HARROW, INC.

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 statisticalsuperiority 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:

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.

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 identifiable patient information that is not health-related. For example, California enacted the California Consumer Privacy Act (the “CCPA”) that creates new individual privacy rights for consumers and places increased privacy and security obligations on entities handling personal data of consumers or households. Effective January 1, 2020, the CCPA gives California residents expanded privacy rights and protections, and provides civil penalties for violations and a private right of action for data breaches. The CCPA exemplifies the vulnerability of our business to not only cyber threats but also the evolving regulatory environment related to personal data and protected health information. In addition, the California Invasion of Privacy Act prohibits the use of “any machine, instrument, or contrivance” to tap any telephonic communication and use of any “electronic amplifying or recording device” to eavesdrop upon a “confidential communication” without consent of all parties to the communication. Other countries also have, or are developing, laws governing the collection, use and transmission of personal information, such as the General Data Protection Regulation (“GDPR”) in the European Union (the “EU”) that became effective in May 2018 and the Personal Information Protection and Electronic Documents Act that became effective in Canada in April 2000. Further, several states have enacted more protective and comprehensive pharmacy-related privacy legislation that not only applies to patient records but also prohibits the transfer or use for commercial purposes of pharmacy data that identifies prescribers. These regulations impose substantial requirements on covered entities and their business associates regarding the storage, utilization and transmission of and access to personal health and non-health information. Many of these laws apply to our business.

International Regulation

If we pursue commercialization of our products in countries other than the U.S. and where we do not have regulatory market approval, then we may need to obtain the approvals required by the regulatory authorities of such foreign countries that are comparable to the FDA and state boards of pharmacy, and we would be subject to a variety of other foreign statutes and regulations comparable to those relating to our U.S. operations. Regulatory frameworks and requirements vary by country and could involve significant additional licensing requirements and product testing and review periods. We currently partner with companies to sell, market and distribute some of our products in certain foreign countries.

Environmental and Other Matters

We are or may become subject to environmental laws and regulations governing, among other things, any use and disposal by us of hazardous or potentially hazardous substances in connection with our research and preparation of our formulations. In addition, we are subject to work safety and labor laws that govern certain of our operations and our employee relations. In each of these areas, as described above, the FDA and other government agencies have broad regulatory and enforcement powers, including, among other things, the ability to levy fines and civil penalties, suspend or delay issuance of approvals, licenses or permits, seize or recall products, and withdraw approvals, any one or more of which could have a material adverse effect on our business.

Research and Development Expenses

Our R&D expenses incurred in 2025, 2024 and 2023 primarily included expenses related to development of intellectual property, researcher and investigator-initiated evaluations, and formulation development related primarily to our ophthalmic products, formulations and certain other assets, in addition to costs associated with our drug candidate development programs. In 2025, R&D expenses included $8,450,000 recorded as acquired-in-process R&D as part of the acquisition of Melt in November 2025. During the year ended December 31, 2025, we incurred $20,940,000 in R&D expenses, compared to $12,230,000 and $6,652,000 during the year ended December 31, 2024 and 2023, respectively.

Financial Information About Segments and Geographic Areas

The Company has identified two operating segments as reportable segments. The Branded segment includes activities of our FDA approved ophthalmology pharmaceutical products, including the out-licensing of rights to certain of our products. The ImprimisRx segment represents activities in our ophthalmology-focused pharmaceutical compounding business. The Company’s chief operating decision-maker (“CODM”) is the Chief Executive Officer (“CEO”) who evaluates the segment contribution to allocate resources. The CODM does not review segment assets when assessing segment performance and deciding how to allocate resources.

The Company categorizes revenues by geographic area based on selling location. All operations are currently located in the U.S.; therefore, total revenues for 2025, 2024 and 2023 were attributed to the U.S. All long-lived assets at December 31, 2025 and 2024 were located in the U.S.

Human Capital

As of February 25, 2026, we employed 373 individuals. Our employees are engaged in sales, marketing, research, development, pharmacy operations, and general and administrative functions. We expect to add additional employees in all departmental functions, with a focus on sales force additions and other commercial activities as we carry out our business plan in the next 12 months. We are not party to any collective bargaining agreements with any of our employees. We have never experienced a work stoppage, and we believe our employee relations are good. We hire independent contractors and consultants on an as-needed basis.

Talent Acquisition and Retention

We recognize that our employees largely contribute to our success. To this end, we support business growth by seeking to attract and retain best-in-class talent. Our talent acquisition team uses internal and external resources to recruit highly skilled candidates in the U.S. We believe that we continue to attract and retain superior talent as measured by our turnover rate and employee service tenure.

Total Rewards

Our total rewards philosophy has been to create investment in our workforce by offering competitive compensation and benefits packages. We provide employees with compensation packages that include base salary, annual incentive bonuses, and long-term equity awards. We also offer comprehensive employee benefits, which vary by country and region, such as life, disability, and health insurance, health savings and flexible spending accounts, paid time off, and a 401(k) plan. It is our expressed intent to be an employer of choice in our industry by providing market-competitive compensation and benefits packages.

Health, Safety, and Wellness

The health, safety, and wellness of our employees is a priority in which we have always invested and will continue to do so. We provide our employees and their families with access to a variety of innovative, flexible, and convenient health and wellness programs. Program benefits are intended to provide protection and security, so employees can have peace of mind concerning events that may require time away from work or that may impact their financial well-being.

Training and Development

We believe in encouraging employees in becoming lifelong learners by providing ongoing learning, training and leadership opportunities. We provide our employees with a tuition reimbursement program, and in certain instances, onsite training programs. While we strive to provide real-time recognition of employee performance, we have a formal annual review process not only to determine pay and equity adjustments tied to individual contributions, but to identify areas where training and development may be needed.

Company Information

We were incorporated in Delaware in January 2006 as Bywater Resources, Inc. In September 2007, we closed a merger transaction with Transdel Pharmaceuticals Holdings, Inc. and changed our name to Transdel Pharmaceuticals, Inc. As part of a corporate re-organization that was led by our CEO, Mark L. Baum and our President and Chief Financial Officer (“CFO”), Andrew R. Boll, we changed our name to Imprimis Pharmaceuticals, Inc. in February 2012. Then to align with a shift in our corporate strategy that included the expansion into branded ophthalmic products and product candidates, we changed the name of our company to Harrow Health, Inc. in December 2018 and then to Harrow, Inc. in September 2023.

Our corporate headquarters are located at 1A Burton Hills Blvd., Suite 200, Nashville, Tennessee, 37215, and our telephone number at such office is (615) 733-4730.

We file reports with the Securities and Exchange Commission (“SEC”), including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports from time to time. We are an electronic filer and the SEC maintains an internet site atwww.sec.gov that contains the reports, proxy and information statements, and other information filed electronically. Our website address, which is provided as an inactive textual reference only, iswww.harrow.com. We make available free of charge through the website Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC. Information contained on our website is not deemed part of this Annual Report.