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 (HROW) reported strong financial results for Q4 and full-year 2024. The company achieved record Q4 revenues of $66.8 million, up 84% year-over-year, while full-year 2024 revenues reached $199.6 million, representing a 53% increase from 2023.
Q4 2024 highlights include GAAP net income of $6.8 million and Adjusted EBITDA of $22.5 million. For the full year 2024, the company reported a GAAP net loss of $(17.5) million and Adjusted EBITDA of $40.3 million.
Notable operational achievements include over 40% quarter-over-quarter growth in both IHEEZO unit demand and VEVYE prescriptions. The company announced its VEVYE Access for All program to drive market share expansion in 2025. Additionally, TRIESENCE received transitional pass-through approval, significantly expanding its market opportunity. Management provided 2025 revenue guidance of 'more than $280 million,' projecting over 40% growth.
Harrow (HROW), a leading North American eyecare pharmaceutical company, has scheduled the release of its fourth quarter and audited financial results for the year ended December 31, 2024. The announcement will be made after market close on March 27, 2025.
The company will publish its fourth quarter Letter to Stockholders on its website's Investors section. A conference call and live webcast are scheduled for March 28, 2025, at 8:00 a.m. Eastern Time to discuss results and provide business updates. Interested participants can access the conference via webcast through Harrow's website or register in advance for telephone access. A replay will be archived on the company's website for one year.
Harrow (HROW) has received approval from the Centers for Medicare & Medicaid Services (CMS) for transitional pass-through reimbursement status for TRIESENCE®, their preservative-free synthetic corticosteroid.
Starting April 1, 2025, TRIESENCE will receive separate reimbursement outside surgical bundled payments in both Ambulatory Surgery Centers and Hospital Outpatient Departments for three years. CMS will reimburse at Average Sales Price plus 6%. The drug previously received a permanent J-Code (J3300), making it the only preservative-free synthetic corticosteroid with separate reimbursement across all traditional care settings.
TRIESENCE is FDA-approved for visualization during vitrectomy and treating ocular inflammatory conditions unresponsive to topical corticosteroids. The drug is available in 40mg/mL single-use vials through major pharmaceutical distributors.
Harrow (HROW) has announced a delay in releasing its audited financial results for Q4 and full-year 2024, as their new independent auditor requires additional time to complete the audit process. The company emphasizes this delay is not due to any disagreements on accounting principles, practices, financial statement disclosure, or auditing procedures.
CEO Mark L. Baum confirmed that Harrow has successfully met the annual leverage ratio term under their senior secured loan agreement, avoiding the issuance of warrants to lenders. The company has provided revenue guidance for 2025 of over $280 million, with growth expected to be primarily driven by their higher-margin branded business.
Harrow (NASDAQ: HROW) has launched VEVYE® Access for All, a groundbreaking program making their dry eye disease therapy more accessible and affordable. The initiative, available through PhilRx specialty pharmacy, guarantees eligible patients access to VEVYE (cyclosporine ophthalmic solution) 0.1% for $59.
Key program benefits include:
- No prior authorization requirements
- Expedited prescription processing with free home delivery
- First prescription available for as low as $0 for eligible patients
- Refills at $59 per bottle with additional discounts for 3-bottle orders
- Money-back guarantee
The program aims to eliminate barriers created by insurance middlemen, streamline the prescribing process, and ensure quick, affordable access to treatment. The initiative is immediately available nationwide through PhilRx, with plans to expand to other pharmacy networks.
Harrow (HROW) has executed a five-year strategic supply and development agreement for TRIESENCE®, a preservative-free synthetic corticosteroid approved by the FDA for visualization during vitrectomy and treatment of certain ocular inflammatory conditions. The agreement is with the current contract manufacturing organization that has over 15 years of experience with TRIESENCE manufacturing.
The company aims to ensure continuous supply of TRIESENCE, which had previously been on the FDA's Drug Shortage List for over five years. Additionally, Harrow has initiated development of a next-generation version of TRIESENCE, with plans to submit a new drug application (NDA) to the FDA by the end of 2027.
Harrow (HROW), a leading North American eyecare pharmaceutical company, has scheduled its fourth quarter and year-end 2024 financial results announcement for March 17, 2025, after market close. The company will simultaneously release its fourth quarter Letter to Stockholders on its website.
A conference call and live webcast are planned for March 18, 2025, at 8:00 a.m. Eastern Time to discuss the results and provide a business update. Investors can access the conference call through the company's website or register for telephone participation, which will provide them with a unique dial-in number and PIN.
Harrow (HROW) has announced a strategic partnership with Cencora (COR) to launch the 'Harrow Cares' program, aimed at improving accessibility and affordability of IHEEZO® and TRIESENCE® for retina specialists and their patients. The program offers comprehensive support services through a state-of-the-art patient support hub.
The initiative includes multiple key features: streamlined enrollment through various channels, real-time benefit verifications for rapid treatment access, flexible affordability options including commercial copay assistance with patients paying as little as $0, and ongoing support services including patient welcome calls and prior authorization denial assistance.
This partnership represents Harrow's strategic focus on expanding its presence in the U.S. retina market and demonstrates the company's commitment to improving healthcare accessibility while driving better patient outcomes.
Harrow (HROW) has appointed Amir H. Shojaei, PharmD, PhD as Chief Scientific Officer (CSO). Dr. Shojaei brings 28 years of life sciences experience, specializing in clinical development, regulatory affairs, and commercialization of biopharmaceutical products. He previously served as CSO at AsclepiX Therapeutics and held executive roles at TherOptix , Novartis, and Shire Pharmaceuticals.
Notable achievements include his instrumental role in the FDA approval of Xiidra® at Shire Pharmaceuticals in 2013, the first product approved for both signs and symptoms of dry eye disease. Dr. Shojaei succeeds Dennis E. Saadeh, who is retiring after nearly a decade of service to Harrow.
OSRX expressed disappointment with the jury verdict in ImprimisRx v. OSRX trademark infringement case. The jury found OSRX and Ocular Science guilty of willful trademark infringement and unfair competition, awarding $34.9 million in damages. OSRX disputes ImprimisRx's claims about trademark ownership of pharmaceutical abbreviations like 'Pred,' 'moxi,' 'dex' and 'brom.' The company argues that these are generic terms in ophthalmology, citing a survey showing 70% of eye care professionals consider them generic. OSRX plans to challenge the verdict, with pending legal issues to be decided in December, including laches, unclean hands, and fraud on the USPTO.
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