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.
Harrow, Inc. (Nasdaq: HROW) is an ophthalmic-focused pharmaceutical company that regularly issues news and updates related to its portfolio of eye-care products, development programs, and corporate activities. The company describes itself as a leading provider of ophthalmic disease management solutions in North America, with products that address conditions such as dry eye disease, wet age-related macular degeneration, cataracts, refractive errors, glaucoma, ocular surface conditions, and retina diseases.
News about Harrow commonly covers financial results and investor communications, including quarterly earnings releases, letters to stockholders, and conference call announcements. The company also announces participation in investor conferences and Investor & Analyst Day events, where it provides overviews of its commercial portfolio, pipeline, and long-term vision.
Another key theme in Harrow’s news flow is business development and pipeline progress. Recent press releases have described the agreement to acquire, and subsequent closing of the acquisition of, Melt Pharmaceuticals, Inc., a clinical-stage company developing non-opioid, non-IV sedation therapies such as MELT-300 and MELT-210. Harrow has used these announcements to explain the strategic rationale for expanding into procedural sedation and to outline regulatory and development milestones for these product candidates.
Harrow’s news also highlights access and affordability initiatives, such as the launch of the VEVYE Access for All (VAFA) program for VEVYE (cyclosporine ophthalmic solution) 0.1% and the broader Harrow Access for All (HAFA) program, which is intended to extend a unified access model across its branded, authorized generics, and compounded ophthalmic medications. Additional releases address leadership changes at ImprimisRx, debt offerings and related credit facilities, and other corporate matters.
Investors and eyecare professionals reviewing Harrow’s news page can expect updates on earnings, capital markets transactions, acquisitions, development milestones for ophthalmic and procedural sedation candidates, and initiatives aimed at improving patient access to the company’s ophthalmic therapies.
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.
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.