PART I – FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited statements show increased revenue and a wider net loss, with a shift from stockholders' equity to a deficit [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) 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](index=37&type=chunk)[38](index=38&type=chunk) - The company has **significant customer concentration**, with two customers accounting for **81% of revenue** for the three months ended March 31, 2025[45](index=45&type=chunk) - 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](index=54&type=chunk)[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses FUROSCIX's commercial performance, revenue growth, rising expenses, and the company's liquidity position [Overview](index=31&type=section&id=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](index=134&type=chunk)[135](index=135&type=chunk) - The company is developing an 80mg/1mL autoinjector and targets an **sNDA submission in the third quarter of 2025**[137](index=137&type=chunk) - Approximately **14,000 FUROSCIX doses** were filled in the quarter ended March 31, 2025[138](index=138&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) 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](index=161&type=chunk) - 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](index=162&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=151&type=chunk)[168](index=168&type=chunk) - 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](index=140&type=chunk)[145](index=145&type=chunk) - In August 2024, the company completed an underwritten public offering, raising **net proceeds of $53.5 million**[149](index=149&type=chunk)[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=183&type=chunk) - 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](index=184&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=187&type=chunk) - **No material changes** were identified in the company's internal control over financial reporting during the quarter ended March 31, 2025[188](index=188&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=190&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) 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](index=191&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=43&type=section&id=Other%20Items) 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](index=195&type=chunk)

[Q1 2025 Financial Results and Business Update](index=1&type=section&id=scPharmaceuticals%20Inc.%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) [Q1 2025 Highlights](index=1&type=section&id=Q1%202025%20Highlights) scPharmaceuticals reported strong Q1 2025 FUROSCIX® net revenue of **$11.8 million**, expanded its CKD indication, and advanced its autoinjector program with **$57.5 million** in cash Q1 2025 Key Financials | Metric | Value | | :--- | :--- | | Net FUROSCIX® Revenue | $11.8 million | | Cash and Cash Equivalents | $57.5 million (as of March 31, 2025) | - Formally launched FUROSCIX® in its second approved indication, Chronic Kidney Disease (CKD), in April 2025[1](index=1&type=chunk) - The new autoinjector, designed to reduce treatment time from five hours to under ten seconds, is on track for a supplemental New Drug Application (sNDA) submission in Q3 2025[1](index=1&type=chunk) [Business and Operational Update](index=1&type=section&id=Business%20Update) FUROSCIX® achieved significant Q1 2025 commercial growth with a **93%** revenue increase, expanded into the CKD market, and progressed its rapid autoinjector development FUROSCIX® Q1 2025 Performance Metrics | Metric | Q1 2025 | YoY Growth | | :--- | :--- | :--- | | Net Revenue | $11.8 million | 93% | | Doses Filled | ~13,900 | 73% | | Metric | Q1 2025 vs Q4 2024 | | :--- | :--- | | Sales to Integrated Delivery Networks | +119% | | Gross-to-Net (GTN) Discount | 23% (vs 19% in Q4 2024) | - The company formally launched FUROSCIX® for the treatment of edema in patients with Chronic Kidney Disease (CKD) in late April 2025, following FDA approval on March 6, 2025[13](index=13&type=chunk) - The CEO noted seasonal headwinds in Q1 but observed a favorable acceleration in prescription fill rates starting in March, expected to support growth for the rest of 2025[3](index=3&type=chunk) - The development of the 80mg/1mL FUROSCIX Autoinjector (SCP-111) is on track, with an sNDA submission planned for Q3 2025, aiming to reduce treatment time to less than ten seconds[13](index=13&type=chunk) [Financial Performance](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Q1 2025 net product revenues grew to **$11.8 million**, but increased operating expenses led to a wider net loss of **$19.7 million** and a reduced cash position of **$57.5 million** [Consolidated Statements of Operations](index=2&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2025 total operating expenses increased to **$29.5 million**, leading to a net loss of **$19.7 million** or **($0.37)** per share, compared to **$14.1 million** in Q1 2024 Q1 2025 Statement of Operations (in thousands, except per share data) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenues, net | $11,752 | $6,102 | | Cost of product revenues | $3,471 | $1,785 | | Research and development | $4,631 | $2,726 | | Selling, general and administrative | $21,407 | $17,447 | | **Loss from operations** | **($17,757)** | **($15,856)** | | **Net loss** | **($19,742)** | **($14,108)** | | **Net loss per share** | **($0.37)** | **($0.36)** | - The increase in R&D expenses was primarily due to higher pharmaceutical development and employee-related costs[6](index=6&type=chunk) - The rise in SG&A expenses was mainly driven by increased employee-related costs, commercial activities, patient support, and professional service fees[7](index=7&type=chunk) [Consolidated Balance Sheet Data](index=7&type=section&id=Consolidated%20Balance%20Sheet%20Data) As of March 31, 2025, cash and cash equivalents decreased to **$57.5 million**, total assets were **$91.0 million**, and stockholders' equity shifted to a **($5.1 million)** deficit Selected Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $57,544 | $75,655 | | Working capital | $73,041 | $90,973 | | Total assets | $90,963 | $107,519 | | Total stockholders' equity (deficit) | ($5,127) | $13,320 | [Product and Corporate Information](index=3&type=section&id=Product%20and%20Corporate%20Information) FUROSCIX® is indicated for edema in chronic heart failure or CKD patients, with safety warnings, and the company's future depends on its commercial success and managing regulatory and operational risks - FUROSCIX® (furosemide injection) is indicated for the subcutaneous treatment of edema in adult patients with chronic heart failure or chronic kidney disease (CKD)[14](index=14&type=chunk) - Key safety risks associated with FUROSCIX include potential for fluid, electrolyte, and metabolic abnormalities, dehydration, and hearing impairment (ototoxicity)[16](index=16&type=chunk)[18](index=18&type=chunk) - The company identifies its dependence on the commercial success of FUROSCIX, regulatory risks, and its history of operating losses as key risk factors in its forward-looking statements[24](index=24&type=chunk)

Generated net FUROSCIX® revenue of $11.8 million in the first quarter of 2025 Formally launched FUROSCIX in second approved indication, Chronic Kidney Disease, in April 2025 Autoinjector on track for sNDA submission in Q3 2025; designed to reduce treatment time from five hours to less than ten seconds Cash and cash equivalents of $57.5 million as of March 31, 2025 Investor conference call and webcast today, Wednesday, May 14th, at 4:30pm ET BURLINGTON, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- scPharmaceutica ...

Company Overview - scPharmaceuticals Inc. is a pharmaceutical company focused on revolutionizing cardiorenal healthcare through patient-centric innovations [3][4] - The company's mission is to advance cardiorenal care with innovative, integrated treatments that address unmet patient needs [3] Upcoming Events - Management will host a conference call and audio webcast on May 14, 2025, at 4:30 p.m. ET to discuss the financial results for the first quarter of 2025 and provide a business update [1] - Registration for the conference call can be completed through a direct registration link, and the live webcast will be accessible on the company's website [2]

Summary of SC Pharmaceuticals Conference Call Company Overview - SC Pharmaceuticals is focused on the cardio-renal space and has launched a product called Furosex, which recently received a label expansion for patients with chronic kidney disease [2][3]. Financial Performance - In Q4 2024, SC Pharmaceuticals reported revenue of $12.2 million from the commercial launch of Furosex, with a projected total of $36 million for the full year 2024 [4]. - Analysts estimate revenue of approximately $73 million for the current year [4]. - The company has a strong financial position with nearly $76 million in cash at the end of 2024 [5]. Product Development and Market Strategy - Furosex is designed to improve the delivery of furosemide, reducing costs of goods sold (COGS) by 70-75% [6]. - The product is aimed at treating fluid overload in patients with chronic heart failure and chronic kidney disease [13][52]. - The company has received approval for expansion into chronic kidney disease and launched the product recently, already seeing prescriptions from nephrologists [6][7]. Market Opportunity - The heart failure market in the U.S. is valued at approximately $10 billion, with about 6.5 million patients annually [8]. - Patients with heart failure account for 11% of the total Medicare population but drive 41% of admissions and 53% of readmissions [10]. - The company estimates that Furosex can address about 2.1 million treatment opportunities, with an average cost of therapy around $4,700, leading to a market opportunity of approximately $10 billion [33]. Medicare Redesign Impact - The recent Medicare redesign is expected to benefit SC Pharmaceuticals by lowering patient out-of-pocket costs to a $2,000 cap, allowing for smoother payments over twelve months [7][42]. - The redesign has already shown positive impacts on fill rates and prescriptions written, indicating a potential increase in revenue [8][43]. Clinical Efficacy and Patient Outcomes - Furosex has demonstrated a bioavailability of 99.6%, providing equivalent diuresis to IV administration, which is crucial for patients experiencing fluid overload [17][18]. - Clinical studies indicate that 96% of patients treated with Furosex did not require hospitalization within 30 days, compared to 100% hospitalization in the control group [20]. - The product is positioned as an acute intervention for chronic heart failure patients, aiming to prevent hospital admissions [23][24]. Stakeholder Alignment - The interests of payers, hospitals, and physicians are aligned with the use of Furosex, as it helps reduce hospital admissions and associated costs [34][36]. - Hospitals face penalties for excess readmissions, making Furosex an attractive option for managing heart failure patients [31][37]. Future Growth Initiatives - The company plans to expand its sales force and has already seen benefits from this expansion, which is expected to drive growth in Q1 and Q2 [49][57]. - The introduction of an auto-injector version of Furosex is anticipated to further enhance market penetration and patient compliance [47][54]. Conclusion - SC Pharmaceuticals is well-positioned for growth with its innovative product Furosex, addressing significant market needs in the cardio-renal space while benefiting from favorable Medicare changes and strong clinical outcomes [58].

BURLINGTON, Mass., May 01, 2025 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, today announced that John Tucker, President and Chief Executive Officer, will participate in the following upcoming investor conferences: The Citizens Life Sciences Conference: Presentation on Wednesday, May 7 at 9:30 a.m. ET.Craig-Hallum 22nd Annual Institutional Investor Conference: Wedne ...

Financial Data and Key Metrics Changes - For Q4 2024, scPharmaceuticals reported net revenue of $12.2 million, a significant increase from $6.1 million in Q4 2023, representing a year-over-year growth of approximately 100% [22][8] - For the full year 2024, net revenue reached $36.3 million, marking a 167% increase compared to $13.6 million in 2023 [22][23] - The gross to net discount for FUROSCIX in Q4 2024 was approximately 19%, with expectations for a long-run discount of 30% to 35% in 2025 [9][10] Business Line Data and Key Metrics Changes - The number of unique providers prescribing FUROSCIX increased by 23% in Q4 2024 compared to Q3 2024, totaling over 3,800 providers [16] - Approximately 13,300 doses of FUROSCIX were filled in Q4 2024, up 23% from 10,800 doses in Q3 2024 [16] - The average number of doses per prescription increased to 7.4 doses, primarily due to more prescriptions for advanced heart failure patients [17] Market Data and Key Metrics Changes - The company anticipates that the Medicare redesign will enhance its commercial strategy and support organic growth of FUROSCIX, particularly with the $2,000 out-of-pocket maximum for Part D beneficiaries [10][11] - The CKD indication approval is expected to significantly expand the market opportunity, with over 700,000 cases of fluid overload annually [11][12] Company Strategy and Development Direction - The company plans to fully launch the CKD indication in April 2025, leveraging its expanded sales force and prior learnings from the heart failure launch [12][15] - The strategy includes focusing on nephrology targets with smaller territories to increase access and frequency of visits to prescribers [19][20] - The company is confident that the CKD expansion will be a meaningful growth driver for the FUROSCIX franchise [13] Management's Comments on Operating Environment and Future Outlook - Management expressed satisfaction with the commercial growth of FUROSCIX in 2024, particularly in Q4, and highlighted the positive impact of the Medicare redesign on patient access [8][45] - The management noted that high out-of-pocket costs were a significant headwind in the previous year, but the redesign is expected to lower these costs and improve fill rates [45][46] - The company remains optimistic about the upcoming CKD launch and the overall growth potential for FUROSCIX in 2025 [15][51] Other Important Information - Research and development expenses for Q4 2024 were $3.2 million, slightly down from $3.3 million in Q4 2023, while full-year R&D expenses increased to $12.1 million from $11.8 million [24][25] - Selling, general, and administrative expenses for Q4 2024 were $21.4 million, up from $16.2 million in Q4 2023, with full-year expenses totaling $77.6 million compared to $53.4 million in 2023 [26][27] - The company ended 2024 with $75.7 million in cash and cash equivalents [28] Q&A Session Summary Question: Can you discuss the potential opportunity that the CKD launch represents for FUROSCIX? - Management highlighted the existing relationships with nephrologists and the potential for quicker uptake due to prior engagement with heart failure patients [34][35] Question: What hurdles have been faced in adoption, and how can the ramp be accelerated? - Management identified high patient out-of-pocket costs as a significant hurdle last year, but the Medicare redesign is expected to alleviate this issue [45][46] Question: How do you assess the burn rate relative to commercial costs? - Management indicated that as revenue increases, the burn rate will decrease, and they are confident in their cash position to support growth [55][56] Question: What is the reimbursement split between commercial and government payers for CKD? - The reimbursement split is similar to heart failure, predominantly involving Medicare patients [94] Question: Are you seeing an impact on fill rates and demand due to the Medicare redesign? - Management noted an increase in patients enrolling in smoothing and a decrease in co-pays, leading to improved fill rates [100][102]

Product Development and Commercialization - The company is heavily dependent on the success of its approved product, FUROSCIX, which received FDA approval in October 2022 and was commercially launched in Q1 2023[136] - A substantial majority of the company's resources have been focused on the commercialization of FUROSCIX, which is aimed at treating congestion due to fluid overload in adults with chronic heart failure[136] - There is no assurance that the company will successfully commercialize FUROSCIX or generate expected revenue levels, which are critical for sustaining and growing the business[140] - The commercial launch of FUROSCIX began in Q1 2023, but there is no assurance of generating substantial revenues from it[196] - Establishing sales and marketing capabilities for FUROSCIX is critical for revenue generation, with significant associated costs and risks[171] - Future success depends on the ability to establish collaborations for commercialization outside the United States[176] - The company intends to identify and develop additional product candidates beyond FUROSCIX, but success is not guaranteed[163] Regulatory Challenges - The company cannot market any of its product candidates in the U.S. until receiving FDA approval, which is a lengthy and resource-intensive process[137] - The company must conduct extensive clinical trials to demonstrate safety and efficacy before obtaining regulatory approvals, which can be delayed for various reasons[144] - Changes in regulatory requirements, such as the EU Clinical Trials Regulation, may impact the company's development plans and timelines[152] - The company relies on third-party consultants for regulatory submissions, and any failure to secure marketing approvals could materially harm its business[139] - The company must obtain FDA approval for any proposed product names, and delays or failures in this process could hinder commercialization efforts[233] - The company is subject to extensive post-marketing regulatory requirements and oversight, including ongoing compliance with good manufacturing practices[217] - The company may experience delays in product commercialization due to regulatory timing constraints and uncertainties in the approval process[215] Financial Performance and Funding - The company incurred net losses of $54.8 million and $85.1 million for the years ended December 31, 2023 and 2024, respectively, with an accumulated deficit of $366.5 million as of December 31, 2024[189] - The company anticipates significant increases in expenses related to commercialization efforts for FUROSCIX[190] - The company may need additional funding to support ongoing operations and product development, which may not be available on acceptable terms[197] - The Credit Agreement established a $75.0 million term loan facility, with $50.0 million funded at closing and an additional $25.0 million available upon meeting regulatory and sales targets[200] Market Competition and Risks - The company faces substantial competition from other pharmaceutical companies with greater resources, which may limit market potential[177] - Regulatory approval timelines may be affected by competitors obtaining approvals more rapidly or developing more effective products[179] - Market acceptance of FUROSCIX may be limited due to the established use of oral medication and IV drug delivery for heart failure[181] - Competition from generic products could adversely affect sales of FUROSCIX and other product candidates, as generic manufacturers may only need to conduct limited studies to demonstrate bioequivalence[229] Intellectual Property Concerns - Protecting intellectual property is vital for maintaining competitive advantage, with the patent application process being costly and time-consuming[279] - The company relies heavily on intellectual property, particularly patents, which are subject to legal complexities and uncertainties due to recent reforms like the America Invents Act[304] - The company must certify non-infringement of third-party patents when filing for FDA approval, which could lead to costly and time-consuming litigation[315] - The company faces challenges in enforcing its intellectual property rights globally, particularly in jurisdictions with less favorable legal protections[316] Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for the production of its products and product candidates, which increases the risk of insufficient supply and cost issues[331] - The company has engaged third-party manufacturers for the furosemide formulation used in FUROSCIX and the on-body infusor, but there is no guarantee of maintaining these relationships[332] - Failure to secure necessary supply arrangements could materially adversely affect the commercialization of FUROSCIX[332] - The company does not own or operate manufacturing facilities and lacks the resources to do so, relying entirely on third parties for active pharmaceutical ingredients[331] Pricing and Reimbursement Challenges - The commercial success of FUROSCIX depends on adequate coverage and reimbursement rates from third-party payers, which is critical for new product acceptance[220] - The company may face downward pricing pressures and restrictions from third-party payers regarding access to drug formularies, impacting market competitiveness[221] - Future coverage and reimbursement rates for product candidates are expected to face increased restrictions in both the United States and international markets, potentially adversely affecting the company's business and financial condition[224] - Pricing negotiations for prescription pharmaceuticals in international markets can be lengthy and may be subject to governmental control, which could negatively affect revenues[239] Compliance and Legal Risks - Compliance with cGMP and QSR requirements is critical for the manufacturing of FUROSCIX, and failure to comply could jeopardize commercialization efforts[185] - The company is subject to numerous environmental, health, and safety laws, and failure to comply could result in significant fines or penalties, adversely impacting the business[230] - Compliance with anti-kickback and fraud laws is critical, as violations could lead to significant civil and criminal penalties, including exclusion from government healthcare programs[267] - Non-compliance with Medicaid Drug Rebate Program obligations could result in penalties and negatively impact the company's financial results[259]

Financial Data and Key Metrics Changes - SC Pharmaceuticals reported net revenue of $12.2 million for Q4 2024, a significant increase from $6.1 million in Q4 2023, representing approximately 167% year-over-year growth [15][18] - The gross to net discount for Furosix in Q4 2024 was approximately 19%, with expectations of a long-term discount in the range of 30% to 35% for 2025 [7][8] - The company reported a net loss of $18.8 million for Q4 2024, compared to a net loss of $13.8 million in Q4 2023, and a full-year net loss of $85.1 million for 2024, up from $54.8 million in 2023 [18][19] Business Line Data and Key Metrics Changes - Furosix revenues for the full year 2024 reached $36.3 million, driven by increased demand and market penetration [15][16] - The average number of doses per prescription increased to 7.4 doses in Q4 2024, largely due to more prescriptions written for advanced heart failure patients [11][12] Market Data and Key Metrics Changes - The company has seen a 23% increase in unique providers prescribing Furosix, totaling over 3,800 since its launch in February 2023 [11] - Approximately 70% to 75% of Furosix prescriptions are filled by Part D beneficiaries, indicating a strong reliance on Medicare for patient access [8] Company Strategy and Development Direction - The company plans to fully launch the CKD indication for Furosix in April 2025, which is expected to significantly enhance growth opportunities [9][10] - SC Pharmaceuticals is focusing on expanding its sales force and targeting nephrology specialists to maximize the potential of the CKD indication [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the impact of the Medicare redesign, which is expected to lower out-of-pocket costs for patients and enhance prescription fill rates [33][34] - The company is confident that the CKD launch and the expanded sales force will drive significant growth in 2025, despite acknowledging challenges in patient access and high co-pays in the previous year [36][37] Other Important Information - The company ended 2024 with $75.7 million in cash and cash equivalents, slightly down from $76 million at the end of 2023 [19] - Management highlighted the importance of their patient services hub in streamlining the prescribing process and improving patient access to Furosix [14] Q&A Session Summary Question: Can you discuss the potential opportunity that the CKD launch represents for Furosix? - Management indicated that the CKD indication provides a significant growth opportunity, especially since many nephrology patients also have heart failure, allowing for cross-prescribing [22][24] Question: What hurdles have been faced in adoption rates? - Management noted that high out-of-pocket costs were a significant barrier last year, but the Medicare redesign is expected to alleviate this issue [31][33] Question: How do you assess the burn rate relative to commercial costs? - Management stated that as revenue increases, the burn rate will decrease, and they are confident in their cash position to support growth initiatives [40][41] Question: What is the expected impact of the CKD launch on fill rates and demand? - Management has observed an increase in fill rates and demand as patient co-pays decrease, particularly with the recent Medicare changes [81][90] Question: How will the sales force manage interactions with nephrologists and cardiologists? - Management believes that the expanded sales force will allow for effective coverage of both nephrologists and cardiologists, enhancing overall patient access [62][66]

Core Viewpoint - scPharmaceuticals reported significant revenue growth for FUROSCIX in 2024, driven by increased demand and FDA approval for a new indication in chronic kidney disease [1][4][9]. Financial Performance - Fourth quarter 2024 net FUROSCIX revenue was $12.2 million, a 99% increase from $6.1 million in Q4 2023 [4][5]. - Full year 2024 revenue reached $36.3 million, up 167% from $13.6 million in 2023 [4][5]. - Cost of product revenues for Q4 2024 was $4.0 million, compared to $1.8 million in Q4 2023 [5]. - R&D expenses for Q4 2024 were $3.2 million, slightly down from $3.3 million in Q4 2023 [7]. - SG&A expenses increased to $21.4 million in Q4 2024 from $16.2 million in Q4 2023 [8]. - The company reported a net loss of $18.8 million for Q4 2024, compared to a net loss of $13.8 million in Q4 2023 [9]. Product Development and Market Expansion - The FDA approved FUROSCIX for treating edema in chronic kidney disease on March 6, 2025, with a formal launch anticipated in April 2025 [5][6]. - The company filled approximately 13,300 FUROSCIX doses in Q4 2024, a 23% increase from Q3 2024 [5]. - scPharmaceuticals is advancing the 80mg/1mL FUROSCIX Autoinjector program, targeting a supplemental New Drug Application submission mid-year 2025 [5]. Cash Position and Shareholder Information - As of December 31, 2024, cash and cash equivalents were $75.7 million, slightly down from $76.0 million at the end of 2023 [9][25]. - Total shares outstanding as of December 31, 2024, were 50,095,689 [10].