scPharmaceuticals (SCPH) - 2025 Q1 - Quarterly Report

PART I – FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (unaudited) Unaudited statements show increased revenue and a wider net loss, with a shift from stockholders' equity to a deficit Condensed Consolidated Balance Sheets Total assets decreased while liabilities increased, shifting the company from stockholders' equity to a deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2024 | Mar 31, 2025 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $75,655 | $57,544 | | Total current assets | $105,849 | $89,353 | | Total assets | $107,519 | $90,963 | | Liabilities & Equity | | | | Total current liabilities | $14,876 | $16,312 | | Term loan, long-term | $51,350 | $51,050 | | Total liabilities | $94,199 | $96,090 | | Total stockholders' equity (deficit) | $13,320 | $(5,127) | Condensed Consolidated Statements of Operations and Comprehensive Loss Product revenue nearly doubled, but higher operating expenses led to a wider net loss compared to the prior year Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2024 | Q1 2025 | | :--- | :--- | :--- | | Product revenues, net | $6,102 | $11,752 | | Cost of product revenues | $1,785 | $3,471 | | Research and development | $2,726 | $4,631 | | Selling, general and administrative | $17,447 | $21,407 | | Loss from operations | $(15,856) | $(17,757) | | Net loss | $(14,108) | $(19,742) | | Net loss per share | $(0.36) | $(0.37) | Condensed Consolidated Statements of Cash Flows Net cash used in operations remained stable, but a lack of investing inflows led to a net decrease in cash Cash Flow Summary (in thousands) | Activity | Q1 2024 | Q1 2025 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,701) | $(17,139) | | Net cash provided by investing activities | $29,319 | $0 | | Net cash provided by (used in) financing activities | $15 | $(972) | | Net increase (decrease) in cash | $11,633 | $(18,111) | Notes to Condensed Consolidated Financial Statements Notes detail liquidity, significant customer concentration, and fair value accounting for new financing agreements - The company believes its existing cash and cash equivalents of $57.5 million will be sufficient to meet its cash commitments for at least the next 12 months[37][38] - The company has significant customer concentration, with two customers accounting for 81% of revenue for the three months ended March 31, 2025[45] - The company elected the fair value option to account for its Credit Agreement and Revenue Purchase and Sale Agreement with Perceptive, with changes in fair value recorded in the statement of operations[54][55] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses FUROSCIX's commercial performance, revenue growth, rising expenses, and the company's liquidity position Overview The company focuses on commercializing FUROSCIX for heart failure and CKD while developing a new autoinjector version - FUROSCIX is approved for treating congestion due to fluid overload in adults with NYHA Class II/III/IV chronic heart failure and, as of March 6, 2025, for edema in adult patients with chronic kidney disease (CKD)[134][135] - The company is developing an 80mg/1mL autoinjector and targets an sNDA submission in the third quarter of 2025[137] - Approximately 14,000 FUROSCIX doses were filled in the quarter ended March 31, 2025[138] Results of Operations Higher FUROSCIX demand drove a $5.7 million revenue increase, but rising R&D and SG&A costs widened the net loss Comparison of Results of Operations (in thousands) | Line Item | Q1 2024 | Q1 2025 | Change ($) | | :--- | :--- | :--- | :--- | | Product revenues, net | $6,102 | $11,752 | $5,650 | | Cost of product revenues | $1,785 | $3,471 | $1,686 | | Research and development | $2,726 | $4,631 | $1,905 | | Selling, general and administrative | $17,447 | $21,407 | $3,960 | | Net loss | $(14,108) | $(19,742) | $5,634 | - The $1.9 million increase in R&D expenses was primarily due to a $2.0 million increase in pharmaceutical development costs[161] - The $4.0 million increase in SG&A expenses was mainly attributable to higher employee-related costs (+$1.7M), commercial costs (+$1.1M), and patient support (+$0.9M)[162] Liquidity and Capital Resources The company holds $57.5 million in cash and believes recent financing activities provide sufficient funding for over 12 months - As of March 31, 2025, the company had cash and cash equivalents of $57.5 million and an accumulated deficit of $386.2 million[151][168] - In August 2024, the company entered into a $75.0 million term loan facility and a $50.0 million Revenue Purchase and Sale Agreement with Perceptive Credit Holdings IV, LP[140][145] - In August 2024, the company completed an underwritten public offering, raising net proceeds of $53.5 million[149][150] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are foreign currency fluctuations and interest rate changes affecting its liabilities - The company has exposure to foreign currency risk from vendors in foreign countries but believes it to be immaterial[183] - The company's primary market risk is interest rate sensitivity, as the fair value of its Credit Agreement and Revenue Purchase and Sale Agreement liabilities will fluctuate with changes in market interest rates[184] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - As of March 31, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures are effective at the reasonable assurance level[187] - No material changes were identified in the company's internal control over financial reporting during the quarter ended March 31, 2025[188] PART II – OTHER INFORMATION Item 1. Legal Proceedings The company is not aware of any legal proceedings that would materially impact its business or financial condition - The company reports no material legal proceedings[190] Item 1A. Risk Factors No material changes to the risk factors disclosed in the company's most recent Annual Report have been identified - No material changes to risk factors have occurred since the filing of the last Annual Report[191] Other Items (Items 2, 3, 4, 5, 6) This section confirms no unregistered equity sales or defaults and notes no new director or officer trading plans - During the three months ended March 31, 2025, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement[195]