Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 75

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 2
Chunk 75
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 opportunities for certain of our ophthalmology and other assets that we have not yet made
commercially available. We believe we have built a tangible and intangible infrastructure that will allow us to scale revenues efficiently
in the near and long-term. All of these activities may require significant costs and other resources, which we may not have or be able
to obtain from operations or other sources. See “Liquidity and Capital Resources” below.

Recent
Developments

The
following describes certain developments in 2025 to date that are important to understand our financial condition and results of operations.
See the notes to our unaudited condensed consolidated financial statements included in this Quarterly Report for additional information
about each of these developments.

BYOOVIZ®
and OPUVIZTM – Commercialization Agreement

In
July 2025, we entered into a development and commercialization agreement (the “Samsung Agreement”) with Samsung Bioepis Co.,
Ltd. (“Samsung”). Under the terms of the Samsung Agreement, following completion of the transition of commercial rights from
Biogen, Inc. back to Samsung, Samsung will develop, manufacture, and supply BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy)
(individually, a “Product” and together, the “Products”) for Harrow to commercialize in the U.S. market (the
“Rights”).. In consideration of such Rights, we will make a one-time upfront payment to Samsung, and Samsung will be eligible
to receive additional one-time payments based on the achievement of net sales-based milestones of the Products. In addition to other
mutually agreed terms, we shall pay to Samsung a share of net sales from the Products generated in the U.S. market.

Acquisition
of Commercial Rights to BYQLOVITM

In
June 2025, we announced a licensing agreement whereby we acquired the exclusive U.S. commercial rights to BYQLOVI (clobetasol propionate
ophthalmic suspension) 0.05% from Taiwan-based Formosa Pharmaceuticals. BYQLOVI was recently approved by the FDA for the treatment of
post-operative inflammation and pain following ocular surgery and is the first new ophthalmic steroid in its class in over 15 years.
Harrow expects BYQLOVI to be available in the fourth quarter of 2025.

VEVYE® Access for All

In
March 2025, we announced a patient