8-K: Harrow Q2 2025 Revenue Jumps 30%, Strategic Acquisitions

Harrow, Inc. announced a 30% increase in Q2 2025 revenues to $63.7 million, alongside strategic acquisitions and positive product momentum.

Summary

• Total revenues for Q2 2025 reached $63.7 million, marking a 30% increase over the prior-year period and a 33% sequential increase from Q1 2025.
• GAAP net income for Q2 2025 was $5.0 million, a significant improvement from a GAAP net loss of $(6.5) million in Q2 2024.
• Adjusted EBITDA for Q2 2025 was $17.0 million, nearly doubling from $8.8 million in Q2 2024.
• Cash and cash equivalents stood at $53.0 million as of June 30, 2025.
• Secured exclusive U.S. commercial rights to Samsung Bioepis' ophthalmology biosimilar portfolio (BYOOVIZ and OPUVIZ) in July 2025.
• Acquired exclusive U.S. commercial rights for BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% in June 2025.
• VEVYE gained nearly 3% in market share in the quarter, reaching 7.8% of the national DED market, with 66% sequential prescription growth, including approximately 50,000 new prescriptions.
• IHEEZO revenue rose to $18.3 million in Q2 2025, a 251% sequential increase over Q1 2025 and a 62% increase over Q2 2024.
• TRIESENCE volumes improved, achieving 32% quarter-over-quarter unit growth in Q2.
• Reiterated 2025 revenue guidance of greater than $280 million.
• Active discussions are underway to refinance or repay a portion of the $222.75 million in outstanding debt, with completion expected by late Q3 or early Q4 2025.
• ImprimisRx, the compounding business, reported revenues of $21.5 million, a 7% sequential increase from Q1 2025.
• The ImprimisRx v. OSRX, Inc. litigation, involving a $34.9 million jury verdict award, is in its final stages, with a ruling expected shortly.

Sentiment

Score: 8

Explanation: The company demonstrated robust financial performance in Q2 2025, with significant revenue growth and a return to GAAP net income. Key products are gaining market share and showing strong momentum. Strategic acquisitions expand future growth potential, and management expresses high confidence in achieving financial goals and debt refinancing. The overall outlook is highly positive, indicating strong operational execution and strategic positioning.

Positives

• Total revenues increased by 30% year-over-year to $63.7 million and 33% sequentially, demonstrating strong top-line growth.
• Achieved GAAP net income of $5.0 million in Q2 2025, a significant turnaround from a GAAP net loss of $(6.5) million in the prior-year period.
• Adjusted EBITDA nearly doubled to $17.0 million in Q2 2025 from $8.8 million in Q2 2024, indicating improved operational efficiency and profitability.
• VEVYE showed strong commercial momentum with 66% sequential prescription growth, 50,000 new prescriptions, and a 7.8% market share in the dry eye disease market.
• The VEVYE Access for All (VAFA) program has significantly improved patient access and reduced out-of-pocket costs for eligible commercially insured patients by over 95%.
• IHEEZO experienced accelerated growth, with Q2 revenue rising 251% sequentially to $18.3 million and unit demand increasing 63% year-over-year.
• TRIESENCE achieved 32% quarter-over-quarter unit growth and is expected to demonstrate a revenue trajectory consistent with its original acquisition thesis.
• Strategic acquisitions of Samsung Bioepis' biosimilar portfolio (BYOOVIZ and OPUVIZ) and BYQLOVI expand the product offerings into high-value ophthalmic markets like wet AMD and post-operative inflammation.
• Successful recruitment of top talent to leadership roles, enhancing scientific credibility, commercial operations, and strategic execution.
• Reiterated strong 2025 revenue guidance of greater than $280 million, signaling confidence in continued performance.
• Net cash provided by operating activities for the six months ended June 30, 2025, was $18.9 million, a substantial improvement from net cash used in operating activities in the prior-year period.
• VEVYE boasts industry-leading refill rates, with covered patients through PhilRx receiving an average of nine refills in 2024.
• IHEEZO coverage is pervasive at 81% across commercial and government payers, with only 3% of claims classified as not covered.

Negatives

• The company still carries $222.75 million in outstanding debt, requiring active refinancing efforts.
• Q1 VEVYE average selling price (ASP) was an anomaly, leading to a quarterly revenue reduction relative to Q1 2025 despite volume increase, though ASP is now stabilizing.
• Management is cautious about growing VEVYE too rapidly for the balance of the year until appropriate safety stock levels are achieved.
• Only 26% of IHEEZO accounts are currently ordering TRIESENCE, indicating an untapped cross-selling opportunity for the commercial team.

Risks

• Risks related to liquidity or results of operations.
• Ability to successfully implement the business plan, develop and commercialize products, product candidates, and proprietary formulations in a timely manner or at all.
• Ability to identify and acquire additional products, manage pharmacy operations, refinance and otherwise service debt, and obtain necessary financing.
• Challenges in recruiting and retaining qualified personnel, managing any growth experienced, and successfully realizing the benefits of previous and future acquisitions and collaborative arrangements.
• 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 pharmacy operations and the pharmaceutical business, including ongoing communications with the U.S. Food and Drug Administration (FDA) relating to compliance and quality plans at the New Jersey outsourcing facility.
• Physician interest in and market acceptance of current and any future formulations and compounding pharmacies generally.

Future Outlook

The company expects to deliver greater than $280 million in revenue for 2025, with VEVYE quarterly revenues projected to expand meaningfully and exceed $100 million for the year, supported by a stable to upward-biased average selling price. IHEEZO is anticipated to deliver record performance through the balance of the year, and TRIESENCE is expected to achieve $100 million in annual revenue with its upcoming launch in the ocular inflammation market. New revenue streams from the Samsung biosimilars portfolio and BYQLOVI are on deck. The company plans to complete debt refinancing by late Q3 or early Q4 2025 to lower the cost of capital, increase financial flexibility, and support future growth. A staged new investment cycle for VEVYE growth is planned after achieving appropriate safety stock, and a second VEVYE product site is expected online next year. The CEO's main financial goal is to achieve a $250 million revenue quarter by 2027.

Management Comments

• "The second quarter provided a strong financial and operational foundation for the back half of the year. These results have positioned us to strengthen our capital base and are a proof point as to the financial leverage we believe our business has."
• "We remain on track to deliver greater than $280 million in revenue for the year."
• "Now, with an average selling price (ASP) that is stable with an upward bias over the coming quarters, we expect quarterly revenues to begin to expand meaningfully and exceed $100 million for 2025."
• "Im highly confident that we will successfully achieve all our objectives [for debt refinancing]."
• "Frankly, we did not expect VEVYE to be this successful so soon."
• "My assessment, and I believe Andrew would agree, is that we are in the best shape weve ever been in."

Industry Context

Harrow operates as a leading provider of ophthalmic disease management solutions in North America, addressing a broad range of eye conditions. The acquisition of Samsung Bioepis' biosimilar portfolio positions the company to significantly compete in the wet age-related macular degeneration (wet AMD) market, which is identified as the largest single eyecare market in the U.S. BYQLOVI's introduction as the first new ophthalmic steroid in its class in over 15 years highlights innovation in the post-operative ocular inflammation and pain market. The company's focus on dry eye disease with VEVYE, now the second largest cyclosporine-based brand, demonstrates its competitive stance in a significant market segment.

Comparison to Industry Standards

• VEVYE has captured a 7.8% share of the national Dry Eye Disease (DED) market, a 2.6% gain quarter over quarter, and is now the second largest cyclosporine-based dry eye brand being prescribed, validating its commercial strategy.
• TRIESENCE patients' out-of-pocket co-payments are approximately $37, making them the lowest among all intraocular injectable steroid choices, offering superior value to consumers.
• BYQLOVI is the first novel steroid introduced to the market in over a decade, positioning it as a clinically differentiated product in the post-operative ocular inflammation and pain market.
• The wet AMD market, which BYOOVIZ and OPUVIZ will target, is the largest single eyecare market in the U.S., with each percentage point of market share representing over $80 million per year, indicating a substantial opportunity.

Management Changes

Legal Proceedings

• The case of ImprimisRx, LLC v. OSRX, Inc. (OSRX), concerning a previously announced $34.9 million jury verdict award to ImprimisRx, is in the final stages of litigation, with a final legal ruling expected shortly.

Stakeholder Impact

• Shareholders are likely to benefit from strong financial results, strategic acquisitions, reiterated positive guidance, and efforts to improve the capital structure through debt refinancing.
• Patients will experience improved access to ophthalmic disease management solutions, reduced out-of-pocket costs through programs like VAFA, and access to new and clinically differentiated products.
• Eyecare Professionals (ECPs) will benefit from an expanded product portfolio, streamlined ordering processes through initiatives like Harrow Cares and GPO agreements, and enhanced support for integrating products into their practices.
• Employees will see opportunities for growth and development due to the company's expansion and strategic recruitment of new talent.
• Creditors are impacted by the company's active discussions to refinance its outstanding debt, aiming to improve its long-term financial foundation and manage obligations effectively.

Next Steps

• Complete debt refinancing by late Q3 or early Q4 2025.
• Host the First Annual Investor & Analyst Day on September 26, 2025, in New York City.
• Launch BYQLOVI within the next few quarters, with revenues expected to begin in Q1 2026.
• Begin a staged new investment cycle to fuel the next wave of VEVYE growth after achieving appropriate safety stock.
• Bring a second VEVYE product site online next year.
• Actively prepare for the Harrow launch of BYOOVIZ and OPUVIZ.
• Move more aggressively into the ocular inflammation market for TRIESENCE, led by the new Specialty Brands sales team.
• Drive several initiatives to enhance ImprimisRx gross margins, revenue growth, and operational efficiency.
• Await a final legal ruling in the ImprimisRx v. OSRX, Inc. litigation regarding the $34.9 million jury verdict award.

Key Dates

Recommendation

The company demonstrated robust financial performance in Q2 2025, with significant revenue growth, a return to GAAP net income, and strong Adjusted EBITDA. Key products like VEVYE and IHEEZO are exceeding expectations and gaining substantial market share. Strategic acquisitions of Samsung Bioepis' biosimilars and BYQLOVI significantly expand the company's portfolio into high-growth markets like wet AMD and post-operative inflammation. Management's confidence in achieving 2025 revenue guidance and successfully refinancing debt further de-risks the investment. The operational leverage and new revenue streams position Harrow for sustained, meaningful profitability, making it an attractive long-term investment in the ophthalmic sector.

Keywords

Ophthalmic, Dry Eye Disease, Wet AMD, Retinal Diseases, Biosimilars, Pharmaceutical, FDA, VEVYE, IHEEZO, TRIESENCE, BYOOVIZ, OPUVIZ, BYQLOVI, ImprimisRx, Financial Results, Q2 2025, Revenue Growth, Adjusted EBITDA, Debt Refinancing, Corporate Presentation, Stockholders Letter