ScPharmaceuticals Inc. reported a net loss of $85.1 million for the year ended December 31, 2024, a significant increase from the $54.8 million net loss reported in 2023. This increase is largely attributable to a $24.3 million rise in selling, general, and administrative expenses, driven by increased headcount and commercialization costs for FUROSCIX, their novel subcutaneous furosemide injection. Product revenues, however, increased substantially to $36.3 million in 2024, compared to $13.6 million in 2023, reflecting increased demand for FUROSCIX following its launch in the first quarter of 2023. Research and development expenses also saw a modest increase to $12.1 million in 2024.

A key development during the fiscal year was the FDA approval of a supplemental new drug application expanding FUROSCIX's indication to include NYHA Class IV heart failure patients in August 2024 and to include patients with chronic kidney disease (CKD) in March 2025. The company also submitted an Investigational New Drug application for an 80mg/1mL autoinjector in February 2024, completing enrollment in a PK/PD study in May 2024 with positive results announced in August 2024. A supplemental NDA for the autoinjector is planned for 2025. The company also received a three-year exclusivity period for FUROSCIX in October 2024.

ScPharmaceuticals' commercialization efforts for FUROSCIX in the United States are focused on heart failure specialists, cardiologists, and nurse practitioners. As of the end of the reporting period, approximately 3,900 unique prescribers had utilized FUROSCIX. The company's commercial strategy includes building its own sales force and working with national associations to update treatment protocols. Medicare Part D is currently reimbursing FUROSCIX with prior authorization.

The company's financial statements reflect the use of the fair value option for certain liabilities, resulting in changes in fair value being recognized in other income (expense). The company's liquidity is supported by cash and cash equivalents of $75.7 million as of December 31, 2024, and they anticipate that their existing resources will be sufficient to fund operations for at least the next twelve months. However, the company expects to incur substantial additional expenditures in the near future and may seek additional funding through equity or debt financing. As of March 18, 2025, the company employed 164 people, with 83 dedicated to sales.

The 10-K filing highlights several risk factors, including dependence on FUROSCIX's success, the challenges of obtaining and maintaining regulatory approvals, competition from other pharmaceutical companies, manufacturing and supply chain risks, and the need for additional funding. The filing also details the complexities of navigating various governmental regulations, including those related to pricing, reimbursement, and intellectual property. The company acknowledges the significant uncertainties associated with its future financial performance and profitability.

About scPharmaceuticals Inc.

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