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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 27, 2025

 

HARROW, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-35814   45-0567010

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1A Burton Hills Blvd., Suite 200    
Nashville, Tennessee   37215
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (615) 733-4730

 

  Not Applicable  
  (Former Name or Former Address, if Changed Since Last Report)  

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name on exchange on which registered
Common Stock, $0.001 par value per share   HROW   The Nasdaq Stock Market LLC
8.625% Senior Notes due 2026   HROWL   The Nasdaq Stock Market LLC
11.875% Senior Notes due 2027   HROWM   The Nasdaq Stock Market LLC

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Act of 1934: Emerging growth company ☐

 

If any emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

 

On March 27, 2025, Harrow, Inc. (the “Company”) issued a press release and a letter to stockholders announcing its financial results for the period ended December 31, 2024 and an update on recent corporate events. The press release and letter to stockholders are being furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.

 

The information furnished under this Item 2.02 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 2.02, including Exhibits 99.1 and 99.2, shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent it is specifically incorporated by reference but regardless of any general incorporation language in such filing.

 

The information furnished under this Item 2.02 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed to constitute an admission that such information or exhibit is required to be furnished pursuant to Regulation FD or that such information or exhibit contains material information that is not otherwise publicly available. In addition, the Company does not assume any obligation to update such information or exhibit in the future.

 

Item 9.01. Financial Statements and Exhibits

 

(d)   Exhibits
     
99.1   Press Release issued by Harrow, Inc. on March 27, 2025
     
99.2   Letter to Stockholders by Harrow, Inc. dated March 27, 2025
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  HARROW, INC.
   
Dated: March 27, 2025 By: /s/ Andrew R. Boll
  Name: Andrew R. Boll
  Title: Chief Financial Officer

 

 

EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

Harrow Announces Fourth-Quarter and Year-End 2024 Audited Financial Results

 

Fourth-Quarter, Full-Year 2024, and Recent Highlights:

 

Record revenues of $66.8 million for Q4 2024, an 84% increase over Q4 2023
Revenues of $199.6 million for FY 2024, a 53% increase over FY 2023
GAAP net income of $6.8 million for Q4 2024, for a GAAP net loss of $(17.5) million for FY 2024
Adjusted EBITDA of $22.5 million for Q4 2024, leading to Adjusted EBITDA of $40.3 million for FY 2024
IHEEZO® unit demand and VEVYE® prescriptions for Q4 2024 each increased over 40% over Q3 2024
VEVYE® Access for All program expected to drive continued market share expansion in 2025
TRIESENCE® transitional pass-through approved, significantly increasing addressable market opportunity

 

NASHVILLE, Tenn., March 27, 2025 – Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, announced results for the fourth quarter and year ended December 31, 2024. The Company also posted its fourth quarter Letter to Stockholders and corporate presentation to the “Investors” section of its website, harrow.com. The Company encourages all Harrow stockholders to review these documents, which provide additional details concerning the historical quarterly period and future expectations for the business.

 

“Our stellar fourth-quarter performance, including an 84% year-over-year increase in revenues to a record $66.8 million, marked the end of a monumental year for Harrow, with 2024 revenues rising 53% over 2023 to $199.6 million,” said Mark L. Baum, Chief Executive Officer of Harrow. “This strong finish, driven by over 40% quarter-over-quarter growth in both IHEEZO unit demand and VEVYE prescriptions, showcases market uptake for our expanding portfolio and the overall success of the Harrow team. We expect our momentum to continue in 2025, particularly in the second half, as the recently announced VEVYE Access for All program gains traction – accelerating market share capture, expanding commercially covered prescriptions, and bolstering prescriber confidence by ensuring their patients can affordably start treatment with VEVYE, regardless of insurance status. Meanwhile, in addition to our success in stabilizing the supply chain for TRIESENCE, the Centers for Medicare & Medicaid Services recently approved our transitional pass-through application, significantly increasing its addressable market. This terrific news should add fuel to our commercial efforts concurrent with our development of a next-generation version of this high-value and high-trust product. Because we remain at the initial stages of market penetration for our core products, we expect revenue growth in these cornerstone products for years to come.”

 

Baum added, “We continue to review new ways to better serve our customers and leverage our commercial infrastructure by adding attractive low-risk, high-return products. This includes product candidates we have been quietly nurturing internally, which we expect to discuss in more detail later this year; those being brought to us by third parties; and those in which we already have a stake, such as the MELT-300 program. Finally, Harrow stockholders should know that while we expect normal seasonal revenue fluctuations, we are confident in the remainder of 2025, as demonstrated by our 2025 revenue guidance of ‘more than $280 million,’ representing an increase over 2024 revenue of more than 40% in annual revenues.”

 

Fourth-quarter and year-end 2024 figures of merit:

 

    For the Three Months Ended
December 31,
    For the Year Ended
December 31,
 
    2024     2023     2024     2023  
Total revenues   $ 66,831,000     $ 36,355,000     $ 199,614,000     $ 130,193,000  
Gross margin     79 %     69 %     75 %     70 %
Core gross margin(1)     84 %     75 %     80 %     77 %
Net income (loss)     6,777,000       (9,148,000 )     (17,481,000 )     (24,411,000 )
Core net income (loss)(1)     11,366,000       (7,016,000 )     (2,089,000 )     (11,512,000 )
Adjusted EBITDA(1)     22,489,000       2,563,000       40,327,000       28,119,000  
Net income (loss) per share:                                
Basic     0.19       (0.26 )     (0.49 )     (0.75 )
Diluted     0.24       (0.26 )     (0.49 )     (0.75 )
Core net income (loss) per share:(1)                                
Basic     0.32       (0.20 )     (0.06 )     (0.35 )
Diluted     0.40       (0.20 )     (0.06 )     (0.35 )

 

(1) Core gross margin, core net income (loss), core basic and diluted net income (loss) per share (collectively, “Core Results”), and Adjusted EBITDA are non-GAAP measures. For additional information, including a reconciliation of such Core Results and Adjusted EBITDA to the most directly comparable measures presented in accordance with GAAP, see the explanation of non-GAAP measures and reconciliation tables at the end of this release.

 

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Harrow Announces Fourth-Quarter and Year-End 2024 Financial Results

Page 2

March 27, 2025

  

Conference Call and Webcast

 

The Company’s management team will host a conference call and live webcast tomorrow morning, Friday, March 28, 2025, at 8:00 a.m. Eastern time to discuss the fourth-quarter and year-end 2024 results and provide a business update. Participants can access the live conference call via webcast on the “Investors” page of Harrow’s website. 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, for accessing the call. A replay of the conference call webcast will be archived on the Company’s website for one year.

 

About Harrow

 

Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com.

 

Forward-Looking Statements

 

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2023, 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 web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

 

Contact:

 

Jamie Webb, Director of Communications and Investor Relations HARROW, INC. CONDENSED CONSOLIDATED BALANCE SHEETS

jwebb@harrowinc.com

615-733-4737

 

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Harrow Announces Fourth-Quarter and Year-End 2024 Financial Results

Page 3

March 27, 2025 

 

   

December 31, 2024

    December 31, 2023  
    (unaudited)        
ASSETS                
Cash and cash equivalents   $ 47,247,000     $ 74,085,000  
All other current assets     142,404,000       65,397,000  
Total current assets     189,651,000       139,482,000  
All other assets     199,320,000       172,682,000  
TOTAL ASSETS   $ 388,971,000     $ 312,164,000  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities   $ 91,343,000     $ 49,344,000  
Loans payable, net of unamortized debt discount     219,539,000       185,885,000  
All other liabilities     8,792,000       6,524,000  
TOTAL LIABILITIES     319,674,000       241,753,000  
TOTAL STOCKHOLDERS’ EQUITY     69,297,000       70,411,000  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 388,971,000     $ 312,164,000  

 

HARROW, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

    For the Three Months Ended
December 31,
    For the Year Ended
December 31,
 
    2024     2023     2024     2023  
Total revenues   $ 66,831,000     $ 36,355,000     $ 199,614,000     $ 130,193,000  
Cost of sales     14,135,000       11,302,000       49,245,000       39,640,000  
Gross profit     52,696,000       25,053,000       150,369,000       90,553,000  
Selling, general and administrative     34,789,000       26,212,000       129,064,000       83,090,000  
Research and development     4,755,000       3,336,000       12,230,000       6,652,000  
Impairment of long-lived assets     253,000       380,000       253,000       380,000  
Total operating expenses     39,797,000       29,928,000       141,547,000       90,122,000  
Income (loss) from operations     12,899,000       (4,875,000 )     8,822,000       431,000  
Total other expense, net     (6,636,000 )     (4,808,000 )     (26,142,000 )     (24,141,000 )
Income tax benefit (expense)     514,000       535,000       (161,000 )     (701,000 )
Net income (loss) attributable to Harrow, Inc.   $ 6,777,000     $ (9,148,000 )   $ (17,481,000 )   $ (24,411,000 )
Net income (loss) per share:                                
Basic   $ 0.19     $ (0.26 )   $ (0.49 )   $ (0.75 )
Diluted   $ 0.24     $ (0.26 )   $ (0.49 )   $ (0.75 )

  

HARROW, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

  

   

For the Year Ended

December 31,

 
    2024     2023  
Net cash (used in) provided by:                
Operating activities   $ (22,202,000 )   $ 3,840,000  
Investing activities     (33,164,000 )     (152,553,000 )
Financing activities     28,528,000       126,528,000  
Net change in cash and cash equivalents     (26,838,000 )     (22,185,000 )
Cash and cash equivalents at beginning of the period     74,085,000       96,270,000  
Cash and cash equivalents at end of the period   $ 47,247,000     $ 74,085,000  

 

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Harrow Announces Fourth-Quarter and Year-End 2024 Financial Results

Page 4

March 27, 2025

 

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 and Core Results, unaudited financial measures that are not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA and Core Results are considered “non-GAAP” financial measures within the meaning of Regulation G promulgated by the SEC. Management believes that these non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provide a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA and Core Results provide meaningful supplemental information regarding the Company’s performance because (i) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) they exclude 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) they are used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA, Core Results, and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

 

Adjusted EBITDA

 

The Company defines Adjusted EBITDA as net income (loss), excluding the effects of stock-based compensation and expenses, impairment of intangible assets, interest, taxes, depreciation, amortization, investment (income) loss, net, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net income (loss). Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net loss as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.

 

The following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net income (loss), for the three months and year ended December 31, 2024 and for the same periods in 2023:

 

HARROW, INC.

RECONCILIATION OF NET INCOME (LOSS) TO ADJUSTED EBITDA

  

    For the Three Months Ended
December 31,
    For the Year Ended
December 31,
 
    2024     2023     2024     2023  
GAAP net income (loss)   $ 6,777,000     $ (9,148,000 )   $ (17,481,000 )   $ (24,411,000 )
Stock-based compensation and expenses     4,794,000       4,175,000       17,619,000       15,696,000  
Impairment of intangible assets     253,000       380,000       253,000       380,000  
Interest expense, net     6,375,000       5,124,000       22,786,000       21,324,000  
Income tax (benefit) expense     (514,000 )     (535,000 )     161,000       701,000  
Depreciation     468,000       435,000       1,850,000       1,530,000  
Amortization of intangible assets     4,075,000       2,448,000       11,783,000       10,082,000  
Investment (income) loss, net     -       (416,000 )     3,171,000       (3,092,000 )
Loss on disposal of equipment     -       146,000       -       168,000  
Other expense (income), net     261,000       (46,000 )     185,000       5,741,000 (1)
Adjusted EBITDA   $ 22,489,000     $ 2,563,000     $ 40,327,000     $ 28,119,000  

  

(1) Includes $5,465,000 for the loss on extinguishment of debt.

 

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Harrow Announces Fourth-Quarter and Year-End 2024 Financial Results

Page 5

March 27, 2025

  

Core Results

 

Harrow Core Results, including core gross margin, core net income (loss), and core basic and diluted income (loss) per share exclude (1) all amortization and impairment charges of intangible assets, excluding software development costs, (2) net gains and losses on investments and equity securities, including equity method gains and losses and equity valued at fair value through profit and loss (FVPL), and preferred stock dividends, and (3) gains/losses on forgiveness of debt. In certain periods, Core Results may also exclude fair value adjustments of financial assets in the form of options to acquire a company carried at FVPL, obligations related to product recalls, certain acquisition-related items, restructuring charges/releases and associated items, related legal items, gains/losses on early extinguishment of debt or debt modifications, impairments of property, plant and equipment and software, as well as income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a $100,000 threshold.

 

The following is a reconciliation of Core Results, non-GAAP measures, to the most comparable GAAP measures for the three months and year ended December 31, 2024 and for the same periods in 2023:

 

For the Three Months Ended December 31, 2024
   

GAAP

Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment

Gains

(Losses)

   

Other

Items

   

Core

Results

 
Gross profit   $ 52,696,000     $ 3,622,000     $ -     $        -     $ -     $ 56,318,000  
Gross margin     79 %                                     84 %
Operating income     12,899,000       4,075,000       253,000       -       -       17,227,000  
Income before taxes     6,263,000       4,075,000       253,000       -       261,000       10,852,000  
Taxes     514,000       -       -       -       -       514,000  
Net income     6,777,000       4,075,000       253,000       -       261,000       11,366,000  
Income per share ($)(1):                                                
Basic     0.19                                       0.32  
Diluted     0.24                                       0.40  
Weighted average number of shares of common stock outstanding:                                                
Basic     35,807,767                                       35,807,767  
Diluted     28,317,740                                       28,317,740  

 

For the Year Ended December 31, 2024

   

GAAP

Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment

Gains

(Losses)

   

Other

Items

   

Core

Results

 
Gross profit   $ 150,369,000     $ 10,093,000     $ -     $ -     $ -     $ 160,462,000  
Gross margin     75 %                                     80 %
Operating income     8,822,000       11,783,000       253,000       -       -       20,858,000  
(Loss) income before taxes     (17,320,000 )     11,783,000       253,000       3,171,000       185,000       (1,928,000 )
Tax expense     (161,000 )     -       -       -       -       (161,000 )
Net (loss) income     (17,481,000 )     11,783,000       253,000       3,171,000       185,000       (2,089,000 )
Basic and diluted loss per share ($)(1)     (0.49 )                                     (0.06 )
Weighted average number of shares of common stock outstanding, basic and diluted     35,650,714                                       35,650,714  

 

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Harrow Announces Fourth-Quarter and Year-End 2024 Financial Results

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March 27, 2025

  

For the Three Months Ended December 31, 2023
   

GAAP

Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment

Gains

(Losses)

   

Other

Items

   

Core

Results

 
Gross profit   $ 25,053,000     $ 2,140,000     $        -     $ -     $ -     $ 27,193,000  
Gross margin     69 %                                     75 %
Operating (loss) income     (4,875,000 )     2,448,000       -       -       -       (2,427,000 )
(Loss) income before taxes     (9,683,000 )     2,448,000       -       (416,000 )     100,000       (7,551,000 )
Tax benefit     535,000       -       -       -       -       535,000  
Net (loss) income     (9,148,000 )     2,448,000       -       (416,000 )     100,000       (7,016,000 )
Basic and diluted loss per share ($)(1)     (0.26 )                                     (0.20 )
Weighted average number of shares of common stock outstanding, basic and diluted     35,353,848                                       35,353,848  

 

For the Year Ended December 31, 2023

   

GAAP

Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment

Gains

(Losses)

   

Other

Items

   

Core

Results

 
Gross profit   $ 90,553,000     $ 9,314,000     $ -     $ -     $ -     $ 99,867,000  
Gross margin     70 %                                     77 %
Operating income     431,000       10,082,000       -       -       -       10,513,000  
(Loss) income before taxes     (23,710,000 )     10,082,000       -       (3,092,000 )     5,909,000       (10,811,000 )
Tax expense     (701,000 )     -       -       -       -       (701,000 )
Net (loss) income     (24,411,000 )     10,082,000              -       (3,092,000 )     5,909,000       (11,512,000 )
Basic and diluted loss per share ($)(1)     (0.75 )                                     (0.35 )
Weighted average number of shares of common stock outstanding, basic and diluted     32,616,777                                       32,616,777  

 

(1) Core basic and diluted income (loss) per share is calculated using the weighted-average number of shares of common stock outstanding during the period. Core basic and diluted income (loss) per share also contemplates dilutive shares associated with equity-based awards as described in Note 2 and elsewhere in the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

 

-END-

 

 

EX-99.2 3 ex99-2.htm

 

Exhibit 99.2

 

 

Letter to Stockholders

 

March 27, 2025

 

Dear Harrow Stockholders:

 

We had a tremendous close to a monumental year – and today, I am pleased to report another period of record financial performance by the Harrow team, with fourth-quarter revenue of $66.8 million, an impressive 84% year-over-year increase. Revenues for 2024 increased 53% to $199.6 million, exceeding the 47% annual growth achieved in the previous year (2022-2023). Notably, these results were attained with only a minimal contribution from the recently relaunched TRIESENCE®, which is anticipated to make a more substantial positive financial impact later this year (see page 5 for more details).

 

In addition, thanks to our strong financial performance in the fourth quarter, which included net income of $6.8 million and Adjusted EBITDA (a non-GAAP measure1) of approximately $22.5 million, we successfully met the annual leverage ratio term under our senior secured loan agreement, and, as promised, we avoided the need to issue warrants to our lender. This achievement reflects our continued commitment to disciplined execution, profitability, and long-term value creation for our stockholders.

 

Our steady revenue growth, over many years, is a testament to the strength of our Five-Year Strategic Plan, the discipline behind its execution, and the dedication of the nearly 400-strong members of the Harrow Family, motivated by a common goal of helping patients safeguard one of their most precious gifts – the gift of sight – and increasing the value of our company. While not everything will go our way, much will. Therefore, I expect our growth to continue as we execute our vision of becoming North America’s leading ophthalmic pharmaceutical company.

 

For the rest of 2025, we are focused on revenue growth from increased IHEEZO® unit demand, improving patient access to VEVYE® and significantly and rapidly growing our U.S. dry eye disease (DED) market share, making TRIESENCE the injectable steroid of choice for U.S. ophthalmologists, and leveraging our portfolio of products and commercial organization throughout the enterprise.

 

Some stockholders have expressed concerns regarding the potential impact of tariffs on our business. However, based on our analysis, we do not anticipate a noticeable impact on our financial results.

 

Finally, based on current visibility and consistent with our historical approach to providing directional financial guidance, we are issuing full-year 2025 revenue guidance of “over $280 million,” with our higher-margin branded business expected to drive the lion’s share of our growth. While we anticipate typical seasonal revenue patterns, we expect the momentum from recent initiatives to begin gaining traction in the second quarter and continue to build throughout the remainder of 2025.

 

Fourth Quarter and Full-Year 2024 Financials

 

Harrow delivered record revenues in the fourth quarter of 2024, reaching $66.8 million, an 84% increase over the prior year’s fourth quarter revenues of $36.4 million and a 36% sequential increase over the third quarter of 2024 revenues of $49.3 million. Full-year 2024 revenues grew 53% to $199.6 million from $130.2 million in 2023 – a reflection of our strong execution and strategic portfolio expansion.

 

  1  

  

GAAP net income for the fourth quarter of 2024 was $6.8 million compared with a GAAP net loss in the prior year’s fourth quarter of $(9.1) million. Core net income (a non-GAAP measure1) for the fourth quarter of 2024 was $11.4 million compared with a core net loss of $(7.0) million in the prior year’s fourth quarter.

 

Adjusted EBITDA (a non-GAAP measure1) for the fourth quarter of 2024 increased to $22.5 million compared with Adjusted EBITDA of $2.6 million during the same quarter last year. Adjusted EBITDA for full-year 2024 increased 43% to $40.3 million compared with Adjusted EBITDA for full-year 2023 of $28.1 million.

 

As of December 31, 2024, cash and cash equivalents totaled $47.2 million. Accounts receivable stood at $116.4 million, reflecting the robust increase in branded sales. However, during the fourth quarter, we extended payment terms to our largest distributor customer, a Fortune 500 company, to allow end users of our branded products to complete revenue cycles before making payments. While this negatively impacted our cash flows from operations by approximately $17.8 million in the fourth quarter, our strong cash position allowed us to extend this strategic concession without compromising stability. Given the distributor’s financial strength and reliability, we view this as a prudent credit decision and remain confident in the long-term benefits of this approach. Importantly, going forward and beginning in 2025, we do not expect to see impacts from these kinds of working capital changes and should be back on track to producing cash flow from operations.

 

GAAP gross margins were 79% for the fourth quarter of 2024 compared to 69% in the same quarter in 2023. Core gross margins (a non-GAAP measure1) rose to 84% in the fourth quarter of 2024 compared with 75% in the same period in 2023. GAAP gross margins were 75% for full-year 2024 compared to 70% in full-year 2023, with core gross margins being 80% for full-year 2024 compared with 77% for full-year 2023.

 

A key highlight of the fourth quarter was the continued strong performance of IHEEZO and VEVYE, both of which surpassed the threshold of contributing 10% or more of total Harrow revenues. As a result, we reported individual revenues for these products in the Form 10-K filing, as reflected in the table below:

 

    For the Three Months Ended
December 31,
    For the Year Ended
December 31,
 
    2024     2023     2024     2023  
IHEEZO   $ 22,805,000       34 %   $ 10,548,000       29 %   $ 49,303,000       25 %   $ 20,621,000       16 %
VEVYE     15,962,000       24 %     1,766,000       5 %     28,061,000       14 %     1,766,000       1 %
Other branded products     7,028,000       10 %     1,919,000       5 %     37,836,000       19 %     15,124,000       12 %
Other revenues     540,000       1 %     2,162,000       6 %     915,000       -%       12,747,000       10 %
Branded revenue, net     46,335,000       69 %     16,395,000       45 %     116,115,000       58 %     50,258,000       39 %
ImprimisRx revenue, net     20,496,000       31 %     19,960,000       55 %     83,499,000       42 %     79,935,000       61 %
Total revenues, net   $ 66,831,000       100 %   $ 36,355,000       100 %   $ 199,614,000       100 %   $ 130,193,000       100 %

  

The strength of our branded pharmaceutical portfolio – particularly the outstanding growth of IHEEZO and VEVYE – highlights the increasing market adoption of our innovative ophthalmic pharmaceutical products. With IHEEZO contributing 34% of total revenue and VEVYE accounting for 24% of sales in the fourth quarter of 2024, we see a clear shift toward a more diversified and higher-margin revenue base.

 

As we move into 2025, in addition to the traditional quarter-to-quarter revenue build we experienced in 2024, we expect growth across our branded portfolio, enhancing profitability through operational efficiencies and strategically positioning Harrow for continued leadership in the ophthalmic pharmaceutical sector.

 

 

1 A reconciliation of all non-GAAP measures can be found starting on page 10 of this letter.

 

  2  

  

VEVYE® Access for All

 

VEVYE is a patented formulation of 0.1% cyclosporine delivered in a semi-fluorinated alkane (SFA) vehicle, indicated for the signs and symptoms of DED. It is also the only SFA-based product in the U.S. market that contains an anti-inflammatory active pharmaceutical ingredient, differentiating it in function and feel from every competitor.

 

January 2025 marked the first anniversary of VEVYE’s launch, with physician and patient interest continuing to exceed our expectations, particularly regarding our exceptional refill rate. VEVYE’s prescription growth rose by 44% from the third quarter to the fourth quarter of 2024 (see slide 7 of our 4Q24 corporate deck). National market share gains were impressive, with VEVYE approaching 5% of the total DED market, based on IQVIA datasets.

 

Our commercial team has done a fantastic job spearheading VEVYE’s debut, leveraging prescriber and patient dissatisfaction with older, less efficacious, and less tolerable treatments that led many to over-the-counter (OTC) non-disease-modifying options. However, with the introduction of more effective and tolerable prescription products like VEVYE, these patients are returning to prescription therapies, resulting in market expansion for the prescription category – and an outstanding first year for VEVYE.

 

The real VEVYE market share story is in many discrete markets where VEVYE massively outperforms national market share numbers. In fact, we have a greater than 10% share in eight major metropolitan markets we cover.

 

Here is the even better VEVYE news: We believe we have a clear signal that we can achieve our market leadership goals for VEVYE – including double-digit market share status in other major markets – with a few tweaks to our market access program.

 

Regarding market access, even the most phenomenal drugs can still fail due to procedural and financial barriers, as well as other logistical impediments, which are often imposed by middlemen between patients, prescribers, and the necessary prescription medications. The net effect for patients is not having access to what they are prescribed. Access is critical to ensuring patients benefit from the best available treatments, and Harrow is 100% committed to rooting out and eliminating access barriers to VEVYE. After all, a great clinical option like VEVYE means little if patients can’t obtain or afford it.

 

To match words with action, we recently launched the groundbreaking VEVYE® Access for All Program. This program guarantees access to VEVYE for eligible patients and health plans, ensuring that every patient can affordably start treatment without obstacles. I believe this is the most generous market access program in the U.S. prescription dry eye market.

 

VEVYE Access for All unshackles eyecare professionals and their staff from the costs of managing prior authorizations, “step-therapy,” and other administrative burdens. It improves VEVYE accessibility for patients with Medicare Part D, Commercial insurance, Medicaid, or no insurance. It also expands our market by providing affordable access to a disease-modifying prescription product choice for individuals suffering from dry eye who currently use high-priced OTC tear substitutes and lubricants.

 

I expect VEVYE Access for All, coupled with another soon-to-be-announced program, to accelerate our market momentum, increase commercially covered prescriptions, and strengthen prescriber confidence by ensuring that when they write a VEVYE prescription, their patients will receive it – free from any implicit challenge to their professional ethics or clinical intelligence.

 

  3  

 

 

For Harrow stockholders, VEVYE Access for All should translate into higher prescription volumes – both initial fills and refills – and steady revenue growth for our VEVYE franchise. Most importantly, it ensures profitability for every VEVYE prescription without forcing Harrow to “invest in coverage” and risk losing money on a significant portion of these prescriptions. In industry terms, “investing in coverage” typically means offering large rebates to middlemen over several years in exchange for formulary access. In competitive markets like dry eye disease, these rebates, combined with other steep commercial costs, can result in a net loss per prescription that is hard to reverse. Even worse, for most branded dry eye products, patients often face out-of-pocket costs exceeding what most patients will now pay for VEVYE, regardless of insurance coverage or formulary status. And – even worse for prescribers – they remain on the hook to wrestle with prior authorization and step-therapy hassles. I hope our stockholders are pleased with the approach we’ve decided to take!

 

Lastly, during the second quarter of 2025, some of our partners will cease reporting VEVYE prescription data to third-party aggregators, such as IQVIA. Consequently, VEVYE data from these sources will soon become more inaccurate. That said, we will continue to update the market with certain performance metrics in our public-facing communications at the end of each reporting period.

 

Harrow’s Posterior Segment

 

Harrow’s posterior segment portfolio includes IHEEZO and TRIESENCE. This portfolio achieved significant milestones during the fourth quarter, driven by our all-star commercial team that delivered increased product adoption, expanded and strengthened strategic relationships with the U.S. retina community, and fostered strong customer engagement by highlighting the clinical merits of our product portfolio.

 

Of note, during the fourth quarter, Harrow executed its first agreement with a Group Purchasing Organization (GPO) for both IHEEZO and TRIESENCE, providing access to a key product procurement marketplace relied upon by retina accounts of all sizes. This first GPO agreement has been well received, enhancing awareness of both products. Harrow is already planning additional GPO agreements to expand market access, increase product visibility, and streamline the ordering process for the retina community.

 

Harrow remains focused on expanding patient access and utilization for IHEEZO and TRIESENCE across Medicare and commercial patient populations. This commitment is exemplified by the late January 2025 launch of “Harrow Cares,” a comprehensive program designed to enhance access and affordability. The initiative streamlines enrollment, accelerates therapy initiation, and provides personalized support, empowering retina specialists to confidently utilize IHEEZO and TRIESENCE in their practices. Additionally, Harrow is strengthening its engagement with the retina community through peer-to-peer education, key opinion leader (KOL) collaborations, and strategic initiatives at major industry congresses.

 

IHEEZO Update

 

Our previously announced “Retina Pivot” drove IHEEZO’s strong momentum in the fourth quarter, with customer unit demand volumes increasing 43% to 49,130 units compared with 34,468 units in the third quarter of 2024. This represents IHEEZO’s highest quarter-over-quarter revenue growth since its launch in April of 2023 and resulted in revenue of $23 million in the fourth quarter of 2024, or 34% of Harrow’s total revenues. Customer unit demand remains on the rise, supported by an impressive 86% reorder rate, consistent numbers of new IHEEZO accounts, and positive feedback from physicians and patients regarding the numerous clinical benefits IHEEZO offers. Given the overall market opportunity for IHEEZO, while there will be quarterly fluctuations in unit demand, we expect meaningful and continued year-over-year revenue growth for many years.

 

  4  

  

TRIESENCE Update

 

As expected, TRIESENCE is fulfilling a critical unmet market need. Highly trusted by eyecare physicians and much preferred over the potentially dangerous off-label alternatives, TRIESENCE has a broad label and cost advantages over other branded steroids. These factors have enabled us to position TRIESENCE as a clinically compelling choice for retina specialists during this relaunch. Since its relaunch in October 2024, Harrow has expanded its customer base by over 230 new accounts, significantly increasing its presence among retina specialists nationwide.

 

With the above said, eyecare professionals will not purchase TRIESENCE if they cannot receive adequate and timely reimbursement. When we acquired TRIESENCE, market access activities were not maintained and needed attention. Our team has been working diligently and has made significant progress. As you will see below, we are optimizing access for prescribers and patients at both private and public payor levels, with more payers establishing coverage for TRIESENCE in office and hospital settings. We expect this trend to continue, enabling TRIESENCE to contribute more meaningfully to our revenues. Here are some specific TRIESENCE wins our team is responsible for:

 

We recently announced a five-year strategic supply and development agreement for TRIESENCE with the current U.S.-based contract manufacturing organization (CMO) producing TRIESENCE. This agreement will increase supply assurance by leveraging more than 15 years of experience with the TRIESENCE manufacturing process

 

We also announced that we had begun developing a next-generation version of TRIESENCE and intend to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) before the end of 2027.

 

The TRIESENCE permanent, product-specific J-Code (J3300), which enables individual billing in the in-office setting for ophthalmologists, optometrists, and retina specialists, has now been successfully billed by all 12 Medicare Administrative Contractors (MACs).

 

The Centers for Medicare & Medicaid Services (CMS) recently published and confirmed the Average Sales Price (ASP) amount for TRIESENCE, effective April 1, 2025.  This transparency provides clarity into the expected reimbursement per unit, assurance of coverage through Medicare (including Medicare Advantage), and market validation for ASP pricing among commercial carriers – all while offering physicians greater simplicity and predictability in the adjudication and reimbursement process for TRIESENCE.

 

CMS recently granted TRIESENCE transitional pass-through reimbursement status – similar to what was granted to IHEEZO in March 2023. Starting on April 1, 2025, and for the following three years, TRIESENCE will be eligible for separate, full reimbursement outside of the bundled surgical payment in both Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) settings of care. This change is particularly beneficial for ASCs, where procedures are typically reimbursed under a bundled payment system that includes both the procedure and the associated drugs. With pass-through status, ASCs can now receive reimbursement based on the Average Sales Price (ASP) + 6% in both the ASC and HOPD settings of case.

 

Specialty Branded Products

 

Our Specialty Branded Products (SBPs), one of the broadest portfolios in the North American market, consists of ILEVRO®, NEVANAC®, VIGAMOX®, MAXITROL®, MAXIDEX®, IOPIDINE®, NATACYN™, FLAREX®, TOBRADEX® ST, VERKAZIA®, FRESHKOTE®, and ZERVIATE®. These trusted products have helped establish Harrow as a leading ophthalmic pharmaceutical company by ensuring eyecare professionals can access these important products. For our stockholders, this portfolio represents a strong and growing financial asset, driving meaningful revenue and margin contributions that support Harrow’s continued success.

 

  5  

  

ImprimisRx

 

ImprimisRx performed well during the fourth quarter, contributing record quarterly revenues and the highest annual revenue level in its 10-plus-year history.

 

As some of you may know, the Harrow you know today was largely built by leveraging ImprimisRx. Consistent with that theme, we launched Project Beagle this year, a 360-degree review of opportunities to offer ImprimisRx customers a Harrow-owned FDA-approved SBP alternative to a compounded formulation. To be clear, we are not exiting compounding. Thousands of U.S. eyecare professionals rely on our ImprimisRx compounded products to treat sight-threatening and sight-preserving conditions. ImprimisRx products are also used by numerous eyecare professionals each year to help give the gift of sight to tens of thousands of patients worldwide in medical missions. I don’t want our commitment to support mission work ever to end. That said, we’ve successfully reduced the cost structure for many of our SBPs (manufactured by third-party CMOs) to the point that we can lower costs for customers while potentially increasing our profitability.

 

Finally, during the fourth quarter of last year, we announced that we had received a $34.9 million jury verdict award in the case of ImprimisRx, LLC v. OSRX, Inc. (OSRX). The eight-member jury in this case unanimously found OSRX, Inc. or Ocular Science, Inc. acted with malice, fraud, or oppression and willfully engaged in trademark infringement and unfair competition under California and federal law. As a part of their verdict, the jury awarded over $20 million in punitive damages. We look forward to updating our stockholders as this case progresses through the final litigation stages before collection proceedings can commence.

 

Future Acquisitions

 

Andrew and I are excited about a few acquisition and in-licensing opportunities we’ve been working on. As usual, there are two sides to every deal, and we cannot control whether we will ultimately close any specific deal. Count on us to not waver from our approach to acquisitions and the co-opted “Buffett Criteria” I described in my last Letter to Stockholders, requiring that an opportunity must be (1) meaningful, (2) sensible, and (3) increase stockholder value on a per-share basis. We have zero interest in risky science projects. Instead, we look for very “easy pitches” – meaning (a) a clear and defined regulatory pathway, (b) limited development investment requirements and rapid completion of development to an NDA submission, and (c) an informed expectation of payment sufficient to generate an attractive return on our investment.

 

One opportunity may be with a business we founded – Melt Pharmaceuticals, Inc. (Melt). Melt is a clinical-stage pharmaceutical company focused on developing non-opioid, non-IV sedation therapeutics for medical procedures in the hospital, outpatient, and in-office settings – including ophthalmic procedures. Melt’s core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the Middle East. Harrow already owns approximately 45% of Melt’s equity interests and a 5% royalty interest in Melt’s MELT-300 program. For Harrow stockholders, an FDA-approved MELT-300 would result in a loss of revenue from ImprimisRx’s compounded MKO Melt, equivalent to approximately 1% of our overall revenue. However, concurrently, Harrow would expect an increased value in its Melt equity and a royalty structure that could far exceed the profits from the MKO Melt. With projected sales of over 175,000 MKO Melt units in 2025, an FDA-approved MELT-300 could significantly boost market unit demand, setting the stage for a powerful launch and potentially serving as another example of Project Beagle.

 

  6  

  

Capital Structure

 

Below are the details of Harrow’s current debt obligations, which total approximately $222.75 million:

 

Type

 

Principal Amount

(in millions)

   

Details

 

Issued

 

Maturing

Senior Debt   $ 107.50     Oaktree facility, interest-only   Mar 2023   Jan 2026
Unsecured Senior Notes   $ 75.00     Nasdaq: HROWL, 8.625% interest rate   Apr 2021   Apr 2026
Unsecured Senior Notes   $ 40.25     Nasdaq: HROWM, 11.875% interest rate   Dec 2022   Dec 2027

 

We are currently engaged in discussions with our lenders and other potential partners to review options for refinancing or fully or partially repaying our debt obligations. These discussions involve multiple parties.

 

Our objective is to reduce our cost of capital, enhance financial flexibility, and ensure that we have the necessary resources to continue pursuing strategic opportunities. Given the business’s performance, we remain confident in our ability to achieve these goals in a manner that delivers long-term value to our stockholders.

 

Finally, it’s worth highlighting that Andrew and I have been working for over 12 years for our equity in Harrow. A substantial portion of our personal net worth is invested in Harrow common stock – shares we have earned, purchased for cash, and never sold. Therefore, rest assured that our interests are aligned, and we are working diligently to ensure that Harrow’s debt does not jeopardize the value of Harrow’s common stock – now or in the future.

 

Conclusion

 

I hope you are pleased with our 2024 performance and the expectations we have set for this year. Last year, there are things we could have done better, but we ultimately got many things right. All in all, it was an incredibly positive year of growth, setting the stage for our march toward achieving the long-term goals outlined in our Five-Year Strategic Plan. With 2025 underway, we aim to accelerate our momentum and reach even more remarkable successes this year and beyond.

 

To our stockholders, partners, and the entire Harrow Family, thank you for your trust and support. The future at Harrow is bright, and we look forward to sharing its promise with each of you. As many of you have heard me say… and it remains my perspective – “We are just getting started!”

 

Sincerely,

 

Mark L. Baum

Founder, Chairman of the Board, and Chief Executive Officer

Nashville, Tennessee

 

Index to Previous Letters to Stockholders

 

2024   2023   2022   2021   2020   2019
    4Q 2023   4Q 2022   4Q 2021   4Q 2020   4Q 2019
3Q 2024   3Q 2023   3Q 2022   3Q 2021   3Q 2020   3Q 2019
2Q 2024   2Q 2023   2Q 2022   2Q 2021   2Q 2020    
1Q 2024   1Q 2023   1Q 2022   1Q 2021   1Q 2020    

 

  7  

 

Fourth Quarter and Full-Year 2024 Financial Overview

 

GAAP Operating Results

 

Selected financial highlights regarding GAAP operating results for the three months and year ended December 31, 2024 and for the same periods in 2023 are as follows:

 

   

For the Three Months Ended
December 31,

   

For the Year Ended
December 31,

 
   

2024

   

2023

   

2024

   

2023

 
Total revenues   $ 66,831,000     $ 36,355,000     $ 199,614,000     $ 130,193,000  
Cost of sales     14,135,000       11,302,000       49,245,000       39,640,000  
Gross profit     52,696,000       25,053,000       150,369,000       90,553,000  
Selling, general and administrative     34,789,000       26,212,000       129,064,000       83,090,000  
Research and development     4,755,000       3,336,000       12,230,000       6,652,000  
Impairment of long-lived assets     253,000       380,000       253,000       380,000  
Total operating expenses     39,797,000       29,928,000       141,547,000       90,122,000  
Income (loss) from operations     12,899,000       (4,875,000 )     8,822,000       431,000  
Total other expense, net     (6,636,000 )     (4,808,000 )     (26,142,000 )     (24,141,000 )
Income tax benefit (expense )     514,000       535,000       (161,000 )     (701,000 )
Net income (loss) attributable to Harrow, Inc.   $ 6,777,000     $ (9,148,000 )   $ (17,481,000 )   $ (24,411,000 )
Net income (loss) per share:                                
Basic   $ 0.19     $ (0.26 )   $ (0.49 )   $ (0.75 )
Diluted   $ 0.24     $ (0.26 )   $ (0.49 )   $ (0.75 )

 

Core Results (Non-GAAP Measures)

 

Core Results (non-GAAP measures), which we define as the after-tax earnings and other operational and financial metrics generated from our principal business, for the three months and year ended December 31, 2024 and for the same periods in 2023 are as follows:

 

   

For the Three Months Ended
December 31,

   

For the Year Ended
December 31,

 
   

2024

   

2023

   

2024

   

2023

 
Total revenues   $ 66,831,000     $ 36,355,000     $ 199,614,000     $ 130,193,000  
Gross margin     79 %     69 %     75 %     70 %
Core gross margin(1)     84 %     75 %     80 %     77 %
Net income (loss)     6,777,000       (9,148,000 )     (17,481,000 )     (24,411,000 )
Core net income (loss)(1)     11,366,000       (7,016,000 )     (2,089,000 )     (11,512,000 )
Adjusted EBITDA(1)     22,489,000       2,563,000       40,327,000       28,119,000  
Net income (loss) per share:                                
Basic     0.19       (0.26 )     (0.49 )     (0.75 )
Diluted     0.24       (0.26 )     (0.49 )     (0.75 )
Core net income (loss) per share:(1)                                
Basic     0.32       (0.20 )     (0.06 )     (0.35 )
Diluted     0.40       (0.20 )     (0.06 )     (0.35 )

 

(1) Core gross margin, core net income (loss), core basic and diluted net income (loss) per share (collectively, “Core Results”), and Adjusted EBITDA are non-GAAP measures. For additional information, including a reconciliation of such Core Results and Adjusted EBITDA to the most directly comparable measures presented in accordance with GAAP, see the explanation of non-GAAP measures and reconciliation tables at the end of this Letter to Stockholders.

 

  8  

 

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, 2024, subsequent Quarterly Reports on Form 10-Q, 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, specifically Adjusted EBITDA, adjusted earnings, core gross margin, core net income (loss), and core basic and diluted net income (loss) per share. A reconciliation of non-GAAP measures with the most directly comparable GAAP measures is included in 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.

 

  9  

  

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 and Core Results, unaudited financial measures that are not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA and Core Results are considered “non-GAAP” financial measures within the meaning of Regulation G promulgated by the SEC. Management believes that these non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provide a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA and Core Results provide meaningful supplemental information regarding the Company’s performance because (i) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) they exclude 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) they are used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA, Core Results, and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

 

Adjusted EBITDA

 

The Company defines Adjusted EBITDA as net income (loss), excluding the effects of stock-based compensation and expenses, impairment of intangible assets, interest, taxes, depreciation, amortization, investment (income) loss, net, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net income (loss). Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net loss as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.

 

The following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net income (loss), for the three months and year ended December 31, 2024 and for the same periods in 2023:

 

    For the Three Months Ended
December 31,
    For the Year Ended
December 31,
 
    2024     2023     2024     2023  
GAAP net income (loss)   $ 6,777,000     $ (9,148,000 )   $ (17,481,000 )   $ (24,411,000 )
Stock-based compensation and expenses     4,794,000       4,175,000       17,619,000       15,696,000  
Impairment of intangible assets     253,000       380,000       253,000       380,000  
Interest expense, net     6,375,000       5,124,000       22,786,000       21,324,000  
Income tax (benefit) expense     (514,000 )     (535,000 )     161,000       701,000  
Depreciation     468,000       435,000       1,850,000       1,530,000  
Amortization of intangible assets     4,075,000       2,448,000       11,783,000       10,082,000  
Investment (income) loss, net     -       (416,000 )     3,171,000       (3,092,000 )
Loss on disposal of equipment     -       146,000       -       168,000  
Other expense (income), net     261,000       (46,000 )     185,000       5,741,000 (1)
Adjusted EBITDA   $ 22,489,000     $ 2,563,000     $ 40,327,000     $ 28,119,000  

 

(1) Includes $5,465,000 for the loss on extinguishment of debt.

 

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Core Results

 

Harrow Core Results, including core gross margin, core net income (loss), and core basic and diluted income (loss) per share exclude (1) all amortization and impairment charges of intangible assets, excluding software development costs, (2) net gains and losses on investments and equity securities, including equity method gains and losses and equity valued at fair value through profit and loss (FVPL), and preferred stock dividends, and (3) gains/losses on forgiveness of debt. In certain periods, Core Results may also exclude fair value adjustments of financial assets in the form of options to acquire a company carried at FVPL, obligations related to product recalls, certain acquisition-related items, restructuring charges/releases and associated items, related legal items, gains/losses on early extinguishment of debt or debt modifications, impairments of property, plant and equipment and software, as well as income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a $100,000 threshold.

 

The following is a reconciliation of Core Results, non-GAAP measures, to the most comparable GAAP measures for the three months and year ended December 31, 2024 and for the same periods in 2023:

 

For the Three Months Ended December 31, 2024
   

GAAP

Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment

Gains

(Losses)

   

Other

Items

   

Core

Results

 
Gross profit   $ 52,696,000     $ 3,622,000     $ -     $      -     $ -     $ 56,318,000  
Gross margin     79 %                                     84 %
Operating income     12,899,000       4,075,000       253,000       -       -       17,227,000  
Income before taxes     6,263,000       4,075,000       253,000       -       261,000       10,852,000  
Taxes     514,000       -       -       -       -       514,000  
Net income     6,777,000       4,075,000       253,000       -       261,000       11,366,000  
Income per share ($)(1):                                                
Basic     0.19                                       0.32  
Diluted     0.24                                       0.40  
Weighted average number of shares of common stock outstanding:                                                
Basic     35,807,767                                       35,807,767  
Diluted     28,317,740                                       28,317,740  

 

For the Year Ended December 31, 2024

   

GAAP

Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment

Gains

(Losses)

   

Other

Items

   

Core

Results

 
Gross profit   $ 150,369,000     $ 10,093,000     $ -     $ -     $ -     $ 160,462,000  
Gross margin     75 %                                     80 %
Operating income     8,822,000       11,783,000       253,000       -       -       20,858,000  
(Loss) income before taxes     (17,320,000 )     11,783,000       253,000       3,171,000       185,000       (1,928,000 )
Tax expense     (161,000 )     -       -       -       -       (161,000 )
Net (loss) income     (17,481,000 )     11,783,000       253,000       3,171,000       185,000       (2,089,000 )
Basic and diluted loss per share ($)(1)     (0.49 )                                     (0.06 )
Weighted average number
of shares of common stock outstanding, basic and diluted
    35,650,714                                       35,650,714  

 

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For the Three Months Ended December 31, 2023
   

GAAP
Results

   

Amortization
of Certain
Intangible
Assets

   

Impairments

   

Investment
Gains
(Losses)

   

Other 
Items

   

Core
Results

 
Gross profit   $ 25,053,000     $ 2,140,000     $      -     $ -     $ -     $ 27,193,000  
Gross margin     69 %                                     75 %
Operating (loss) income     (4,875,000 )     2,448,000       -       -       -       (2,427,000 )
(Loss) income before taxes     (9,683,000 )     2,448,000       -       (416,000 )     100,000       (7,551,000 )
Tax benefit     535,000       -       -       -       -       535,000  
Net (loss) income     (9,148,000 )     2,448,000       -       (416,000 )     100,000       (7,016,000 )
Basic and diluted loss per share ($)(1)     (0.26 )                                     (0.20 )
Weighted average number of shares of common stock outstanding, basic and diluted     35,353,848                                       35,353,848  

 

For the Year Ended December 31, 2023

   

GAAP
Results

   

Amortization 
of Certain
Intangible
Assets

   

Impairments

   

Investment
Gains
(Losses)

   

Other 
Items

   

Core
Results

 
Gross profit   $ 90,553,000     $ 9,314,000     $       -     $ -     $ -     $ 99,867,000  
Gross margin     70 %                                     77 %
Operating income     431,000       10,082,000       -       -       -       10,513,000  
(Loss) income before taxes     (23,710,000 )     10,082,000       -       (3,092,000 )     5,909,000       (10,811,000 )
Tax expense     (701,000 )     -       -       -       -       (701,000 )
Net (loss) income     (24,411,000 )     10,082,000       -       (3,092,000 )     5,909,000       (11,512,000 )
Basic and diluted loss per share ($)(1)     (0.75 )                                     (0.35 )
Weighted average number of shares of common stock outstanding, basic and diluted     32,616,777                                       32,616,777  

 

(1) Core basic and diluted income (loss) per share is calculated using the weighted-average number of shares of common stock outstanding during the period. Core basic and diluted income (loss) per share also contemplates dilutive shares associated with equity-based awards as described in Note 2 and elsewhere in the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

 

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