HROW US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

(Mark

One)

For

the fiscal year ended December 31, 2025

OR

For

the transition period from to

Commission

File Number: 001-35814

HARROW,

INC.

(Exact

name of registrant as specified in its charter)

(State or other jurisdiction of (IRS Employer

incorporation or organization) Identification No.)

1A

Burton Hills Blvd., Suite 200

Nashville,

TN37215

(Address

of Principal Executive Offices)(Zip Code)

(615)733-4730

(Registrant’s

telephone number, including area code)

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 per share HROW The Nasdaq Stock Market LLC

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 Exchange 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 (§ 229.405 of this chapter) 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. (Check one):

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 new 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 error 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 Exchange Act).

Yes

☐ No☒

As

of June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market

value of the common stock held by non-affiliates of the registrant was approximately $1,004 million, based on the closing price of $30.54

for the registrant’s common stock as quoted on The Nasdaq Stock Market LLC on that date. For purposes of this calculation, it has

been assumed that shares of common stock held by each director, each officer and each person who owns 10% or more of the outstanding

common stock of the registrant are held by affiliates of the registrant. The treatment of these persons as affiliates for purposes of

this calculation is not conclusive as to whether such persons are affiliates of the registrant for any other purpose.

As

of February 25, 2026, there were 37,229,705 shares of the registrant’s common stock outstanding.

Portions

of the registrant’s definitive Proxy Statement for its 2026 Annual Meeting of Stockholders to be held on June 18, 2026 are incorporated

by reference in Part II and III of this Annual Report on Form 10-K, to the extent stated herein.

TABLE

OF CONTENTS

Page

PART I 4

Item 1. Business 4

Item 1A. Risk Factors 18

Item 1B. Unresolved Staff Comments 48

Item 1C. Cybersecurity 48

Item 2. Properties 49

Item 3. Legal Proceedings 49

Item 4. Mine Safety Disclosures 49

Item 6. [Reserved] 51

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 62

Item 8. Financial Statements and Supplementary Data 62

Item 9A. Controls and Procedures 62

Item 9B. Other Information 63

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 63

PART III 64

Item 10. Directors, Executive Officers and Corporate Governance 64

Item 11. Executive Compensation 64

Item 14. Principal Accountant Fees and Services 64

Item 15. Exhibits, Financial Statement Schedules 65

SIGNATURES 68

As

used in this Annual Report on Form 10-K (this “Annual Report”), unless indicated or the context requires otherwise, the terms

the “Company,” “Harrow,” “we,” “us” and “our” refer to Harrow, Inc. and its

consolidated subsidiaries.

In

addition to historical information, the following discussion contains forward-looking statements regarding future events and our future

performance. In some cases, you can identify forward-looking statements by terminology such as “will,” “may,”

“should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,”

“predicts,” “forecasts,” “potential” or “continue” or the negative of these terms or

other comparable terminology. All statements made in this Annual Report other than statements of historical fact are forward-looking

statements. These forward-looking statements involve risks and uncertainties and reflect only our current views, expectations and assumptions

with respect to future events and our future performance. If risks or uncertainties materialize or assumptions prove incorrect, actual

results or events could differ materially from those expressed or implied by such forward-looking statements. Risks that could cause

actual results to differ from those expressed or implied by the forward-looking statements we make include, among others, risks related

to: liquidity or results of operations; our ability to successfully implement our business plan, manage our pharmacy operations, service

our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience

and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue;

the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility

in New Jersey; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions,

including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and

the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future products

and formulations and compounding pharmacies generally; our limited operating history; and the other risks and uncertainties described

under the heading “Risk Factors” in Part I, Item 1A of this Annual Report. You should not place undue reliance on forward-looking

statements. Forward-looking statements speak only as of the date they are made and, except as required by law, we undertake no obligation

to revise or publicly update any forward-looking statement for any reason.

We

have registered trademarks, copyrights and/or pending trademark and copyright applications for a number of proprietary names in the United

States of America (“U.S.”), including, but not limited to: VEVYE®, IHEEZO®, ILEVRO®,

TRIESENCE®, ImprimisRx®, and LessDrops®. We may choose to pursue trademark protection in

other jurisdictions for one or more of these or other marks in the future. All other trademarks, service marks and trade names included

or incorporated by reference into this Annual Report, are the property of their respective owners.

PART

I

ITEM

1. BUSINESS

Overview

We

are a leading provider of ophthalmic disease management solutions in North America, and were founded with a commitment to deliver safe,

effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For over a decade, we

have partnered with U.S. eyecare professionals to develop a comprehensive portfolio of high-quality products used to manage ophthalmic

conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration,

cataracts, refractive errors, glaucoma, and a range of other ocular surface conditions and retina diseases. By prioritizing clinical

value – to the provider and the patient – Harrow empowers professionals to enhance patient outcomes and preserve vision.

By combining our culture of creativity, entrepreneurship and groundbreaking innovation with operational discipline and strong financial

performance, we are building a future where life-changing ophthalmic treatments are within reach for all.

Branded

Ophthalmic Pharmaceuticals

Over

the past several years, we have expanded our portfolio of the U.S. Food and Drug Administration (the “FDA”)-approved ophthalmic

products through acquisitions, licensing transactions, and internal investment. These efforts are focused primarily on the U.S. and Canadian

markets. We believe continued investment in our branded portfolio supports our ability to offer eyecare prescribers and patients access

to a broader range of ophthalmic therapies across multiple disease states. We own U.S. commercial rights to the following products, which

we market and sell:

We

also own U.S. rights to some discontinued products (MOXEZA, VEXOL, ECONOPRED and TOBRASONE). In February 2024, we announced that we

out-licensed Canadian rights for VERKAZIA, Cationorm® PLUS (a preservative-free formulation for dry eye or allergy

relief), VEVYE, ZERVIATE and IHEEZO to Apotex Inc. (“Apotex”). We also own worldwide rights to NATACYN and

FRESHKOTE.

R&D

Development Pipeline

Our

development pipeline is focused on developing and commercializing differentiated pharmaceutical therapies designed to address unmet needs

in eye care and selected adjacent markets. The pipeline is weighted toward late-stage and near-commercial assets with demonstrated clinical

utility and clearer regulatory pathways, and we seek to advance programs through a disciplined, capital-efficient development strategy.

Current development-stage programs include:

Development

timelines and potential launch timing are subject to change based on clinical results, regulatory feedback, manufacturing readiness,

and other factors.

MELT-300

We

believe MELT-300 represents a transformative opportunity, building on more than a decade of real-world experience with MKO Melt®

— a compounded sublingual sedation product sold by ImprimisRx and currently administered by over 800 U.S. ophthalmic institutions,

primarily for used for procedural sedation during cataract surgery. As a potential FDA-approved successor, MELT-300 is a patented, sublingually

delivered formulation of a fixed dose of midazolam (3mg) and ketamine (50mg) designed to provide rapid, predictable sedation without

the need for intravenous administration. The MELT-300 Phase 2 and Phase 3 clinical programs previously demonstrated statistical superiority

to midazolam alone. The innovative approach to sedation MELT-300 offers has the potential to transform patient experiences across a wide

range of office-based and outpatient procedures, addressing the healthcare system’s growing demand to reduce exposure to opioids,

including fentanyl.

The

MELT-300 program was the subject of a Special Protocol Assessment (SPA) with the FDA, confirming that the completed Phase 3 study design,

statistical approach, and endpoints adequately support a future regulatory submission. Having completed the Phase 3 program, our focus

now turns to advancing MELT-300 toward FDA approval and commercialization.

In

support of a new drug application (an “NDA”) filing, we recently initiated one non-clinical animal study and three pharmacokinetic

(“PK”) studies to generate the balance of the data we believe is necessary for an NDA package. Following completion of these

studies, we expect to prepare and submit an NDA for MELT-300 in the first half of 2027. If promptly approved by the FDA, we expect to

commercially launch MELT-300 in the second half of 2028.

We

believe these next steps position MELT-300 to become the first FDA-approved, non-opioid, non-IV sublingual sedation therapy in the U.S.,

representing a meaningful growth opportunity for Harrow and a major advancement in patient-centric procedural care. With patent coverage

in the U.S. and other international markets and potential applications beyond ophthalmology—including gastroenterology, dental

care, and other outpatient settings where sedation or anxiety management may be beneficial, such as diagnostic imaging, endoscopy and

pre-anesthesia—MELT-300 may provide us the opportunity to expand into procedural sedation and anxiety management indications outside

of eye care domestically and in international markets.

ImprimisRx

ImprimisRx

is our ophthalmology-focused pharmaceutical compounding business. Since inception in 2014, ImprimisRx has provided ophthalmologists,

optometrists, and their patients access to compounded medications intended to address needs that may be unmet by commercially available

products, including combination therapies, alternative dosage strengths, and preservative-free formulations. Depending on formulation,

applicable state requirements, and patient need, ImprimisRx products may be dispensed as patient-specific prescriptions from our 503A

pharmacy or manufactured for in-office use in our FDA-registered 503B outsourcing facility in New Jersey. Our current ophthalmology formulary

includes over 30 compounded formulations, many of which are patented or patent-pending, and our customer base includes more than 10,000

U.S. eyecare-dedicated prescribers and institutions.

We

operate two compounding facilities in Ledgewood, New Jersey. One facility is registered with the FDA as an outsourcing facility under

Section 503B of the Federal Food, Drug and Cosmetic Act (the “FDCA”) (NJOF). The other facility is a licensed pharmacy operating

under Section 503A of the FDCA (RxNJ). All compounded products we sell, produce, and dispense are made in the United States. We believe

our current infrastructure supports continued scaling within the current regulatory landscape, and we may pursue additional capacity,

redundancy, and market access through investments, partnerships, or strategic transactions.

Pharmaceutical

Compounding

Pharmaceutical

compounding involves preparing customized formulations for patients when commercially available products do not meet a patient’s

clinical needs. Compounded formulations contain FDA-approved ingredients, but the compounded formulations themselves are not FDA-approved.

Compounding is subject to extensive federal and state regulation and oversight, which can affect permissible activities, cost structure,

and the ability to dispense into particular states.

Carved-Out

Subsidiaries (De-Consolidated Businesses)

We

have an ownership interest in Surface Ophthalmics, Inc. (“Surface”) and hold royalty interests in some of Surface’s

drug candidates. Surface is pursuing market approval for its drug candidates under the FDCA, including in some instances under the abbreviated

pathway described in Section 505(b)(2), which permits the submission of an NDA where at least some of the information required for approval

comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. We previously

held ownership interests in Eton Pharmaceuticals, Inc. (“Eton”) and sold the last of our interests in April 2024.

Acquisition

of the Remaining Equity Interests of Melt Pharmaceuticals

Prior

to November 2025, we held a minority ownership interest in Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical

company focused on the development and commercialization of proprietary non-intravenous, sedation and anesthesia therapeutics for human

medical procedures in hospital, outpatient, and in-office settings. Melt sought regulatory approval for its proprietary technologies,

where possible.

As

of December 31, 2024, we owned approximately 45% of Melt’s equity and voting interests issued and outstanding, along with a mid-single

digit royalty on future net sales of MELT-300.

In

September 2025, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among Harrow, Harrow Acquisition

Sub, Inc., a wholly owned subsidiary of Harrow, Melt, and D. Brad Osborne, as stockholder representative. Under the terms of the Merger

Agreement and a related milestone payment agreement, we agreed to acquire the remaining equity interests of Melt in exchange for an initial

cash payment of approximately $4,300,000 at closing, and contingent consideration consisting of cash and Harrow equity upon achievement

of (i) FDA approval of the MELT-300 product candidate, (ii) coding and reimbursement of the MELT-300 product candidate, and (iii) various

one-time sales milestones. The regulatory and commercial milestones must be achieved on or before December 31, 2035.

The

Melt acquisition closed on November 17, 2025, and was treated as an asset acquisition for accounting purposes. As a result of such

transaction, Melt’s drug candidates are now owned by Harrow and its research and development (“R&D”)

activities subsequent to the acquisition are included in Harrow’s consolidated financial results as of the year ended December

31, 2025.

Sales

and Marketing

The

focus of our sales and marketing is in the U.S. We do, however, believe that our drug candidates and drug products could have commercial

appeal in international markets, and have engaged distributors and entered into out-licensing arrangements for certain of our products

and proprietary formulations in certain non-U.S. markets, including Canada. Our sales and marketing activities consist primarily of efforts

to educate doctors, ambulatory surgery centers, healthcare systems, hospitals and other users throughout the U.S. about our drug products.

We expect that we may experience growth in the sales of our products in future periods, particularly in light of our recent product launches

and commercial campaigns. However, we may not be successful in doing so, whether due to the size of the markets for such products, which

could be smaller than we expect, the timing of market entry relative to competitive products, the availability of alternative compounded

formulations or FDA-approved drugs, the price of our products relative to alternative products or the success of our sales and marketing

efforts, which is dependent on our ability to further build and continue to grow a qualified and adequate internal sales function.

We

expect to continue to acquire and/or develop additional FDA-approved products that allow us to leverage our existing commercial infrastructure

to promote, sell, and ultimately bring these products to market. As we execute this strategy, we will continue to expand our sales and

marketing team, expertise and expenses.

Supply

Chains

100%

of our ImprimisRx finished compounded products are made in the U.S. at our compounding facilities located in New Jersey.

We

do not manufacture any of our branded pharmaceutical products and rely on third party manufacturing partners to make finished goods.

The following table describes by product the country where our finished branded products are made. In some instances, multiple countries

are listed to reflect either (i) expected changes in our contract manufacturer and location; and (ii) in certain cases, to reflect the

country of a second contract manufacturer site:

Product Country Finished Product Is Manufactured

IHEEZO France

VEVYE U.S. and Spain

TRIESENCE U.S.

VIGAMOX Belgium

ILEVRO Belgium

FLAREX U.S., by end of 2026 production is expected to be in Taiwan

NATACYN U.S.

TOBRADEX ST U.S.; by end of 2026 production is expected to be in Taiwan

ZERVIATE France; by end of 2026 production is expected to be in Spain

VERKAZIA France

NEVANAC U.S.; by end of 2026 production is expected to be in Belgium

FRESHKOTE France; by end of 2026 production is expected to be in Spain

MAXIDEX U.S.; by end of 2026 production is expected to be in Belgium

MAXITROL Belgium

IOPIDINE 1% France

BYQLOVI Taiwan

Ophthalmology

Market

Ophthalmic

pharmaceuticals are used across several major categories of eye care, including high-volume procedures (such as cataract/lens procedures

and refractive surgeries like LASIK), chronic ocular surface conditions (including dry eye disease), retina disease management (often

involving physician-administered therapies delivered by intravitreal injection), and posterior-segment surgical care (including vitrectomy

and related visualization and inflammation management). These settings drive demand for different classes of ophthalmic products—such

as anesthetics, anti-infectives, anti-inflammatories (including corticosteroids and NSAIDs), immunomodulators, and ocular surface lubricants—used

before, during, and after procedures and for ongoing disease management. Utilization across these categories is influenced by procedure

volumes and clinical practice patterns, the availability of therapeutic alternatives (including generics and biosimilars), and market

access factors such as formulary placement, prior authorization/step therapy, reimbursement, and patient out-of-pocket costs. Our portfolio

is focused on these major ophthalmic categories and spans products used in ocular surface disease, perioperative care, posterior-segment

surgical and retina settings. We have limited exposure to glaucoma therapies.

Competition

The

pharmaceutical industry is highly competitive. We compete with branded and generic pharmaceutical companies, biosimilar manufacturers,

and other companies developing or commercializing ophthalmic therapies, including products used in ocular surface disease, perioperative

care, and retina. Certain competitors have substantially greater financial, technical, manufacturing, and commercial resources than we

do, and may be able to develop, obtain regulatory approval for, manufacture, market, and sell products more effectively than we can,

including through larger sales forces, broader distribution networks, and greater access to capital. As a result, we may face competitive

disadvantages in gaining or maintaining market share, achieving favorable formulary placement and reimbursement, securing manufacturing

capacity and supply chain reliability, and sustaining pricing and margins.

Biotechnology

and pharmaceutical technologies are subject to rapid and significant change. Our success depends in part on our ability to maintain a

competitive position with respect to new therapies, delivery methods, and competitive entrants, including generics and biosimilars. Competitors

may introduce products that are safer, more effective, easier to use, more durable, more convenient, or more cost-effective than our

products, or that achieve greater market access through reimbursement or contracting advantages. New competitive products could reduce

demand for, or the market opportunity of, our existing products and could render our product candidates or lifecycle management initiatives

less attractive or commercially viable before we recover development or commercialization investments.

Competition

also depends on factors such as clinical performance, physician adoption and practice patterns, timing of market entry, regulatory developments,

product availability and supply reliability, pricing and patient affordability, third-party reimbursement, and the effectiveness of sales,

marketing, and distribution efforts. If we are unable to compete effectively with current or future products of our competitors, our

revenues, profitability, and growth prospects could be materially and adversely affected.

To

the extent we offer compounded formulations through our pharmacy operations, those products also face competition from FDA-approved alternatives

and other compounded products, and utilization may be affected by physician and patient preferences and applicable regulatory requirements.

Factors

Affecting Our Performance

We

believe the primary factors affecting our performance are our ability to increase revenues of our ophthalmic products, grow and gain

operating efficiencies in our pharmacy operations, successfully adjust our operations to account for any future regulatory-related restrictions,

optimize pricing and obtain reimbursement options for our ophthalmic products, and continue to pursue development and commercialization

opportunities for certain of our ophthalmology and other assets that we have not yet made commercially available or have been recently

launched. We believe we have built a tangible and intangible infrastructure that will allow us to scale revenues efficiently in the near

and long-term. All of these activities will require increased costs and other resources, which we may not have or be able to obtain from

operations or other sources. See Item 7. “Management’s Discussion and Analysis of Financial Condition and Result of Operations

- Liquidity and Capital Resources.”

Medicare,

Medicaid and Other Reimbursement Options

Sales

in the U.S. of our marketed products are dependent, in large part, on the availability and extent of reimbursement from third-party payors,

including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and

government programs such as Medicare and Medicaid. See Item 1A. “Risk Factors” for risks related to reimbursement and government

programs.

We

participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate

program(s), and other governmental pricing programs. We also have obligations to report the average sales price for certain drugs to

the Medicare program. Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our

covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having

federal funds being made available for our drugs under Medicaid and Part B of the Medicare program.

Medicare

is a federal program that is administered by the federal government that covers individuals age 65 and over or that are disabled as well

as those with certain health conditions. Medicare Part B generally covers drugs that must be administered by physicians or other health

care practitioners; are provided in connection with certain durable medical equipment; or are certain oral anti-cancer drugs and certain

oral immunosuppressive drugs. Medicare Part B pays for such drugs under a payment methodology based on the average sales price of the

drugs. Manufacturers, including us, are required to report average sales price information to the Centers for Medicare & Medicaid

Services (“CMS”) on a quarterly basis. The manufacturer-submitted information may be used by CMS to calculate Medicare payment

rates. Starting in 2023, manufacturers are now required to pay refunds to Medicare for single-source drugs or biological products, or

biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units

of discarded drug reimbursed by Medicare Part B in excess of 10% of total allowed charges under Medicare Part B for that drug. Manufacturers

that fail to pay refunds could be subject to civil monetary penalties. Further, starting in 2023, the Inflation Reduction Act of 2022

(“IRA”) established a Medicare Part B inflation rebate scheme, effective in 2023, under which, generally speaking, manufacturers

will owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation. Failure to timely pay a Part

B inflation rebate is subject to a civil monetary penalty.

The

IRA also created a drug price negotiation program under which, after being on the market for a certain period of time, the prices for

certain high Medicare spending drugs and biological products provided to Medicare patients without generic or biosimilar competition

will be capped by reference to, among other things, a specified non-federal average manufacturer price, starting in 2026. Failure to

comply with requirements under the drug price negotiation program is subject to an excise tax and a civil monetary penalty. This or any

other legislative change could impact the market conditions for our products.

BYOOVIZ,

OPUVIZ, IHEEZO and TRIESENCE are covered under Medicare Part B and we are developing other product candidates and may acquire drug products

that are also covered under Medicare Part B. In February 2023, we announced that CMS had issued a permanent, product specific J-code

for IHEEZO (J2403) which became effective under the Healthcare Procedure Coding System (HCPCS) on April 1, 2023. TRIESENCE has a permanent

product specific J-code (J3300) as well, which physicians can use for reimbursement purposes of that product. Similarly, BYOOVIZ and

OPUVIZ have permanent product specific reimbursement codes of Q5124 and Q5153, respectively, which healthcare professionals can use for

reimbursement of those biosimilar products.

New

drugs approved by the FDA that are used in surgeries performed in a hospital outpatient departments or ambulatory surgical centers may

receive a transitional pass-through reimbursement under Medicare, provided they meet certain criteria, including a “not insignificant”

cost criterion. Pass-through status allows for separate payment (i.e., outside the packaged payment rate for the surgical procedure)

under Medicare Part B, which consists of Medicare reimbursement for a drug based on a defined formula for calculating the minimum fee

that a manufacturer may charge for the drug. Under current regulations of CMS, pass-through status applies for a period of three years;

which is measured from the date Medicare makes its first pass-through payment for the product. Following the three-year period, the product

would be incorporated into the cataract bundled payment system, which could significantly reduce the pricing for that product. Temporary

pass-through reimbursement for IHEEZO was awarded by CMS and made effective in the second quarter of 2023 and temporary pass-through

reimbursement for TRIESENCE was made effective April 1, 2025. We expect pass-through status for IHEEZO to expire March 31, 2026. Following

the expiration of pass-through status, under current CMS policy, non-opioid pain management surgical drugs when used on Medicare Part

B patients in an outpatient setting can qualify for ongoing separate payments. CMS’ current non-opioid separate payment policy,

like other CMS policies, can be changed by CMS through its annual rulemaking and comment process.

Medicaid

is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries. Medicaid rebates are

based on pricing data reported by us on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid and Medicare

programs. These data include the average manufacturer price and, in the case of innovator products, the best price for each drug which,

in general, represents the lowest price available from the manufacturer to any entity in the U.S. in any pricing structure, calculated

to include all sales and associated rebates, discounts, and other price concessions. The amount of the rebate is adjusted upward if the

average manufacturer price increases at a faster rate than inflation (measured by reference to the Consumer Price Index – Urban).

The rebate was previously capped at 100% of the average manufacturer price, but effective January 1, 2024, this cap on the rebate was

removed, and our rebate liability could increase accordingly.

If

we become aware that our reporting for a prior quarter was incorrect or has changed as a result of recalculation of the pricing data,

we are obligated to resubmit the corrected data for up to three years after those data originally were due, which revisions could affect

our rebate liability for prior quarters. The federal Patient Protection and Affordable Care Act (the “PPACA” or “Health

Care Reform Law”) made significant changes to the Medicaid Drug Rebate program, and CMS issued a final regulation, which became

effective on April 1, 2016, to implement the changes to the Medicaid Drug Rebate program under the PPACA. Effective in 2022, CMS modified

Medicaid Drug Rebate program regulations to, among other things, permit reporting multiple best price figures with regard to value-based

purchasing arrangements and provide definitions for “line extension,” “new formulation,” and related terms with

the practical effect of expanding the scope of drugs considered to be line extensions.

Civil

monetary penalties can be applied if we are found to have knowingly submitted any false pricing or other information to the government,

if we are found to have made a misrepresentation in the reporting of our average sales price, or if we fail to submit the required data

on a timely basis. Such conduct also could be grounds for CMS to terminate our Medicaid drug rebate agreement, in which case federal

payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

Federal

law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service’s

340B drug pricing program (the “340B program”) in order for federal funds to be available for the manufacturer’s drugs

under Medicaid and Medicare Part B. The 340B program, which is administered by the Health Resources and Services Administration (“HRSA”),

requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price”

for the manufacturer’s covered outpatient drugs. Covered entities include hospitals that serve a disproportionate share of financially

needy patients, community health clinics, and other entities that receive certain types of grants under the Public Health Service Act.

The PPACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral

centers, and sole community hospitals, but exempts “orphan drugs” from the ceiling price requirements for these covered entities.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate

amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program. In general, products subject to Medicaid

price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement.

HRSA

issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers

that knowingly and intentionally overcharge covered entities, which became effective on January 1, 2019. It is currently unclear how

HRSA will apply its enforcement authority under this regulation. Any charge by HRSA that we have violated the requirements of the regulation

could result in civil monetary penalties. Moreover, under a final regulation effective January 13, 2021, HRSA established a new administrative

dispute resolution (“ADR”) process for claims by covered entities that a manufacturer has engaged in overcharging, and by

manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts. Such claims are to be resolved

through an ADR panel of government officials rendering a decision that could be appealed only in federal court. An ADR proceeding could

subject us to onerous procedural requirements and could result in additional liability. On November 30, 2022, HRSA issued a notice of

proposed rulemaking that proposes several changes to the ADR process. HRSA also implemented a price reporting system under which we are

required to report our 340B ceiling prices to HRSA on a quarterly basis, which then publishes those prices to 340B covered entities.

In addition, legislation could be passed that would further expand the 340B program to additional covered entities or would require participating

manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

In

order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by

certain federal agencies and grantees, we participate in the U.S. Department of Veterans Affairs (“VA”) Federal Supply Schedule

(“FSS”) pricing program. FSS participation is required for our products to be purchased by the VA, Department of Defense

(“DoD”), Coast Guard, and Public Health Service (“PHS”). Prices for innovator drugs purchased by the VA, DoD,

Coast Guard, and PHS are subject to a cap (known as the “Federal Ceiling Price”) equal to 76% of the annual non-federal average

manufacturer price (“non-FAMP”) minus, if applicable, an additional discount. The additional discount applies if non-FAMP

increases more than inflation (measured by reference to the Consumer Price Index - Urban). We also participate in the Tricare Retail

Pharmacy Program, under which we pay quarterly rebates to DoD for prescriptions of our innovator drugs dispensed to Tricare beneficiaries

through Tricare Retail network pharmacies. The governing statute provides for civil monetary penalties for failure to provide information

timely or for knowingly submitting false information to the government.

Medicare

Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a physician).

Medicare Part D is administered by private prescription drug plans approved by the U.S. government and, subject to detailed program rules

and government oversight, each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which

the drug plan may modify from time to time. The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may

condition formulary placement on the availability of manufacturer discounts. In addition, manufacturers, including us, are required to

provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are

in the coverage gap phase of the Part D benefit design. The IRA includes a sunset provision with respect to the coverage gap discount

program starting in 2025 and replaces it with a new manufacturer discount program. In addition, as of October 2022, the IRA established

a Medicare Part D inflation rebate scheme under which, manufacturers will generally owe additional rebates if the average manufacturer

price of a Part D drug increases faster than the pace of inflation. Failure to timely pay a Part D inflation rebate is subject to a civil

monetary penalty.

Private

payor healthcare and insurance providers, health maintenance organizations, and pharmacy benefit managers in the U.S. are adopting more

aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a

condition to including products on formulary with favorable coverage and copayment/coinsurance. These payors may not cover or adequately

reimburse for use of our products or may do so at levels that disadvantage them relative to competitive products.

Intellectual

Property

Our

success and ability to compete depends upon our ability to protect our intellectual property. We conduct a fulsome analysis of the intellectual

property landscape prior to acquiring rights to formulations and filing patent applications. In addition, as of March 2, 2026, we owned

and/or licensed more than 50 issued and pending patent applications, which include U.S.-issued patents, international-issued patents,

and U.S. and foreign/international patent pending applications. We expect to file additional patent applications in the U.S. and pursue

patent protection for certain of our formulations in other important international jurisdictions in the future.

As

of March 2, 2026, we had, on a worldwide basis, more than 100 issued trademarks, pending trademark and copyright applications, or registered

copyrights and/or trademarks. We also rely on unpatented trade secrets and know-how and continuing technological innovation in order

to develop our products and formulations, which we seek to protect, in part, by confidentiality agreements with our employees, consultants,

collaborators and others, including certain service providers. We also have invention or patent assignment agreements with our current

employees and certain consultants. However, our employees and consultants may breach these agreements, and we may not have adequate remedies

for any breach, or our trade secrets may otherwise become known or be independently discovered by competitors. In addition, inventions

relevant to us could be developed by a person not bound by an invention assignment agreement with us, in which case we may have no rights

to use the applicable invention.

The

following table lists some of our outstanding material patents in the U.S. covering certain branded products we own commercial rights

to, general subject matter and latest expiry date. One or more patents with the same or earlier expiry dates may fall under the same

general subject matter and are not listed separately.

Product General Subject Matter Expiration

Governmental

Regulation

Our

business is subject to federal, state and local laws, regulations, and administrative practices, including, among others: federal, state

and local licensure and registration requirements concerning the operation of pharmacies and the practice of pharmacy; the Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”); the Health Care Reform Law; statutes and regulations of the FDA, the

U.S. Federal Trade Commission (the “FTC”), the U.S. Drug Enforcement Administration and the U.S. Consumer Product Safety

Commission, as well as regulations promulgated by comparable state agencies concerning the sale, advertisement and promotion of the products

we sell. The regulatory and quality compliance environment for compounded drugs has become significantly more rigorous, complex and strict

since the passage of The Drug Quality and Security Act of 2013 (the “DQSA”). The complexity of the current state and federal

regulatory environment, as well as the expected continued evolution of state and federal laws governing pharmaceutical compounding, have

presented, and will continue to present, potentially significant challenges to our business model and the fulfillment of our mission

as a company. Below are descriptions of some of the various federal and state laws and regulations which may govern or impact our current

and planned operations.

FDA

New Drug Application (NDA) Process

As

discussed in other sections of this Annual Report, we are pursuing, and may continue to pursue, alone or with project partners, FDA approval

to market and sell one or more of our product candidates through the FDA’s NDA process. As a condition of approval, the FDA or

other regulatory authorities may require further studies, including Phase 4 post-marketing studies, to provide additional data. Other

post-marketing studies may be required to gain approval for the use of a product as a treatment for clinical indications other than those

for which the product was initially tested and approved. Also, the FDA or other regulatory authorities require post-marketing reporting

to monitor the adverse effects of a drug. Results of post-marketing programs may limit or expand the further marketing of a product.

The

FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer

advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet.

A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements

can result in adverse publicity, warning letters, corrective advertising, fines and potential civil and criminal penalties.

Section

505(b)(2) New Drug Applications

As

an alternate path for FDA approval of new indications or new formulations of previously-approved products, a company may file a Section

505(b)(2) NDA instead of a “stand-alone” or “full” NDA. Section 505(b)(2) of the FDCA was enacted as part of

the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments. Section 505(b)(2)

permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by or

for the applicant and for which the applicant has not obtained a right of reference. Some examples of products that may be allowed to

follow a Section 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation or

indication.

The

Hatch-Waxman Amendments permit the applicant to rely upon certain published nonclinical or clinical studies conducted for an approved

product or the FDA’s conclusions from prior review of such studies. The FDA may require companies to perform additional studies

or measurements to support any changes from the approved product. The FDA may then approve the new product for all or some of the labeled

indications for which the reference product has been approved, as well as for any new indication supported by the Section 505(b)(2) application.

While references to nonclinical and clinical data not generated by the applicant or for which the applicant does not have a right of

reference are allowed, all development, process, stability, qualification and validation data related to the manufacturing and quality

of the new product must be included in an NDA submitted under Section 505(b)(2).

To

the extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already

approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s

Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Specifically, the applicant must certify that: (i) the

required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will

expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed

by the new product. The Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity

for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired. Thus, the Section

505(b)(2) applicant may invest a significant amount of time and expense in the development of its products only to be subject to significant

delay and patent litigation before its products may be commercialized.

Pharmacy

Regulation

Our

pharmacy operations are regulated by both the federal government and the states in which we operate or dispense. State laws and regulations

generally address licensing of pharmacists, pharmacy technicians and pharmacies, as well as requirements applicable to compounding activities,

including quality standards, sterility assurance, storage, controlled substances, recordkeeping and inspections. State requirements are

administered and updated periodically, generally under the jurisdiction of state boards of pharmacy. Failure to comply with applicable

state requirements could result in fines, corrective action, heightened oversight, restrictions on operations, suspension, non-renewal

or revocation of licenses, or limitations on our ability to dispense into particular jurisdictions. In addition, some states have adopted,

or may adopt, more stringent requirements applicable to compounding pharmacies, which could increase compliance costs or limit permissible

activities.

The

federal regulatory framework for compounding is set forth primarily in Sections 503A and 503B of the FDCA, as amended by the Drug Quality

and Security Act (“DQSA”). Section 503A generally addresses pharmacy compounding of patient-specific prescriptions and includes

limitations on compounding in advance of receiving prescriptions. Section 503B establishes “outsourcing facilities,” which

may compound certain sterile drug products without patient-specific prescriptions, subject to additional requirements, including current

good manufacturing practices (“cGMP”) and FDA inspection. Our operations include both a Section 503A pharmacy and a Section

503B outsourcing facility, each subject to the applicable requirements and oversight framework.

Many

states require non-resident or out-of-state pharmacies and outsourcing facilities to register with, or obtain licensure from, the applicable

state board of pharmacy or other authority to dispense into that state. These requirements vary by state and may change over time. In

January 2026, the California Board of Pharmacy approved a settlement agreement between ImprimisRx and the California State Board of Pharmacy,

resolving an administrative action brought by the California Board of Pharmacy regarding certain regulatory compliance matters. As part

of the settlement, ImprimisRx agreed to surrender its 503B out-of-state outsourcing facility license and its 503A out-of-state compounding

pharmacy license on February 1, 2026. If additional states were

to take similar actions, or if we are unable to obtain or maintain required registrations or licenses, our ability to dispense compounded

products into certain states could be limited and the cumulative effect could be material.

Our

Section 503B outsourcing facility is subject to FDA inspection and enforcement authority. We have been subject to FDA inspection and

have undertaken remediation and quality initiatives, including engaging an independent third-party cGMP expert. If we are unable to

demonstrate sustained compliance with cGMP or other applicable requirements, the FDA could pursue administrative or judicial

enforcement actions, which could be costly and could result in restrictions on operations or other adverse consequences. See Item 1A

“Risk Factors.”

We

compound formulations consistent with applicable standards and requirements, including USP 795 and USP 797, as adopted or applied by

regulators, and other applicable state and federal law. Changes in USP standards, FDA policies, state requirements, or enforcement priorities

may require operational adjustments and could increase costs or limit permissible activities.

Confidentiality,

Privacy and HIPAA

Our

pharmacy operations involve the receipt, use and disclosure of confidential medical, pharmacy and other health-related information. In

addition, we use aggregated and blinded (anonymous) data for research and analysis purposes. The federal privacy regulations under HIPAA

are designed to protect the medical information of a healthcare patient or health plan enrollee that could be used to identify the individual.

Among other things, HIPAA limits certain uses and disclosures of protected health information and requires compliance with federal security

regulations regarding the storage, utilization and transmission of and access to electronic protected health information. The requirements

imposed by HIPAA are extensive. In addition, most states and certain other countries have enacted privacy and security laws that protect