Xeris Biopharma(XERS) - 2025 Q1 - Quarterly Report

Part I. Financial Information Financial Statements Xeris reported strong Q1 2025 revenue growth, a narrowed net loss, and improved operating cash flow Condensed Consolidated Balance Sheets As of March 31, 2025, total assets slightly decreased, liabilities marginally declined, and the stockholders' deficit widened due to the quarterly net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $58,440 | $71,621 | | Total current assets | $163,494 | $167,662 | | Total assets | $315,453 | $323,060 | | Total current liabilities | $95,072 | $100,443 | | Long-term debt, net | $217,805 | $217,006 | | Total liabilities | $350,581 | $352,675 | | Total stockholders' equity (deficit) | $(35,128) | $(29,615) | Condensed Consolidated Statements of Operations and Comprehensive Loss Q1 2025 total revenue increased 47.9% to $60.1 million, significantly reducing the operating loss to $3.1 million and narrowing the net loss to $9.2 million Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenue | $60,119 | $40,638 | | Total costs and expenses | $63,209 | $54,883 | | Loss from operations | $(3,090) | $(14,245) | | Net loss | $(9,220) | $(18,980) | | Net loss per common share | $(0.06) | $(0.14) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities significantly improved to $10.0 million in Q1 2025, while investing activities remained minimal and financing activities shifted to a net use Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,031) | $(20,303) | | Net cash used in investing activities | $(13) | $(19,650) | | Net cash provided by (used in) financing activities | $(3,137) | $35,194 | | Decrease in cash | $(13,181) | $(4,759) | Notes to Condensed Consolidated Financial Statements Notes provide details on business operations, accounting policies, product revenue growth, debt obligations, and confirm sufficient cash resources for the next 12 months despite a cumulative deficit - The company is a commercial-stage biopharmaceutical firm focused on endocrine and neurological diseases, with key products being Recorlev, Gvoke, and Keveyis[19] - Despite an accumulated deficit of $681.1 million as of March 31, 2025, management believes current cash resources are sufficient to sustain operations for at least the next 12 months[22] Disaggregated Revenue by Product (in thousands) | Product | Q1 2025 Revenue | Q1 2024 Revenue | | :--- | :--- | :--- | | Recorlev | $25,530 | $10,599 | | Gvoke | $20,845 | $16,579 | | Keveyis | $11,427 | $13,085 | | Total Product Revenue, net | $57,802 | $40,263 | - In March 2025, $3.2 million of 2025 Convertible Notes were converted into common stock, with the remaining $12.0 million converted in April 2025[59][60] - Total stock-based compensation expense was $4.4 million in Q1 2025, compared to $3.8 million in Q1 2024[97] - Due to the net loss, 43.2 million potentially dilutive securities were excluded from the diluted EPS calculation for Q1 2025[111][112] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses strong Q1 2025 revenue growth driven by commercial products, significantly narrowed net loss, and sufficient capital resources for the next twelve months Overview and Strategy The company's strategy focuses on maximizing commercial product potential, advancing its pipeline including XP-8121, and leveraging proprietary formulation technologies to achieve profitability - The company's top priority is maximizing the potential of its three commercial products: Recorlev, Gvoke, and Keveyis[121] - The pipeline is led by XP-8121, a once-weekly subcutaneous injection of levothyroxine for hypothyroidism, with plans to initiate a Phase 3 trial[122] - The core strategy is to achieve profitability by growing commercial product sales, funding new therapies for unmet medical needs[124] Results of Operations Q1 2025 total revenue grew 47.9% to $60.1 million, primarily driven by strong Recorlev and Gvoke sales, leading to a significant reduction in operating loss Q1 2025 vs Q1 2024 Results of Operations (in thousands) | Line Item | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $60,119 | $40,638 | $19,481 | 47.9% | | Cost of goods sold | $8,728 | $5,971 | $2,757 | 46.2% | | Research and development | $7,753 | $7,821 | $(68) | (0.9%) | | Selling, general and administrative | $44,018 | $38,380 | $5,638 | 14.7% | | Loss from operations | $(3,090) | $(14,245) | $11,155 | (78.3%) | | Net loss | $(9,220) | $(18,980) | $9,760 | (51.4%) | - Recorlev revenue increased by $14.9 million (140.9%), primarily driven by a 156.6% increase in volume[141] - Gvoke revenue increased by $4.3 million (25.7%), driven by both higher volume (14.9%) and favorable net pricing (10.8%)[142] - Keveyis revenue decreased by $1.7 million (12.7%) due to unfavorable net pricing, offsetting a slight increase in volume[143] Liquidity and Capital Resources The company maintains sufficient liquidity for the next 12 months, supported by improved operating cash flow and recent financing activities, despite a cumulative deficit - The company believes its cash resources as of March 31, 2025, are sufficient to sustain operations and capital needs for at least the next twelve months[154] - Net cash used in operating activities decreased from $20.3 million in Q1 2024 to $10.0 million in Q1 2025, primarily due to higher sales[157] - In March 2024, the company entered into an Amended and Restated Credit Agreement for $200.0 million in term loans[152] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate fluctuations affecting cash and SOFR-indexed debt, with foreign currency exchange risk deemed immaterial - The company is exposed to interest rate risk on its cash, cash equivalents, and SOFR-indexed long-term debt[165][167] - A hypothetical 1% change in interest rates would impact annual interest income by approximately $0.6 million[166] - Foreign currency exchange risk is not considered material[168] Controls and Procedures Management concluded disclosure controls were effective as of March 31, 2025, following the Q1 2025 implementation of a new ERP system and related control updates - The CEO and CFO concluded that disclosure controls and procedures were effective as of March 31, 2025[169] - A new Enterprise Resource Planning (ERP) system was implemented in Q1 2025, leading to updates in internal controls over financial reporting[170] Part II. Other Information Legal Proceedings The company is not currently subject to any material legal proceedings expected to have an adverse effect on its business - As of the report date, the company is not a party to any legal proceedings expected to have a material adverse effect on its business[172] Risk Factors No material changes have occurred in the company's risk factors since the filing of its Annual Report on Form 10-K for FY2024 - No material changes have occurred in the company's risk factors since the filing of the Annual Report on Form 10-K for the year ended December 31, 2024[174] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no sales of unregistered equity securities during the period - There were no sales of unregistered securities in the reported period[175] Other Information No directors or officers adopted, modified, or terminated Rule 10b5-1 trading plans during Q1 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the three months ended March 31, 2025[180]