scPharmaceuticals (SCPH) - 2025 Q2 - Quarterly Results

Executive Summary Provides an overview of scPharmaceuticals Inc.'s Q2 2025 financial and operational achievements, including FUROSCIX® growth and strategic initiatives Highlights of Q2 2025 scPharmaceuticals Inc. reported strong financial and operational performance for the second quarter of 2025, driven by significant growth in FUROSCIX® revenue and patient doses, alongside strategic advancements in product development and market expansion Q2 2025 Performance Metrics | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net FUROSCIX® Revenue | $16 million | $8.1 million | +99% | | FUROSCIX® Doses Shipped/Filled | ~20,200 | ~9,300 | +117% | - Doses shipped to patients increased 45% over Q1 2025[1] - Cash and cash equivalents stood at $40.8 million as of June 30, 2025[1] - Launch of FUROSCIX® in chronic kidney disease (CKD) market[1][9] - Autoinjector remains on track for sNDA submission in Q3 2025, designed to reduce treatment time from five hours to less than ten seconds[1][9] CEO Commentary CEO John Tucker expressed satisfaction with FUROSCIX®'s continued momentum, attributing growth to strong execution and increasing prescriber adoption. He highlighted the strategic expansion into the chronic kidney disease (CKD) market and the potential positive impact of the proposed Ambulatory Specialty Model (ASM) by CMS - The growth in FUROSCIX® net revenue reflects strong execution across the organization and increasing adoption by prescribers who recognize its clinical and economic value[3] - Expanding FUROSCIX® into the chronic kidney disease (CKD) market is a critical step forward in transforming diuretic therapy delivery, offering nephrologists a much-needed tool[3] - The proposed Ambulatory Specialty Model (ASM) by the Centers for Medicare and Medicaid Services (CMS) is seen as a potential tailwind for FUROSCIX® uptake, by improving upstream management of heart failure and shifting accountability to clinical specialists[3] Business Update Details the commercial performance of FUROSCIX®, including sales growth and market expansion, alongside progress in product development and strategic initiatives Product Performance and Milestones FUROSCIX® demonstrated robust commercial performance in Q2 2025, marked by significant increases in doses filled and sales to Integrated Delivery Networks (IDNs). The company also successfully launched FUROSCIX® for the CKD indication and advanced its autoinjector development FUROSCIX® Commercial Performance | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net FUROSCIX® Revenue | $16.0 million | $8.1 million | +99% | | FUROSCIX® Doses Filled | ~20,200 | ~9,300 | +117% | - Sales to Integrated Delivery Networks (IDNs) increased 70% in Q2 2025 compared to Q1 2025[9] - The gross-to-net (GTN) discount was 27% for Q2 2025, compared to 23% for Q1 2025[9] - Approximately 4,700 unique prescribers have prescribed FUROSCIX® from launch through the end of Q2 2025[9] - FUROSCIX® CKD Indication Expansion was formally launched in late April 2025, with nephrologists now writing prescriptions for this expanded indication[9] - The 80mg/1mL FUROSCIX® Autoinjector (SCP-111 program) is on track for a targeted sNDA filing in the current quarter (Q3 2025)[9] Strategic Initiatives The company's strategic focus includes expanding FUROSCIX® into the chronic kidney disease market and leveraging potential benefits from the proposed Ambulatory Specialty Model (ASM) to enhance heart failure management - Expansion of FUROSCIX® into the chronic kidney disease (CKD) market is a critical strategic step to transform diuretic therapy delivery[3][9] - The proposed Ambulatory Specialty Model (ASM) by CMS is anticipated to be a tailwind for FUROSCIX® uptake by improving upstream management of heart failure and shifting accountability to clinical specialists[3] Financial Results Presents scPharmaceuticals' Q2 2025 financial performance, highlighting revenue growth, increased operating expenses, and the resulting net loss Second Quarter 2025 Financial Performance scPharmaceuticals reported increased product revenues driven by demand for FUROSCIX®, but also saw higher operating expenses, resulting in an increased net loss for Q2 2025 compared to the prior year Revenue and Cost of Goods Sold Product revenues nearly doubled in Q2 2025 due to increased demand for FUROSCIX®, leading to a proportional rise in the cost of product revenues Product Revenues and Costs | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $16,041 | $8,054 | +99.2% | | Cost of product revenues | $5,011 | $2,300 | +117.9% | - The increase in both product revenues and costs of product revenues was primarily due to increased demand for FUROSCIX® further into its commercial launch, and related manufacturing costs[5] Operating Expenses Research and development expenses increased due to device and pharmaceutical development, while selling, general, and administrative expenses rose primarily from employee-related and commercial costs Operating Expense Summary | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Research and development | $4,098 | $2,677 | +53.1% | | Selling, general and administrative | $21,226 | $17,508 | +21.2% | | Total operating expenses | $30,335 | $22,485 | +34.9% | - The increase in R&D expenses was primarily due to higher device development costs, pharmaceutical development costs, and employee-related costs, partially offset by a decrease in clinical study costs[6] - The increase in SG&A expenses was mainly due to higher employee-related costs, commercial costs, and professional service costs, partially offset by a decrease in patient support costs[7] Net Loss The company reported an increased net loss for Q2 2025, despite higher revenues, due to rising operating expenses and other non-operating charges Net Loss and Per Share Data | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Net loss | $(18,024) | $(17,090) | +5.5% | | Net loss per share, basic and diluted | $(0.34) | $(0.44) | -22.7% | - Weighted-average common shares outstanding increased to 53,719,662 for Q2 2025 from 38,984,745 for Q2 2024[25] Product Information Outlines the approved indications for FUROSCIX® and critical safety information, including contraindications and potential adverse reactions FUROSCIX® Indication FUROSCIX® is indicated for the treatment of edema in adult patients suffering from chronic heart failure or chronic kidney disease, including nephrotic syndrome - FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use, is indicated for the treatment of edema (congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome[13] Important Safety Information FUROSCIX® carries important safety warnings, including contraindications for patients with anuria or hypersensitivity, risks of fluid/electrolyte imbalances, dehydration, ototoxicity, and potential for acute urinary retention. Patients should be monitored for adverse reactions and proper use of the On-body Infusor - FUROSCIX® is contraindicated in patients with anuria and those with a history of hypersensitivity to furosemide, any component of the formulation, or medical adhesives[14] - Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, those with inadequate oral electrolyte intake, and elderly patients, requiring frequent monitoring of serum electrolytes and other blood parameters[15] - Excessive diuresis can lead to dehydration and blood volume reduction, potentially causing circulatory collapse, vascular thrombosis, and embolism, especially in elderly patients[15] - The most common adverse reactions observed in clinical trials were site and skin reactions, including erythema, bruising, edema, and injection site pain[19] Company Information Provides background on scPharmaceuticals, clarifies forward-looking statements, and includes details for investor communications and media contacts About scPharmaceuticals scPharmaceuticals is a pharmaceutical company dedicated to advancing cardiorenal healthcare through innovative, patient-centric treatments, with a mission to address unmet patient needs and drive global health improvements - scPharmaceuticals Inc. is a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations[2][20] - The company's mission is focused on advancing cardiorenal care through innovative, integrated treatments that address unmet patient needs[20] - The goal is to become the foremost advocate for patient-centric cardiorenal care, driving global health improvements through specialized, multidisciplinary approaches[21] Forward-Looking Statements This section highlights that the press release contains forward-looking statements subject to various risks and uncertainties, including dependence on product success, regulatory approvals, manufacturing capabilities, funding needs, and broader economic factors, which could cause actual results to differ materially - Statements regarding the development and commercialization of products (e.g., Autoinjector sNDA submission in Q3 2025), commercial strategy for FUROSCIX®, and the impact of the ASM program are considered forward-looking[22] - Key risks and uncertainties include dependence on the commercial success of FUROSCIX® and other product candidates, risks related to regulatory approval, ability to manufacture sufficient product, history of operating losses, need for additional funding, and the impact of global economic factors[22][23] - Readers are advised to consult the Company's Annual Report on Form 10-K for the year ended December 31, 2024, for a comprehensive discussion of potential risks and uncertainties[23] Conference Call and Webcast Details for the investor conference call and webcast held on August 7, 2025, to discuss the company's second quarter 2025 results, including access information - scPharmaceuticals' management hosted a conference call and webcast to review Q2 2025 results on Thursday, August 7, 2025, at 4:30 p.m. ET[1][11] - Participants could dial (800) 715-9871 (toll-free) or (646) 307-1963 (toll) using passcode 4965353, with live webcast and replay accessible via the company's website[12] Contact Information Contact details for media inquiries and investor relations for scPharmaceuticals Inc - For scPharmaceuticals Inc., contact Katherine Miranda at kmiranda@scpharma.com. For investors, contact Matthew Beck at matthew.beck@astrpartners.com[24] Unaudited Financial Statements Contains the detailed consolidated statements of operations and balance sheet data for the specified periods, reflecting the company's financial position Consolidated Statements of Operations The unaudited consolidated statements of operations detail the company's financial performance for the three and six months ended June 30, 2025, and 2024, showing revenues, operating expenses, and net loss Consolidated Statements of Operations (in thousands) | | THREE MONTHS ENDED JUNE 30, | | SIX MONTHS ENDED JUNE 30, | | :--- | :--- | :--- | :--- | | | 2024 | 2025 | 2024 | 2025 | | Product revenues, net | $8,054 | $16,041 | $14,156 | $27,793 | | Cost of product revenues | $2,300 | $5,011 | $4,085 | $8,482 | | Research and development | $2,677 | $4,098 | $5,403 | $8,729 | | Selling, general and administrative | $17,508 | $21,226 | $34,955 | $42,633 | | Total operating expenses | $22,485 | $30,335 | $44,443 | $59,844 | | Loss from operations | $(14,431) | $(14,294) | $(30,287) | $(32,051) | | Net loss | $(17,090) | $(18,024) | $(31,198) | $(37,766) | | Net loss per share, basic and diluted | $(0.44) | $(0.34) | $(0.80) | $(0.70) | | Weighted-average common shares outstanding, basic and diluted | 38,984,745 | 53,719,662 | 38,968,438 | 53,698,138 | Consolidated Balance Sheet Data The unaudited consolidated balance sheet data as of June 30, 2025, and December 31, 2024, shows a decrease in cash and working capital, and a shift to a total stockholders' deficit Consolidated Balance Sheet Data (in thousands) | Metric | DECEMBER 31, 2024 | JUNE 30, 2025 | | :--- | :--- | :--- | | Cash and cash equivalents | $75,655 | $40,809 | | Working capital | $90,973 | $58,299 | | Total assets | $107,519 | $80,255 | | Term loan | $51,350 | $51,200 | | Revenue purchase and sale liability | $26,869 | $28,957 | | Accumulated deficit | $(366,494) | $(404,260) | | Total stockholders' equity (deficit) | $13,320 | $(21,316) | - Total shares outstanding was 53,290,227 as of June 30, 2025[10]