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Surging Earnings Estimates Signal Upside for Harrow (HROW) Stock
ZACKS· 2025-08-15 17:21
Core Viewpoint - Harrow (HROW) shows potential as a strong investment opportunity due to significant upward revisions in earnings estimates, indicating an improving earnings outlook [1][2]. Earnings Estimate Revisions - The trend of increasing estimate revisions reflects growing analyst optimism regarding Harrow's earnings prospects, which is expected to positively influence its stock price [2]. - For the current quarter, Harrow is projected to earn $0.16 per share, marking a year-over-year increase of +233.3%. The Zacks Consensus Estimate has risen by 18.52% in the last 30 days, with two estimates increasing and no negative revisions [5]. - For the full year, the earnings estimate stands at $0.28 per share, representing a +171.8% change from the previous year. Similar to the current quarter, two estimates have been revised upward with no negative changes [6]. Zacks Rank - Harrow has achieved a Zacks Rank 1 (Strong Buy) due to favorable estimate revisions, which is a reliable indicator of potential stock performance. Historically, Zacks 1 Ranked stocks have delivered an average annual return of +25% since 2008 [3][7]. - Stocks with Zacks Rank 1 (Strong Buy) and Rank 2 (Buy) have been shown to significantly outperform the S&P 500 [7]. Stock Performance - Harrow's stock has increased by 10.7% over the past four weeks, driven by strong estimate revisions, suggesting that there may still be further upside potential [8].
Wall Street Analysts Think Harrow (HROW) Could Surge 53.24%: Read This Before Placing a Bet
ZACKS· 2025-08-15 14:55
Group 1 - Harrow (HROW) shares have increased by 10.7% in the past four weeks, closing at $40.01, with a mean price target of $61.31 indicating a potential upside of 53.2% [1] - The mean estimate consists of seven short-term price targets with a standard deviation of $8.32, where the lowest estimate is $52.20 (30.5% increase) and the highest is $76.00 (90% increase) [2] - Analysts show strong agreement in revising earnings estimates higher, with the Zacks Consensus Estimate for the current year increasing by 39% over the past month [11][12] Group 2 - HROW holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [13] - The clustering of price targets with a low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement [9] - While price targets can be misleading, the direction implied by them may serve as a useful guide for potential price movements [10][14]
Harrow's Ambitious Guidance Puts It In The Proving Ground
Seeking Alpha· 2025-08-15 03:09
Group 1 - The article discusses Stephen's background as a Registered Nurse (RN) and an MBA, emphasizing his analytical approach to healthcare and tech stocks through a proprietary system called the "Dizzy Framework" [1] - The "Dizzy Framework" is designed to mitigate common behavioral errors in investing, such as reacting to market noise or adhering too rigidly to prior beliefs, promoting a disciplined investment strategy [1] - Influences on Stephen's investment philosophy include concepts from "Superforecasting" and "Fooled by Randomness," which highlight the importance of quality and timing of information in investment decisions [1]
Harrow: Exciting Times In Store
Seeking Alpha· 2025-08-13 21:39
The Pioneer Of Seeking Alpha's BAD BEAT Investing, Quad 7 Capital is a team of 7 analysts with a wide range of experience sharing investment opportunities for nearly 12 years. They are best known for their February 2020 call to sell everything & go short, & have been on average 95% long 5% short since May 2020. The broader company has expertise in business, policy, economics, mathematics, game theory, & the sciences. They share both long & short trades & invest personally in equities they discuss within the ...
Harrow (HROW) FY Conference Transcript
2025-08-13 13:30
Summary of Harrow (HROW) FY Conference - August 13, 2025 Company Overview - **Company**: Harrow (HROW) - **Industry**: Ophthalmology and Biopharmaceuticals Key Points and Arguments Acquisition and Product Development - Harrow acquired commercial rights to biosimilar drugs referencing Lucentis and Eylea from Sensome Bioethics, indicating a strategic focus on the retina market [3][4] - The company plans to launch these biosimilars in mid-2026, with expectations of significant clinical synergy with their existing anesthetic product, iHizo [6][7] - Harrow also acquired US commercial rights to Biclovy, a novel steroid for postoperative inflammation, which is differentiated by its robust clinical efficacy and safety profile [21][22][24] Market Position and Competitive Landscape - The biosimilar market for Lucentis and Eylea is competitive, with several existing products; however, Harrow's approach is described as bespoke and customer-oriented, leveraging existing relationships with retina clinics [9][10] - Harrow aims to capture market share in the wet AMD and DME markets, targeting both low-cost options and branded products, with each percentage point of market share representing over $80 million in revenue opportunity [12][13] Financial Outlook and Revenue Growth - The company does not anticipate significant revenue contributions from the new biosimilars in 2026 but expects more substantial contributions in 2027 and 2028 [15] - iHizo reported $18.3 million in revenue for Q2, showing a 25% sequential growth, with strong demand in the retina market [30][31] - The existing product portfolio, including Veevae, is experiencing rapid growth, with a current market share of 7.8% in the US dry eye market, aiming to become the number one prescribed cyclosporine [25][26][28] Regulatory and Market Access - The reimbursement landscape for biosimilars is favorable, with established product-specific Q codes for reimbursement [14] - Harrow emphasizes the importance of coverage, reporting low rejection rates for claims related to iHizo and Triassence, which enhances market access [36][38] Future Prospects and Strategic Goals - Harrow is focused on maintaining a stable presence in the market while exploring additional acquisitions to enhance its product portfolio [50][52] - The company is optimistic about the upcoming launch of MELT 300, expected in 2027, which targets sublingual sedation for cataract surgery [44][47] - Upcoming catalysts include the launch of BioViz and continued growth of existing products, with an investor and analyst day scheduled for September 26, 2025, to discuss these developments [56][57] Additional Important Content - The company is committed to patient-first initiatives, welcoming any new products that can benefit patients in the competitive anti-VEGF market [17][18][20] - Harrow's in-premise Rx business is described as stable and cash-generating, with plans to transition more products to FDA-approved status [39][41][43]
Harrow Health(HROW) - 2025 Q2 - Earnings Call Transcript
2025-08-12 13:00
Financial Data and Key Metrics Changes - Total revenue for the second quarter was $63.7 million, a 30% increase year-over-year and a sequential increase of 33% from the previous quarter [13][14] - Adjusted EBITDA for the second quarter was $17 million, with net income of $5 million, highlighting the operating leverage built into the business [15][16] - The company aims for more than $280 million in revenue for 2025, needing approximately $169 million in the second half to meet this guidance [13][14] Business Line Data and Key Metrics Changes - VeeVai generated $18.6 million in revenue, a 13% decrease from the previous year, attributed to a normalization in average selling price (ASP) [16][17] - iHizo generated $18.3 million in revenue, a 251% increase from the previous year, driven by momentum from the retina pivot and expanded distribution [19][20] - Triassence achieved $5.2 million in revenue, a 447% increase from the previous year, with volumes accelerating and market share expanding [20][21] - ImprimisRx generated $21.5 million in revenue, a 7% increase from the previous year, performing as expected and on track to reach $80 million for the year [21] Market Data and Key Metrics Changes - VeeVai captured a 7.8% share of the national dry eye disease market, a 2.6% increase quarter-over-quarter [26] - iHizo's volume grew 33% quarter-over-quarter within the largest retina GPO, representing approximately 70% of the retina market [34] - Triassence achieved 84% coverage with only 8% of claims requiring prior authorization, indicating strong market penetration [36] Company Strategy and Development Direction - The company aims to deliver a quarterly revenue of $250 million by 2027, supported by a sophisticated infrastructure and a diverse portfolio of over 59 prescription products [8][9] - Recent strategic alliances, such as with Apollo Care, are expected to enhance distribution networks and improve ASP for VeeVai [18][19] - The company is preparing to launch Biclovy, a new FDA-approved steroid, in 2026, which is expected to capture significant market opportunities [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting revenue guidance for 2025, citing strong momentum in key growth drivers and a stable cost basis [15][16] - The company anticipates meaningful revenue growth as early as the third quarter, driven by increased prescription volumes and a more stable ASP [24][25] - Management highlighted the importance of maintaining a strong supply chain and safety stock to support future growth [59][60] Other Important Information - The company has secured additional manufacturing capacity for 2025 to meet growing demand for VeeVai and other products [25] - The recent acquisition of Samsung's ophthalmic biosimilars portfolio is expected to enhance the company's competitive position in the market [38] Q&A Session Summary Question: Can you help us with any kind of business rule changes within VeeVai as you onboard Apollo Care? - Management indicated that minor tweaks to the algorithm are ongoing, and the ASP is expected to stabilize and potentially improve by the end of the year due to expanded network coverage [44][45][47] Question: Any thoughts on the contribution of the biosimilars to the model in 2026 and 2027? - Management expressed excitement about the Samsung portfolio and anticipates launching BioViz in 2026, expecting immediate demand due to the existing market [49][50][51] Question: How much of the growth in new prescriptions for VeeVai was driven by Clarity C switchers? - Approximately 7,000 units came from Clarity C during the period, and management is confident in the loyalty of these patients for refills [55][56] Question: What are the expectations for the Specialty Branded and Triassence segment? - Management expects to double revenue levels for ex-Tri Essence products by the end of the year and sees strong growth potential for Triassence in the ocular inflammation market [60][62] Question: How does ApolloCare differ from PHIL in terms of integration with existing plans? - ApolloCare offers extensive contracted plans, which helps capture more commercial covered prescriptions, enhancing ASP stability [78][80]
Harrow Health(HROW) - 2025 Q2 - Earnings Call Presentation
2025-08-12 12:00
Corporate Presentation Aug 2025 Safe Harbor This presentation contains "forward-looking statements" as defined in the U.S. Private Securities Litigation Reform Act of 1995. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Harrow, Inc. (the "Company ...
Harrow Health(HROW) - 2025 Q2 - Quarterly Report
2025-08-11 20:16
[Part I FINANCIAL INFORMATION](index=4&type=section&id=Part%20I%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Harrow, Inc.'s unaudited condensed consolidated financial statements for Q2 and H1 2025 highlight debt reclassification, Q2 profitability, and improved operating cash flow Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$345,033,000** | **$388,971,000** | | Cash and cash equivalents | $52,963,000 | $47,247,000 | | Accounts receivable, net | $78,822,000 | $116,373,000 | | Intangible assets, net | $176,666,000 | $184,949,000 | | **Total Liabilities** | **$295,734,000** | **$319,674,000** | | Current portion of notes payable | $183,619,000 | $0 | | Notes payable, non-current | $38,484,000 | $219,539,000 | | **Total Stockholders' Equity** | **$49,299,000** | **$69,297,000** | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **$63,742,000** | **$48,939,000** | **$111,573,000** | **$83,526,000** | | Gross Profit | $47,512,000 | $36,400,000 | $79,819,000 | $60,434,000 | | Income (Loss) from Operations | $11,409,000 | $1,530,000 | $177,000 | $(5,398,000) | | **Net Income (Loss)** | **$4,995,000** | **$(6,473,000)** | **$(12,785,000)** | **$(20,038,000)** | | Diluted EPS | $0.13 | $(0.18) | $(0.35) | $(0.56) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Net Cash from Operating Activities | $18,865,000 | $(7,374,000) | | Net Cash from Investing Activities | $(505,000) | $4,993,000 | | Net Cash from Financing Activities | $(12,644,000) | $(736,000) | | **Net Change in Cash** | **$5,716,000** | **$(3,117,000)** | [Note 2: Summary of Significant Accounting Policies](index=9&type=section&id=NOTE%202.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note details significant accounting policies, emphasizing liquidity risk from upcoming 2026 debt maturities that raise going concern doubts without successful refinancing - The Oaktree Loan and 2026 Notes, totaling **$182.5 million** in principal, mature in January and April 2026, respectively. The company's ability to continue as a going concern is contingent on refinancing these obligations[21](index=21&type=chunk) - Management is in discussions with current and potential lenders to refinance the debt and believes it is probable they will succeed based on collateral strength and expected cash flows. However, there is no guarantee of success[22](index=22&type=chunk) - As an alternative to refinancing, management is considering the sale of one or more company assets, though the timing and terms of any potential sale are uncertain[23](index=23&type=chunk) [Note 3: Revenues](index=13&type=section&id=NOTE%203.%20REVENUES) Revenue is primarily from product sales, detailing the five-step ASC 606 recognition process and significant judgments for variable consideration like rebates and returns Revenue by Source | Revenue Source | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $63,657,000 | $48,871,000 | $111,402,000 | $83,379,000 | | Other revenues | $85,000 | $68,000 | $171,000 | $147,000 | | **Total revenues** | **$63,742,000** | **$48,939,000** | **$111,573,000** | **$83,526,000** | - Sales of branded pharmaceutical products are subject to variable consideration, including chargebacks, government rebates, returns, and co-pay assistance, which require significant estimation[42](index=42&type=chunk) [Note 10: Debt](index=19&type=section&id=NOTE%2010.%20DEBT) This note details the company's **$222.75 million** total debt, with **$183.6 million** reclassified as current liabilities due to early 2026 maturities - The Oaktree Loan has a principal of **$107.5 million**, matures in January 2026, and carries an interest rate of SOFR + 6.5% (**10.84%** at June 30, 2025)[68](index=68&type=chunk)[69](index=69&type=chunk) - The **8.625%** Senior Notes (HROWL) have a principal of **$75 million** and mature in April 2026[72](index=72&type=chunk) - The **11.875%** Senior Notes (HROWM) have a principal of **$40.25 million** and mature in December 2027[75](index=75&type=chunk) Debt Classification | Debt Portion | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Portion | $183,619,000 | $0 | | Non-Current Portion | $38,484,000 | $219,539,000 | [Note 13: Commitments and Contingencies](index=26&type=section&id=NOTE%2013.%20COMMITMENTS%20AND%20CONTINGENCIES) This note outlines legal proceedings, including a **$34.9 million** jury verdict for ImprimisRx, and contractual commitments, such as **$8.5 million** for 2025 manufacturing - In November 2024, a jury awarded the company's subsidiary, ImprimisRx, **$34.9 million** (**$20.4 million** punitive, **$14.5 million** actual damages) in a trademark infringement and unfair competition lawsuit against OSRX. The company has not recognized any gain due to uncertainty of collection[105](index=105&type=chunk) - The company entered into a license and supply agreement with Formosa Pharmaceuticals for BYQLOVI in June 2025, which includes a **$500,000** payment upon first commercial sale and potential future milestones and royalties[108](index=108&type=chunk) - The company has committed to approximately **$8.527 million** in payments for contract manufacturing agreements for the year ending December 31, 2025[112](index=112&type=chunk) [Note 14: Segments and Concentrations](index=29&type=section&id=NOTE%2014.%20SEGMENTS%20AND%20CONCENTRATIONS) The company operates in Branded and ImprimisRx segments, with Q2 2025 revenues of **$42.3 million** and **$21.5 million** respectively, and faces significant customer concentration risk Segment Performance (Three Months Ended June 30, 2025) | Segment | Total Revenues | Gross Profit | Segment Contribution | | :--- | :--- | :--- | :--- | | Branded | $42,274,000 | $33,540,000 | $10,820,000 | | ImprimisRx | $21,468,000 | $13,972,000 | $6,432,000 | Revenue by Key Products (Q2 2025 vs Q2 2024) | Product | Q2 2025 Revenue | Q2 2024 Revenue | | :--- | :--- | :--- | | IHEEZO | $18,336,000 | $11,295,000 | | VEVYE | $18,641,000 | $4,315,000 | - Significant customer concentration exists, with two customers representing **87%** of total consolidated accounts receivable at June 30, 2025[118](index=118&type=chunk) [Note 15: Subsequent Events](index=31&type=section&id=NOTE%2015.%20SUBSEQUENT%20EVENTS) Subsequent events include a July 2025 agreement with Samsung Bioepis for U.S. rights to BYOOVIZ and OPUVIZ, and the grant of **1.3 million** performance stock units to executives - In July 2025, Harrow entered into a development and commercialization agreement with Samsung Bioepis for the U.S. rights to BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy). The agreement includes an upfront payment, sales-based milestones, and a share of net sales for Samsung[123](index=123&type=chunk) - In July 2025, the company granted **1,295,249** performance stock units to its CEO and CFO, which vest based on achieving stock price targets from **$50** to **$100** per share and a minimum three-year service period[124](index=124&type=chunk)[125](index=125&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **30%** Q2 2025 revenue growth to **$63.7 million**, strategic initiatives, and plans to address upcoming 2026 debt maturities and liquidity challenges - Recent strategic developments include a commercialization agreement with Samsung for BYOOVIZ and OPUVIZ, the acquisition of U.S. rights to BYQLOVI, and the launch of the 'VEVYE Access for All' program[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) - The company initiated 'Project Beagle' to transition ImprimisRx compounding customers to Harrow's FDA-approved products, discontinuing the Klarity-C compounded formulation in favor of VEVYE[134](index=134&type=chunk) Total Revenue Growth (Q2 and H1 2025 vs 2024) | Period | 2025 Revenue | 2024 Revenue | $ Variance | % Variance | | :--- | :--- | :--- | :--- | :--- | | **Q2** | $63,742,000 | $48,939,000 | $14,803,000 | +30.2% | | **H1** | $111,573,000 | $83,526,000 | $28,047,000 | +33.6% | - The company faces significant liquidity challenges with the Oaktree Loan (**$107.5 million** principal) and 2026 Notes (**$75 million** principal) maturing in early 2026. Management believes refinancing is probable but acknowledges the risk and is also considering asset sales[150](index=150&type=chunk)[157](index=157&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure from its variable-rate Oaktree Loan, where a **100 basis point** SOFR increase would raise annual interest expense by **$1.075 million** - The company is exposed to interest rate risk through its Oaktree Loan, which has a variable interest rate based on SOFR plus a **6.5%** spread[162](index=162&type=chunk)[164](index=164&type=chunk) - A **100 basis point** increase in SOFR would increase annual interest expense by approximately **$1.075 million**[164](index=164&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[166](index=166&type=chunk) - No material changes to internal control over financial reporting were identified during the quarter ended June 30, 2025[167](index=167&type=chunk) [Part II OTHER INFORMATION](index=39&type=section&id=Part%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 13 for legal matters, highlighting the **$34.9 million** jury verdict awarded to ImprimisRx in a trademark infringement lawsuit - For detailed information on legal proceedings, the company refers to Note 13 in the financial statements[169](index=169&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section updates key risk factors, including potential FDA enforcement, pricing pressures, global economic conditions, and increased costs from U.S. trade policy and tariffs - The company details a history of FDA inspections and warning letters concerning its NJOF, noting that discussions with the federal government regarding a 2024 inspection are now closed after the company took remedial actions[175](index=175&type=chunk)[177](index=177&type=chunk) - Sales are dependent on third-party payer reimbursement, which is under pressure from cost-containment initiatives and legislation like the Inflation Reduction Act, potentially limiting the company's pricing power and profitability[179](index=179&type=chunk) - Global economic conditions, including inflation and higher interest rates, may reduce demand for products and increase operating costs[182](index=182&type=chunk) - Potential U.S. tariffs on imported active pharmaceutical ingredients (APIs) and other components could significantly increase costs and disrupt the supply chain[183](index=183&type=chunk)[184](index=184&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[186](index=186&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during the six months ended June 30, 2025 - No directors or officers adopted or terminated Rule 10b5-1 trading plans during the six months ended June 30, 2025[190](index=190&type=chunk)
Harrow Health(HROW) - 2025 Q2 - Quarterly Results
2025-08-11 20:05
[Letter to Stockholders](index=1&type=section&id=Letter%20to%20Stockholders) This section provides an overview of Harrow's strong Q2 2025 financial performance, strategic corporate developments, and detailed product portfolio achievements, including significant growth in VEVYE and IHEEZO [Q2 2025 Performance Highlights](index=1&type=section&id=Q2%202025%20Performance%20Highlights) Harrow reported strong Q2 2025 growth with $63.7 million revenue, $5.0 million net income, and $17.0 million Adjusted EBITDA, supported by strategic acquisitions Q2 2025 Key Financial Metrics | Metric | Q2 2025 | YoY Change | QoQ Change | | :--- | :--- | :--- | :--- | | Revenues | $63.7 million | +30% | +33% | | Net Income | $5.0 million | - | - | | Adjusted EBITDA | $17.0 million | - | - | - Harrow solidified its market position through two strategic acquisitions: the Samsung Bioepis ophthalmic biosimilars portfolio (**BYOOVIZ®** and **OPUVIZ™**) and U.S. commercial rights to **BYQLOVI™** from Formosa Pharmaceuticals[3](index=3&type=chunk)[5](index=5&type=chunk) [Corporate and Strategic Developments](index=2&type=section&id=Corporate%20and%20Strategic%20Developments) Harrow is refinancing its $222.75 million debt for financial flexibility, strengthening its leadership, and preparing for its inaugural Investor & Analyst Day - Harrow is in active discussions to refinance its **$222.75 million** in outstanding debt with the objectives of lowering capital costs, increasing financial flexibility, and improving its ability to pursue growth opportunities[9](index=9&type=chunk)[13](index=13&type=chunk) - The company has made several key leadership appointments, including a Chief Scientific Officer and SVP of Commercial Operations, to bolster its expertise and drive future success[6](index=6&type=chunk) - Harrow will host its first annual Investor & Analyst Day on September 26 in New York City to provide deeper insights into its leadership, products, and development pipeline[12](index=12&type=chunk) [Product Portfolio Performance](index=3&type=section&id=Product%20Portfolio%20Performance) Harrow's product portfolio showed strong performance, with VEVYE, IHEEZO, and TRIESENCE achieving significant growth, complemented by strategic acquisitions and ImprimisRx's recovery [VEVYE](index=3&type=section&id=VEVYE) VEVYE, Harrow's flagship dry eye product, achieved exceptional Q2 2025 growth with 66% sequential prescription volume increase and 7.8% market share, on track for over $100 million revenue VEVYE Q2 2025 Performance Metrics | Metric | Value | Note | | :--- | :--- | :--- | | Total Prescriptions (TRx) | 119,526 units | +66% sequentially from Q1 2025 | | New Prescriptions (NRx) | ~50,000 units | Part of the total TRx volume | | National DED Market Share | 7.8% | +2.6% gain quarter-over-quarter | - The company reiterates its guidance for VEVYE to surpass **$100 million** in annual revenue in 2025, expecting to generate over **$60 million** in the second half of the year[24](index=24&type=chunk) - Supply chain is being scaled up to meet surging demand, including adding a second manufacturing site expected to be online next year[22](index=22&type=chunk) [Buy and Bill Products](index=4&type=section&id=Buy%20and%20Bill%20Products) Harrow's 'Buy and Bill' portfolio, including IHEEZO and TRIESENCE, achieved robust growth, with IHEEZO revenue up 251% sequentially, further strengthened by BYOOVIZ and OPUVIZ acquisitions IHEEZO Q2 2025 Performance | Metric | Value | YoY / QoQ Change | | :--- | :--- | :--- | | Revenue | $18.3 million | +62% YoY / +251% QoQ | | Unit Demand | 48,765 units | +63% YoY / +25% QoQ | - TRIESENCE achieved **32%** quarter-over-quarter unit growth in Q2 and added **870 new accounts** year-to-date in 2025. The company is preparing to market it more aggressively to the larger ocular inflammation market[31](index=31&type=chunk)[35](index=35&type=chunk) - Harrow acquired exclusive U.S. commercial rights to **BYOOVIZ** (biosimilar to LUCENTIS) and **OPUVIZ** (biosimilar to EYLEA) from Samsung Bioepis to compete in the wet AMD market[40](index=40&type=chunk) [Specialty Branded Products](index=6&type=section&id=Specialty%20Branded%20Products) Harrow expanded its Specialty Branded Product portfolio with the acquisition of **BYQLOVI**, a novel steroid for post-operative ocular inflammation and pain, targeting over 7 million annual U.S. ophthalmic surgeries - The portfolio was expanded with the acquisition of **BYQLOVI**, an FDA-approved steroid for treating inflammation and pain after ocular surgery[45](index=45&type=chunk) - **BYQLOVI** is positioned to address a significant market, with over **7 million** ophthalmic surgeries performed annually in the U.S. The commercial launch is planned within the next few quarters[46](index=46&type=chunk) [ImprimisRx](index=7&type=section&id=ImprimisRx) ImprimisRx, Harrow's compounding business, recovered in Q2 2025 with **$21.5 million** revenue, a **7%** sequential increase, and awaits a final ruling on a **$34.9 million** jury verdict ImprimisRx Q2 2025 Revenue | Metric | Q2 2025 | QoQ Change | | :--- | :--- | :--- | | Revenue | $21.5 million | +7% | - The business demonstrated sequential recovery after Q1 seasonal softness, with April marking a record revenue month[48](index=48&type=chunk) - A final legal ruling is expected shortly in the case where ImprimisRx was awarded a **$34.9 million** jury verdict against OSRX, Inc[50](index=50&type=chunk) [Closing and Outlook](index=7&type=section&id=Closing%20and%20Outlook) Harrow reaffirms its full-year 2025 revenue guidance of **more than $280 million**, anticipating stronger second-half performance driven by key products VEVYE, IHEEZO, and TRIESENCE - Harrow is confident in its 2025 revenue guidance of '**more than $280 million**,' expecting stronger performance in the second half of the year[52](index=52&type=chunk) - Key growth drivers for the second half of 2025 are expected to be **VEVYE**, **IHEEZO**, and **TRIESENCE**[52](index=52&type=chunk) [Financials](index=8&type=section&id=Financials) This section details Harrow's Q2 2025 financial performance, highlighting significant revenue growth, a shift to net income, and increased Adjusted EBITDA, along with comprehensive non-GAAP reconciliations [Commentary on Second Quarter 2025 Financials](index=8&type=section&id=Commentary%20on%20Second%20Quarter%202025%20Financials) Harrow's Q2 2025 revenues grew **30%** YoY to **$63.7 million**, achieving **$5.0 million** net income and **$17.0 million** Adjusted EBITDA, with IHEEZO and VEVYE as key revenue drivers Q2 2025 Financial Performance vs. Q2 2024 | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenues | $63.7 million | $48.9 million | | GAAP Net Income (Loss) | $5.0 million | $(6.5) million | | Adjusted EBITDA | $17.0 million | $8.8 million | | GAAP Gross Margin | 75% | 74% | Revenue Breakdown for the Three Months Ended June 30, 2025 | Product/Segment | Revenue (Millions) | % of Total | | :--- | :--- | :--- | | IHEEZO | $18.3 | 29% | | VEVYE | $18.6 | 29% | | Other branded products | $5.2 | 8% | | ImprimisRx revenue, net | $21.5 | 34% | | **Total revenues, net** | **$63.7** | **100%** | - As of June 30, 2025, the company held **$53.0 million** in cash and cash equivalents and had accounts receivable of **$78.8 million**[60](index=60&type=chunk) [Second Quarter 2025 Financial Overview](index=9&type=section&id=Second%20Quarter%202025%20Financial%20Overview) This section details Q2 2025 GAAP results, showing **$5.0 million** net income and **$0.13** diluted EPS, alongside non-GAAP Core net income of **$9.2 million** and Adjusted EBITDA of **$17.0 million** GAAP Operating Results (Three Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Total revenues | $63,742,000 | $48,939,000 | | Gross profit | $47,512,000 | $36,400,000 | | Income (loss) from operations | $11,409,000 | $1,530,000 | | Net income (loss) | $4,995,000 | $(6,473,000) | | Diluted EPS | $0.13 | $(0.18) | Core Results (Non-GAAP) (Three Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Core gross margin | 80% | 79% | | Core net income (loss) | $9,227,000 | $(2,047,000) | | Adjusted EBITDA | $17,006,000 | $8,803,000 | | Core diluted EPS | $0.24 | $(0.06) | [Non-GAAP Financial Measures and Reconciliations](index=11&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) This section explains and reconciles non-GAAP financial measures, including Adjusted EBITDA and Core Results, to GAAP figures, providing a clearer view of Harrow's core operating performance - Management utilizes non-GAAP measures like **Adjusted EBITDA** and **Core Results** to evaluate financial performance, believing they provide a clearer view of core operations by excluding non-cash or non-recurring items[76](index=76&type=chunk) Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA (Three Months Ended June 30) | Line Item | 2025 | 2024 | | :--- | :--- | :--- | | **GAAP net income (loss)** | **$4,995,000** | **$(6,473,000)** | | Stock-based compensation | $875,000 | $4,271,000 | | Interest expense, net | $6,408,000 | $5,471,000 | | Depreciation & Amortization | $4,722,000 | $3,002,000 | | Other adjustments | $6,000 | $1,877,000 | | **Adjusted EBITDA** | **$17,006,000** | **$8,803,000** | Reconciliation of GAAP Results to Core Results (Three Months Ended June 30, 2025) | Metric | GAAP Results | Adjustments | Core Results | | :--- | :--- | :--- | :--- | | Gross Profit | $47,512,000 | $3,780,000 | $51,292,000 | | Net Income | $4,995,000 | $4,232,000 | $9,227,000 | | Diluted EPS | $0.13 | - | $0.24 |
Harrow Announces Second-Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-11 20:01
Core Insights - Harrow reported strong financial results for Q2 2025, with total revenues of $63.7 million, a 30% increase from $48.9 million in the same period last year [8][11] - The company is on track to exceed $280 million in revenue for the full year 2025, supported by the growth of its product VEVYE® and the expansion of its pharmacy network [3][4] - Harrow's net income for Q2 2025 was $5.0 million, a significant improvement compared to a net loss of $6.5 million in Q2 2024 [8][11] Business Highlights - VEVYE® gained nearly 3% in market share with a 66% sequential growth in prescriptions, totaling approximately 50,000 new prescriptions [4] - The average selling price (ASP) for VEVYE® is stable with an upward trend expected, which should contribute to quarterly revenues exceeding $100 million for 2025 [4] - The IHEEZO® product is anticipated to deliver record performance, while TRIESENCE® is expected to demonstrate a revenue trajectory consistent with original acquisition expectations [5] Financial Performance - Adjusted EBITDA for Q2 2025 was $17.0 million, compared to $8.8 million in Q2 2024, indicating improved operational efficiency [8][11] - The gross margin for Q2 2025 was 75%, slightly up from 74% in the prior year, while the core gross margin improved to 80% from 79% [11][24] - Cash and cash equivalents as of June 30, 2025, stood at $53.0 million, up from $47.2 million at the beginning of the year [8][16] Strategic Developments - Harrow entered a strategic alliance with Apollo Care to enhance the VAFA program, expanding patient access through a network of over 500 pharmacies [9] - The company secured exclusive U.S. commercial rights to the ophthalmology biosimilar portfolio from Samsung Bioepis, which includes two FDA-approved products [9][10] - Harrow acquired exclusive U.S. commercial rights for BYQLOVI™, a new ophthalmic steroid approved for post-operative inflammation and pain, marking a significant addition to its product portfolio [10]