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NASHVILLE - Harrow, Inc. (NASDAQ:HROW), which has seen its stock surge over 37% in the past year according to InvestingPro data, announced Thursday it has entered into a definitive agreement with Samsung Bioepis to secure exclusive U.S. commercial rights to two ophthalmology biosimilars - BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy).
The company will assume full responsibility for commercializing these products by the end of 2025, following the completion of the transition of commercial rights from Biogen back to Samsung Bioepis. Biogen had previously notified Samsung Bioepis in October 2024 of its decision to terminate their 2019 Development and Commercialization Agreement for the U.S. and Canada.
BYOOVIZ, a biosimilar referencing Lucentis, has been available in the U.S. since June 2022. OPUVIZ is a biosimilar referencing Eylea. Both products are FDA-approved treatments for various retinal diseases including neovascular (wet) age-related macular degeneration.
The acquisition positions Harrow in the retinal disease treatment market, which represents a $9 billion opportunity in the U.S., according to the company’s press release. Anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual U.S. spending exceeding $4.2 billion. With revenue growth of 53.5% in the last twelve months and a strong gross profit margin of 74.5%, InvestingPro analysis shows Harrow is well-positioned to capitalize on this market opportunity. InvestingPro subscribers can access 13 additional key insights about Harrow’s growth potential and financial health.
"This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community," said Mark L. Baum, Chairman and Chief Executive Officer of Harrow.
The company plans to leverage its established commercial infrastructure to market these biosimilars, which are designed to provide more affordable alternatives to existing anti-VEGF therapies for retinal diseases.
Financial terms of the agreement were not disclosed in the press release statement.
In other recent news, Harrow Health reported its first-quarter 2025 financial results, revealing a revenue of $47.8 million, which marked a 38% increase year-over-year but fell short of analyst expectations of $61.0 million. The company experienced a net loss of $17.8 million, or $0.50 per share, which was significantly below the projected income. Despite these figures, Harrow Health remains optimistic about achieving its 2025 revenue guidance of over $280 million, driven by strong demand for its lead product, Vevye. Analysts from Cantor Fitzgerald have initiated coverage with an Overweight rating, highlighting Vevye’s potential to reach peak sales of $600 million.
H.C. Wainwright adjusted its price target for Harrow Health to $60.00, maintaining a Buy rating, following the company’s financial results. Meanwhile, BTIG and William Blair have also expressed positive outlooks, with BTIG setting a $62.00 price target and William Blair assigning an Outperform rating. Both firms emphasize the growth prospects of Harrow’s ophthalmic products, including Vevye, Iheezo, and Triesence. Harrow’s management has reiterated its guidance for 2025, emphasizing strategic initiatives to expand market access and product penetration, which are expected to drive growth in the upcoming quarters.
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