CorMedix Inc. (CRMD) Business

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).

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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.

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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.

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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.

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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.

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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”).

8

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
drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the FDA’s implementing regulations.
If we fail to comply with the applicable U.S. requirements at any time during the product development process, clinical testing, and
during the approval process or after approval, we may become subject to administrative or judicial sanctions. These sanctions could include
the FDA’s refusal to approve pending applications, withdrawal of an approval, warning letters, adverse publicity, product recalls,
product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties or criminal prosecution,
among other actions. Any agency enforcement action and/or any related impact could have a material adverse effect on us.

Clinical Trial Programs

Clinical trial programs in
humans generally follow a three-phase process. Typically, Phase 1 studies are conducted in small numbers of healthy volunteers or, on
occasion, in patients afflicted with the target disease. Phase 1 studies are conducted to determine the metabolic and pharmacological
action of the product line in humans and the side effects associated with increasing doses, and, if possible, to gain early evidence
of effectiveness. In Phase 2, studies are generally conducted in larger groups of patients having the target disease or condition in
order to validate clinical endpoints, and to obtain preliminary data on the effectiveness of the product line and optimal dosing. This
phase also helps determine further the safety profile of the product line. In Phase 3, large-scale clinical trials are generally conducted
in patients having the target disease or condition to provide sufficient data for the statistical proof of effectiveness and safety of
the product line as required by United States and foreign regulatory agencies. Typically, two Phase 3 trials are required for marketing
approval, though one such trial, plus confirmatory evidence, may be acceptable.

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Post-approval trials, sometimes
referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience
from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding
use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition
of approval of an NDA or post-approval.

The clinical trial process
for a new compound can take ten years or more to complete. The FDA may prevent clinical trials from beginning or may place clinical trials
on hold at any point in this process if, among other reasons, it concludes that study subjects are being exposed to an unacceptable health
risk. Trials may also be prevented from beginning or may be terminated by institutional review boards, or IRBs, who must review and approve
all research involving human subjects and amendments thereto. The IRB must continue to oversee the clinical trial while it is being conducted.
This includes the IRB receiving information concerning unanticipated problems involving risk to subjects. Side effects or adverse events
that are reported during clinical trials can delay, impede, or prevent marketing authorization. Similarly, adverse events that are reported
after marketing authorization can result in additional limitations being placed on a product’s use and, potentially, withdrawal
of the product from the market.

Following the completion
of a clinical trial, the data is analyzed by the sponsoring company to determine whether the trial successfully demonstrated safety and
effectiveness and whether a product approval application may be submitted. In the United States, if the product is regulated as a new
drug, an NDA must be submitted and approved by the FDA before commercial marketing may begin. The NDA must include a substantial amount
of data and other information concerning the safety and effectiveness of the compound from laboratory, animal, and human clinical testing,
as well as data and information on manufacturing, product quality and stability, and proposed product labeling.

Once accepted for filing,
the FDA’s review of an application may involve review and recommendations by an independent FDA advisory committee. The FDA must
refer applications for drugs that contain active ingredients, including any ester or salt of the active ingredients that have not previously
been approved by the FDA to an advisory committee or provide in an action letter a summary for not referring it to an advisory committee.
The FDA may also refer drugs to advisory committees when it is determined that an advisory committee’s expertise would be beneficial
to the regulatory decision-making process, including the evaluation of novel products and the use of new technology. An advisory committee
is typically a panel that includes clinicians and other experts, which review, evaluate, and make a recommendation as to whether the
application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it
considers such recommendations carefully when making decisions.

Approval Process

After evaluating the NDA
and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing
facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter, or CRL. If
a CRL is issued, the applicant may either resubmit the NDA, addressing all the deficiencies identified in the letter; withdraw the application;
or request an opportunity for a hearing. A CRL indicates that the review cycle of the application is complete, and the application is
not ready for approval and describes all the specific deficiencies that the FDA identified in the NDA. A CRL generally contains a statement
of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or pre-clinical
testing in order for the FDA to reconsider the application. The deficiencies identified may be minor, for example, requiring labeling
changes; or major, for example, requiring additional clinical trials. Even with submission of this additional information, the FDA ultimately
may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to
the FDA’s satisfaction, the FDA may issue an approval letter. An approval letter authorizes commercial marketing of the drug with
specific prescribing information for specific indications.

Even if the FDA approves
a product, it may limit the approved therapeutic uses for the product as described in the product labeling, require that warning statements
be included in the product labeling, require that additional studies be conducted following approval as a condition of the approval,
impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a Risk Evaluation and Mitigation
Strategy (“REMS”) or otherwise limit the scope of any approval.

In addition, under the PREA,
an NDA or supplement to an NDA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration must
contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric
subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until
after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Such deferred studies
become required post-marketing studies upon approval of the product.

11

Special FDA Expedited Review and Approval
Programs

The FDA has various programs,
including Fast Track designation, priority review and breakthrough designation, that are intended to expedite or simplify the process
for the development and FDA review of certain drug products that are intended for the treatment of serious or life-threatening diseases
or conditions, and demonstrate the potential to address unmet medical needs or present a significant improvement over existing therapy.
The purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review procedures.

To be eligible for a Fast
Track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening
disease or condition and demonstrates the potential to address an unmet medical need. The FDA will determine that a product will fill
an unmet medical need if the product will provide a therapy where none exists or provide a therapy that may be potentially superior to
existing therapy based on efficacy, safety, or public health factors. If Fast Track designation is obtained, drug sponsors may be eligible
for more frequent development meetings and correspondence with the FDA. In addition, the FDA may initiate review of sections of an NDA
before the application is complete. This “rolling review” is available if the applicant provides and the FDA approves a schedule
for the remaining information. A Fast Track product is also eligible to apply for accelerated approval and priority review.

Exclusivity

For approved drug products,
market exclusivity provisions under the FDCA provide periods of exclusivity, which gives the holder of an approved NDA limited protection
from new competition in the marketplace for the innovation represented by its approved drug.

Section 505 of the FDCA
describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for a new drug. A
Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A Section 505(b)(2)
NDA is an application in which the applicant, in part, relies on investigations that were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. Section 505(j)
establishes an abbreviated approval process for a generic version of approved drug products through the submission of an Abbreviated
New Drug Application (“ANDA”). An ANDA provides for marketing of a generic drug product that has the same active ingredients,
dosage form, strength, route of administration, labeling, performance characteristics, and intended use, among other things, to a previously
approved product. Limited changes must be pre-approved by the FDA via a suitability petition.

Five years of exclusivity
are available to NCEs. A NCE is a drug that contains no active moiety that has been approved by the FDA in any other NDA submitted under
Section 505 of the FDCA. An active moiety is the molecule or ion, excluding those appended portions of the molecule, that cause the drug
to be an ester, salt, including a salt with hydrogen or coordination bonds, or other noncovalent derivatives, such as a complex, chelate,
or clathrate, of the molecule, responsible for the physiological or pharmacological action of the drug substance. During the exclusivity
period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA application submitted by another company that contains the previously
approved active moiety, except that an ANDA or 505(b)(2) that contains a certification that the patents listed by the NCE sponsor in FDA’s
list of Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”), are invalid or will not be infringed
by the manufacture, use, or sale of the drug product for which approval is sought, may be submitted one year before NCE exclusivity expires.
Five-year exclusivity will also not delay the submission or approval of a 505(b)(1) NDA; however, an applicant submitting a 505(b)(1)
NDA would be required to conduct or obtain a right of reference to all the pre-clinical studies and adequate and well-controlled clinical
trials necessary to demonstrate safety and efficacy.

The FDCA also provides three
years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than
bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the
application, for example, new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the conditions
of use associated with the new clinical investigations and does not prohibit the FDA from approving NDAs or ANDAs for drugs containing
the original active agent.

Pediatric exclusivity is
another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional
six months of exclusivity to the term of any existing exclusivity for the product, such as NCE exclusivity. This six-month exclusivity
may be granted if an NDA sponsor submits pediatric data that fairly responds to a written request from the FDA for such data. The data
does not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly
respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to
and accepted by the FDA within the required time frames, whatever statutory or regulatory periods of exclusivity that cover the drug
are extended by six months. For patent protection, pediatric exclusivity does not extend the term of the patent or the term a patent
extension, but rather the period during which FDA cannot approve an ANDA or 505(b)(2) NDA that certifies to a patent listed in the Orange
Book. Moreover, pediatric exclusivity attaches to all formulations, dosage forms, and indications for products with existing marketing
exclusivity or patent life that contain the same active moiety as that which was studied.

12

The Orphan Drug Act also
provides incentives for the development of drugs intended to treat rare diseases or conditions, which generally are diseases or conditions
affecting fewer than 200,000 individuals annually in the United States, or affecting more than 200,000 in the United States and for which
there is no reasonable expectation that the cost of developing and making the drug available in the United States will be recovered from
sales in the United States. Additionally, sponsors must present a plausible hypothesis for clinical superiority to obtain orphan designation
if there is a drug already approved by the FDA that is intended for the same indication and that is considered by the FDA to be the same
drug as the already approved drug. This hypothesis must be demonstrated to obtain orphan drug exclusivity. If granted, prior to product
approval, Orphan Drug Designation entitles a party to financial incentives such as opportunities for grant funding towards clinical study
costs, tax advantages, and user-fee waivers. In addition, if a product receives FDA approval for the indication for which it has orphan
designation, the product is generally entitled to orphan drug exclusivity, which means the FDA may not approve any other application
to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical
superiority over the product with orphan exclusivity.

For
certain infectious disease products, the above discussed exclusivity periods may be further extended if the product is designated as a
QIDP and receives GAIN Act exclusivity. A qualified infectious disease product, or QIDP, is an antibacterial or antifungal drug for human
use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen,
including novel or emerging infectious pathogens; or qualifying pathogens designated by the FDA that have the potential to pose a serious
threat to public health. Subject to the specified statutory limitations, a drug that is designated as a QIDP and is approved for the use
for which the QIDP designation was granted will receive a 5-year extension to any exclusivity for which the application qualifies upon
approval. For example, if the FDA approves an NDA for a drug designated as a QIDP, the NCE exclusivity period is extended to ten years,
and the FDA may not accept applications for nine years. Moreover, if a product is designated as a QIDP and an orphan product, the orphan
product exclusivity period is extended to twelve years. These extensions are in addition to any extension that an application may be entitled
to under the pediatric exclusivity provisions. To receive a QIDP designation, the sponsor must request that the FDA designate the product
as such prior to the submission of an NDA. This designation may not be withdrawn except if the FDA finds that the request for designation
contained an untrue statement of material fact. QIDPs are also eligible for Fast Track status and priority review.

Post Approval Requirements

Significant legal and regulatory
requirements also apply after FDA approval to market under an NDA. These include, among other things, requirements related to adverse
event and other reporting, product tracking and tracing, suspect and illegitimate product investigations and notifications, product advertising
and promotion and ongoing adherence to cGMPs, as well as the need to submit appropriate new or supplemental applications and obtain FDA
approval for certain changes to the approved product, product labeling, or manufacturing process. FDA can also require the completion
of studies post-approval, such as required studies under PREA. The FDA also enforces the requirements of the Prescription Drug Marketing
Act which, among other things, imposes various requirements in connection with the distribution of product samples to physicians. The
FDA enforces these requirements through, among other ways, review of promotional material submissions, review of adverse events, review
of annual reports, periodic announced and unannounced facility inspections.

The FDA also strictly regulates
marketing, labeling, advertising, and promotion of products that are placed on the market. Physicians, in their independent professional
medical judgment, may prescribe legally available products for unapproved indications that are not described in the product’s labeling
and that differ from those tested and approved by the FDA. Pharmaceutical companies, however, are allowed to promote their drug products
only for the approved indications and in accordance with the provisions of the approved label; off-label promotion is prohibited, as
is false and misleading promotion. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of
off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including,
but not limited to, criminal and civil penalties under the FDCA and the civil False Claims Act, or FCA, exclusion from participation
in federal healthcare programs, mandatory compliance programs under corporate integrity agreements, debarment, and refusal of government
contracts.

13

FDA regulations require that
products be manufactured in specific approved facilities and in accordance with cGMP regulations. We rely, and expect to continue to
rely, on third parties for the production of clinical and commercial quantities of our products in accordance with cGMP regulations.
These manufacturers must comply with cGMP regulations that require, among other things, quality control and quality assurance, the maintenance
of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities
involved in the manufacture and distribution of approved drugs or biologics are required to register their establishments with the FDA
and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance
with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production
and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to cGMP regulations,
could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product,
manufacturer or holder of an approved NDA or Biologics License Application (“BLA”), including recall.

After approval of a drug
is granted, FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur
after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated
severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions
to the approved labeling to add new safety information, or imposition of additional post-market surveillance or clinical trials to assess
new safety risks. Other potential consequences include, among other things: restrictions on the marketing or manufacturing of the product,
complete withdrawal of the product from the market or product recalls; fines, warning letters or other enforcement-related letters
or clinical holds on investigational or post-approval clinical trials; refusal by FDA to approve pending NDAs or supplements to
approved NDAs, or suspension or revocation of product approvals; product seizure or detention, or refusal to permit the import or
export of products; injunctions or the imposition of civil or criminal penalties; and consent decrees, corporate integrity
agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling
and the issuance of corrective information.

Moreover, individual states
may have laws and regulations that we must comply with, such as laws and regulations concerning licensing, promotion, sampling, distribution,
and reporting.

Healthcare Regulation

Federal and state healthcare
laws, including fraud and abuse and health information privacy and security laws, also govern our business. If we fail to comply with
those laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely
affected. Such laws include, but are not limited to: the federal Anti-Kickback Statute (“AKS”); federal pricing transparency
and reporting laws and regulations; federal Physician Payments Sunshine Act and Open Payments requirements to track and report certain
payments and other transfers of value; federal and state civil and criminal false claims laws, including the civil False Claims Act.
Additionally, we are subject to state and local law equivalents of the above federal laws, which may be broader in scope and apply regardless
of whether the payer is a governmental healthcare program. We may also be subject to certain state healthcare laws that may not have
a federal parallel, such as pharmaceutical detailing and disclosure laws and requirements.

We are subject to federal
government price reporting, such as those applicable to the Medicare Part B program, those under the Medicaid Drug Rebate Program (“MDRP”),
the 340 Drug Pricing Program and individual state laws relating to pricing and sales and marketing practices. Manufacturers report Average
Sales Price (“ASP”) data for Part B-covered drugs and biologicals and related items, services, supplies, and products that
are paid as drugs or biologicals. We also participate in the MDRP and report ASP, Best Price and other metrics related to our participation
in such program. We pay rebates to state Medicaid agencies based on those metrics on Medicaid beneficiary utilization of products. In
addition, we are required to sell our covered outpatient drugs at or below the 340B Ceiling Price to 340B Covered Entities. We are also
required to discount our products to authorized users of the Federal Supply Schedule, under which additional laws and requirements apply.
Each of these programs require submission of pricing data and calculation of discounts and/or rebates pursuant to complex statutory formulas
and regulatory guidance, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations,
and the guidance governing such calculations is not always clear. Compliance with such requirements can require significant investment
in personnel, systems and resources. Failure to properly calculate prices, or to offer required discounts or rebates could subject us
to substantial penalties including, but not limited to, potential False Claims Act liability. CMS continues to issue guidance and rulemaking
governing our participation in the MDRP, and we cannot predict how future guidance or rules would affect our profitability (including
the potential for increases in our overall Medicaid rebate liability and the obligation to charge greatly reduced prices to 340B Covered
Entities).

In the U.S., the federal
and state governments are considering proposals or have enacted legislative and regulatory changes to the healthcare system that could
affect our ability to sell our products profitably. Among policy makers and payers in the U.S., there is significant interest in promoting
changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.

14

There has been increasing
legislative and enforcement interest in the U.S. with respect to drug pricing practices. In particular, there have been several recent
U.S. Congressional inquiries, hearings and proposed and enacted federal legislation and rules, as well as executive orders and sub-regulatory
guidance that may impact pricing for pharmaceutical products. These initiatives include, among others:

Governments have shown significant
interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution
of generic products. For example, President Trump signed multiple executive orders aimed at reducing prescription drug costs in the U.S.,
including: the Lowering Drug Prices by Once Again Putting Americans First executive order issued on April 15, 2025, which provided several
actions the Secretary of the Department of HHS must take to optimize healthcare regulations designed to provide access to prescription
drugs at lower costs, and the Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients executive order issued on
May 12, 2025, which sought to establish “most favored nation” drug pricing policy that would tie U.S. drug prices to the
prices paid for drugs in other countries. The Trump administration has continued to exert pressure on drug manufacturers to implement
“most favored nation” pricing, including by suggesting that the administration may impose significant tariffs on pharmaceuticals
if such manufacturers do not reach agreements to implement “most favored nation” pricing and by reaching agreements with
certain drug manufacturers to offer most-favored-nation pricing on certain existing and future products. On November 6, 2025, CMS announced
a new voluntary payment initiative called the GENEROUS Model (GENErating cost Reductions for U.S. Medicaid Model) a limited duration
payment model conducted through the CMS Innovation Center to allow drug manufacturers to voluntarily provide coordinated supplemental
rebates to state Medicaid agencies that match international prices in certain enumerated countries. Failure to participate in the model
could result in less favorable Medicaid coverage against competitors that choose to participate. Additionally, on December 19, 2025,
CMS issued two additional notices of proposed rulemaking to test alternative calculations for manufacturer rebates aimed at bringing
drug prices closers to those paid in identified economically similar countries: the GLOBE Model (Global Benchmark for Efficient Drug
Pricing) for certain Medicare Part B drugs and the GUARD Model (Guarding U.S. Medicare Against Rising Drug Costs) for certain Medicare
Part D drugs. Under these proposals, CMS would replace existing domestic inflation-based rebate calculations with new rebate obligations
tied to international reference pricing benchmarks in a basket of economically comparable countries.

In addition, at the state
level, legislatures have increasingly passed legislation and implemented regulations similar to those under consideration at the federal
level, as well as laws designed to control pharmaceutical and biotherapeutic product pricing, including restrictions on pricing or reimbursement
at the state government level, limitations on discounts to patients, marketing cost disclosure and transparency measures, restrictions
or other limitations on patient assistance, and, in some cases, policies to encourage importation from other countries (subject to federal
approval) and bulk purchasing.

In addition, the U.S. Foreign
Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper
payments for the purpose of obtaining or retaining business.

These laws and regulations
may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. In addition,
given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty
provisions of the pertinent state and federal authorities.

15

Government
Contracts and Regulation

We currently contract with
the federal government (see section entitled “Biomedical Advanced Research and Development Authority Contract” above).
As a government contractor, we are subject to complex and wide-ranging federal and agency-specific regulations and contractual requirements
that not only govern how we perform under the contract but also impose other requirements that affect our operations, including socioeconomic
obligations such as obligations related to affirmative action and maintaining a drug-free workplace. Failure to comply with government
contracting requirements could result in termination of our contract and the imposition of penalties.

Foreign
Regulatory Requirements

We have not made any filings seeking approval for our Products outside
of the U.S. For us to market any product outside of the U.S., we would need to comply with numerous and varying regulatory requirements
of other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial
sales and distribution of our products.  In lieu of this, we have licensing relationships with pharmaceutical companies outside
of the U.S. under which we license rights to commercialize our Products in exchange for payments, potentially including upfront licensing
fees, milestone fees and royalties on sales of the applicable Product or Products in their respective territories. The revenue associated
with these licensing relationships is not expected to be material to our current or future financial statements, representing 5% or less
of total revenue in 2025. For details on these arrangements, see Note 2 to the Consolidated Financial Statements in this Annual Report
on Form 10-K.

Employees and Human Capital Resources

As of February 28, 2026 we employed approximately 191 full-time employees,
who work out of our corporate headquarters in Parsippany, NJ, our corporate office in Lake Forest, IL, or remotely in various locations
throughout the U.S.

We invest in our workforce by offering competitive salaries and benefits.
We endeavor to foster a strong sense of ownership by offering equity awards under our stock incentive program. We also offer comprehensive
benefits for all eligible employees. We recognize and support the growth and development of our employees through a number of programs
including annual performance feedback reviews and employee goal and development discussions.

None of our employees are
subject to a collective bargaining agreement. We emphasize organizational communication and consider our relationship with our employees
to be strong.

Corporate Information

We were organized as a Delaware
corporation on July 28, 2006 under the name “Picton Holding Company, Inc.” and we changed our corporate name to “CorMedix
Inc.” on January 18, 2007. Our principal executive offices are located at 389 Interpace Parkway, Suite 450, Parsippany, New Jersey,
07054.

Available Information

We maintain our website at www.cormedix.com. This
Annual Report on Form 10-K and all of our filings under the Exchange Act, including copies of annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports, are available free of charge through our website
on the date we file those materials with, or furnish them to, the SEC. Such filings are also available to the public on the internet
at the SEC’s website at www.sec.gov. The information contained on, or that can be accessed through, the websites referenced
in this Annual Report on Form 10-K is not a part of, nor shall it be deemed to be, incorporated by reference into this filing or any
of our other filings with the SEC. Further, the Company’s references to website URLs are intended to be inactive textual references
only.