Form 8-K
8-K — HARROW, INC.
Accession: 0001493152-26-022227
Filed: 2026-05-11
Period: 2026-05-11
CIK: 0001360214
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — form8-k.htm (Primary)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 11, 2026
HARROW, INC.
(Exact
name of registrant as specified in its charter)
Delaware
001-35814
45-0567010
(State
or other jurisdiction
of
incorporation)
(Commission
File
Number)
(IRS
Employer
Identification
No.)
1A
Burton Hills Blvd., Suite 200
Nashville,
Tennessee
37215
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (615) 733-4730
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
on exchange on which registered
Common
Stock, $0.001 par value per share
HROW
The
Nasdaq Stock Market LLC
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2
of the Securities Act of 1934: Emerging growth company ☐
If
any emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02. Results of Operations and Financial Condition.
On
May 11, 2026, Harrow, Inc. (the “Company”) issued a press release and a letter to stockholders announcing its financial results
for the quarter ended March 31, 2026 and providing an update on recent corporate developments. The press release and letter to stockholders
are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
Item
7.01. Regulation FD Disclosure.
Attached
as Exhibit 99.3 to this Current Report on Form 8-K is a presentation of the Company that may be used by the management of the Company
in connection with its earnings call, at investor conferences, and at meetings describing the Company.
The
information furnished under Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, 99.2 and 99.3, shall not
be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act, except as expressly set
forth by specific reference in such filing.
Item
9.01. Financial Statements and Exhibits
(d)
Exhibits
99.1
Press Release issued by Harrow, Inc. on May 11, 2026
99.2
Letter to Stockholders by Harrow, Inc. dated May 11, 2026
99.3
Harrow Corporate Presentation dated May 2026
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
HARROW,
INC.
Dated:
May 11, 2026
By:
/s/
Andrew R. Boll
Name:
Andrew
R. Boll
Title:
President
& Chief Financial Officer
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit 99.1
Harrow
Announces First Quarter 2026 Financial Results
First
Quarter 2026 and Selected Highlights:
● VEVYE®
delivered record new and total prescription performance (despite an approximate 18% decline
in the overall branded dry eye category)
● VEVYE
demand growth on track to deliver 2026 revenue of over $100 million
● Quarterly
revenue of $44.2 million, including a non-recurring gross-to-net revenue adjustment connected
to new VEVYE commercial coverage, which lowered Q1 revenue by approximately $8 million
● IHEEZO®
unit demand increased 18% year-over-year, with 82% of units from retina accounts
● TRIESENCE®
unit demand more than doubled year-over-year, the sixth consecutive quarter of growth
● Second
Quarter revenue expected between $71 million and $81 million
● Full-year
2026 revenue guidance reaffirmed at $350 million to $365 million
● Cash
and cash equivalents of $94.6 million as of March 31, 2026
NASHVILLE,
Tenn., May 11, 2026 – Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, announced
results for the first quarter ended March 31, 2026. The Company also posted its first-quarter Letter to Stockholders and corporate presentation
to the “Investors” section of its website at harrow.com. The Company encourages Harrow stockholders to review these
documents, which provide additional details concerning the historical results and future expectations for the business.
“The
demand for Harrow’s key products has never been stronger, and our visibility into our demand trajectory –
across our portfolio – keeps us entirely on track to reach our forecasted financial goals for the year,” said Mark
L. Baum, Chief Executive Officer of Harrow. “Although our first-quarter reported revenue reflects an estimated $8 million gross-to-net
reduction associated with our new commercial coverage for VEVYE, this adjustment does not reflect the profitable, recurring,
and significant patient base established during the quarter. Harrow is now positioned to realize the full financial benefits of this
coverage relationship beginning in Q2 2026.”
Baum
continued, “Prior to the quarter, we established business rules with specific assumptions regarding these new VEVYE commercial
patients. As the period unfolded, the surge in demand among patients with high-deductible plans significantly outpaced our initial
models. This created temporary gross-to-net pressure, which was resolved through business rules adjustments. With these rules now in
place, we are now positioned to realize the expected financial benefit of our expanded commercial access, and we are already seeing highly
encouraging net pricing indicators early in the second quarter.”
“Our
core commercial engine is accelerating. VEVYE delivered record prescription performance and has officially surpassed XIIDRA on a monthly
total prescription basis. Across our key growth drivers - VEVYE, IHEEZO, and TRIESENCE - we are seeing robust prescriber adoption, expanding
market share, and durable momentum. With our expanded commercial organization now fully deployed, we remain highly confident in our ability
to deliver on our 2026 revenue guidance of $350 million to $365 million.”
Harrow Announces First Quarter 2026 Financial Results
Page 2
May 11, 2026
Key
First Quarter Demand Indicators:
VEVYE:
● Prescription
growth of approximately 170% sequentially within our new national pharmacy benefit manager’s
Tier 1 accounts
● Record
quarterly prescription performance, with NRx up 25% and TRx up 11% quarter-over-quarter,
despite a decline in the overall branded dry eye market
● Surpassed
XIIDRA on a monthly TRx basis, achieving approximately 14% market share as of the end
of March 2026
IHEEZO:
● Unit
demand increased 18% year-over-year, with March 2026 up 34% versus the prior-year period
● Retina
accounts represented approximately 82% of total volume, reflecting continued strength
in the core market
● Ordering
accounts continued to expand, driven by growing adoption across both retina and in-office
procedural settings
TRIESENCE:
● Unit
demand more than doubled year-over-year, increasing 136% versus the prior-year period
● Sixth
consecutive quarter of growth, supported by continued expansion of the customer base,
including 195 new accounts in the quarter, representing approximately 28% of total ordering
accounts
First
Quarter 2026 Financial Results:
For the Three Months Ended
March 31,
2026
2025
Total revenues
$ 44,203,000
$ 47,831,000
Gross margin
61 %
68 %
Net loss
(27,602,000 )
(17,780,000 )
Adjusted EBITDA(1)
(12,659,000 )
(1,985,000 )
Net loss per share, basic and diluted
(0.74 )
(0.50 )
(1) Adjusted
EBITDA is a non-GAAP measure. For additional information, including a reconciliation of Adjusted
EBITDA to the most directly comparable measure presented in accordance with GAAP, see the
explanation of non-GAAP measures and reconciliation tables at the end of this release.
Conference
Call and Webcast
Harrow
will host a conference call to discuss the results at 8:00 a.m. ET on Tuesday, May 12, 2026. Participants can access the live webcast
of Harrow’s presentation on the “Investors” page of Harrow’s website. A replay of the webcast will be available
on the Company’s website for one year.
To
participate via telephone, please register in advance using this link. Upon registration, all telephone participants will receive
a confirmation email with detailed instructions, including a unique dial-in number and PIN, to access the call.
-END-
Harrow Announces First Quarter 2026 Financial Results
Page 3
May 11, 2026
About
Harrow
Harrow,
Inc. (Nasdaq: HROW) is 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. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.
Forward-Looking
Statements
This
press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act
of 1995. Any statements in this release that are not historical facts may be considered such “forward—looking statements.”
Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties
that could cause actual results to differ from those predicted 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, 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; 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,
including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing
facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies
generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange
Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such
documents may be read free of charge on the SEC’s web site at sec.gov. Undue reliance should not be placed on forward-looking-statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking-statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated
events.
Contact:
Mike
Biega, VP of Investor Relations and Communications
mbiega@harrowinc.com
617-913-8890
-END-
Harrow Announces First Quarter 2026 Financial Results
Page 4
May 11, 2026
HARROW, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
March
31, 2026
December
31, 2025
ASSETS
Cash and cash equivalents
$ 94,644,000
$ 72,927,000
All other current assets
131,740,000
138,823,000
Total current assets
226,384,000
211,750,000
All other assets
193,159,000
187,732,000
TOTAL ASSETS
$ 419,543,000
$ 399,482,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
$ 91,439,000
$ 96,302,000
Loans payable, net of unamortized debt discount
292,087,000
243,184,000
All other liabilities
7,666,000
7,905,000
TOTAL LIABILITIES
391,192,000
347,391,000
TOTAL STOCKHOLDERS’ EQUITY
28,351,000
52,091,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 419,543,000
$ 399,482,000
HARROW, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Months Ended
March 31,
2026
2025
Total revenues
$ 44,203,000
$ 47,831,000
Cost of sales
(17,158,000 )
(15,524,000 )
Gross profit
27,045,000
32,307,000
Selling, general and administrative
43,230,000
40,513,000
Research and development
5,895,000
3,026,000
Total operating expenses
49,125,000
43,539,000
Loss from operations
(22,080,000 )
(11,232,000 )
Interest expense, net
(5,497,000 )
(6,548,000 )
Income tax expense
(25,000 )
-
Net loss
$ (27,602,000 )
$ (17,780,000 )
Net loss per share:
Basic and diluted
$ (0.74 )
$ (0.50 )
-END-
Harrow Announces First Quarter 2026 Financial Results
Page 5
May 11, 2026
HARROW, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Three Months Ended
March 31,
2026
2025
Net cash provided by (used in):
Operating activities
$ (8,992,000 )
$ 19,668,000
Investing activities
(18,203,000 )
(212,000 )
Financing activities
48,912,000
23,000
Net change in cash and cash equivalents
21,717,000
19,479,000
Cash and cash equivalents at beginning of the period
72,927,000
47,247,000
Cash and cash equivalents at end of the period
$ 94,644,000
$ 66,726,000
Non-GAAP
Financial Measures
In
addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP),
which are presented and discussed above, management also utilizes Adjusted EBITDA, an unaudited financial measure that is not calculated
in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted
EBITDA is considered a “non-GAAP” financial measure within the meaning of Regulation G promulgated by the SEC. Management
believes that this non-GAAP financial measure reflects an additional way of viewing aspects of the Company’s operations that, when
viewed with GAAP results, provides a more complete understanding of the Company’s results of operations and the factors and trends
affecting its business. Management believes Adjusted EBITDA provides meaningful supplemental information regarding the Company’s
performance because (i) it allows for greater transparency with respect to key metrics used by management in its financial and operational
decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to
the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii)
it is used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA,
and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding
measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated
may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies,
including the Company’s competitors.
-END-
Harrow Announces First Quarter 2026 Financial Results
Page 6
May 11, 2026
Adjusted
EBITDA
The
Company defines Adjusted EBITDA as net income (loss), excluding the effects of stock-based compensation and expenses, impairment of intangible
assets, interest, taxes, depreciation, amortization, investment loss, net, and, if any and when specified, other non-recurring income
or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net income (loss).
Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net income (loss) as a measure of operating
performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.
The
following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net income (loss), for the
three months ended March 31, 2026 and for the same period in 2025:
HARROW,
INC.
RECONCILIATION
OF NET LOSS TO ADJUSTED EBITDA
For
the Three Months Ended
March 31,
2026
2025
GAAP net loss
$ (27,602,000 )
$ (17,780,000 )
Stock-based compensation and expenses
3,837,000
4,556,000
Interest expense, net
5,497,000
6,548,000
Income tax expense
25,000
-
Depreciation
455,000
465,000
Amortization of intangible assets
5,129,000
4,226,000
Adjusted EBITDA
$ (12,659,000 )
$ (1,985,000 )
-END-
EX-99.2
EX-99.2
Filename: ex99-2.htm · Sequence: 3
Exhibit 99.2
26th
Quarterly Letter to Stockholders
May
11, 2026
Dear
Harrow Stockholders:
The
first quarter of 2026 saw unprecedented market demand for VEVYE® and an unavoidable modeling challenge related to our
new commercial coverage. While we were pleased with the former (the unprecedented demand for VEVYE), the latter resulted in a non-recurring
revenue reduction for the quarter. That said, the underlying fundamentals of Harrow have never been stronger. Because demand trends for
our key products remain robust and track in line with or above our expectations, our full-year 2026 financial outlook remains entirely
intact. We continue to expect 2026 revenue in the range of $350 million to $365 million and Adjusted EBITDA of $80 million to $100
million, alongside over $100 million in VEVYE revenue for the full year.
New
Commercial Coverage and Gross-to-Net Recalibration
Securing
coverage with the largest U.S. manager of commercial lives was an important achievement for Harrow. Prior to the quarter, anticipating
a meaningful burst of VEVYE prescription growth from this new relationship, we established business rules with specific assumptions regarding
these new commercial patients. And, as the period unfolded, we in fact experienced the exact surge in demand we had modeled. However,
we also experienced higher-than-anticipated buy-down costs for these patients, including those on higher-deductible plans. This dynamic
was impossible to accurately predict and created gross-to-net pressure that exceeded our internal assumptions, temporarily degrading
net pricing for VEVYE before we could collect enough data to implement operational adjustments within the quarter. Consequently, our
reported VEVYE revenue of $20.9 million for the quarter was approximately $8 million below what we believe it would have been had we
made these operational adjustments at the beginning of the year.
The
Silver Lining: Seeding a Profitable Recurring Revenue Base
While
this gross-to-net dynamic temporarily impacted first-quarter reported revenue, it masks the substantial, long-term value we created during
this period. Our co-pay program is a strategic investment intentionally designed to capture patient market share early in the year when
insurance resets and out-of-pocket costs are highest. This dynamic, while temporarily pressuring net pricing, enabled us to drive a highly
meaningful increase in new patient starts.
Importantly,
once patients initiate VEVYE, thankfully, they remain on therapy, with covered prescriptions refilling approximately 9 times annually.
By strategically absorbing these initial buy-down costs, we have effectively seeded a much larger, highly profitable, and recurring revenue
base that will compound over the coming quarters. With the high-deductible season now largely behind us, new business rules in place,
and normalized net pricing strictly aligned with our internal expectations, we expect VEVYE performance to strengthen considerably over
the balance of the year.
Looking Ahead
Setting
aside the VEVYE modeling recalibration, the first quarter unfolded consistently with our forecast. Q1 is historically our lightest revenue
period due to standard industry seasonality: patient deductibles reset (impacting pharmacy benefits), surgical scheduling is lighter
(affecting our surgical portfolio), and we fully anticipated limited GAAP revenue from IHEEZO® as Q4 channel inventory
was absorbed.
Ultimately,
the Q1 financial numbers do not reflect the true state of our business—especially from a go-forward perspective. With our expanded
sales force deployed and demand across our portfolio accelerating, I strongly believe Harrow is in great shape for the balance of the
year, is set up beautifully for 2027, and is more valuable as a business than ever.
The
first quarter of 2026 reinforced what I have been saying for several quarters: our core growth drivers – VEVYE, IHEEZO, and TRIESENCE®
are each on distinct and durable growth trajectories with significant and durable runways ahead. I am encouraged by the continued momentum
and the strong demand trends we experienced in the first quarter: (1) VEVYE delivered strong growth in both new prescriptions (NRx) and
total prescriptions (TRx) throughout the quarter (while the overall dry eye prescription category declined); and (2) IHEEZO and
TRIESENCE each continued to demonstrate robust unit demand growth, building on their momentum in their respective markets. With the most
challenging part of the year now behind us, we are entering a period of accelerating commercial execution.
From
a strategic perspective, we entered 2026 with a clear mandate: invest to scale our commercial organization and unlock the full potential
of our portfolio. I initially set a Memorial Day target for completing this buildout that, candidly, I believed was aggressive. Our
talent team exceeded even those expectations, successfully hiring just over 100 representatives in approximately 45 days. In today’s
environment, hiring on this scale and quality is not easy; this was an exceptional accomplishment.
Just
as important as the speed was the caliber. A review of our new hires—many of whom you can see on LinkedIn—shows we have attracted
experienced, high-performing commercial talent. We also saw an extraordinary level of inbound applicant interest throughout the process,
with over 2,400 candidates applying for just over 100 open positions. Top-tier commercial talent does not take leaps of faith on unproven
leadership. The fact that over 2,400 professionals applied to join us is a direct reflection of our management team’s track record
of execution, our successful integration of major brand acquisitions, and our consistent history of delivering on our promises. Sales
professionals go where they can win, and this overwhelming response is a strong leading indicator of where Harrow is headed.
As
I write this letter, the expansion of our sales force is complete, and our new representatives are entering the field and beginning to
engage physicians, expand access, and build awareness across our markets. While you may see early signs of progress in the second quarter,
we expect the true impact to build meaningfully in the second half of the year as the team reaches full deployment, gains rhythm in their
territories, and begins to convert that activity into sustained momentum.
2026
Financial Outlook
Our
full-year outlook remains unchanged. We continue to expect 2026 revenue in the range of $350 million to $365 million and Adjusted EBITDA
of $80 million to $100 million, with performance weighted toward the second half of the year. For the second quarter, we expect to report
revenues between $71 million and $81 million.
While
Q1 reflected higher-than-anticipated seasonality, underlying demand trends across our portfolio, including VEVYE, IHEEZO, and TRIESENCE,
continue to strengthen. We are seeing encouraging momentum, particularly as our expanded sales force ramps and converts this growing
demand into revenue. We expect a meaningful acceleration in performance through the balance of the year. Based on the strength of underlying
demand across our portfolio, our growing visibility into an expanding sales funnel, and the deployment of our scaled commercial organization,
we have a high degree of confidence in our ability to deliver on these objectives.
VEVYE
Market Share Gains, Sales Force Expansion, and Coverage Growth
During
the first quarter following preferred coverage with the largest manager of commercial lives in the U.S., we saw acceleration across all
key demand indicators. VEVYE delivered a record quarterly performance in both new prescriptions (NRx) and total prescriptions (TRx),
with NRx increasing by approximately 25% sequentially and TRx by approximately 11% sequentially. These figures are more impressive given
that total prescriptions in the overall dry eye market declined by approximately 14%, and the branded dry eye segment dropped by 18%
during the period. VEVYE was effectively the only meaningful source of growth in a quarter when the entire branded category went backward.
This divergence highlights that improved access is driving meaningful, share-taking demand for VEVYE.
I
am proud that we are broadening our base of prescribers. Total prescribers increased by 12% quarter-over-quarter, with the majority of
new writers attributable to the expanded payer coverage. We continue to see monthly prescribers expand, with VEVYE’s writer base
growing every month over the last year.
I
view these trends as early indicators of a durable demand inflection. As coverage expands and awareness builds, we expect continued growth
in both NRx and TRx throughout 2026. This trajectory will be further amplified by the expansion of our commercial organization. Together,
improved coverage and increased field execution position us to accelerate demand and prescriber growth as we move through the year. Coupled
with an average refill rate of approximately 9x for covered patients, this creates a highly attractive, high-margin recurring revenue
profile once patients are initiated on VEVYE.
Within
the leading national pharmacy benefit manager’s Tier 1 accounts, VEVYE prescription volume grew approximately 170% in the first
quarter of 2026 versus the prior quarter. VEVYE was the only branded product to post meaningful growth within those covered lives in
the first quarter; the only other branded product to grow at all, RESTASIS, was approximately flat.
VEVYE
is rapidly reshaping the competitive landscape in dry eye, a market that, on an annualized basis, continues to expand, with approximately
20% year-over-year growth in prescription volume each of the past two years.
Over
the past year, VEVYE’s branded market share has more than tripled, exiting March at approximately 14% share. By the end of March,
VEVYE officially surpassed XIIDRA on a monthly TRx market share basis and continues to close the gap with MIEBO.
Crucially,
our team accomplished this rapid capture of market share with a sales force of fewer than 50 reps, zero direct-to-consumer advertising,
and limited insurance coverage. This remarkable capital efficiency demonstrates the massive leverage we are poised to unlock as our fully
expanded, 100-person VEVYE commercial team targets the #1 position in the cyclosporine market.
Here
is a simple summary of Harrow’s near-term goals for VEVYE:
● Leverage
our market momentum, the value patients’ experience with VEVYE, and our expanding prescriber
base by driving volume, improving coverage, deepening prescriber engagement, and maximizing
the lifetime economic value of each VEVYE patient.
● Make
VEVYE the #1 cyclosporine therapy in the U.S. market, eclipsing Restasis®
(which still serves approximately 24% of the U.S. market – more than 23 years after
it was launched!)
● Make
VEVYE the #1 dry eye prescription product in the U.S. market.
With
the expansion of the VEVYE sales force now complete, our focus has shifted to leveraging a data-driven approach to strategically place
representatives across both previously uncovered markets and underpenetrated territories—areas where we see clear opportunities
to expand Tier 1 and Tier 2 account coverage (our highest-value prescriber targets) and drive adoption among new-to-brand prescribers.
As a result of this buildout, we have significantly enhanced our reach and commercial execution capabilities.
We
expect our investment in the VEVYE team to drive a step-change in volume. Given the number of markets that historically lacked adequate
coverage, our expanded footprint positions us to meaningfully increase volume and unlock demand across new territories, while engaging
a broader base of new-to-brand prescribers.
I
watch our PhilRx daily prescription volumes like a hawk. As I write this Letter to Stockholder, now that our new sales force is deployed,
I am seeing new daily and weekly new prescription records. Importantly, I see usually slower days begin to ramp past what have been historically
busier days (e.g., signs of higher highs and higher lows). It’s still early, but the net result of our investments should be a
modest impact in the second quarter, and a more pronounced and sustained contribution beginning in the second half of the year as reps
gain tenure in their territories and deliver greater reach, frequency, and overall commercial effectiveness, significantly improving
VEVYE’s overall 2026 performance.
IHEEZO:
Demand is Accelerating in a Massive Total Addressable Market (TAM)
IHEEZO
demand accelerated in the first quarter, with unit demand reaching 45,509 units. Despite the expected drag from losing pass-through (only
for procedures administered in the ambulatory surgery center (ASC)), we still saw an 18% increase compared to the first quarter of 2025
(when pass-through was not at risk). March alone was up 34% versus March 2025 – a clear indication that underlying demand continues
to grow as more retina practices and in-office accounts integrate IHEEZO into their practice.
Retina
accounts primarily drove this growth, accounting for 82% of total units, with the remaining 18% coming from the ASC setting. This dynamic
reflects continued strength in our core market alongside expanding adoption for in-office procedural use – where we have durable
reimbursement and nearly pervasive coverage.
All
key demand indicators are trending in the right direction. A total of 219 accounts ordered IHEEZO during the first quarter, including
approximately 45 new accounts, representing 21% of total customers. Ordering accounts increased 49% year-over-year, underscoring the
accelerating adoption and continued expansion of our user base. Finally, we experienced an 85.5% reorder rate for IHEEZO!
As
we previously communicated, we did not expect to report meaningful GAAP revenue for IHEEZO in the first quarter. This was fully anticipated
and reflects the planned absorption of fourth-quarter channel inventory—a mechanical dynamic completely independent of the robust
underlying patient demand.
Following
recent meetings with IHEEZO customers and seeing Q2 demand trends, my conviction in this asset has only deepened. IHEEZO delivers tremendous
clinical value and given the immensity of the TAM, remains significantly underpenetrated. When we aggregate the relevant reimbursed,
in-office procedure-based markets where IHEEZO’s clinical profile and J-Code reimbursement provide a compelling value proposition—including
retina intravitreal injections and a broad array of office-based procedures—we estimate a TAM of more than 14 million annual
procedures in the United States. Against that backdrop, our current market penetration remains below 2%, underscoring how early we are
unlocking the IHEEZO opportunity.
While
GAAP revenue recognition for IHEEZO is temporarily constrained in the first half of 2026 due to inventory dynamics, our underlying operational
initiatives have reset the foundation for a step-change in revenue growth. We expect this to inflect sharply in the second half of the
year and beyond.
The
in-office channel for IHEEZO has been encouraging. This new stream of IHEEZO orders began during the first quarter. Some of the new accounts
are sizable and, in general, these initial trends further support our confidence in the scalability and eventual impact of our expansion
into the office.
Based
on current demand trends and pipeline visibility, we expect the in-office IHEEZO channel to fully offset the loss of ASC volume this
year. In parallel, we are advancing pilot agreements with several large multi-practice eye-care networks, as well as the largest players
in the office-based cataract surgery market, all of which we expect to contribute meaningfully to IHEEZO’s overall volume in the
second half of the year.
IHEEZO’s
progress to date in the retina market has been driven entirely by the strength of its value proposition—its clinical profile, its
workflow efficiency benefits, including meaningful time and motion savings in high-volume injection settings, and its favorable reimbursement
characteristics. This has all been achieved without data on retina-specific procedures. That dynamic is set to change in a few months.
We
expect two important clinical milestones in 2026:
● The
first presentation of IHEEZO data in retina procedures will be at ASRS in July; and
● Data
from our QUELL study in the fourth quarter.
Retina-specific
data should propel the next leg of IHEEZO growth. Favorable results from these studies would represent a genuine inflection point —
providing prospective, procedure-specific evidence to support broader and deeper adoption in retina, a market that has already embraced
IHEEZO on the strength of its clinical and economic profile alone.
Looking
ahead, we are positioning IHEEZO for its next phase of revenue growth, which will begin to materialize in the third quarter. Supporting
this acceleration will be continued strength in retina, expanding adoption in the in-office procedural market, an estimated 20–25%
improvement in net pricing, and the introduction of multi-unit packaging in the second half of the year, alongside incremental commercial
synergies from BYOOVIZ and IOPIDINE®. IHEEZO remains early in its lifecycle, and the foundation for durable, scalable
growth is firmly in place to drive value for Harrow stockholders for many years to come.
IOPIDINE
1% – Reimbursement Leads to Expanded Utilization
Complementing
IHEEZO’s continued in-office momentum, I see IOPIDINE 1% emerging as an incremental growth driver within our procedural portfolio.
As a single-source brand-name product, IOPIDINE 1% is the only physician-administered, FDA-approved therapy indicated to prevent intraocular
pressure (IOP) spikes following ophthalmic laser procedures. It fits perfectly into our proven commercial playbook for maximizing the
value of unique, underappreciated assets across a wide range of in-office procedures where elevated eye pressure is a risk. Critically,
physicians can now administer IOPIDINE 1% in-office at the point of care, providing immediate control and improving patient outcomes.
Despite
this well-established clinical utility, adoption has historically been constrained by reimbursement dynamics, as IOPIDINE 1% functioned
as a cost center within capitated payment structures. The assignment of a permanent J-Code, which goes into effect on July 1, 2026, represents
a clear inflection point. Wholesale acquisition cost (WAC) pricing has been set at $740 for 5 pouches (each pouch contains 2 blow-fill-seal
units) or $148 per pouch. Each procedure would consume a single pouch. With initial reimbursement expected to be WAC + 6% or 3% at launch
(and eventually ASP + 6%), IOPIDINE 1% now offers an attractive economic profile, aligning physician incentives with its clinical value
and enabling broader integration into routine practice through the same physician call point as IHEEZO.
Strategically,
IOPIDINE 1% strengthens and expands our in-office franchise alongside IHEEZO. Physicians can utilize IHEEZO to anesthetize the eye and
then IOPIDINE 1% to control pressure from the procedure—creating a cohesive, end-to-end solution. This integrated approach enhances
practice efficiency, improves patient experience, and deepens our presence across the in-office care continuum.
With
more than 1.5 million annual on-label procedures and a 91% proven reduction in risk associated with intraocular pressure spikes when
IOPIDINE 1% is administered, we view this product as a compelling growth opportunity and a clear example of our strategy in action: maximizing
the value of all assets in our portfolio by expanding access and affordability for patients, leveraging our strength in securing reimbursement
and coding, and enabling physicians to deliver better care with greater clinical control and stronger economic alignment in the office
setting.
TRIESENCE
in Surgery: Six Consecutive Quarters of Growth; A+ Clinical Outcomes
My
first exposure to eyecare was in 2013, when I met groups of doctors who were injecting preservative-free triamcinolone acetonide into
the eyes of cataract surgery patients to reduce or obviate the need for eyedrops. I will never forget meeting the brilliant and colorful
surgeon, Dr. James P. Gills, who, in 2014, “schooled me” on his use – dating back to the 1970s – of various injectable
steroid formulations for his cataract surgery patients. My mentor and friend for more than a decade, and an international legend in ophthalmology,
Dr. Richard Lindstrom, also shared numerous innovative ideas about injectable formulations and, in general, inspired me to think outside
the box about how Harrow could rethink the patient experience in cataract surgery, which remains, in terms of surgical volume, the most
common surgical procedure in the U.S.
At
Harrow, we approach each surgery as if it were ourselves or someone close to us going under the knife. For over a decade, dating back
to our earliest compounding initiatives, Harrow has been pioneering the movement to reduce patient reliance on topical post-surgical
drops, given that patient compliance is notoriously poor. TRIESENCE is simply the next, powerful evolution of a vision we have been
successfully executing since 2014—giving surgeons the tools to place medications directly into the patient’s eye at the time
of surgery.
Our
Surgical Vision
Our
surgical team has a single purpose: deliver what I call “Amazing Cataract Surgery,” defined as (1) IV-free, (2) Opioid-free,
and (3) Eyedrop-free surgery. Following our successful acquisition of the remaining equity interests in Melt Pharmaceuticals late last
year, we are in full control of the asset that will hopefully deliver those first two items. We anticipate filing a new drug application
(NDA) for G-MELT within the next 12 months. Regarding the third item, TRIESENCE plays a critical role in Harrow’s strategy to reduce
exposure to eyedrops.
Physician
feedback regarding clinical outcomes using TRIESENCE has been consistently outstanding (in fact, I would call it “A+++”).
These surgeons are seeing meaningful practice-level benefits: fewer postoperative visits, a more efficient recovery experience, and the
elimination of compliance-dependent eye-drop regimens for patients. Importantly, this positive clinical experience is translating into
tangible commercial traction, as evidenced by rising reorder rates, new account adoption, and growing conviction within the surgical
community.
Now
squarely focused on the surgical inflammation market, TRIESENCE continued to build momentum in the first quarter, with both unit demand
and adoption trends strengthening. Demand data demonstrates increasing utilization, supported by expanding awareness and broader clinical
adoption, which I believe positions TRIESENCE for sustained growth ahead. Having just returned from meeting with surgical accounts in
Texas, I can attest that demand has only scratched the surface for TRIESENCE, and new, very substantial accounts are adopting TRIESENCE
into their protocols. More are adopting TRIESENCE weekly.
In
the first quarter (once again, typically a weaker quarter for ophthalmic surgery), TRIESENCE demand reached 10,492 units, more than doubling
(+136%) compared to the first quarter of 2025 and increasing 2% sequentially versus Q4, with March 2026 setting a new monthly high, delivering
a 113% increase in demand year-over-year.
Adoption
metrics remain particularly strong. A total of 709 accounts ordered TRIESENCE during the quarter, including 195 new accounts, representing
28% of the total customer base. This level of new account activation, alongside continued ordering from existing customers, underscores
both expanding market penetration and deepening utilization.
Our
experience so far is that the sales cycle to get initial adoption takes time, and initial account activation doesn’t yield 100%
of a customers’ surgical cases. But we are also seeing that in due course, given the successful clinical outcomes doctors are seeing,
they want more of their patients to experience the benefits of TRIESENCE. As I’ve said before, the nice thing about a product like
TRIESENCE is that once it is adopted and trusted, it becomes hard to displace.
To
support our long-term intentions, we have launched a clinical study designed to expand the TRIESENCE label to expressly include cataract
surgery and pain—a development positioned to materially broaden its commercial opportunity. The study is underway, and we expect
the last patient visit by the end of this year with top-line data shortly thereafter. We are also developing a pre-filled syringe (PFS)
format for TRIESENCE. Once again, this program is underway, and we expect to present a filing to the FDA within the next 18-20 months.
Taken
together, these demand and adoption trends point to a franchise gaining meaningful traction and having long-term growth potential. As
awareness continues to build and our expanded sales force reaches full productivity, we expect TRIESENCE to sustain this momentum, with
most of the future growth driven by our expansion into the ocular inflammation market. I remain highly confident in TRIESENCE as a durable,
multi-year growth asset.
Biosimilars:
BYOOVIZ® Launch in Q3 and OPUVIZ™ Getting Ready for 2027
We
remain on track to commercially launch BYOOVIZ®, a LUCENTIS®-referenced biosimilar (developed by
Samsung Bioepis), on July 1, 2026—and our conviction in this opportunity has grown over the past several quarters. Revenue from
initial stocking orders is expected to begin in the current quarter.
As
we have sharpened our commercial strategy and deepened engagement with retina practices, BYOOVIZ is entering the market with a clear
and differentiated path to adoption. BYOOVIZ is well-positioned to compete in the retina buy and bill market, offering physicians a high-quality
interchangeable biosimilar paired with the opportunity for attractive practice-level returns. A clinically meaningful subset of patients
may not respond adequately to aflibercept, with reported rates varying by indication and by how response is defined. While each patient’s
need is specific, many are transitioned to alternative anti-VEGF therapies, including ranibizumab. This represents a defined and clinically
appropriate segment of the market where BYOOVIZ can compete directly as a cost-efficient, high-quality alternative within the existing
standard of care.
Our
go-to-market approach is designed to capitalize on a distinct advantage: our established account-level relationships across retina practices.
Rather than competing on price alone, we are engaging retina practices at the account level, leveraging the trust we have built over
years of serving these customers across our broader portfolio. Our commercial infrastructure is particularly meaningful in the injectable
therapy category, where physicians place a premium on trust, supplier reliability, service, and consistency—attributes that we,
and our partners at Samsung Bioepis, have demonstrated at scale.
In
addition, our portfolio enables a more comprehensive patient-focused engagement with physicians. With offerings spanning anesthesia (IHEEZO),
anti-VEGF therapy (BYOOVIZ), and inflammation control (TRIESENCE), we are positioned to support the full continuum of care—from
procedure through recovery. This integrated approach differentiates our commercial model and strengthens our value proposition at the
practice and patient level.
We
are also taking deliberate steps to enhance our commercial offering from day one. Leveraging the flexibility afforded by our recent notes
offering, we intend to extend payment terms to creditworthy customers—a meaningful lever in a buy-and-bill market that we expect
will strengthen BYOOVIZ’s value proposition and accelerate adoption at launch.
Looking
ahead, the anticipated launch of OPUVIZ™, an EYLEA®-referenced biosimilar that was developed by Samsung Bioepis,
in 2027 will further extend this platform, broadening our reach into one of the largest segments of the U.S. ophthalmic market and reinforcing
our strategy of building a scaled, integrated ophthalmic pharmaceutical company.
Refocusing
on Two Great Specialty Products
In
my last Letter to Stockholders, I highlighted an interest in unlocking value from three underappreciated assets within this portfolio.
Weeks later, we delivered on the first of the three assets I mentioned: IOPIDINE 1% (which is discussed more in the preceding pages).
The remaining two assets, each with the potential to enter new on-label markets and contribute meaningful incremental revenue, represent
extraordinary opportunities:
● VERKAZIA®
for vernal keratoconjunctivitis (VKC) in children and adults. VKC, a severe ocular allergy
that we believe is extremely underdiagnosed, presents in mild, moderate, and severe forms
and needs to be treated early on before sight-threatening consequences occur.
● NATACYN®
for Fungal Blepharitis and other sight-threatening fungal infections.
In
the coming weeks, we will begin to share our thoughts about the VERKAZIA opportunity specifically, and as a study we have underway provides
important data for our NATACYN strategy, we will provide our stockholders with additional information. That said, the Specialty team
is now focused on supporting our interest in ensuring patient access to both highly efficacious and uniquely labeled premium products.
Our intention is to reignite growth in these products this year, accelerating utilization, improving patient access, and broadening awareness.
These initiatives are underway, and we expect momentum to build throughout the year.
Access+
Cash Pay Products
At
its core, Access+ is built on a simple, durable value proposition: delivering the everyday essential ophthalmic medications that physicians
and patients rely on. Through a curated portfolio of FDA-approved cash-pay branded ophthalmic products alongside our proprietary compounded
formulations, the Access+ team provides consistent, affordable access to therapies that underpin routine ophthalmic care. This foundational
role in the practice workflow — reliable supply, competitive economics, and a breadth of offerings that few competitors can match
— positions Access+ as a steady, cash-generative contributor to Harrow’s broader platform and an important touchpoint for
building long-term customer relationships that extend across our full product portfolio.
I
want to recognize Frank Mullery (and his team) and their work to bring our compounded products business back to full operational footing.
Under Frank’s leadership, we have cleared back orders, rebuilt inventory across key stock-keeping units (SKUs), and in general,
restored customer confidence.
Closing
I
have been hustling alongside our team to build this business for over 14 years. Speaking directly to my fellow stockholders: my confidence
in Harrow’s future has never been higher, and the company we own has never been more valuable. Our growth trajectory has never
been perfectly up and to the right, and I appreciate that this first quarter requires even more patience than normal, but our track record
over the past five years has consistently shown that disciplined execution and a “longer than a single quarterly period”
mindset has created outsized stockholder value—and we are positioned to continue that trend. Based on demand trends we are seeing
and the visibility we have into our forward sales funnel, I am confident in our ability to deliver on our 2026 guidance.
Andrew
and I are actively shaping our next five-year strategic plan, which will take effect beginning in 2027. This will be our fourth such
plan. When we drafted our first, Harrow was little more than an ambitious concept and a stock trading at less than $0.25 a share. Through
every subsequent plan, we have successfully scaled our infrastructure, navigated massive regulatory shifts, integrated highly strategic
acquisitions, and consistently compounded stockholder value. We approach this upcoming 2027-2031 plan with the exact same founder’s
mentality, but now – with vastly superior resources, a larger commercial infrastructure, and the broadest and most clinically valuable
portfolio in our history. Over the next three to five years, we see a clear path to driving VEVYE, TRIESENCE, and IHEEZO to critical
mass. This commercial engine, combined with cash from our creativity in unlocking value from underappreciated assets across our portfolio,
underpins our unified corporate initiative to achieve $250 million in quarterly revenue by the end of 2027.
In
parallel, we are advancing a pipeline of high-impact products—including G-MELT™, which is positioned to become one of the
most important and largest assets in our portfolio, as well as a next-generation TRIESENCE and a another super exciting sedation drug
candidate called YOCHIL™. Alongside this growth, we will continue to pursue disciplined, strategic M&A to further strengthen
and expand our platform. Taken together, Harrow is entering a multi-year period of sustained, scalable growth, with a long runway ahead
to drive meaningful value for our stockholders.
On
behalf of the entire Harrow team, thank you for your continued trust and support.
Sincerely,
Mark
L. Baum
Founder,
Chairman of the Board, and Chief Executive Officer
Nashville,
Tennessee
Index
to Previous Letters to Stockholders
2025
2024
2023
2022
2021
2020
2019
4Q 2025
4Q 2024
4Q 2023
4Q 2022
4Q 2021
4Q 2020
4Q 2019
3Q 2025
3Q 2024
3Q 2023
3Q 2022
3Q 2021
3Q 2020
3Q 2019
2Q 2025
2Q 2024
2Q 2023
2Q 2022
2Q 2021
2Q 2020
1Q 2025
1Q 2024
1Q 2023
1Q 2022
1Q 2021
1Q 2020
Commentary
on First Quarter 2026 Financials
Revenues
of $44.2 million for the first quarter of 2026 represent an 8% decrease over the prior-year first quarter revenues of $47.8 million.
The decline was primarily due to VEVYE gross-to-net reductions tied to our coverage changes and our cash pay program, and a decrease
in sales of our compounded products.
Selling,
general and administrative (“SG&A”) costs for the first quarter of 2026 were $43.2 million compared with $40.5 million
during the same period last year. The increase in SG&A was primarily driven by an increase in headcount and related expenses, along
with an increase in other commercial-related activities.
Research
and development (“R&D”) costs for the first quarter of 2026 were $5.9 million compared with $3.0 million during the same
period last year. The increase in R&D was primarily driven by costs from NDA enabling clinical trials associated with the G-Melt.
GAAP
net loss for the first quarter of 2026 was $27.6 million compared with a GAAP net loss of $17.8 million during the same period last year.
Adjusted
EBITDA (a non-GAAP measure) for the first quarter of 2026 was $(12.7) million compared with Adjusted EBITDA of $(2.0) million during
the same quarter last year.
As
of March 31, 2026, cash and cash equivalents totaled $94.6 million while accounts receivable stood at $101.3 million, compared with cash
and cash equivalents of $66.7 million and accounts receivable of $77.1 million as of March 31, 2025.
GAAP
gross margins were 61% for the first quarter of 2026 and 68% for the first quarter in 2025. The decline in gross margins was primarily
attributable lower net revenue recognized on a per unit basis of VEVYE sold and lower utilization of our compounding facility during
the first quarter of 2026 compared to the same period in 2025.
Additional
product-related revenue figures are reflected in the table below:
For the Three Months Ended
March 31,
2026
2025
IHEEZO
$ 1,851,000
4 %
$ 5,222,000
11 %
VEVYE
20,947,000
47 %
21,516,000
45 %
Other branded products
7,833,000
18 %
956,000
2 %
Other revenues
73,000
0 %
86,000
0 %
Branded revenue, net
30,704,000
69 %
27,780,000
58 %
ImprimisRx revenue, net
13,499,000
31 %
20,051,000
42 %
Total revenues, net
$ 44,203,000
100 %
$ 47,831,000
100 %
We
expect continued growth across our branded portfolio and continue to expect traditional quarter-to-quarter revenue build, enhancing profitability
through operational efficiencies and strategically positioning Harrow for continued leadership in the North American ophthalmic pharmaceutical
sector.
First
Quarter 2026 Financial Overview
GAAP
Operating Results
Selected
financial highlights regarding GAAP operating results for the three months ended March 31, 2026 and 2025 are as follows:
For the Three Months Ended
March 31,
2026
2025
Total revenues
$ 44,203,000
$ 47,831,000
Cost of sales
(17,158,000 )
(15,524,000 )
Gross profit
27,045,000
32,307,000
Selling, general and administrative
43,230,000
40,513,000
Research and development
5,895,000
3,026,000
Total operating expenses
49,125,000
43,539,000
Loss from operations
(22,080,000 )
(11,232,000 )
Interest expense, net
(5,497,000 )
(6,548,000 )
Income tax expense
(25,000 )
-
Net loss
$ (27,602,000 )
$ (17,780,000 )
Net loss per share:
Basic
$ (0.74 )
$ (0.50 )
Diluted
$ (0.74 )
$ (0.50 )
Non-GAAP
Results
Selected
financial highlights regarding Non-GAAP operating results for the three months March 31, 2026 and 2025 are as follows:
For the Three Months Ended
March 31,
2026
2025
Total revenues
$ 44,203,000
$ 47,831,000
Gross margin
61 %
68 %
Net loss
(27,602,000 )
(17,780,000 )
Adjusted EBITDA(1)
(12,659,000
(1,985,000 )
Net loss per share:
Basic
(0.74 )
(0.50 )
Diluted
(0.74 )
(0.50 )
(1) Adjusted
EBITDA is a non-GAAP measure. For additional information, including a reconciliation of Adjusted
EBITDA to net loss, the most directly comparable GAAP measure, see the explanation of non-GAAP
financial measures and reconciliation table at the end of this letter.
FORWARD-LOOKING
STATEMENTS
Management’s
remarks in this stockholder letter include forward-looking statements within the meaning of federal securities laws. Forward-looking
statements are subject to numerous risks and uncertainties, many of which are beyond Harrow’s control, including risks and uncertainties
described from time to time in its Securities and Exchange Commission (“SEC”) filings, such as the risks and uncertainties
related to the Company’s ability to make commercially available its FDA-approved products and compounded formulations and technologies,
and FDA approval of certain drug candidates in a timely manner or at all.
For
a list and description of those risks and uncertainties, please see the “Risk Factors” section of the Company’s Annual
Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Report on Form 10-Q for the three months ended March 31, 2026,
and other filings with the SEC.
Harrow’s
results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections
or forward-looking statements, whether because of new information, future events, or otherwise. This stockholder letter contains time-sensitive
information and is accurate only as of today.
Additionally,
Harrow refers to non-GAAP financial measures in this letter, specifically Adjusted EBITDA. A reconciliation of Adjusted EBITDA with the
most directly comparable GAAP measure, net loss is included at the end of this letter.
No
compounded formulation is FDA-approved. All compounded formulations are customizable. Other than drugs compounded at a registered outsourcing
facility, all compounded formulations require a prescription for an individually identified patient consistent with federal and state
laws.
All
trademarks, service marks, and trade names included or referenced in this publication are the property of their respective owners.
Non-GAAP
Financial Measures
In
addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP),
which are presented and discussed above, management also utilizes Adjusted EBITDA, an unaudited financial measure that is not calculated
in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted
EBITDA is considered a “non-GAAP” financial measure within the meaning of Regulation G promulgated by the SEC. Management
believes that this non-GAAP financial measure reflects an additional way of viewing aspects of the Company’s operations that, when
viewed with GAAP results, provides a more complete understanding of the Company’s results of operations and the factors and trends
affecting its business. Management believes Adjusted EBITDA provides meaningful supplemental information regarding the Company’s
performance because (i) it allows for greater transparency with respect to key metrics used by management in its financial and operational
decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to
the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii)
it is used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA,
and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding
measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated
may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies,
including the Company’s competitors.
Adjusted
EBITDA
The
Company defines Adjusted EBITDA as net income (loss), excluding the effects of stock-based compensation and expenses, impairment of intangible
assets, interest, taxes, depreciation, amortization, investment loss, net, and, if any and when specified, other non-recurring income
or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net income (loss).
Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net income (loss) as a measure of operating
performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.
The
following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net loss, for the three months
ended March 31, 2026 and for the same period in 2025:
For the Three Months Ended
March 31,
2026
2025
GAAP net loss
$ (27,602,000 )
$ (17,780,000
Stock-based compensation and expenses
3,837,000
4,556,000
Interest expense, net
5,497,000
6,548,000
Income tax expense
25,000
-
Depreciation
455,000
465,000
Amortization of intangible assets
5,129,000
4,226,000
Adjusted EBITDA
$ (12,659,000 )
$ (1,985,000 )
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May 11, 2026
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HARROW, INC.
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DE
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Burton Hills Blvd.
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