Welcome to our dedicated page for Harrow Health news (Ticker: HROW), a resource for investors and traders seeking the latest updates and insights on Harrow Health stock.
Company Overview
Harrow Health Inc (HROW) is an innovative eyecare pharmaceutical company focused on addressing unmet medical needs through the discovery, development, production, and commercialization of specialized ophthalmic formulations and therapeutic products across the United States. Operating at the intersection of advanced research and clinical application, the company brings together deep industry expertise, rigorous R&D, and a commitment to improving patient care.
Business Model and Operations
At its core, Harrow Health provides a comprehensive portfolio that blends ophthalmology-based drug development with non-intravenous sedation and anesthesia therapeutics for a variety of medical procedures. Its operations are structured around:
- Ophthalmic Therapeutics: Focusing on the management of ocular surface diseases, the company develops topical eye drop formulations that serve both preventative and therapeutic roles.
- Compounded Medications: Offering both sterile and non-sterile formulations, it meets the needs of physicians seeking tailored solutions for diverse clinical scenarios.
- Non-Intravenous Sedation: Developing products designed to facilitate conscious sedation during procedures such as cataract surgery, thereby enhancing patient comfort and procedural efficiency.
This multi-pronged approach not only diversifies its product portfolio but also creates a resilient business model that appeals to healthcare professionals and institutions across outpatient, in-office, and hospital settings.
Market Position and Competitive Landscape
Harrow Health Inc has carved a niche within the highly regulated US pharmaceutical market. Its strategic focus on ocular and sedation therapeutics differentiates it from broader scale pharmaceutical companies, while its commitment to advanced research and quality production standards reinforces its reputation among eyecare professionals. In a competitive landscape where precision and safety are paramount, Harrow Health’s integration of clinical insights with innovative drug formulations positions it as a noteworthy player devoted to addressing specific medical challenges effectively.
Product Portfolio and Therapeutic Solutions
The company has developed an extensive range of products that address conditions related to the ocular surface and procedural sedation. Its portfolio includes:
- Topical Ophthalmic Formulations: Designed to manage diseases affecting the ocular surface and support rehabilitation of vision-related functions.
- Compounded Medications: Both sterile and non-sterile, these are tailored to meet precise medical requirements across various treatment settings.
- Sedation Therapeutics: Products intended for sublingual administration provide non-intravenous sedation, enabling safe and effective patient management during surgical procedures.
Research, Development, and Quality Assurance
The foundation of Harrow Health Inc’s operations lies in robust research and development. The company continually refines its product offerings through comprehensive clinical research and adherence to stringent quality assurance protocols. Its approach underscores a commitment to safety and efficacy while addressing the evolving needs of healthcare providers and patients. This rigorous scientific methodology exemplifies the company’s dedication to maintaining high standards of regulatory compliance and industry best practices.
Commitment to Scientific Integrity and Patient Care
Across its diverse operations, Harrow Health demonstrates a sustained commitment to improving patient outcomes. The company’s emphasis on continuous innovation, strategic R&D, and quality-focused manufacturing processes helps ensure that its pharmaceutical solutions not only meet but often exceed industry benchmarks. This dedication to scientific integrity and patient well-being has established Harrow Health as a trusted entity within the field of eyecare therapeutics.
Strategic Value Proposition
Harrow Health Inc’s value proposition is rooted in its specialized expertise in ophthalmic formulations and sedation therapies. By addressing critical gaps in current medical treatments, the company supports healthcare providers in delivering effective and accessible care. Its balanced focus on innovation, quality, and clinical relevance positions it as a vital contributor to the pharmaceutical landscape, particularly within the realms of eye care and procedural sedation.
Overall, Harrow Health Inc exemplifies a dedicated, research-driven approach to pharmaceutical development that leverages deep industry expertise to meet unmet medical needs. Through its integrated operations and commitment to quality, it remains a significant, unbiased source of therapeutic solutions for healthcare professionals nationwide.
Harrow (Nasdaq: HROW), a U.S. eyecare pharmaceutical company, will release its financial results for Q1 2023 on May 11, 2023, after market close. The results will be accompanied by a Letter to Stockholders available on their website, harrow.com. A conference call is scheduled for the same day at 4:45 p.m. Eastern Time, where the company will discuss the financial results and provide a business update. Investors can participate via the provided U.S. and international dial-in numbers, and a replay will be available through May 18, 2023. Harrow is focused on developing affordable ophthalmic prescription therapies and owns U.S. commercial rights to ten FDA-approved products, along with operating ImprimisRx, a leading ophthalmic compounding business.
B. Riley Financial, Inc. (NASDAQ: RILY) announced it led financing for Harrow Health, Inc. (NASDAQ: HROW) to support its acquisition of exclusive commercial rights to five FDA-approved ophthalmic products. The financing included $59.75 million in debt provided in January 2023 and a fully backstopped $125 million commitment. The loan was fully repaid on March 27, 2023, coinciding with Harrow's new $100 million credit facility. B. Riley also managed Harrow's equity and senior notes offerings in December 2022, raising $65.25 million. Harrow aims to enhance its position in the U.S. ophthalmic pharmaceuticals market through this acquisition.
Harrow (Nasdaq: HROW) announced a $100 million secured credit financing agreement with Oaktree Capital Management, designed to enhance its financial flexibility. The facility has an interest rate of SOFR plus 6.50% and will mature in approximately three years. Part of the proceeds will pay off existing debts, with the remaining funds allocated for milestone payments linked to a recent acquisition and general corporate uses. CEO Mark L. Baum expressed optimism about this credit facility, stating it strengthens the balance sheet and aligns with Harrow’s growth strategy, while Oaktree’s Managing Director highlighted the partnership during a critical transformation phase for Harrow.
Harrow reported full-year 2022 revenues of $88.6 million, a 22% increase from $72.5 million in 2021. The company divested non-ophthalmic assets, becoming a pure-play ophthalmic pharmaceutical firm. Key developments included FDA approval for IHEEZO™ and the issuance of a Permanent J-Code (J2403), which facilitates reimbursement for ophthalmologists. Additionally, Harrow acquired U.S. rights to several branded products and launched new compounded formulations. Despite a net income loss of $14.1 million, adjusted EBITDA rose to $13 million, reflecting improved operational performance.
Harrow (Nasdaq: HROW) has received transitional pass-through reimbursement status from the Centers for Medicare & Medicaid Services (CMS) for IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%, effective April 1, 2023. This status allows for separate reimbursement in Ambulatory Surgery Centers (ASC) and Hospital Outpatient Departments (HOPD) for three years. IHEEZO is now the only ocular anesthetic eligible for such reimbursement across all care settings. The company aims to enhance patient access to IHEEZO, with a commercial launch scheduled for May 2023 at the ASCRS meeting. IHEEZO is a significant product for cataract surgeries and intravitreal injections, highlighting its relevance in the eyecare market.
Harrow (Nasdaq: HROW) has appointed Mark Mannebach, Ph.D., R.Ph., as the new Head of Regulatory Affairs and Pharmacovigilance. With over 30 years of experience in the pharmaceutical industry, particularly in ophthalmology, Dr. Mannebach will oversee regulatory submissions and strategy for Harrow's product portfolio. His previous roles include Vice President of Global Regulatory Affairs at Mallinckrodt and Santen Pharmaceuticals. Harrow aims to leverage Dr. Mannebach's expertise to expand its branded ophthalmic products and enhance regulatory processes as it prepares for the launch of IHEEZO™ and future product developments.
Harrow (Nasdaq: HROW) will release its financial results for Q4 and the fiscal year ended December 31, 2022, on March 23, 2023, after the market close. A conference call will follow at 4:45 PM Eastern Time to discuss the results and provide a business update. Harrow specializes in eyecare pharmaceuticals, holding U.S. commercial rights to ten FDA-approved ophthalmic products. The company also operates ImprimisRx, a leading ophthalmic compounding business, and has equity positions in Surface Ophthalmics and Melt Pharmaceuticals, along with royalty rights in four drug candidates under development.
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