Harrow, Inc. Company Profile

Background

Overview

Harrow, Inc. is a leading U.S. eyecare pharmaceutical company dedicated to the discovery, development, and commercialization of innovative ophthalmic therapies that are accessible and affordable. The company offers a comprehensive portfolio of prescription and non-prescription pharmaceutical products, including both FDA-approved and compounded formulations, to address a wide range of ophthalmic conditions. Harrow's mission is to help patients preserve their sight by providing access to effective and affordable eyecare solutions.

Mission and Vision

• Mission: To help patients manage the preservation of their sight by providing access to innovative and affordable medicines and services.

• Vision: To deliver novel eyecare solutions to physicians and patients today at accessible prices.

Primary Area of Focus

Harrow focuses exclusively on the ophthalmic pharmaceutical market, offering a diverse range of products used in ophthalmic surgeries, as well as treatments for chronic and acute eye conditions such as dry eye disease, glaucoma, allergies, infections, and other ophthalmic inflammatory disorders.

Industry Significance

With a robust portfolio of branded ophthalmic pharmaceutical products, Harrow has established itself as a significant player in the North American eyecare market. The company's commitment to innovation and patient access has positioned it as a trusted partner for eyecare professionals and patients alike.

Key Strategic Focus

Core Objectives

• Expand the portfolio of FDA-approved ophthalmic products.

• Enhance patient access and affordability through strategic partnerships and market access programs.

• Strengthen relationships with eyecare professionals to improve patient outcomes.

Specific Areas of Specialization

• Ophthalmic surgical products for cataract and refractive surgeries.

• Chronic care medications for conditions like dry eye disease and glaucoma.

• Acute care treatments for allergies, infections, and other ophthalmic inflammatory disorders.

Key Technologies Utilized

• Proprietary compounding technologies for customized ophthalmic formulations.

• Advanced manufacturing processes to ensure product quality and consistency.

Primary Markets Targeted

• U.S. eyecare professionals, including ophthalmologists and optometrists.

• Hospitals and ambulatory service centers.

• Patients requiring ophthalmic treatments.

Financials and Funding

Funding History

Harrow has pursued a strategic approach to funding, including:

• Equity Offerings: Raising capital through public offerings to support growth initiatives.

• Debt Financing: Utilizing senior notes and credit facilities to manage capital needs.

Recent Funding Rounds

• September 2025: Completed a $250 million senior notes offering to prepay existing debt and provide capital for business development and general corporate purposes.

Notable Investors

Specific investor details are not publicly disclosed.

Utilization of Capital

The capital raised has been allocated towards:

• Product Acquisitions: Securing commercial rights to new ophthalmic products.

• Research and Development: Investing in the development of new formulations and treatments.

• Operational Expansion: Enhancing manufacturing capabilities and distribution networks.

Pipeline Development

Key Pipeline Candidates

• Melt Pharmaceuticals: A patented technology for procedural sedation, with an anticipated New Drug Application (NDA) filing in 2027 and launch in 2028. Expected to become a $100 million-plus high-margin annual revenue product.

• BYQLOVI™ (Clobetasol Propionate Ophthalmic Suspension) 0.05%: Acquired in June 2025, with plans for a Q1 2026 launch.

• Samsung Bioepis' Ophthalmology Biosimilars Portfolio: Includes BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy), with expected launches in mid-2026 and the second half of 2027, respectively.

Stages of Clinical Trials or Product Development

• Melt Pharmaceuticals: Anticipated NDA filing in 2027, with a planned launch in 2028.

• BYQLOVI: FDA-approved, with a planned launch in Q1 2026.

• Samsung Bioepis' Biosimilars: Expected to launch in mid-2026 and the second half of 2027.

Target Conditions

• Melt Pharmaceuticals: Procedural sedation.

• BYQLOVI: Post-operative inflammation and pain following ocular surgery.

• Samsung Bioepis' Biosimilars: Retinal diseases, including wet age-related macular degeneration and diabetic macular edema.

Anticipated Milestones

• Melt Pharmaceuticals: NDA filing in 2027; product launch in 2028.

• BYQLOVI: Launch in Q1 2026.

• Samsung Bioepis' Biosimilars: Launch of BYOOVIZ in mid-2026; OPUVIZ in the second half of 2027.

Technological Platform and Innovation

Proprietary Technologies

• Compounding Technologies: Enables the creation of customized ophthalmic formulations tailored to specific patient needs.

• Water-Free Formulation: Utilized in VEVYE®, a cyclosporine-based product for dry eye disease, enhancing patient comfort and reducing irritation.

Significant Scientific Methods

• Clinical Trials: Conducted to assess the safety and efficacy of new ophthalmic products, such as VEVYE®, which demonstrated high patient satisfaction rates in clinical studies.

• Market Access Programs: Implemented to streamline prescribing processes and improve patient access to treatments, exemplified by partnerships for VEVYE® to enhance availability and affordability.

Leadership Team

Key Executives

• Mark L. Baum: Founder, Chairman of the Board, and Chief Executive Officer. He has been instrumental in Harrow's growth, leading the company from its inception in 2011 to becoming a leader in ophthalmic pharmaceuticals.

• Mike Biega: Vice President of Investor Relations and Communications. Appointed in June 2025, he is responsible for managing investor relations and corporate communications.

Leadership Changes

• June 2025: Appointment of Mike Biega as Vice President of Investor Relations and Communications.

Competitor Profile

Market Insights and Dynamics

The ophthalmic pharmaceutical market is characterized by a growing demand for innovative treatments for various eye conditions, including dry eye disease, glaucoma, and retinal diseases. Advancements in biotechnology and an aging population contribute to the expansion of this market.

Competitor Analysis

• Alcon Inc.: A global leader in eye care, offering a wide range of surgical and vision care products. Alcon's extensive resources and R&D capabilities place it in a strong position to innovate and dominate the market.

• Bausch & Lomb: A well-known player in the eye care industry, producing a range of products including contact lenses, surgical products, and over-the-counter eye health products. Bausch & Lomb benefits from its established market position and extensive distribution network.

• EyePoint Pharmaceuticals: Focuses on developing innovative therapies for eye diseases, including sustained-release drug delivery systems. EyePoint's specialized delivery systems offer distinct advantages in long-term treatment adherence.

• Santen Pharmaceutical: A global company specializing in ophthalmology, with a strong portfolio of patented therapies addressing both common and rare ophthalmic diseases. Santen's extensive R&D capabilities and international presence make it a formidable competitor.

Strategic Collaborations and Partnerships

• PhilRx: A patient access platform that provides end-to-end solutions for pharmacy and patient services aimed at improving medication adherence and reducing costs for ophthalmic treatments.