{"url_path":"/sec/hrow/10-q/2026/item-1a","section_key":"item-1a","section_title":"Item 1A Risk Factors**","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-11","source_url":"https://www.sec.gov/Archives/edgar/data/1360214/0001493152-26-022254-index.html","accession_number":"0001493152-26-022254","cik":"0001360214","ticker":"HROW","issuer_name":"HARROW, INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1360214/0001493152-26-022254-index.html","primary_entity_key":"0001360214","primary_entity_name":"HARROW, INC."},"word_count":885,"has_tables":true,"body_markdown":"**Item\n1A. Risk Factors**\n\n \n\n*In\naddition to the other information contained in this Quarterly Report you should consider the risk factors and the other information in\nour Annual Report on Form 10-K for the year ended December 31, 2025, including our audited financial statements and the related notes\nand “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any such risks actually\noccur, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely\naffected. In these circumstances, the market price of our common stock would likely decline and you may lose all or part of your investment.\nAdditional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.*\n\n \n\nBelow\nwe provide, in supplemental form, material changes to the risk factors previously disclosed in Part I, Item 1A of our Annual Report on\nForm 10-K for the year ended December 31, 2025. Except as set forth below, there have been no material changes to the risk factors previously\ndisclosed in our Annual Report on Form 10-K, which are incorporated herein by reference.\n\n \n\nThe\nfollowing risk factor amends and restates in its entirety the risk factor titled “Our sales depend on coverage and reimbursement\nfrom government and commercial third-party payors, and pricing and reimbursement pressures have affected, and are likely to continue\nto affect, our profitability” included in our Annual Report on Form 10-K for the year ended December 31, 2025.\n\n** **\n\n**Our\nsales depend on coverage and reimbursement from government and commercial third-party payors, and pricing and reimbursement pressures\nhave affected, and are likely to continue to affect, our profitability.**\n\n \n\nSales\nof our products depend on the availability and extent of coverage and reimbursement from third-party payors, including government healthcare\nprograms and private insurance plans. Payors continue to implement measures to manage utilization and contain costs, including step edits,\nprior authorization, formulary restrictions, increased patient cost sharing, and reimbursement rate reductions. These actions may reduce\nthe number of patients for whom our products are reimbursed, delay or restrict patient access, and limit our ability to increase prices\nor maintain pricing levels, any of which could adversely affect our revenues and profitability.\n\n \n\nIn\nthe United States, legislative and regulatory actions continue to focus on reducing drug costs, including measures affecting Medicare\nreimbursement and manufacturer financial obligations. In addition, policymakers and CMS have advanced proposals that would reference\nprices in other economically comparable countries in determining Medicare beneficiary cost-sharing and/or additional manufacturer rebate\nobligations, sometimes described as “most-favored-nation” or international reference pricing policies. CMS has proposed mandatory\ndemonstration models, including GLOBE for Medicare Part B and GUARD for Medicare Part D, that would assess additional manufacturer rebates\nbased on international benchmarks for certain therapeutic categories that include ophthalmology or ophthalmic agents. Because certain\nof our ophthalmic products are reimbursed under Medicare Part B, and we may develop or acquire additional products reimbursed by government\nprograms, these and similar initiatives could be particularly relevant to our business. Moreover, because we do not own global rights\nto many of the products we market in the United States and generally do not control commercialization or pricing outside the United States\nfor those products, we may have limited or no ability to affect non-U.S. pricing that could be used as a benchmark under most-favored-nation\nor international reference pricing initiatives, which could increase our exposure to such policies.\n\n \n\n26\n\n \n\n \n\nOur\nreported revenues also depend on significant estimates of variable consideration, including estimates for government rebates, commercial\nrebates, chargebacks, wholesaler fees, distribution service fees, returns, administrative fees, patient assistance programs, and other\ngross-to-net revenue deductions. These estimates require judgment and are based on available information regarding contractual terms,\nchannel inventory, product utilization, payor mix, wholesaler and distributor data, government program requirements, and historical and\nexpected claims activity. Actual deductions may differ from our estimates, and we may be required to adjust revenues in future periods\nas new information becomes available or as claims are submitted, reconciled, disputed, validated, settled, or otherwise resolved.\n\n \n\nFrom\ntime to time, we may receive rebate claims, chargebacks, fee-for-service deductions, invoices, or other claims from government agencies,\nwholesalers, distributors, customers, former product owners, or other third parties that we believe are unsupported, overstated, duplicative,\nattributable to another party or product, or otherwise inconsistent with applicable contracts, statutes, regulations, or program requirements.\nThe resolution of these matters may require significant management judgment, data reconciliation, legal analysis, and interaction with\nthird parties, and may involve uncertainty regarding matters such as product attribution, labeler codes, utilization data, 340B exclusions,\nMedicaid and Medicare program rules, wholesaler deduction timing, and other assumptions. If our estimates are inaccurate, if disputed\namounts are ultimately resolved adversely to us, or if we are unable to obtain credits, offsets, refunds, recoupments, or other recoveries\nfor amounts we believe were improperly claimed or deducted, our revenues, gross margins, cash flows, financial condition, and results\nof operations could be adversely affected.\n\n \n\nWe\ncannot predict the scope, timing, or ultimate impact of these or other policy, payor, reimbursement, pricing, or gross-to-net developments.\nIf such developments decrease coverage or reimbursement, increase rebates or other price concessions, limit utilization, or result in\nrevenue adjustments that differ materially from our estimates, our business, financial condition, results of operations, and cash flows\ncould be materially adversely affected."}