Core Viewpoint - MannKind Corporation has signed a definitive merger agreement to acquire scPharmaceuticals Inc, marking a strategic expansion into cardiorenal medicine and enhancing its cardiometabolic business alongside its orphan lung division [1][2]. Strategic and Financial Benefits - The acquisition is expected to diversify and accelerate double-digit revenue growth, particularly through FUROSCIX, which addresses significant unmet needs in chronic heart failure and chronic kidney disease [6][7]. - MannKind will pay an upfront cash of $5.35 per share, representing a 36% premium to scPharmaceuticals' 90 trading day VWAP, with total consideration potentially reaching $6.35 per share [6][9]. - The total equity value of the transaction is approximately $303 million, with a total deal value of up to $360 million, expected to close in Q4 2025 [9]. Commercial Momentum - scPharmaceuticals has shown strong commercial momentum, with net sales of $27.8 million for the first half of 2025, reflecting a 96% year-over-year increase [3]. - The FUROSCIX ReadyFlow Autoinjector is on track for a supplemental New Drug Application submission in Q3 2025, which could significantly reduce treatment time for patients [3][6]. Revenue Diversification - The combined company will have a stronger revenue base with three commercial assets: Afrezza, FUROSCIX, and V-Go, leading to an annualized run rate of over $370 million based on Q2 2025 results [7]. - MannKind anticipates double-digit annual growth from its commercial products, supported by upcoming product launches and indication expansions [7][8]. Integration and Growth Opportunities - The integration of scPharmaceuticals' established commercial and medical capabilities into MannKind's infrastructure is expected to unlock meaningful growth opportunities [6][8]. - MannKind's existing strengths in endocrinology and scPharmaceuticals' expertise in cardiovascular care will enhance the market opportunity for FUROSCIX in chronic kidney disease [8].

Core Insights - scPharmaceuticals Inc. has received five Notices of Allowance from the USPTO for patent applications related to its furosemide formulation, SCP-111, which is expected to have a supplemental NDA filed this quarter [1][2] - The additional patent protection is seen as a strategic achievement that enhances the company's intellectual property portfolio and supports the development of next-generation formulations [2] Company Overview - scPharmaceuticals is focused on advancing cardiorenal care through innovative treatments that address unmet patient needs [3] - The company's mission includes becoming a leading advocate for patient-centric cardiorenal care and improving global health through specialized approaches [4]

Core Insights - scPharmaceuticals reported a significant increase in net FUROSCIX revenue, reaching $16 million in Q2 2025, which is a 99% increase compared to Q2 2024 [1][3] - The company has expanded FUROSCIX into the chronic kidney disease market, which is seen as a critical step in enhancing diuretic therapy delivery [2] - The Autoinjector for FUROSCIX is on track for sNDA submission in Q3 2025, aiming to reduce treatment time from five hours to less than ten seconds [1][3] Financial Performance - Net FUROSCIX revenue for Q2 2025 was $16.0 million, compared to $8.1 million in Q2 2024, indicating approximately 99% annual growth [3][4] - Approximately 20,200 FUROSCIX doses were filled in Q2 2025, a 117% increase from about 9,300 doses in Q2 2024 [3] - The gross-to-net (GTN) discount increased to 27% in Q2 2025 from 23% in Q1 2025 [3] Expenses - Cost of product revenues for Q2 2025 was $5.0 million, up from $2.3 million in Q2 2024, driven by increased demand and manufacturing costs [4] - Research and development expenses rose to $4.1 million in Q2 2025 from $2.7 million in Q2 2024, primarily due to higher device and pharmaceutical development costs [5] - Selling, general, and administrative expenses increased to $21.2 million in Q2 2025 from $17.5 million in Q2 2024, mainly due to higher employee-related and commercial costs [6] Losses and Cash Position - The company reported a net loss of $18.0 million for Q2 2025, compared to a net loss of $17.1 million in Q2 2024 [7] - As of June 30, 2025, cash and cash equivalents stood at $40.8 million, down from $75.7 million at the end of 2024 [21]

Financial Performance & Position - FUROSCIX achieved \$12.2 million in Q4 2024 net revenue, a 21% sequential increase from Q3 2024[7,47] - Full Year 2024 net revenue reached \$36.3 million, up 167% from Full Year 2023[7,47] - The company held \$75.7 million in cash and cash equivalents as of year-end 2024[8] FUROSCIX & Market Opportunity - FUROSCIX is indicated for congestion due to fluid overload in adult patients with chronic heart failure, delivering 80 mg/10 mL dose over 5 hours with 99.6% bioavailability[16] - The addressable US market opportunity for heart failure is estimated at \$9.9 billion[11,39] - The average cost of a heart failure hospitalization is \$11,840, with heart failure patients representing 33% (\$123B) of annual Medicare Part A and B spending[25] Clinical Study Results - The AT HOME-HF Study showed FUROSCIX subjects demonstrated augmented decongestion vs enhanced oral diuretics, with a 37% relative risk reduction in heart failure hospitalizations[21,23] - The Autoinjector PK/PD study achieved a bioavailability of 107.3% (90% CI: 103.9 – 110.8) compared to IV furosemide[84] Long-Term Growth Initiatives - The company received FDA approval for expanded FUROSCIX indication to include NYHA Class IV heart failure patients on August 9, 2024, representing approximately 10% of all heart failure patients[58,59] - The company received FDA approval for Chronic Kidney Disease indication on March 6, 2025, with launch planned in April 2025[9,57] - The addressable market opportunity for Chronic Kidney Disease is estimated at \$3.32 billion, targeting 0.7 million FUROSCIX addressable CKD fluid events[75] - The company is targeting an sNDA submission to the FDA for the 80mg/1mL FUROSCIX Autoinjector in 2025, which could reduce COGS by approximately 70%[9,56,82]

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]