Harrow Health Inc Stock Price, News & Analysis

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.

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.