Harrow
28 named things its latest annual report says its results depend on, each in the company's own words. 17 of them are also named by other companies we've read.
Customers
Pharmacy benefit managers (CVS, Express Scripts, UnitedHealth Group)
earns from · nearly 95% of prescriptionsnamed as a riskCVS, Express Scripts and United Health Group (among the top five integrated health plans and PBMs), each have Rebate Management Organizations that further increase their leverage to negotiate deeper discounts.Risk factors (Item 1A)
McKesson Corporation
concentrated innamed as a riskThe substantial majority of our U.S. branded product sales are made through four pharmaceutical product wholesaler distributors: McKesson Corporation, Cencora Inc., Western Wellness and Cardinal Health, Inc.Risk factors (Item 1A)
Also named by ABBV, AMGN, CAH, COR, GILD, HALO, HSIC, LLY and 1 more
Cardinal Health, Inc.
concentrated innamed as a riskThe substantial majority of our U.S. branded product sales are made through four pharmaceutical product wholesaler distributors: McKesson Corporation, Cencora Inc., Western Wellness and Cardinal Health, Inc.Risk factors (Item 1A)
Also named by ABBV, AMGN, BAX, COR, CVS, GILD, LLY, MCK and 1 more
Cencora Inc.
concentrated innamed as a riskThe substantial majority of our U.S. branded product sales are made through four pharmaceutical product wholesaler distributors: McKesson Corporation, Cencora Inc., Western Wellness and Cardinal Health, Inc.Risk factors (Item 1A)
Western Wellness
concentrated innamed as a riskThe substantial majority of our U.S. branded product sales are made through four pharmaceutical product wholesaler distributors: McKesson Corporation, Cencora Inc., Western Wellness and Cardinal Health, Inc.Risk factors (Item 1A)
Suppliers
Partners and platforms
Other companies
8.625% Senior Notes due 2030
$250 millionnamed as a riskIn September 2025, we issued $250 million aggregate principal amount of 8.625% Senior Notes due September 2030 (the “2030 Notes”) and used the proceeds to refinance debt.Risk factors (Item 1A)
Melt Pharmaceuticals
approximately $4,300,000Under 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.Business (Item 1)
Places
Ledgewood, New Jersey
concentrated in · 100%100% of our ImprimisRx finished compounded products are made in the U.S. at our compounding facilities located in New Jersey.Business (Item 1)
Taiwan
depends onThe following table describes by product the country where our finished branded products are made.Business (Item 1)
Also named by AAOI, AAPL, AB, ADI, AEHR, ALAB, AMAT, AMD and 50 more
France
depends onThe following table describes by product the country where our finished branded products are made.Business (Item 1)
Also named by ATR, BAM, DDOG, IDCC, MS, UBER, UGI, WAB and 1 more
Belgium
depends onThe following table describes by product the country where our finished branded products are made.Business (Item 1)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskFrom March 2024 through April 2024, NJOF was inspected by the FDA (the “2024 Inspection”), and the FDA issued a Form 483 with five observations.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Centers for Medicare & Medicaid Services (CMS)
subject tonamed as a riskCMS’ current non-opioid separate payment policy, like other CMS policies, can be changed by CMS through its annual rulemaking and comment process.Business (Item 1)
Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more
California State Board of Pharmacy
subject tonamed as a riskThe loss of these licenses restricts our ability to sell or dispense certain compounded products in California and has reduced revenues from that state.Risk factors (Item 1A)
Laws and programs
Inflation Reduction Act of 2022
subject tonamed as a riskThe IRA’s drug pricing controls and Medicare redesign is likely to have a material adverse effect on our sales (particularly for our branded products that are more substantially reliant on Medicare reimbursement), our business and our results of operations.Risk factors (Item 1A)
Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more
340B Drug Pricing Program
subject tonamed as a riskFederal 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.Business (Item 1)
Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more
Medicaid Drug Rebate Program
subject tonamed as a riskThe 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.Business (Item 1)
Medicare Part B
earns fromnamed as a riskBYOOVIZ, 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.Business (Item 1)
Medicare transitional pass-through payment
subject tonamed as a riskWe expect pass-through status for IHEEZO to expire March 31, 2026.Business (Item 1)
CMS GLOBE and GUARD models
subject tonamed as a riskCMS has proposed mandatory demonstration models—GLOBE (Medicare Part B) and GUARD (Medicare Part D)—that would assess additional manufacturer rebates based on international benchmarks for certain therapeutic categories that include ophthalmology/ophthalmic agents.Risk factors (Item 1A)
FDCA Section 503B
subject tonamed as a riskNonetheless, if all or some of the bulk drug substances we use are removed from the 503B Bulk’s List, this may result in a disruption in our operations, revenues and cash flows.Risk factors (Item 1A)
Drug Quality and Security Act of 2013
subject tonamed as a riskThe 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”).Business (Item 1)
U.S. tariffs on pharmaceuticals
subject tonamed as a riskAlthough a significant portion of our products (compounded and branded) are manufactured in the United States, we and our third-party manufacturers and suppliers rely on global supply chains for certain finished pharmaceuticals APIs, materials, components, and services.Risk factors (Item 1A)
State drug importation programs from Canada
subject tonamed as a riskAdditionally, Colorado, Florida, Maine, New Hampshire, New Mexico and Vermont have enacted laws, and several other states have proposed bills, to implement importation of drugs from Canada.Risk factors (Item 1A)