DANBURY, Conn. and BURLINGTON, Mass., Oct. 07, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) successfully completed the previously announced acquisition of scPharmaceuticals Inc. The acquisition of scPharmaceuticals is expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX® (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease. The transaction will strengthen MannKind’s commercial and medical ca ...

DANBURY, Conn. and BURLINGTON, Mass., Oct. 07, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) successfully completed the previously announced acquisition of scPharmaceuticals Inc. The acquisition of scPharmaceuticals is expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX® (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease. The transaction will strengthen MannKind’s commercial and medical ca ...

Group 1 - Halper Sadeh LLC is investigating Vital Energy, Inc. for potential violations related to its sale to Crescent Energy Company, where shareholders will receive 1.9062 shares of Crescent Class A common stock for each share of Vital common stock [1] - scPharmaceuticals Inc. is being investigated for its sale to MannKind Corporation, offering shareholders a cash payment of $5.35 per share plus a non-tradable contingent value right (CVR) worth up to $1.00 per CVR upon achieving specific milestones [2] - The firm may seek increased consideration for shareholders and additional disclosures regarding the proposed transactions [3] Group 2 - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [4] - Halper Sadeh LLC represents investors globally who have experienced securities fraud and corporate misconduct, recovering millions for defrauded investors [4]

Core Viewpoint - Wohl & Fruchter LLP is investigating the fairness of the sale of scPharmaceuticals, Inc. to MannKind Corporation for $5.35 per share in cash, plus a contingent value right offering milestone-based payments of up to $1.00 per share [1][3]. Summary by Relevant Sections Sale Details - scPharmaceuticals, Inc. has agreed to be sold to MannKind Corporation for $5.35 per share in cash, along with a non-tradable contingent value right that offers milestone-based payments of up to $1.00 per share [1][3]. Price Evaluation - The sales price of $5.35 per share is below the price targets set by multiple Wall Street analysts prior to the announcement, indicating potential undervaluation [2][3]. - Analysts' price targets include $25.00 by TD Cowen, $18.00 by H.C. Wainwright, $13.00 by Jefferies, and $12.00 by Craig-Hallum [5]. Investigation Rationale - The investigation aims to determine whether the SCPH Board of Directors acted in the best interests of shareholders and if the agreed price is fair, along with the completeness of material information disclosed regarding the transaction [3].

Core Insights - MannKind Corporation has agreed to acquire scPharmaceuticals Inc. for a deal value of up to approximately $360 million, or $5.35 per share, marking a strategic expansion into cardiorenal medicine [1] - The acquisition is supported by MannKind's recent $500 million strategic financing agreement with Blackstone [1] Company Overview - ScPharmaceuticals markets Furoscix, an FDA-approved on-body infuser for treating fluid overload in adult patients with chronic heart failure and chronic kidney disease, with a total addressable market opportunity exceeding $10 billion in the U.S. [2] - For the six months ended June 30, scPharmaceuticals reported net sales of $27.8 million, reflecting a 96% year-over-year increase [2] Product Development - The Furoscix ReadyFlow Autoinjector is expected to submit a supplemental New Drug Application in Q3 2025, aiming to reduce treatment time from five hours to less than 10 seconds [3] Strategic Goals - MannKind's CEO highlighted that the acquisition expands patient-centered brands and demonstrates the company's commitment to innovative therapies for cardiometabolic and orphan lung diseases, with expectations for double-digit growth over the next decade [4] - The combined company will own Afrezza, Furoscix, and V-Go, with an annualized run rate of over $370 million based on second-quarter 2025 earnings [4] Market Reaction - Following the acquisition announcement, scPharmaceuticals' stock rose by 15.36% to $5.59, while MannKind's stock decreased by 4.50% to $3.93 [5] Pipeline Advancements - MannKind is advancing a late-stage pipeline that includes inhaled Clofazimine (MNKD-101) for nontuberculous mycobacterial lung disease and Nintedanib DPI (MNKD-201), which is expected to initiate a phase 2 clinical trial for idiopathic pulmonary fibrosis by the end of 2025 [6]

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]

Company Performance - scPharmaceuticals reported a quarterly loss of $0.34 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.30, representing an earnings surprise of -13.33% [1] - The company posted revenues of $16.04 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 2.19%, compared to revenues of $8.05 million a year ago [2] - Over the last four quarters, scPharmaceuticals has surpassed consensus EPS estimates only once [2] Stock Movement and Outlook - scPharmaceuticals shares have increased by approximately 48.6% since the beginning of the year, significantly outperforming the S&P 500's gain of 7.9% [3] - The company's earnings outlook is crucial for assessing future stock performance, with current consensus EPS estimates at -$0.29 for the coming quarter and -$1.04 for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which scPharmaceuticals belongs, is currently ranked in the top 41% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - The performance of scPharmaceuticals may also be influenced by the overall industry outlook, as top-ranked industries tend to outperform lower-ranked ones by a significant margin [8]

Financial Data and Key Metrics Changes - In Q2 2025, the company generated $16 million in net revenue, representing a 99% increase compared to Q2 2024 [5] - Approximately 20,200 doses of Furosex were filled, marking a 117% increase over Q2 2024 and a 45% increase over Q1 2025 [6] - The gross to net discount for Furosex in Q2 2025 was approximately 27%, with an anticipated increase to around 30% in Q3 2025 [15][16] - The company ended Q2 2025 with $40.8 million in cash and cash equivalents, down from $75.5 million at the end of 2024 [16] Business Line Data and Key Metrics Changes - The majority of the increase in doses shipped came from cardiology, while nephrology had just started to contribute [6] - The company launched Feroxix into nephrology in late April 2025, with a faster uptake observed compared to the cardiology launch [7] - The number of unique prescribers reached approximately 4,700, with expectations for steady growth as the company expands further into nephrology [12] Market Data and Key Metrics Changes - The growing number of Part D patients reaching their out-of-pocket maximums positively impacted Q2 performance [8] - The company anticipates continued growth in the IDN business segment, which has been performing above internal expectations [9][14] Company Strategy and Development Direction - The company remains optimistic about Furosex's future, particularly with the expanded CKD indication, favorable Part D dynamics, and the launch of the auto injector [11] - The proposed ambulatory specialty model by CMS is expected to enhance the management of heart failure and could provide a significant tailwind for Furosex [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercialization and marketing of Furosex, highlighting key growth drivers such as nephrology uptake and IDN business advancements [6][9] - The company is focused on reaching profitability and is evaluating impacts of tariffs, FX fluctuations, and increased COGS [34] Other Important Information - The company is on track for the submission of its sNDA for the auto injector in the current quarter, which is expected to significantly reduce COGS [10] Q&A Session Summary Question: Can you talk about the growth in cardiology and Class IV heart failure patients? - Management noted that fill rates increased in Q2 and anticipate continued growth in Q3 and Q4, driven by lower co-pays [21][22] Question: What are the early learnings from the CKD launch? - The nephrology launch is progressing well, with faster adoption rates compared to cardiology, and nephrologists tend to write larger prescriptions [25][33] Question: Can you provide details on the CKD launch trajectory and cash runway? - The majority of doses shipped in Q2 were for heart failure, with nephrology expected to have a meaningful impact starting in Q3. The company has access to additional capital if needed [31][34] Question: What is the timeline for the ASM program and its implementation? - The ASM program is anticipated to roll out in January 2027, with data collection starting then and implementation affecting payments in 2028 [37][39] Question: How has the Medicare Part D redesign impacted the business? - The redesign has shifted from a headwind to a tailwind, contributing to significant growth in new prescriptions written [42][44]

PART I – FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) Presents unaudited condensed consolidated financial statements, highlighting decreased assets and cash, increased liabilities, a shift to negative equity, and increased net losses despite higher product revenues [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | December 31, 2024 (in thousands) | June 30, 2025 (in thousands) | Change (%) | | :-------------------------- | :------------------------------- | :----------------------------- | :--------- | | Cash and cash equivalents | $75,655 | $40,809 | -46.0% | | Accounts receivable, net | $11,721 | $19,409 | 65.6% | | Inventory, net | $13,903 | $14,573 | 4.8% | | Total current assets | $105,849 | $78,729 | -25.6% | | Total assets | $107,519 | $80,255 | -25.4% | | Total current liabilities | $14,876 | $20,430 | 37.3% | | Total liabilities | $94,199 | $101,571 | 7.8% | | Total stockholders' equity (deficit) | $13,320 | $(21,316) | -260.0% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | | Product revenues, net | $8,054 | $16,041 | 99.2% | | Cost of product revenues | $2,300 | $5,011 | 117.8% | | Research and development | $2,677 | $4,098 | 53.1% | | Selling, general and administrative | $17,508 | $21,226 | 21.2% | | Total operating expenses | $22,485 | $30,335 | 35.0% | | Loss from operations | $(14,431) | $(14,294) | -1.0% | | Net loss | $(17,090) | $(18,024) | 5.5% | | Net loss per share | $(0.44) | $(0.34) | -22.7% | | Metric (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | | Product revenues, net | $14,156 | $27,793 | 96.3% | | Cost of product revenues | $4,085 | $8,482 | 107.7% | | Research and development | $5,403 | $8,729 | 61.6% | | Selling, general and administrative | $34,955 | $42,633 | 22.0% | | Total operating expenses | $44,443 | $59,844 | 34.7% | | Loss from operations | $(30,287) | $(32,051) | 5.8% | | Net loss | $(31,198) | $(37,766) | 21.0% | | Net loss per share | $(0.80) | $(0.70) | -12.5% | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Common Stock (shares) | 50,095,689 | 53,290,227 | | Common Stock (amount) | $5 | $5 | | Additional Paid-in Capital | $379,809 | $382,939 | | Accumulated Deficit | $(366,494) | $(404,260) | | Total Stockholders' Equity (Deficit) | $13,320 | $(21,316) | - Accumulated deficit increased by **$37.8 million** from December 31, 2024, to June 30, 2025, primarily due to net losses[26](index=26&type=chunk) - Total stockholders' equity shifted from a positive **$13.3 million** to a deficit of **$21.3 million**[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Change ($) | | :-------------------------------- | :----------------------------- | :----------------------------- | :--------- | | Net cash used in operating activities | $(37,928) | $(33,250) | $4,678 | | Net cash provided by investing activities | $29,320 | $0 | $(29,320) | | Net cash provided by (used in) financing activities | $298 | $(1,596) | $(1,894) | | Net decrease in cash and cash equivalents | $(8,310) | $(34,846) | $(26,536) | | Cash and cash equivalents at end of period | $38,504 | $40,809 | $2,305 | - Net cash used in operating activities decreased by **$4.7 million (12.3%)** for the six months ended June 30, 2025, compared to the prior year[29](index=29&type=chunk) - Net cash provided by investing activities decreased significantly from **$29.3 million** in 2024 to **$0** in 2025[29](index=29&type=chunk) - Net cash used in financing activities was **$1.6 million** in 2025, a significant shift from **$0.3 million** provided in 2024[29](index=29&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Description of Business and Basis of Presentation](index=11&type=section&id=Note%201.%20Description%20of%20Business%20and%20Basis%20of%20Presentation) Details the company's focus on subcutaneous drug delivery, its accumulated deficit, cash position, and liquidity outlook for the next 12 months - scPharmaceuticals Inc. focuses on developing and commercializing products for subcutaneous administration of therapies previously limited to intravenous (IV) delivery[32](index=32&type=chunk) - As of June 30, 2025, the Company had an accumulated deficit of approximately **$404.3 million**[35](index=35&type=chunk) - As of June 30, 2025, the Company had cash and cash equivalents of **$40.8 million**[36](index=36&type=chunk) - The Company's existing cash and cash equivalents, along with funds available under the Revenue Purchase and Sale Agreement, are expected to be sufficient to meet its cash commitments for at least the next **12 months**[37](index=37&type=chunk) [Note 2. Significant Accounting Policies](index=13&type=section&id=Note%202.%20Significant%20Accounting%20Policies) Outlines key accounting policies, including the fair value option for financial instruments, revenue recognition for product sales, and expensing of research and development costs - The Company elected the fair value option to account for the Credit Agreement and the Revenue Purchase and Sale Agreement (Perceptive Financing)[51](index=51&type=chunk)[52](index=52&type=chunk) - Revenue from product sales (FUROSCIX) is recognized at the net sales price, including estimates for sales discounts, rebates, co-pay assistance, and product returns[54](index=54&type=chunk) - Research and development costs are expensed as incurred[61](index=61&type=chunk) - The Company operates in one segment, with the chief executive officer as the chief operating decision-maker[69](index=69&type=chunk) [Note 3. Net Loss per Share](index=20&type=section&id=Note%203.%20Net%20Loss%20per%20Share) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(17,090) | $(18,024) | $(31,198) | $(37,766) | | Weighted-average common shares outstanding | 38,984,745 | 53,719,662 | 38,968,438 | 53,698,138 | | Net loss per share — basic and diluted | $(0.44) | $(0.34) | $(0.80) | $(0.70) | - Potentially dilutive securities (stock options, warrants, unvested restricted stock units) were excluded from diluted net loss per share computation as their effect would be anti-dilutive[74](index=74&type=chunk) [Note 4. Inventory](index=20&type=section&id=Note%204.%20Inventory) | Inventory (in thousands) | December 31, 2024 | June 30, 2025 | | :----------------------- | :---------------- | :------------ | | Raw materials | $4,784 | $5,815 | | Work-in-process | $7,012 | $6,780 | | Finished goods | $2,107 | $1,978 | | Total Inventory | $13,903 | $14,573 | - Total inventory increased by **4.8%** from **$13.9 million** at December 31, 2024, to **$14.6 million** at June 30, 2025[76](index=76&type=chunk) - Allowance for excess, damaged and obsolete inventory increased from **$100 thousand** to **$135 thousand**[76](index=76&type=chunk) [Note 5. Property and Equipment](index=21&type=section&id=Note%205.%20Property%20and%20Equipment) | Property and Equipment (in thousands) | December 31, 2024 | June 30, 2025 | | :------------------------------------ | :---------------- | :------------ | | Office equipment | $27 | $27 | | Office furniture | $85 | $85 | | Computer equipment | $15 | $15 | | Leasehold improvements | $9 | $9 | | Less: Accumulated depreciation | $(80) | $(88) | | Property and equipment, net | $56 | $48 | - Net property and equipment decreased by **14.3%** from **$56 thousand** at December 31, 2024, to **$48 thousand** at June 30, 2025[78](index=78&type=chunk) - Depreciation expense for the six months ended June 30, 2025, was **$8 thousand**, down from **$11 thousand** in the prior year period[78](index=78&type=chunk) [Note 6. Accrued Expenses](index=21&type=section&id=Note%206.%20Accrued%20Expenses) | Accrued Expenses (in thousands) | December 31, 2024 | June 30, 2025 | | :------------------------------ | :---------------- | :------------ | | Sales allowances and related costs | $2,690 | $6,889 | | Employee compensation and related costs | $5,203 | $4,137 | | Contract research and development | $644 | $1,685 | | Revenue purchase and sale agreement | $971 | $1,283 | | Manufacturing costs | $330 | $882 | | Consulting and professional service fees | $529 | $789 | | Royalty | $317 | $406 | | Other | $18 | $11 | | Total accrued expenses | $10,702 | $16,082 | - Total accrued expenses increased by **50.3%** from **$10.7 million** at December 31, 2024, to **$16.1 million** at June 30, 2025[79](index=79&type=chunk) - Sales allowances and related costs increased by **156.1%** to **$6.9 million**, and contract research and development increased by **161.7%** to **$1.7 million**[79](index=79&type=chunk) [Note 7. Fair Value of Financial Instruments](index=21&type=section&id=Note%207.%20Fair%20Value%20of%20Financial%20Instruments) | Liabilities (in thousands) | December 31, 2024 (Level 3) | June 30, 2025 (Level 3) | | :------------------------- | :-------------------------- | :---------------------- | | Term loan | $51,350 | $51,200 | | Revenue purchase and sale liability | $27,840 | $30,240 | | Total | $79,190 | $81,440 | - The fair value of the term loan and revenue purchase and sale liability are measured using Level 3 inputs, with the term loan valued using a binomial lattice model and the revenue purchase and sale liability using the Monte Carlo simulation method[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk) - The fair value of the revenue purchase and sale liability increased by **$2.4 million** from December 31, 2024, to June 30, 2025[85](index=85&type=chunk) [Note 8. Financial Liabilities](index=23&type=section&id=Note%208.%20Financial%20Liabilities) Details the $75.0 million term loan facility and the $50.0 million revenue purchase and sale agreement, including associated warrants and prepayment of prior obligations - The Company entered into a Credit Agreement on August 9, 2024, establishing a **$75.0 million** term loan facility, with **$50.0 million** funded (Tranche A) and **$25.0 million** available (Tranche B) subject to conditions[91](index=91&type=chunk)[137](index=137&type=chunk) - Borrowings under the Term Loan bear interest at one-month term SOFR (**3.25% floor**) plus **6.75% margin**, with no scheduled principal repayments before August 9, 2029[92](index=92&type=chunk)[138](index=138&type=chunk) - Warrants to purchase **300,000 shares** of common stock were issued to lenders, with an exercise price adjusted to **$4.00 per share**[93](index=93&type=chunk)[138](index=138&type=chunk) - The Company also entered into a Revenue Purchase and Sale Agreement for up to **$50.0 million**, selling a tiered single-digit percentage of FUROSCIX net sales[99](index=99&type=chunk)[142](index=142&type=chunk) - Proceeds from the Perceptive Financing were used to prepay all outstanding obligations under the Oaktree Agreement on August 9, 2024, including a **$1.0 million** exit fee and a **$2.6 million** prepayment premium[102](index=102&type=chunk)[108](index=108&type=chunk)[178](index=178&type=chunk) [Note 9. Stockholders' Equity (Deficit)](index=26&type=section&id=Note%209.%20Stockholders%27%20Equity%20%28Deficit%29) Reports on the August 2024 public offering that generated $53.5 million in net proceeds and the status of the At-the-Market program - On August 13, 2024, the Company completed an underwritten public offering of **13,875,000 shares** of common stock and **500,000 pre-funded warrants**, generating net proceeds of **$53.5 million**[112](index=112&type=chunk)[113](index=113&type=chunk)[147](index=147&type=chunk)[179](index=179&type=chunk) - As of June 30, 2025, no shares were issued under the 2024 At-the-Market (ATM) Program[110](index=110&type=chunk)[177](index=177&type=chunk) [Note 10. Stock-Based Compensation](index=27&type=section&id=Note%2010.%20Stock-Based%20Compensation) | Stock Option Activity (in thousands, except share and per share data) | Number of Shares | Weighted Average Exercise Price | | :---------------------------------------------------- | :--------------- | :------------------------------ | | Outstanding, December 31, 2024 | 5,530,823 | $5.89 | | Granted | 1,792,652 | $3.40 | | Forfeited | (127,960) | $5.31 | | Expired | (18,695) | $8.12 | | Outstanding, June 30, 2025 | 7,176,820 | $5.27 | | Vested and exercisable, June 30, 2025 | 4,248,599 | $5.98 | | RSU Activity (in thousands, except share data) | RSUs | Average Grant Date Fair Value (per share) | | :--------------------------------------------- | :-------- | :---------------------------------------- | | RSUs outstanding, December 31, 2024 | 736,229 | $5.87 | | Granted | 851,747 | $3.33 | | Released | (188,236) | $5.97 | | Forfeited | (37,880) | $5.15 | | RSUs outstanding at June 30, 2025 | 1,361,860 | $4.29 | | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $410 | $406 | $775 | $765 | | General and administrative | $1,081 | $1,113 | $2,156 | $2,049 | | Total | $1,491 | $1,519 | $2,931 | $2,814 | - Unrecognized compensation expense for unvested options was **$6.3 million**, to be recognized over a weighted-average period of **2.4 years**[120](index=120&type=chunk) - Unrecognized compensation expense for unvested RSUs was **$3.6 million**, to be recognized over a weighted-average period of **2.9 years**[120](index=120&type=chunk) [Note 11. Commitments and Contingencies](index=29&type=section&id=Note%2011.%20Commitments%20and%20Contingencies) | Year Ended December 31 (in thousands) | Total Minimum Lease Payments | | :------------------------------------ | :--------------------------- | | 2025 | $196 | | 2026 | $384 | | 2027 | $367 | | 2028 | $369 | | 2029 | $249 | | Thereafter | $0 | | Total | $1,565 | | Less imputed interest | $(317) | | Total Lease Liability | $1,248 | - Weighted-average remaining lease term for operating leases was **4.0 years** as of June 30, 2025, with a weighted-average discount rate of **11.6%**[125](index=125&type=chunk) [Note 12. Segment](index=29&type=section&id=Note%2012.%20Segment) - The Company operates in a single segment, with the chief executive officer as the chief operating decision-maker[69](index=69&type=chunk)[127](index=127&type=chunk) | Segment Net Loss (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 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 expenses | $2,164 | $3,585 | $4,438 | $7,750 | | Selling, general and administrative expenses | $16,148 | $19,800 | $32,271 | $39,954 | | Segment net loss | $(17,090) | $(18,024) | $(31,198) | $(37,766) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, covering FUROSCIX commercialization, strategic financing, revenue and expense trends, liquidity, and critical accounting policies [OVERVIEW](index=31&type=section&id=OVERVIEW) Provides an overview of FUROSCIX's expanded FDA approvals, the development of an autoinjector, its estimated market opportunity, and recent dose fills - FUROSCIX, the first and only FDA-approved subcutaneous loop diuretic, was approved for NYHA Class II/III chronic heart failure in October 2022 and expanded to NYHA Class IV heart failure patients on August 9, 2024[132](index=132&type=chunk) - FDA approved FUROSCIX for the treatment of edema due to fluid overload in adult patients with chronic kidney disease (CKD) on March 6, 2025, with product launch commencing in April 2025[133](index=133&type=chunk) - The Company is developing an **80mg/1mL autoinjector** for FUROSCIX, targeting an sNDA submission in Q3 2025, which is expected to significantly reduce manufacturing costs[135](index=135&type=chunk) - The total addressable market opportunity for FUROSCIX in the United States is estimated at **$12.5 billion** for patients with chronic heart failure and CKD[136](index=136&type=chunk) - Approximately **20,200 FUROSCIX doses** were filled in the quarter ended June 30, 2025[136](index=136&type=chunk) [Perceptive Financing](index=33&type=section&id=Perceptive%20Financing) Details the $75.0 million term loan facility and $50.0 million revenue purchase and sale agreement, including associated warrants and financial covenants - On August 9, 2024, the Company entered into a Credit Agreement establishing a **$75.0 million** term loan facility, with **$50.0 million** funded on the closing date and **$25.0 million** available subject to conditions[137](index=137&type=chunk) - The Company also entered into a Revenue Purchase and Sale Agreement for up to **$50.0 million**, selling its right to receive a tiered single-digit percentage of net sales of FUROSCIX[142](index=142&type=chunk) - Warrants to purchase **300,000 shares** of common stock were issued to lenders, with an exercise price adjusted to **$4.00 per share**[138](index=138&type=chunk) - Financial covenants require maintaining at least **$5.0 million** in cash and cash equivalents and meeting minimum quarterly net sales targets[140](index=140&type=chunk) [2024 Public Offering](index=35&type=section&id=2024%20Public%20Offering) Reports on the August 2024 public offering of common stock and pre-funded warrants, which generated $53.5 million in net proceeds - On August 13, 2024, the Company completed an underwritten public offering of **13,875,000 shares** of common stock and **500,000 pre-funded warrants**[146](index=146&type=chunk) - The net proceeds from the offering were **$53.5 million**[147](index=147&type=chunk) [COMPONENTS OF OUR RESULTS OF OPERATIONS](index=35&type=section&id=COMPONENTS%20OF%20OUR%20RESULTS%20OF%20OPERATIONS) Explains the components of product revenues, cost of product revenues, research and development, and selling, general and administrative expenses - Product revenues, net, consist of net sales of FUROSCIX, recognized upon customer receipt, net of allowances for discounts, fees, returns, and rebates[149](index=149&type=chunk) - Cost of product revenues includes third-party manufacturing, packaging, freight, and royalty expenses, with an anticipated increase of **15-25%** in 2026 due to device manufacturer negotiations[150](index=150&type=chunk) - Research and development (R&D) expenses are expensed as incurred and are expected to increase with new product development and enhancements[151](index=151&type=chunk)[155](index=155&type=chunk) - Selling, general and administrative (SG&A) expenses are expected to increase to support FUROSCIX commercialization and corporate infrastructure[153](index=153&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) [Comparison of Three Months Ended June 30, 2024 and 2025](index=37&type=section&id=Comparison%20of%20Three%20Months%20Ended%20June%2030%2C%202024%20and%202025) | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Increase (Decrease) | | :-------------------- | :------------------------------- | :------------------------------- | :------------------ | | Product revenues, net | $8,054 | $16,041 | $7,987 | | Cost of product revenues | $2,300 | $5,011 | $2,711 | | Research and development | $2,677 | $4,098 | $1,421 | | Selling, general and administrative | $17,508 | $21,226 | $3,718 | | Loss from operations | $(14,431) | $(14,294) | $(137) | | Net loss | $(17,090) | $(18,024) | $934 | - Product revenues increased by **$8.0 million (99.2%)** due to increased demand for FUROSCIX[154](index=154&type=chunk) - R&D expenses increased by **$1.4 million (53.1%)**, primarily due to device and pharmaceutical development costs[157](index=157&type=chunk) - SG&A expenses increased by **$3.7 million (21.2%)**, mainly driven by employee-related and commercial costs[158](index=158&type=chunk) [Comparison of Six Months Ended June 30, 2024 and June 30, 2025](index=38&type=section&id=Comparison%20of%20Six%20Months%20Ended%20June%2030%2C%202024%20and%20June%2030%2C%202025) | Metric (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Increase (Decrease) | | :-------------------- | :----------------------------- | :----------------------------- | :------------------ | | Product revenues, net | $14,156 | $27,793 | $13,637 | | Cost of product revenues | $4,085 | $8,482 | $4,397 | | Research and development | $5,403 | $8,729 | $3,326 | | Selling, general and administrative | $34,955 | $42,633 | $7,678 | | Loss from operations | $(30,287) | $(32,051) | $1,764 | | Net loss | $(31,198) | $(37,766) | $6,568 | - Product revenues increased by **$13.6 million (96.3%)** due to increased demand for FUROSCIX[165](index=165&type=chunk) - R&D expenses increased by **$3.3 million (61.6%)**, primarily due to pharmaceutical and device development costs[167](index=167&type=chunk) - SG&A expenses increased by **$7.7 million (22.0%)**, mainly driven by employee-related and commercial costs[168](index=168&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=39&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Discusses the company's cash position, expected sufficiency of funds for the next 12 months, anticipated future expenditures, and potential additional funding sources - As of June 30, 2025, the Company had cash and cash equivalents of **$40.8 million**[174](index=174&type=chunk) - Existing cash and cash equivalents, including available proceeds from the Revenue Purchase and Sale Agreement, are expected to be sufficient to meet cash commitments for at least the next **12 months**[174](index=174&type=chunk) - The Company expects to incur substantial additional expenditures for FUROSCIX commercialization (sales force expansion, manufacturing capacity) and research and development[180](index=180&type=chunk) - Additional funding may be sought through equity, royalty-based, or debt financings if needed[180](index=180&type=chunk)[182](index=182&type=chunk) [CASH FLOWS](index=42&type=section&id=CASH%20FLOWS) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(37,928) | $(33,250) | | Net cash provided by investing activities | $29,320 | $0 | | Net cash provided by (used in) financing activities | $298 | $(1,596) | | Net decrease in cash and cash equivalents | $(8,310) | $(34,846) | - Net cash used in operating activities was **$33.3 million** for the six months ended June 30, 2025, primarily due to net loss and increased operating assets[184](index=184&type=chunk) - Net cash provided by investing activities was **$0** for the six months ended June 30, 2025, compared to **$29.3 million** in the prior year[186](index=186&type=chunk) - Net cash used in financing activities was **$1.6 million** for the six months ended June 30, 2025, primarily due to payments on the revenue purchase and sale liability[187](index=187&type=chunk) [CRITICAL ACCOUNTING POLICIES AND ESTIMATES](index=44&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) Confirms no material changes to critical accounting policies and estimates since the last annual report - There have been no material changes to the critical accounting policies and estimates disclosed in the Annual Report on Form 10-K for the six months ended June 30, 2025[189](index=189&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from foreign currency exchange rates, primarily Swiss franc and Euro, which are currently deemed immaterial. Additionally, it faces interest rate sensitivity risk, as the fair value of certain liabilities (term loan and revenue purchase and sale liability) is affected by changes in market interest rates and the company's credit rating, potentially impacting future earnings - The Company is exposed to market risks related to changes in foreign currency exchange rates (principally Swiss franc and Euro) and interest rates[190](index=190&type=chunk)[191](index=191&type=chunk) - The fair value of the term loan and revenue purchase and sale liability, accounted for under the fair value option, will increase as market interest rates decrease and may fluctuate based on the Company's credit rating[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2025 - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of June 30, 2025[194](index=194&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2025[195](index=195&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any legal proceedings or claims expected to materially adversely affect its business or financial condition - The Company is not currently aware of any legal proceedings or claims that are believed to have a material adverse effect on its business, financial condition, or results of operations[197](index=197&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) Updates risk factors, emphasizing the potential adverse impact of new healthcare legislation on marketing approval, commercialization, drug pricing, and reimbursement - Investing in the Company's common stock involves a high degree of risk, with no material changes from previously disclosed risk factors other than those stated[198](index=198&type=chunk) - Recently enacted and future legislation, including the Patient Protection and Affordable Care Act (ACA), American Rescue Plan Act of 2021, and Inflation Reduction Act of 2022 (IRA), may increase the difficulty and cost for obtaining marketing approval and commercializing FUROSCIX, and may affect prices[199](index=199&type=chunk)[203](index=203&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk) - The Inflation Reduction Act of 2022 (IRA) requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates for price increases that outpace inflation, and redesigns the Medicare Part D benefit[205](index=205&type=chunk)[206](index=206&type=chunk) - The One Big Beautiful Bill Act, enacted in July 2025, imposes significant reductions in Medicaid program funding, which could adversely affect FUROSCIX sales[209](index=209&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities or use of proceeds to report[214](index=214&type=chunk) [Item 3. Defaults Upon Senior Securities](index=48&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reports no defaults upon senior securities for the period - No defaults upon senior securities to report[215](index=215&type=chunk) [Item 4. Mine Safety Disclosures](index=48&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[216](index=216&type=chunk) [Item 5. Other Information](index=48&type=section&id=Item%205.%20Other%20Information) Reports no Form 8-K disclosures, no material changes to board nominee procedures, and no Rule 10b5-1 trading arrangements adopted or terminated by directors or officers - No disclosure in lieu of reporting on a Current Report on Form 8-K[217](index=217&type=chunk)[219](index=219&type=chunk) - No material changes to the procedures by which security holders may recommend nominees to the board of directors[219](index=219&type=chunk) - No Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements were adopted or terminated by any director or officer during the three months ended June 30, 2025[219](index=219&type=chunk) [Item 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) Provides an index of exhibits filed with the Quarterly Report, including corporate documents, warrants, certifications, and XBRL documents - The Exhibit Index includes corporate documents (Certificate of Incorporation, By-laws), warrants, certifications (Principal Executive Officer, Principal Financial Officer), and Inline XBRL Document Set[222](index=222&type=chunk) [Signatures](index=51&type=section&id=Signatures) Contains the required signatures for the Quarterly Report on Form 10-Q, confirming its submission - The report was signed on August 7, 2025, by Rachael Nokes, Chief Financial Officer of scPharmaceuticals Inc[228](index=228&type=chunk)