Exhibit
99.1

Harrow
Announces Second Quarter 2026 Financial Results
Second
Quarter 2026 and Selected Highlights:
| ● | Quarterly
revenue of $70.7 million, an increase of 60% sequentially, and 11% year over year |
| ● | Reiterated
full-year 2026 financial guidance of $350 million to $365 million in revenue and $80 million
to $100 million in Adjusted EBITDA (a non-GAAP measure) |
| ● | VEVYE®
delivered quarterly revenue of $29.4 million, up approximately 40% sequentially and approximately
58% year over year, with continued prescription, prescriber, and market-share growth |
| | ● | VEVYE
secured another coverage win, after gaining expanded formulary coverage with a top-three
national commercial pharmacy benefit manager, effective August 1, 2026 |
| ● | IHEEZO®
delivered quarterly revenue of $15.6 million, and achieved record quarterly unit demand,
with unit demand increasing 44% sequentially and 34% year over year |
| ● | TRIESENCE®
delivered record quarterly unit demand, increasing 39% sequentially and 162% year over year |
| ● | Announced
the acquisition of TYRVAYA®, which is expected to close during the second
half of 2026 |
| ● | Cash
and cash equivalents of $83.9 million as of June 30, 2026 |
NASHVILLE,
Tenn., August 10, 2026 – Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America,
announced results for the second quarter ended June 30, 2026. The Company also posted its second-quarter Letter to Stockholders and corporate
presentation in 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.
“We
spent the first half of 2026 building demand and positioning the business to achieve our 2026 and 2027 financial objectives. The second
half of 2026 is about converting that demand into accelerating revenue growth and profitability,” said Mark L. Baum, Chairman and
Chief Executive Officer of Harrow. “Over the past six months, we expanded our commercial organization, strengthened our portfolio,
improved pricing across key products, launched BYOOVIZ®, advanced multiple clinical programs, and announced the acquisition
of TYRVAYA. VEVYE delivered record quarterly revenue while improving its underlying economics, and momentum continues to build, supported
by our recent coverage win that went into effect August 1. IHEEZO achieved the strongest commercial quarter in its history despite
the loss of pass-through reimbursement, and TRIESENCE continued to generate exceptional demand growth – reinforcing our conviction
that physician demand continues to strengthen across our portfolio.”
Baum
continued, “As we enter the second half of the year, the business looks fundamentally different than it did just a few months ago:
IHEEZO’s pricing improvements are now in effect, IHEEZO’s channel inventories have normalized, VEVYE’s updated business
rules have been fully implemented, BYOOVIZ has launched, and TYRVAYA is expected to join our portfolio later this year. Our commercial
organization, which already expanded this year (and is now helping to fueling our growth), will increase further with the addition of
experienced eye care sales professionals from Viatris. Together, these steps position us to convert the demand we’ve built into
meaningful revenue growth and profitability. I believe Harrow has reached an important inflection point. The heavy lifting required to
position the business for accelerated growth has largely been completed. The table is set. Now it’s about execution. Based on what
we’re seeing across the business today, I remain confident in our ability to deliver our full-year guidance of $350 million to
$365 million in revenue and $80 million to $100 million in adjusted EBITDA.”
Harrow Announces Second Quarter 2026 Financial Results Page 2 August 10, 2026 |
Key
Second Quarter Commercial Metrics:
VEVYE:
| ● | Total
prescriptions (TRx) increased approximately 21% sequentially, ahead of branded dry eye disease
sequential market growth of 14% |
| ● | New
prescriptions (NRx) increased approximately 4% sequentially |
| ● | Unique
prescribers increased approximately 15% sequentially |
| ● | Branded
TRx market share expanded to 14.6%, nearly doubling from 7.8% one year ago |
IHEEZO:
| ● | Unit
demand of 65,477 units, up 44% sequentially and 34% year-over-year — the product’s
highest unit volume quarter to date, achieved despite the April 1, 2026 loss of pass-through
reimbursement status for cataract surgery |
| ● | Total
ordering accounts reached 224, up 32% year-over-year, with 62 accounts placing their first-ever
IHEEZO order in the quarter — the strongest new-account quarter since launch |
| ● | Reorder
rate of approximately 85.5%, reflecting durable account retention and continued strength
in the retina segment |
| ● | Effective
July 1, 2026, IHEEZO net price per unit improved by approximately 25% |
| ● | Channel
inventories have normalized, and the Company expects reported revenue to more closely reflect
underlying demand going forward |
TRIESENCE:
| ● | Unit
demand of 14,529 units, the strongest quarter ever — up 39% sequentially and 162% year-over-year |
| ● | Total
ordering accounts reached 805, a net addition of 69 accounts sequentially, with ocular surgery
accounts representing 54% of Q2 unit volume |
| ● | May
2026 was the strongest single month in the product’s commercial history, up 151% versus
May 2025 |
Business
Highlights:
VEVYE
Expanded Coverage:
| ● | Effective
August 1, 2026, VEVYE gained expanded formulary coverage with a top-three national commercial
pharmacy benefit manager, representing a meaningful expansion in patient access and another
important milestone in the Company’s long-term growth strategy for VEVYE. The Company
also expects an increasing proportion of VEVYE prescriptions to shift to the commercial channel
over the balance of 2026. |
TYRVAYA
Acquisition:
| ● | Expands
Harrow’s dry eye disease portfolio with a highly complementary and synergistic therapy |
| ● | Expected
to expand Harrow’s commercial organization with new experienced dry eye sales representatives |
| ● | Creates
one of ophthalmology’s most comprehensive branded dry eye disease portfolios |
| ● | Creates
additional opportunities to expand VEVYE adoption across new and existing accounts |
| ● | Expected
to contribute more than $30 million in revenue in 2027, with revenue expected to exceed the
incremental operating costs required to support the business |
| ● | Given
the anticipated timing of the transaction close and integration into Harrow’s portfolio,
TYRVAYA is expected to contribute modestly to 2026 revenue |
-END-
Harrow Announces Second Quarter 2026 Financial Results Page 3 August 10, 2026 |
BYOOVIZ
Launch:
| ● | Successfully
launched BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS®, expanding
Harrow’s retina portfolio and marking the Company’s entry into the U.S. retinal
anti-VEGF market. BYOOVIZ complements Harrow’s growing retina franchise alongside IHEEZO®
and TRIESENCE®, with OPUVIZ™ (aflibercept biosimilar) expected to further
expand the portfolio in 2027. BYOOVIZ launched in July 2026, and the Company expects revenue
to build over the balance of the year. |
Pipeline
and Regulatory Highlights:
| ● | Prospective
Launches: The Company expects to launch at least one new product every year through 2029,
within its existing cost structure and commercial footprint. |
| ● | G-MELT:
The FDA has granted Harrow a pre-NDA meeting, an important milestone that will help finalize
the Company’s regulatory strategy as it works toward an NDA submission. |
| ● | IHEEZO
(QUELL): Topline data from QUELL, a prospective, randomized, multi-center clinical trial
evaluating IHEEZO in patients undergoing intravitreal injections, are expected in the fourth
quarter of 2026. |
| ● | TRIESENCE:
The Company’s Phase 3 trial evaluating TRIESENCE for the treatment of ocular inflammation
and pain following cataract surgery is on track to fully enroll in 2026, with topline data
expected in early 2027. |
| ● | NATACYN®:
The first patients were enrolled in an investigator-initiated clinical study during the second
quarter, with topline data expected in the fourth quarter of 2026. |
| ● | YOCHIL™:
The Company completed its End-of-Phase 2 meeting with the FDA and is incorporating the Agency’s
feedback into refinements of its Phase 3 study design and protocol. |
| ● | IOPIDINE®:
A permanent J-code went into effect on July 1, 2026, removing a reimbursement barrier that
the Company believes has constrained broader utilization. |
| ● | VERKAZIA®:
Successfully re-launched with growing prescription volumes. |
Second
Quarter 2026 Financial Results:
| | |
For
the Three Months Ended
June 30, | | |
For
the Six Months Ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Total
revenues | |
$ | 70,661,000 | | |
$ | 63,742,000 | | |
$ | 114,864,000 | | |
$ | 111,573,000 | |
| Gross
margin | |
| 71 | % | |
| 75 | % | |
| 67 | % | |
| 72 | % |
| Net
(loss) income | |
| (17,270,000 | ) | |
| 4,995,000 | | |
| (44,872,000 | ) | |
| (12,785,000 | ) |
| Adjusted
EBITDA(1) | |
| (1,232,000 | ) | |
| 17,006,000 | | |
| (13,891,000 | ) | |
| 15,021,000 | |
| Net
income (loss) per share: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| (0.46 | ) | |
| 0.14 | | |
| (1.20 | ) | |
| (0.35 | ) |
| Diluted | |
| (0.46 | ) | |
| 0.13 | | |
| (1.20 | ) | |
| (0.35 | ) |
| (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. |
-END-
Harrow Announces Second Quarter 2026 Financial Results Page 4 August 10, 2026 |
Conference
Call and Webcast
Harrow
will host a conference call to discuss the results at 8:00 a.m. ET on Tuesday, August 11, 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.
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, or complete pending acquisitions on terms and in the timeframe
expected, or at all, 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; and 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, subsequent Quarterly Reports on Form 10-Q and other filings with
the SEC. Such documents may be read free of charge on the SEC’s website 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 Second Quarter 2026 Financial Results Page 5 August 10, 2026 |
HARROW,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| | |
June 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| ASSETS | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 83,889,000 | | |
$ | 72,927,000 | |
| All other current assets | |
| 145,418,000 | | |
| 138,823,000 | |
| Total current assets | |
| 229,307,000 | | |
| 211,750,000 | |
| All other assets | |
| 187,509,000 | | |
| 187,732,000 | |
| TOTAL ASSETS | |
$ | 416,816,000 | | |
$ | 399,482,000 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| Current liabilities | |
$ | 102,171,000 | | |
$ | 96,302,000 | |
| Loans payable, net of unamortized debt discount | |
| 292,379,000 | | |
| 243,184,000 | |
| All other liabilities | |
| 7,421,000 | | |
| 7,905,000 | |
| TOTAL LIABILITIES | |
| 401,971,000 | | |
| 347,391,000 | |
| TOTAL STOCKHOLDERS’ EQUITY | |
| 14,845,000 | | |
| 52,091,000 | |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 416,816,000 | | |
$ | 399,482,000 | |
-END-
Harrow Announces Second Quarter 2026 Financial Results Page 6 August 10, 2026 |
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | |
For the Three Months Ended
June 30, | | |
For the Six Months Ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Total revenues | |
$ | 70,661,000 | | |
$ | 63,742,000 | | |
$ | 114,864,000 | | |
$ | 111,573,000 | |
| Cost of sales | |
| 20,298,000 | | |
| 16,230,000 | | |
| 37,456,000 | | |
| 31,754,000 | |
| Gross profit | |
| 50,363,000 | | |
| 47,512,000 | | |
| 77,408,000 | | |
| 79,819,000 | |
| Selling, general and administrative | |
| 53,298,000 | | |
| 33,235,000 | | |
| 96,528,000 | | |
| 73,748,000 | |
| Research and development | |
| 8,072,000 | | |
| 2,868,000 | | |
| 13,967,000 | | |
| 5,894,000 | |
| Total operating expenses | |
| 61,370,000 | | |
| 36,103,000 | | |
| 110,495,000 | | |
| 79,642,000 | |
| (Loss) income from operations | |
| (11,007,000 | ) | |
| 11,409,000 | | |
| (33,087,000 | ) | |
| 177,000 | |
| Total other expense, net | |
| (6,263,000 | ) | |
| (6,414,000 | ) | |
| (11,760,000 | ) | |
| (12,962,000 | ) |
| Income tax expense | |
| - | | |
| - | | |
| 25,000 | | |
| - | |
| Net (loss) income attributable to Harrow, Inc. | |
$ | (17,270,000 | ) | |
$ | 4,995,000 | | |
$ | (44,872,000 | ) | |
$ | (12,785,000 | ) |
| Net (loss) income per share: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.46 | ) | |
$ | 0.14 | | |
$ | (1.20 | ) | |
$ | (0.35 | ) |
| Diluted | |
$ | (0.46 | ) | |
$ | 0.13 | | |
$ | (1.20 | ) | |
$ | (0.35 | ) |
-END-
Harrow Announces Second Quarter 2026 Financial Results Page 7 August 10, 2026 |
HARROW,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
| | |
For
the Six Months Ended
June 30, | |
| | |
2026 | | |
2025 | |
| Net
cash (used in) provided by: | |
| | | |
| | |
| Operating
activities | |
$ | (18,747,000 | ) | |
$ | 18,865,000 | |
| Investing
activities | |
| (18,737,000 | ) | |
| (505,000 | ) |
| Financing
activities | |
| 48,446,000 | | |
| (12,644,000 | ) |
| Net
change in cash and cash equivalents | |
| 10,962,000 | | |
| 5,716,000 | |
| Cash
and cash equivalents at beginning of the period | |
| 72,927,000 | | |
| 47,247,000 | |
| Cash
and cash equivalents at end of the period | |
$ | 83,889,000 | | |
$ | 52,963,000 | |
-END-
Harrow Announces Second Quarter 2026 Financial Results Page 8 August 10, 2026 |
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 measure 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 (loss) income, 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 (loss) income.
Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net (loss) income 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) income, for the
three and six months ended June 30, 2026 and for the same periods in 2025:
-END-
Harrow Announces Second Quarter 2026 Financial Results Page 9 August 10, 2026 |
HARROW,
INC.
RECONCILIATION
OF NET LOSS TO ADJUSTED EBITDA
| | |
For
the Three Months Ended
June 30, | | |
For
the Six Months Ended
June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP
net (loss) income | |
$ | (17,270,000 | ) | |
$ | 4,995,000 | | |
$ | (44,872,000 | ) | |
$ | (12,785,000 | ) |
| Stock-based
compensation and expenses | |
| 3,788,000 | | |
| 875,000 | | |
| 7,625,000 | | |
| 5,431,000 | |
| Interest
expense, net | |
| 6,263,000 | | |
| 6,408,000 | | |
| 11,760,000 | | |
| 12,956,000 | |
| Income
tax expense | |
| - | | |
| - | | |
| 25,000 | | |
| - | |
| Depreciation | |
| 460,000 | | |
| 496,000 | | |
| 915,000 | | |
| 961,000 | |
| Amortization
of intangible assets | |
| 5,527,000 | | |
| 4,226,000 | | |
| 10,656,000 | | |
| 8,452,000 | |
| Investment
loss, net | |
| - | | |
| - | | |
| - | | |
| - | |
| Other
expense, net | |
| - | | |
| 6,000 | | |
| - | | |
| 6,000 | |
| Adjusted
EBITDA | |
$ | (1,232,000 | ) | |
$ | 17,006,000 | | |
$ | (13,891,000 | ) | |
$ | 15,021,000 | |
The
Company is unable to provide a reconciliation of projected Adjusted EBITDA to expected results due to the unknown effect, timing and
potential significance of expenses and the tax effect of such expenses.
-END-
Exhibit 99.2

28th
Quarterly Letter to Stockholders
August
10, 2026
Dear
Harrow Stockholders:
The
first half of 2026 was about driving demand and fine-tuning business rules; the second half is about converting growing demand
into revenue and profits. The balance of this Letter to Stockholders describes why I believe we are set up well – for not only
the second half of 2026, but for many years to come, including the opportunity to achieve our ambitious company-wide goal of a $250 million
revenue quarter by the end of 2027. While this goal will be difficult to achieve, we see a pathway there and the entire Harrow Family
is focused on maximizing productivity to give us the best chance of success. It’s now time for commercial execution!
Harrow
delivered second quarter 2026 revenue of $70.7 million, a 60% sequential increase over the $44.2 million we reported in the first quarter.
To bridge to our 2026 guidance and support what we intend to achieve in 2027, we’ve expanded our commercial organization (including
the teams selling every Harrow product), strengthened our product portfolio, improved net pricing for VEVYE and IHEEZO, fine-tuned our
access programs, advanced our pipeline, and built the infrastructure that will support our next phase of growth. Recent data demonstrates
that those investments are starting to show up across the business, positioning Harrow for what I believe will be a significantly stronger
second half of 2026.
IHEEZO
will be a major contributor in the second half of 2026, and here are a few IHEEZO data points of merit:
| ● | As
of July 1, IHEEZO’s net price improved by approximately 25%; |
| ● | Despite
losing pass-through reimbursement status on April 1, a headwind that eliminated all our ambulatory
surgery center (ASC) volume virtually overnight, IHEEZO posted its best quarter ever for
unit demand in Q2 2026, with units up 44% sequentially and 34% year over year, driven by
ongoing growth in retina and in-office procedures; and |
| ● | During
the second quarter, we added a record number of new IHEEZO accounts. |
These
data are not the results of a product navigating a headwind. These are the results of a product that has found its footing and is beginning
to run. Fortunately, every IHEEZO metric we track — new accounts, unit volume, pricing, and initial clinical data — is moving
in the right direction. We expect that to translate into materially higher IHEEZO revenue in Q3 and Q4, compared to the first two quarters
of the year.
Beyond
IHEEZO, other drivers of growth for the second half of 2026, such as VEVYE, should benefit from a fully ramped commercial organization
following the doubling of our sales force, a recent major coverage win that took effect on August 1, the addition of TYRVAYA®
in our portfolio, as well as new initiatives designed to expand physician utilization and accelerate prescription growth, which I discuss
in more detail below.
TRIESENCE®
continues to deliver exceptional unit demand growth both year over year and sequentially, and with our surgical sales force now tripled,
we believe the product is well positioned to build on that momentum.
We
also recently launched BYOOVIZ®, marking Harrow’s entry into the retinal biologics market and further strengthening
our rapidly expanding retina franchise.
Across
our specialty portfolio, IOPIDINE® now has a permanent J-code, removing an important reimbursement barrier; VERKAZIA®
has been successfully re-launched; and our broader product family continues to benefit from deep physician relationships, expanding patient
access, and a commercial organization that is increasingly able to drive growth across multiple products simultaneously.
As
you now hopefully know, we strengthened our dry eye disease (DED) leadership position through our recent agreement to acquire the global
rights to TYRVAYA from Viatris. Together with VEVYE, TYRVAYA broadens the solutions we can offer physicians while increasing the productivity
and reach of our commercial organization. (I’ll discuss the strategic rationale for this acquisition later in this Letter to Stockholders.)
As
we describe in more detail in our Corporate Presentation, demand trends across our key growth drivers remain strong, commercial execution
continues to strengthen, and we are seeing the early benefits of the investments we made during the first half of the year. As a result,
we are reiterating our full-year 2026 guidance of $350 million to $365 million in revenue and $80 million to $100 million in Adjusted
EBITDA.
I
recognize that our 2026 financial guidance implies second-half revenue of more than double what we delivered in the first half. We sized
that ramp deliberately:
| ● | VEVYE
gross-to-net is improving, prescriptions are ramping and should accelerate as more patients
satisfy their annual deductibles, and we just got another major coverage win that became
effective August 1, further broadening patient access; |
| ● | IHEEZO’s
improved net pricing took effect July 1; |
| ● | Channel
inventories – system-wide – are now normalized; |
| ● | Our
expanded sales teams are approaching full productivity and will expand further upon closing
of the TYRVAYA deal; |
| ● | Large
TRIESENCE accounts we have been working on bringing online are now ordering; |
| ● | BYOOVIZ
is launched, and revenues will build in the second half; |
| ● | With
full formulary availability, sales of our compounded products are now recovering; and |
| ● | Given
the anticipated timing of the TYRVAYA transaction close and its integration into our portfolio,
it should contribute to revenue in 2026. |
The
above factors (and others) are building blocks supporting a much larger second half, and they are in place. From here, we need to deliver
on the variable we control – commercial execution. Based on what we are seeing today, I expect our team to deliver on our
2026 commitments.
Relentlessly
Committed to U.S. Dry Eye Leadership
The
U.S. dry eye market is a core long-term value driver for Harrow. This is a large, highly underserved market that we intend to relentlessly
compete in – with an unrivaled product set, coupled with an access and distribution model that ophthalmologists and optometrists
are increasingly embracing.
Key
performance indicators for VEVYE demonstrate building momentum. I want to spend some time walking through the numbers in detail, because
the story behind them matters as much as the numbers themselves. The broader dry eye disease market behaved as we expected during the
second quarter, rebounding from a seasonally softer first quarter. Total branded prescription volume increased approximately 14% sequentially,
and VEVYE once again outperformed the category, with total prescriptions (TRx) growing approximately 21% sequentially and, despite significant
business rule changes in April, new prescriptions (NRx) still increased approximately 4% sequentially. Just as encouraging, physician
adoption continued to broaden, with unique prescribers increasing approximately 15% during the quarter, validating our belief that there
was an untapped reservoir of VEVYE prescribers that our expanded field force is now enabling us to reach. By the end of June, VEVYE’s
market share of total branded prescriptions had reached 14.6%, up from 14% at the end of March, and 7.8% a year ago, further extending
its TRx share gains and continuing to march towards our primary goal of establishing VEVYE as the number one prescribed branded anti-inflammatory
in the U.S. dry eye disease market.
VEVYE
generated $29.4 million in revenue during the quarter, representing approximately 40% sequential growth from the first quarter and nearly
58% growth versus the prior-year second quarter. More importantly, those results confirmed that the amendments to our business rules
we discussed on our first quarter 2026 conference call are largely working as we intended.
Recall
that those changes were designed to improve the economics of VEVYE while preserving patient access and prescription growth that are fundamental
to its long-term success. The results were on target: as average selling price improved sequentially and VEVYE delivered record quarterly
revenue while continuing to grow both new and total prescriptions. In other words, we strengthened the economics of the business without
sacrificing demand or patient access.
As
we discussed on our last earnings call, expanding VEVYE coverage remains a top priority. I’m happy to share that, effective August
1, 2026, VEVYE had another major coverage win, gaining expanded formulary access with one of the nation’s three largest commercial
pharmacy benefit managers, increasing access to millions of new commercial lives. This represents a meaningful improvement in patient
access, as VEVYE previously had little coverage under these formularies – and in many cases was blocked. Importantly, this new
coverage will operate under the same business rules we implemented in late-April. We expect this expanded access to support continued
VEVYE prescription growth and believe it represents another important milestone in our long-term strategy to ensure access to as many
patients in need as possible.
Commercially,
we’ve recently implemented two initiatives to further strengthen VEVYE tailwinds:
| ● | First,
we replaced our $0 first-fill program with physician sampling. The $0 first-fill program
carried costs with no corresponding revenue. Physician sampling is a cleaner, more effective
way to drive physician adoption and new patient starts, and patient acquisition beginning
this year. |
| ● | Second,
as many of you have seen on social media, we’ve also launched our PrioritEYEs™
initiative, where our sales representatives are directly challenging ophthalmologists and
optometrists to rethink where VEVYE fits in their treatment approach. Inflammation is a central
driver across the dry eye disease continuum, and despite the available treatments, many patients
continue to experience inflammation-driven signs and symptoms that go unaddressed. We believe
VEVYE, with its rapid onset of action, durable efficacy, excellent tolerability, and differentiated
water-free formulation, is uniquely positioned to become the anti-inflammatory foundation
of dry eye disease treatment. Our representatives are having that conversation every day,
practice by practice, with the goal of moving VEVYE earlier in the treatment paradigm. |
Early
feedback from physicians has been encouraging, and I believe both initiatives will support durable prescription growth over time.
Looking
ahead, VEVYE is entering its strongest commercial position since launch. We expect an increasing proportion of prescriptions to return
to the commercial channel as more patients satisfy their annual deductibles throughout the second half of the year. Combined with the
expanded sales force, expanded coverage, and the commercial initiatives we’ve implemented, I believe VEVYE enters the second half
of 2026 with multiple tailwinds supporting both prescription growth and profitability.
Lastly,
because we’ve received several questions about it: third-party prescription data services like Symphony Health and IQVIA Xponent,
standing alone, are not a complete proxy for VEVYE demand right now. That is why the metrics discussed earlier in this Letter to Stockholders
include IQVIA data and our proprietary internal data, capturing dispensing activity those services do not fully reflect. Symphony tracking
was directionally accurate last year, but from what we have seen, that data has become progressively less representative as an increasing
percentage of VEVYE prescriptions are fulfilled through our specialty pharmacy partners. If you’re tracking VEVYE through Symphony
or IQVIA alone, you’re not seeing a full picture of VEVYE — you’re seeing an increasingly incomplete subset of it.
Before
I turn to IHEEZO, I’d like to comment on our recently announced acquisition of TYRVAYA because while the transaction itself is
certainly exciting, what excites me even more is what comes next. TYRVAYA expands our commercial organization by adding Viatris’
experienced dry eye disease sales representatives, and it naturally fits within the commercial infrastructure we’ve already built.
VEVYE
remains the cornerstone of our dry eye disease franchise and is, we believe, the therapy that will be appropriate for most patients.
That said, TYRVAYA provides physicians with a differentiated trifecta prescription DED option for patients: (1) it has zero contraindications;
(2) it has zero ocular adverse events; and (3) it has zero warnings on its label. TYRVAYA’s most common adverse reaction is transient
sneezing, which is a manageable trade-off given the tolerability profile of the other basal tear-producing product in the category. Overall,
we are thrilled to broaden our offering without changing VEVYE’s strategic role.
The
synergy between the products is real. Every TYRVAYA prescriber call becomes an opportunity to introduce VEVYE, and every VEVYE relationship
becomes an opportunity to discuss TYRVAYA. What I love most about the deal is that these products are complementary (i.e., they can be
prescribed together). TYRVAYA allows us to offer a better solution to promote during every physician interaction, as it deepens our relationships
with existing customers, expands our reach into new accounts, and strengthens what we believe is the leading dry eye disease franchise
in eye care.
From
a financial perspective, the TYRVAYA deal is exceptional. The acquisition will be funded from cash on hand — no dilution to stockholders
and no incremental interest costs. The way the terms were constructed, if we make any one-time net sales-driven milestone payments, that
is a signal of success – and would mean a higher ROI on the deal. We expect TYRVAYA to contribute more than $30 million
in revenue during 2027, with revenue exceeding the incremental operating costs required to support the business. More importantly, owning
both VEVYE and TYRVAYA creates leverage that neither product could achieve independently. By expanding our commercial reach and giving
physicians a more comprehensive dry eye disease portfolio, I believe this acquisition will accelerate the long-term growth of VEVYE while
further strengthening Harrow’s brand and leadership position in the U.S. dry eye disease market.
With
TYRVAYA added to our portfolio, there is a new slide (slide 15) in our updated corporate presentation that depicts how we have strategically
constructed our presence in the U.S. dry eye and related ocular surface disease market. You will see how we think about the U.S. DED
market and where and how we intend to compete and win. It’s worth taking a look at.
One
final item on TYRVAYA: I made a point to highlight that we acquired the global rights to TYRVAYA, which is approved in the US
and China, and has marketing authorizations under regulatory review in five other countries. I did want to clarify that we intend to
stay laser-focused on what we know best – the U.S. market – and will seek competent partners for rights outside the United
States.
IHEEZO:
The Inflection Point
No
product in our portfolio has exceeded my expectations the way IHEEZO has, and things seem to be getting better. In the second quarter
of 2026, IHEEZO unit demand reached 65,477 units — a 44% increase over the prior quarter and a 34% increase over the prior-year
second quarter. While those numbers are impressive on their own, what makes them extraordinary is the context in which they were achieved,
namely during the period when we lost reimbursement in the ASC. Thanks to our incredible sales team, IHEEZO growth was driven by in-office
procedures – the setting where IHEEZO’s value proposition is strongest, our reimbursement is most durable, and thus where
our commercial team has been focused.
The
purchasing account data tells the same story. We exited Q2 with 224 total ordering accounts, up 32% year over year. 62 of those accounts
placed their first-ever IHEEZO order during the quarter — the single strongest quarter for new account acquisition since the product’s
launch. That does not happen by accident either. It happens when physicians talk to other physicians, when word spreads through a specialty
that a product is changing how procedures feel for patients, and when a commercial team earns trust – one practice at a time. Paired
with our trailing twelve-month reorder rate of approximately 85.5% (i.e., over the past 12 months, more than eight out of ten practices
that adopted IHEEZO placed a repeat order), the compounding effect on the account base is becoming a powerful and durable revenue engine.
That
commercial momentum translated into stronger financial performance than we had anticipated. During the quarter, we successfully worked
through the remaining accumulated in-channel inventory while continuing to experience robust underlying demand, allowing IHEEZO to deliver
second-quarter revenue of $15.6 million, which was above our internal expectations. To be clear, reported revenue remains below the $18.3
million recorded in the prior-year second quarter, a comparison that reflects the loss of pass-through reimbursement in the ASC and our
previously forecasted drawdown of in-channel inventory rather than underlying demand. With channel inventories now normalized, reported
revenue should increasingly mirror the strength of the underlying business. With the drawdown behind us and improved net pricing effective
July 1, second-half IHEEZO revenue is expected to look materially different.
I
want to add some color from the recent American Society of Retina Specialists (ASRS) Annual Meeting. There, Dr. Dang presented encouraging
interim clinical data evaluating IHEEZO in patients undergoing intravitreal injections. Compared with subconjunctival lidocaine, IHEEZO
demonstrated promising early trends toward reduced post-procedure pain, an improved patient experience, and fewer ocular symptoms through
24 hours following injection. While these findings represent an early look at a relatively small patient population, they reinforce our
enthusiasm for QUELL—our prospective, randomized, multi-center clinical trial being conducted under an IND—with topline data
expected in the fourth quarter of 2026. Retina is already one of our fastest-growing areas, and this data could add fuel to that momentum.
The
second half of 2026 is set up to be IHEEZO’s best commercial period to date — by a wide margin. We have introduced our new
5-unit packaging, which is purpose-built for the high-volume practices that have adopted the product most enthusiastically. We also achieved
a meaningful improvement in our net pricing for IHEEZO that went into effect on July 1, 2026, representing an estimated 25% improvement
in net price per unit relative to prior periods. This pricing improvement, combined with the volume trajectory we are seeing, sets up
a powerful earnings contribution from IHEEZO beginning in Q3.
In
sum, we are still early in IHEEZO’s lifecycle. The retina opportunity alone is enormous and largely untapped. Moreover, we’ve
recently expanded into the broader in-office procedure market, which has added 2.5+ million additional annual procedures to our addressable
opportunity. IHEEZO has the clinical profile, the reimbursement infrastructure, and the GPO relationships to achieve a leading position
in every setting in which anesthesia is used in eye care. I believe the next two years of IHEEZO’s commercial trajectory will look
very different from the last two — and the last two were already impressive.
TRIESENCE:
Hitting Its Stride
TRIESENCE
momentum continues. In the second quarter of 2026, TRIESENCE delivered 14,529 units — its strongest quarter ever, up 39% sequentially
from the first quarter and up 162% year over year from the second quarter of 2025. May 2026 was the strongest single month in the product’s
commercial history, up 151% versus May of last year. To put that growth in perspective: TRIESENCE is generating more than two-and-a-half
times the unit volume it was twelve months ago, in a market where physician adoption is in the very early innings – in fact, I
would characterize the state of play as the teams still warming up and taking batting practice.
Account
activation data reinforces the story. TRIESENCE exited Q2 2026 with 805 total ordering accounts — the highest level since launch,
adding a net 69 new accounts sequentially from the 736 that ordered in Q1. Notably, 54% of Q2 unit volume came from ocular surgery accounts,
demonstrating uptake in this key use case and foreshadowing where we expect future growth to come from.
Because
of the growth we are experiencing, we made a meaningful investment in the surgical team during the second quarter by tripling the size
of our dedicated surgical sales organization. (Keep in mind that this is the same team we anticipate would be selling the G-MELT™,
pending marketing approval.) Most of those new representatives joined during the quarter, so the full productivity benefit has not yet
been realized. We expect those investments to begin paying dividends in the second half of 2026 as our expanded commercial team gains
experience, deepens physician relationships, and further broadens awareness of TRIESENCE across the surgical community.
The
core reason TRIESENCE is being adopted is the growing awareness of the outstanding clinical outcomes the product is delivering. That
is what really excites me. For over a decade, I’ve had a near professional obsession with reducing or eliminating patient exposure
to eye drops. TRIESENCE is part of how I believe this can be accomplished. And we are investing to validate that – in the form
of a Phase 3 clinical trial evaluating TRIESENCE for the treatment of ocular inflammation and pain following cataract surgery. This study
is underway and on track to fully enroll this year and report topline data in early 2027. If successful, this study has the potential
to meaningfully expand the product’s addressable market and further strengthen the financial value of this compelling franchise.
Looking
ahead, we expect TRIESENCE unit demand and revenue to continue growing. However, the true financial opportunity is expected to expand
with the anticipated launch, subject to regulatory approval, of our next-generation product candidate in late 2028 or 2029. Such an approval
would be a transformational catalyst for the TRIESENCE brand — creating a differentiated commercial profile with greater pricing
flexibility and meaningfully stronger net product profitability.
When
I step back and look at TRIESENCE, I see a product and brand that was completely calcified when we acquired it in November of 2023. Our
team saw the opportunity, invested in restoring the value we saw, and now ensures the supply of a product that truly delivers value for
patients. Today, TRIESENCE has multiple drivers of long-term value creation, including growing physician demand that is accelerating
rather than plateauing, an expanded commercial organization that has not yet reached full productivity, a potential label expansion supported
by our Phase 3 program, and a highly attractive next-generation opportunity ahead. We are investing behind each of those catalysts because
we believe TRIESENCE remains in the early innings of what will become a very significant franchise for Harrow.
BYOOVIZ:
Building Out Our Retina Platform
BYOOVIZ
is off to an encouraging start. Following our July 2026 launch, I am thrilled about what BYOOVIZ represents. Our retina team now has
another important product to discuss with physicians, increasing the productivity of every customer interaction while further strengthening
our position within the retina community. Just as importantly, BYOOVIZ represents another step toward building a broader, more diversified
retina franchise – one capable of delivering long-term growth through multiple products rather than relying on any single asset.
We believe that commercial leverage – not simply another product launch – will create meaningful long-term value as our retina
franchise continues to expand.
We
are only one month into the launch. It is still early, but the foundation is in place, physician interest has been encouraging, and we
believe BYOOVIZ is well positioned to become another important contributor to Harrow’s expanding retina franchise.
Keep
in mind, BYOOVIZ is also only the first of the two ophthalmic biosimilars we acquired from Samsung Bioepis, and we expect to launch OPUVIZ™,
our EYLEA-referenced biosimilar, in the United States in 2027, further broadening our comprehensive retina portfolio.
G-MELT:
Likely Our Biggest Opportunity
I
believe G-MELT, if approved, will not only make a tremendous impact on patients’ lives, but it also has the possibility become
the largest revenue driver for our company. I don’t make that statement lightly. I make it because, after spending considerable
time with the clinical data, evaluating the market opportunity, talking to our customers, and observing the current and likely long-term
market dynamics, I have never been more convinced of this program’s long-term potential.
My
conviction is grounded in a real, and I believe underappreciated, market problem. At this year’s American Society of Retina Specialists
meeting, the market problem was on full display at our advisory board meeting and during dozens of conversations with retina specialists:
the same theme came up again and again – practices are struggling to secure reliable anesthesia coverage for their surgical procedures,
with many now paying “stipends” out of their own facility and global surgical fees just to keep anesthesia services available.
We
believe this “anesthesia/sedation dilemma” is not a short-term event but will be a reality that eye surgeons (and others)
will be dealing with for many years to come. G-MELT, if FDA-approved, could be part of the solution to this growing problem. The bottom
line, though, is that in nearly 15 years of running this company, I have never seen as consistently positive a reaction to a Harrow product
candidate. This is a present, material need, and I believe we’re positioned to solve it.
Related
to the G-MELT development program, I am excited to let our stockholders know that the FDA has granted us a pre-NDA meeting, an important
milestone that will help finalize our regulatory strategy as we work toward an NDA submission. Our clinical team has done an amazing
job since we acquired this program in November of last year, and I am incredibly proud of the progress we’ve made to position G-MELT
for what we believe should eventually be a highly successful launch.
I
always like to think about things from a patient’s perspective as well. And from that standpoint, who would prefer an IV to an
orally disintegrating tablet? Certainly not the many patients for whom needle fear is a genuine barrier to care, as documented in a systematic
review and meta-analysis published in the Journal of Advanced Nursing and summarized in this Harvard Health article: needle fear
is present in 20% to 30% of young adults, and 16% of adult patients avoid influenza vaccination because of it. Who would prefer an opioid
sedation medication to an alternative that provided sufficient sedation without the potentially addictive agents?
Believe
it or not, we have already begun laying the commercial foundation for an eventual G-MELT launch – engaging key opinion leaders,
developing our commercial strategy, preparing market access initiatives, and building the infrastructure we believe will be required
for a successful launch.
Investors
often ask me what Harrow looks like five years from now. While I believe our existing portfolio alone has tremendous runway for growth,
I also believe G-MELT has the potential to redefine what Harrow can become. It represents an opportunity to build an entirely new platform
with significant long-term value creation potential, and I believe it can become one of the defining growth drivers of our company for
many years to come.
YOCHIL™,
our midazolam orally disintegrating tablet (ODT) program, also continues to advance and represents an attractive opportunity in its own
right. During the quarter, we completed our End-of-Phase 2 meeting with the FDA and are incorporating the Agency’s feedback into
refinements of our Phase 3 study design and protocol. We are also advancing a pharmacokinetic bridging program to the currently marketed
midazolam syrup and expect to evaluate multiple dosage strengths designed to align with the existing dosing paradigm. In addition, we
are considering a pediatric usability study using a matching placebo to ensure the tablet’s size, thickness, color, and taste are
appropriate for pediatric patients.
Together,
these programs have the potential to establish an entirely new franchise for Harrow and meaningfully expand our leadership beyond our
core ophthalmic pharmaceuticals business. We look forward to providing a more comprehensive update on both the G-MELT and YOCHIL development
programs, including our clinical and regulatory strategy, at our Investor Day in March 2027.
Specialty
Products
I
continue to be incredibly excited about the opportunity we have with VERKAZIA. While severe vernal keratoconjunctivitis (VKC) is a rare
disease, it can be devastating for the children and families affected by it. We believe VERKAZIA, which uniquely can reduce pediatric
exposure to steroids, has the potential to become the standard of care for many of these patients.
Over
the past several months, our focus has been on building the foundation for long-term success. That starts with ensuring a reliable, consistent
supply so physicians can prescribe VERKAZIA with confidence, while continuing to expand patient access, improve reimbursement, and invest
in physician education and disease awareness. We believe VKC, especially in its mild form, remains highly underdiagnosed and undertreated.
Our initiatives will be critical to unlock VERKAZIA’s long-term commercial potential.
NATACYN®
is another program that continues to generate enthusiasm across the organization. During the second quarter, the first patients were
enrolled in our investigator-initiated clinical study, marking an important milestone for the program. We continue to expect topline
data in the fourth quarter of this year and believe these results have the potential to further highlight NATACYN’s important role
in treating fungal keratitis—a serious, sight-threatening infection with significant unmet medical need.
IOPIDINE’s
permanent J-code went into effect on July 1, removing a reimbursement barrier we believe has constrained broader utilization. We are
now focused on expanding IOPIDINE’s use, and the early feedback has been remarkable. At this year’s ASRS meeting, physicians
expressed strong, unprompted enthusiasm for IOPIDINE’s role in managing intraocular pressure, especially with higher volume procedures
that are known to cause transient vision loss. With reimbursement now memorialized with a product-specific J-code, and physician interest
building, we believe IOPIDINE is well positioned for meaningful utilization growth ahead.
We
believe the initiatives underway across VERKAZIA, NATACYN, and IOPIDINE position these products for renewed growth, and I look forward
to sharing our progress in the quarters ahead.
Access+:
A Broad Portfolio of Workhorse Products
Access+
has evolved into an increasingly important part of Harrow’s commercial strategy. Today, this team represents the broadest cash-pay
ophthalmic portfolio in our company’s history, offering physicians a unique combination of FDA-approved branded prescription products
alongside our proprietary compounded formulations.
We
believe no other company provides eye care professionals with this breadth of affordable cash-pay solutions across ophthalmology and
optometry. Recognizing that opportunity, we expanded the Access+ commercial organization as part of our broader sales force expansion
during the quarter, adding dedicated representatives to support this growing portfolio and further strengthen our relationships with
physicians nationwide.
Before
discussing where this business is headed, I want to address the reported numbers directly. ImprimisRx net revenue was $14.6 million in
the second quarter of 2026, compared with $21.5 million in the prior-year second quarter. That decline reflects three specific factors:
(i) previously discussed inventory shortfalls that constrained our ability to supply certain products; (ii) exiting the California market;
and (iii) a deliberate decision we made last year to transition certain compounded units to branded units, like our transition of Klarity-C
patients to VEVYE— it is revenue moving by design from ImprimisRx into our branded portfolio, that results in higher value to Harrow.
During
the second quarter, we completed our inventory rebuild – 100%, and our history with this business is clear: when we have inventory,
we grow, and we drive revenue and profits. We are now situated to do exactly that. We began to see this recovery take hold during the
second quarter, and we expect it to continue throughout the balance of the year. Our goal is for the ImprimisRx business to be near fully
recovered, from a financial perspective, by the end of 2026. We believe we are well on our way.
Our
Access+ strategy remains straightforward: provide physicians with high-quality, affordable ophthalmic medications, deliver exceptional
service and reliability, and make it easier for patients to access the therapies they need. That formula has served us well for many
years, and we believe it remains a meaningful competitive advantage. Access+ continues to play a critical role in Harrow’s long-term
strategy. Together with our branded pharmaceutical portfolio, it allows us to offer one of the most comprehensive collections of ophthalmic
treatment solutions available in the United States.
Closing
As
I bring this Letter to Stockholders to a close, I am thinking about how, for many years, our focus has been on building—acquiring
and developing differentiated products, expanding our commercial capabilities, improving access, and assembling what we believe is the
premier ophthalmic portfolio in the United States. Much of that work happened behind the scenes. Today, I believe we are beginning to
see the results of those investments and, importantly, I believe we are still in the early stages.
One
of the initiatives our Board, Andrew and I have devoted considerable time to over the past several months is finalizing Harrow’s
next five-year strategic plan – our fourth such plan since we began this adventure in December of 2011. While we remain intensely
focused on executing today, we’re equally committed to ensuring that the decisions we make now position Harrow for sustained growth
well into the next decade. I look forward to sharing our vision with our stockholders at our next Investor Day, which I am pleased to
announce will be held on Monday, March 22, 2027, in New York City. Institutional investors and analysts can reach out to Mike Biega,
VP of Investor Relations and Communications, for more information. Similar to last year, the event will be webcast live and recorded.
Our
next Investor Day will be an important milestone for Harrow. We will outline and discuss our 2027–2031 Five-Year Strategic Vision,
outlining how we intend to build upon the foundation we’ve established and continue creating long-term value for patients, physicians,
employees, and stockholders. We’ll provide comprehensive updates across each of our major growth platforms, including VEVYE, IHEEZO,
TRIESENCE, our expanding retina franchise, and Access+, while also discussing the next phase of Harrow’s evolution. We also expect
to provide our most comprehensive update yet on our MELT platform, including G-MELT and YOCHIL. We’ll discuss regulatory progress,
anticipated development milestones, our commercial strategy, and why we believe these programs have the potential to become one of the
most important growth drivers in Harrow’s history. In addition, we anticipate sharing important clinical and commercial updates
across the portfolio, including data from the QUELL study evaluating IHEEZO, topline results from our Phase 3 TRIESENCE program, progress
on the launch of BYOOVIZ, the VERKAZIA relaunch, and, if timing permits, clinical updates from the NATACYN development program. I think
we should have much to celebrate and discuss next March!
We
have multiple meaningful growth engines across our business, each with significant runway ahead. We expect to launch at least one new
product every year between now and the end of 2029 while continuing to invest in expanding the commercial potential of our existing portfolio.
Just as importantly, we are putting in place the strategies, infrastructure, and development programs today that we believe will drive
meaningful and durable revenue growth well into the 2030s.
Harrow
has also reached an important inflection point. Historically, much of our energy was devoted to building the next product, the next acquisition,
or the next opportunity. Today, we have the benefit of a broad, incredibly diversified portfolio that we believe will generate substantial
cash flow for years to come. That allows us to think differently—to invest with a longer horizon, pursue larger strategic opportunities,
and build enduring value for our stockholders.
Looking
specifically at 2026, I remain highly confident in our outlook. We entered the year knowing the first half would be about laying the
foundation for future growth – expanding our commercial organization, improving product access, strengthening supply, launching
new products, and advancing our clinical pipeline. We accomplished what we set out to do. As a result, I believe Harrow is exceptionally
well positioned for a strong second half of the year, and I remain confident in our ability to achieve our full-year revenue and Adjusted
EBITDA guidance.
The
table is set. Now we serve. As always, thank you for your continued trust, confidence, and support.
Sincerely,
Mark
L. Baum
Founder,
Chairman of the Board, and Chief Executive Officer
Nashville,
Tennessee
Index
to Previous Letters to Stockholders
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Commentary
on Second Quarter 2026 Financials
Revenues
of $70.7 million for the second quarter of 2026 represent an 11% increase over the prior-year second quarter revenues of $63.7 million.
During the quarter, branded revenue, net, grew 33% year over year to $56.1 million, partially offset by ImprimisRx revenue of $14.6 million,
which declined from $21.5 million in the prior-year second quarter as a result of discontinuation of Klarity-C,exiting the California
market, and the transition of certain compounded units to branded units. A portion of the year-over-year ImprimisRx decline therefore
reflects revenue shifting by design into our branded portfolio. We expect ImprimisRx revenue to improve over the balance of 2026.
Selling,
general and administrative (“SG&A”) costs for the second quarter of 2026 were $53.3 million compared with $33.2 million
during the same period last year. The increase in SG&A was primarily driven by an increase in headcount and related expenses within
our commercial organization, along with an increase in other commercial-related activities.
Research
and development (“R&D”) costs for the second quarter of 2026 were $8.1 million compared with $2.9 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
program, and clinical trials for IHEEZO and TRIESENCE.
GAAP
net loss for the second quarter of 2026 was $17.3 million compared with a GAAP net income of $5.0 million during the same period last
year.
Adjusted
EBITDA (a non-GAAP measure) for the second quarter of 2026 was $(1.2) million compared with Adjusted EBITDA of $17.0 million during the
same quarter last year.
As
of June 30, 2026, cash and cash equivalents totaled $83.9 million while accounts receivable stood at $118.6 million.
GAAP
gross margins were 71% for the second quarter of 2026 and 75% for the second quarter of 2025. The decrease year over year is largely
due to an increase in fixed costs associated with the amortization of acquired NDAs, the overall revenue and product mix, and decreased
efficiency at ImprimisRx.
Additional
product-related revenue figures are reflected in the table below:
| | |
For the Three Months Ended June 30, | |
For the Six Months Ended June 30, |
| | |
2026 | |
2025 | |
2026 | |
2025 |
| IHEEZO | |
$ | 15,619,000 | | |
| 22 | % | |
$ | 18,336,000 | | |
| 29 | % | |
$ | 17,535,000 | | |
| 15 | % | |
$ | 23,558,000 | | |
| 21 | % |
| VEVYE | |
| 29,387,000 | | |
| 42 | % | |
| 18,641,000 | | |
| 29 | % | |
| 50,335,000 | | |
| 44 | % | |
| 40,156,000 | | |
| 36 | % |
| Other branded products | |
| 11,009,000 | | |
| 16 | % | |
| 5,212,000 | | |
| 8 | % | |
| 18,776,000 | | |
| 16 | % | |
| 6,169,000 | | |
| 6 | % |
| Other revenues | |
| 90,000 | | |
| 0 | % | |
| 85,000 | | |
| 0 | % | |
| 163,000 | | |
| 0 | % | |
| 171,000 | | |
| 0 | % |
| Branded revenue, net | |
| 56,105,000 | | |
| 79 | % | |
| 42,274,000 | | |
| 66 | % | |
| 86,809,000 | | |
| 76 | % | |
| 70,054,000 | | |
| 63 | % |
| ImprimisRx revenue, net | |
| 14,556,000 | | |
| 21 | % | |
| 21,468,000 | | |
| 34 | % | |
| 28,055,000 | | |
| 24 | % | |
| 41,519,000 | | |
| 37 | % |
| Total revenues, net | |
$ | 70,661,000 | | |
| 100 | % | |
$ | 63,742,000 | | |
| 100 | % | |
$ | 114,864,000 | | |
| 100 | % | |
$ | 111,573,000 | | |
| 100 | % |
Second
Quarter 2026 Financial Overview
GAAP
Operating Results
Selected
financial highlights regarding GAAP operating results for the three months and six months ended June 30, 2026 and 2025 are as follows:
| | |
For the Three Months Ended June 30, | | |
For the Six Months Ended
June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Total revenues | |
$ | 70,661,000 | | |
$ | 63,742,000 | | |
$ | 114,864,000 | | |
$ | 111,573,000 | |
| Cost of sales | |
| 20,298,000 | | |
| 16,230,000 | | |
| 37,456,000 | | |
| 31,754,000 | |
| Gross profit | |
| 50,363,000 | | |
| 47,512,000 | | |
| 77,408,000 | | |
| 79,819,000 | |
| Selling, general and administrative | |
| 53,298,000 | | |
| 33,235,000 | | |
| 96,528,000 | | |
| 73,748,000 | |
| Research and development | |
| 8,072,000 | | |
| 2,868,000 | | |
| 13,967,000 | | |
| 5,894,000 | |
| Total operating expenses | |
| 61,370,000 | | |
| 36,103,000 | | |
| 110,495,000 | | |
| 79,642,000 | |
| (Loss) income from operations | |
| (11,007,000 | ) | |
| 11,409,000 | | |
| (33,087,000 | ) | |
| 177,000 | |
| Total other expense, net | |
| (6,263,000 | ) | |
| (6,414,000 | ) | |
| (11,760,000 | ) | |
| (12,962,000 | ) |
| Income tax expense | |
| - | | |
| - | | |
| 25,000 | | |
| - | |
| Net (loss) income | |
$ | (17,270,000 | ) | |
$ | 4,995,000 | | |
$ | (44,872,000 | ) | |
$ | (12,785,000 | ) |
| Net (loss) income per share: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.46 | ) | |
$ | 0.14 | | |
$ | (1.20 | ) | |
$ | (0.35 | ) |
| Diluted | |
$ | (0.46 | ) | |
$ | 0.13 | | |
$ | (1.20 | ) | |
$ | (0.35 | ) |
Selected
Financial Highlights
Selected
financial highlights and Non-GAAP operating results for the three months and six months ended June 30, 2026 and 2025 are as follows:
| | |
For
the Three Months Ended June 30, | | |
For the Six Months Ended
June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Total
revenues | |
$ | 70,661,000 | | |
$ | 63,742,000 | | |
$ | 114,864,000 | | |
$ | 111,573,000 | |
| Gross
margin | |
| 71 | % | |
| 75 | % | |
| 67 | % | |
| 72 | % |
| Net
(loss) income | |
| (17,270,000 | ) | |
| 4,995,000 | | |
| (44,872,000 | ) | |
| (12,785,000 | ) |
| Adjusted
EBITDA(1) | |
| (1,232,000 | ) | |
| 17,006,000 | | |
| (13,891,000 | ) | |
| 15,021,000 | |
| Net
(loss) income per share: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| (0.46 | ) | |
| 0.14 | | |
| (1.20 | ) | |
| (0.35 | ) |
| Diluted | |
| (0.46 | ) | |
| 0.13 | | |
| (1.20 | ) | |
| (0.35 | ) |
| (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 June 30, 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) income, 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 (loss) income, 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 (loss)
income. Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net (loss) income 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) income, for the
three and six months ended June 30, 2026 and for the same periods in 2025:
| | |
For
the Three Months Ended June 30, | | |
For
the Six Months Ended
June
30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| GAAP
net (loss) income | |
$ | (17,270,000 | ) | |
$ | 4,995,000 | | |
$ | (44,872,000 | ) | |
$ | (12,785,000 | ) |
| Stock-based
compensation and expenses | |
| 3,788,000 | | |
| 875,000 | | |
| 7,625,000 | | |
| 5,431,000 | |
| Interest
expense, net | |
| 6,263,000 | | |
| 6,408,000 | | |
| 11,760,000 | | |
| 12,956,000 | |
| Income
tax expense | |
| - | | |
| - | | |
| 25,000 | | |
| - | |
| Depreciation | |
| 460,000 | | |
| 496,000 | | |
| 915,000 | | |
| 961,000 | |
| Amortization
of intangible assets | |
| 5,527,000 | | |
| 4,226,000 | | |
| 10,656,000 | | |
| 8,452,000 | |
| Investment
loss, net | |
| - | | |
| - | | |
| - | | |
| - | |
| Other
expense, net | |
| - | | |
| 6,000 | | |
| - | | |
| 6,000 | |
| Adjusted
EBITDA | |
$ | (1,232,000 | ) | |
$ | 17,006,000 | | |
$ | (13,891,000 | ) | |
$ | 15,021,000 | |