Harrow Health Inc - HROW STOCK NEWS

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.

Harrow (Nasdaq: HROW), a prominent U.S. eyecare pharmaceutical company, has announced the launch of its patent-pending compounded Atropine formulations, now accessible via its subsidiary, ImprimisRx. These innovative formulations, priced from $39 per 5mL bottle, are preservative-free and have a physiologic pH of 5.5, with a storage life of up to 180 days at room temperature. CEO Mark L. Baum emphasized the commitment to providing accessible and affordable ophthalmic medications to address unresolved patient needs. However, compounded medications are not FDA-reviewed for safety or efficacy.

Harrow (Nasdaq: HROW) announced that the Centers for Medicare & Medicaid Services has issued a permanent J-code (J2403) for its ocular anesthetic IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%, effective April 1, 2023. This code will simplify the billing process for eyecare professionals. CEO Mark L. Baum expressed gratitude for CMS's support, emphasizing IHEEZO's clinical advantages and the commitment to accessibility. IHEEZO, approved by the FDA on September 26, 2022, is the first branded ocular anesthetic in the U.S. in nearly 14 years, protected by a patent valid until 2038.

Harrow (Nasdaq: HROW) has successfully closed its acquisition of U.S. commercial rights to five branded ophthalmic products for $130 million. The products include ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and TRIESENCE®. A milestone payment is also expected upon TRIESENCE's market availability. A six-month transition period is in place where the seller will continue selling the products and transfer profits to Harrow. The company projects the acquisition will be financially accretive, reaffirming its 2023 revenue guidance of $135 million to $143 million and adjusted EBITDA of $44 million to $50 million.

Harrow (Nasdaq: HROW) has made its compounded antibiotic formulation, Fortisite (Tobramycin 1.5% + Vancomycin 5%), available for immediate in-office use by eyecare professionals. This product, sourced from its FDA-registered ImprimisRx 503B facility, marks a significant advancement in treating sight-threatening infections. Fortisite is distinguished by its high concentration and stability, allowing for improved patient care. The company also offers a robust access program and a 100% replacement guarantee for expired products, enhancing its service to healthcare providers.

Melt Pharmaceuticals has announced positive top-line results from its Phase 2 study of MELT-300, a novel sublingual formulation for procedural sedation during cataract surgery. The study demonstrated that MELT-300 was statistically superior in efficacy compared to both midazolam (P=0.0129) and ketamine (P=0.0096), and patients treated with MELT-300 were significantly less likely to require rescue sedation (50% less than midazolam, P=0.0198). The company plans to approach the FDA to discuss further development plans.

Harrow Health has announced the pricing of an underwritten public offering of $35 million of 11.875% senior notes due 2027. The offering is expected to close on December 20, 2022. The company has also granted underwriters a 30-day option to purchase an additional $5.25 million in notes. Proceeds will be used for a previously announced acquisition, along with funding general corporate purposes. The notes have received a 'BB' rating from Egan-Jones Ratings Company and will be listed under the symbol 'HROWM' on Nasdaq.

Harrow Health, Inc. (Nasdaq: HROW) has launched a public offering of $100 million in senior notes due 2027. The offering is subject to market conditions, with underwriters potentially acquiring an additional 15%. The proceeds will fund a previously announced acquisition and support other corporate activities. Egan-Jones Ratings Company has rated the notes as 'BB'. The notes will be offered under an SEC effective shelf registration statement. Harrow focuses on innovative ophthalmic prescription therapies in the U.S. market.