Harrow Enters into Agreement to Acquire Exclusive U.S. Rights to ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE

On Dec 15, 2022

Harrow, an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovative ophthalmic therapies, announced that it has entered into a binding agreement for the acquisition of the exclusive U.S. commercial rights to five FDA‑approved ophthalmic products from the Novartis group of companies (“Novartis”). This acquisition, when closed, will further expand and diversify Harrow’s portfolio of branded pharmaceutical products and its ability to serve the U.S. ophthalmic surgical and acute care markets. Subject to customary closing conditions, this acquisition is expected to close in early 2023.

This transaction, which is the second acquisition transaction between Harrow and Novartis, transfers exclusive U.S. rights to the following ophthalmic products:

ILEVRO® (nepafenac ophthalmic suspension) 0.3%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated with cataract surgery.
NEVANAC® (nepafenac ophthalmic suspension) 0.1%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated with cataract surgery.
VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms.
MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%, a steroid eye drop for steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/ml, a steroid injection for the treatment of certain ophthalmic diseases and for visualization during vitrectomy.

Mark L. Baum, Chairman and CEO of Harrow, stated, “This is a landmark transaction for Harrow, catapulting Harrow into a leadership position in the U.S. ophthalmic pharmaceuticals market. Following the satisfaction of the relevant closing conditions, these products will be immediately accretive to our revenues and excellently complement our current portfolio of ophthalmic prescription products.

“We know these products very well and have long appreciated and admired them for the value they have delivered to thousands of U.S. eyecare professionals and many millions of their patients. We believe the addition of these five products to our ophthalmic pharmaceutical portfolio, which includes newly FDA‑approved IHEEZO®, MAXITROL® 3.5mg/10,000 units/0.1%, IOPIDINE® 1%, and the market-leading ImprimisRx compounded formulary, will be of tremendous value to our customers – giving them more choices and flexibility when considering the best treatment options for their patients and the specific needs of their practices.

“Our market research indicates an increasing demand for the indications these products treat. Based on U.S. demographic growth, favorable competitive trends, and broad public and private payor reimbursement, revenue contribution from these products is expected to grow for many years. Assuming this transaction closes during the first quarter of 2023, Harrow expects 2023 net revenues to be between $135 million and $143 million and adjusted EBITDA to be between $44 million and $50 million, with both net revenues and adjusted EBITDA ramping up during 2024 and beyond.”

Under the terms of the agreement:

Harrow will make a one-time payment of $130 million at closing, with up to an additional $45 million payable in a milestone payment upon the commercial availability of TRIESENCE, which is expected in the second half of 2023.
During an estimated 6-month NDA transfer period, Novartis will continue to sell the products in the U.S. market and will transfer all net profits to Harrow.
Following the NDA transfer period, Harrow will assume control over all U.S. market activities and will begin a process to have the products manufactured by third parties.
Novartis will retain all rights to the products outside of the U.S.
The transaction is expected to close in the first quarter of 2023, subject to the satisfaction of customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.