erus BioSciences(CHRS) - 2025 Q1 - Quarterly Results

Q1 2025 Business and Financial Highlights Coherus completed its strategic transformation to an oncology company, driven by LOQTORZI growth and advancing immuno-oncology pipeline assets Overview Coherus reported Q1 2025 results, highlighting its strategic transformation to an oncology company, growing LOQTORZI revenues, and advancing its immuno-oncology pipeline - Completed its strategic transformation to an innovative oncology company in Q2 2025 with the divestiture of the UDENYCA franchise[1][3] - The company is focused on maximizing LOQTORZI revenues and advancing its novel immuno-oncology candidates, CHS-114 and casdozokitug, toward key data milestones in 2026[3] Q1 2025 Product Net Revenue | Product | Net Revenue (Q1 2025) | | :--- | :--- | | LOQTORZI | $7.3 million | | UDENYCA (Discontinued Operations) | $31.5 million | Business Highlights and Pipeline Update Coherus focuses on maximizing LOQTORZI revenue, which saw significant patient demand growth, while advancing its immuno-oncology pipeline and completing the UDENYCA divestiture LOQTORZI® (toripalimab-tpzi) LOQTORZI achieved $7.3 million in Q1 2025 sales with growing patient demand, maintaining its FDA-approved and NCCN-preferred status for NPC - LOQTORZI net product sales were $7.3 million in Q1 2025, with patient demand growing over 15% compared to Q4 2024[4] - It is the only FDA-approved treatment for recurrent, locally advanced, or metastatic nasopharyngeal carcinoma (NPC) and holds a 'Preferred' status with a Category 1 designation from NCCN for first-line treatment[4] - Coherus plans to maximize LOQTORZI's value by combining it with internal pipeline assets and pursuing external partnerships for label expansions[5][8] Innovative Immuno-Oncology Pipeline (CHS-114 & Casdozokitug) The immuno-oncology pipeline, featuring CHS-114 and casdozokitug, is advancing with promising early clinical data and ongoing trials, targeting key data readouts in 2026 - CHS-114 (anti-CCR8 antibody): Presented promising early clinical data at AACR 2025, showing a confirmed partial response in a heavily pre-treated PD-1 refractory HNSCC patient, with first data readouts expected in Q2 2026[1][8] - Casdozokitug (IL-27 antagonist): Enrollment is ongoing in a Phase 2 randomized trial in combination with toripalimab/bevacizumab for 1L hepatocellular carcinoma (HCC), with the first data readout expected in 1H 2026[1][8] UDENYCA® (Discontinued Operations) UDENYCA generated $31.5 million in Q1 2025 net product sales before its divestiture was completed in April 2025 for up to $558.4 million - UDENYCA net product sales were $31.5 million for Q1 2025[8] - In April 2025, Coherus completed the divestiture of its UDENYCA franchise for up to $558.4 million, with an upfront payment of $483.4 million received at closing[8] Q1 2025 Financial Performance Coherus's Q1 2025 financial performance reflects increased revenue from continuing operations, reduced net loss, and the impact of the UDENYCA divestiture on cash Financial Results from Continuing Operations Q1 2025 revenue from continuing operations significantly increased to $7.6 million, while net loss narrowed to $47.4 million due to reduced R&D and SG&A expenses Q1 Financials from Continuing Operations (YoY Comparison) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Net Revenue | $7.6M | $2.3M | +$5.3M | | R&D Expenses | $24.4M | $28.4M | -$4.0M | | SG&A Expenses | $26.0M | $40.2M | -$14.2M | | Net Loss | $47.4M | $68.0M | Improved by $20.6M | | Diluted EPS | $(0.41) | $(0.60) | Improved by $0.19 | - The decrease in R&D expenses was primarily due to reduced co-development costs for toripalimab and the termination of the TIGIT Program[12] - The decrease in SG&A was mainly driven by a net $6.8 million charge in Q1 2024 that did not recur, as well as lower headcount and operating costs following recent divestitures[13] Discontinued Operations Discontinued operations reported a Q1 2025 net loss of $9.2 million, a significant shift from Q1 2024's $170.9 million net income, primarily due to the CIMERLI franchise sale gain Net Income (Loss) from Discontinued Operations | Period | Net Income (Loss) | Diluted EPS | | :--- | :--- | :--- | | Q1 2025 | $(9.2) million | $(0.08) | | Q1 2024 | $170.9 million | $1.52 | - The significant year-over-year change was primarily due to the $153.6 million gain on the sale of the CIMERLI franchise in March 2024 and negative impacts on UDENYCA revenues in Q1 2025 from a temporary supply interruption[17] Balance Sheet and Cash Flow Coherus ended Q1 2025 with $82.4 million in cash, a decrease from year-end 2024, with the $483.4 million UDENYCA divestiture cash inflow to be reflected in Q2 2025 Cash and Cash Equivalents | Date | Amount | | :--- | :--- | | March 31, 2025 | $82.4 million | | December 31, 2024 | $126.0 million | - The upfront, all-cash consideration of $483.4 million for the UDENYCA divestiture was received in April 2025 and is not included in the March 31, 2025 cash balance[18] - Net cash used in operating activities for the three months ended March 31, 2025, was $25.8 million[35] Appendix: Financial Statements and Reconciliations This appendix provides detailed unaudited consolidated financial statements, including statements of operations, balance sheets, and cash flows, along with GAAP to non-GAAP reconciliations Condensed Consolidated Statements of Operations This section presents the unaudited consolidated statement of operations for the three months ended March 31, 2025, detailing revenues, costs, and net income or loss from continuing and discontinued operations Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 | 2024 | | Net revenue | $ 7,599 | $ 2,308 | | Total costs and expenses | 53,034 | 70,095 | | Loss from operations | (45,435) | (67,787) | | Net loss from continuing operations | (47,398) | (68,036) | | Net income (loss) from discontinued operations, net of tax | (9,171) | 170,911 | | Net income (loss) | $ (56,569) | $ 102,875 | Condensed Consolidated Balance Sheets This section presents the unaudited consolidated balance sheet as of March 31, 2025, outlining the company's assets, liabilities, and stockholders' deficit compared to December 31, 2024 Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $ 82,411 | $ 125,987 | | Assets held for sale | 138,972 | 116,423 | | Total assets | $ 371,066 | $ 448,533 | | Liabilities and Stockholders' Deficit | | | | Convertible notes | 228,569 | 228,229 | | Total stockholders' deficit | (183,470) | (131,990) | | Total liabilities and stockholders' deficit | $ 371,066 | $ 448,533 | Condensed Consolidated Statements of Cash Flows This section details cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025, compared to the prior-year period Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 | 2024 | | Net cash used in operating activities | $ (25,826) | $ (46,766) | | Net cash provided by (used in) investing activities | (17,486) | 202,763 | | Net cash provided by (used in) financing activities | (264) | 887 | | Net increase (decrease) in cash | (43,576) | 156,884 | | Cash, cash equivalents and restricted cash at end of period | $ 82,674 | $ 260,227 | Reconciliation of GAAP to Non-GAAP Financial Measures This section reconciles GAAP net loss from continuing operations to non-GAAP measures, excluding items like stock-based compensation and amortization for a clearer view of operating trends Reconciliation of GAAP to Non-GAAP Net Loss from Continuing Operations (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 | 2024 | | GAAP net loss from continuing operations | $ (47,398) | $ (68,036) | | Stock-based compensation expense | 5,046 | 6,816 | | Impairment/remeasurement, net | — | 6,772 | | Change in fair value of Royalty Fee Derivative Liability | 810 | — | | Amortization of intangible assets | 667 | 863 | | Non-GAAP net loss from continuing operations | $ (40,875) | $ (53,585) | GAAP vs. Non-GAAP Net Loss Per Share from Continuing Operations | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 | 2024 | | GAAP Net loss per share | $ (0.41) | $ (0.60) | | Non-GAAP Net loss per share | $ (0.35) | $ (0.48) |