Harrow Health(US:HROW)2025-11-10 22:09Financial Performance - Harrow reported record Q3 2025 revenues of $71.6 million, a 45% increase from $49.3 million in Q3 2024, and a 12% sequential increase from Q2 2025[2]. - The company achieved $1.0 million in net income and $22.7 million in Adjusted EBITDA during Q3 2025[2]. - Revenues for Q3 2025 were $71.6 million, a 45% increase from $49.3 million in Q3 2024, and a 12% increase from Q2 2025[67]. - Total revenues for Q3 2025 reached $71.638 million, a 45.5% increase from $49.257 million in Q3 2024[72]. - Gross profit for Q3 2025 was $53.926 million, compared to $37.239 million in Q3 2024, reflecting a gross margin of 75%[72][74]. - Net income for Q3 2025 was $1.020 million, a significant improvement from a net loss of $4.220 million in Q3 2024[72][74]. - Core net income for Q3 2025 was $12.933 million, compared to a loss of $1.619 million in Q3 2024[74]. - Adjusted EBITDA for Q3 2025 was $22.732 million, up from $8.808 million in Q3 2024[86]. - For the nine months ended September 30, 2025, total revenues were $183.211 million, up from $132.783 million in the same period of 2024[72]. - Operating income for the three months ended September 30, 2025, was $14,747,000, while for the nine months it was $14,924,000[89]. - Net income for the three months ended September 30, 2025, was $1,020,000, and for the nine months, it was a loss of $11,765,000[89]. Product Performance - VEVYE revenue increased 22% quarter-over-quarter to $22.6 million, capturing a 10.5% share of the national dry eye disease market, reflecting a 2.7% gain from the previous quarter[16][19]. - IHEEZO revenue reached $21.9 million in Q3 2025, representing a 70% increase year-over-year and a 20% sequential increase[28]. - IHEEZO generated $21.9 million in revenue for Q3 2025, representing a 31% increase from $12.9 million in Q3 2024[70]. - VEVYE contributed $22.6 million in revenue for Q3 2025, a significant increase from $5.2 million in Q3 2024[70]. - TRIESENCE achieved 67% quarter-over-quarter unit growth in Q3 2025, with 53% of accounts being new customers[35]. - IHEEZO is on track to exceed $50 million in annual revenue by year-end 2025, supported by strong demand and new orders[32]. - The company anticipates a strong finish for VEVYE in Q4 2025, with October being the strongest month since launch[24]. - VEVYE's market share has doubled in two quarters, with expectations for continued growth driven by expanded coverage and new commercial resources[16][25]. Strategic Initiatives - The company launched Harrow Access for All (HAFA) to enhance patient access and streamline the prescriber experience, aiming to drive volume growth and profitability[9]. - The pending acquisition of MELT Pharmaceuticals and its candidate MELT-300 is expected to transform Harrow's growth strategy in ophthalmic surgery[9]. - The upcoming launch of the Harrow Access for All initiative in Q4 2025 aims to improve patient access and affordability across the Rare & Specialty Product portfolio[42]. - The NDA for MELT-300 is expected to be submitted in the first half of 2027, with a potential commercial launch in 2028[48]. Financial Guidance and Expectations - The company anticipates full-year revenue guidance of $270 million to $280 million, reflecting a conservative approach due to unexpected underperformance[55]. - The company expects a typical seasonal decline from Q4 2025 to Q1 2026 but anticipates stocking activity from new products launching in 2026[60]. Cost and Expenses - Research and development expenses increased to $3.323 million in Q3 2025 from $2.273 million in Q3 2024, indicating a focus on innovation[72]. - Selling, general and administrative expenses rose to $35.856 million in Q3 2025, compared to $33.645 million in Q3 2024[72]. - The company reported a core gross margin of 81% for Q3 2025, compared to 80% in Q3 2024[74]. Risks and Challenges - Management highlighted risks related to FDA approvals and the commercialization of products in their forward-looking statements[76].