CORMEDIX THERAPEUTICS REPORTS THIRD QUARTER 2026 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
CorMedix Inc. (CRMD) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 CORMEDIX THERAPEUTICS REPORTS THIRD QUARTER 2026 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE ‒ Recently announced acquisition of assets of Heron Therapeutics ‒ ‒ Q3 2026 consolidated revenue of $54.5 million ‒ ‒ Q3 2026 net loss of $14.7 million ; Adjusted EBITDA
Facts are quoted from the filing text and checked against it.
How this was made
The 30-second read
Why it matters
The combination of earnings, narrowed guidance, and a strategic acquisition provides a multi‑factor catalyst that could drive the stock higher in the near term.
Market read
The filing delivers fresh earnings data and a material acquisition, making it a high‑value trading event for CRMD.
What to watch
Potential cash burn from the $150M term loan and uncertainty around the REZZAYO sNDA approval timeline.
CorMedix reports Q3 2026 consolidated revenue of $54.5 million and a net loss of $14.7 million, maintains FY 2026 revenue guidance, narrows Adjusted EBITDA guidance, and announces the Heron asset acquisition
Revenue of $54.5 million is described by the company as above street consensus of $51.2 million, and FY 2026 revenue guidance is maintained. Against that, revenue fell from $104.3 million a year earlier, the quarter produced a GAAP net loss of $14.7 million, Adjusted EBITDA was $3.1 million versus $71.9 million, and the company suspended its 2027 DefenCath revenue guidance.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenue and grant income, Q3 2026GAAP | $54.5M | – | – |
| Total revenue and grant income, Q3 2026 (table)GAAP | $54.52M | – | – |
| Product sales, net, Q3 2026GAAP | $48.62M | – | – |
| Contract revenue, Q3 2026GAAP | $2.64M | – | – |
| Grant income, Q3 2026GAAP | $3.25M | – | – |
| DefenCath sales (net revenue), Q3 2026GAAP | $17.2M | – | – |
| Remaining portfolio total revenue and grant income, Q3 2026GAAP | $37.3M | – | – |
| Cost of sales (exclusive of amortization of intangibles), Q3 2026GAAP | $14.21M | – | – |
| Amortization of intangibles, Q3 2026GAAP | $10.3M | – | – |
| Gross profit, Q3 2026GAAP | $30.00M | – | – |
| Research and development, Q3 2026GAAP | $7M | – | – |
| Selling and marketing, Q3 2026GAAP | $11.7M | – | increased approximately 4% |
| General and administrative, Q3 2026GAAP | $17.9M | – | decreased approximately 30% |
| Total operating expenses, Q3 2026GAAP | $36.6M | – | decrease of approximately 12% |
| Income (loss) from operations, Q3 2026GAAP | −$6.62M | – | – |
| Change in contingent consideration, Q3 2026GAAP | −$11.54M | – | – |
| Income (loss) before income taxes, Q3 2026GAAP | −$16.45M | – | – |
| Tax expense (benefit), Q3 2026GAAP | −$1.73M | – | – |
| Net income (loss), Q3 2026GAAP | −$14.7M | – | – |
| Net income (loss) per share, basic, Q3 2026GAAP | $(0.19) | – | – |
| Net income (loss) per share, diluted, Q3 2026GAAP | $(0.19) | – | – |
| Adjusted EBITDA, Q3 2026non-GAAP | $3.1M | – | – |
| EBITDA (non-GAAP), Q3 2026non-GAAP | −$6.50M | – | – |
| Total revenue and grant income, nine months 2026GAAP | $283.9M | – | – |
| Product sales, net, nine months 2026GAAP | $264.9M | – | – |
| Contract revenue, nine months 2026GAAP | $10.69M | – | – |
| Grant income, nine months 2026GAAP | $8.31M | – | – |
| Cost of sales (exclusive of amortization of intangibles), nine months 2026GAAP | $40.73M | – | – |
| Amortization of intangibles, nine months 2026GAAP | $30.9M | – | – |
| Gross profit, nine months 2026GAAP | $212.3M | – | – |
| Research and development, nine months 2026GAAP | $20.93M | – | – |
| Selling and marketing, nine months 2026GAAP | $36.66M | – | – |
| General and administrative, nine months 2026GAAP | $54.71M | – | – |
| Total operating expenses, nine months 2026GAAP | $112.3M | – | – |
| Income from operations, nine months 2026GAAP | $99.95M | – | – |
| Change in contingent consideration, nine months 2026GAAP | −$22.39M | – | – |
| Income before income taxes, nine months 2026GAAP | $77.93M | – | – |
| Tax expense (benefit), nine months 2026GAAP | $28.06M | – | – |
| Net income, nine months 2026GAAP | $49.87M | – | – |
| Net income per share, basic, nine months 2026GAAP | $0.63 | – | – |
| Net income per share, diluted, nine months 2026GAAP | $0.57 | – | – |
| Adjusted EBITDA, nine months 2026non-GAAP | $131.9M | – | – |
| EBITDA (non-GAAP), nine months 2026non-GAAP | $109.2M | – | – |
| Net cash provided by operating activities, nine months 2026GAAP | $218.3M | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| DefenCath (taurolidine and heparin) net revenueCompany states that sales decreased year over year largely due to the transition to the post-TDAPA period on July 1, 2026, which resulted in lower net pricing. Company states that utilization by large outpatient dialysis customers was largely maintained, which impacted price, and that a $5.0 million favorable change in estimate related to certain sales allowances was included. | $17.2M | – | – |
| Remaining portfolio total revenue and grant incomeCompany states that higher revenue from the acquired Melinta portfolio partly offset the DefenCath decline, given a full quarter of sales in 2026 compared with one month in 2025 after the Melinta acquisition closed on August 29, 2025. | $37.3M | – | – |
FY 2026 outlook
- Revenue$325 to $345 million (maintained)
- Operating expensesCash-based OpEx $140 to $145 million (reduced from $145 to $155 million)
- NoteAdjusted EBITDA $130 to $140 million (narrowed from $125 to $140 million)
- Note2027 DefenCath revenue guidance suspended; company defers future guidance until early 2027
- NoteHeron acquisition: company expects anticipated full-year 2027 revenue contribution of between $125 million and $150 million (CEO statement)
- NoteREZZAYO sNDA for prophylaxis of invasive fungal disease: FDA PDUFA date in the first quarter of 2027; company anticipates agency action in the first quarter of 2027
Capital returns
- No share repurchases or dividends are reported in the filing.
- Company announced a term loan agreement providing up to $150 million, of which it expects to utilize $75 million upon closing of the Heron acquisition.
What drove it
- Company states that DefenCath sales decreased year over year largely due to the transition to the post-TDAPA period on July 1, 2026, which resulted in lower net pricing.
- Company states that Melinta portfolio revenue was higher because the quarter included a full period of sales versus one month in the prior-year period.
- Company states that Q3 2026 revenue of $54.5 million was above street consensus of $51.2 million, as printed in the release.
- Company states that the $5.0 million favorable change in estimate related to sales allowances was included in Q3 2026 DefenCath sales, and excluded from Adjusted EBITDA.
- Company states that the decrease in total operating expenses was driven primarily by merger-related and reorganization expenses following the Melinta acquisition in Q3 2025, partly offset by a full quarter of Melinta operating expenses in 2026.
- Company states that the Q3 2026 net loss was negatively impacted by $11.5 million of non-cash expense from the remeasurement of contingent consideration associated with the Melinta acquisition.
- Company states that the Q3 2025 net income included a one-time tax benefit of $59.7 million from the realization of deferred tax assets.
- Company states that R&D increased due to higher personnel and clinical trial services supporting ongoing clinical programs.
- Company states that the G&A decrease was primarily attributable to Melinta-related transaction and integration costs incurred in Q3 2025, partly offset by higher costs of operating as a combined company.
Concerns
- Q3 2026 GAAP net loss of $14.7 million, compared with net income of $108.6 million in Q3 2025 (which included a $59.7 million one-time tax benefit).
- Adjusted EBITDA of $3.1 million in Q3 2026, compared with $71.9 million in Q3 2025.
- Total revenue and grant income of $54.5 million, compared with $104.3 million in Q3 2025.
- Company suspended previously issued 2027 DefenCath revenue guidance in light of recently announced CMS reimbursement framework changes.
- Amortization of intangibles rose to $10,300 thousand in Q3 2026 from $3,628 thousand in Q3 2025.
- Trade receivables fell to $76,706 thousand from $171,233 thousand at December 31, 2025, and the company describes the nine-month operating cash flow increase as partly reflecting timing of contractual rebate payments.
- Company states that DefenCath depends on a limited number of large dialysis organization customers, per the forward-looking statements section.
What to watch
- Closing of the Heron asset acquisition, expected by the company in the first quarter of 2027, subject to Heron stockholder approval and regulatory clearance.
- Integration of the Heron products and the company's stated expectation that the transaction is immediately accretive to earnings and free cash flow upon closing.
- FDA action on the REZZAYO prophylaxis sNDA, with a PDUFA date in the first quarter of 2027.
- Early 2027 update on 2027 DefenCath guidance, once the company has visibility into utilization, pricing and any Medicare Advantage contracting upside.
- Draw of $75 million under the term loan (of up to $150 million) upon closing of the Heron acquisition.
- Delivery against the narrowed FY 2026 Adjusted EBITDA range of $130 to $140 million and the cash-based OpEx range of $140 to $145 million.
Balance sheet and cash flow
- Cash and short-term investments, excluding restricted cash, at September 30, 2026: $355.2 million (cash and cash equivalents $355,150 thousand; compared with $144,837 thousand at December 31, 2025, per balance sheet table).
- Total assets at September 30, 2026: $917,745 thousand (December 31, 2025: $826,142 thousand).
- Total liabilities at September 30, 2026: $456,039 thousand (December 31, 2025: $420,835 thousand).
- Stockholders' equity at September 30, 2026: $461,706 thousand (December 31, 2025: $405,307 thousand).
- Trade receivables, net at September 30, 2026: $76,706 thousand (December 31, 2025: $171,233 thousand). Inventories: $43,144 thousand (December 31, 2025: $29,716 thousand).
- Goodwill and intangible assets at September 30, 2026: $378,174 thousand (December 31, 2025: $409,074 thousand).
- Nine months 2026 net cash provided by operating activities: $218.3 million, compared with $80.6 million in the first nine months of 2025. Company attributes the increase to higher year-to-date earnings and working capital movements, including the timing of certain contractual rebate payments.
- Nine months 2026 net cash provided by investing activities: $491 thousand (2025: $(311,727) thousand).
- Nine months 2026 net cash used in financing activities: $(8,496) thousand (2025: provided $239,866 thousand).
- Company states it believes it has sufficient resources to fund operations for at least twelve months from the issuance of its Form 10-Q for the quarter.
Analysis
CorMedix reported Q3 2026 total revenue and grant income of $54.5 million, against $104.3 million in the same quarter of 2025. The company attributes the decline mainly to DefenCath moving into the post-TDAPA period on July 1, 2026, which it says lowered net pricing. DefenCath net revenue was $17.2 million in the quarter, and the company notes that this figure includes a $5.0 million favorable change in estimate related to sales allowances. The remaining portfolio contributed $37.3 million of total revenue and grant income, which the company links to a full quarter of Melinta sales compared with one month a year earlier. The release states that revenue was above street consensus of $51.2 million, but no prior-year DefenCath figure is printed, so the DefenCath trend cannot be quantified from this filing.
Profitability is weaker than the revenue line. Cost of sales was $14,215 thousand against $7,567 thousand a year earlier, and amortization of intangibles rose to $10,300 thousand from $3,628 thousand, so gross profit fell to $30,004 thousand from $93,081 thousand. Total operating expenses declined to $36.6 million from $41.7 million, mainly because the prior-year quarter carried Melinta-related merger and reorganization costs. Within that, R&D rose to $7.0 million from $5.1 million, and G&A fell to $17.9 million from $25.5 million. The result was an operating loss of $(6,619) thousand, compared with operating income of $51,346 thousand. A non-cash $11.5 million remeasurement of contingent consideration pushed the GAAP net loss to $14.7 million, or $(0.19) per share, compared with net income of $108.6 million in the prior-year quarter. That prior-year figure included a one-time tax benefit of $59.7 million. Adjusted EBITDA, a non-GAAP measure, was $3.1 million against $71.9 million, and the company states that it excludes the $5.0 million sales allowance change.
For the first nine months, the picture is stronger. Total revenue and grant income was $283,877 thousand against $183,094 thousand, net income was $49,867 thousand against $149,035 thousand, and net cash from operating activities was $218.3 million against $80.6 million. The company attributes the cash increase to higher earnings and to the timing of certain contractual rebate payments. Cash and short-term investments excluding restricted cash were $355.2 million at September 30, 2026, against $144.8 million in cash and cash equivalents at December 31, 2025, although the nine-month figure also reflects the company's financing activity, which the release does not break down further.
Guidance is mixed. FY 2026 revenue guidance of $325 to $345 million is maintained. Adjusted EBITDA guidance is narrowed to $130 to $140 million from $125 to $140 million, and cash-based OpEx guidance is reduced to $140 to $145 million from $145 to $155 million. The company suspended previously issued 2027 DefenCath guidance and will defer new guidance until early 2027. Capital allocation centers on the pending Heron asset acquisition, expected to close in the first quarter of 2027 subject to Heron stockholder approval and regulatory clearance. The company expects to draw $75 million of a term loan of up to $150 million upon closing, and states that the acquisition is expected to be immediately accretive to earnings and free cash flow. The company also expects a full-year 2027 Heron revenue contribution of $125 million to $150 million. The REZZAYO sNDA has been accepted with a PDUFA date in the first quarter of 2027. The figures to weigh most are the net loss, the sharp fall in Adjusted EBITDA, the decline in DefenCath pricing after the TDAPA transition, and the dependence of 2027 visibility on the Heron closing and the early-2027 guidance update.
Management, verbatim
CorMedix will be entering 2027 with two meaningful potential growth drivers. First, our pending acquisition of the Heron assets adds four commercial products used in institutional settings of care and is expected to be immediately accretive to earnings and free cash flow upon closing.
Joseph Todisco, Chairman & Chief Executive Officer, CorMedix
With an anticipated revenue contribution of between $125 million and $150 million for the full-year 2027, we expect the Heron transaction to effectively double the Company's non-DefenCath annual product revenue.
Joseph Todisco, Chairman & Chief Executive Officer, CorMedix
Not in the filing
stated, not guessed- Gross margin percentage for Q3 2026 and Q3 2025 (not printed).
- Prior-year Q3 2025 DefenCath sales figure, so the DefenCath year-over-year change cannot be stated.
- Prior-year Q3 2025 remaining portfolio revenue figure.
- Prior-year figure for Q3 2025 grant income (table shows a dash, no value).
- Year-over-year percentage change for total revenue and grant income, and for product sales, contract revenue, cost of sales, gross profit, operating income and net income.
- Prior-quarter (Q2 2026) figures for any metric; the release does not present sequential comparisons.
- Consensus estimates for EPS and Adjusted EBITDA (only the revenue consensus of $51.2 million is printed).
- Share price reaction to the results (not in the filing).
- Effective tax rate for any period.
- Full-year 2026 gross margin and tax guidance (not provided).
- Breakdown of the nine-month financing cash flow of $(8,496) thousand.
- Prior-year Adjusted EBITDA for Q3 2025 as a percentage change, and the DefenCath gross-to-net or pricing data behind the post-TDAPA decline.
- Heron acquisition purchase price and the number of CorMedix shares to be issued to Heron (not printed in the release).
- Restricted cash at September 30, 2026 (the release excludes it from the cash figure; the cash flow table reports cash plus restricted cash of $356,138 thousand).
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure is checked against the filing text, and a metric the filing does not print, or whose value, prior period and change do not add up, is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
CorMedix filed a Form 8‑K reporting its Q3 2026 financial results, updated FY guidance, and a definitive asset purchase agreement for Heron Therapeutics.
Ticker impact
CorMedix reported Q3 2026 results with $54.5M revenue, $14.7M loss and narrowed FY 2026 adjusted EBITDA guidance, plus announced a pending acquisition of Heron Therapeutics assets.
likely modest upside as the market prices in the narrowed EBITDA guidance and the expected revenue boost from the Heron asset purchase.
New earnings numbers and updated guidance are primary disclosures; the acquisition is expected to be immediately accretive, supporting a positive price reaction.
Market effects
Strengthens the specialty pharma sector by showing successful integration of acquired assets and potential revenue diversification.
US biotech investors may view the deal as a template for consolidation in the post‑TDAPA environment.
Limited to investors tracking US‑listed biotech and specialty drug companies.
Counterpoint
If the Heron integration faces delays or regulatory hurdles, the anticipated revenue boost could be overstated, weighing on the stock.
Key entities
- companyCorMedix Therapeutics
US‑listed biotech reporting Q3 results and acquisition.
- companyHeron Therapeutics
Target of the asset purchase agreement.
