Harrow第二季收入7070萬美元按季增60% 惟虧損擴大並維持全年指引

EX-99.1
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ex99-1.htm
EX-99.1

 

 

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

[email protected]

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-