Executive Summary / Key Takeaways

• scPharmaceuticals is transitioning from a single-product launch to a multi-indication growth story, leveraging its proprietary subcutaneous furosemide delivery technology (FUROSCIX) to address significant unmet needs in cardiorenal care.
• Recent FDA approval and launch of FUROSCIX for edema in Chronic Kidney Disease (CKD) patients significantly expands the addressable market, building on the prior expansion to include NYHA Class IV heart failure patients.
• The Medicare Part D redesign in 2025 is anticipated to be a net tailwind, with lower patient out-of-pocket costs and copay smoothing expected to drive increased fill rates and demand, offsetting the impact of higher gross-to-net discounts.
• Progress on the FUROSCIX autoinjector (targeting Q3 2025 sNDA submission) promises significant manufacturing cost reductions (70-75% COGS reduction) and improved patient convenience, potentially increasing market penetration.
• Despite historical operating losses and ongoing cash burn, recent financing has bolstered the balance sheet ($57.5M cash end Q1 2025) and is projected to fund operations through expected profitability, contingent on successful commercial execution and revenue growth acceleration.

A New Chapter in Cardiorenal Care: SCPH's Subcutaneous Strategy Takes Hold

scPharmaceuticals Inc. is a pharmaceutical company with a clear mission: to revolutionize cardiorenal healthcare by enabling the subcutaneous administration of therapies traditionally limited to intravenous (IV) delivery. This strategy, born from the company's formation in 2013 and subsequent incorporation in 2014, aims to optimize drug delivery, advance patient care, and crucially, reduce healthcare costs by shifting treatment away from high-cost hospital settings to the home. The culmination of these efforts arrived with the FDA approval of FUROSCIX (furosemide injection) in October 2022, marking SCPH's transition to a commercial entity and setting the stage for its current growth trajectory.

At the heart of SCPH's approach is its differentiated technology: a novel, concentrated formulation of furosemide delivered via West Pharmaceutical Services (WST)' on-body infusor. This system delivers an 80mg/10mL dose over approximately 5 hours. The key technological advantage lies in its ability to provide IV-equivalent diuresis at home. A clinical study demonstrated 99.6% bioavailability and similar 8-hour urine output compared to IV furosemide, a tangible, quantifiable benefit over traditional oral furosemide which can have less predictable bioavailability, particularly in patients with worsening congestion or reduced gut absorption.

The strategic "so what" for investors is clear: this technology creates a unique competitive moat. In a market where fluid overload often necessitates costly and inconvenient IV infusions, SCPH offers the first and only FDA-approved subcutaneous loop diuretic for at-home use. This differentiation is foundational to the company's value proposition – providing effective, IV-strength treatment with the convenience and potential cost savings of outpatient administration. The company is also actively pursuing further technological innovation with the development of an 80mg/1mL autoinjector (SCP-111). This next-generation delivery system aims to reduce treatment time from 5 hours to less than 10 seconds and is expected to yield a significant 70-75% reduction in manufacturing costs compared to the current on-body infusor. Positive PK/PD data in August 2024 supported its potential, and the company is targeting an sNDA submission in Q3 2025. This R&D initiative directly supports the long-term strategy of increasing market penetration by offering a more convenient and cost-effective format.

Expanding Horizons: Addressing Fluid Overload in Heart Failure and CKD

SCPH's growth strategy is heavily reliant on expanding the addressable market for FUROSCIX. Initially approved for NYHA Class II-III chronic heart failure, the label was expanded in August 2024 to include the more symptomatic NYHA Class IV patients. This is strategically important as Class IV patients, while representing only about 10% of the total chronic heart failure population, account for over 30% of heart failure hospitalizations. These patients often require more aggressive fluid management, and SCPH is already observing an uptick in prescription size for this group, averaging around 8 doses per prescription compared to 6-6.5 for earlier-stage patients.

Building on this, a major catalyst materialized with the FDA approval on March 6, 2025, of the sNDA expanding the FUROSCIX indication to include edema due to fluid overload in adult patients with chronic kidney disease (CKD). The formal launch for the CKD indication commenced in April 2025. This expansion is projected to be a meaningful growth driver, adding an estimated 700,000 additional patients to the potential market. Nephrologists, who are primary diuretic managers in the cardiorenal space and often treat patients with both CKD and heart failure, represent a concentrated target audience. Early feedback and prescription trends from the initial CKD launch indicate a potentially faster adoption rate compared to the initial heart failure launch, suggesting pent-up demand and strong clinical need. The company estimates the total addressable market opportunity for FUROSCIX in the U.S. across chronic heart failure and CKD patients to be approximately $12.5 billion.

Competitive Dynamics and Market Positioning

The cardiorenal and outpatient infusion market is complex, featuring a mix of large, diversified players and smaller, specialized companies. SCPH's direct competitors include companies like Baxter International (BAX), Fresenius Medical Care (FMS), and Novartis (NVS), each with their own strengths and market positions.

Baxter, with its significant presence in IV solutions and renal care, and Fresenius, a dominant force in dialysis and CKD management through its clinic network, represent large-scale competitors. Their financial performance reflects established businesses with steady, albeit lower, revenue growth rates (BAX 5-7%, FMS 4-6%) compared to SCPH's early-stage explosive growth (167% FY 2024 vs FY 2023). These companies benefit from extensive distribution networks and integrated care models. However, SCPH's technological edge in enabling at-home subcutaneous administration directly challenges the traditional IV and clinic-based models offered by Baxter and Fresenius, respectively. SCPH's higher gross margins (e.g., ~70% in Q1 2025) compared to Baxter (~40-45%) and Fresenius (~25-30%) reflect the efficiency and value proposition of its product, although SCPH currently operates at a net loss while competitors are profitable.

Novartis, a major player in cardiovascular pharmaceuticals with blockbuster drugs like Entresto, competes on innovative therapies for heart failure. While Novartis has strong R&D capabilities and global reach, its focus is primarily on pharmaceutical agents delivered via traditional routes (oral/IV). SCPH's subcutaneous delivery technology offers a differentiated approach to managing a specific symptom (fluid overload) that complements pharmacological treatments. SCPH's agility in securing niche regulatory approvals (like the CKD indication) allows it to potentially enter specific market segments faster than larger pharmaceutical companies might with entirely new drug entities.

Indirect competitors include generic oral diuretics, which are significantly cheaper but lack the predictable bioavailability and efficacy needed for acute fluid overload management, and emerging remote monitoring technologies that aim to prevent fluid overload but do not treat it once it occurs. SCPH's strategic positioning leverages its unique technology to fill a gap between less effective oral therapies and costly, inconvenient IV treatments, offering a compelling value proposition for patients, physicians, and payers. The company's success in opening new accounts and securing reorders from Integrated Delivery Networks (IDNs) highlights the appeal of its at-home solution within established healthcare systems.

Financial Performance and Liquidity

SCPH's financial performance reflects its status as a commercial-stage company focused on growth and market penetration. Product revenues have shown significant sequential and year-over-year increases since the FUROSCIX launch in Q1 2023. In Q1 2025, product revenues reached $11.8 million, a substantial increase from $6.1 million in Q1 2024. Full-year 2024 revenue was $36.3 million, representing 167% growth over $13.6 million in 2023. This growth is driven by increasing demand, expanding prescriber base (over 4,000 unique prescribers since launch), and the impact of the expanded sales force (90 territories by end Q3 2024).

Cost of product revenues has increased in line with revenue growth, resulting in consistent gross margins around 70% in Q1 2025 and Q1 2024, and averaging around 68.6% for FY 2024. Operating expenses, particularly Selling, General, and Administrative (SG&A), have increased significantly as the company invests in its commercial infrastructure (SG&A was $21.4 million in Q1 2025 vs $17.4 million in Q1 2024, and $77.6 million in FY 2024 vs $53.4 million in FY 2023). Research and Development (R&D) expenses also increased in Q1 2025 ($4.6 million vs $2.7 million in Q1 2024) due to pharmaceutical development and employee costs, reflecting ongoing investment in pipeline initiatives like the autoinjector.

As a result, the company continues to incur significant operating losses ($17.8 million loss from operations in Q1 2025) and net losses ($19.7 million net loss in Q1 2025), leading to an accumulated deficit of approximately $386.2 million as of March 31, 2025.

Net cash used in operating activities was $17.1 million in Q1 2025, primarily driven by the net loss and investment in working capital (accounts receivable and inventory) to support commercial scale-up.

Liquidity is a critical factor for SCPH. As of March 31, 2025, the company held $57.5 million in cash and cash equivalents. A transformative financing package in August 2024, including senior debt and a revenue purchase agreement with Perceptive Advisors and a public equity offering, provided approximately $75 million upfront and access to an additional $50 million. This financing is projected to extend the company's cash runway through expected profitability. Management expects quarterly net cash outflows to decrease for the balance of 2025 as revenues increase and other cash outflows normalize. While the company has access to an at-the-market (ATM) offering program, future capital requirements remain substantial and depend on the pace of commercialization, manufacturing scale-up, clinical development, and regulatory approvals.

Outlook and Key Catalysts

Management is bullish on the outlook for 2025, citing several key catalysts expected to accelerate growth. The formal launch of the CKD indication in April 2025 is a primary driver, opening a large, receptive market segment. The Medicare Part D redesign, effective in 2025, is viewed as a significant net tailwind. While it will increase the gross-to-net discount (anticipated blended GTN of ~30% for the balance of 2025, up from 23% in Q1 2025) due to mandatory manufacturer rebates, the resulting lower patient out-of-pocket costs (capped at $2,000 annually with smoothing options) are expected to dramatically improve fill rates and increase overall demand. Management has observed a direct correlation between lower patient copays and higher fill rates (e.g., 58% fill rate in December 2024 with low copays vs. 46% in Q1 2025 overall), and they project a target fill rate of 65% or higher with the redesign benefits.

The ongoing impact of the expanded sales force is expected to continue driving increased reach and frequency with target prescribers across both heart failure and CKD. Progress on the autoinjector, with an sNDA submission targeted for Q3 2025, represents a future catalyst for both cost reduction and market penetration.

Risks and Considerations

Despite the positive outlook and strategic catalysts, several risks warrant investor attention. The company is heavily dependent on the commercial success of FUROSCIX; as its only approved product, failure to achieve market acceptance or generate sufficient revenue would materially harm the business. Manufacturing and supply chain risks, particularly reliance on third-party manufacturers for the drug product and on-body infusors, could lead to delays or shortages impacting commercialization. The company's history of significant operating losses means it will require substantial future revenues to achieve and maintain profitability. While recent financing has extended the cash runway, the need for additional funding could arise, and access to capital on favorable terms is not guaranteed. Regulatory risks persist for pipeline candidates like the autoinjector. Protecting intellectual property is crucial to maintaining the competitive moat. Product liability lawsuits are an inherent risk for pharmaceutical companies. Finally, competition from existing therapies and potential new market entrants could impact market share and pricing.

Conclusion

scPharmaceuticals stands at a pivotal juncture, poised to leverage its unique subcutaneous delivery technology to capitalize on expanded market opportunities in chronic heart failure and chronic kidney disease. The recent CKD approval, coupled with the anticipated favorable impact of the Medicare Part D redesign on patient access and demand, provides significant tailwinds for revenue growth in 2025 and beyond. Progress on the autoinjector offers the potential for future cost efficiencies and increased market penetration. While the company faces inherent risks associated with commercial execution, manufacturing dependencies, and the need to achieve profitability, its differentiated technology and expanding market reach position it as a compelling growth story in the cardiorenal space. The success of the CKD launch and the realization of benefits from the Medicare redesign will be critical indicators to watch as SCPH aims to translate its strategic vision into sustained financial performance and achieve its goal of revolutionizing outpatient fluid management.