Harrow Announces First Quarter 2024 Financial Results

Rhea-AI Summary

Harrow (Nasdaq: HROW) reported its first quarter 2024 financial results, with revenues reaching $34.6 million, a 33% increase from the prior-year quarter. Gross margin was steady at 69%, while net loss increased to $13.6 million from $6.6 million in Q1 2023. Key highlights include IHEEZO's new CMS reimbursement approval, seven new supply agreements, and new patent claims valid through 2039. VEVYE's coverage expanded to 150 million lives, and ImprimisRx returned to quarterly growth. Cash reserves totaled $76 million as of March 31, 2024, with an additional $5.5 million from recent Eton Pharmaceuticals stock sales. Harrow remains focused on expanding its dry eye and retina franchises and stabilizing ImprimisRx.

Positive

• Revenues rose by 33% to $34.6 million in Q1 2024.
• Gross margin remained stable at 69%.
• IHEEZO received CMS reimbursement approval, effective from January 1, 2024.
• New IHEEZO patent claims granted, valid through 2039.
• VEVYE's coverage increased to over 150 million lives.
• ImprimisRx returned to sequential quarterly growth.
• Cash and cash equivalents were $76 million as of March 31, 2024.
• Recent Eton Pharmaceuticals stock sales yielded an additional $5.5 million.

Negative

• Net loss increased to $13.6 million, up from $6.6 million in Q1 2023.
• Core net loss widened to $9.8 million from $1 million in the prior-year quarter.
• Adjusted EBITDA dropped significantly to $227,000 from $5.3 million in Q1 2023.
• Basic and diluted net loss per share increased to $0.38 from $0.22.

Insights

Financial Analyst

The recent financial report from Harrow shows a revenue increase of 33% year-over-year, reaching $34.6 million for Q1 2024. This surge is a positive indicator of the company's growth trajectory, especially in the competitive eyecare pharmaceutical market. While the gross margin remains stable at 69%, the net loss has widened to $13.6 million compared to $6.6 million in Q1 2023. Despite the revenue growth, the core net loss and adjusted EBITDA levels suggest that the company is still navigating through substantial operational costs.

On the liquidity front, Harrow reported $76.0 million in cash and cash equivalents as of March 31, 2024. The sale of Eton Pharmaceuticals stock added $5.5 million, providing additional strategic capital.

For retail investors, the key takeaway here is that while the company shows promising revenue growth, the bottom line is still in the red. This indicates a need for cautious optimism. Long-term growth prospects look positive given the strategic investments, but the immediate financial health is a mixed bag.

Market Research Analyst

Harrow’s expansion with IHEEZO, supported by new multi-practice supply agreements and CMS reimbursement confirmation, signals a strong push into the retina franchise. The CMS news extends the product's reach, making it more financially accessible for procedures, which is important for market penetration.

Additionally, the granting of new patent claims for IHEEZO through 2039 provides a long-term competitive edge, securing its position in the market. VEVYE's growth trajectory also looks promising, with a significant increase in covered lives from 40 million to 150+ million, indicating a robust uptake and acceptance in the market.

For investors, these developments underscore a strategic positioning in the market, with patents and reimbursements serving as key growth levers. The company's focus on these products suggests that there are solid foundations for future revenue streams.

Medical Research Analyst

The sequential growth in prescriptions and prescribers for VEVYE and the preliminary passing of assays for TRIESENCE highlight Harrow's strides in advancing its product pipeline. VEVYE’s increasing coverage indicates a broadening market acceptance, essential for capturing a larger share of the dry eye disease market.

On a clinical front, meeting preliminary assay criteria for TRIESENCE is a critical step towards its reintroduction. This product’s return to the market could bolster Harrow's portfolio, particularly in the retina segment, enhancing its appeal to clinicians and patients alike.

Investors should take note of these product developments as they signify potential for substantial market penetration and revenue generation in the near future. Successful clinical advancements often translate to strong market performance.

First Quarter 2024 and Recent Selected Highlights:

• Revenues of $34.6 million, a 33% increase over the $26.1 million realized in the prior-year quarter.
• Received confirmation from the Centers for Medicare & Medicaid Services (CMS) on March 20 that IHEEZO is separately reimbursable for unilateral and bilateral in-office procedures, retroactive to January 1, 2024.
• Recently signed IHEEZO supply agreements with seven multi-practice strategic accounts.
• U.S. Patent and Trademark Office recently granted new IHEEZO patent claims with an expiry through 2039.
• Sequential month-over-month growth in VEVYE total prescriptions, new prescriptions, prescribers, and refills.
• Covered lives for VEVYE increased to 150⁺ million, up from 40⁺ million, as reported in March.
• Passing all preliminary assays for recent TRIESENCE process performance qualification (PPQ) batch.
• ImprimisRx revenues returned to sequential quarterly growth.
• Cash and cash equivalents as of March 31, 2024, of $76.0 million (including Eton Pharmaceuticals shares).
• Sold Eton Pharmaceuticals common stock in April 2024, yielding $5.5 million in cash that can be deployed strategically to drive value in Harrow’s core ophthalmic pharmaceuticals business.

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, announced results for the first quarter ended March 31, 2024. The Company also posted its first 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 primary focus for 2024 remains on three key operational initiatives – building a formidable dry eye disease franchise, including successfully launching VEVYE®; continuing to build a retina franchise with IHEEZO® and TRIESENCE®; and stabilizing ImprimisRx and our Anterior Segment Products and returning them to a growth trajectory,” said Mark L. Baum, Chief Executive Officer of Harrow. “I am very pleased with the success we had in all three of these areas during the first quarter, and I remain optimistic for 2024 based on what we are seeing in the second quarter.

“Given the strength we see with both IHEEZO and VEVYE, the upcoming re‑introduction of TRIESENCE to the ophthalmic market, and the significant momentum that we have built so far in 2024, we are well positioned to meet our 2024 revenue guidance of more than $180 million.”

First quarter 2024 figures of merit:

	For the Three Months Ended March 31,
	2024				2023
Net revenues	$	34,587,000			$	26,103,000
Gross margin		69	%			68	%
Core gross margin(1)		76	%			76	%
Net loss		(13,565,000	)			(6,643,000	)
Core net loss(1)		(9,789,000	)			(1,042,000	)
Adjusted EBITDA(1)		227,000				5,342,000
Basic and diluted net loss per share		(0.38	)			(0.22	)
Core basic and diluted net loss per share(1)		(0.28	)			(0.03	)

(1)

Core gross margin, core net loss, core basic and diluted net 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.

Conference Call and Webcast

The Company’s management team will host a conference call and live webcast tomorrow morning, Tuesday, May 14, 2024, at 8:00 a.m. Eastern Time to discuss the first quarter 2024 results and provide a business update. To participate in the call, see details below:

Conference Call Details:
Date:	Tuesday, May 14, 2024
Time:	8:00 a.m. Eastern time
Participant Dial-in:	1-833-953-2434 (U.S.) 1-412-317-5763 (International)
Replay Dial-in (Passcode 3093849): (telephonic replay through May 21, 2024)	1-877-344-7529 (U.S.) 1-412-317-0088 (International)
Webcast: (online replay through May 14, 2025)	harrow.com

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 comprehensive portfolio of prescription and non‑prescription 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; 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, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. 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.

HARROW, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
	March 31, 2024			December 31, 2023
	(unaudited)
ASSETS
Cash and cash equivalents	$	68,538,000		$	74,085,000
All other current assets		56,920,000			66,407,000
Total current assets		125,458,000			140,492,000
All other assets		170,078,000			172,682,000
TOTAL ASSETS	$	295,536,000		$	313,174,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities	$	41,753,000		$	50,354,000
Loans payable, net of unamortized debt discount		184,148,000			183,172,000
All other liabilities		9,429,000			9,237,000
TOTAL LIABILITIES		235,330,000			242,763,000
TOTAL STOCKHOLDERS' EQUITY		60,206,000			70,411,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	295,536,000		$	313,174,000

HARROW, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
	For the Three Months Ended March 31,
	2024				2023
Net revenues	$	34,587,000			$	26,103,000
Cost of sales		10,553,000				8,271,000
Gross profit		24,034,000				17,832,000
Selling, general and administrative		28,813,000				15,888,000
Research and development		2,149,000				734,000
Total operating expenses		30,962,000				16,622,000
(Loss) income from operations		(6,928,000	)			1,210,000
Total other expense, net		(6,637,000	)			(8,141,000	)
Income tax expense		-				288,000
Net loss attributable to Harrow, Inc.	$	(13,565,000	)		$	(6,643,000	)
Net loss per share of common stock, basic and diluted	$	(0.38	)		$	(0.22	)

HARROW, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
	For the Three Months Ended March 31,
	2024				2023
Net cash provided by (used in):
Operating activities	$	(4,628,000	)		$	(8,214,000	)
Investing activities		(110,000	)			(130,970,000	)
Financing activities		(809,000	)			62,162,000
Net change in cash and cash equivalents		(5,547,000	)			(77,022,000	)
Cash and cash equivalents at beginning of the period		74,085,000				96,270,000
Cash and cash equivalents at end of the period	$	68,538,000			$	19,248,000

Non-GAAP Financial Measures

In addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP), which are presented and discussed above, management also utilizes Adjusted EBITDA 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 loss, excluding the effects of stock‑based compensation and expenses, 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 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 loss, for the three months ended March 31, 2024 and 2023:

HARROW, INC. RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA
	For the Three Months Ended March 31,
	2024				2023
GAAP net loss	$	(13,565,000	)		$	(6,643,000	)
Stock-based compensation and expenses		4,169,000				1,633,000
Interest expense, net		5,415,000				4,747,000
Income tax benefit		-				(288,000	)
Depreciation		432,000				292,000
Amortization of intangible assets		2,554,000				2,207,000
Investment loss (income), net		1,248,000				(2,042,000	)
Other (income) expense, net		(26,000	)		5,436,000(1)
Adjusted EBITDA	$	227,000			$	5,342,000

(1)

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

Core Results

Harrow Core Results, including core gross margin, core net loss, and core basic and diluted 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 other 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 ended March 31, 2024 and 2023:

For the Three Months Ended March 31, 2024
	GAAP Results				Amortization of Certain Intangible Assets			Investment Gains			Other Items				Core Results
Gross profit	$	24,034,000			$	2,140,000		$	-		$	-			$	26,174,000
Gross margin		69	%													76	%
Operating loss		(6,928,000	)			2,554,000			-			-				(4,374,000	)
Loss before taxes		(13,565,000	)			2,554,000			1,248,000			(26,000	)			(9,789,000	)
Tax benefit		-				-			-			-				-
Net loss		(13,565,000	)			2,554,000			1,248,000			(26,000	)			(9,789,000	)
Basic and diluted loss per share ($)(1)		(0.38	)													(0.28	)
Weighted average number of shares of common stock outstanding, basic and diluted		35,469,638														35,469,638

For the Three Months Ended March 31, 2023
	GAAP Results				Amortization of Certain Intangible Assets			Investment Gains				Other Items			Core Results
Gross profit	$	17,832,000			$	2,045,000		$	-			$	-		$	19,877,000
Gross margin		68	%													76	%
Operating income		1,210,000				2,207,000			-				-			3,417,000
Loss before taxes		(6,931,000	)			2,207,000			(2,042,000	)			5,436,000			(1,330,000	)
Tax expense		288,000				-			-				-			288,000
Net loss		(6,643,000	)			2,207,000			(2,042,000	)			5,436,000			(1,042,000	)
Basic and diluted loss per share ($)(1)		(0.22	)													(0.03	)
Weighted average number of shares of common stock outstanding, basic and diluted		30,289,730														30,289,730

(1)

Core basic and diluted loss per share is calculated using the weighted-average number of shares of common stock outstanding during the period. Core basic and diluted 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240513953027/en/

Jamie Webb, Director of Communications and Investor Relations

jwebb@harrowinc.com

615-733-4737

Source: Harrow, Inc.

FAQ

What were Harrow's Q1 2024 revenues?

Harrow's Q1 2024 revenues were $34.6 million, a 33% increase from the prior-year quarter.

What is the new CMS reimbursement approval for IHEEZO?

IHEEZO received CMS reimbursement approval for unilateral and bilateral in-office procedures, retroactive to January 1, 2024.

What are the new patent claims for IHEEZO?

The U.S. Patent and Trademark Office granted new patent claims for IHEEZO, valid through 2039.

How many covered lives does VEVYE now have?

VEVYE's coverage expanded to over 150 million lives, up from 40 million as reported in March.

What was Harrow's cash position as of March 31, 2024?

Harrow had $76 million in cash and cash equivalents as of March 31, 2024.

How did Harrow's net loss change in Q1 2024?

Harrow's net loss increased to $13.6 million in Q1 2024, up from $6.6 million in the prior-year quarter.

What was the impact of Eton Pharmaceuticals stock sales?

The sale of Eton Pharmaceuticals common stock in April 2024 yielded $5.5 million in cash.

What is Harrow's revenue guidance for 2024?

Harrow's 2024 revenue guidance is set at more than $180 million.