meeting included a brief mention of an unexpected fire alarm that required evacuation, highlighting the preparedness of the staff [2]

Core Insights - The discussion features Coherus' leadership, including CEO Denny Lanfear and Chief Scientific and Development Officer Theresa Lavallee, indicating a focus on the company's strategic direction and scientific advancements [1][2]. Group 1 - The event is structured as a fireside chat, allowing for an interactive Q&A session with the management team, which emphasizes transparency and engagement with stakeholders [2]. - Attendees are encouraged to participate by submitting questions via a QR code, showcasing the company's commitment to addressing investor inquiries in real-time [2].

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's CHS-114 shows promising results in selectively depleting CCR8+ Tregs and enhancing immune response in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2][3] Clinical Trial Results - The Phase 1b clinical trial of CHS-114 demonstrated a greater than 50% increase in intratumoral CD8 T cells, indicating a shift towards a "hot" tumor microenvironment [1][2] - CHS-114 treatment resulted in a 74% reduction in CCR8+ Treg density and a 73% increase in CD8+ T cell density, showcasing effective immune remodeling [5][6] Safety and Efficacy - The combination of CHS-114 with toripalimab has shown a manageable safety profile and early signs of antitumor activity in HNSCC patients [2][3] - A partial response was observed in a refractory head and neck cancer patient during initial safety testing of the combination therapy [3] Development Strategy - The data supports advancing CHS-114 in combination with toripalimab or other immune activators, aligning with the company's development plan [3][4] - Ongoing enrollment in the dose optimization arm aims to address the FDA's Project Optimus and define a phase 2 dose for CHS-114 [3][7] Company Overview - Coherus Oncology is focused on developing innovative oncology therapies, including the next-generation PD-1 inhibitor LOQTORZI and CHS-114, targeting various cancers [9][10]

Core Insights - Coherus Oncology announced new multiomic tumor and blood-based biomarker data from the Phase 1b clinical trial of CHS-114, a selective anti-CCR8 antibody, presented at the SITC Annual Meeting [1][2] - The data indicate that CHS-114, both as a monotherapy and in combination with toripalimab, shows promising early antitumor activity and a manageable safety profile in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][3] Clinical Trial Findings - The interim analysis shows significant immune activation enhancement with CHS-114 and toripalimab, including selective depletion of CCR8+ Tregs and increased CD8+ T cells in the tumor microenvironment [2][5] - CHS-114 treatment resulted in a 74% decrease in CCR8+ Treg density and a 73% increase in CD8+ T cell density, indicating effective tumor microenvironment remodeling [6][5] - A partial response was observed in a refractory HNSCC patient during initial safety testing of the combination therapy [3] Development Strategy - The data support advancing CHS-114 in combination with toripalimab or other immune activators, with ongoing enrollment in the dose optimization arm of the study [3][8] - The study aims to define a phase 2 dose and address the FDA's Project Optimus [3] About CHS-114 - CHS-114 is designed to selectively target and deplete CCR8+ Tregs while preserving CD8+ effector T cells, showing potential for enhanced antitumor activity [9][10] - The drug is currently being evaluated in multiple Phase 1b clinical trials for various advanced solid tumors, including HNSCC, colorectal cancer, gastric cancer, and esophageal cancer [9][11] Company Overview - Coherus Oncology is a commercial-stage oncology company with an approved PD-1 inhibitor, LOQTORZI, and a promising pipeline targeting various cancers [10][11] - The company's strategy focuses on growing sales of LOQTORZI and advancing new indications in combination with its pipeline candidates [10]

Core Insights - Coherus Oncology reported a quarterly loss of $0.33 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.32, and a significant decline from a loss of $0.01 per share a year ago, indicating a negative earnings surprise of -3.13% [1] - The company generated revenues of $11.57 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 5.23% and down from $70.77 million in the same quarter last year [2] - Coherus Oncology's stock has increased by approximately 13.4% year-to-date, underperforming the S&P 500's gain of 15.6% [3] Earnings Outlook - The earnings outlook for Coherus Oncology is uncertain, with current consensus EPS estimates at -$0.30 for the upcoming quarter and -$1.31 for the current fiscal year, alongside expected revenues of $14.26 million and $56.71 million respectively [7] - The company currently holds a Zacks Rank of 3 (Hold), suggesting that its shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Coherus Oncology belongs, is currently ranked in the top 41% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Coherus Oncology's stock performance [5]

Financial Data and Key Metrics Changes - Coherus Oncology reported Q3 2025 net revenue of LOQTORZI at $11.2 million, reflecting a 12% increase quarter-over-quarter and a 92% increase year-over-year, although this is a decline from the 35% growth seen in Q2 [26][32] - The total cash and investments at the end of Q3 was $192 million, with total liabilities of $429 million, of which $254 million related to transition service agreements [33][34] - R&D expenses for the quarter were $27.3 million, up 24% from Q3 last year, while SG&A expenses were $24.9 million, down 11% compared to last year [35] Business Line Data and Key Metrics Changes - LOQTORZI's growth was driven by new patient starts and increasing duration of treatment, with a total number of accounts purchasing LOQTORZI growing over 15% [26][28] - The average growth for three out of four regions was 21%, with one region experiencing flat demand due to staffing issues [27][30] Market Data and Key Metrics Changes - The addressable market for LOQTORZI in nasopharyngeal cancer (NPC) is estimated to be between $150 million and $200 million, with expected average demand growth of 10%-15% over the next three years [28][29] - Approximately 2,000 LOQTORZI eligible patients are seen each year, with key differences in treatment dynamics between hospital-based specialists and community physicians [29][30] Company Strategy and Development Direction - The company aims to achieve a step change in patient survival through drug combinations and is focusing on expanding its pipeline with LOQTORZI and CHS-114 [6][10] - Coherus is pursuing partnerships to offset ongoing clinical development costs and is focused on global rights for its pipeline products [10][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and highlighted strong execution across all business dimensions [5][37] - The company is well-positioned to continue scientific leadership in TREG depletion and is excited about the potential of its pipeline assets [9][18] Other Important Information - The company has transitioned to focus solely on novel oncology after exiting the biosimilar business, using divestiture proceeds to pay off near-term debts [33][34] - The clinical program for CHS-114 is designed to explore its utility across multiple tumor types, with a focus on colorectal cancer and other solid tumors [22][80] Q&A Session Summary Question: Potential for bispecific format targeting CCR8 and PD-1 - Management acknowledged the interest in bispecifics but emphasized the challenges in combining mechanisms and suggested traditional combination therapy may yield stronger clinical responses [40][44] Question: Trajectory and inflection points for LOQTORZI - Management indicated that with a consistent growth rate of 10%-15% per quarter, the company could reach its sales target of $150 million-$200 million earlier than mid-2028, emphasizing the importance of physician education [47][50] Question: Expectations for colorectal cancer study benchmarks - Management highlighted the need to exceed current response rates in the fourth-line setting and emphasized the importance of durability and disease stability in evaluating outcomes [51][53] Question: Justification for moving to pivotal studies for casdozokitug - Management stated that they would look for solid overall response rates and durability in the upcoming data readouts to justify moving forward with pivotal studies [62][63] Question: Increase in duration of therapy for LOQTORZI - Management noted that duration of therapy is increasing each quarter, although they have not yet reached the average seen in clinical trials [67][69] Question: Expectations around dose optimization data for CHS-114 - Management expressed optimism about the ongoing study and the importance of biopsy data in determining the recommended phase two dose [70][74]

Financial Performance - Coherus Oncology reported net revenue of $11.571 million for the three months ended September 30, 2025, a 91.5% increase from $6.052 million in the same period of 2024[13]. - The company incurred a net loss of $35.531 million for the three months ended September 30, 2025, compared to a net loss of $10.751 million in the same period of 2024[15]. - Coherus Oncology reported a net income of $205.67 million for the nine months ended September 30, 2025, compared to $79.20 million for the same period in 2024, reflecting a significant increase[20]. - The company experienced a net cash used in operating activities of $118.80 million for the nine months ended September 30, 2025, compared to $49.05 million for the same period in 2024[20]. - The net loss from continuing operations for the three months ended September 30, 2025, was $44.517 million, compared to a loss of $47.599 million in 2024[107]. Revenue and Sales - The company anticipates continued growth in product sales and is focused on maintaining regulatory approvals for its product candidates[7]. - LOQTORZI generated net product revenue of $11.169 million for the three months ended September 30, 2025, compared to $5.832 million for the same period in 2024[39]. - For the nine months ended September 30, 2025, total net revenue reached $29.424 million, compared to $18.656 million in 2024, indicating a 58% increase[39]. - The company launched LOQTORZI in December 2023, contributing to the overall revenue growth[39]. - The company reported total net revenue from discontinued operations of $10,663,000 for the three months ended September 30, 2025, a decrease from $64,722,000 in the same period of 2024[66]. Assets and Liabilities - Total current assets rose to $460.955 million as of September 30, 2025, compared to $341.583 million as of December 31, 2024, marking a 35% increase[12]. - The company reported total liabilities of $428.745 million as of September 30, 2025, down from $580.523 million as of December 31, 2024, indicating a 26.1% decrease[12]. - Coherus Oncology's total stockholders' equity improved to $87.774 million as of September 30, 2025, compared to a deficit of $131.990 million as of December 31, 2024[12]. - The total balance of chargebacks and discounts for prompt payment as of September 30, 2025, was $69.826 million, down from $275.645 million at December 31, 2024[42]. - Total accrued and other current liabilities decreased significantly to $13.1 million as of September 30, 2025, from $60.3 million as of December 31, 2024, representing a reduction of approximately 78.2%[58]. Research and Development - Research and development expenses increased to $27.252 million for the three months ended September 30, 2025, up from $22.052 million in the same period of 2024, reflecting a 23.5% rise[13]. - The company recognized a reduction in research and development expenses of $4.8 million during the nine months ended September 30, 2024, related to obligations to Junshi Biosciences[74]. - Coherus has a pipeline that includes two mid-stage clinical candidates targeting various cancers, aiming to grow sales of its PD-1 inhibitor, LOQTORZI[21]. Divestitures and Transactions - The Company divested the UDENYCA franchise to Intas Pharmaceuticals for an upfront cash consideration of $483.4 million, including $118.4 million for product inventory[22]. - The company recognized a net gain of $338.7 million from the sale of the UDENYCA business, which included cash receipts less net assets transferred and transaction expenses[60]. - The company is eligible for two additional earnout payments of $37.5 million each based on UDENYCA's net sales performance over specified periods[61]. - The company completed the divestiture of the UDENYCA business for $483.4 million, including $118.4 million for product inventory[60]. Stock and Shares - The weighted-average number of shares used in computing net loss per share was 116,229,170 for the three months ended September 30, 2025[13]. - Coherus Oncology's total common stock shares outstanding increased to 116,236,018 as of September 30, 2025, from 115,907,216 as of March 31, 2025[17]. - The company issued 287,473 shares under the employee stock purchase plan (ESPP), generating $188,000 in additional paid-in capital[17]. - The company had approximately 30.9 million outstanding dilutive potential shares excluded from the calculation of diluted net income (loss) per share for the three months ended September 30, 2025[107]. Cash and Cash Equivalents - Coherus Oncology's cash and cash equivalents decreased to $103.352 million as of September 30, 2025, from $125.987 million as of December 31, 2024, a decline of 17.9%[12]. - As of September 30, 2025, cash equivalents totaled $103.2 million, while marketable debt securities amounted to $152.4 million, leading to a total fair value of financial assets of $191.5 million[48]. - The company anticipates that its available cash, cash equivalents, and marketable securities will be sufficient to fund planned expenditures and meet obligations in the future[7]. Debt and Interest - The company entered into a senior secured term loan facility for up to $38.7 million, with net proceeds of $37.5 million used to repay the 2027 Term Loans[78]. - Interest expense for the 2029 Term Loan was $1.3 million for the three months ended September 30, 2025, and $3.9 million for the nine months ended September 30, 2025[80]. - The 2029 Term Loan matures on May 8, 2029, with an interest rate of 8.0% plus a three-month SOFR rate, and the company was in full compliance with the loan agreement as of September 30, 2025[79]. - The company recognized a loss on debt extinguishment of $10.3 million during the nine months ended September 30, 2025[70].

Financial Performance - Coherus reported Q3 2025 net revenue of $11.6 million, a 90% increase compared to $6.1 million in Q3 2024[8] - LOQTORZI® net revenue was $11.2 million in Q3 2025, representing a 12% increase from $10.0 million in Q2 2025 and a 92% increase from $5.8 million in Q3 2024[3] - Coherus reported net revenue of $11,571,000 for the three months ended September 30, 2025, a 91.5% increase from $6,052,000 in the same period of 2024[28] - The total costs and expenses for the three months ended September 30, 2025, were $55,904,000, compared to $52,908,000 for the same period in 2024, reflecting a 5.7% increase[28] - The company reported a net income from discontinued operations of $8,986,000 for the three months ended September 30, 2025, down from $36,848,000 in the same period of 2024[28] Loss and Expenses - The net loss from continuing operations for Q3 2025 was $44.5 million, or $(0.38) per share, an improvement from a net loss of $47.6 million, or $(0.41) per share, in Q3 2024[14] - Coherus experienced a net loss from continuing operations of $44,517,000 for the three months ended September 30, 2025, compared to a loss of $47,599,000 in the same period of 2024[28] - The company reported a non-GAAP net loss from continuing operations of $38,897,000 for the three months ended September 30, 2025, compared to $40,019,000 in the same period of 2024[37] - Research and development expenses for Q3 2025 were $27.3 million, compared to $22.1 million in Q3 2024, driven by increased costs for the development of casdozokitug and CHS-114[11] - Selling, general and administrative expenses decreased to $24.9 million in Q3 2025 from $28.1 million in Q3 2024, primarily due to lower headcount and decreased operating costs[12] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $191.7 million as of September 30, 2025, up from $126.0 million as of December 31, 2024[16] - Cash and cash equivalents at the end of the period were $103,352,000, a decrease from $125,987,000 at the end of December 31, 2024[30] - Coherus' total assets increased to $516,519,000 as of September 30, 2025, compared to $448,533,000 as of December 31, 2024[30] - Coherus' cash used in operating activities was $46,339,000 for the three months ended September 30, 2025, compared to $62,016,000 in the same period of 2024[32] - The company had total stockholders' equity of $87,774,000 as of September 30, 2025, compared to a deficit of $(131,990,000) as of December 31, 2024[30] Clinical Development and Strategy - Coherus expanded the CHS-114 clinical program to include colorectal cancer, addressing a significant unmet medical need[2] - The company plans to combine LOQTORZI with internal pipeline candidates for additional solid tumor indications and pursue external partnerships for label expansions[9] - Initial data readouts for ongoing studies of CHS-114 and casdozokitug are expected throughout 2026, with multiple data readouts anticipated across various tumor types[2] - Coherus aims to deepen adoption of LOQTORZI among general oncologists by driving education on clinical data and updated NCCN guidelines[3]