UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

Commission file number 001-34673

CORMEDIX INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		20-5894890
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

300 Connell Drive, Suite 4200, Berkeley Heights, NJ		07922
(Address of Principal Executive Offices)		(Zip Code)

(908) 517-9500

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, $0.001 par value		CRMD		Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares outstanding of the issuer’s common stock, as of November 10, 2025 was 78,789,045.

CORMEDIX INC. AND SUBSIDIARIES

INDEX

		Page
PART I FINANCIAL INFORMATION		1

Item 1.	Unaudited Condensed Consolidated Financial Statements	1

	Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024	1

	Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2025 and 2024	2

	Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2025 and 2024	3

	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024	5

	Notes to Unaudited Condensed Consolidated Financial Statements	6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	36

Item 3.	Quantitative and Qualitative Disclosure About Market Risk	48

Item 4.	Controls and Procedures	48

PART II OTHER INFORMATION		49

Item 1.	Legal Proceedings	49

Item 1A.	Risk Factors	49

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	57

Item 3.	Defaults Upon Senior Securities	57

Item 4.	Mine Safety Disclosure	57

Item 5.	Other Information	57

Item 6.	Exhibits	59

SIGNATURES		60

PART I
FINANCIAL INFORMATION

Item 1. Unaudited Condensed Consolidated Financial Statements.

CorMedix Inc. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

	September 30, 2025			December 31, 2024
	(Unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	48,493,076		$	40,650,770
Short-term investments		7,223,735			11,036,857
Trade receivables, net		158,574,116			51,653,583
Inventories		28,916,616			7,599,535
Prepaid expenses and current assets		16,327,730			3,634,691
Total current assets		259,535,273			114,575,436
Property and equipment, net		4,347,360			1,828,016
Other long-term assets (including restricted cash of $988,233 and $105,368 at September 30, 2025, and December 31, 2024)		22,913,753			105,368
Goodwill		17,515,265			-
Intangible assets, net		390,011,711			1,844,156
Deferred tax assets		52,500,000			-
Operating lease- right-of-use assets, net		3,173,567			492,697
Finance lease- right-of-use assets, net		864,549			-
TOTAL ASSETS	$	750,861,478		$	118,845,673

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	20,454,367		$	1,720,177
Accrued expenses		109,091,898			31,951,533
Contingent Consideration, short-term		2,673,933
Operating lease liability, short-term		844,431			167,922
Financing lease liability, short-term		579,168			-
Total current liabilities		133,643,797			33,839,632
Convertible senior notes, net of deferred financing costs		144,528,552			-
Contingent Consideration, net of current portion		95,591,067			-
Operating lease liabilities, net of current		2,411,243			349,091
Finance lease liabilities, net of current		557,413			-
TOTAL LIABILITIES		376,732,072			34,188,723

COMMITMENTS AND CONTINGENCIES (Note 8)

STOCKHOLDERS’ EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 91,623 and 136,623 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		92			137
Common stock - $0.001 par value: 160,000,000 shares authorized; 78,349,057 and 64,411,295 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		78,350			64,411
Accumulated other comprehensive gain		87,640			90,646
Additional paid-in capital		564,558,498			424,131,789
Accumulated deficit		(190,595,174	)		(339,630,033	)
TOTAL STOCKHOLDERS’ EQUITY		374,129,406			84,656,950
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	750,861,478		$	118,845,673

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CorMedix Inc. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2025			2024			2025			2024
Revenue:
Product sales, net	$	101,546,423		$	11,456,115		$	180,364,870		$	12,262,234
Contract revenue		2,728,866			-			2,728,866			-
Total Revenues		104,275,289			11,456,115			183,093,736			12,262,234
Cost of sales (exclusive of amortization of intangibles)		(7,566,067	)		(634,650	)		(10,921,333	)		(1,911,079	)
Amortization of intangibles		(3,628,549	)		(51,948	)		(3,732,445	)		(103,896	)
Gross profit		93,080,673			10,769,517			168,439,958			10,247,259
Operating Expenses:
Research and development		(5,097,644	)		(727,119	)		(10,732,793	)		(2,215,551	)
Selling and marketing		(11,186,046	)		(6,748,900	)		(22,043,959	)		(20,472,961	)
General and administrative		(25,451,017	)		(6,580,834	)		(44,648,454	)		(22,851,144	)
Total Operating Expenses		(41,734,707	)		(14,056,853	)		(77,425,206	)		(45,539,656	)
Income (loss) From Operations		51,345,966			(3,287,336	)		91,014,752			(35,292,397	)
Other Income (Expense):
Interest income		1,560,272			553,856			2,956,019			2,068,407
Foreign exchange transaction loss		(72,727	)		(33,325	)		(127,195	)		(38,806	)
Unrealized gain on marketable security		3,090,909			-			3,090,909			-
Other income		-			-			-			500,000
Change in contingent consideration		(2,400,000	)					(2,400,000	)
Interest expense		(948,242	)		(10,007	)		(964,921	)		(26,398	)
Total Other Income		1,230,212			510,524			2,554,812			2,503,203
Income (loss) before income taxes		52,576,178			(2,776,812	)		93,569,564			(32,789,194	)
Tax (expense) benefit		55,986,802			-			55,465,295			1,394,770
Net Income (Loss)		108,562,980			(2,776,812	)		149,034,859			(31,394,424	)
Other Comprehensive Income (Loss):
Unrealized income (loss) from investments		8,181			5,040			1,700			(3,832	)
Foreign currency translation (loss) gain		24			(1,651	)		(4,706	)		(1,156	)
Total Other Comprehensive (Loss) Income		8,205			3,389			(3,006	)		(4,988	)
Comprehensive Income (Loss)	$	108,571,185		$	(2,773,423	)	$	149,031,853		$	(31,399,412	)
Net Income (Loss) Per Common Share – Basic	$	1.42		$	(0.05	)	$	2.12		$	(0.54	)
Net Income (Loss) Per Common Share - Diluted	$	1.26		$	(0.05	)	$	1.97		$	(0.54	)
Weighted Average Common Shares Outstanding – Basic		75,930,243			58,825,221			69,739,907			57,986,190
Weighted Average Common Shares Outstanding – Diluted		86,214,170			58,825,221			75,676,776			57,986,190

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CorMedix Inc. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY

(Unaudited)

For the three months ended September 30, 2025:

	Common Stock				Preferred Stock- Series C-3, Series E and Series G				Accumulated Other Comprehensive		Additional Paid-in			Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		Income		Capital			Deficit			Equity
Balance at June 30, 2025		74,620,742	$	74,621		91,623	$	92	$	79,435	$	519,634,193		$	(299,158,154	)	$	220,630,187
Stock issued in connection with options exercised		367,622		368		-		-		-		1,322,322			-			1,322,690
Stock issued in connection with public offering, net		-		-		-				-		3,891						3,891
Stocks issued in connection with Melinta acquisition		3,323,833		3,324		-				-		39,996,676						40,000,000
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes		36,860		37		-		-		-		(464,125	)					(464,088	)
Stock-based compensation		-		-		-		-		-		4,065,541			-			4,065,541
Other comprehensive income		-		-		-		-		8,205		-			-			8,205
Net income		-		-		-		-		-		-			108,562,980			108,562,980
Balance at September 30, 2025		78,349,057	$	78,350		91,623	$	92	$	87,640	$	564,558,498		$	(190,595,174	)	$	374,129,406

For the three months ended September 30, 2024:

	Common Stock				Preferred Stock- Series C-3, Series E and Series G				Accumulated Other Comprehensive		Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		Income		Capital		Deficit			Equity
Balance at June 30, 2024		55,274,791	$	55,274		181,622	$	182	$	85,731	$	396,360,369	$	(350,317,625	)	$	46,183,931
Stock issued in connection with ATM sale of common stock, net		2,290,024		2,290		-		-		-		12,364,191		-			12,366,481
Stock issued in connection with options exercised		322,334		322		-		-		-		1,707,481		-			1,707,803
Stock-based compensation		-		-		-		-		-		1,227,476		-			1,227,476
Other comprehensive income		-		-		-		-		3,389		-		-			3,389
Net loss		-		-		-		-		-		-		(2,776,812	)		(2,776,812	)
Balance at September 30, 2024		57,887,149	$	57,886		181,622	$	182	$	89,120	$	411,659,517	$	(353,094,437	)	$	58,712,268

For the nine months ended September 30, 2025

	Common Stock				Preferred Stock- Series C-3, Series E and Series G						Accumulated Other Comprehensive			Additional Paid-in			Accumulated			Total Stockholders’
	Shares		Amount		Shares			Amount			Income			Capital			Deficit			Equity
Balance at January 1, 2025		64,411,295	$	64,411		136,623		$	137		$	90,646		$	424,131,789		$	(339,630,033	)	$	84,656,950
Stock issued in connection with ATM sale of common stock, net		620,444		621		-			-			-			6,760,952			-			6,761,573
Stock issued in connection with options exercised		736,581		737		-			-			-			2,795,277			-			2,796,014
Stock issued in connection with public offering, net		6,604,507		6,605		-			-			-			82,363,995						82,370,600
Stocks issued in connection with Melinta acquisition		3,323,833		3,324		-			-			-			39,996,676						40,000,000
Conversion of Series G preferred stock to common stock		2,502,062		2,502		(45,000	)		(45	)		-			(2,457	)					-
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes		150,335		150											(1,730,710	)					(1,730,560	)
Stock-based compensation		-		-		-			-			-			10,242,976			-			10,242,976
Other comprehensive loss		-		-		-			-			(3,006	)		-			-			(3,006	)
Net income		-		-		-			-			-			-			149,034,859			149,034,859
Balance at September 30, 2025		78,349,057	$	78,350		91,623		$	92		$	87,640		$	564,558,498		$	(190,595,174	)	$	374,129,406

For the nine months ended September 30, 2024

	Common Stock						Preferred Stock- Series C-3, Series E and Series G				Accumulated Other Comprehensive			Additional Paid-in			Accumulated			Total Stockholders’
	Shares			Amount			Shares		Amount		Income			Capital			Deficit			Equity
Balance at January 1, 2024		54,938,258		$	54,938			181,622	$	182	$	94,108		$	391,693,214		$	(321,700,013	)	$	70,142,429
Stock issued in connection with ATM sale of common stock, net		2,521,121			2,521			-		-		-			13,373,560			-			13,376,081
Stock issued in connection with options exercised		371,499			371			-		-		-			1,893,914			-			1,894,285
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes		78,103			78										(236,693	)					(236,615	)
Cancellation of shares held in escrow		(21,832	)		(22	)									22						-
Stock-based compensation		-			-			-		-		-			4,935,500			-			4,935,500
Other comprehensive loss		-			-			-		-		(4,988	)		-			-			(4,988	)
Net loss		-			-			-		-		-			-			(31,394,424	)		(31,394,424	)
Balance at September 30, 2024		57,887,149		$	57,886			181,622

SEC Form 10-Q filed by CorMedix Inc.