Full Press Release Details
Inc. Reports second Quarter 2025 Financial Results and Provides Business Update
Revenue of $39.7mm; Net Income of $19.8mm; Adjusted EBITDA of $22.4mm
Acquisition of Melinta Therapeutics
Conference Call Scheduled for Today at 8:30 a.m. Eastern Time
NJ - August 7, 2025 - CorMedix Inc. (Nasdaq: CRMD) today announced financial results for the second quarter and six
months ended June 30, 2025 and provided an update on its business announcing the acquisition of Melinta Therapeutics LLC, with a target
closing date as early as September 1, 2025.
Second Quarter and Six Months 2025 Financial
For the second quarter of 2025, CorMedix recorded
$39.7 million in net revenue from sales of DefenCath, compared to $0.8 million for the same period last year, and recorded net income
of $19.8 million, or $0.29 per share, compared with a net loss of $14.2 million, or $0.25 per share, in the second quarter of 2024, driven
primarily by net sales of DefenCath during the period.
Operating expenses in the second quarter of 2025
were $18.3 million, compared with $15.6 million in the second quarter of 2024, an increase of approximately 18%. The increase was
driven primarily by an increase in G&A expense and R&D expense for the period. R&D expense in the second quarter of 2025 was
$2.4 million, compared with $0.7 million for the same period in 2024, due to an increase in personnel and clinical trial services in support
of the ongoing clinical programs. Selling and Marketing expense for the second quarter of 2025 amounted to $6.4 million, compared with
$7.4 million in the second quarter of 2024, a decrease of 14% which was primarily due to increased marketing costs in the prior period
related to the launch of DefenCath. General and administrative expense in the second quarter of 2025 amounted to $9.5 million, compared
with $7.6 million in the second quarter of 2024, an increase of 25%. The increase was primarily driven by non-cash charges for stock-based
compensation and costs related to business development.
For the six months ended June 30, 2025, the Company
recorded $78.8 million in net revenue from the sales of DefenCath, compared to $0.8 million in net revenue for the same period last year,
and recorded net income of $40.5 million, or $0.60 per share, during the first half of 2025, compared to a net loss of $28.6 million,
or $0.50 per share, for the same period in 2024.
Operating expenses in the first half of 2025 were
$35.7 million, compared to $31.5 million in the same period in 2024, an increase of approximately $4.2 million or 13%. This increase
was primarily due to an increase in R&D expense and G&A expense, partially offset by a decrease in S&M expense related to
the commercial launch activities of DefenCath.
The Company reported cash and short-term investments
of $190.7 million as of June 30, 2025, excluding restricted cash. The Company believes that it has sufficient resources to fund operations
for at least twelve months from the issuance of the Company's Quarterly Report on Form 10-Q.
Conference Call Information
The management team of
CorMedix will host a conference call and webcast today, August 7, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments
and financial results. Call details and dial-in information are as follows:
Thursday, August 7th @ 8:30am ET
Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of
life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath (taurolidine
and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April
2024 and in outpatient settings in July 2024. CorMedix commenced clinical studies in adult Total Parenteral Nutrition (TPN) patients and
pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other
therapeutic areas. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section
21E of the Exchange, as amended (the "Exchange Act"), that are subject to risks and uncertainties. Forward-looking statements
are often identified by the use of words such as, but not limited to, "anticipate," "believe," "can,"
"continue," "could," "estimate," "expect," "intend," "may," "will,"
"plan," "project," "seek," "should," "target," "will," "would,"
and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical
facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects should be considered forward-looking
statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important
factors, and readers are directed to the Risk Factors identified in CorMedix's filings with the SEC, including its most recent Annual
Report on Form 10-K, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix
and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans
described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors
should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking
statements, except as required by law.
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.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial
measures, including EBITDA, adjusted EBITDA, which are intended as supplemental measures of the Company's performance that are not
required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company's
operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance
relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that
vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes
do not reflect the Company's operations and underlying operational performance.
The Company believes that these non-GAAP measures
also provide useful information to investors regarding certain financial and business trends relating to the Company's financial
condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent
basis. Providing this information therefore allows investors to make independent assessments of the Company's financial performance,
results of operations and trends while viewing the information through the eyes of management.
These non-GAAP measures are subject to limitations.
The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other
companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses
and income that are required by GAAP to be recorded in the Company's financial statements; do not reflect changes in, or cash requirements
for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or
financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures
in conjunction with the Company's GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to
any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single
financial measure to evaluate the Company's business.
Inc. and SubsidiarIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | ||||||||||||||||
| Revenue, net | $ | 39,736,790 | $ | 806,119 | $ | 78,818,447 | $ | 806,119 | ||||||||
| Cost of revenues | (1,862,448 | ) | (509,839 | ) | (3,459,162 | ) | (1,328,377 | ) | ||||||||
| Gross profit (loss) | 37,874,342 | 296,280 | 75,359,285 | (522,258 | ) | |||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | (2,442,709 | ) | (650,988 | ) | (5,635,149 | ) | (1,488,432 | ) | ||||||||
| Selling and marketing | (6,384,072 | ) | (7,386,841 | ) | (10,857,913 | ) | (13,724,061 | ) | ||||||||
| General and administrative | (9,504,056 | ) | (7,559,277 | ) | (19,197,437 | ) | (16,270,310 | ) | ||||||||
| Total operating expenses | (18,330,837 | ) | (15,597,106 | ) | (35,690,499 | ) | (31,482,803 | ) | ||||||||
| Income (Loss) from Operations | 19,543,505 | (15,300,826 | ) | 39,668,786 | (32,005,061 | ) | ||||||||||
| Other Income (Expense) | ||||||||||||||||
| Total other income | 805,983 | 1,149,337 | 1,324,600 | 1,992,679 | ||||||||||||
| Net Income (Loss) Before Income Taxes | 20,349,488 | (14,151,489 | ) | 40,993,386 | (30,012,382 | ) | ||||||||||
| Tax (expense) benefit | (521,507 | ) | - | (521,507 | ) | 1,394,770 | ||||||||||
| Net Income (Loss) | 19,827,981 | (14,151,489 | ) | 40,471,879 | (28,617,612 | ) | ||||||||||
| Other Comprehensive Income (Loss) | ||||||||||||||||
| Total other comprehensive (loss) income | (5,121 | ) | 2,270 | (11,211 | ) | (8,377 | ) | |||||||||
| Other Comprehensive (Loss) Income | $ | 19,822,860 | $ | (14,149,219 | ) | $ | 40,460,668 | $ | (28,625,989 | ) | ||||||
| Net Income (Loss) Per Common Share - Basic | $ | 0.29 | $ | (0.25 | ) | $ | 0.60 | $ | (0.50 | ) | ||||||
| Net Income (Loss) Per Common Share - Diluted | $ | 0.28 | $ | (0.25 | ) | $ | 0.58 | $ | (0.50 | ) | ||||||
| Weighted Average Common Shares Outstanding - Basic | 67,927,710 | 57,620,974 | 66,593,438 | 57,562,064 | ||||||||||||
| Weighted Average Common Shares Outstanding - Diluted | 71,918,624 | 57,620,974 | 70,354,212 | 57,562,064 |