CorMedix Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
CRMD$5.32+1.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-06.
0001213900-25-039908
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001213900-25-072843
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 70 previous paragraphs and 100 current paragraphs.
49 unchanged; 16 reworded; 35 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (35)
Current report
Forward-looking statements involve estimates, expectations, projections, goals, forecasts, assumptions, risks and uncertainties. Actual outcomes or results may differ from anticipated results, sometimes materially. Factors that could cause actual results to differ include, but are not limited to: the ultimate outcome of the acquisition of Melinta; the satisfaction of the conditions to the closing of the proposed transaction in a timely manner; the ability of the combined company to achieve the identified synergies; the ability to integrate the Melinta business into CorMedix and realize the anticipated strategic benefits of the transaction within the expected time-frames or at all; that such integration may be more difficult, time-consuming or costly than expected; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers or suppliers) may be greater than expected following the proposed transaction or the public announcement of the proposed transaction; the retention of certain key employees of Melinta; the expected benefits and success of Melinta’s products and product candidates; potential litigation relating to the potential transaction that could be instituted against CorMedix or its directors; rating agency actions and CorMedix’s ability to access short- and long-term debt markets on a timely and affordable basis; general economic conditions that are less favorable than expected; geopolitical developments and additional changes in international trade policies and relations, including tariffs; and the ability of our products and product candidates to compete effectively against current and future competitors.
Current report
Recent Developments
Current report
On August 7, 2025, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Melinta Therapeutics, LLC, a Delaware limited liability company (“Melinta”), Coriander BidCo LLC, a Delaware limited liability company and a wholly owned subsidiary of the Company (“Merger Sub”), and Deerfield Private Design Fund IV, L.P., a Delaware limited partnership, solely in its capacity as representative, agent and attorney-in-fact of the Melinta equity holders (the “Members’ Representative”).
Current report
Pursuant to the terms of the Merger Agreement, and subject to the conditions contained therein, the Company has agreed to acquire Melinta via a merger in which Merger Sub will merge with and into Melinta (the “Merger”), with Melinta surviving as a wholly owned subsidiary of the Company. The closing of the Merger is referred to herein as the “Closing.”
Current report
The boards of directors of the Company and Melinta have both unanimously approved the proposed transaction, and the requisite members of Melinta, Deerfield Private Design Fund III, L.P. and Deerfield Private Design Fund IV, L.P. (the “Consenting Melinta Members”), have approved the Merger. The Merger is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Clearance”), and the satisfaction of other customary conditions, and the Merger currently is expected to be completed in September 2025.
Current report
Under the terms and subject to the conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time” and the date of the Effective Time, the “Closing Date”), the Company will (i) pay to the Melinta equityholders (including the Consenting Melinta Members) an aggregate of $260 million in cash (subject to adjustment for the Aggregate Exercise Price, Estimated Company Cash, Estimated Company Debt, Estimated Working Capital as compared to the Working Capital Target, and Estimated Transaction Expenses (each as defined in the Merger Agreement)), and (ii) to the Consenting Melinta Members an aggregate of $40 million worth of common shares, par value $0.001 per share, of the Company (the “Merger Shares”) or, at the election of a Consenting Melinta Member, in lieu of any of the Merger Shares it is so entitled to receive, a pre-funded warrant exercisable for such number of Merger Shares (each, a “Merger Warrant”). Additionally, the Consenting Melinta Members and certain Company Optionholders (as defined in the Merger Agreement) will be eligible to receive certain contingent payments pursuant to the terms of the Merger Agreement, the Contingent Payment Agreement (as defined and described below) and the Option Treatment Agreements (as defined in the Merger Agreement). The cash consideration will be funded by a combination of the Company’s existing cash on hand and a $150 million Convertible Notes Offering (as defined below).
Current report
Representations and Warranties; Covenants; Conditions to Closing; Termination
Current report
The Merger Agreement contains a number of representations and warranties made by the Company, Merger Sub and Melinta as of the date of such agreement or other specific dates solely for the benefit of certain of the parties to the Merger Agreement, which in certain cases are subject to specified exceptions and materiality, Company Material Adverse Effect or Parent Material Adverse Effect (each as defined in the Merger Agreement), knowledge and other qualifications contained in the Merger Agreement or in information provided pursuant to certain disclosure schedules to the Merger Agreement. The representations and warranties made under the Merger Agreement will not survive the Closing.
Current report
The Merger Agreement contains certain customary covenants for transactions of this type by the Company and Melinta. None of the covenants and agreements of the parties contained in the Merger Agreement will survive the Closing, except for those covenants and agreements that by their terms expressly apply in whole or in part after the Closing.
Current report
The Merger is subject to various closing conditions, including, but not limited to: (i) HSR Clearance; (ii) the absence of any statute, rule, order, decree or regulation prohibiting the Merger; (iii) the absence of any Parent Material Adverse Effect or Company Material Adverse Effect (each as defined in the Merger Agreement) on the Company or Melinta, respectively; and (iv) the accuracy of the representations and warranties and the compliance by each party with the covenants contained in the Merger Agreement, subject to the materiality standards and exceptions set forth in the Merger Agreement.
Current report
The Merger Agreement may be terminated under certain customary and limited circumstances prior to the closing of the Merger.
Current report
Contingent Payment Agreement
Current report
Pursuant to the terms of the Merger Agreement, simultaneously with the Closing, the Company, Melinta, the Consenting Melinta Members and the Members' Representative will enter into a contingent payment agreement (the "Contingent Payment Agreement"), pursuant to which in connection with the Merger Agreement and as part of the Merger Consideration payable to the Consenting Melinta Members, the Company will make certain payments to the Contingent Payment Holders (as defined in the Contingent Payment Agreement) as described below.
Current report
The Contingent Payment Agreement provides for milestone and net sales based payments. Upon the issuance of the U.S. Food and Drug Administration (“FDA”) marketing approval of (a) the product known as REZZAYOTM (rezafungin) as of the date hereof or as may be modified thereafter, or (b) any product that contains the active ingredient rezafungin, for the prevention or prophylaxis of invasive fungal infections in adult patients undergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029, the Company shall pay, in cash or common shares, par value $0.001 per share, of the Company (“Common Stock”) at the Company’s election, to the Contingent Payment Holders and certain Company Optionholders the following payments:
Current report
Further, the Contingent Payment Agreement provides that the Company will pay to the Contingent Payment Holders tiered royalties on REZZAYOTM (rezafungin) U.S. net sales and low-single-digit royalties on MINOCIN® (minocycline) U.S. net sales.
Current report
Registration Rights Agreement
Current report
Pursuant to the terms of the Merger Agreement, simultaneously with the Closing, the Company and the Consenting Melinta Members will enter into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company will agree to register for resale, pursuant to Rule 415 under the Securities Act, the Merger Shares, the shares of Common Stock issuable upon exercise of any Merger Warrants (the “Merger Warrant Shares”) and other equity securities issued to the Consenting Melinta Members, if any, pursuant to the Contingent Payment Agreement. One third of the Merger Shares and Merger Warrant Shares will be subject to a 60-day lock-up, and one third of Merger Shares and Merger Warrant Shares will be subject to a 120 day lock-up.
Current report
Convertible Notes Offering
Current report
On August 6, 2025, the Company entered into subscription agreements (the “Subscription Agreements”) with certain investors to provide for the issuance of $150,000,000 aggregate principal amount of its convertible senior notes due 2030 (the “Notes”) in a private placement, exempt from registration pursuant to Section 4(a)(2) of the Securities Act. Such offering is herein referred to as the “Convertible Notes Offering.” Upon issuance, the Notes will be eligible for resale to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A of the Securities Act. Subject to the terms and conditions of the Subscription Agreements, the Company expects the Notes to be issued on August 12, 2025 (the “Notes Closing Date”).
Current report
Upon issuance, the Notes will be governed by an Indenture (the “Indenture”), by and between the Company and U.S. Bank Trust Company, National Association, as trustee (in such capacity, the “Trustee”). Upon issuance, the Notes will bear interest at a rate of 4.00% per annum, payable semi-annually in arrears on February 1 and August 1 of each year, commencing on February 1, 2026. The Notes will mature on August 1, 2030 (the “Maturity Date”) and will be senior, unsecured obligations of the Company.
Current report
Following issuance of the Notes, the Company intends to use the net proceeds from the Convertible Notes Offering to fund a portion of the purchase price payable in connection with the Merger, including related fees and expenses, and to the extent there are any remaining proceeds in excess of the funds needed for the forgoing purposes, for such other general corporate purposes as the Company determines as appropriate.
Current report
The Company has the option to redeem all, but not part, of the Notes if the Company publicly announces that the Merger Agreement has been terminated or that the Merger will not otherwise be consummated (the “Melinta Acquisition Redemption” and on such date, the “Melinta Acquisition Redemption Date”), at a redemption price equal to the greater of (i) 102% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the Melinta Acquisition Redemption Date, and (ii) the sum of (a) 100% of the principal amount of such Notes, plus accrued and unpaid interest, if any, to but excluding, the Melinta Acquisition Redemption Date plus (b) 70% of the difference, if positive, between the Melinta Acquisition Redemption Conversion Value and the Initial Conversion Value (each such term as defined in the Indenture).
Current report
In addition, on or after August 4, 2028 and prior to the 26 th Scheduled Trading Day (as defined in the Indenture) immediately preceding the Maturity Date, the Company may redeem for cash all or any portion of the Notes, at its option, subject to certain conditions and requirements set forth in the Indenture, if the last reported sale price of the Company’s Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which it provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.
Current report
If the Company experiences a Fundamental Change (as defined in the Indenture) at any time prior to the Maturity Date, any holder of the Notes may require the Company to repurchase all of such holder’s Notes, or any portion of the principal amount thereof equal to $1,000 or an integral multiple of $1,000, at a repurchase price equal to 100% of the principal amount of such Notes, respectively, plus accrued and unpaid interest, if any, to, but excluding, the date of repurchase.
Current report
Following issuance of the Notes, the Notes will be convertible at the option of the holders (i) during any calendar quarter commencing after the calendar quarter ending on September 30, 2025 (and only during such calendar quarter), if the closing price of the Common Stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is equal to or greater than 130% of the applicable conversion price per share, which is $1,000 divided by the then applicable conversion rate, on each applicable trading day, (ii) if the Company calls any or all of the Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; (iii) upon the occurrence of specified corporate events; or (iv) during the five business day period after any five consecutive trading day period (the “Measurement Period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the Measurement Period was less than 98% of the product of the last reported sale price of the Common Stock and the applicable conversion rate in effect on each such trading day. On or after May 1, 2030 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.
Current report
Upon conversion, the Company will satisfy its conversion obligation by paying or delivering, as the case may be, cash, shares of the Company’s Common Stock or a combination of cash and shares of Common Stock, at the Company’s election (provided that for so long as the Exchange Cap (as defined in the Indenture) applies, the Company may only elect Cash Settlement or Capped Combination Settlement (as such terms are defined in the indenture)), in the manner and subject to the terms and conditions provided in the Indenture. Notwithstanding the foregoing, prior to receipt of approval from the Company’s stockholder in accordance with Nasdaq rules, the Company will not issue any shares of Common Stock under the Indenture (including any shares issued pursuant to conversions of the Notes), together with any transactions aggregated with the foregoing (including any issuance of shares (including Merger Warrant Shares) contemplated by the Merger Agreement and any issuance of shares (including Merger Warrant Shares) pursuant to the Contingent Payment Agreement), if the issuance of such shares of Common Stock would exceed 19.99% of the aggregate number of shares of Common Stock issued and outstanding as of August 6, 2025.
Current report
The conversion rate for the Notes will be determined upon issuance in accordance with the Indenture, and will be equal to an amount (rounded to four decimal places) equal to (i) $1,000 divided by (ii) the greater of (x) 130% of the arithmetic average of the Daily VWAP (as defined in the Indenture) on each of the three consecutive trading days beginning on, and including, the trading day immediately after the public announcement of the execution of the Merger Agreement (i.e., August 7, 2025) and (y) 110% of the lowest bona fide sale price of the Common Stock on any national securities exchange or automated interdealer quotation system on August 6, 2025.
Current report
The conversion rate is subject to adjustment under certain circumstances in accordance with the Indenture. In connection with certain corporate events or if the Company issues a notice of redemption, it will, under certain circumstances, increase the conversion rate for holders who elect to convert their Notes in connection with such corporate event or during the relevant redemption period.
Current report
Follow-On Offering
Current report
On June 30, 2025, the Company completed an underwritten public offering of common stock pursuant to the Company’s universal shelf registration statement on Form S-3, selling an aggregate of 6,604,507 shares, at the price of $12.87 per share less an underwriting discount of $0.229 per share. The Company received aggregate net proceeds of approximately $82.4 million after deducting the underwriting discounts and commissions and offering expenses payable by the Company. The Company intends to use the proceeds for general corporate purposes, which may include working capital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions, joint ventures or collaborations, involving companies, products or assets that complement our business. No payments were made by the Company to directors, officers or persons owning 10% or more of the Company’s common stock or to their associates, or to the Company’s affiliates.
Current report
*Selling and Marketing Expense.*S&M expense was $6.4 million for the three months ended June 30, 2025, a decrease of $1.0 million, or 14%, from $7.4 million for the same period in 2024. S&M expense was $10.9 million for the six months ended June 30, 2025, a decrease of $2.8 million, or 21%, from $13.7 million for the same period in 2024. These decreases were primarily due to additional marketing costs related to the pre-launch and launch of DefenCath in 2024.
Current report
General and Administrative Expense. G&A expense for the three ended June 30, 2025 was $9.5 million, an increase of $1.9 million, or 25%, from $7.6 million for the same period in 2024. G&A expense for the six months ended June 30, 2025 was $19.2 million, an increase of $2.9 million, or 18%, from $16.3 million for the same period in 2024. The increase for the three months ended June 30, 2025, was primarily driven by the non-cash charges for stock-based compensation of $1.1 million and an increase in costs related to business development of $0.5 million. The increase for the six months ended June 30, 2025 was primarily due to non-cash charges for stock-based compensation of $2.4 million and an increase in costs related to business development of $0.3 million.
Current report
On June 30, 2025, the Company completed an underwritten public offering of common stock pursuant to the Company’s universal shelf registration statement on Form S-3, selling an aggregate of 6,604,507 shares, at the price of $12.87 per share less an underwriting discount of $0.229 per share. The Company received aggregate net proceeds of approximately $82.4 million after deducting the underwriting discounts and commissions and offering expenses payable by the Company. The Company intends to use the proceeds for general corporate purposes, which may include working capital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions, joint ventures or collaborations, involving companies, products or assets that complement our business. No payments were made by the Company to directors, officers or persons owning 10% or more of the Company’s common stock or to their associates, or to the Company’s affiliates.
Current report
During the six months ended June 30, 2025, we received net proceeds of approximately $1.5 million through the issuance of 368,959 shares of common stock related to the exercise of stock options.
Current report
Variable consideration pertaining to accrued Medicaid rebates requires estimation as our customers may have differing utilizations rates of Medicaid coverage, different utilization within States which may be in either the primary or secondary positions, together with as well as general fluctuations in patient populations over time. Based on the relatively short time since product launch and the inherent lag time in State Medicaid processing, the utilization information the Company has received is limited and, as such, , there is a lack of significant historical trends for Medicaid utilization. The Company’s accrual does take into consideration its customers’ recent actual Medicaid utilization rates as well as anticipated Medicaid utilization rates. At June 30, 2025, the Company had $3.8 million in accrued Medicaid rebates. During the three and six months ended June 30, 2025, a change in estimate was recorded for variable consideration pertaining to Medicaid and commercial rebates. During the three months ended June 30, 2025, new information was obtained by the Company surrounding Medicaid utilization rates for certain states that reimburse service providers using DefenCath. The resulting change in accounting estimate negatively impacted net sales, income from continuing operations and net income for the three and six months ended June 30, 2025. For the three months ended June 30, 2025, net income was impacted by $2,029,000, basic and diluted earnings per share were negatively impacted by $0.03 and $0.02 cents per share, respectively, which would have caused earnings per share and diluted earnings per share to be $0.32 and $0.30, respectively. Excluding the impact of the change in accounting estimate, net income would have been $21,856,000. The resulting change in estimate negatively impacts year to date revenue, continuing operations and net income in the amount of $1,695,000. Basic and diluted earnings per share were negatively impacted by $0.02 cents per share, which would have caused earnings per share and diluted earnings per share to be $0.62 and $0.60, respectively. Excluding the impact of the change in accounting estimate, net income would have been $42,167,000.
Removed paragraphs (5)
Previous report
*Selling and Marketing Expense.*S&M expense was $4.5 million for the three months ended March 31, 2025, a decrease of $1.8 million, or 29%, from $6.3 million for the same period in 2024. This decrease is considered temporary as we severed our internal sales force in early January 2025, while the related severance costs were recognized in the fourth quarter of 2024. Costs associated with our newly established outsourced sales force have been ramping throughout the period ended March 31, 2025. We expect these costs to be normalized for the second quarter of 2025 and to be more closely in-line with the comparison period.
Previous report
General and Administrative Expense. G&A expense for the three months ended March 31, 2025 was $9.7 million, an increase of $1.0 million, or 11%, from $8.7 million for the same period in 2024. The increase was driven by non-cash charges for stock-based compensation of $1.3 million offset by a decrease in medical affairs of $0.3 million.
Previous report
● Litigation contingencies are assessed and judgments are made to determine if an unfavorable outcome is considered probable or reasonably possible, and when considered reasonably possible but not probable, the contingency is disclosed along with an estimate of the possible loss or range of loss. If a liability is possible or probable, but no reasonable estimation of loss can be made, we will disclose the nature of the contingency and state that such an estimate cannot be made. Such estimates and judgements are based on information obtained through the discovery process, court filings and follow on filings by the plaintiffs as well as the stage of litigation. There have been no changes in management’s estimates through the filing of this Form 10-Q.
Previous report
● We account for product revenue from the sale of our product, DefenCath, in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”) which entails our estimates and judgments primarily in determining the transaction price and more specifically as it relates to variable consideration associated with the contracts. Our customers are located in the United States and consist primarily of outpatient service providers and to a lesser extent specialty wholesale distributors. Variable consideration pertaining to an allowance for product returns of short-dated or expired product requires estimation as our customers may have differing utilization, storage and distribution methods and we do not yet have significant historical trends. The Company’s product accrual takes into consideration estimates of product held by its customers, the distribution channel, the shelf life of the product held by customers, as well as when the product is eligible for return based on our returns good policy. At March 31, 2025, the Company had $1.4 million in accrued returns allowance. We have established the estimate for returns based on specific customer circumstances, industry best practices and management experiences. Once return windows open and we experience actual returns we will further refine our estimate methods.
Previous report
● As of March 31, 2025, we continue to maintain a full valuation allowance against our deferred tax assets. While we generated taxable income in the current quarter and may be profitable for the full year, we believe that a full valuation allowance remains appropriate due to the uncertainty pertaining to the full year level of forecasted profitability as compared to our recent historical losses. We will continue to evaluate all available evidence, both positive and negative, in future periods. A sustained trend of profitability could result in a reduction of the valuation allowance, which would favorably impact our effective tax rate.
Reworded paragraphs (16)
Previous wording
Subsequent to the launch of DefenCath in April 2024, we announced U.S.-based multi-year commercial supply agreements consisting of a large and several mid-sized dialysis organizations. Each provider has customized an implementation plan to provide access to patients based on a variety of clinical and other factors. We believe the currently contracted customer base represents roughly 60% of the outpatient dialysis centers in the U.S., in terms of the total addressable patient market.
Current wording
Subsequent to the launch of DefenCath in April 2024, we announced U.S.-based multi-year commercial supply agreements consisting of a large and several mid-sized dialysis organizations. Each provider has customized an implementation plan to provide access to patients based on a variety of clinical and other factors. We believe the currently contracted customer base represents roughly 60% of the outpatient dialysis centers in the U.S., in terms of the total addressable patient market. During the second quarter of 2025, the Company’s large dialysis organization customer commenced ordering.
Previous wording
We generate product revenue from commercial sales of DefenCath to a limited number of direct customers as well as distributors. Revenue from product sales is recognized when our direct customers obtain control of the product and is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns and rebates. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary materially from our estimates, we will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted.
Current wording
We generate product revenue from commercial sales of DefenCath to a limited number of direct customers as well as distributors. Revenue from product sales is recognized when our direct customers obtain control of the product and is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns, rebates, shelf-stock adjustments and data fees. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary materially from our estimates, we will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted.
Previous wording
Comparison of the Three Months Ended March 31, 2025 and 2024
Current wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Previous wording
The following is a tabular presentation of our consolidated operating results for the three months ended March 31, 2025 and 2024*(in thousands)*:
Current wording
The following is a tabular presentation of our consolidated operating results for the three and six months ended June 30, 2025 and 2024*(in thousands)*:
Previous wording
*Revenue.*Revenue for the three months ended March 31, 2025 was $39.1 million as compared to $0 for the same period in 2024. Revenue consists of sales of DefenCath, which was approved by the FDA in November 2023 and launched in the U.S in April 2024 (inpatient setting) and July 2024 (outpatient setting) and reflects the shipment of DefenCath to direct customers and specialty distributors, net of estimates for applicable variable consideration, which consists primarily of distribution service fees, prompt pay and other discounts, product returns, chargebacks, rebates and volume incentive rebates.
Current wording
*Revenue.*Revenue for the three months ended June 30, 2025 was $39.7 million as compared to $0.8 million for the same period in 2024, an increase of $38.9 million, or 4,829%. Revenue for the six months ended June 30, 2025 was $78.8 million as compared to $0.8 million for the same period in 2024, an increase of $78.0 million, or 9,678%. Revenue consists of sales of DefenCath, which was approved by the FDA in November 2023 and launched in the U.S in April 2024 (inpatient setting) and July 2024 (outpatient setting) and reflects the shipment of DefenCath to direct customers and specialty distributors, net of estimates for applicable variable consideration, which consists primarily of distribution service fees, prompt pay and other discounts, product returns, chargebacks, rebates and volume incentive rebates, shelf-stock adjustments and data fees.
Previous wording
*Cost of Revenue.*Cost of revenue for the three months ended March 31, 2025 was $1.6 million as compared to $0.8 for the same period in 2024. Cost of revenues include direct and indirect costs related to the manufacturing and distribution of DefenCath, including product cost, packaging services, freight, amortization of the license intangible asset and an allocation of overhead costs that are primarily fixed such as salaries, benefits and insurance. No product costs were recognized in the period ended March 31, 2024, the costs recognized pertained to indirect costs related to the proportion of supply chain and quality personnel, benefits and insurance expenses, representing excess capacity in the production of sellable product. As unit sales increase, a greater proportion of these costs will be capitalized as a component of inventory and expensed at the point-of-sale.
Current wording
*Cost of Revenue.*Cost of revenue for the three months ended June 30, 2025 was $1.9 million as compared to $0.5 million for the same period in 2024, an increase of $1.4 million, or 265%. Cost of revenue for the six months ended June 30, 2025 was $3.5 million as compared to $1.3 million for the same period in 2024, an increase of $2.2 million, or 160%. Cost of revenues include direct and indirect costs related to the manufacturing and distribution of DefenCath, including product cost, packaging services, freight, amortization of the license intangible asset and an allocation of overhead costs that are primarily fixed such as salaries, benefits and insurance. Product costs during the three and six month periods ended June 30, 2024 were minimal, and the costs recognized pertained to indirect costs related to the proportion of supply chain and quality personnel, benefits and insurance expenses, representing excess capacity in the production of sellable product. As unit sales increase, a greater proportion of these costs will be capitalized as a component of inventory and expensed at the point-of-sale. The current cost of goods sold excludes certain API that was previously expensed as R&D prior to the approval of DefenCath. We continue to utilize certain previously expensed API and expect to sell through the related inventory in the second half of 2026.
Previous wording
Research and Development Expense. R&D expense for the three months ended March 31, 2025 was $3.2 million, an increase of $2.4 million, or 281%, from $0.8 million for the same period in 2024. The increase was due primarily to the increase in personnel and clinical trial services in support of the ongoing clinical studies initiated in the fourth quarter of 2024.
Current wording
Research and Development Expense*. R&D expense for the three months ended June 30, 2025 was $2.4 million, an increase of $1.7 million, or 275%, from $0.7 million for the same period in 2024. R&D expense for the six months ended June 30, 2025 was $5.6 million, an increase of $4.1 million, or 279%, from $1.5 million for the same period in 2024. These increases were due primarily to the increases in personnel and clinical trial services in support of the ongoing clinical studies initiated in the fourth quarter of 2024.
Previous wording
Interest Income. Interest income was $0.6 million for the three months ended March 31, 2025 compared to $0.8 million for the same period last year, a decrease of $0.2 million, or 25%. The decrease was attributable to lower average interest rates during this period as compared to the same period last year.
Current wording
Interest Income. Interest income was $0.8 million for the three months ended June 30, 2025 compared to $0.7 million for the same period last year, an increase of $0.1 million, or 26%, primarily driven by higher average cash balances. Interest income was $1.4 million for the six months ended June 30, 2025 compared to $1.5 million for the same period last year, a decrease of $0.1 million, or 8%, primarily driven by lower average interest rates.
Previous wording
Foreign Exchange Transaction Income (Loss). Foreign exchange transaction income (loss) for the three months ended March 31, 2025 and 2024 were due to the re-measuring of transactions denominated in a currency other than our functional currency. Balances and changes were immaterial for all periods presented.
Current wording
Foreign Exchange Transaction Income (Loss). Foreign exchange transaction income (loss) for the three and six months ended June 30, 2025 and 2024 were due to the re-measuring of transactions denominated in a currency other than our functional currency. Balances and changes were immaterial for all periods presented.
Previous wording
*Tax Benefit.*Tax benefit for the three months ended March 31, 2024 of $1.4 million, was due to the sale of our unused NJ State net operating losses for fiscal year 2023, which were sold in fiscal year 2024, through the NJEDA Program. No net operating losses were sold during the three months ended March 31, 2025, or planned to be sold pertaining to unused net operating losses for fiscal year 2024.
Current wording
Tax (Expense) Benefit. Tax expense for the three and six months ended June 30, 2025 of $0.5 million, is primarily related to the Company’s earnings and expected state tax profile for the period.* *Tax benefit for the six months ended June 30, 2024 of $1.4 million, was due to the sale of our unused NJ State net operating losses for fiscal year 2023, which were sold in fiscal year 2024, through the NJEDA Program. No net operating losses were sold during the six months ended June 30, 2025, or planned to be sold pertaining to unused net operating losses for fiscal year 2024.
Previous wording
We achieved profitability in the fourth quarter of 2024 and the first quarter of 2025, driven by product sales of DefenCath. During the three months ended March 31, 2025, we received net proceeds of $6.8 million from the issuance of 620,444 shares of common stock under our at-the-market-issuance sales agreement, or ATM program. We may continue to utilize external sources of cash to further fund operations.
Current wording
We achieved profitability for the three and six months ended June 30, 2025, driven by product sales of DefenCath. During the six months ended June 30, 2025, we received net proceeds of $6.8 million from the issuance of 620,444 shares of common stock under our at-the-market-issuance sales agreement, or ATM program. We may continue to utilize external sources of cash to further fund operations.
Previous wording
Net cash provided by operating activities for the three months ended March 31, 2025 was $19.7 million as compared to net cash used in operating activities of $17.3 million for the same period in 2024. Net cash provided by operating activities was attributable to the net income of $20.6 million for the three months ended March 31, 2025 compared to a net loss of $14.5 million in the comparison period in 2024. There were also increases in trade receivables and prepaid expenses and other current assets of $2.9 million and $1.0 million, respectively, during the three months ended March 31, 2025. These increases are partially offset by net increases in accounts payable and accrued expenses in an aggregate amount of $4.4 million.
Current wording
Net cash provided by operating activities for the six months ended June 30, 2025 was $49.7 million as compared to net cash used in operating activities of $31.4 million for the same period in 2024. Net cash provided by operating activities was primarily attributable to the net income of $40.5 million for the six months ended June 30, 2025 compared to a net loss of $28.6 million in the comparison period in 2024, and a decrease in trade receivables of $8.9 million.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2025 was $0.2 million as compared to $8.9 million of net cash provided by investing activities for the same period in 2024. The net cash used during the three months ended March 31, 2025, was mainly driven by lower maturity of the amount invested in short-term investments, as compared to the same period in 2024.
Current wording
Net cash used in investing activities for the six months ended June 30, 2025 was $20.4 million as compared to $15.2 million of net cash provided by investing activities for the same period in 2024. The net cash used during the six months ended June 30, 2025, was mainly driven by increased short-term investments, as compared to the same period in 2024, offset by lower maturities of short-term investments.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $6.1 million due to the net proceeds generated from the sale of our common stock in our ATM program, partially offset by payments of employee withholding taxes for vested restricted stock units of $1.0 million. Net cash used in financing activities for the three months ended March 31, 2024 was $0.1 million attributable to the payment of employee withholding taxes for vested restricted stock units.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $89.3 million due to the net proceeds generated from the sale of our common stock in the underwritten offering and in our ATM program of $82.4 million and $6.8 million, respectively. Net cash provided by financing activities for the six months ended June 30, 2024 was $1.0 million attributable to the net proceeds received from the sale of our common stock in our ATM program.
Previous wording
Our total cash, cash equivalents and short-term investments as of March 31, 2025, was $77.5 million, excluding restricted cash of $0.1 million, compared with $51.7 million as of December 31, 2024, excluding restricted cash of $0.1 million. As of March 31, 2025, $23.2 million of the Company’s common stock remains available for potential sale under the ATM program. Additionally, we have $100.0 million of remaining capacity available under our 2024 Shelf Registration Statement for the issuance of Company securities.
Current wording
Our total cash, cash equivalents and short-term investments as of June 30, 2025, was $190.7 million, excluding restricted cash of $0.1 million, compared with $51.7 million as of December 31, 2024, excluding restricted cash of $0.1 million. As of June 30, 2025, $23.2 million of the Company’s common stock remains available for potential sale under the ATM program. Additionally, we have $15.0 million of remaining capacity available under our 2024 Shelf Registration Statement for the issuance of Company securities, after taking effect of the $85.0 million public offering that closed on June 30, 2025.
Previous wording
In December 2024, we entered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos will provide a dedicated inpatient field sales force that will exclusively promote DefenCath to hospitals and health systems. We have paid an up-front implementation fee and are obligated to pay a fixed monthly fee. Upon the twelve-month anniversary of the deployment date, expected to be in the second quarter of 2026, the agreement is cancelable upon 60 day’s written notice. As of March 31, 2025, the minimum amount committed under this agreement totals $9.1 million.
Current wording
In December 2024, we entered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos will provide a dedicated inpatient field sales force that will exclusively promote DefenCath to hospitals and health systems. We have paid an up-front implementation fee and are obligated to pay a fixed monthly fee. Upon the twelve-month anniversary of the deployment date, expected to be in the second quarter of 2026, the agreement is cancelable upon 60 day’s written notice. As of June 30, 2025, the minimum amount committed under this agreement totals $7.8 million.