Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Management’s Annual Report on Internal Controls Over Financial
Reporting
Our management is responsible
for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal
control over financial reporting. As defined by the Securities and Exchange Commission, internal control over financial reporting is a
process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our Board of
Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of the consolidated financial statements in accordance with U.S. generally accepted accounting principles.
Our internal control over
financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect our transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of the consolidated financial statements in accordance with generally accepted accounting
principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets
that could have a material effect on the consolidated financial statements.
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
Changes in Internal Control Over Financial
Reporting
There
were no changes in our internal control over financial reporting during our year ended December 31, 2025, or in other factors that could
significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Internal Controls Assessment
In
connection with the preparation of our annual consolidated financial statements for the year ended December 31, 2025, management identified
a deficiency in its internal control over financial reporting related to the operational effectiveness of an internal control to ensure
adequate and timely review of significant, non-routine transactions.
During the third quarter of
2025, the Company had recently completed a large acquisition and a convertible debt offering, and as a result, encountered numerous and
competing financial reporting demands with a limited number of finance resources and with heavy reliance on a third-party accounting
firm. The capacity constraints of our team at this time contributed to the control deficiency, which resulted in an immaterial error
in the measurement of equity-based consideration and goodwill that were recorded on the Company’s consolidated balance sheet as
of September 30, 2025 in connection with the acquisition of Melinta. The Company made appropriate corrections of this error during the
preparation of the Company’s consolidated financial statements for the year ended December 31, 2025.
44
While
the error did not result in a material misstatement or a restatement of the Company’s consolidated financial statements, management
concluded that there is a reasonable possibility that a material misstatement could have occurred without being prevented or detected
on a timely basis, and therefore, the control deficiency was deemed to be a material weakness.
Managements’
Internal Controls Conclusions
In connection with the
preparation of our annual consolidated financial statements, management, including, our Principal Executive and Financial Officer,
has undertaken an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025,
based on the criterial established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”). Management’s assessment included an evaluation of the design of
our internal control over financial reporting and testing of the operational effectiveness of those controls. Based on this
evaluation, management has concluded that our internal control over financial reporting was not effective as of December 31,
2025 due to the material weakness described above.
In addition, as of the end
of the period covered by this Annual Report on Form 10-K, we carried out an evaluation, under the supervision and with the participation
of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation
of our disclosure controls and procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)) (the “Exchange Act”).
Based on the material weakness described above, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure
controls and procedures were not effective to ensure that information required to be disclosed by us in the reports we file or submit
under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the
SEC, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial
Officer, to allow timely decisions regarding required disclosures.
The Company excluded Melinta
from our assessment of internal control over financial reporting as of December 31, 2025, because it was acquired by the Company in a
business combination during 2025. Total assets and total revenues of Melinta, a wholly-owned subsidiary, represent 62 percent and 17 percent,
respectively, of the related consolidated financial statement amounts as of and for the year ended December 31, 2025.
Remediation Efforts
Management has initiated remediation
measures designed to address the material weakness identified above. These measures include the implementation of an enhanced review control
over the accounting for significant non-routine transactions, including the preparation of contemporaneous technical accounting memoranda
and enhanced management review and approval procedures.
In connection with remediation
efforts, management will evaluate its workforce capacity relative to resourcing needs to determine if additional resources, including
both internal and external to the Company, are necessary to facilitate timely analysis and review of significant non-routine transactions.
In addition, Management believes that the integration of the financial systems and streamlining the combined-company close process this
year will create additional capacity within the finance function to support the remediation efforts.
The
material weakness will be considered remediated once the applicable controls have been fully implemented, have operated for a sufficient
period of time, and have been tested for operating effectiveness .
Item 9B. Other Information
Rule 10b5-1 Plans
During the quarter ended December
31, 2025, no director or officer of the Company (as defined in Rule 16a-1(f) under the Exchange Act) informed us of the adoption or termination of
a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item
408 of SEC Regulation S-K.
Item 9C. Disclosure
Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
45
PART III
Item 10. Directors, Executive Officers, and Corporate Governance
The information required
by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the 2025 fiscal year, or
an amendment to this Annual Report, and is hereby incorporated by reference.
Code of Ethics
We
have adopted a written Code of Conduct and Ethics that applies to our directors, executive officers and all employees. We intend to disclose
any amendments to, or waivers from, our code of ethics and business conduct that are required to be publicly disclosed pursuant to rules
of the SEC by filing such amendment or waiver with the SEC. This code of ethics and business conduct can be found in the “Investors
- Corporate Governance” section of our website, www.cormedix.com .
Insider Trading Policy
We
have adopted insider trading and 10b5-1 trading plan policies and procedures applicable to our directors, officers, employees,
and other covered persons, and have implemented processes for the company, that we believe are reasonably designed to promote compliance
with insider trading laws, rules and regulations, and the Nasdaq Stock Market LLC listing standards. Our insider trading policy and our
10b5-1 trading plan policy are filed as Exhibit 19.1 to this Annual Report on Form 10-K.
Item 11. Executive Compensation
The
information required by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the
2025 fiscal year, or an amendment to this Annual Report, and is hereby incorporated by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholders Matters
The
information required by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the
2025 fiscal year, or an amendment to this Annual Report, and is hereby incorporated by reference.
Item 13. Certain Relationships and Related Transactions and Director
Independence
The
information required by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the
2025 fiscal year, or an amendment to this Annual Report, and is hereby incorporated by reference.
Item 14. Principal Accountant Fees and Services
The
information required by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the
2025 fiscal year, or an amendment to this Annual Report, and is hereby incorporated by reference.
46
PART IV
Item 15. Exhibits, Financial Statement Schedules
1. Financial Statements . The following
consolidated financial statements of CorMedix Inc. are filed as part of this Annual Report on Form 10-K:
Report of Independent Registered Public Accounting Firm (PCAOB ID #
199)
F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID #
688)
F-4
Consolidated Balance Sheets as of December 31, 2025 and 2024
F-5
Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2025 and 2024
F-6
Consolidated Statements of Changes in Stockholders’ Equity Years Ended December 31, 2025 and 2024
F-7
Consolidated Statements of Cash Flows Years Ended December 31, 2025 and 2024
F-8
Notes to Consolidated Financial Statements
F-9
2. Financial Statement Schedules. The Financial
Statement Schedules have been omitted because of the absence of conditions under which they are required or because the required information,
where material, is shown in the financial statements or notes thereto.
3. Exhibit Index . The following is a list of exhibits filed
as part of this Annual Report on Form 10-K:
Exhibit Number
Description of Document
Registrant’s
Form
Dated
Exhibit Number
Filed or Furnished
Herewith
1.1
At-the-Market
Issuance Sales Agreement, dated August 12, 2021, by and among CorMedix Inc., Truist Securities, Inc. and JMP Securities LLC
8-K
08/12/2021
1.1
2.1
Agreement and Plan of Merger, dated as of August 7, 2025, by and among CorMedix Inc., Melinta Therapeutics, LLC, Coriander BidCo LLC and Deerfield Private Design Fund IV, L.P., solely in its capacity as representative, agent and attorney-in-fact of the Company Members
8-K
08/07/2025
2.1
3.1
Form
of Amended and Restated Certificate of Incorporation
S-1/A
3/01/2010
3.3
3.2
Certificate
of Amendment to Amended and Restated Certificate of Incorporation, dated February 24, 2010
S-1/A
3/19/2010
3.5
3.3
Second
Amended and Restated Bylaws as amended October 8, 2020
8-K
10/14/2020
3.1
3.4
Certificate
of Amendment to Amended and Restated Certificate of Incorporation, dated December 3, 2012
10-K
3/27/2013
3.3
3.5
Certificate
of Amendment to Amended and Restated Certificate of Incorporation, dated August 9, 2017
8-K
8/10/2017
3.1
3.6
Certificate
of Amendment to Amended and Restated Certificate of Incorporation, dated March 25, 2019
8-K
3/25/2019
3.1
3.7
Amended
and Restated Certificate of Designation of Series C-3 Non-Voting Convertible Preferred Stock of CorMedix Inc., filed with the Delaware
Secretary of State on September 15, 2014
8-K
9/16/2014
3.16
47
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed or
Furnished
Herewith
3.8
Third Amended and Restated Certificate of Designation of the Series E Convertible Preferred Stock of CorMedix Inc., dated August 6, 2025.
10-Q
8/07/2025
3.1
4.1
Specimen
of Common Stock Certificate
S-1/A
3/19/2010
4.1
4.2
Description of Capital Stock of CorMedix Inc.
X
4.3
Form of Indenture, to be entered into by and between CorMedix Inc. and U.S. Bank Trust Company, National Association
8-K
08/07/2025
4.1
4.4
Form of 4.00% Convertible Senior Notes due 2030 of CorMedix Inc. (included in Exhibit 4.1)
8-K
08/07/2025
4.2
10.1*
License
and Assignment Agreement, dated as of January 30, 2008, between CorMedix Inc. and ND Partners LLC
S-1/A
12/31/2009
10.5
10.2+
Form
of Indemnification Agreement between CorMedix Inc. and each of its directors and executive officers
10-Q
5/15/2023
10.1
10.3
Backstop
Agreement, dated November 9, 2017, between CorMedix Inc. and the investor named therein
8-K
11/13/2017
10.2
10.4
Form
of Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc. and the investor named therein
8-K
11/13/2017
10.3
10.5
Amendment
No. 1, dated as of December 11, 2017, to Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc. and
the investor named therein
8-K
12/11/2017
10.1
10.6
Securities
Purchase Agreement, dated December 31, 2018, between CorMedix Inc. and the investor named therein
8-K
1/03/2019
10.1
10.7
Securities
Exchange Agreement, dated August 14, 2019, by and among CorMedix Inc. and the Existing Security holders listed on the Schedule of
Holders thereto
8-K
8/15/2019
10.1
10.8
Amended
and Restated Registration Rights Agreement, dated as of September 6, 2019, by and among CorMedix Inc. and Manchester Securities Corp.,
and Elliot International, L.P. and Elliot Associates, L.P.
8-K
9/11/2019
10.1
10.9+
Amended
and Restated 2019 Omnibus Stock Incentive Plan
S-8
10/26/2022
99.1
10.10+
Amendment No. 1 to the Amended and Restated CorMedix Inc. 2019 Omnibus Stock Incentive Plan
8-K
11/21/2024
10.1
48
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed or
Furnished
Herewith
10.11+
Amendment No. 2 to the Amended and Restated CorMedix Inc. 2019 Omnibus Stock Incentive Plan.
10-Q
11/12/2025
10.5
10.12+
2021
Executive Bonus Plan
8-K
12/23/2021
10.1
10.13
Contingent Payment Agreement, dated August 29, 2025, by and among Deerfield Private Design Fund IV, L.P., Deerfield Private Design Fund III, L.P., CorMedix Inc., a Delaware corporation, Melinta Therapeutics, LLC, and Deerfield Private Design Fund IV, L.P., a Delaware limited partnership, solely in its capacity as representative
8-K
9/2/2025
10.1
10.14
Registration Rights Agreement, dated August 29, 2025, by and among CorMedix Inc., Deerfield Private Design Fund IV, L.P., Deerfield Private Design Fund III, L.P. and each other Holder (as defined in the Registration Rights Agreement)
8-K
9/2/2025
10.2
10.15+
Executive Employment Agreement, dated December 12, 2023, between CorMedix Inc. and Beth Zelnick Kaufman.
10-K
3/25/2025
10.16
10.16+
Employment Agreement by and between CorMedix, Inc. and Susan Blum, dated August 28, 2025
8-K
9/2/2025
10.3
10.17+
Employment Agreement by and between CorMedix, Inc. and Elizabeth Hurlburt, dated August 29, 2025
8-K
9/2/2025
10.4
10.18+
Employment
Agreement by and between CorMedix, Inc. and Matthew David, dated August 31, 2025
8-K
9/2/2025
10.5
10.19+
Amended and Restated Employment Agreement by and between CorMedix, Inc. and Joseph Todisco, dated January 5, 2026.
X
19.1
Insider Trading Policies and Procedures
X
21.1
List of Subsidiaries
X
23.1
Consent of Independent Registered
Public Accounting Firm (CBIZ CPAs P.C)
X
23.2
Consent of Independent Registered Public Accounting Firm (Marcum LLP)
X
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
32.1***
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2***
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
97.1
Board
Policy on Recouping Incentive Compensation
10-K
3/12/2024
97.1
101.INS
Inline XBRL Instance Document
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained
in Exhibit 101).
X
*
Confidential treatment has been granted for portions of this document.
The omitted portions of this document have been filed separately with the SEC.
**
Portions of the exhibit have been omitted in reliance on Item 601(b)(10)(iv)
of Regulation S-K.
***
These certifications are furnished.
+
Indicates management contract or compensation plan.
Item 16. Form 10-K Summary
Not applicable.
49
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CORMEDIX INC.
March 5, 2026
By:
/s/ Joseph Todisco
Joseph Todisco
Chief Executive Officer
(Principal Executive Officer)
March 5, 2026
By:
/s/ Susan Blum
Susan Blum
Chief Financial Officer
(Principal Financial and Accounting Officer)
Pursuant to the requirements
of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in
the capacities and on the dates indicated:
Signature
Title
Date
/s/ Joseph Todisco
Chief Executive Officer, Director and Chairman of the Board
March 5, 2026
Joseph Todisco
(Principal Executive Officer)
/s/ Susan Blum
Executive Vice President and Chief Financial Officer
March 5, 2026
Susan Blum
(Principal Financial and Accounting Officer)
/s/ Myron Kaplan
Lead Independent Director
March 5, 2026
Myron Kaplan
/s/ Janet Dillione
Director
March 5, 2026
Janet Dillione
/s/ Gregory Duncan
Director
March 5, 2026
Gregory Duncan
/s/ Alan Dunton
Director
March 5, 2026
Alan Dunton
/s/ Steven Lefkowitz
Director
March 5, 2026
Steven Lefkowitz
/s/ Robert Stewart
Director
March 5, 2026
Robert Stewart
50
CORMEDIX INC. AND SUBSIDIARIES
FINANCIAL STATEMENTS
Financial Statements Index
Report of Independent Registered Public Accounting Firm (PCAOB ID #
199 ) F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID #
688) F-4
Consolidated Balance Sheets as of December 31, 2025 and 2024 F-5
Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2025 and 2024 F-6
Consolidated Statements of Changes in Stockholders’ Equity Years Ended December 31, 2025 and 2024 F-7
Consolidated Statements of Cash Flows Years Ended December 31, 2025 and 2024 F-8
Notes to Consolidated Financial Statements F-9
F- 1
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors of
CorMedix Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of CorMedix Inc. (the “Company”) and Subsidiaries as of December 31, 2025, the related consolidated statements
of operations and comprehensive income (loss), stockholders’ equity and cash flows for the year ended December 31, 2025, and the
related notes (collectively referred to as the “financial statements”). In our opinion, based on our audit, the financial
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and the results of
its operations and its cash flows for the year ended December 31, 2025, in conformity with accounting principles generally accepted in
the United States of America.
As discussed in Notes 2 and 8 to the financial
statements, the Company adopted ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU
2023-09”). We have also audited the adjustments to the 2024 financial statements to retrospectively adjust the disclosures for the
adoption of ASU 2023-09 in 2025. In our opinion, such retrospective adjustments are appropriate and have been properly applied. We were
not engaged to audit, review, or apply any procedures to the 2024 financial statements of the Company other than with respect to these
retrospective adjustments, and accordingly, we do not express an opinion or any other form of assurance on the 2024 financial statements
taken as a whole.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below
are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to
the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our
especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion
on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions
on the critical audit matters or on the accounts or disclosures to which they relate.
F- 2
Variable Consideration: Revenue Recognition
Critical Audit Matter Description
As discussed in Note 2 of the financial statements, the Company includes estimates of variable consideration in its transaction price at the time control of the product transfers to the customer. The variable consideration includes an estimate for future product returns, chargebacks and Medicaid rebates in the same period as the related sale occurs. At December 31, 2025, the Company had $35 million in accrued returns, chargebacks and Medicaid rebates.
Auditing the product returns, chargebacks and Medicaid rebates liabilities is challenging because of the subjectivity of certain assumptions required to estimate the liabilities. In calculating the appropriate accrual amount, the Company considers historical returns and payments by product as a percentage of their historical sales as well as any significant changes in sales trends, the lag in payment timing, changes in rebate contracts, an evaluation of the current Medicaid laws and interpretations, the percentage of products that are sold via Medicaid, and product pricing. Given variability in prescription drug costs and variability in prescription data, historical information may not be predictive for management to estimate the variable consideration and thus, management supplements its historical data analysis with qualitative adjustments based upon current expectations, particularly for select products which contribute the largest portion of the Company's revenue.
How We Addressed the Matter in Our Audit
We obtained an understanding and evaluated the procedures over management’s process for the estimation of sales returns, Medicaid rebates and chargebacks. Our audit procedures included, among others, evaluating for reasonableness the significant assumptions used in the product profiles including the contractual terms of the chargeback rates, Medicaid pricing information and other regulatory factors. Our testing involved assessing the historical accuracy of management’s estimates by comparing actual activity to previous estimates and performing analytical procedures, based on internal and external data sources, to evaluate the completeness of the reserves. We estimated the reserves using internal information and historical data and compared the result to the Company’s estimated reserves. Additionally, our procedures included reviewing a sample of contracts, testing a sample of product returns, chargebacks and Medicaid rebate payments and testing the underlying data used in management’s evaluation.
Auditing the Fair Value of Contingent Consideration
and Intangible Assets Acquired in a Business Combination
Critical Audit Matter Description
As described in Note 3 to the financial statements, the Company completed the acquisition of Melinta Therapeutics, LLC on August 29, 2025 for total consideration of $453.7 million and included fair value of contingent consideration of $95.9 million. The Company accounted for this transaction as a business combination under the acquisition method of accounting whereby the fair value of the consideration transferred was allocated to the assets acquired, including intangible assets, excluding goodwill, of $391.1 million and assets and liabilities assumed based upon their acquisition date fair values. Management estimated the fair value of the contingent consideration liability using the probability weighted outcome and discounting the estimated payments and the Monte Carlo simulation for the product royalties. Management estimated the fair value of the intangible assets using the Multi-Period Excess Earnings Method valuation technique for all marketed products and in-process research and development whereby residual forecasted cash flows expected to be derived from the intangible asset over the economic life of the asset, adjusted for expected attrition, are discounted to present value.
We identified the valuation of the contingent consideration and intangible assets at the acquisition date as a critical audit matter because of the significant assumptions management used in estimating the fair values, including forecasted cash flows and the selection of a discount rates used. Auditing management’s assumptions involved a high degree of auditor judgment and an increased audit effort, including the use of valuation specialists, due to the impact these assumptions could have on the accounting estimates.
How We Addressed the Matter in Our Audit
We obtained an understanding and evaluated the procedures over management’s technical accounting analysis and valuation process. We inspected the governing agreements for the transaction and evaluated the application of the Company’s technical accounting analysis including evaluating the terms and management’s conclusion on the interpretation and application of the relevant accounting literature. We tested the reasonableness of management’s forecasted cash flows used in the valuation of the intangible assets and contingent consideration. This testing included analyzing historical revenue trends, margins, and capital expenditures and comparing them to the forecasted amounts. With the assistance of our valuation specialists, we evaluated the reasonableness of the valuation methodology used, the reasonableness of the key inputs and assumptions to develop the fair value measurements, and verified the accuracy and completeness of the underlying data utilized.
/s/ CBIZ CPAs P.C.
CBIZ CPAs P.C .
We have served as the Company’s auditor
since 2014 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C. effective November 1,
2024).
Morristown, New Jersey
March 5, 2026
F- 3
Report of Independent Registered Public Accounting
Firm
To the Shareholders and Board of Directors of
CorMedix Inc.
Opinion on the Financial Statements
We have audited, before the effects of the retrospective
adjustments to the disclosures for the adoption of ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU
2023-09”) as discussed in Notes 2 and 8 to the consolidated financial statements, the accompanying consolidated balance sheet of
CorMedix Inc. (the “Company”) and Subsidiaries as of December 31, 2024, the related consolidated statements of operations
and comprehensive income (loss), stockholders’ equity and cash flows for the year ended December 31, 2024, and the related notes
(collectively referred to as the “financial statements”) (the 2024 financial statements before the effects of the adjustments
discussed in Notes 2 and 8 to the financial statements are not presented herein). In our opinion, based on our audit, the financial statements,
before the effects of the retrospective adjustments to the disclosures for the adoption of ASU 2023-09 as discussed in Notes 2 and 8 to
the financial statements, present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and
the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted
in the United States of America.
We were not engaged to audit, review, or apply
any procedures to the retrospective adjustments to the disclosures for the adoption of ASU 2023-09 as discussed in Notes 2 and 8 to the
financial statements and, accordingly, we do not express an opinion or any other form of assurance about whether such adjustments are
appropriate and have been properly applied. Those retrospective adjustments were audited by CBIZ CPAs P.C.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ Marcum LLP
We have served as the Company’s auditor
from 2014 to 2025.
Morristown, New Jersey
March 25, 2025
F- 4
CorMedix
Inc. And Subsidiaries
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share Data)
December 31,
2025
2024
ASSETS
Current assets
Cash and cash equivalents
$ 144,837
$ 40,651
Short-term investments
3,694
11,037
Account receivables, net
171,233
51,654
Inventories
29,716
7,600
Prepaid expenses and other current assets (including restricted cash of $ 656 and $ 0 at December 31, 2025, and December 31, 2024)
17,571
3,633
Total current assets
367,051
114,575
Property and equipment, net
5,959
1,829
Other long-term assets (including restricted cash of $ 332 and $ 105 at December 31, 2025, and December 31, 2024, net of current)
23,816
105
Goodwill
30,002
-
Intangible asset, net
379,072
1,844
Deferred tax assets
16,276
-
Operating lease right-of-use assets, net
3,020
493
Finance lease- right-of-use assets, net
946
-
TOTAL ASSETS
$ 826,142
$ 118,846
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 7,884
$ 1,720
Accrued expenses
161,921
31,952
Contingent Consideration, short-term
3,015
-
Operating lease liabilities, short-term
853
168
Financing lease liability, short-term
596
-
Total current liabilities
174,269
33,840
Convertible senior notes, net of deferred financing costs
144,626
-
Contingent Consideration, net of current portion
99,101
-
Operating lease liabilities, net of current
2,253
349
Finance lease liabilities, net of current
586
-
TOTAL LIABILITIES
420,835
34,189
COMMITMENTS AND CONTINGENCIES (Note 9)
STOCKHOLDERS’ EQUITY
Preferred stock - $ 0.001 par value: 2,000,000 shares authorized; 91,623 and 136,623 shares issued and outstanding at December 31, 2025 and 2024, respectively
-
-
Common stock - $ 0.001 par value: 160,000,000 shares authorized at December 31, 2025 and 2024; 79,260,667 and 64,411,295 shares issued and outstanding at December 31, 2025 and 2024, respectively
79
64
Accumulated other comprehensive gain
3
91
Additional paid-in capital
581,800
424,132
Accumulated deficit
( 176,575 )
( 339,630 )
TOTAL STOCKHOLDERS’ EQUITY
405,307
84,657
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 826,142
$ 118,846
The accompanying notes are an integral part of
these consolidated financial statements.
F- 5
CorMedix
Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
INCOME (LOSS)
(In Thousands, Except Per Share Data)
December 31,
2025
2024
Revenue:
Product sales, net
$ 304,344
$ 43,472
Contract revenue
7,365
-
Total Revenues
311,709
43,472
Cost of sales (exclusive of amortization of intangibles)
22,089
3,034
Amortization of intangibles
13,872
156
Gross profit
275,748
40,282
Operating Expenses:
Research and development
19,333
3,942
Selling and marketing
38,054
28,737
General and administrative
68,220
29,959
Total operating expenses
125,607
62,638
Income (Loss) From Operations
150,141
( 22,356 )
Other Income (Expense):
Interest income
3,846
2,579
Foreign exchange transaction loss
( 52 )
( 31 )
Unrealized gain on marketable security
5,364
-
Other income
-
519
Change in contingent consideration
( 6,501 )
-
Interest expense
( 2,782 )
( 36 )
Total other income (expense)
( 125 )
3,031
Net Income (Loss) Before Income Taxes
150,016
( 19,325 )
Income Tax (benefit)
( 13,039 )
( 1,395 )
Net Income (Loss)
163,055
( 17,930 )
Other Comprehensive Income (Loss):
Unrealized (loss) from investments
( 2 )
( 5 )
Foreign currency translation gain (loss)
( 86 )
2
Total other comprehensive (loss)
( 88 )
( 3 )
Comprehensive Income (Loss)
$ 162,967
$ ( 17,933 )
Net Income (Loss) Per Common Share – Basic
$ 2.25
$ ( 0.30 )
Net Income (Loss) Per Common Share – Diluted
$ 2.04
$ ( 0.30 )
Weighted Average Common Shares Outstanding – Basic
72,034
58,872
Weighted Average Common Shares Outstanding – Diluted
80,308
58,872
The accompanying notes are an integral part of
these consolidated financial statements.
F- 6
CORMEDIX INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
(In Thousands)
Common Stock
Preferred
Stock –
Series C-3,
Series E,
Series F and
Series G
Accumulated
Other
Comprehensive
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Gain (Loss)
Capital
Deficit
Equity
Balance at December 31, 2023
54,938
$
55
182
$
-
$
94
$
391,693
$
( 321,700
)
$
70,142
Stock issued in connection with ATM sale of common stock, net
3,050
3
-
-
-
18,879
-
18,882
Stock issued in connection with the exercise of pre-funded warrants
2,501
3
-
-
-
-
-
3
Stock issued in connection with options exercised
1,358
1
-
-
-
7,723
-
7,724
Conversion of Series G preferred stock to common stock
2,502
2
( 45
)
-
-
( 2
)
-
-
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes
84
-
-
-
-
( 290
)
-
( 290
)
Cancelation of shares held in escrow
( 22
)
-
-
-
-
-
-
-
Stock-based compensation
-
-
-
-
-
6,129
-
6,129
Other comprehensive loss
-
-
-
-
( 3
)
-
-
( 3
)
Net loss
-
-
-
-
-
-
( 17,930
)
( 17,930
)
Balance at December 31, 2024
64,411
$
64
137
$
-
$
91
$
424,132
$
( 339,630
)
$
84,657
Stock issued in connection with ATM sale of common stock, net
715
1
-
-
-
7,787
-
7,788
Stock issued in connection with options exercised
1,511
2
-
-
-
6,387
-
6,389
Stock issued in connection with public offering, net
6,605
6
-
-
-
82,364
-
82,370
Stocks issued in connection with Melinta acquisition
3,324
3
-
-
-
49,289
-
49,292
Conversion of Series G preferred stock to common stock
2,502
3
( 45
)
-
-
( 3
)
-
-
Issuance of vested restricted stock, net of shares withheld for employee withholding taxes
193
-
-
-
-
( 1,988
)
-
( 1,988
)
Stock-based compensation
-
-
-
-
-
13,832
-
13,832
Elimination of cumulative translation adjustment upon closing of wholly-owned subsidiary
-
-
-
-
( 84
)
-
-
( 84
)
Other comprehensive loss
-
-
-
-
( 4
)
-
-
( 4
)
Net income
-
-
-
-
-
-
163,055
163,055
Balance at December 31, 2025
79,261
79
92
-
3
581,800
( 176,575
)
405,307
The accompanying notes are an integral part of
these consolidated financial statements.
F- 7
CORMEDIX INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
December 31,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Income (loss)
$ 163,055
$ ( 17,930 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
13,832
6,129
Change in right-of-use assets
438
148
Depreciation
677
154
Amortization of intangible
13,872
156
Change in contingent consideration
6,501
-
Change in fair value of equity securities
( 5,364 )
-
Deferred income taxes
( 25,797 )
-
Amortization of debt finance costs
398
-
Provision for current expected credit losses
252
137
Gain on liquidation of foreign entity
( 86 )
-
Changes in operating assets and liabilities:
Increase in account receivables
( 90,924 )
( 51,791 )
Increase in inventory
( 3,478 )
( 5,493 )
Increase in prepaid expenses and other current assets
( 2,061 )
( 2,399 )
(Decrease) Increase in accounts payable
3,329
( 2,560 )
Increase in accrued expenses
100,771
22,985
Decrease in operating lease liabilities
( 308 )
( 151 )
Payment of contingent liability
( 61 )
-
Net cash provided by (used in) operating activities
175,046
( 50,615 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions of businesses, net of cash acquired
( 308,511 )
-
Investment in equity securities
( 5,000 )
-
Purchase of short-term investments
( 47,952 )
( 26,769 )
Maturity of short-term investments
55,293
48,116
Purchase of equipment
( 2,260 )
( 116 )
Net cash provided by (used in) investing activities
( 308,430 )
21,231
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from public offering, net
82,370
-
Proceeds from senior convertible notes
150,000
-
Proceeds from sale of common stock from at-the-market program, net
7,788
18,882
Payment of employee withholding taxes on vested restricted stock units
( 1,988 )
( 290 )
Proceeds from exercise of pre-funded warrants
-
3
Proceeds from exercise of stock options
6,389
7,724
Payment of debt issuance costs associated with the convertible notes
( 5,729 )
-
Payment of contingent consideration liabilities
( 189 )
ROU financing lease fees
( 188 )
-
Net cash provided by financing activities
238,453
26,319
Foreign exchange effects on cash
-
( 2 )
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
105,069
( 3,067 )
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR
40,756
43,823
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – END OF YEAR
$ 145,825
$ 40,756
Cash paid for interest
$ 17
$ 36
Supplemental Disclosure of Non-Cash, Investing, and Financing Activities:
Liability related to license agreement
$ -
$ 2,000
Unpaid debt issuance costs associated with the convertible notes
43
-
Issuance of common stock for Melinta acquisition
49,292
-
Fair value of contingent payments
95,865
-
ROU assets and liabilities for finance lease
203
-
Fair value of assets acquired from Melinta
513,977
-
Liabilities assumed from Melinta
45,430
-
Goodwill recognized on Melinta
30,002
-
The accompanying notes are an integral part of
these consolidated financial statements.
F- 8
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1 - Organization and Description of Business:
Organization and Business:
CorMedix Inc. ( “CorMedix” or the
“Company”) was incorporated in the State of Delaware on July 28, 2006 . The Company is a biopharmaceutical company focused
on developing and commercializing therapeutic products for life-threatening diseases and conditions. The Company commercializes its lead
product, DefenCath ® (taurolidine and heparin) in the United States. CorMedix launched the product commercially in
2024 in both the hospital inpatient and outpatient hemodialysis settings of care.
On August 7, 2025, the
Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) to acquire Melinta Therapeutics, LLC, a
Delaware limited liability company (“Melinta”), which transaction closed on August 29, 2025 (the “Merger”).
The acquisition of Melinta expanded the Company’s team and commercial platform and increased the commercial portfolio with six
marketed, hospital- and clinic-focused infectious disease products, comprised of REZZAYO® (rezafungin for injection),
MINOCIN® (minocycline) for Injection, VABOMERE® (meropenem and vaborbactam), KIMYRSA® (oritavancin), ORBACTIV®
(oritavancin), BAXDELA® (delafloxacin), and an additional well-established cardiovascular product, TOPROL-XL® (metoprolol
succinate) (together, the “Melinta Portfolio”, and, together with DefenCath, “our Products”). REZZAYO is
currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the
prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion
of the Phase III study for REZZAYO is expected in 2026.
The financial results of Melinta are included
in the Company’s consolidated financial statements starting August 29, 2025. Further information relating to the acquisition of
Melinta, including the related financing transaction, is included in Note 3.
Note 2 - Summary of Significant Accounting Policies:
Basis of Consolidation
The consolidated financial
statements include the accounts of the Company and its wholly owned subsidiaries, including the Company’s wholly owned subsidiary
CorMedix Europe GmbH which was dissolved during the year ended December 31, 2025. All significant intercompany accounts and transactions
have been eliminated in consolidation.
Use of Estimates
The preparation of financial
statements in conformity with U.S. Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates
and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates
and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts
of assets and liabilities and disclosure of contingent assets and liabilities in the Company’s consolidated balance sheets and
the reported The more significant areas in which estimates and the exercise of judgment include: variable consideration for product returns
and Medicaid utilization rates; realization of receivables, valuation of inventory; valuation and measurement of contingent consideration,
in-process research and development (“IPR&D”), amortizable intangibles, and goodwill in connection with business combinations;
share-based payment grant date valuation; deferred tax asset valuation changes; and contingent liability recognition and disclosures.
Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances. They are continuously
reviewed but may vary from the actual values.
Reclassifications
Certain reclassifications
were made to the prior year’s amounts to conform to the 2025 presentation.
F- 9
Business Combinations
The Company accounts for business combinations in accordance with FASB
Accounting Standard Codification Topic No. 805, Business Combinations (“ASC 805”), which requires that all business combinations
be accounted for using the acquisition method of accounting. Under this method, the identifiable assets acquired, the liabilities assumed,
and any noncontrolling interest in the acquiree are recognized at their fair values as of the acquisition date. The excess of the total
purchase consideration over the fair value of the identifiable net assets acquired is recorded as goodwill.
In evaluating whether a transaction represents the acquisition of a
business, the Company applies the guidance in ASC 805, considering whether substantially all of the fair value of the gross assets acquired
is concentrated in a single identifiable asset or group of similar identifiable assets. If not, the Company evaluates whether the acquired
set includes an input and a substantive process that together significantly contribute to the ability to create outputs. Transactions
that meet these criteria are accounted for as business combinations; otherwise, they are accounted for as asset acquisitions under ASC
805-50.
For the acquisition of a business, the purchase price is allocated
to the assets acquired and liabilities assumed based on their estimated fair values at the acquisition date. The Company conducts a valuation
analysis to determine the fair value of significant tangible and intangible assets acquired, including marketed product values, trademarks,
and IPR&D. Management determines the fair values of working capital accounts, property and equipment, and certain other assets and
liabilities based on available information and market data.
During the measurement period,
which may be up to one year from the acquisition date, the Company may record adjustments to the fair
value of these tangible and intangible assets acquired and liabilities assumed, with the corresponding offset to goodwill. In addition,
uncertain tax positions and tax-related valuation allowances are initially established in connection with a business combination
as of the acquisition date. Upon the conclusion of the measurement period or final determination of the fair value of assets
acquired or liabilities assumed, whichever comes first, any subsequent adjustments are recorded to the Company’s consolidated
statements of operations.
Accounts Receivable and Allowances
The Company recognizes an
allowance that reflects a current estimate of credit losses expected to be incurred over the life of a financial asset, including trade
receivables. The allowance for credit losses reflects the best estimate of expected credit losses of the accounts receivable portfolio
determined on the basis of current information, forecasts of future economic conditions, industry knowledge and to some extent our historical
experience. The Company determines its allowance methodology by pooling receivable balances. The Company considers various factors, including
individual credit risk associated with each customer, the current and future condition of the general economy and industry knowledge.
These credit risk factors are monitored on a quarterly basis and updated as necessary. Also, to the extent any individual debtor is identified
whose credit quality has deteriorated, the Company establishes allowances based on the individual risk characteristics of such customer.
The Company makes concerted efforts to collect all outstanding balances due, however account balances are charged off against the allowance
when management believes it is probable the receivable will not be recovered. The Company does not have any off-balance sheet credit exposure
related to its customers.
A roll forward of allowance
for credit losses for the years ended December 31, 2025 and December 31, 2024 is as follows:
Year Ended
December 31,
2025
2024
Beginning Balance
$ 137
$ -
Melinta portfolio beginning balance
244
-
Provision for expected credit losses
252
137
Write-offs or recoveries
( 18 )
-
Ending Balance
$ 615
$ 137
Concentrations
The
following table summarizes net revenue from each of the Company’s customers, who individually represent at least 10% of total revenue.
Year Ended
December 31,
2025
2024
Customer A
38 %
86 %
Customer B
20 %
9 %
Customer C
21 %
0 %
F- 10
The following table summarizes
accounts receivable concentrations for each of the Company’s customers, who individually represent at least 10% of total accounts
receivable.
December 31,
2025
December 31,
2024
Customer A
20 %
87 %
Customer B
23 %
12 %
Customer C
41 %
0 %
For DefenCath, the Company
currently has one FDA-approved source (contract manufacturing organization, or “CMO”) for each of its two key active pharmaceutical
ingredients (“APIs”), taurolidine and heparin sodium, respectively. With regards to taurolidine, the Company has a drug master
file (“DMF”) filed with the FDA. There is a master commercial supply agreement between a third-party manufacturer that has
been in place since August 2018. With respect to heparin sodium API, the Company has identified an alternate third-party supplier and
may qualify such supplier under the DefenCath NDA over the next twelve months.
The Company received FDA
approval of DefenCath with finished dosage production from its European based CMO, Rovi Pharma Industrial Services. The Company believes
this CMO has adequate capacity to produce the volumes needed to meet near-term projected demand for DefenCath. In addition, the Company
also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling up production at
the facility.
Each of the products in the
Melinta Portfolio has one FDA-approved contract manufacturing organization, primarily in Europe or in the United States. The Company
has ongoing technology transfers intended to reduce costs of goods sold as well as to onshore the manufacture of several of its products,
which it expects to complete over the next two to three years.
Financial Instruments
Financial instruments that
potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments
and accounts receivable. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the
balances of which often exceed federally insured limits.
The following table is the reconciliation of the accounting standard
that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s
consolidated statement of cash flows:
December 31,
2025
2024
Cash and cash equivalents
144,837
$ 40,651
Restricted cash, (included in prepaid expenses and other current assets)
656
-
Restricted cash, (included in other long-term assets)
332
105
Total cash, cash equivalents and restricted cash
145,825
$ 40,756
The appropriate classification
of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable
debt, classified as available-for-sale, are reported at fair value. Fair value is determined using quoted market prices in active markets
for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered
temporary are reported in other comprehensive income. Realized gains and losses, amortization of premiums and discounts and interest
and dividends earned are included in other income (expense). The Company considers available evidence in evaluating potential impairments
of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments
at December 31, 2025 or December 31, 2024.
The Company’s marketable
securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper
with original maturities of more than 90 days. In addition, the Company holds marketable equity securities in Talphera, Inc., (“Talphera”)
a publicly-traded biotechnology company and has elected the fair value option for accounting for this investment. The related unrealized
gain pertaining to Talphera is recorded in Other income. During the fourth quarter of 2025, the Company’s CEO was appointed to
the Board of Directors of Talphera, and as such, Talphera is considered a related party for any subsequent transactions. The Company
has no related party transactions with Talphera to date.
F- 11
As of December 31, 2025 and
2024, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized
cost, unrealized gains and losses and the fair value at December 31, 2025 and 2024 (in thousands).
Amortized
Cost
Gross
Unrealized
Losses
Gross
Unrealized
Gains
Fair Value
December 31, 2025:
Money Market Funds included in Cash Equivalents
$ 4,805
$ -
$ -
$ 4,805
Commercial Paper
3,694
-
-
3,694
Total December 31, 2025 short-term assets
$ 8,499
$ -
$ -
$ 8,499
December 31, 2024:
Money Market Funds included in Cash Equivalents
$ 23,122
$ -
$ -
$ 23,122
U.S. Government Agency Securities
11,033
-
4
11,037
Total December 31, 2024 short-term assets
$ 34,155
$ -
$ 4
$ 34,159
Fair Value Measurements
In accordance with Accounting
Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments
is required, whether or not recognized in the consolidated balance sheet, for which it is practicable to estimate that value. The Company’s
financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment
securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents,
accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature
of their maturity dates.
The Company categorizes its
financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair
value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the
lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy,
the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial
assets recorded at fair value on the Company’s consolidated balance sheets are categorized as follows:
●
Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted)
for identical assets or liabilities in active markets.
●
Level 2 inputs— Significant other observable inputs (e.g., quoted
prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other
than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs).
●
Level 3 inputs—Unobservable inputs for the asset or liability,
which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market
participants would use in pricing the asset or liability.
F- 12
The following table provides
the carrying value and fair value of the Company’s financial assets measured at fair value on a reoccurring basis as of December
31, 2025 and 2024 (in thousands):
Carrying
Value
Level 1
Level 2
Level 3
December 31, 2025:
Money Market Funds and Cash Equivalents
$ 4,805
$ 4,805
$ -
$ -
Commercial Paper
3,694
-
3,694
-
Total December 31, 2025, short-term assets
8,499
4,805
3,694
-
Marketable Equity Securities
10,364
10,364
-
-
Contingent Consideration liability
102,116
-
-
102,116
December 31, 2024:
Money Market Funds and Cash Equivalents
$ 23,122
$ 23,122
$ -
$ -
U.S. Government Agency Securities
11,037
11,037
-
-
Total December 31, 2024 short-term assets
$ 34,159
$ 34,159
$ -
$ -
Foreign Currency Translation and Transactions
The consolidated financial
statements are presented in U.S. Dollars (USD), the reporting currency of the Company. For the financial statements of the Company’s
foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if any, are translated into
USD at end-of-period exchange rates. The Company dissolved its only foreign subsidiary during the fourth quarter of 2025. Foreign currency
income and expenses are translated at average exchange rates in effect during the year. Translation gains and losses are included in
other comprehensive income (loss). The Company had a foreign currency translation loss of $ 0.1 million in the year ended December 31,
2025 and a gain of $ 0.0 million for the year ended December 31, 2024.
Foreign currency exchange
transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the
entity recording the transaction.
Restricted Cash
The restricted cash as of December 31, 2025 was comprised of $ 0.7 million
in VAT refunds and $ 0.3 million in lease security deposits associated with the ROU operating lease. The VAT refunds are reported in prepaid
expenses and other current assets while the lease security deposits are reported in other long-term assets. The VAT was related to bank
guarantees issued to the Italian Tax Authority (“ITA”) for VAT refunds authorized and received in 2022 and 2023. The bank
guarantees will remain in place until the expiry of statute of limitations imposed by the ITA, which is typically 3 years after the refund
was received.
The Company’s restricted cash of $ 0.1 million
as of December 31, 2024 related solely to a lease security deposit.
Prepaid expenses and other current assets
Prepaid expenses consist
of payments made in advance to vendors relating primarily to service contracts for clinical trial development, manufacturing, pre-clinical
development and insurance policies. These advanced payments are amortized to expense as services are performed over the relevant service
period.
F- 13
Debt Issuance Costs
Debt issuance costs represent
legal and other direct costs incurred in connection with the issuance of the Company’s convertible senior notes due 2030. These
costs are recorded as contra-notes payable on our balance sheet and amortized as a non-cash component of interest expense using the effective
interest method over the term of the loan agreement (see Note 7 – Convertible Senior Notes).
Inventories
The Company engages third
parties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale. Costs
related to the manufacturing of our Products prior to FDA approval to support the preparation for commercial launch are expensed as research
and development expenses (“R&D”) as incurred. Upon FDA approval, costs related to the manufacturing of inventory are
stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis.
Inventory is stated at the
lower of cost or estimated net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material
costs, third-party manufacturing costs, overhead—principally the cost of managing the company’s manufacturers—and related
transportation costs. The Company regularly reviews inventory quantities on hand and writes down to its net realizable value any inventory
that it believes to be impaired. Management considers forecasted demand in relation to the inventory on hand, competitiveness of product
offering and sales volume assumptions, market conditions and product life cycle and expiration dating when determining net realizable
value adjustments. Once inventory is written down and a new cost basis is established, it is not written back up if demand increases.
The Company has not experienced any write-downs for any items listed above as of December 31, 2025 or 2024 respectively.
Inventories consist of raw
materials (including labeling and packaging), work-in-process, and finished goods. Inventories consist of the following (in thousands):
December 31,
2025
December 31,
2024
Raw materials
$ 3,635
$ 1,111
Work in progress
11,691
3,528
Finished goods
14,390
2,961
Total
$ 29,716
$ 7,600
The pre-commercial inventory
previously expensed as R&D prior to FDA approval, which has a book value of $ 0 , consists of certain raw materials and inventory at
various stages of completion with a fair value approximating $ 3.8 million and $ 5.3 million as of December 31, 2025 and 2024, respectively.
Revenue Recognition
The Company recognizes revenue
from the sale of its Products in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”).
The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer;
(2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to
the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
The Company recognizes revenue
when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services
that will be transferred to the customer. The Company’s product revenue is recognized at a point in time when the performance obligation
is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts
with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is received by a customer.
The Company’s customers are located in the United States and consist primarily of outpatient service providers and wholesale distributors.
F- 14
Variable Consideration
The Company includes an estimate
of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable
consideration includes:
●
Distribution service fees;
●
Prompt pay and other discounts;
●
Product returns;
●
Chargebacks;
●
Rebates;
●
Volume incentive rebates;
●
Shelf-stock adjustments;
●
Administrative and data fees.
The Company assesses whether
or not an estimate of variable consideration is constrained based on the probability that a significant reversal in the amount of cumulative
revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts
of consideration ultimately received may vary from our estimates. If actual results in the future vary from estimates, the Company adjusts
these estimates, which would affect product sales and earnings in the period such variances become known.
The specific considerations
that the Company uses in estimating these amounts related to variable considerations are as follows:
Distribution services fees –
The Company pays distribution service fees primarily to its wholesale distributors. The Company reserves these fees based on actual net
sales and the contractual fee rates negotiated with the customers in the distribution channel. The Company records these fees as contra
accounts receivable on the balance sheet.
Prompt pay and other discounts
– The Company provides certain customers with prompt pay discounts. The specific prompt pay terms vary by customer and are contractually
fixed. Prompt pay discounts are expected to be taken by the Company’s customers, so an estimate of the discount is recorded at
the time of sale based on the invoice price. Prompt pay discount estimates are recorded as contra accounts receivable on the balance
sheet.
Product returns- Customers
have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date
by no more than six months (12 months for the legacy Melinta Portfolio). The Company determines its estimate for product returns based
on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held
by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold
to both inpatient and outpatient facilities), and (ii) the estimated remaining shelf life of the Company’s Products held by the
wholesale distributors and outpatient service providers. Since the returns primarily consist of expired and short dated products that
will not be resold, the Company does not record a return asset for the right to recover the goods returned by the customer at the time
of the initial sale (when recognition of revenue is deferred due to the anticipated return). Estimated product returns are recorded as
accrued expenses on the balance sheet.
Chargebacks –
Certain covered entities, group purchasing organizations (“GPO”) and government entities will be able to purchase the product
at a price discounted below wholesaler acquisition cost (“WAC”). The difference between the GPO, government or covered entity
purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount
in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product
that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra accounts receivable
on the balance sheet.
F- 15
Medicaid and Commercial Rebates –
The Company is or may become subject to negotiated discount obligations to different GPO, direct purchasers, other commercial organizations
or government programs, including Medicaid. The rebate amounts for these programs are determined by statutory requirements or contractual
arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates are typically
invoiced in arrears. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that
have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter based on expected product
utilization, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution
channel at the end of each reporting period. Rebate estimates are recorded as accrued expenses on the balance sheet.
Volume Incentive Rebates
– The Company is subject to negotiated volume incentive rebates with certain direct and indirect customers (primarily outpatient
service providers). Rebates are owed based on predetermined volume levels and payable per the terms in the customer contracts. The Company
estimates and records volume incentive rebates based on anticipated purchase volume with specific customers based on communications with
the customer. Volume incentive rebates are recorded as accrued expenses on the balance sheet.
Shelf-stock adjustments –
The Company is subject to quarterly shelf-stock adjustments with certain direct customers to account for contract price changes as related
to quarterly decreases to our published Average Selling Price (“ASP”). Inventory levels subject to shelf-stock adjustment
are determined based on current customer utilization rates and current inventory levels at the customer. Shelf-stock adjustments are
recorded as accrued expenses on the balance sheet.
Administrative and data fees – The Company is subject to negotiated
administrative fees and data fees with certain direct and indirect customers.
Provisions for the revenue
variable consideration described above totaled $ 355.8 million and $ 24.1 million for the year ended December 31, 2025 and 2024 respectively.
As of December 31, 2025 and December 31, 2024, total accrued reserves and allowances to accounts receivable on the balance sheet associated
with variable consideration were $ 132.4 million and $ 23.2 million, respectively.
A roll forward of the significant
categories of variable consideration deductions for the years ended December 31, 2025 and 2024, respectively is as follows:
Volume
Incentive
Rebates
Medicaid
Distribution
Service Fees
Accrued
Shelf-
stock
Liability
Accrued
Returns
Allowance
Chargebacks
Balance at December 31, 2023
$ -
$ -
$ -
$ -
$ -
$ -
Provisions related to sales recorded in the period
21,582
42
335
-
746
63
Credits/payments issued during the period
( 664 )
-
( 33 )
-
-
-
Balance at December 31, 2024
$ 20,918
$ 42
$ 302
$ -
$ 746
$ 63
Melinta portfolio beginning balances
81
1,608
2,107
-
11,817
1,708
Provisions related to sales recorded in the period
113,336
11,448
37,510
9,599
7,629
28,900
Credits/payments issued during the period
( 48,334 )
( 3,002 )
( 34,139 )
( 7,344 )
( 1,901 )
( 26,367 )
Effect of change in estimate
-
2,322
-
-
-
-
Balance at December 31, 2025
$ 86,001
$ 12,418
$ 5,780
$ 2,255
$ 18,291
$ 4,304
During the year ended December 31, 2025, a change in estimate was recorded
for variable consideration pertaining to Medicaid 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 year ended December
31, 2025. During 2025, net income was impacted by $ 1.7 million, basic and diluted earnings per share were negatively impacted by $ 0.02
and $ 0.02 per share, which would have caused earnings per share and diluted earnings per share to be $ 2.27 and $ 2.06 respectively, with a corresponding net income of $164.7 million.
F- 16
License Agreement
In connection with the Merger,
the Company acquired Melinta’s license and collaboration agreements for the R&D and/or commercialization of its therapeutic
products. The terms of these agreements may include nonrefundable licensing fees, funding for research and development and manufacturing,
milestone payments and royalties on any product sales derived from the collaborations in exchange for the delivery of licenses and rights
to sell Melinta’s products within specified territories outside the United States. Because the partners in these agreements are
deemed to be customers under ASC 606, the consideration associated with any performance obligations is accounted for as revenue under
ASC 606. Such revenue is classified as Contract Revenue in the Consolidated Statement of Operations.
In addition, in connection
with these license and collaboration agreements, the Company recognizes revenue from the sale of bulk raw materials and work-in-process
inventory to its partners when it transfers title of the product to such partners. Contract revenue and sales of inventory to partners
are classified as Contract Revenue in the Consolidated Statement of Operations.
Government Contract Revenue
In connection with the Melinta
Portfolio, the Company now holds contracts in partnership with BARDA, a government agency, to advance research and development of certain
of our Products. All aspects of the BARDA contract represent a transaction with a customer to obtain services that are an output of the
Company’s ordinary activities in exchange for consideration, and therefore, the arrangement is accounted for in accordance with
ASC 606.
The Company recognizes government
contract revenue as services are performed under in accordance with ASC 606. Revenue and related reimbursable expenses are presented
on a gross basis in the Company’s Consolidated Statements of Operations. The related reimbursable expenses are expensed as incurred
as research and development expenses. See Note 11 – BARDA Agreement for details of the agreement.
Intangible Assets and Goodwill
Intangible assets represent
the fair value of identifiable intangible assets primarily in connection with the Merger (see Note 3). The Company also holds rights under
the License and Assignment Agreement with ND Partners, LLP, which were recorded at cost (see Note 9 – Commitments and Contingencies
for further discussion). The Company amortizes the cost of intangible assets on a straight-line basis over the estimated economic life
of each asset, generally the patent lives of each associated product (remaining amortization periods are between 5 and 9 years).
As of December 31, 2025,
gross product right intangible assets and the related accumulated amortization were as follows:
Gross
Amount Accumulated
Amortization Net Carrying
Value Weighted-Average Remaining Amortization Period (years)
December 31, 2025
Product licensing rights $ 250,100 $ ( 14,028 ) $ 236,072 5.9
Indefinite-lived asset 143,000 -
143,000 N/A
Intangible asset- net $ 393,100 ( 14,028 ) 379,072
December 31, 2024
Product licensing rights 2,000 ( 156 ) 1,844 8.9
Intangible asset- net 2,000 ( 156 ) 1,844
F- 17
The amortization expense
of acquired intangible assets for each of the following periods are expected to be as follows:
Year ending December 31,
Amortization
Expense
2026
41,200
2027
41,200
2028
41,200
2029
41,200
2030
37,833
2031 and thereafter
33,439
Total
$ 236,072
Amortization of product rights
intangible assets, which is included in cost of goods sold, was $ 13.9 million and $ 0.2 million for year ended December 31, 2025
and 2024 respectively.
Indefinite-lived assets and
goodwill are not amortized but are subject to an impairment review annually and more frequently when indicators of impairment exist.
The Company operates as one reporting unit/one segment, thus the goodwill is deemed to be enterprise goodwill.
Goodwill represents the excess
of the purchase price over the fair value of identifiable net assets acquired in the business combination completed on August 29, 2025.
Goodwill and indefinite lived intangible assets are not amortized and are evaluated for impairment at least annually and more frequently
if events or changes in circumstances indicate that it is more likely than not that the fair value of a reporting unit is less than its
carrying amount.
The Company has elected October
1 as its annual goodwill and indefinite lived impairment testing date.
Since goodwill was recognized on August 29, 2025, and the Company’s
annual testing date is October 1 st . Management performed a qualitative assessment of events and circumstances for the period
between the acquisition date and October 1, 2025 and determined that no triggering events or indicators of impairment occurred. Accordingly,
no impairment loss was recognized.
Impairment of Long-Lived Assets
Long-lived assets consist primarily of property and equipment, and
intangible assets with definite lives. The Company records impairment losses on long-lived assets used in operations when events and circumstances
indicate that the carrying amount of an asset or group of assets may not be fully recoverable at the lowest level of identifiable cash
flows. If impairment indicators are present, the Company assesses whether the future estimated undiscounted cash flows attributable to
the assets in question are greater than their carrying amounts. If these future estimated cash flows are less than carrying value, it
then measures an impairment loss for the amount that carrying value exceeds fair value of the assets. For the year ended December 31,
2025 and 2024, the Company recorded no impairment of long-lived assets.
Leases
The Company accounts for
leases in accordance with ASC 842, Leases . At the inception of a contract, the Company determines whether the arrangement contains
a lease by assessing whether there is an identified asset and whether the Company has the right to control the use of that asset during
the term of the arrangement.
The Company recognizes a
right-of-use (“ROU”) asset and a corresponding lease liability for all leases with a term greater than 12 months. ROU assets
and lease liabilities are measured at the present value of future lease payments at the lease commencement date, discounted using the
rate implicit in the lease, or, if that rate is not readily determinable, the Company’s incremental borrowing rate.
F- 18
Leases are classified as
operating or finance leases at commencement. For operating leases, lease expense is recognized on a straight-line basis over the lease
term within operating expenses. The related ROU assets and lease liabilities are presented separately on the balance sheet. For finance
leases, interest expense on the lease liability and amortization of the ROU asset are recognized separately within interest expense and
depreciation and amortization expense, respectively. Lease liabilities are remeasured if there are changes to the lease term, payments,
or other relevant assumptions.
Income (Loss) Per Common Share
Income (loss) per common
share requires consideration of the two-class method when an entity has participating securities. The Company’s outstanding shares
of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common
stock, participating pro-rata in the earnings of the Company as if the Series E preferred stock was converted into common shares of the
Company. As a result, the Series E preferred stock meets the definition of a participating security, and the Company is required to apply
the two-class method. The Company’s convertible debt is a contingently participating security. The dividends are contingent and
only paid to holders of the convertible debt if dividends declared are equal or greater than the share price. If this occurs, the Company
may be required to apply the two-class method. Under the two-class method, earnings available to common shareholders, including both
distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends
declared and participating rights in undistributed earnings. Since the Series E preferred stock and convertible debt do not have contractual
obligations that require participation in the Company’s losses, the two-class method is not required for periods in which Company
has a net loss.
Basic income (loss) per common share excludes dilution and is computed
by dividing net income (loss) by the weighted average number of common shares, including applicable participating securities, outstanding
during the period. For the year ended December 31, 2025, basic income per common share is calculated assuming the Series E preferred stock
was converted into common shares and participates in the earnings of the Company on a pro-rata basis. The Company’s convertible
debt is excluded from the weighted average shares outstanding for purposes for determining income (loss) per common share as there have
been no conversion for the year ended December 31, 2025. The Company’s convertible debt was not included in the basic income (loss)
per common share under the two-class method because no contingent dividends were declared. As a result, net income for the year ended
December 31, 2025 is allocated pro-rata between the Company’s weighted average outstanding common shares and Series E preferred
stock (on an as-if converted basis). On an as-if converted basis, the Series E preferred stock weighted average shares is equal to 439,010
common shares of the Company and would be allocated $ 1.0 million of the Company’s earnings for the year ended December 31, 2025.
For periods of net income,
diluted net income per share is computed using the more dilutive of the treasury method or two-class method. Because the Company’s
Series E preferred stock does not contain non-forfeitable rights to dividends, the “two-class method” results in the same
diluted net income per share as the “treasury method.” Diluted net income (loss) per common share reflects the potential
dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted
in the issuance of common stock that then shared in the earnings of the Company. The Company calculates dilutive potential common shares
using the treasury stock method for stock options and restricted units, which assumes the Company will use the proceeds from the exercise
of stock options and vesting of restricted stock units to repurchase shares of common stock to hold in its treasury stock reserves. The
Company calculates dilutive potential common shares using the if-converted method for preferred stock and convertible debt, which assumes
they are converted at the beginning of the period (or at time of issuance, if later).
For the year ended December
31, 2024, the two-class method was not required since the Company was in a net loss position and the participating securities do not
have contractual obligations that require participation in the Company’s losses.
F- 19
A reconciliation of the Company’s
basic and diluted income (loss) per common share is as follows (in thousands):
Year Ended December 31,
2025
2024
Numerator:
Net income (loss)
$ 163,055
$ ( 17,930 )
Less: Allocation of undistributed income of Series E securities
( 988 )
-
Undistributed income (loss) available to common stockholders
$ 162,067
$ ( 17,930 )
Denominator:
Basic weighted average common shares outstanding
72,034
58,872
Effect of Series E dilutive securities
439
-
Effect of stock Options and restricted stock dilutive securities
3,533
-
Effect of Convertible Senior Notes dilutive securities
4,302
-
Diluted weighted average common shares outstanding
80,308
58,872
The following potentially
dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be antidilutive
(in thousands):
December 31,
2025
2024
(Number of Shares of
Common Stock Issuable)
Series C-3 non-voting preferred stock
-
4
Series E voting preferred stock
-
392
Series G voting preferred stock
-
2,502
Shares issuable for payment of deferred board compensation
-
49
Shares underlying outstanding stock options
78
6,282
Shares underlying restricted stock units
563
292
Total potentially dilutive shares
641
9,521
Stock-Based Compensation
Stock-based compensation
is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with
service conditions. Restricted stock unit (“RSU”) compensation is based upon the fair value of the Company’s common
stock on the date of the grant for RSU’s that vest upon service conditions. Performance stock units (“PSU’s”)
which vest upon market and service conditions, utilize a Monte-Carlo simulation model. Stock-based compensation is recognized as expense
over the requisite service period on a straight-line basis. See Note 10.
Research and Development
Research and development
costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical
research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract
central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues
for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external
service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs
related to the acquisition of technology rights and patents for which development work is still in process are charged to operations
as incurred and considered a component of research and development expense.
F- 20
Income Taxes
Estimated deferred taxes are
determined based on the difference between the financial statement and tax basis of assets and liabilities, using enacted tax rates, as
well as any net operating loss or tax credit carry forwards expected to reduce taxes payable in future years. A valuation allowance is
provided when it is more likely than not that all or some portion of the estimated deferred tax assets will not be realized. While the
Company considers future taxable income in assessing the need for the valuation allowance, in the event that the Company anticipates that
it will be able to realize the estimated deferred tax assets in the future in excess of its net recorded amount, an adjustment to the
provision for deferred tax assets would increase income in the period such determination was made. Similarly, in the event that the Company
anticipates that it will not be able to realize the estimated deferred tax assets in the future considering future taxable income, an
adjustment to the provision for deferred tax assets would decrease income in the period such determination was made. Changes in the valuation
allowance from period to period are included in the Company’s tax provision in the period of change.
The Company accounts for income taxes regarding uncertain tax positions
and recognizes interest and penalties related to uncertain tax positions in income tax expense in the consolidated statements of operations
and comprehensive income.
Recently Issued and Adopted Accounting Pronouncements
ASU No. 2023-09
In December 2023, the
FASB issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures (Topic 740). The
standard requires disaggregation of the effective rate reconciliation into standard categories, enhances disclosure of income taxes
paid, and modifies other income tax-related disclosures. CorMedix adopted this guidance retrospectively in annual reporting period
ending December 31, 2025. The adoption impacted the CorMedix’s income tax disclosures (see Note 8 – Income Taxes).
Recent Authoritative Pronouncements, not
yet adopted
From time to time, new accounting pronouncements
are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts
as of the specified effective date. Unless otherwise discussed below, the Company does not believe the adoption of recently issued standards
have or may have a material impact on its consolidated financial statements or disclosures.
ASU 2025-11
In November 2025, the FASB
issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements , which clarifies interim disclosure requirements.
The guidance is effective for CorMedix’s interim reporting periods within annual reporting periods beginning after December 15,
2027. Early adoption is permitted. CorMedix is assessing the impact of adopting this guidance on its consolidated financial statements.
ASU 2024-03
In November 2024, the FASB
issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40),
which requires public business entities to provide additional disaggregated disclosures of certain expense categories included in income
statement captions. The guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years
beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. CorMedix
is currently evaluating the impact of adopting this guidance on its consolidated financial statement disclosures.
ASU 2025-05
In July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit
Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets , which provides a practical expedient
for estimating expected credit losses on current trade receivables and contract assets arising from revenue transactions. The guidance
is effective for CorMedix’s annual reporting period beginning after December 15, 2025, with early adoption permitted, and must be
applied prospectively. CorMedix is evaluating the impact of this guidance on its consolidated financial statements.
Note 3 - Acquisition of Melinta:
On August 29, 2025 (the “Closing
Date”), the Company completed the acquisition of Melinta, pursuant to that certain Agreement and Plan of Merger with 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. Pursuant to the terms of the Merger Agreement, the Company acquired Melinta via a merger in which Merger Sub
merged with and into Melinta, with Melinta surviving as a wholly-owned subsidiary of the Company.
F- 21
In consideration for the Merger,
the Company (i) paid to the former Melinta equity holders an aggregate of $ 260 million in cash, subject to adjustment for estimated Company
Cash and estimated Working Capital as compared to the Working Capital Target (each as defined in the Merger Agreement), and (ii) issued
to the to certain of the former Melinta equity holders an aggregate of 3.3 million of common shares of the Company. In addition, in connection
with the Merger, the Company paid $ 23.2 million to acquire the Toprol XL product, which Melinta had licensed from a third party. The total
cash consideration in connection with the Merger Agreement was funded by a combination of the Company’s existing cash on hand and
net proceeds from the Company’s $ 150 million Convertible Notes Offering (see Note 7 for details on the Convertible Notes Offering).
Additionally, the former
Melinta equity holders are eligible to receive certain contingent payments pursuant to the terms of the Merger Agreement and the Contingent
Payment Agreement, which provides for milestone and net sales-based payments. Upon the issuance of the U.S. Food and Drug Administration
(“FDA”) marketing approval of REZZAYO (or 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 (the “REZZAYO Second Indication”) 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 at the Company’s election, to the former Melinta equity holders the following payments
(the “REZZAYO Milestone”):
(i) if the FDA-approved labeling includes candida, $20 million;
(ii)
if the FDA-approved labeling includes aspergillus, $2.5 million; and
(iii)
if the FDA-approved labeling includes pneumocystis, $2.5 million.
Further, the Contingent Payment
Agreement provides that the Company will pay to the former Melinta equity holders tiered royalties on REZZAYO U.S. net sales and low-single-digit
royalties on MINOCIN U.S. net sales (each the “REZZAYO Royalties” and “MINOCIN Royalties”).
The Merger is accounted for using the acquisition method of accounting
for business combinations under ASC 805, Business Combination , with CorMedix representing the accounting acquirer under this guidance.
The estimates relating to the allocation of the purchase price are preliminary through the conclusion of the measurement period, which
will be no longer than one year from the Closing Date.
Summary of Consideration Transferred
The following tables summarizes
the total consideration for the acquisition of Melinta under the Merger Agreement, net of cash, cash equivalents and restricted cash
acquired of $ 44.9 million
Cash Consideration paid to Melinta equity holders
$ 285,292
Cash Consideration paid to acquire Toprol XL
23,219
Fair value of common shares of CorMedix
49,292
Fair value of contingent payments
95,865
Total consideration transferred
$ 453,668
The fair value of the contingent
payments of $ 95.9 million includes the REZZAYO Milestone and the REZZAYO and MINOCIN Royalties (together, the “Royalties”).
The Company estimated the fair value of the REZZAYO Milestone by probability-weighting each outcome and discounting the estimated payment
back to the Closing Date. Key assumptions used in the valuation included probability of milestone achievement, the estimated timing of
approval, an estimated weighted-average cost of capital, and the estimated timing of the REZZAYO Milestone payment occurring in 2027.
In the fourth quarter of 2025,
the Company revised the fair value of common stock issued in connection with the Merger to properly reflect the stock price on the Closing
Date. This revision resulted in an increase to equity and goodwill of approximately $ 9.3 million.
The Company estimated the fair value of the REZZAYO Royalties using
a Monte Carlo simulation framework. Specifically, the Company simulated future net sales assuming a Geometric Brownian Motion framework,
and these simulated metrics were used to determine the applicable percentage of REZZAYO Royalties. The fair value of the MINOCIN Royalties
is linear with no thresholds, caps, tiers, or carry forwards, and was estimated using the Scenario Based Method. For each method, the
Royalties were calculated based on the contractual terms and then discounted from each payment date back to Closing Date. Key assumptions
used in the valuation included projected net sales, the estimated duration of the related cash flows, and an estimated weighted-average
cost of capital. Royalties payments are expected to occur until the expiration of patent or regulatory exclusivity in the late 2030’s.
F- 22
During the year ended, the
Company recognized transaction costs related to the Merger of $ 10.2 million. These costs were primarily associated with financial
advisory, legal and other professional services related to the Acquisition and are reflected within general and administrative expenses
in our consolidated statements of operations.
The preliminary allocation
of the purchase price to acquired assets and liabilities assumed based on their estimated fair values as of Closing Date is reflected
in the table below. Goodwill represents the expected synergies resulting from acquiring the remaining interests in the acquirees that
do not qualify for separate recognition as intangible assets. The goodwill is not deductible for tax purposes as it was a stock acquisition.
Acquired assets and (liabilities) assumed
Assets
Cash, cash equivalents and restricted cash
$ 44,881
Accounts Receivable
28,907
Inventory
18,639
Prepaid expenses and current assets
11,146
Property and equipment, net
2,403
Intangible assets
391,100
Other long-term assets
16,901
Liability
Accounts payable
( 2,835 )
Accrued expenses
( 29,011 )
Other current liabilities
( 1,246 )
Deferred tax liability
( 9,521 )
Other long term liabilities
( 2,817 )
Net assets acquired
468,547
Purchase price consideration
498,549
Goodwill
$ 30,002
In the preliminary purchase
price allocation, the Company identified intangible assets associated with marketed product values and in-process research and development,
the fair value of which were $ 248.1 million, and $ 143.0 million, respectively. In determining the fair value of these intangible assets,
the Company considered many factors, including financial forecasts associated with each of the products, the estimated duration of the
related cash flows, and an estimated weighted-average cost of capital. The estimated net cash flow attributed to each marketable and
licensed product is discounted back to Closing Date using a discount rate of approximately 15 %. The marketed product values will be amortized
on a straight-line basis over their estimated useful lives, on a weighted-average basis, of 6.2 years. The in-process research and development
relates to the future cash flows associated with the REZZAYO Second Indication if and when approved by the FDA, the fair value of which
was determined using probability-weighted, discounted cash flows using a discount rate of 17 %.
The amount of revenue attributable
to the Melinta business included in consolidated statements of operations for the year ended December 31, 2025 is $ 52.9 million.
Fair value measurement of contingent consideration
liability
Consideration paid in a business
combination may include potential future payments that are contingent upon the acquired business achieving certain levels of earnings
in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value
as of the date of acquisition, with subsequent changes in fair value recorded as Other income in the consolidated statements of operations.
Fair value as of the date of acquisition is estimated based on projections of expected future cash flows of the acquired business. The
Company estimates the contingent consideration liability using the Probability-Weighted Discounted Cash Flows, Monte Carlo simulation
framework, and Scenario Based Method approach for REZZAYO Milestone payments, REZZAYO Royalties, and MINOCIN Royalties, respectively.
These approaches require the Company to make estimates and assumptions regarding the future cash flows and profits. Changes in these
estimates and assumptions could have a significant impact on the amounts recognized.
F- 23
The following table summarizes
the change in fair value, as determined by Level 3 inputs, for the contingent consideration liability using unobservable Level 3 inputs
for the year ended December 31, 2025:
Contingent
Consideration
Balance as of August 29, 2025
$ 95,865
Payments against contingent consideration
( 250 )
Change in fair value of contingent consideration liability
6,501
Balance as of December 31, 2025
$ 102,116
For the year ended December
31, 2025, we recognized a $ 6.5 million change in contingent consideration, primarily driven by the changes in the present value of expected
payments resulting from discount accretion and updates to the risk-free rate used in the initial Closing Date valuation as of August
29, 2025. The following table summarizes key assumptions and inputs used in the fair value simulation as of the valuation dates:
Valuation Dates
December 31, 2025
August 29,
2025
Risk-free rate over simulated period
4.30 %
4.41 %
Net sales of REZZAYO product volatility
75.00 %
75.00 %
Net sales REZZAYO product discount rate (continuous)
13.15 %
13.20 %
Net sales Minocin product discount rate (continuous)
8.75 %
8.65 %
Earnout payment discount rate (continuous)
7.13 %
7.32 %
REZZAYO Milestone payment discount rate
6.25 %
6.55 %
Unaudited Pro Forma Financial Information
The following unaudited pro
forma financial information presents the combined results of operations of CorMedix and Melinta as if the Merger occurred at the beginning
of the years presented. The unaudited pro forma financial information includes impact of certain adjustment related to changes from the
purchase of Toprol XL product which was previously licensed to Melinta, amortization of intangibles, transaction related cost incurred,
stock compensation expenses, interest expense on related borrowings, and related income tax effects. The unaudited pro forma financial
information presented does not include any impact of transaction synergies. The unaudited pro forma financial information is presented
for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had
taken place on the date indicated or of results that may occur in the future.
2025
2024
Total Revenue
$ 401,321
$ 163,442
Net Income
$ 138,616
$ ( 55,253 )
Net Income Per Common Share – Basic
$ 1.91
$ ( 0.94 )
Net Income Per Common Share – Diluted
$ 1.75
$ ( 0.94 )
The unaudited pro forma financial
information presented above includes the following adjustments:
Year ended December 31, 2025:
● Elimination of $ 1.7 million of licensing fees and profit sharing costs associated with the Toprol XL brand
● Elimination of $ 10.5 million of acquisition related expenses
● Elimination of historical stock compensation expense of $ 18.9 million
F- 24
● Inclusion of intangible asset amortization of $ 25.9 million
● Net impact of new convertible notes payable of $ 0.4 million
● $ 1.6 million tax effect on proforma adjustments
Year ended December 31, 2024:
● Elimination of $ 2.9 million of licensing fees and profit sharing costs associated with the Toprol XL brand
● Inclusion of $ 10.5 million of acquisition related expenses
● Elimination of historical stock compensation expense of $ 0.6 million
● Inclusion of intangible asset amortization of $ 38.9 million
● Net impact of new convertible notes payable of $ 0.5 million
● $ 12.7 million tax benefit on proforma adjustments
Post-Employment Benefit Costs
In connection with the Merger, the Company eliminated certain positions
across both CorMedix and Melinta personnel and incurred associated severance costs under its benefit plans. The Company incurred an associated
$ 4.1 million of severance expenses during the year ended December 31, 2025. The Company had $ 3.6 million of related severance on its balance
sheet and is included in Accrued Expenses at December 31, 2025. The Company expects to pay all severance associated with the Merger by
December 31, 2026.
Note 4 - Other Prepaid Expenses and
Current Assets:
Other Prepaid Expenses and Current Assets
Other prepaid expenses and
current assets consist of the following:
December 31,
2025
December 31,
2024
Prepaid API (short-term)
$ 9,054
$ 1,039
FDA filing fee
2,653
450
Insurance
1,977
342
Restricted Cash
656
-
Commercial
1,026
666
Subscriptions and Other
2,205
1,136
Total
$ 17,571
$ 3,633
F- 25
Note 5 - Other Long term Assets
Other Long Term Assets
Other long term consist of
the following:
December 31,
2025
December 31,
2024
Restricted Cash (long-term)
332
105
Prepaid API (long-term)
13,029
-
Marketable Equity Securities
10,364
-
Other
91
-
Total
$ 23,816
$ 105
Note 6 - Accrued Expenses:
Accrued Expenses
Accrued expenses consist of the following:
December 31,
December 31,
2025
2024
Accrued gross-to-net-deductions
$ 120,071
$ 21,860
Payroll related liabilities (including severance)
16,853
6,530
License agreement payable
804
2,000
Professional and consulting fees
6,264
865
Income tax payable
12,758
-
Manufacturing related
546
573
Accrued interest
2,332
-
Other
2,293
124
Total
$ 161,921
$ 31,952
Note 7 - Convertible Senior Notes
Convertible Senior Notes
On August 12, 2025, the Company
completed a private placement offering of $ 150 million aggregate principal amount of its 4.00 % Convertible Senior Notes due 2030 (the
“Notes”). The Notes were issued at par and mature on August 1, 2030 . The Company incurred $ 5.7 million in financing costs
related to the issuance, resulting in net proceeds of $ 144.3 million. The financing costs will be amortized over the term of the Notes
up to the face value of $ 150 million.
The Notes bear interest at
a rate of 4.00 % per annum, payable semi-annually in arrears on February 1 and August 1, commencing on February 1, 2026 through August
1, 2030. The Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of the Company’s
future senior unsecured indebtedness.
The Company may, at its option,
redeem all or any portion of the Notes for cash at 100 % of the principal amount of such Notes, plus accrued and unpaid interest, at any
time on or after August 4, 2028, provided that the last reported sale price of the Company’s common stock is at least 130 % of the
conversion price on each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and
including, the trading day immediately prior to the date the redemption notice is given, as well as on the trading day immediately preceding
such notice.
F- 26
Holders may convert their
Notes into shares of the Company’s common stock at their option for any reason on or after May 1, 2030 and prior to the close of
business on the second scheduled trading day immediately preceding the maturity date, or prior to the close of business on the business
day immediately preceding May 1, 2030 under the following circumstances:
● Stock Price Condition: During any calendar quarter commencing after the quarter ending September 30, 2025, if the last reported sale price per share of the Company’s common stock exceeds 130 % of the conversion price for at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter.
● Trading Price Condition: During the five consecutive business days immediately following any five consecutive trading day period (the “Measurement Period”), if the trading price per $ 1,000 principal amount of Notes for each trading day of the Measurement Period is less than 98 % of the product of the last reported sale price per share of common stock and the conversion rate on such trading day.
● Distribution of Rights or Assets: If the Company distributes to all or substantially all holders of its common stock (i) rights, options, or warrants to subscribe for or purchase shares of common stock at a price per share less than the average sale price for the ten consecutive trading days preceding the announcement, or (ii) assets or securities of the Company (other than pursuant to a stockholder rights plan prior to separation), where the value of such distribution exceeds 10 % of the last reported sale price per share of common stock on the trading day immediately before the announcement.
●
Fundamental Change or Share Exchange Event: Upon the occurrence of
a Fundamental Change, Make-Whole Fundamental Change (prior to May 1, 2030), or Share Exchange Event as defined in the Indenture governing
the Notes (other than a merger or business combination solely to change the Company’s jurisdiction of incorporation that does
not constitute a Fundamental Change or Make-Whole Fundamental Change).
●
Redemption: If the Company calls any Note for redemption, the holder
may convert such Note.
The initial conversion rate
for the Notes was set at the time of closing and is equal to 74.2515 shares of common stock per $ 1,000 principal amount of Notes. The
initial conversion price is subject to adjustment as described in the Indenture governing the Notes, not to exceed 96.5269 shares of common
stock per $ 1,000 principal amount of Notes. Upon conversion, the Company will settle its conversion obligation in cash, shares of common
stock, or a combination thereof, at the Company’s election.
Convertible senior notes payable are comprised
of the following as of December 31, 2025:
December 31,
2025
Convertible senior note payable
$ 150,000
Less debt discounts
( 5,374 )
Convertible senior note payable, net
$ 144,626
As of December 31, 2025 accrued
interest on Notes was $ 2.3 million. During the year ended December 31, 2025, the Company amortized debt discount of $ 0.4 million to interest
expense.
Note 8 - Income Taxes:
The Company’s U.S. and foreign loss before
income taxes are set forth below (in thousands):
December 31,
2025
2024
United States
$ 150,016
$ ( 19,066 )
Foreign
-
( 259 )
Total
$ 150,016
$ ( 19,325 )
F- 27
The income tax (benefit)/expense
consisted of the following
December 31,
2025
2024
Current tax expense:
Federal
$ 2,721
$ -
State
10,037
( 1,395 )
Foreign
-
-
Total current
$ 12,758
$ ( 1,395 )
Deferred tax expense
-
Federal
( 28,883 )
-
State
3,086
-
Foreign
-
-
Total deferred
$ ( 25,797 )
$ -
Total income tax (benefit)
$ ( 13,039 )
$ ( 1,395 )
The Company’s deferred tax assets consist
of the following (are tax effected):
December 31,
2025
2024
Deferred tax assets
Net operating loss carryforwards – Federal
$ 117,135
$ 55,778
Net operating loss carryforwards – State
37,811
2,820
Net operating loss carryforwards – Foreign
-
10
Capitalized licensing fees
31
86
Interest expense
6,656
-
Stock-based compensation
3,952
2,976
Accrued compensation
3,495
1,601
Section 174 capitalization
-
5,159
Sales Return
7,756
210
Tax Credit
3,385
-
Inventory reserve
256
-
Other
616
528
Total gross deferred tax assets
181,093
69,168
Less valuation allowance
( 113,330 )
( 69,168 )
Total Deferred tax assets net of valuation allowance
$ 67,763
$ -
Deferred tax liabilities
In Process R&D
( 36,281 )
-
Intangible asset
( 15,206 )
-
Total gross deferred tax liabilities
( 51,487 )
-
Net deferred tax assets
16,276
-
A valuation allowance is provided when it is more likely than not that
some portion or all of the deferred tax assets will not be realized. The net change in the total valuation allowance for the year ended
December 31, 2025 was ($ 44.2 ) million as a result of the acquisition of Melinta and its NOLs.
The tax benefit for year ended
December 31, 2025 was $ 13.0 million, an increase of 11.6 million, or 835 % from 1.4 million for the same period in 2024. As of December
31, 2025, the Company partially released a valuation allowance of $ 61.5 million primarily related to US Federal net operating losses.
The release of valuation allowance was mainly attributed to the expected utilization of historical CorMedix federal NOLs. The Company
will continue to evaluate the realizability of its remaining deferred tax assets each reporting period and adjust the valuation allowance
as appropriate based on changes in cumulative results, forecasts of future taxable income, or other objective evidence as required by
ASC 740-10-35.
The Company has not completed a formal study to
determine whether ownership changes, as defined under Section 382 of the Internal Revenue Code, have occurred that could limit the utilization
of its net operating loss carryforwards and other tax attributes. Until such a study is completed, the Company cannot determine the extent
to which its tax attributes may be subject to annual limitations. The Company does not expect the results of study to have material effects
of the financial statements for the year ended December 31, 2025.
F- 28
As a result of the Merger,
Melinta experienced a Section 382 ownership change on August 29, 2025. This ownership change limits our ability to utilize federal net
operating loss carryforwards and certain other tax attributes that accrued prior to the ownership change and may continue to limit our
ability to utilize such attributes in the future.
The Company recognizes income
tax benefits associated with uncertain tax positions, when, in our judgment, it is more likely than not that the position will be sustained
upon examination by a taxing authority. For a tax position that meets the more likely than not recognition threshold, the Company initially
and subsequently measures the tax benefit as the largest amount that judged to have a greater than 50% likelihood of being realized upon
ultimate settlement with the taxing authority. The Company accrues interest and penalties related to uncertain tax positions in income
tax expense. The Company has concluded that there are no uncertain tax positions requiring recognition in its financial statements as
of December 31, 2025.
The Company files its federal and state income tax returns with the
Internal Revenue Service and the relevant state taxing authorities. The Company is no longer subject to U.S. federal income tax examinations
for tax years prior to 2022 and is no longer subject to state income tax examinations for tax years prior to 2021. As of December 31,
2025, there are no ongoing federal or state income tax audits
The Company had the following potentially utilizable
net operating loss tax carryforwards:
December 31,
2025
2024
Federal
$ 557,786
$ 265,610
State
$ 636,556
$ 41,090
Foreign
$ -
$ 38
Approximately $ 91.5 million of net operating losses generated will expire in 2026 through 2037 for Federal purposes whereas the operating losses for state purposes will start to expire in 2025. The Tax Cuts and Jobs Act of 2017 (the “Act”) limits the net operating loss deduction to 80 % of taxable income for losses arising in tax years beginning after December 31, 2017. However, the net operating losses now have an indefinite carryforward as opposed to the former 20 -year carryforward. Our federal and state operating loss carry forwards include windfall tax deductions from stock option exercises.
The Company’s foreign
earnings, if any, are derived from its foreign subsidiaries which were dissolved in the year ended December 31, 2025 and there was no
income during the year.
The following table summarizes
the Company’s effective tax rate for the periods indicated:
December 31,
2025 2024
Profit (Loss) before income taxes $ 150,016 $ ( 19,325 )
Provision (Benefit) for income taxes $ ( 13,039 ) $ ( 1,395 )
Effective tax rate ( 8.7 )% $ 7.2 %
The Company’s effective tax rate varied
from the statutory rate as follows:
2025
2024
Amount
Percent
Amount
Percent
U.S. federal statutory tax rate
$ 31,503
21.0 %
$ ( 4,058 )
21.0 %
State and local income tax (net of federal) (a)
10,367
6.9 %
( 1,395 )
7.2 %
Foreign tax effects
-
0.0 %
57
( 0.3 )%
Effects of changes in tax laws or rates enacted in the current period
-
0.0 %
-
0.0 %
Changes in valuation allowances:
( 60,713 )
( 40.5 )%
675
( 3.5 )%
Non-taxable or non-deductible items
Stock compensation
( 851 )
( 0.6 )%
1,473
( 7.6 )%
Transaction Cost
2,122
1.4 %
-
0.0 %
Officer’s Compensation
1,646
1.1 %
332
( 1.7 )%
Change in Fair Value of Contingent Liability
1,365
0.9 %
-
-
Other non-taxable or non-deductible items
507
0.4 %
186
( 1.0 )%
Other adjustments:
Stock compensation prior year true-up
79
0.1 %
1,318
( 6.8 )%
Other
936
0.6 %
17
( 0.1 )%
Effective tax rate
$ ( 13,039 )
( 8.7 )%
$ ( 1,395 )
7.2 %
(a) State taxes in Tennessee, Kentucky and California made up the
majority (greater than 50 percent) of the tax effect in this category in 2025. State taxes in New Jersey made up the majority (greater
than 50 percent) of the tax effect in this category in 2024.
F- 29
Individual jurisdictions equaling 5% or more of the total income taxes
paid (net of refunds) for the year ended December 31, 2025 include Tennessee at $ 28 thousand, Texas at $ 18 thousand, South Carolina at
$ 5 thousand and Massachusetts at $ 4 thousand.
Income taxes paid:
December 31,
2025
2024
U.S. Federal
-
-
U.S. State and Local
62
6
Total Taxes paid
$ 62
$ 6
Note 9 - Commitments and Contingencies:
Contingency Matters
In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020
(D.N.J.)
On October 13, 2021, the
United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation , Case
No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and
appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class
action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated
thereunder, and Sections 11 and 15 of the Securities Act of 1933.
On October 10, 2022, the lead
plaintiff filed a second amended consolidated complaint that superseded the original complaints in In re CorMedix Securities Litigation .
On March 21, 2024, the Court denied Defendants’ motion to dismiss without prejudice and granted Lead Plaintiff leave to amend the
complaint.
On April 22, 2024, the Lead
Plaintiff filed a third amended consolidated complaint that superseded the second amended consolidated complaint. In the third amended
complaint, the Lead Plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between
October 16, 2019 and August 8, 2022, inclusive. The third amended complaint names as defendants the Company and six (6) current and former
officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco (the “Officer
Defendants” and collectively with CorMedix, the “CorMedix Defendants”). The third amended complaint alleges that the
CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a).
In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions
to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s
contract manufacturing organization and heparin supplier. The Company filed its motion to dismiss the third amended complaint on June
6, 2024. The motion to dismiss was fully briefed on August 21, 2024.
On August 19, 2025, the Court
issued a revised opinion and order, denying the CorMedix Defendants’ motion to dismiss the third amended complaint. Since then,
the case has proceeded to discovery.
On August 26, 2025, the parties
proposed a revised Pretrial Scheduling Order, which the Court so-ordered on August 27, 2025. Among other things, the Scheduling Order
provides for the (i) substantial completion of document production by January 27, 2026; (ii) completion of fact discovery by June 25,
2026; and (iii) completion of expert discovery by December 28, 2026.
The parties participated in a mediation before
Michelle Yoshida, Esq. of Phillips ADR on November 18, 2025, which did not result in a settlement.
On December 1, 2025, in response to, among other
things, the death of an Officer Defendant, Lead Plaintiff filed an Unopposed Motion for Leave to Amend the complaint, which the Court
granted on December 17, 2025. The CorMedix Defendants filed their answer to the Fourth Amended Consolidated Class Action Complaint on
January 2, 2026.
In re CorMedix Inc. Derivative Litigation ,
Case No. 2:21-cv-18493-JXN-LDW (D.N.J.)
On or about October 13, 2021,
a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District
Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al. , Case No. 2:21-cv-18493-JXN-LDW (the “Derivative
Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo
F. Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco, along with the Company as Nominal Defendant. The complaint alleges
breaches of fiduciary duty, abuse of control, and waste of corporate assets against the individual defendants, and a claim for contribution
for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. On January 21, 2022, pursuant to a
stipulation between the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit was
pending.
F- 30
On or about January 13, 2023,
another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States
District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al. , Case No. 2:23-cv-00150-JXN-CLW. The
complaint names as defendants Paulo F. Costa, Janet D. Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco,
Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, and John L. Armstrong, along with the Company as Nominal Defendant. The complaint
alleges breaches of fiduciary duty and unjust enrichment against the individual defendants.
On or about January 25, 2023,
another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States
District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al. , Case No. 2:23-cv-00406-ES-ESK. The
complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan,
Matthew David, and Phoebe Mounts, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty.
On or about April 18, 2023,
the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings,
trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation , C.A. No. 2:21-cv-18493-JXN-LDW.
The provisions of the Order to Stay that was previously entered in the Voter litigation on January 21, 2022 applied to the consolidated
derivative action.
On August 19, 2025, the Court
issued a revised opinion and order denying the CorMedix Defendants’ motion to dismiss the third amended complaint in the securities
litigation. On November 10, 2025, the derivative plaintiffs filed a verified consolidated shareholder derivative complaint (the “Consolidated
Complaint”), which alleges that during the relevant period (October 16, 2019 – August 8, 2022), the Individual Defendants,
made or caused to be made materially false and misleading statements regarding CorMedix’s business and operations, specifically
relating to purported manufacturing deficiencies during the Relevant Period that the Individual Defendants knew or should have known would
impact the FDA approval of the developmental drug “DefenCath” prior to its ultimate approval by the FDA.
The Consolidated Complaint asserts claims for
breach of fiduciary duty and unjust enrichment. On this basis, the Consolidated Complaint seeks unspecified damages and corporate
governance reforms.
On November 18, 2025, the parties participated
in a mediation before Michelle Yoshida, Esq. of Phillips ADR. On December 20, 2025, the parties signed a binding settlement term
sheet. On January 19, 2026, the parties executed a binding stipulation of settlement, which, if approved, would resolve the case.
The plaintiffs in a new and
separate action––the Jhoe action (discussed below)––filed a motion to intervene and stay this case on December
18, 2025. On January 6, 2026, the plaintiffs filed their opposition to the motion to intervene and stay. The Jhoe plaintiff
filed his reply on January 13, 2026. That motion remains pending and will be decided on the papers.
On January 19, 2026, the plaintiffs
filed their Unopposed Motion for Preliminary Approval of Settlement (“Preliminary Approval Motion”). Following an exchange
of letters, on February 3, 2026, the Jhoe plaintiff filed his purported opposition to the Preliminary Approval Motion raising,
among other things, various objections to the proposed settlement. On February 10, 2026, the plaintiffs filed their reply in further support
of preliminary approval of the proposed settlement, in which Defendants joined and advanced additional arguments in favor of preliminary
approval. The Preliminary Approval Motion remains pending and will be decided on the papers.
Raval v. Baluch, Case No. UNN-L-003721-25
(N.J. Super Ct. Law Div.)
On or about September 26,
2025, a purported shareholder, derivatively and on behalf of CorMedix, filed a shareholder derivative complaint in the Law Division of
the Union County Superior Court of New Jersey, in a case entitled, Raval v. Baluch, et al. , Case No. UNN-L-003721-25 (N.J. Super
Ct. Law Div.) (the “State Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W.
Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David, and Phoebe Mounts, along with CorMedix as Nominal
Defendant. The complaint alleges breaches of fiduciary duty, waste of corporate assets, and abuse of control against the defendants and
contains similar allegations to the previously-filed consolidated derivative complaint pending in federal court. The Raval complaint
seeks unspecified money damages, governance reforms, and costs and expenses. On October 22, 2025, the parties filed a proposed Stipulation
and Consent Order, which the Court entered on the same day. The Stipulation and Consent Order provided that Plaintiff would have until
December 4, 2025 to file an amended complaint or designate the complaint as operative. On December 4, 2025, Plaintiff filed a notice
with the Court designating its September 26, 2025 complaint as the operative complaint.
F- 31
The parties attended a mediation
before Michelle Yoshida, Esq. of Phillips ADR on November 18, 2025. On December 20, 2025, the parties signed a binding settlement
term sheet. On January 5, 2026, the parties filed a Stipulation and Consent Order Staying Action staying the case pending approval
of the settlement in the federal derivative action, which the court entered on the same day. On January 19, 2026, the parties signed
a stipulation of settlement. This action will be dismissed in the event that the proposed settlement is approved by the court in the
federal derivative action.
Jhoe v. Todisco, et al ., C.A. No. 2025-1367-PAF (Del.
Ch.)
On November 24, 2025, an action was initiated
under seal by Robert Jhoe, a purported shareholder of the Company, asserting claims derivatively and on behalf of CorMedix. A public
version of the complaint was filed on December 1, 2025. The complaint names as defendants Khoso Baluch, Janet D. Dillione, Alan
W. Dunton, Robert Cook, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts, John L. Armstrong,
and Joseph Todisco, along with the Company as Nominal Defendant.
The
complaint asserts claims for breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment, and waste. Mr.
Jhoe made a books-and-records demand on CorMedix pursuant to Section 220 of the Delaware General Corporation Law prior to initiating
this action, and the complaint purports to quote and cite board-level materials in support of Mr. Jhoe’s claims. It seeks
unspecified damages and costs along with certain governance reforms.
On December 29, 2025, the defendants moved to
stay or dismiss this action, pending approval of the settlement in the federal derivative action. On January 15, 2026, the parties
filed a Stipulation and Proposed Order Governing the Briefing Schedule for the Motion to Dismiss or Stay, which the court so-ordered
the following day. Per the Stipulation, Defendants filed their Opening Brief on February 16, 2026. Further, Plaintiff’s Opposition
Brief is due on March 18, 2026 and Defendants’ Reply is due on April 2, 2026.
On February 27, 2026, the
parties filed a stipulation and proposed order to stay this case––including the Motion to Dismiss or Stay––pending
decisions by the court in the New Jersey derivative case on two motions: (i) Mr. Jhoe’s Motion to Intervene and (ii) the plaintiffs’
Motion for Preliminary Approval of Settlement, which Mr. Jhoe opposes. The stipulation, which the court so-ordered on March 2, 2026, further
provides that following the New Jersey court’s decisions on these motions, the parties in the Jhoe case will confer regarding appropriate
next steps and update the court accordingly.
Melinta Legal Proceedings
Melinta markets MINOCIN,
which is indicated for the treatment of certain bacterial infections. Melinta holds Orange Book listed patents for MINOCIN, including
two formulation patents (patents 11,944,634 and 12,161,656) issued in 2024.
In 2020, Nexus Pharmaceuticals
(“Nexus”) filed an Abbreviated New Drug Application (“ANDA”) with Paragraph IV (“PIV”) certification
against the only Orange Book listed patents at the time, specifically patents ‘802 and ‘105 (“Minocin Treatment Patents”),
on the alleged basis that the Minocin Treatment Patents were invalid and, in the alternative, that its ANDA did not infringe.
Melinta filed suit against
Nexus in the US District Court for the Northern District of Illinois (the “Court”), asserting that the Minocin Treatment Patents
were valid and accordingly, Nexus’s ANDA for its generic version of MINOCIN infringed these patents. In November 2024, the
Court found that the Minocin Treatment Patents are valid, enforceable and infringed and issued a permanent injunction against the Nexus
ANDA as part of that decision. Nexus subsequently filed an appeal with the U.S. Court of Appeals for the Federal Circuit. The appeal is
ongoing.
Additionally, in February
2025, Melinta received a PIV certification for all four Orange Book listed patents from Gland Pharma (“Gland”) on the alleged
basis that the patents were invalid, and in the alternative that its ANDA did not infringe these patents. Melinta filed a suit against
Gland in the same Court in April 2025. The case is ongoing.
Commitments
License and Assignment Agreement
In 2008, the Company entered
into a License and Assignment Agreement (the ND License Agreement) with ND Partners, LLP (NDP). Pursuant to the ND License Agreement,
NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting
infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and
applications (the NDP Technology). As consideration in part for the rights to the NDP Technology, upon execution of the ND License Agreement,
the Company paid NDP an initial licensing fee of $ 0.3 million and granted NDP a 5 % equity interest in the Company, consisting of 7,996
shares of the Company’s common stock.
F- 32
Under the ND License Agreement,
the Company is required to make cash and equity payments to NDP upon the achievement of certain milestones. Under the ND License Agreement,
the maximum aggregate amount of cash payments due upon achievement of applicable milestones was $ 2.5 million, with the balance being
$ 2 million as of March 31, 2025. The initial licensing fee of $ 0.3 million, the fair value of the 5 % equity interest ( 7,996 shares of
the Company’s common stock) and an additional $ 0.5 million, as a result of the achievement of one milestone, were recognized on
the Company’s statement of operations in R&D in prior periods, as the related milestones were achieved by the Company prior
to the FDA approval. During the year ended December 31, 2024, the Company determined it was probable that the net sales milestones would
be achieved in future periods and, as a result, the Company recorded a license intangible asset of $ 2 million and a license agreement
liability of $ 2 million, which was included within accrued expenses in the Company’s consolidated balance sheet as of December
31, 2024. In May 2025, the Company paid the final milestone liability in the aggregate amount of $ 2 million.
The ND License Agreement
will expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement
in a given country, or (ii) the payment of all milestone payments. Upon the expiration of the ND License Agreement in each country, the
Company will have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country.
Melinta Commitments
Melinta is party to several
license agreements, under which it will be required to make payments based on the achievement of agreed-upon milestones or circumstances.
As of December 31, 2025, Melinta was not obligated to make any of the future payments discussed below.
Wakunaga Pharmaceutical
Co., Ltd . In May 2006, Wakunaga and Melinta executed a license agreement under which Melinta acquired rights to certain patents, patent
applications, and other intellectual property related to BAXDELA. Melinta is obligated to pay royalties to Wakunaga on sales of BAXDELA.
Under the license, Melinta has the right to grant sublicenses, although Wakunaga is entitled to a substantial portion of non-royalty income
received from a sublicense of the Wakunaga technology. Wakunaga has certain termination rights, should Melinta fail to perform its obligations
under the agreement, it becomes subject to bankruptcy or similar events, or Melinta’s business is transferred or sold and the successor
requires us to terminate a substantial part of its development activities under the agreement. Melinta has the right to terminate the
license for cause upon six months’ written notice to Wakunaga. Unless earlier terminated, the license agreement will continue in
effect on a country-by-country and product-by-product basis until Melinta is no longer required to pay any royalties, which is the later
of the date the manufacture, use or sale of a licensed product in a country is no longer covered by a valid patent claim, or a specified
number of years following the first commercial sale in such country.
CyDex Pharmaceuticals,
Inc . In November 2010, Melinta entered into a license and supply agreement with CyDex Pharmaceuticals, Inc. (now a wholly-owned subsidiary
of Ligand Pharmaceuticals Incorporated, both hereafter referred to as Ligand) under which Melinta obtained an exclusive right, under certain
patents and patent applications, to use Ligand’s beta sulfobutyl cyclodextrin, Captisol, in the development and commercialization
of a BAXDELA product. In addition, under the terms of the license agreement, Melinta obtained a nonexclusive license to Ligand’s
Captisol data package. Melinta is obligated to pay royalties to them based on our sales of BAXDELA. Melinta is obligated to certain diligence
requirements and have the right to grant sublicenses to third parties. The license agreement provides for future payments to Ligand upon
the achievement of a future commercial milestone, and obligations to make percentage royalty payments in the single digits based on net
sales, if any, of the licensed product. Additionally, Melinta has agreed to purchase our requirements of Captisol from Ligand for use
in a BAXDELA product, with pricing established pursuant to a tiered pricing schedule. Ligand has certain rights to terminate the agreement
following a cure period, should Melinta fail to perform our obligations under the agreement. In addition, Ligand may terminate the agreement
immediately if Melinta fails to pay milestones or royalties due under the agreement or if Melinta becomes subject to bankruptcy or similar
events. Melinta has the right to terminate the license upon 90 days’ written notice to Ligand. Unless earlier terminated, the agreement
will continue in effect until the expiration of our obligation to pay royalties. Such obligation expires, on a country-by-country basis,
over a specified number of years following the expiration date of the last valid claim of a licensed product in the country of sale; if
there has never been a valid claim of a licensed product in the country of sale, then such number of years after the first sale of the
licensed product in such country.
F- 33
AstraZeneca AB (“AZ”).
In connection with the acquisition of Toprol XL, the seller assigned its rights, title, interests and obligations for the Toprol product
in the U.S. under the supply and license agreements with AZ to Melinta, as a wholly-owned subsidiary of the Company. AZ is obligated
to supply the Toprol product to Melinta in accordance with the supply agreement, and Melinta is obligated to pay royalties based on net
sales of the Toprol product.
Mundipharma. In July
2022, Melinta entered into a license agreement with Cidara Therapeutics (“REZZAYO License Agreement”) (who in April 2024
sold all of its rights in REZZAYO to Napp Pharmaceutical Group Limited (“Napp”), a member of Mundipharma independent associated
companies) to acquire an exclusive license to develop and sell REZZAYO in the U.S. Napp acquired of all assets and rights related to
rezafungin globally, including ongoing development and distribution, while commercialization rights to rezafungin in the United States
remain licensed to Melinta.
As of December 31, 2025, the commitments under the REZZAYO License
Agreement include a regulatory milestone of between $ 30 million and $ 40 million upon receipt of the marketing approval for the prophylaxis
indication, a number of commercial milestones upon exceeding certain net sales targets, and net sales-based royalties. The agreement additionally
stipulates that upon the earlier of thirty-days following the receipt of the marketing approval for the prophylaxis indication or on June
30, 2028, Napp shall assign and transfer to Melinta all rights, title and interest in and to all product filings for the current product
in the U.S. Following the first anniversary of the contract effective date, Melinta may terminate this agreement, in its sole discretion,
upon 90 days prior written notice; otherwise, this agreement shall expire on the expiration of Melinta’s obligation to pay royalties
to Napp when there is no valid claim of the licensed patent rights in the United States.
In connection with the purchase
of the active pharmaceutical ingredient (API) for VABOMERE, Melinta has committed to API deliveries from the CMO in 2026 with a total
cost of € 5.9 million, subject to inflation adjustments.
Other Commitments
In December 2024, the Company
entered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos agreed to provide
a dedicated inpatient field sales force to exclusively promote DefenCath to hospitals and health systems. The Company paid an up-front
implementation and was obligated to pay a fixed monthly fee. The Company signed a termination agreement, effective October 1, 2025
whereas the related services to CorMedix were completed on December 31, 2025. As of December 31, 2025, the Company has a total
net obligation of $ 2.3 million, consisting of $ 1.3 million of accrued termination fees and $ 1.6 million of unpaid expenses incurred through
Q4 2025, which will be partially offset by a security deposit of $ 0.6 million. We expect complete settlement to occur in Q1 2026.
Note 10 - Stockholders’ Equity
Common Stock
On May 9, 2024, the Company
filed a shelf registration statement (the “2024 Shelf Registration Statement”) for the issuance of up to $ 150 million of
Company securities. Also on May 9, 2024, the Company entered into an At-The-Market Issuance Sales Agreement with Leerink Partners LLC,
as sales agent, pursuant to which the Company may sell, from time to time, an aggregate of up to $ 50 million of its common stock through
the sales agents under the 2024 Shelf Registration Statement, subject to limitations imposed by the Company and subject to the sales
agent’s acceptance (the “2024 ATM program”). The sales agent is entitled to a commission of up to 3 % of the gross proceeds
from the sale of common stock sold under the 2024 ATM program. During the year ended December 31, 2025, the Company sold an aggregate
of 715,051 shares of its common stock under the 2024 ATM program and realized aggregate net proceeds of approximately $ 7.8 million. As
of December 31, 2025, approximately $ 22.1 million of the Company’s common stock remains available for sale under its 2024 ATM program,
with $ 15 million of capacity remaining under its 2024 Shelf Registration Statement for the issuance of Company securities.
F- 34
On June 30, 2025, the Company
completed a Follow on 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.
In addition, the Company granted the underwriter a 30-day option to purchase an additional 15 % of the shares of its common stock offered
in the offering, which expired unexercised.
On August 29, 2025, the Company
issued 3,323,833 shares of common stock in connection with the Merger and has registered an additional 3,000,000 shares of common stock
that may be issuable, at the Company’s election, upon the achievement of the REZZAYO Milestone in connection with the Merger (see
Note 3).
During the years ended December
31, 2025 and 2024, 45,000 and 44,999 shares of Series G preferred stock were converted to 2,502,062 and 2,502,005 shares
of common stock, respectively.
Preferred Stock
The Company is authorized
to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company’s board of directors
has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion
rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock
authorized, the Company’s board of directors has designated (all with par value of $ 0.001 per share) the following:
As of December 31, 2025 As of December 31, 2024
Preferred
Shares
Outstanding Liquidation
Preference
(Per Share) Total
Liquidation
Preference Preferred
Shares
Outstanding Liquidation
Preference
(Per Share) Total
Liquidation
Preference
Series C-3 2,000 $ 10.00 20,000 2,000 $ 10.00 $ 20,000
Series E 89,623 $ 62.76 5,624,739 89,623 $ 49.20 $ 4,409,452
Series G - $ - - 45,000 $ 187.36 $ 8,431,200
Total 91,623 5,644,739 136,623 $ 12,860,652
In July 2025, the stated value of the Series E
Convertible Preferred Stock was amended from $ 49.20 to $ 62.76 per share.
The following rights,
privileges, terms and conditions apply to the outstanding preferred stock at December 31, 2025:
Series C-3 Non-Voting Preferred Stock
Rank. The Series
C-3 non-voting preferred stock will rank senior to our common stock; senior to any class or series of capital stock created
after the issuance of the Series C-3 non-voting preferred stock; and junior to the Series E voting convertible preferred stock in each
case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
F- 35
Conversion. Each
share of Series C-3 preferred stock is convertible into 2 shares of our common stock (subject to adjustment in the event of
stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock) at a per share
price of $ 5.00 at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series
C-3 preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would
beneficially own more than 9.99 % of the total number of shares of our common stock then issued and outstanding.
Liquidation Preference. In
the event of our liquidation, dissolution or winding up, holders of Series C-3 preferred stock will receive a payment equal to $ 10.00 per
share of Series C-3 preferred stock before any proceeds are distributed to the holders of our common stock. After the payment of this
preferential amount, and subject to the rights of holders of any class or series of our capital stock hereafter created specifically
ranking by its terms senior to the Series C-3 preferred stock and holders of Series C-3 preferred stock will participate ratably in the
distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that
participates with the common stock in such distributions.
Voting Rights. Shares
of Series C-3 preferred stock will generally have no voting rights, except as required by law and except that the consent of holders
of two thirds of the outstanding Series C-3 preferred Stock will be required to amend the terms of the Series C-3 preferred stock or
the certificate of designation for the Series C-3 preferred stock.
Dividends. Holders
of Series C-3 preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3 preferred stock
equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common
stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)
are paid on shares of the common stock.
Redemption. We
are not obligated to redeem or repurchase any shares of Series C-3 preferred stock. Shares of Series C-3 preferred stock are not otherwise
entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.
Listing. There
is no established public trading market for the Series C-3 preferred stock, and we do not expect a market to develop. In addition, we
do not intend to apply for listing of the Series C-3 preferred stock on any national securities exchange or trading system.
Fundamental Transactions. If,
at any time that shares of Series C-3 preferred stock are outstanding, we effect a merger or other change of control transaction, as
described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive,
upon any subsequent conversion of a share of Series C-3 preferred stock (in lieu of conversion shares) for each issuable conversion share,
the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such
fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.
Series E Voting Convertible Preferred Stock
Rank. The Series
E voting preferred stock will rank senior to our common stock; senior to any class or series of capital stock created after the issuance
of the Series E voting convertible preferred stock; senior to the Series C-3 non-voting convertible preferred stock; and on parity with
the Series G voting convertible preferred stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution
or winding up whether voluntarily or involuntarily.
Conversion. Each
share of Series E preferred stock is convertible into 5.5787 shares of our common stock (subject to adjustment as provided
in the certificates of designation for the Series E preferred stock) at a per share price of $ 3.75 at any time at the option of
the holder, except that a holder will be prohibited from converting shares of Series E preferred stock into shares of common stock if,
as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number
of shares of our common stock then issued and outstanding.
F- 36
Liquidation Preference. In
the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment equal to $ 62.76 per
share of Series E preferred stock on parity with the payment of the liquidation preference due the Series G preferred stock, but before
any proceeds are distributed to the holders of common stock, and the Series C-3 non-voting convertible preferred stock. After the payment
of this preferential amount, holders of Series E preferred stock will participate ratably in the distribution of any remaining assets
with the common stock and any other class or series of our capital stock that participates with the common stock in such distributions.
Voting Rights. Shares
of Series E preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price of $ 7.93 .
Dividends. Holders
of Series E preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series E preferred stock
equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common
stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)
are paid on shares of the common stock.
Redemption. We
are not obligated to redeem or repurchase any shares of Series E preferred stock. Shares of Series E preferred stock are not otherwise
entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.
Listing. There
is no established public trading market for the Series E preferred stock, and we do not expect a market to develop. In addition, we do
not intend to apply for listing of the Series E preferred stock on any national securities exchange or trading system.
Fundamental Transactions. If,
at any time that shares of Series E preferred stock are outstanding, we effect a merger or other change of control transaction, as described
in the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive, upon any
subsequent conversion of a share of Series E preferred stock (in lieu of conversion shares) for each issuable conversion share, the same
kind and amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such fundamental
transaction if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.
Debt Restriction. As
long as any of the Series E preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer to exist any indebtedness,
other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $ 10 million
aggregate principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may
include up to $ 5 million of letters of credit outstanding at any time.
Other Covenants. In
addition to the debt restrictions above, as long as any of the Series E preferred stock is outstanding, we cannot, among others things:
create, incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase or pay any cash dividend
or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and
Series G preferred stock); redeem, repurchase or prepay any indebtedness (other than as permitted); or engage in any material line of
business substantially different from our current lines of business.
Purchase Rights. In
the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common
stock, then a holder of Series E preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or
securities as if the Series E preferred stock had been converted to common stock.
F- 37
Restricted and Performance Stock Units
The Company has granted restricted
stock units (“RSUs”) to certain employees and non-employee directors and performance stock units (“PSUs”) to
certain executive employees as compensation for services. The grant date fair value of the RSUs is based upon the fair value of the Company’s
common stock on the date of the grant for RSUs that vest upon service or performance conditions. For RSUs that vest upon market conditions,
the grant date fair value of RSUs is based upon a Monte-Carlo simulation model.
During the year ended December
31, 2025 and 2024 the Company granted 1,747,308 and 283,333 RSUs to its employees and non-employee directors with service based vesting
conditions and a weighted average grant date fair value of $ 11.10 and $ 3.47 per share respectively. Compensation expense related to these
RSUs is recognized on a straight-line basis over the vesting period. As of the year ended, December 31, 2015, and 2024, the Company had
1,550,883 and 291,494 shares unvested with a weighted average fair value of $ 10.50 and $ 3.44 , respectively.
During the year ended December
31, 2025 and 2024, 371,166 and 145,574 RSUs vested, respectively, of which 193,032 and 84,559 shares of common stock were issued by the
Company, respectively, and 178,134 and 61,015 shares, respectively, were withheld in lieu of withholding taxes.
In addition to the RSUs noted
above, during the year ended December 31, 2025, the Company granted 487,500 PSUs to its executive officers with market performance and
service based vesting conditions and, as such, the grant date fair value of $ 11.79 was calculated using a Monte-Carlo simulation model.
Of the total PSUs granted, 62,500 of these PSUs were forfeited in August 2025 due to the resignation of an employee. During the year ended
December 31, 2025, 33,220 additional shares were the result of the end of the Period 1 measurement period. As of December 31, 2025,
458,220 PSUs are outstanding, which have a weighted average fair value of 11.79 . The following key assumptions were used to determine
the fair value of the PSUs granted during the period:
Assumption
Period 1
Period 2
Period 3
Share price
$ 8.10
N/A
N/A
Equity volatility
71.2 %
69.7 %
87.0 %
Remaining term at time of valuation (years)
0.99
1.99
2.99
Dividend yield
0 %
0 %
0 %
Risk-free rate
4.13 %
4.20 %
4.25 %
Compensation expense related
to these PSUs is recognized on a straight-line basis over the requisite service period, regardless of whether the market condition is
ultimately satisfied.
As of December 31, 2025,
the Company had 2,009,103 outstanding RSUs and PSUs. As of December 31, 2025, unrecognized compensation expense related to unvested RSUs
and PSUs was $ 14.3 million, which will be recognized over a weighted average remaining period of 1.7 years as of December 31, 2025.
Stock Options
On October 13, 2022, the
Company’s shareholders approved the CorMedix Inc. Amended and Restated 2019 Omnibus Stock Incentive Plan (the “2022 Plan”),
pursuant to which the Company may issue as additional 4,800,000 shares of its common stock, respectively, plus any shares that remain
available for grant under its existing plan as of the effective date, as long-term equity incentives to the Company’s employees,
consultants, and directors. On November 21, 2024, the Company’s shareholders approved Amendment No. 1 to the 2022 Plan, which increased
the number of shares authorized for issuance by an additional 3,360,000 shares. The long-term incentives may be in the form of stock
options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or other rights or benefits
(collectively, “stock rights”) to employees, consultants, and directors of the Company or a related entity (collectively,
“participants”). The Company believes that the effective use of long- term equity incentives is essential to attract, motivate,
and retain employees, consultants and directors, to further align participants’ interests with those of the Company’s stockholders,
and to provide participants incentive compensation opportunities that are competitive with those offered by other companies in the same
industry and locations as the Company.
F- 38
The 2022 Plan amends and
restates the 2019 Stock Incentive Plan. The 2013 Stock Incentive Plan and the Amended and Restated 2006 Stock Incentive Plan are referred
to collectively as the “Prior Plans.” No further awards will be granted under the Prior Plans. Awards outstanding under the
Prior Plans will remain outstanding in accordance with their terms and the Prior Plans.
During the year ended December
31, 2024, the Company granted ten-year qualified and non-qualified stock options to its officers, directors, employees and consultants
in the aggregate of 2,196,167 shares of the Company’s common stock under the 2019 Plan. The weighted average exercise price of
these options was $ 3.80 . The Company did not grant any stock options during the year ended December 31, 2025.
During the years ended December
31, 2025 and 2024, the Company issued 1,510,887 and 1,357,802 shares of common stock, respectively, as a result of the exercise of stock
options. The Company realized net proceeds of $ 6.4 million and $ 7.7 million, respectively, from the exercise of stock options with a
weighted average exercise price of $ 4.22 and $ 5.69 per share, respectively.
During the year ended December
31, 2025 no stock options were issued. As of December 31, 2025, there was approximately $ 2.3 million in total unrecognized compensation
expense related to stock options granted, which will be recognized over an expected remaining weighted average period of 1.0 years. All
share-based awards are recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards
are recognized in the period in which they occur.
The fair value at grants
dates of the grants issued subject to service and performance-based vesting conditions were determined using the Black-Scholes option
pricing model with the following assumptions:
Year
Ended
December 31,
2025
2024
Risk-free interest rate
N/A
3.60 % - 4.65 %
Expected volatility
N/A
93.2 % - 100.5 %
Average Expected term (years)
N/A
6 years
Expected dividend
yield
N/A
0.0 %
Weighted-average grant date
fair value of options granted during the period
N/A
$ 3.04
The Company estimated the
expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted
to consultants, if any, is based upon the full term of the respective option agreements. The expected stock price volatility for the
Company’s stock options is calculated based on the historical volatility of the Company’s common stock. The expected dividend
yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine
the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent
with the expected term of the Company’s awards.
The following table summarizes the Company’s stock options activity
and related information for the year ended December 31, 2025 and 2024 (in thousands except share data):
Shares
Underlying
Stock
Options Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term
(Years) Aggregate
Intrinsic
Value
Outstanding at December 31, 2023 6,211,508 $ 5.44 6.4 $ 700
Granted 2,196,167 $ 3.80 - -
Exercised ( 1,357,802 ) $ 5.69 - $ 3,750
Expired/Cancelled ( 418,932 ) $ 12.27 - -
Forfeited ( 348,548 ) $ 3.68 - -
Outstanding at December 31, 2024 6,282,393 $ 4.46 7.8 $ 23,568
Granted -
$ -
- -
Exercised ( 1,510,887 ) $ 4.22 - $ 11,149
Expired/Cancelled ( 28,741 ) $ 19.16 - -
Forfeited ( 220,944 ) $ 4.13 - -
Outstanding at December 31, 2025 4,521,821 $ 4.46 7.7 $ 32,532
Vested at December 31, 2025 3,208,698 $ 4.72 6.5 $ 22,321
Expected to vest in the future 1,313,123 $ 3.85 7.7 $ 10,211
F- 39
The aggregate intrinsic value
is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock
of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price.
Stock-Based Compensation
Total stock-based compensation
expense recognized in the consolidated statements of operations is as follows:
Year Ended
December 31,
Award type
2025
2024
RSUs
$ 8,197
$ 690
PSUs
1,644
-
Stock options
3,991
5,439
Total
$ 13,832
$ 6,129
The following table represents the allocation
of stock-based compensation expense by financial statement line item:
Year Ended
December 31,
Financial statement line item
2025
2024
Cost of sales
$ 513
$ 270
Research and development
709
438
Selling and marketing
1,690
582
General and administrative
10,920
4,839
Total
$ 13,832
$ 6,129
During the year ended December
31, 2025, $ 0.9 million of expense related to stock option and RSUs pertained to equity modifications for employees who were provided
notice of Merger-related terminations.
Stock-based Deferred Compensation Plan for Non-Employee Directors
In 2014, the Company established
an unfunded stock-based deferred compensation plan, providing non-employee directors the opportunity to defer up to one hundred percent
of fees and compensation, including restricted stock units. The amount of fees and compensation deferred by a non-employee director is
converted into stock units, the number of which is determined based on the closing price of the Company’s common stock on the date
such compensation would have otherwise been payable. At all times, the plan participants are one hundred percent vested in their respective
deferred compensation accounts. On the tenth business day of January in the year following a director’s termination of service,
the director will receive a number of common shares equal to the number of stock units accumulated in the director’s deferred compensation
account. The Company accounts for this plan as stock-based compensation under ASC 718. During the years ended December 31, 2025 and 2024,
no compensation was deferred under this plan.
On September 17, 2025, the
Board approved the termination and liquidation of the plan in accordance with IRC Section 409A. As of the termination date, one director
participated in the plan. All accrued benefits under the plan will be distributed on the date that is one business day following the twelve-month
anniversary of the termination date.
Note 11 - BARDA Agreement
In July 2023, Melinta entered
into partnership with BARDA to advance BAXDELA and VABOMERE for use in pediatrics and to partner on the development of BAXDELA against
certain biothreat pathogens (BARDA-Supported Studies). Under this contract, BARDA reimburses Melinta certain percentages of costs incurred,
as defined in the agreement, in connection with the BARDA-Supported Studies. BARDA has awarded a total of $ 47.5 million of funding with
the potential of additional funding of $ 97.1 million, amounting to total funding up to $ 144.6 million, if all options are exercised. If
all contract options are exercised, the contract is expected to continue through 2034. Through December 2025, Melinta has recognized BARDA
reimbursement totaling $ 19.4 million.
F- 40
There are two performance
obligations under the BARDA contract, which are research and development services performed for (a) BAXDELA and VABOMERE pediatric studies
and (b) BAXDELA biodefense studies. These research and development services were performance obligations because they are distinct within
the context of the contract; that is, the services are separately identifiable from other obligations within the arrangement. In addition,
the transaction prices included within the BARDA contract were equivalent to the standalone selling price of the research and development
services and would be allocated. Therefore, research and development services are recognized as contract revenue over time, as the performance
obligation is satisfied, in accordance with the BARDA agreement. The Company recognized $ 4.2 million of contract revenue under the BARDA
agreement for the year-ended December 31, 2025.
Note 12 - Segment Reporting
The Company has determined
that it has one reportable segment- Drug Product primarily sold in the United States with contract revenue consisting of BARDA in the
US and product, royalty and milestone revenues outside of the US.
The Company’s Chief
Executive Officer is the Chief Operating Decision Maker (“CODM”). The CODM manages the Company’s business activities
as a single reportable segment. The CODM uses consolidated profit and loss to evaluate and measure performance against progress in its
commercialization efforts and clinical trials. The following table sets forth significant segment expenses.
Year Ended
December 31,
2025
2024
Research and development:
Employee expense
$ 7,756
$ 2,455
Other research and development
11,577
1,487
Total research and development
19,333
3,942
Selling and marketing
Employee and contracted employee expense
$ 22,618
$ 13,494
Other selling and marketing
15,436
15,243
Total selling and marketing expense
38,054
28,737
General and administrative
Employee expense
$ 32,584
$ 18,321
Other general and administrative
35,636
11,638
Total general and administrative expense
68,220
29,959
Total operating expenses
$ 125,607
$ 62,638
The CODM also reviews DefenCath
sales separately from sales from the Melinta Portfolio; the following table sets forth the breakdown of sales:
Year Ended
December 31,
2025
2024
Product Sales:
DefenCath
$ 258,813
$ 43,472
Melinta Portfolio
45,531
-
Total product sales
304,344
43,472
Contract Revenue
7,365
-
Total Revenues
311,709
43,472
F- 41