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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 Inc. (Nasdaq: HROW), a leading U.S. ophthalmic pharmaceutical company, has announced a significant expansion of its corporate headquarters in Nashville, Tennessee. The expansion will create nearly 150 new jobs in the area. Harrow, originally founded in San Diego in 2012, relocated its headquarters to Nashville in 2019.
Since the relocation, Harrow has invested in Nashville by building a state-of-the-art analytical chemistry lab, expanding its sales and marketing organization, and hiring for other critical business operations. The company has also recently expanded its total leased square footage in Nashville to approximately 30,000 square feet.
Tennessee Governor Bill Lee and other state officials praised the expansion, highlighting the state's growing economy and business-friendly environment. Harrow's CEO, Mark L. Baum, cited Nashville's advantageous location, beneficial tax environment, and dynamic culture as key factors in the company's decision to expand in the city.
Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, has announced its participation in three investor conferences in New York this September. The events include:
- H.C. Wainwright 26th Annual Global Investment Conference (Sept 9-11, 2024)
- Lake Street 8th Annual Best Ideas Growth Conference (Sept 12, 2024)
- Cantor 2024 Global Healthcare Conference (Sept 17-19, 2024)
Harrow will present at the H.C. Wainwright conference on Sept 10 at 8:00 a.m. ET and host a Fireside Chat at the Cantor conference on Sept 18 at 2:30 p.m. ET. The company will conduct one-on-one meetings at all three events. Audio webcasts for the H.C. Wainwright and Cantor conferences will be available on Harrow's website.
Harrow (Nasdaq: HROW) reported record Q2 2024 revenues of $48.9 million, a 46% increase year-over-year and 42% quarter-over-quarter. The company saw significant growth across all business segments, particularly in IHEEZO and VEVYE sales. Key highlights include:
- GAAP net loss of $(6.5) million
- Adjusted EBITDA of $8.8 million
- Cash and cash equivalents of $71.0 million as of June 30, 2024
- IHEEZO customer unit demand volume increased by 98% from Q1 2024
- VEVYE total prescriptions increased by 212% from Q1 2024
- Anterior Segment revenues up over 40% from Q1 2024
Harrow is progressing with the relaunch of TRIESENCE®, with positive initial analytical test results for the second process performance qualification batch.
Novaliq has received a positive opinion from the European Medicines Agency's CHMP for Vevizye®, a treatment for moderate to severe dry eye disease in adults. Vevizye® is a clear ciclosporin 0.1% solution based on Novaliq's unique EyeSol® water-free technology. The recommendation is based on comprehensive data from over 1,500 patients, showing clinically meaningful improvements in ocular surface conditions as early as two weeks, with excellent tolerability.
In clinical trials, Vevizye® demonstrated statistically significant improvements across various endpoints, with up to 71.6% of patients responding within four weeks. The therapy showed continued improvement in both signs and symptoms over 56 weeks. If approved, Vevizye® would be the first medicinal therapy approved to treat dry eye disease in both the US and EU.
Harrow (HROW), a leading U.S. eyecare pharmaceutical company, has announced it will release its second quarter 2024 financial results on August 7, 2024, after market close. The company will also publish its Q2 Letter to Stockholders on its website. A conference call and live webcast are scheduled for August 8, 2024, at 8:00 a.m. Eastern Time to discuss the results and provide a business update.
Investors can access the live conference call via webcast on Harrow's website or register in advance for telephone participation. A replay of the call and webcast will be available on the company's website for one year.
Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, will attend the 2024 American Society of Retina Specialists (ASRS) Annual Meeting in Stockholm, Sweden, from July 17-20, 2024.
The meeting gathers top retina specialists, researchers, and industry leaders to discuss the latest advancements in retinal health.
Harrow plans to showcase its expanding portfolio, including IHEEZO®, a novel anesthetic gel for ocular surface anesthesia, and provide updates on the relaunch of TRIESENCE®, used for vitrectomy and treating posterior uveitis.
The company's participation aims to build a strong retina franchise and demonstrate its commitment to serving the U.S. retina community.
Harrow (Nasdaq: HROW) has entered into an agreement with Apexus to offer its products, including IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, through the 340B Prime Vendor Program starting July 1, 2024. The 340B PVP, managed by Apexus, aims to enhance purchasing power for U.S. hospitals and ensure access to discounted medications. Additional Harrow products included are VIGAMOX®, a bacterial conjunctivitis treatment, and ILEVRO®, an NSAID for ocular pain and inflammation. This agreement aims to open access to Harrow's products for the U.S. hospital market, significantly impacting the 44% of hospitals participating in the program.
Harrow (Nasdaq: HROW) has successfully manufactured the first of three commercial-scale process performance qualification (PPQ) batches of TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, an FDA-approved corticosteroid for ocular surgeries and inflammatory conditions. The remaining two PPQ batches are scheduled, and if all batches meet specifications, TRIESENCE will relaunch in 2024. TRIESENCE has been on the FDA Drug Shortage List for over five years, with no inventory available in the U.S. for over two years. Harrow is committed to quickly building commercial inventories, though initial supplies may not meet market demand. Pre-commercial activities and discussions with strategic accounts for pre-orders are underway.
Melt Pharmaceuticals has dosed the first patient in its Phase 3 clinical trial for MELT-300, a non-IV, non-opioid sedation tablet, targeting procedural sedation during cataract surgery. MELT-300 combines midazolam and ketamine in a sublingual, fast-dissolving format. The trial is a randomized, double-blind study involving 528 patients across 14 clinical sites, comparing MELT-300 to sublingual midazolam and a placebo. Previous Phase 2 trials showed MELT-300's superior efficacy. Topline results are expected in Q4 2024. CEO Dr. Larry Dillaha highlighted the innovation in sedation and potential expansion to over 100 million annual procedures in various medical fields.
Harrow (Nasdaq: HROW) announced results from its ESSENCE-2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, aimed at treating dry eye disease (DED). The 52-week study, involving 202 patients, demonstrated sustained safety and efficacy of VEVYE, with significant improvements in corneal staining, tear production, and symptomatology. Mild instillation site pain and reduced visual acuity were the most common adverse events. Only one patient withdrew due to mild ocular discomfort. 33.1% of patients rated the eye drop satisfaction at 10, and 91% rated it 5 or higher. Investigators highlighted VEVYE’s tolerability and long-term potential. Harrow’s CEO emphasized the product’s unique formulation and clinical benefits.
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