UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended: December 31,
2025
OR
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _________________
to ______________________
Commission file number: 001-34673
CORMEDIX INC.
(Exact name of Registrant as Specified in Its Charter)
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including
area code: (908)517-9500
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol Name of each exchange on which registered
Common Stock, $0.001 Par Value CRMD Nasdaq Global Market
Securities registered pursuant to Section 12(g)
of the Act: None.
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☒ No ☐
Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐No☒
Indicate by check mark whether the registrant:
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes☒
No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit such files).
Yes☒
No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any news or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☐
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those corrections
are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive
officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐
No ☒
The aggregate market value of the registrant’s
voting common equity held by non-affiliates of the registrant, based upon the closing price of the registrant’s common stock on
the last business day of the registrant’s most recently completed second fiscal quarter was approximately $909.7 million.
The number of outstanding shares of the registrant’s
common stock was 79,050,395 as of March 2, 2026.
DOCUMENTS INCORPORATED BY REFERENCE
Specified portions of the registrant’s
definitive Proxy Statement to be issued in conjunction with the registrant’s 2026 Annual Meeting of Stockholders, which is expected
to be filed not later than 120 days after the registrant’s fiscal year ended December 31, 2025, are incorporated by reference
into Part III of this Annual Report. Except as expressly incorporated by reference, the registrant’s Proxy Statement shall not
be deemed to be a part of this Annual Report on Form 10-K.
CORMEDIX INC.
2025 Form 10-K Annual Report
Table of Contents
PART I 1
Item 1. Business 1
Item 1A. Risk Factors 17
Item 1B. Unresolved Staff Comments 31
Item 1C. Cybersecurity 31
Item 2. Properties 32
Item 3. Legal Proceedings 32
Item 4. Mine Safety Disclosures 32
Item 6. [RESERVED] 33
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 43
Item 8. Financial Statements and Supplementary Data 43
Item 9A. Controls and Procedures 44
Item 9B. Other Information 45
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 45
PART III 46
Item 10. Directors, Executive Officers, and Corporate Governance 46
Item 11. Executive Compensation 46
Item 14. Principal Accounting Fees and Services 46
Item 15. Exhibits, Financial Statement Schedules 47
SIGNATURES 50
i
Forward-Looking Statements
This Annual Report on Form
10-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often
identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,”
“seek,” “should,” “target,” “will,” “would,” and similar expressions or variations
intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s
expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned
that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed
to the Risk Factors identified in the Risk Factor Summary and section titled “Item 1A. Risk Factors” of this Annual Report
on Form 10-K and in CorMedix’s other filings with the Securities and Exchange Commission (the “SEC”) copies of which
are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve
the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this
Annual Report on Form 10-K. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not
intend to update these forward-looking statements, except as required by law.
ii
PART I
Item 1. Business
Overview
CorMedix Inc. (collectively,
with our wholly owned subsidiaries, referred to herein as “we,” “us,” “our” or the “Company”)
is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions.
Our primary focus has been commercializing DefenCath® (taurolidine and heparin), in the U.S., which we launched in 2024 in the hemodialysis
setting. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration (“FDA”).
On August 29, 2025, the Company
acquired Melinta Therapeutics, LLC, a Delaware limited liability company (“Melinta”), which expanded the Company’s
team, 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 (“MINOCIN IV”), VABOMERE®
(meropenem and vaborbactam), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin), and BAXDELA® (delafloxacin), as well as an
additional well-established cardiovascular product, TOPROL-XL® (metoprolol succinate) (together, the “Melinta Portfolio,”
and, together with DefenCath, “our Products”). The Melinta Portfolio supports a multi-channel strategy of delivering anti-infectives
for serious gram-positive, gram-negative and fungal infections within hospitals and the hospital ecosystem, including emergency departments,
outpatient clinics and home infusion care, and provides synergy opportunities to drive growth for DefenCath.
Business Strategy
Our corporate strategy is focused on increasing stockholder value by
maximizing the value of our current portfolio, with promotional efforts focused on DefenCath, REZZAYO, MINOCIN IV and VABOMERE. In addition,
we seek to create additional value through the pursuit of expanded indications for both DefenCath, for the reduction of central line associated
bloodstream infection (“CLABSI”) in adult patients receiving total parental nutrition (“TPN”), and REZZAYO in
the prophylaxis of invasive fungal infections in adult patients that are immune compromised. We also engage in the pursuit of business
development opportunities that could be highly synergistic with our existing or future sales infrastructure deployment.
Promoted Commercial Products
DefenCath
On November 15, 2023, we
announced that the FDA approved the new drug application (“NDA”) for DefenCath, an antimicrobial catheter lock solution (“CLS”)
(a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream
infections (“CRBSI”) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter
(“CVC”). We launched DefenCath commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis
setting, and it is the largest contributor to our net sales.
Subsequent to the launch of DefenCath in April 2024, we announced U.S.-based
multi-year commercial supply agreements consisting of a large and several mid-sized dialysis organizations. Each customer has customized
an implementation plan to provide access to their patients based on a variety of clinical and other factors. We believe the currently
contracted customer base represents roughly 60% of the outpatient dialysis centers in the U.S., in terms of the total addressable patient
market.
Market Opportunity
CVCs or ‘central lines’
are an important and frequently used method for accessing the vasculature for hemodialysis (a form of dialysis where the patient’s
blood is circulated through a dialysis filter), administering chemotherapy and basic fluids in cancer patients and for cancer chemotherapy,
administering long term antibiotic therapy, and administering total parenteral nutrition (complete or partial dietary support via intravenous
nutrients).
1
Bloodstream infections resulting from the use of central venous catheters
known as CLABSIs and a subset of them, referred to as CRBSIs, can result in significant morbidity and increased rates of hospital admissions,
readmissions, and mortality. One of the major and common risk factors for all patients requiring CVCs is the risk of acquiring a CLABSI
and the clinical complications associated with them. The total annual cost for treating outpatient derived CRBSI episodes and their related
complications in the U.S. is up to $2.3 billion, with approximately 80,000 CRBSI episodes and up to 28,000 deaths per year (Pronovost
et al., The New England Journal of Medicine, 2006).
According to the 2025 United States Renal Disease System, reporting
data from 2023, there were approximately 485,000 End-Stage-Renal-Disease (“ESRD”) patients on permanent hemodialysis in the
U.S. and over 25% of these utilized a CVC for vascular access. Of the total population, approximately 108,000 hemodialysis patients were
new patients diagnosed with ESRD during the year and 80% of those were receiving dialysis through a CVC. Patients are typically treated
in various care settings including inpatient hospitals and outpatient dialysis clinics. Kidney failure patients can include both those
affected by acute kidney injury and chronic kidney disease populations that progress into dialysis. Kidney failure patients who are admitted
to the hospital have an average length of stay of approximately two weeks and additionally high 30-day readmission rates both for the
same diagnosis and all-cause with the all-cause readmissions being higher.
The two primary causes of
CLABSI are the external introduction of pathogens to the catheter site and the internal proliferation of pathogens within the catheter
lumens. Intraluminal infections are caused by pathogens entering and proliferating within the sterile internal surfaces of the CVC and
are often associated with late stages of biofilm dispersion. Biofilm build up can be the pathogenesis of both infections and thrombotic
complications in central venous catheters. Prevention of CRBSI and inflammatory complications requires both removal of pathogens from
the internal surface of the catheter to prevent the systemic dissemination of organisms contained within the biofilm as well as an anticoagulant
to retain blood flow during dialysis that may be hindered by clot formation. Biofilm forms when bacteria adhere to surfaces in aqueous
environments and begin to excrete a slimy, glue-like substance that can anchor them to various types of materials, including intravenous
catheters. The presence of biofilm has many adverse effects, including the ability to release bacteria into the bloodstream. The current
standard of catheter care is to instill a heparin lock solution at a concentration of 1000 u/mL into each catheter lumen immediately
following treatment, to prevent clotting between dialysis treatments. However, a heparin lock solution has no antimicrobial activity
and thus provides no protection from the risk of infection.
Other than DefenCath, there are no pharmacologic drug products FDA-approved
in the U.S. for the prevention or reduction of CRBSIs in CVCs. We believe there is a significant need for reduction or prevention of CRBSIs
in the hemodialysis patient population as well as for other patient populations utilizing central venous catheters such as total parenteral
nutrition recipients.
DefenCath is a non-antibiotic,
broad-spectrum antimicrobial and anticoagulant combination that is active against common microbes including antibiotic-resistant strains
and also has a secondary mechanism of action that inhibits adherence of microorganisms to biological surfaces which is the first steps
in biofilm formation. We believe that using DefenCath as an antimicrobial catheter-lock solution significantly reduces the incidence
of life-threatening catheter-related blood stream infections, thus reducing the need for hospital admission and systemic antibiotics
while prolonging catheter function. We are unaware of any drug products other than DefenCath approved by the FDA with an indication for
use as a catheter lock solution.
CRBSIs, a clinically confirmed
subset of the epidemiological surveillance term, CLABSI, can lead to treatment delays and increased costs to the healthcare system when
they occur due to extended and often repeat hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement
of the CVC, related treatment costs, as well as increased mortality. DefenCath is the first and only FDA-approved antimicrobial CLS in
the U.S. and was shown to reduce the risk of CRBSI by up to 71% in a Phase 3 clinical study, and as such, we believe it addresses a significant
medical need. Additionally, in December 2025, we reported data from an interim analysis of a retrospective, real-world evidence (“RWE”)
study that indicates a 70% reduction in annualized number of hospitalizations secondary to CRBSI, when dialysis-patient catheters are
locked with DefenCath, demonstrating a significant value proposition to patients as well as to providers and payers.
Pricing and Reimbursement
Sales of DefenCath depend, in large part, on the extent to which it
will be covered by third-party payors, such as Medicare, Medicaid, and other federal and state government programs, managed care entities,
commercial insurers, and other organizations, as well as the level of reimbursement such third-party payors provide for DefenCath. It
is essential to obtain third-party payor coverage policies and adequate payment to continue to successfully commercialize DefenCath. We
expect to continue to sell DefenCath primarily to outpatient dialysis clinics and inpatient hospitals.
2
Inpatient Reimbursement
For Medicare, inpatient acute-care
hospitals are paid under the inpatient prospective payment system (the “IPPS”). The IPPS pays a flat rate based on the
average charges across all hospitals for a specific diagnosis, regardless of whether that particular patient costs more or less. Under
the IPPS, each case is categorized into a diagnosis-related group (“DRG”), which is weighted and multiplied by a standardized
amount (updated each year for inflation and other factors), to yield a fixed payment for that DRG and adjusted for hospital-specific
factors (e.g., wages, teaching hospitals) to cover care furnished during the inpatient stay. Additional, temporary payment is
available for new medical services and technologies called New Technology Add-on Payment (“NTAP”) if certain criteria are
met.
The Centers for Medicare
& Medicaid Services (“CMS”) issued the IPPS 2024 proposed rule that included an NTAP per-hospital stay for DefenCath.
This NTAP represents reimbursement to inpatient facilities of up to 75% of the WAC price per 3 mL vial, and an average utilization of
19.5 vials per hospital stay. The final IPPS rule was published in early August 2023 and subsequently amended as of October 1, 2024 to
reflect the then current WAC of $249.99 per 3ml vial.
NTAP is granted for a period of 2-3 years after the date of FDA approval.
Although NTAP is intended to identify and ensure adequate payment for qualifying new technologies, it may have a limited effect depending
on the DRG assignment after the NTAP period ends. The NTAP for DefenCath will expire on November 14, 2026 (three years post-approval).
Outpatient Reimbursement
The Medicare ESRD IPPS provides bundled payment for renal dialysis
services and affords a Transitional Drug Add-on Payment Adjustment (“TDAPA”), which provides temporary, additional payments
for certain new drugs and biologicals. TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition
price or manufacturers’ list price, respectively, if such data is unavailable). TDAPA and post-TDAPA add-on payment adjustments
for DefenCath apply for five years from July 1, 2024, (with such add-on payments applying to all ESRD IPPS payments for years three through
five). The HCPCS J-code for DefenCath was published by CMS on April 2, 2024. DefenCath TDAPA began on July 1, 2024 and will transition
into the post-TDAPA Add-On Payment phase on July 1, 2026. As a result of the methodology utilized by CMS, the level of reimbursement provided
to institutions treating dialysis patients will significantly decline, and as a result, we anticipate there will be a corresponding reduction
to the net pricing for DefenCath for the third and fourth quarters of 2026. The 2027 post-TDAPA add-on adjustment will be effective on
January 1, 2027. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January
1, 2027, we estimate the value of the Add-On Adjustment will be three to five-times higher than that granted for the third and fourth
quarters of 2026, which we expect would result in higher DefenCath sales prices in 2027 relative to the second half 2026. After January
1, 2027, the post-TDAPA Add-On Payment will be reassessed again and be made effective on January 1, 2028 and January 1, 2029, covering
the three-year period through June 30, 2029. There can be no assurance that the level of reimbursement determined by CMS will improve.
Further changes in these reimbursement rates could lead to significant fluctuations in our operating income and could have a negative
impact on our revenues, earnings and cash flows.
CMS determined that DefenCath
qualified for pass-through status under the hospital Out-Patient Prospective Payment System (“OPPS”) in June 2024. Pass-through
status provides for separate payment under Medicare Part B for the utilization of DefenCath in the outpatient ambulatory setting for
a period of at least two years, and up to a maximum of three years. While vascular access for hemodialysis can be initiated in an inpatient
setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-based alternative for patients. We
estimate that up to 100,000 HD-CVC placements occur each year, and pass-through status offers providers a separate reimbursement mechanism
in this setting of care administration of DefenCath.
Additional Indications
As a brand expansion opportunity,
in the second quarter of 2025, we initiated a Phase 3, randomized, double-blind, adaptive, two-arm, clinical study assessing the safety
and efficacy of DefenCath in reducing CLABSIs in adult patients receiving TPN via CVC. The study protocol stipulates a total of up to
200 subjects for a total of 12 months treatment, with the primary endpoint being efficacy of DefenCath as a CLS, when compared to heparin,
in delaying time to CLABSI. We currently expect to complete the study in the first half of 2027.
Currently, there is no pharmaceutical standard of care for prevention
of bloodstream infections for TPN patients utilizing a CVC and those patients are highly susceptible to CLABSI. CLABSIs occur in up to
26% of TPN patients with a CVC, and TPN is associated with a 4-fold increase in odds ratio for acquiring CLABSIs. In addition, CLABSIs
are associated with an excess hospital length of stay of 2 to 3 weeks, and patients who develop a CLABSI are 35% to 40% more likely to
be readmitted. We believe that the total addressable market for TPN is between $500 million and $750 million in the inpatient and home
infusion settings – equating to more than 4.5 million potential infusions.
3
Also in 2025, we
initiated our post-marketing requirement for a pediatric hemodialysis (“HD”) study. We are currently obligated by the
FDA to conduct the HD study as communicated in our NDA approval letter: an open-label, two-arm (DefenCath vs. standard of care)
study to assess safety and time to CRBSI in subjects from birth to less than 18 years of age with kidney failure receiving
hemodialysis via a central venous catheter. Pediatric studies for an approved product conducted under the Pediatric Research Equity
Act (the “PREA”) may qualify for pediatric exclusivity, which, if granted, provides an additional six months of
exclusivity that attaches to the end of existing marketing exclusivity and patent periods for DefenCath. Depending on the timing of
final report submission, DefenCath could potentially receive an additional 0.5 years of exclusivity associated with this pediatric
study (a total marketing exclusivity period of 10.5 years). There are factors that could affect whether this exclusivity is received
or the duration of exclusivity, and DefenCath may or may not ultimately be eligible for the additional 0.5 years of exclusivity
associated with this pediatric study.
In 2024, we launched the
Expanded Access Program (“EAP”) for DefenCath, which is designed to provide access to a broader population of adult and pediatric
patients using CVCs for various serious medical conditions to protect their central line from serious infection. A key aspect of this
EAP is its focus on individuals who, due to their unique clinical circumstances, are either ineligible for participation in ongoing clinical
trials or do not meet the criteria outlined in the current approved FDA label for DefenCath.
We may pursue additional indications for DefenCath use as a CLS in
populations with unmet medical needs that may also represent potentially significant market opportunities, and we are regularly assessing
these areas. In addition, we may seek CMS reimbursement for DefenCath in other catheter indications beyond ESRD, including but not limited
to through (i) relevant hospital inpatient DRGs, (ii) additional NTAP payments, or (iii) outpatient ambulatory payment classifications (“APCs”). Payment under these Medicare benefit categories is not guaranteed for these potential additional indications.
REZZAYO
We acquired distribution
and marketing rights to REZZAYO in the U.S. in connection with the acquisition of Melinta in August 2025. REZZAYO is a next
generation, once-weekly, IV-formulation echinocandin, which was approved in the U.S. in March 2023 in patients 18 years of age or
older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. While our licensor Napp
Pharmaceutical Group Limited, a member of Mundipharma independent associated companies (“Mundipharma”), currently holds
the product NDA and intellectual property rights, upon the earlier of thirty-days following the receipt of the marketing approval
for the prophylaxis indication or on June 30, 2028, Mundipharma shall assign and transfer to CorMedix all rights, title and interest
in and to the U.S. NDA and sNDAs for REZZAYO. See Contractual Obligations, included in Managements’ Discussion and
Analysis included within this Annual Report, for additional details on the arrangement with Mundipharma.
Market
Opportunity
REZZAYO offers a convenient alternative to the standard of care, daily
echinocandin dosing regimen, with its once-weekly dosing schedule, highly simplifying management of candidemia and invasive candidiasis.
In practice, REZZAYO’s once-weekly intravenous dosing and efficacy compared to daily echinocandins make it attractive not only in
inpatient settings but also in outpatient patient antimicrobial therapy (“OPAT”) where clinical stability permits transition
from hospital care. Available alternatives to REZZAYO include marketed echinocandins—caspofungin, micafungin, and anidulafungin—which
share a similar mechanism of action and are used in first-line therapy for candidemia and invasive candidiasis, typically require once-daily
intravenous dosing. Azole antifungals (e.g., posaconazole, voriconazole, isavuconazole, fluconazole) are also used for candidemia
and invasive candidiasis and may be limited by clinically significant drug-to-drug interactions, tolerability considerations in complex
regimens and increasing resistance in some candida species.
Candidemia and invasive candidiasis conditions are typically encountered
in acute care hospitals, intensive care units (“ICUs”), and tertiary care centers where patients are critically ill, often
immunocompromised, and at high risk for life-threatening fungal infections. The decision to use REZZAYO typically is made by infectious
disease specialists, hospitalists, and critical care physicians managing these severe candida infections, especially in situations where
daily echinocandin therapy is burdensome or where simplifying antifungal treatment is desirable. Pharmacy and therapeutics committees
are also responsible for formulary decisions in hospitals and health systems evaluating antifungal treatment options that may reduce administration
frequency and resource utilization without compromising clinical outcomes.
There are an estimated 25,000 cases of candidemia and 50,000 invasive
candidiasis each year in the U.S., and REZZAYO is currently indicated for the treatment of such infections. We believe that the total
addressable market for the treatment indication is approximately $250 million to $350 million.
4
Additional Indications
REZZAYO is currently being
evaluated for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation
(“BMT”) (“ReSPECT clinical trial”). The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind
study evaluating the efficacy and safety of once-weekly REZZAYO versus a standard antimicrobial regimen (“SAR”) for the prevention
of invasive fungal diseases (“IFDs”) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a
400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components.
The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to
toxicity, and mortality adjusted for comorbidities. This Phase III study, which is being conducted by our licensor Mundipharma, completed
enrollment in September 2025, and we expect to announce top-line data in the second quarter of 2026.
In BMT settings, antifungal
prophylaxis remains a critical but operationally complex component of care. Current standard options, particularly azole antifungals,
are effective but introduce significant drug–drug interaction risk, often affecting conditioning chemotherapy, targeted oncology
agents, and post-transplant immunosuppressants. These interactions can necessitate dose reductions, regimen modifications, and intensive
therapeutic drug monitoring, increasing clinical burden and the risk of suboptimal cancer treatment delivery. Additional challenges include
variable oral absorption, overlapping hepatic and cardiac toxicities, and the need for daily administration, all of which complicate
care during the most vulnerable phases of transplant.
REZZAYO represents a differentiated
approach to antifungal prophylaxis that directly addresses these limitations. As a once-weekly intravenous echinocandin with minimal
drug–drug interaction potential, REZZAYO offers a more predictable and safer option for use alongside complex oncology and transplant
regimens. Its extended half-life enables convenient dosing while preserving antifungal efficacy without requiring routine dose adjustments
of concomitant therapies. By reducing interaction-driven compromises, simplifying administration, and supporting consistent prophylaxis
during high-risk treatment windows, REZZAYO has the potential to meaningfully improve clinical workflow and risk management in transplant
care, positioning it as a compelling alternative within the evolving antifungal prophylaxis landscape.
We believe that a prophylaxis
indication of REZZAYO could be a key potential growth driver to the business. We estimate that the total addressable market for antifungal
prophylaxis in the U.S. is greater than $2 billion.
MINOCIN IV
MINOCIN IV is an intravenous
formulation of a highly differentiated tetracycline-class antibiotic with safety, tolerability and strong placement in the Infectious
Diseases Society of America (“IDSA”) guidelines. MINOCIN IV is indicated for the treatment of infections caused by susceptible
Gram-positive and Gram-negative organisms, including Acinetobacter species, Staphylococcus aureus, Streptococcus species, Escherichia
coli, Klebsiella pneumoniae, Haemophilus influenzae, Neisseria species, and certain atypical pathogens, and has been on the U.S. market
since 2015.
Market Opportunity
MINOCIN IV addresses a defined
but persistent market opportunity within the U.S. hospital anti-infectives market, particularly in the treatment of serious infections
where intravenous therapy is required and alternative agents may be limited by resistance, tolerability, or route of administration.
Demand for hospital-administered antibiotics remains supported by the ongoing prevalence of serious infections, including multidrug-resistant,
Gram-negative organisms such as Acinetobacter baumannii. Hospitals continue to require multiple therapeutic options to manage these infections
under antimicrobial stewardship protocols, particularly when oral therapy is not appropriate and susceptibility testing supports MINOCIN
IV use.
Acinetobacter baumannii (“CRAB”) as an “urgent”
antimicrobial resistance threat in its 2019 national Antibiotic Resistance Threats in the United States report, first listing CRAB at
the highest threat level due to its limited treatment options and potential to spread resistant genes. Estimates from CDC data indicate
that CRAB accounted for approximately 8,500 infections and about 700 deaths annually in the United States from 2019–2020, with resistant
strains often impervious to multiple antibiotic classes and associated with difficult-to-treat hospital-acquired infections. CDC surveillance
updates during 2021–2022 continued to show CRAB among key healthcare-associated resistant pathogens with infection burdens rising
compared to pre-pandemic levels, reflecting ongoing clinical challenges in prevention and management. The pathogen’s resistance
profile and associated mortality, combined with its designation as an urgent threat by the CDC, underscore its significance as a dangerous
source of drug-resistant infection in U.S. healthcare settings.
5
MINOCIN IV is one of the
few agents approved for treatment of Acinetobacter species. Acinetobacter infections are generally seen in the ICU, particularly in mechanically
ventilated and immunocompromised patients. The IDSA Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections lists
MINOCIN IV as a recommended alternative in combination therapy for the treatment of CRAB infections when susceptibility is demonstrated,
reflecting its role in multidrug regimens used to manage these difficult-to-treat infections and helping address the treatment gaps identified
by the CDC.
The product’s market opportunity is driven primarily by institutional
purchasing decisions, local antibiograms (hospital-specific summaries of antimicrobial susceptibility data), and infectious disease specialist
prescribing patterns rather than broad empiric use. While overall antibiotic utilization in hospitals is moderated by stewardship efforts,
we believe that the need for differentiated IV therapies for resistant infections, treatment-limited patients, and complex clinical scenarios
supports continued demand for MINOCIN IV as part of the hospital anti-infective armamentarium.
VABOMERE
VABOMERE is an IV antibiotic
that is a combination of meropenem, the leading carbapenem used in treatment of gram-negative infections, and vaborbactam, a novel beta-lactamase
inhibitor that inhibits certain types of resistance mechanisms used by bacteria. VABOMERE received FDA approval in August 2017, for the
treatment of patients 18 years of age and older with complicated urinary tract infections (“cUTI”), including pyelonephritis,
caused by designated susceptible Enterobacteriaceae. VABOMERE was specifically developed to address gram-negative bacteria that produce
beta-lactamase enzymes, particularly the Klebsiella pneumoniae carbapenemase (“KPC”) enzyme. In addition, we have a partnership
with the Biomedical Advanced Research and Development Authority (“BARDA”) to advance VABOMERE for use in pediatrics (see
“Biomedical Advanced Research and Development Authority Contract” section below for further details).
Market Opportunity
The market opportunity for
VABOMERE is driven by the growing global prevalence of serious Gram-negative infections, particularly those caused by carbapenem-resistant
Enterobacterales (“CRE”), including infections mediated by Klebsiella pneumoniae carbapenemase (“KPC”)–producing
organisms. KPC-producing CRE are classified by the CDC to be an urgent antimicrobial resistance threat as they represent a significant
and persistent subset of carbapenem resistance in the United States and are associated with high morbidity, mortality, prolonged hospital
stays, and increased healthcare costs. Hospitalized patients, including those in intensive care units or with significant comorbidities,
are at heightened risk for these infections and have limited treatment options, underscoring the ongoing need for effective, targeted
antibacterial therapies.
VABOMERE was designed to
address this unmet medical need by combining a carbapenem antibiotic with a beta-lactamase inhibitor active against KPC enzymes, which
are among the most prevalent carbapenemase enzymes in the United States. The market opportunity for VABOMERE is supported by continued
clinical demand for resistance-directed therapies for KPC-producing CRE, increasing use of rapid diagnostic testing to identify specific
carbapenemase enzymes, and antimicrobial stewardship practices that prioritize agents with activity against defined resistance pathways.
While the antibacterial market is highly competitive and subject to pricing pressure, hospital formulary adoption and use in appropriate
patient populations provide an opportunity for VABOMERE to address a defined segment of serious Gram-negative infections where limited
therapeutic alternatives exist. Additionally, VABOMERE is included in the IDSA guidelines as one of the recommended options for the treatment
of CRE when the isolate is susceptible and particularly when KPC–producing organisms are involved.
Purchasing decisions for
VABOMERE are typically made by hospital pharmacy and therapeutics committees and are affected by factors such as clinical efficacy and
safety data, labeled indications, resistance patterns within the institution, availability of alternative therapies, pricing, and reimbursement.
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Other Commercial Products
While not directly marketed by our sales team,
the following brands have limited and targeted promotional activities, including certain market access and contracting support:
ORBACTIV and KIMYRSA
ORBACTIV and KIMYRSA (the
“ORI Franchise”) are long-acting IV antibiotics indicated for the treatment of adult patients with acute bacterial skin and
skin structure infections (“ABSSSI”) caused by susceptible Gram-positive pathogens, including MRSA, with no dose adjustment
for mild/moderate renal or hepatic impairment or for age, weight, gender, or race. ORBACTIV and KIMYRSA obtained U.S. marketing approval
in August 2014 and March 2021, respectively.
Treatment decision-making
in ABSSSI is increasingly shaped by site-of-care optimization: avoiding potentially preventable hospital admissions, shortening length
of stay, and reducing the operational burden of multi-day IV regimens and OPAT logistics. ORBACTIV and KIMYRSA address these dynamics
by delivering a complete course of therapy in a single dose administration, supporting use across multiple settings (e.g., emergency
departments, outpatient infusion centers, hospital outpatient departments) where a single-visit approach can improve adherence and reduce
the need for extended IV access such as placement of a peripherally inserted central catheter (“PICC”). Within the ORI Franchise,
KIMYRSA provides a 1-hour infusion option, while ORBACTIV is administered over 3 hours, enabling clinicians and health systems to select
an approach aligned to workflow and capacity constraints, while maintaining single-dose therapy for eligible patients. In contrast to
the current standard of care (6 to 10 days of IV therapy), which generally requires a PICC line or hospital stay, single-dose ABSSSI
therapy with the ORI Franchise alternatives increases patient convenience, ensures patient adherence with a single dose, and allows for
treatment in alternative, lower cost care settings.
In addition, oritavancin, the active ingredient
in ORBACTIV and KIMYRSA, is a semisynthetic lipoglycopeptide antibiotic with a distinctive triple mechanism of action against susceptible
Gram-positive pathogens. Specifically, oritavancin (i) inhibits transglycosylation (polymerization of peptidoglycan chains), (ii) inhibits
transpeptidation (cross-linking of peptidoglycan), and (iii) disrupts bacterial cell membrane integrity, leading to rapid, concentration-dependent
bactericidal activity. This multi-targeted activity differentiates oritavancin from agents that act through a single pathway and contributes
to its potency against key Gram-positive pathogens, including MRSA, as well as activity against certain organisms with reduced susceptibility
to other glycopeptides
BAXDELA
BAXDELA is a novel fluoroquinolone that is approved for the treatment
of adult patients with ABSSSI or community-acquired bacterial pneumonia (“CABP”). BAXDELA has a broad-labeled spectrum including
Staphylococcus aureus (including MRSA) as well as certain Gram-negative organisms and is available to initiate therapy on either an IV
or oral formulation. While we do not promote BAXDELA, our partnership with BARDA includes support to advance BAXDELA, as described below
for use in pediatrics and for use against certain biothreat pathogens (see “Biomedical Advanced Research and Development Authority
Contract” section below for further details).
TOPROL XL
TOPROL XL (metoprolol succinate extended-release) is a cardioselective
beta-blocker indicated for the treatment of hypertension, which has been on the U.S. market since 1992. The Toprol XL brand lost market
exclusivity in 2007, lending to market dynamics of a mature, highly competitive beta-blocker class, with broad availability of generic
metoprolol succinate extended-release alternatives, intense payer/formulary pressure, and prescription decisions influenced by total cost
of care and patient adherence considerations. While we do not actively promote TOPROL XL, there remains some brand demand which tends
to concentrate in segments where prescribers and patients value a long-established extended-release option and consistent once-daily dosing
in chronic cardiovascular management, but overall growth is constrained by generic substitution and pricing pressure typical of long-marketed
cardiovascular therapies.
Competitive Landscape
The drug and medical device industries are highly competitive and subject
to rapid and significant technological change. Competitors (and potential competitors) for our Products include large and specialty pharmaceutical
and biotechnology companies and medical device companies. Many of our competitors have substantially greater financial, technical and
human resources than we do and significantly more experience in the development and commercialization of drugs and medical devices. Further,
the development of new treatment methods, antimicrobial resistance, or products could render our commercial products non-competitive or
obsolete.
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We believe that the key competitive factors that will affect the commercial
success of DefenCath are established efficacy and safety, as well as pricing and reimbursement mechanisms across the continuum of care.
Given that DefenCath is the only FDA-approved antimicrobial catheter lock solution in the U.S., we believe that with adequate reimbursement
there is an opportunity for DefenCath to become the new standard of care as a CLS in the U.S. market. Further, as the Company continues
to demonstrate both short and long-term reductions in healthcare costs via the results from our real-world evidence study, we believe
that the overall reduction in both infections and hospitalizations could drive greater utilization and create new opportunities for reimbursement.
We are not aware of any potentially competitive CLSs that are approved or under development by other companies in the U.S. for primary
prevention of infection. As a means to reduce infections, some dialysis providers are using anti-infective infused catheter caps and/or
compounded FDA-unapproved antibiotic containing catheter lock solutions.
Across the Melinta Portfolio,
critical success factors in a highly competitive anti-infective market include clear clinical differentiation and strong alignment with
evolving treatment guidelines. Competitive positioning depends on demonstrating meaningful advantages versus generic and branded alternatives
in areas such as spectrum of activity against resistant organisms, safety and tolerability, reduced drug–drug interactions, dosing
convenience (including long-acting or infrequent dosing regimens), and suitability for both inpatient and outpatient care settings. Success
is also influenced by effective engagement with key hospital stakeholders—including infectious disease physicians, antimicrobial
stewardship program personnel, pharmacists, and hospital administrators—supported by compelling clinical evidence, real-world data,
and health-economic value propositions. In addition, securing and preserving formulary access, navigating pricing and reimbursement pressures,
and adapting to changes in standard-of-care guidelines and competitive product launches are essential to sustaining demand and market
share for these products.
Intellectual Property
Due to the length of time
and expense associated with bringing new products to market, biopharmaceutical companies have traditionally placed considerable importance
on obtaining and maintaining patent protection for significant new technologies, products and processes. The term of individual patents
depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, the patent
term is 20 years from the earliest date of filing a non-provisional patent application. In the U.S., a patent’s term may be lengthened
by Patent Term Adjustment, which compensates a patentee for administrative delays by the U.S. Patent and Trademark Office (“USPTO”)
in granting a patent, or may be shortened if a patent is terminally disclaimed over another patent. In the U.S., and certain other countries,
the patent’s term may also be lengthened by patent term extension or restoration, which compensates a patentee for administrative
delays in granting a regulatory approval by the FDA, or similar agency in other countries.
While we pursue patent protection
and enforcement of all our Products, product candidates, and aspects of our technologies when appropriate, we also rely on trade secrets,
know-how and continuing technological advancement to develop and maintain our competitive position. To protect this competitive position,
we regularly enter into confidentiality and proprietary information agreements with third parties, including employees, independent contractors,
suppliers and collaborators. Our employment policy requires each new employee to enter into an agreement containing provisions generally
prohibiting the disclosure of confidential information to anyone outside of the Company and providing that any invention conceived by
an employee within the scope of his or her employment duties is our exclusive property. We have a similar policy with respect to independent
contractors, generally requiring independent contractors to enter into agreements containing provisions generally prohibiting the disclosure
of confidential information to anyone outside of the Company and providing that any invention conceived by an independent contractor
within the scope of his or her services is our exclusive property with the exception of contracts with universities and colleges that
may be unable to make such assignments. Furthermore, our know-how that is accessed by third parties through collaborations and research
and development contracts and through our relationships with scientific consultants is generally protected through confidentiality agreements
with the appropriate parties.
DefenCath
On August 29, 2023, the USPTO granted U.S. Patent No. 11,738,120, which
was our patent application directed to a locking solution composition for treating and reducing infection and flow reduction in central
venous catheters (expiring April 15, 2042). We have a supplemental patent (U.S. Patent No. 7,696,182), which we believe has potential
to provide an additional layer of patent protection for DefenCath through 2042.
DefenCath is listed in the Orange Book as having new chemical entity
(“NCE”) exclusivity (five years) expiring on November 15, 2028, and the Generating Antibiotic Incentives Now (“GAIN”)
exclusivity extension of the NCE exclusivity (an additional five years) expiring on November 15, 2033. The GAIN exclusivity extension
of five years is the result of the January 2015 designation of DefenCath as a Qualified Infectious Disease Product (“QIDP”).
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REZZAYO
CorMedix holds an exclusive
license from Mundipharma, our European licensor and the current holder of REZZAYO intellectual property and the NDA, to develop and sell
the brand in the U.S. Under the terms of the license, we are required to make certain future milestone payments to Mundipharma (See Contractual
Obligations, included within this Annual Report, for additional details on the arrangement with Mundipharma). REZZAYO has NCE exclusivity
with GAIN extension until 2033, orphan drug exclusivity through 2035 and composition of matter and treatment patent coverage until 2038.
MINOCIN IV
We have patents relating to
the MINOCIN IV product formulation and certain methods of treatment comprising intravenously administering minocycline, which are set
to expire between May 2031 and October 2032. We are also prosecuting other patent applications relating to minocycline formulations and
methods of treatment in the U.S.
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.
VABOMERE
VABOMERE received five years
of NCE exclusivity following its 2017 FDA approval, with an additional five-year GAIN/QIDP extension, resulting in regulatory exclusivity
through August 2027. We hold a portfolio of patents relating to VABOMERE, including the vaborbactam compound, for which we have patent
coverage until 2031, and methods of treatment, for which we have coverage until 2039. We are currently prosecuting related patent applications
relating to VABOMERE’s pharmaceutical composition and its use in the U.S. and in certain foreign countries.
ORI Franchise
We hold U.S. patents relating
to methods of treatment expiring in 2029 and 2030, as well as a U.S. patent relating to high purity oritavancin that expires in 2035.
Numerous foreign counterparts have been filed, including in Europe and Eurasia, for these more recent methods of treatment and compositions.
We are also prosecuting a number of patent applications relating to the ORI Franchise and its uses in the U.S. and certain foreign jurisdictions.
BAXDELA
We have a license, both exclusive and nonexclusive, from Wakunaga Pharmaceutical
Company, Ltd. to certain patents and patent applications, and to certain patents and patent applications of AbbVie Inc. We have also licensed
technology from CyDex Pharmaceuticals, Inc. (now a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated) for the use of Captisol,
a sulfobutylether beta-cyclodextrin excipient, in connection with BAXDELA. We have developed and patented additional technology independently.
The patent portfolio for BAXDELA and delafloxacin meglumine, the active pharmaceutical ingredient in BAXDELA, is related to compositions
of matter, pharmaceutical compositions, manufacturing methods and methods of use. In addition to the licensed and owned U.S. patents,
the portfolio includes pending U.S. patent applications and corresponding foreign national or regional counterpart patents or applications.
We expect that the patents and the patent applications in the portfolio, if issued, will expire between 2026 and 2034.
Manufacturing/Supply Chain
We do not own or operate
any manufacturing facilities related to the production of our products. All our manufacturing processes currently are, and we expect
them to continue to be, outsourced to third parties. We rely on third-party manufacturers to produce sufficient quantities of drug product
for use both commercially and in clinical trials. We intend to continue this practice in the future.
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For DefenCath, we currently
have one FDA-approved source (contract manufacturing organization, or “CMO”) for each of our 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 which 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 in the future.
The Company received FDA
approval of DefenCath with finished dosage production from its European based CMO Rovi Pharma Industrial Services. In addition, the Company
also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling 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 U.S. 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.
CMOs and our API suppliers are subject to FDA oversight and inspection
regarding compliance with Current Good Manufacturing Practices (“cGMP”), and if deemed non-compliant with cGMP by the FDA,
we could face shortages or risk with respect to producing sufficient quantities of drug product or drug substance.
Biomedical Advanced Research and Development
Authority (“BARDA”) Contract
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 agreement, BARDA reimburses certain percentages of costs incurred, as defined in the agreement, in connection
with the BARDA-Supported Studies. As of December 31, 2025, 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 31, 2025, we have recognized BARDA reimbursement totaling
$19.4 million.
The BARDA contract contains
a number of terms and conditions that are customary for government contracts of this nature, including provisions giving the government
the right to terminate the contract at any time for its convenience.
United States Government Regulation
The research, development,
testing, manufacture, labeling, promotion, advertising, distribution, and marketing, among other things, of our products are extensively
regulated by governmental authorities in the U.S. and other countries.
In the U.S., the FDA regulates