CorMedix Inc.

Previous wording

On July 1, 2026, DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients will significantly decline, and as a result, CorMedix expects a corresponding reduction to its net pricing for DefenCath in the second half of 2026. We currently estimate, based on the known CMS methodology for calculation of the post TDAPA Add-on, that the 2027 payment could increase meaningfully above the payment rate for the second half of 2026.

Current wording

On July 1, 2026, DefenCath’s TDAPA reimbursement transitioned into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients significantly declined, and as a result, CorMedix expects a corresponding reduction to its net pricing, resulting in lower net sales, for DefenCath in the second half of 2026 relative to historical periods. We currently estimate, based on the known CMS methodology for calculation of the post TDAPA Add-on, that the 2027 payment could increase meaningfully above the payment rate for the second half of 2026.

Previous wording

Comparison of the Three Months Ended March 31, 2026 and 2025.

Current wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025.

Previous wording

The following is a tabular presentation of our unaudited consolidated operating results for the three months ended March 31, 2026 and 2025(in thousands):

Current wording

The following is a tabular presentation of our unaudited condensed consolidated operating results for the three and six months ended June 30, 2026 and 2025(in thousands):

Previous wording

For the three months ended March 31, 2026 and 2025, Product Sales were $121.9 million and $39.1 million, respectively, representing an increase of $82.8 million or 212%. The increase is primarily due to sustained DefenCath demand, including with the onboarding of our large dialysis customer mid-last year, along with the addition of Melinta revenue. Product Sales during the periods consist primarily of sales of DefenCath 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, and includes a change in accounting estimate for Medicaid and returns' sales allowances of $9.0 million during the three months ended March 31, 2026. Revenue from the Melinta Portfolio represents $24.4 million of product sales in the first quarter of 2026, reflecting typical first quarter purchasing patterns for the Melinta Portfolio, including the impact of lower wholesaler channel inventory levels at the end of the first quarter of 2026 relative to the fourth quarter of 2025.

Current wording

For the three months ended June 30, 2026 and 2025, Product sales were $94.3 million and $39.7 million, respectively, representing an increase of $54.6 million or 137%. For the six months ended June 30, 2026 and 2025, Product sales were $216.3 million and $78.8 million, respectively, representing an increase of $137.4 million or 174%. The increase was primarily due to sustained DefenCath demand, including with the onboarding of our large dialysis customer mid-last year, along with the addition of Melinta revenue. Product sales during the periods consist primarily of sales of DefenCath 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, and includes a change in accounting estimate for Medicaid and returns' sales allowances of zero and $9.0 million during the three and six months ended June 30, 2026, respectively. Revenue from the Melinta Portfolio represents $28.2 million and $52.6 million of product sales in the three and six months ended June 30, 2026. The six-month Melinta Portfolio revenue reflects typical purchasing patterns for the relevant period, including the impact of lower wholesaler channel inventory levels at the end of the second quarter of 2026 relative to the fourth quarter of 2025.

Previous wording

Contract Revenue reflects $2.4 million earned under the BARDA agreement and $3.1 million related to milestone, royalty, and inventory revenue under Melinta’s licensing agreements.

Current wording

Contract revenue reflects $5.0 million and $8.0 million, respectively, related to milestone, royalty, and inventory revenue under Melinta’s licensing agreements for the three and six months ended June 30, 2026. There was no contract revenue for the three and six months ended June 30, 2025.

Previous wording

Cost of Sales for the three months ended March 31, 2026 was $12.0 million as compared to $1.5 million for the same period in 2025, an increase of $10.5 million, or 677%. Cost of revenues include direct and indirect costs related to the manufacturing and distribution of DefenCath and Melinta Portfolio, including product cost, packaging services, freight, and an allocation of overhead costs that are primarily fixed such as salaries, benefits and insurance. The increase from 2025 to 2026 is primarily due to higher product sales, driven by higher volume of DefenCath sales and the acquisition of Melinta in August 2025.

Current wording

Cost of Sales for the three months ended June 30, 2026 was $14.5 million as compared to $1.8 million for the same period in 2025, an increase of $12.7 million, or 701%. Cost of sales for the six months ended June 30, 2026 was $26.5 million compared to $3.4 million in 2025, an increase of $23.1 million, or 690%. Cost of revenues include direct and indirect costs related to the manufacturing and distribution of DefenCath and Melinta Portfolio, including product cost, packaging services, freight, and an allocation of overhead costs that are primarily fixed such as salaries, benefits and insurance. The increase from 2025 to 2026 is primarily due to higher product sales, driven by higher volume of DefenCath sales and the acquisition of Melinta in August 2025.

Previous wording

Intangible Asset Amortization was $10.3 million and $0.1 million for the three months ended March 31, 2026 and March 31, 2025, respectively. The increase was primarily due to the intangible assets acquired as part of the merger completed in the third quarter of 2025.

Current wording

Intangible Asset Amortization was $10.3 million and $0.1 million for the three months ended June 30, 2026 and June 30, 2025, an increase of $10.2 million, or 19,708%, respectively. Intangible asset amortization for the six months ended June 30, 2026 was $20.6 million compared to $0.1 million in 2025, respectively, an increase of $20.5 million or 19,708%, respectively. The increase was due to the intangible assets acquired in connection with the acquisition of Melinta completed in the third quarter of 2025.

Previous wording

Research and Development Expense ("R&D") expense for the three months ended March 31, 2026 was $7.2 million, an increase of $4.0 million, or 126%, from $3.2 million for the same period in 2025. The increase was driven primarily by increased personnel and clinical trial services related to pediatric programs for certain Melinta portfolio products, as well as activities supporting additional DefenCath indications.

Current wording

Research and Development Expense ("R&D") expense for the three months ended June 30, 2026 was $6.7 million, an increase of $4.3 million, or 174%, from $2.4 million for the same period in 2025. R&D expense for the six months ended June 30, 2026 was $13.9 million compared to $5.6 million in 2025, an increase of $8.3 million or 147%. The increase was driven primarily by increased personnel and clinical trial services related to pediatric programs for certain Melinta portfolio products, as well as activities supporting additional DefenCath indications.

Previous wording

Selling and Marketing Expense ("S&M") expense was $12.5 million for the three months ended March 31, 2026, an increase of $8.0 million, or 180%, from $4.5 million for the same period in 2025. The increase was primarily due to higher personnel cost associated with the larger product portfolio and marketing programs resulting from our acquisition of Melinta.

Current wording

Selling and Marketing Expense ("S&M") expense was $12.4 million for the three months ended June 30, 2026, an increase of $6.1 million, or 95%, from $6.4 million for the same period in 2025. S&M expense for the six months ended June 30, 2026 was $25.0 million compared to $10.9 million, an increase of $14.1 million, or 130%. The increase was primarily due to higher personnel cost associated with the larger product portfolio and marketing programs resulting from our acquisition of Melinta.

Previous wording

General and Administrative Expense("G&A") expense for the three months ended March 31, 2026 was $21.7 million, an increase of $12.0 million, or 124%, from $9.7 million for the same period in 2025. The increase was primarily attributable to higher costs associated with operating as a combined company following the merger, including increased facilities, personnel, patent-related costs, information technology infrastructure, and Prescription Drug User Fee Act (“PDUFA”) fees. In addition, general and administrative expense increased due to higher branded prescription drug fees driven by growth in product sales, as well as higher litigation-related costs.

Current wording

General and Administrative Expense("G&A") expense for the three months ended June 30, 2026 was $15.1 million, an increase of $5.6 million, or 59%, from $9.5 million for the same period in 2025. G&A expenses for the six months ended June 30, 2026 was $36.8 million, an increase of $17.6 million, or 92% from the six months ended June 30, 2025 of $19.2 million. The increase was primarily attributable to higher costs associated with operating as a combined company following the merger, including increased facilities, personnel, patent-related costs, information technology infrastructure, and Prescription Drug User Fee Act (“PDUFA”) fees. In addition, general and administrative expense increased due to higher branded prescription drug fees driven by growth in product sales. The increase was partially offset by the recognition of $4.2 million of loss recoveries during the three months ended June 30, 2026, associated with amounts expected to be reimbursed for incurred, qualified litigation-related legal fees under the Company's insurance coverage supporting its ongoing securities litigation. Of the $4.2 million, $2.4 million and $1.5 million, respectively, relates to qualified legal fees incurred in the first quarter of 2026 and the second quarter of 2026.

Previous wording

Unrealized loss on marketable security represents the change in fair value for its marketable equity securities in Talphera, a publicly-traded biotechnology company. For the three months ended, March 31, 2026, we recognized a $3.5 million loss related to the decrease in fair value of the Talphera stock.

Current wording

Unrealized loss on marketable security represents the change in fair value for its marketable equity securities in Talphera, a publicly-traded biotechnology company. For the three months and six months ended, June 30, 2026, we recognized a $2.5 million gain and $1.0 million loss respectively related to the change in fair value of the Talphera stock. As the investment was purchased in the third quarter of 2025, there was no comparative amount in 2025.

Previous wording

Change in contingent considerationfor the three months ended March 31, 2026, we recognized change in the fair value of contingent consideration of $4.2 million, primarily driven by the changes in the present value of expected payments resulting from discount accretion. As the merger closed in the third quarter of 2025, there was no comparative amount in the three months ended March 31, 2025.

Current wording

Change in contingent considerationfor the three and six months ended June 30, 2026, we recognized change in the fair value of contingent consideration of $6.7 million and $10.9 million, primarily driven by the changes in the present value of expected payments resulting from discount accretion. As the merger closed in the third quarter of 2025, there was no comparative amount in 2025.

Previous wording

Other non-operating (expense) incomewas $0.3 million of expense for the three months ended March 31, 2026 compared to $0.5 million of income for the same period last year, a decrease of $0.8 million. The change was primarily due to interest expense on our $150.0 million aggregate principal amount of convertible senior notes due 2030, which were issued during the third quarter of 2025, and partially offset by interest income on cash and short-term investments.

Current wording

Other non-operating (expense) incomewas $0.1 million of expense for the three months ended June 30, 2026 compared to $0.8 million of income for the same period last year, a decrease of $0.9 million, or 109%. Other non-operating (expense) income for the six months ended June 30, 2026 was $0.3 million of expense compared to $1.3 million of income for the same period last year, a decrease of $1.7 million, or 126%. The change was primarily due to interest expense on our $150.0 million aggregate principal amount of convertible senior notes due 2030, which were issued during the third quarter of 2025, and partially offset by interest income on cash and short-term investments.

Previous wording

Tax Expensewas $17.0 million for the three months ended March 31, 2026, compared to $0.0 million for the same period in the prior year. The tax expense for the current period reflects estimated federal and state income taxes. In contrast, no income tax expense was recorded for the three months ended March 31, 2025, as the Company maintained a full valuation allowance against its deferred tax assets during that period.

Current wording

Tax Expensewas $12.7 million for the three months ended June 30, 2026, compared to $0.5 million for the same period in the prior year. Tax expense for the six months ended June 30, 2026 was $29.8 million compared to $0.5 million in the same period of 2025. The tax expense for the current period reflects estimated federal and state income taxes. In contrast, the prior year only reflected state tax as the company had a full valuation allowance against its federal tax basis.

Previous wording

As of March 31, 2026, we had cash, cash equivalents and short-term investments of $178.1 million, excluding restricted cash of $1.0 million, compared to $148.5 million as of December 31, 2025, excluding restricted cash of $1.0 million. Our primary sources of liquidity continue to be cash generated from operations, cash on hand, and available capital raising capacity. As of March 31, 2026, $22.1 million of our common stock remained available for potential sale under our at-the-market issuance sales agreement, and $15.0 million remained available under our shelf registration statement.

Current wording

As of June 30, 2026, we had cash, cash equivalents and short-term investments of $256.7 million, excluding restricted cash of $1.0 million, compared to $148.5 million as of December 31, 2025, excluding restricted cash of $1.0 million. Our primary sources of liquidity continue to be cash generated from operations, cash on hand, and available capital raising capacity. As of June 30, 2026, $22.1 million of our common stock remained available for potential sale under our at-the-market issuance sales agreement, and $15.0 million remained available under our shelf registration statement.

Previous wording

Net cash provided by operating activities for the three months ended March 31, 2026 was $42.4 million, compared to $19.7 million for the three months ended March 31, 2025. Cash flows from operating activities were primarily driven by net income, adjusted for non-cash items, and changes in working capital, including accounts receivable, inventory and accrued liabilities. The period-over-period change was primarily attributable to higher net income driven by product sales.

Current wording

Net cash provided by operating activities for the six months ended June 30, 2026 was $128.6 million, compared to $49.7 million for the six months ended June 30, 2025. Cash flows from operating activities were primarily driven by net income, adjusted for non-cash items, and changes in working capital, including accounts receivable, inventory and accrued liabilities. The period-over-period change was primarily attributable to higher net income driven by product sales.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2026 was $3.0 million, compared to $0.2 million used in investing activities for the three months ended March 31, 2025. Investing activities during the period primarily consisted of proceeds from short-term investments converted into cash partially offset by capital expenditures to support the validation of new contract manufacturing organizations in connection with our initiatives to lower our products' costs of goods as well as to onshore the manufacture of our products, compared to the prior-year period, which did not include significant transactions.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2026 was $2.4 million, compared to $20.4 million used in investing activities for the six months ended June 30, 2025. Investing activities during the period primarily consisted of proceeds from short-term investments converted into cash partially offset by capital expenditures to support the validation of new contract manufacturing organizations in connection with our initiatives to lower our products'

Previous wording

Net cash used in financing activities for the three months ended March 31, 2026 was $12.1 million, compared to $6.1 million in cash provided by financing activities in the three months ended March 31, 2025. Financing activities during the current period primarily consisted of activity under our stock repurchase program and payments of employee withholding taxes for vested restricted stock units, compared to the prior year period which included 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.

Current wording

Net cash used in financing activities for the six months ended June 30, 2026 was $19.2 million, compared to $89.3 million in cash provided by financing activities in the six months ended June 30, 2025. Financing activities during the current period primarily consisted of activity under our stock repurchase program and payments of employee withholding taxes for vested restricted stock units, compared to the prior year period which included 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.

Previous wording

There have been no material changes to our contractual obligations and commitments from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

There have been no material changes to our contractual obligations and commitments from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, with the exception of an additional commitment of €6.2 million for the purchase of the active pharmaceutical ingredient (API) for VABOMERE from the CMO in 2027.

Previous wording

● We account for product revenue from the sale of our Products 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 primarily 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 specific to DefenCath. The Company’s product return 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. We have established the estimate for returns based on specific customer circumstances, industry best practices and management experiences, which will continuously be refined as new information is received. At March 31, 2026, we had $13.3 million in accrued returns allowance including the balance recorded for the Melinta Portfolio.

Current wording

● We account for product revenue from the sale of our Products 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 primarily 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 specific to DefenCath. The Company’s product return 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. We have established the estimate for returns based on specific customer circumstances, industry best practices and management experiences, which will continuously be refined as new information is received. At June 30, 2026, we had $11.9 million in accrued returns allowance including the balance recorded for the Melinta Portfolio.

Previous wording

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, as well as general fluctuations in patient populations over time. Based on the relatively short time since product launch of DefenCath and the inherent lag time in states’ Medicaid processing, the utilization of 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 March 31, 2026, the Company had $10.8 million in accrued Medicaid rebates, including the balance recorded for the Melinta Portfolio.

Current wording

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, as well as general fluctuations in patient populations over time. Based on the relatively short time since product launch of DefenCath and the inherent lag time in states’ Medicaid processing, the utilization of 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, 2026, the Company had $10.3 million in accrued Medicaid rebates, including the balance recorded for the Melinta Portfolio.

Previous wording

During the quarter ended March 31, 2026, the Company recorded a change in estimate related to variable consideration for Medicaid rebates and product returns. During the three months ended March 31, 2026, the Company obtained new information regarding Medicaid utilization and updated its assumptions based on substantially completed historical claims data. Such estimates are subject to uncertainty due to the timing and completeness of claims processing. In addition, the Company updated its estimate of product returns as initial rate of return history for DefenCath recently became available, which was lower than previously estimated. For the quarter ended March 31, 2026, the resulting changes in accounting estimates positively impacted net sales by $9.0 million and positively impacted income from continuing operations and net income by $6.2 million, net of taxes, and increased basic and diluted earnings per share by $0.08 and $0.07 per share, respectively.

Current wording

During the three months ended March 31, 2026, the Company recorded a change in estimate related to variable consideration for Medicaid rebates and product returns. During the three months ended March 31, 2026, the Company obtained new information regarding Medicaid utilization and updated its assumptions based on substantially completed historical claims data. Such estimates are subject to uncertainty due to the timing and completeness of claims processing. In addition, the Company updated its estimate of product returns as initial rate of return history for DefenCath recently became available, which was lower than previously estimated. For the three months ended June 30, 2026, there were no changes in estimate that impacted sales or income. For the six months ended June 30, 2026, the resulting changes in accounting estimates positively impacted net sales by $9.0 million, and positively impacted income from continuing operations and net income by $6.1 million, net of taxes, and increased basic and diluted earnings per share by $0.08 and $0.07 per share, respectively.

Previous wording

Changes to contingent consideration obligations, other than the passage of time, may result from adjustments related, but not limited, to changes in discount rates and the number of remaining periods to which the discount rate is applied, updates in the assumed achievement or timing of any regulatory milestone or changes in the probability of certain clinical events, changes in our forecasted sales of products acquired, and changes in the assumed probability associated with regulatory approval. At the end of each reporting period, we evaluate the need to remeasure the contingent consideration and, if appropriate, we revalue these obligations and record increases or decreases in their fair value in selling, general and administrative expenses within the accompanying consolidated statements of operations.

Current wording

Changes to contingent consideration obligations, other than the passage of time, may result from adjustments related, but not limited, to changes in discount rates and the number of remaining periods to which the discount rate is applied, updates in the assumed achievement or timing of any regulatory milestone or changes in the probability of certain clinical events, changes in our forecasted sales of products acquired, and changes in the assumed probability associated with regulatory approval. At the end of each reporting period, we evaluate the need to remeasure the contingent consideration and, if appropriate, we revalue these obligations and record increases or decreases in their fair value in other (expense) income within the accompanying consolidated statements of operations.

Previous wording

Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period. Accordingly, any change in the assumptions described above, could have a material impact on the amount we may be obligated to pay as well as the results of our consolidated results of operations in any given reporting period.

Current wording

Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period. Accordingly, any change in the assumptions described above, could have a material impact on the amount we may be obligated to pay as well as the results of our condensed consolidated results of operations in any given reporting period.