Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited
condensed consolidated financial statements and the related notes thereto contained in Part I, Item 1 of this Quarterly Report on Form
10-Q (this “Quarterly Report”). Our condensed consolidated financial statements have been prepared and, unless otherwise
stated, the information derived therefrom as presented in this discussion and analysis is presented, in accordance with accounting principles
generally accepted in the United States of America (“GAAP”).
The
information contained in this Quarterly Report is not a complete description of our business or the risks associated with an investment
in our common stock. We urge you to carefully review and consider the various disclosures made by us in this Quarterly Report and in
our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including our Annual Report on Form
10-K for the fiscal year ended December 31, 2024 and subsequent reports, which discuss our business in greater detail. As used in this
discussion and analysis, unless the context indicates otherwise, the terms the “Company,” “Harrow,” “we,”
“us” and “our” refer to Harrow, Inc. and its consolidated subsidiaries, including ImprimisRx, LLC, ImprimisRx
NJ, LLC dba ImprimisRx, Imprimis NJOF, LLC, Harrow IP, LLC and Harrow Eye, LLC. In this discussion and analysis, we refer to our consolidated
subsidiaries ImprimisRx, LLC, ImprimisRx NJ, LLC and Imprimis NJOF, LLC collectively as “ImprimisRx.”
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 Quarterly 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, develop and commercialize our products,
product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy
operations, refinance and otherwise 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 formulations and compounding pharmacies generally; and the other risks and uncertainties described under
the heading “Risk Factors” in Part II, Item 1A of this Quarterly Report and in our other filings with the SEC. 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.
Overview
We
are a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that
address 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. Harrow was founded with a
commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes.
31
Factors
Affecting Our Performance
We
believe the primary factors affecting our performance are our ability to increase revenues of our branded pharmaceutical products, proprietary
compounded formulations and certain non-proprietary products, grow and gain operating efficiencies in our operations, avoid or mitigate
any potential regulatory-related restrictions, optimize pricing and obtain reimbursement options for our drug 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. 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 may require significant costs and other resources, which we may not have or be able
to obtain from operations or other sources. See “Liquidity and Capital Resources” below.
Recent
Developments
The
following describes certain developments in 2025 to date that are important to understand our financial condition and results of operations.
See the notes to our unaudited condensed consolidated financial statements included in this Quarterly Report for additional information
about each of these developments.
Fifth
Third Revolving Credit Facility
In
September 2025, we entered into a Credit Agreement (the “5/3 Revolver”) with Fifth Third Bank, National Association, as administrative
agent for itself and the other lenders (collectively, “Fifth Third”) providing for a senior secured revolving credit facility
in the initial principal amount of $40,000,000, together with an uncommitted incremental revolving line of credit in the principal amount
of up to $20,000,000. The 5/3 Revolver will mature on September 26, 2030, or, if earlier, the date that is 91 days prior to the earliest
maturity date of the Company’s 2030 Notes (as defined below).
Borrowings
under the 5/3 Revolver bear interest at a floating rate equal to, at the Company’s option, either (i) a base rate plus a margin
ranging from 0.25% to 0.75%, or (ii) a Secured Overnight Financing Rate (“SOFR”) based rate plus a margin ranging from 1.25%
to 1.75%. In addition, an unused fee of 0.25% per annum is payable monthly in arrears based on the undrawn portion of the commitments
in respect of the 5/3 Revolver. Borrowings under the 5/3 Revolver are secured by a first priority lien in substantially all of the present
and future property and assets, real and personal, of the Company, subject to customary exceptions.
Under
the 5/3 Revolver, we are subject to certain customary affirmative and negative covenants. In addition, the 5/3 Revolver contains certain
financial covenants requiring the Company to maintain, on a consolidated basis as of the last day of each month, a fixed charge coverage
ratio of at least 1.10 to 1.0.
Harrow
Access for All
In
September 2025, we announced Harrow Access For All (“HAFA”) to expand our proprietary patient access model from a single
product to encompass Harrow’s comprehensive ophthalmic portfolio of branded, authorized generics (AGx), and compounded ophthalmic
medications. Beginning in late 2025 and expanding into 2027, HAFA will provide a single, unified access point for prescribers and patients,
offering affordability, streamlined prescribing, and predictable access. The platform creates a simpler, more predictable path to treatment—supporting
better outcomes for patients and greater efficiency for physicians.
32
Acquisition
of Remaining Interests in Melt Pharmaceuticals, Inc.
In
September 2025, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among us, Harrow Acquisition
Sub, Inc., a wholly owned subsidiary of Harrow, Melt Pharmaceuticals, Inc. (“Melt”), and D. Brad Osborne, as stockholder
representative. Under the terms of the Merger Agreement and related milestone payment agreement, the Company 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 Company equity upon achievement of (i) U.S. Food and Drug Administration (“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, as follows:
●
Upon
FDA approval of MELT-300, the Company shall pay an aggregate amount in cash of approximately $87,200,000.
●
Upon
receipt of pass-through status awarded and J-Code (or any other similar designation) issued by the Center for Medicare & Medicaid
Services for MELT-300 the Company shall issue an aggregate of approximately 1,112,000 shares of the Company’s common stock.
●
Upon
achievement of various annual net sales milestones ranging from $100,000,000 to $1,000,000,000 per year, the Company shall make one-time
cash payments that in the aggregate may total up to approximately $261,000,000 if all annual net sales milestones are achieved.
The
regulatory and commercial milestones must be achieved, if at all, on or before December 31, 2035.
The
Merger Agreement includes representations and warranties and covenants of the parties customary for such a transaction. Until the earlier
of the termination of the Merger Agreement and the effective time of the acquisition, Melt has agreed to operate its business in the
ordinary course and has agreed to certain other operating covenants. In addition, Melt has agreed to use reasonable best efforts to obtain
approval of the Merger Agreement and the transactions contemplated thereby by the requisite Melt stockholders needed for approval.
The
closing of this acquisition has not yet occurred and is subject to certain customary closing conditions, including the approval of the
requisite stockholders of Melt, the continued accuracy of representations and warranties and performance of covenants, and the absence
of any material adverse effect. We expect to close this acquisition before December 31, 2025.
8.625%
Senior Notes Due 2030 and Payoff of Prior Debt
In
September 2025, we closed a private offering of $250,000,000, aggregate principal amount of 8.625% senior notes due 2030 (the “2030
Notes”). The 2030 Notes offering resulted in net proceeds to us of approximately $242,794,000 after deducting underwriting discounts
and commissions and other offering expenses of $7,206,000
The
2030 Notes are senior unsecured obligations and are effectively subordinated to any of our secured indebtedness to the extent of the
value of the assets securing such indebtedness. The 2030 Notes are guaranteed on a senior unsecured basis by us, subject to certain exceptions.
The 2030 Notes bear interest at the rate of 8.625% per annum. Interest on the 2030 Notes is payable semi-annually in arrears on March
15, and September 15 of each year. The issuance costs were recorded as a debt discount and are being amortized as interest expense over
the term of the 2030 Notes using the effective interest rate method.
We
used the net proceeds from the 2030 Notes offering to prepay all then outstanding senior debt borrowings, exit costs, and accrued interest
including $107,500,000 in total principal loan amount borrowed under the Credit Agreement and Guaranty (the “Oaktree Loan”)
with Oaktree Fund Administration, LLC, as administrative agent for the lenders (together, “Oaktree”), $75,000,000 in total
principal amount senior notes due 2026 (the “2026 Notes), and $40,250,000 in total principal amount senior notes due 2027 (the
“2027 Notes”). The 2026 Notes and 2027 Notes were listed on The Nasdaq Stock Market under the symbols “HROWL”
and “HROWM”, respectively. The 2026 Notes were delisted on October 10, 2025 and the 2027 Notes were delisted on October 8,
2025.
BYOOVIZ®
and OPUVIZ TM – Commercialization Agreement
In
July 2025, we entered into a development and commercialization agreement (the “Samsung Agreement”) with Samsung Bioepis Co.,
Ltd. (“Samsung”). Under the terms of the Samsung Agreement, following completion of the transition of commercial rights from
Biogen, Inc. back to Samsung, Samsung will develop, manufacture, and supply BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy)
(individually, a “Product” and together, the “Products”) for Harrow to commercialize in the U.S. market (the
“Rights”). In consideration of such Rights, we will make a one-time upfront payment to Samsung, and Samsung will be eligible
to receive additional one-time payments based on the achievement of net sales-based milestones of the Products. In addition to other
mutually agreed terms, we shall pay to Samsung a share of net sales from the Products generated in the U.S. market.
33
Acquisition
of Commercial Rights to BYQLOVI TM
In
June 2025, we announced a licensing agreement whereby we acquired the exclusive U.S. commercial rights to BYQLOVI (clobetasol propionate
ophthalmic suspension) 0.05% from Taiwan-based Formosa Pharmaceuticals. BYQLOVI was recently approved by the FDA for the treatment of
post-operative inflammation and pain following ocular surgery and is the first new ophthalmic steroid in its class in over 15 years.
Harrow expects BYQLOVI to be available in the fourth quarter of 2025.
VEVYE® Access for All
In
March 2025, we announced a patient access program called VEVYE Access for All. The program is designed to increase patient access to
VEVYE at an out-of-pocket cost of $59 or below and, in many cases, reduce the need for prior authorizations, step edits, and other treatment
obstacles facing dry eye patients and their prescribers.
Project
Beagle
During
the first quarter of 2025 we initiated a 360-degree review of opportunities to offer ImprimisRx customers a Harrow-owned FDA-approved
product alternative to a compounded formulation. We call this initiative Project Beagle. In that vein, we began implementing a continuity
of care program to transition approximately 25,000 ImprimisRx patients from our Klarity-C (0.1% cyclosporine) compounded formulation
to VEVYE (0.1% cyclosporine), and we discontinued compounding Klarity-C on June 30, 2025. We also discontinued another related compounded
formulation called Klarity PF. Klarity PF was primarily purchased by a concentrated group of customers who have accepted our FRESHKOTE
product as an alternative. We continue to review opportunities to reduce the size of our compounded formulary, improve and simplify our
compounding capabilities, and transition other ImprimisRx customers from compounded formulations to Harrow’s FDA-approved products.
Results
of Operations
The
following period-to-period comparisons of our financial results for the three and nine months ended September 30, 2025 and 2024 are not
necessarily indicative of results for any future period.
Revenues
Our
revenues include amounts recorded from sales of proprietary compounded formulations, sales of branded products to wholesalers through
a third-party logistics facility, commissions from third parties and revenues received from royalty payments owed to us pursuant to out-license
arrangements.
The
following presents our revenues for the three and nine months ended September 30, 2025 and 2024:
For the
Three Months Ended
For the Year Ended
September 30,
$
September 30,
$
2025
2024
Variance
2025
2024
Variance
IHEEZO
$ 21,907,000
$ 12,882,000
$ 9,025,000
$ 45,465,000
$ 26,498,000
$ 18,967,000
VEVYE
22,626,000
5,186,000
17,440,000
62,783,000
12,099,000
50,684,000
Other branded products
6,908,000
10,256,000
(3,348,000 )
13,076,000
30,808,000
(17,732,000 )
Other revenues
141,000
228,000
(87,000 )
312,000
375,000
(63,000 )
Branded revenue, net
51,582,000
28,552,000
23,030,000
121,636,000
69,780,000
51,856,000
ImprimisRx revenue, net
20,056,000
20,705,000
(649,000 )
61,575,000
63,003,000
(1,428,000 )
Total revenues, net
$ 71,638,000
$ 49,257,000
$ 22,381,000
$ 183,211,000
$ 132,783,000
$ 50,428,000
The
increase in revenues between periods was related to an increase in sales and units sold of IHEEZO and VEVYE during the three and nine
months ended September 30, 2025 compared to the prior year periods.
34
Cost
of Sales, Gross Profit and Gross Margin
Our
cost of sales includes direct and indirect costs to manufacture formulations and sell products, including active pharmaceutical ingredients,
personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing equipment and tenant improvements depreciation,
the write-off of obsolete inventory, amortization of acquired product rights, and other related expenses.
Branded
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
Variance
2025
2024
Variance
Cost of Sales
$ 9,491,000
$ 5,169,000
$ 4,322,000
$ 26,406,000
$ 14,406,000
$ 12,000,000
Gross profit
$ 42,091,000
$ 23,383,000
$ 18,708,000
$ 95,230,000
$ 55,374,000
$ 39,856,000
Gross margin
81.6 %
81.9 %
-0.3 %
78.3 %
79.4 %
-1.1 %
The
increase in Branded cost of sales was primarily attributable to an increase in units sold during the three and nine months ended September
30, 2025 compared to the prior year periods and an increase in our fixed expenses. The decrease in Branded gross margin between the three
and nine months ended September 30, 2025 and 2024 was primarily attributable to an increase in our fixed expenses, in particular, acquired
product rights amortizations related to the launch of TRIESENCE and a related contingent milestone payment that was capitalized in the
fourth quarter of 2024.
ImprimisRx
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
Variance
2025
2024
Variance
Cost of Sales
$ 8,221,000
$ 6,849,000
$ 1,372,000
$ 23,060,000
$ 20,704,000
$ 2,356,000
Gross profit
$ 11,835,000
$ 13,856,000
$ (2,021,000 )
$ 38,515,000
$ 42,299,000
$ (3,784,000 )
Gross margin
59.0 %
66.9 %
-7.9 %
62.5 %
67.1 %
-4.6 %
The
increase in ImprimisRx costs of sales between the three and nine months ended September 30, 2025 and 2024 was primarily attributable
to product mix that included more sales of lower gross margin products and sales discounts. ImprimisRx gross margin decreased during
the 2025 periods compared to the prior year period due to the previously mentioned product mix as related well as one-time costs
that impacted our efficiency.
Selling,
General and Administrative Expenses
Our
selling, general and administrative (“SG&A”) expenses include personnel costs, including wages and stock-based compensation,
corporate facility expenses, and investor relations, consulting, insurance, filing, legal and accounting fees and expenses as well as
costs associated with our marketing activities and sales of our proprietary compounded formulations and other non-proprietary pharmacy
products and formulations.
The
following presents our SG&A expenses for the three and nine months ended September 30, 2025 and 2024:
For the
Three Months Ended
For the
Nine Months Ended
September 30,
$
September 30,
$
2025
2024
Variance
2025
2024
Variance
Selling, general and administrative
$ 35,856,000
$ 33,645,000
$ 2,211,000
$ 109,604,000
$ 94,275,000
$ 15,329,000
35
The
increase in SG&A expenses between the three-month periods was primarily attributable to the addition of new employees in sales, marketing
and other departments to support current and expected growth, which when combined contributed to a $3,434,000 increase in SG&A expenses
between the periods. These increases were offset by a $1,223,000 decrease in stock-based compensation expense between periods.
The
increase in SG&A expenses between the nine-month periods was primarily attributable to an increase in certain seasonal expenses,
such as increased costs associated with our annual audit and a special project that totaled $3,629,000 during the nine months ended September
30, 2025. In addition, the increase in SG&A expenses between periods was attributable to the addition of new employees in sales,
marketing and other departments to support current and expected growth, which when combined contributed to a $15,933,000 increase in
SG&A expenses between the periods. These increases were offset by a $4,233,000 decrease in stock-based compensation expense between
periods.
Research
and Development Expenses
Our
research and development (“R&D”) expenses primarily include personnel costs, including wages and stock-based compensation,
expenses related to the development of intellectual property, investigator-initiated research and evaluations, formulation development,
acquired in-process R&D and other costs related to the clinical development of our assets.
The
following presents our research and development expenses for the three and nine months ended September 30, 2025 and 2024:
For the
Three Months Ended
For the
Nine Months Ended
September 30,
$
September 30,
$
2025
2024
Variance
2025
2024
Variance
Research and development
$ 3,323,000
$ 2,273,000
$ 1,050,000
$ 9,217,000
$ 7,475,000
$ 1,742,000
The
increase in R&D expenses between the three and nine month periods was primarily attributable to increased development activity related
to our branded product portfolio, new product candidate development efforts, and clinical and medical support.
Interest
Expense, Net
Interest
expense, net was $6,038,000 and $18,994,000 for the three and nine months ended September 30, 2025, respectively, compared to $5,525,000
and $16,411,000 for the same periods in 2024, respectively. The increase during the three and nine months ended September 30, 2025 compared
to the same periods in 2024 was primarily the result of an increase in the outstanding principal amount of our debt obligations.
Investment
Loss from Eton
During
the three and nine months ended September 30, 2024, we recorded a loss of $0 and $3,171,000, respectively, related to the change in fair
market value of common stock of Eton Pharmaceuticals, Inc. (“Eton”) at the time of its sale, including trading expenses and
commissions of approximately $436,000. In April 2024, we sold all of our shares of Eton.
Loss
on Early Extinguishment of Debt
During
the three and nine months ended September 30, 2025 we recorded a loss on extinguishment of debt of $7,750,000, related to the payoff
of the 2026 Notes and 2027 Notes along with the Oaktree Loan. There were no extinguishments of debt during the three and nine months
ended September 30, 2024.
36
Liquidity
and Capital Resources
Liquidity
Our
cash on hand at September 30, 2025 was $74,290,000, compared to $47,247,000 at December 31, 2024.
As
of the date of this Quarterly Report, we believe that cash and cash equivalents of $74,290,000 at September 30, 2025 will be sufficient
to sustain our planned level of operations and capital expenditures for at least the next 12 months.
In
addition, we may consider the sale of certain assets. However, we may pursue acquisitions of products, drug candidates or other strategic
transactions that involve large expenditures or we may experience growth more rapidly or on a larger scale than we expect, any of which
could result in the depletion of capital resources more rapidly than anticipated and could require us to seek additional financing to
support our operations.
We
expect to use our current cash position and funds generated from our operations and any financing to pursue our business plan, which
includes developing and commercializing drug candidates, compounded formulations and technologies, integrating and developing our operations,
pursuing potential future strategic transactions as opportunities arise, including potential acquisitions of additional drug products,
drug candidates, and/or assets or technologies, pharmacies, outsourcing facilities, drug company and manufacturers, and otherwise fund
our operations and potential future milestone payments. We may also use our resources to conduct clinical trials or other studies in
support of our formulations or any drug candidate for which we pursue FDA approval, to pursue additional development programs or to explore
other development opportunities.
Net
Cash Flow
The
following provides detailed information about our net cash flows for the nine months ended September 30, 2025 and 2024:
For the Nine Months Ended
September 30,
2025
2024
Net cash provided by (used in):
Operating activities
$ 35,453,000
$ (4,423,000 )
Investing activities
(730,000 )
4,396,000
Financing activities
(7,680,000 )
(1,457,000 )
Net change in cash and cash equivalents
27,043,000
(1,484,000 )
Cash and cash equivalents at beginning of the period
47,247,000
74,085,000
Cash and cash equivalents at end of the period
$ 74,290,000
$ 72,601,000
Operating
Activities
Net
cash provided by (used in) operating activities during the nine months ended September 30, 2025 was $35,453,000 compared to $(4,423,000)
during the same period in the prior year. The increase in net cash provided by operating activities between the periods was mainly attributed
to a decrease of $38,225,000 in accounts receivable as a result of collections during the nine months ended September 30, 2025, compared
to an increase in accounts receivable of $17,453,000 during the same period in 2024.
Investing
Activities
Net
cash provided by (used in) provided by investing activities during the nine months ended September 30, 2025 was $(730,000) compared to
$4,396,000 during the same period in the prior year. Cash used in investing activities in 2025 was primarily related to equipment and
software purchases. Cash provided by investing activities in 2024 was primarily related to the sale of our investment position in Eton.
37
Financing
Activities
Net
cash used in financing activities during the nine months ended September 30, 2025 and 2024 was $(7,680,000) and $(1,457,000), respectively.
Cash used in financing activities during the nine months ended September 30, 2025 was primarily due to repayment of debt and payment
of payroll taxes upon vesting of stock compensation mostly offset by proceeds from issuance of new debt. Cash used in financing activities
in 2024, was primarily related to payment of payroll taxes upon vesting of PSUs in exchange for shares withheld from employees.
Sources
of Capital
During
the nine months ended September 30, 2025, our principal sources of cash came from proceeds from our operating activities. We expect future
cash needs to be provided by operating activities, but our forecasts may not be accurate, and our plans may change. We may also sell
some of our assets.
In
September 2025, we completed the sale of the 2030 Notes in a private offering and received net proceeds of $242,794,000. We used the
net proceeds from the 2030 Notes to prepay all outstanding borrowings under the Oaktree Loan, the 2027 Notes, and the 2026 Notes, and
to pay certain exit costs related thereto. The remaining funds will be used for general corporate purposes, which may include funding
future strategic business development opportunities and related investments. We also entered into the 5/3 Revolver with Fifth Third in
September 2025, which provided the Company with a secured revolving credit facility of $40,000,000, with an additional $20,000,000 of
uncommitted incremental revolving line of credit. We have not drawn down any amounts under the 5/3 Revolver.
We
may acquire new products, product candidates and/or businesses and, as a result, we may need significant additional capital to support
our business plan and fund our proposed business operations. We may also seek additional financing from a variety of sources, including
other equity or debt financings, funding from corporate partnerships or licensing arrangements, sales of assets or any other financing
transaction. If we issue equity or convertible debt securities to raise additional funds, our existing stockholders may experience substantial
dilution, and the newly issued equity or debt securities may have more favorable terms or rights, preferences and privileges senior to
those of our existing stockholders. If we raise additional funds through collaboration or licensing arrangements or sales of assets,
we may be required to relinquish potentially valuable rights to our product candidates or proprietary technologies or formulations, or
grant licenses on terms that are not favorable to us. If we raise funds by incurring additional debt, we may be required to pay significant
interest expenses and our leverage relative to our earnings or to our equity capitalization may increase. Obtaining commercial loans,
assuming they would be available, would increase our liabilities and future cash commitments and may impose restrictions on our activities,
such as the financial and operating covenants. Further, we may incur substantial costs in pursuing future capital and/or financing transactions,
including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other costs. We may also be required
to recognize non-cash expenses in connection with certain securities we may issue, such as convertible notes and warrants, which would
adversely impact our financial results.
We
may be unable to obtain financing when necessary, as a result of, among other things, our performance, general economic conditions, conditions
in the pharmaceuticals and pharmacy industries, or our operating history. In addition, the fact that we have a limited history of profitability
could further impact the availability or cost to us of future financings. As a result, sufficient funds may not be available when needed
from any source or, if available, such funds may not be available on terms that are acceptable to us. If we are unable to raise funds
to satisfy our capital needs when needed, then we may need to forego pursuit of potentially valuable development or acquisition opportunities,
we may not be able to continue to operate our business pursuant to our business plan, which would require us to modify our operations
to reduce spending to a sustainable level by, among other things, delaying, scaling back or eliminating some or all of our ongoing or
planned investments in corporate infrastructure, business development, sales and marketing and other activities, or we may be forced
to discontinue our operations entirely.
Credit
Ratings
As
of September 8, 2025, Moody’s Investors Service assigned a Long-Term Corporate Family Rating of B3 to Harrow, Inc. and affirmed
a Stable outlook. As of October 9, 2025, Fitch Ratings assigned a Long-Term Issuer Default Rating of B- (Outlook Stable) to Harrow, Inc.,
and a rating of B to our senior unsecured notes due September 2030. Credit ratings are subject to revision or withdrawal at any time
by the issuing agencies and should not be construed as a recommendation to purchase, hold or sell securities or as a guarantee of our
future performance. To the best of our knowledge, there have been no further changes to these ratings as of the date of this filing.
Any downgrade in our corporate or senior unsecured debt rating may increase our cost of borrowing and may negatively impact our ability
to raise additional debt capital.
38
Recently
Issued and Adopted Accounting Pronouncements
See
Note 2 to our unaudited condensed consolidated financial statements included in this Quarterly Report.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.