Nicox Reports First Half Financial Results and Pipeline Developments

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SOPHIA ANTIPOLIS, France—International ophthalmic company Nicox SA (Euronext Paris: FR0013018124, COX) reported Thursday that Nicox Group net revenue for 2018’s first half totaled €0.3 million. This was comprised “exclusively of royalties on [first-half] 2018 sales of Vyzulta by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox,” the company added. The Nicox Group recorded no revenues for the first half of 2017, according to the announcement. The company also noted that operating expenses for the first half, which ended June 30, “were consistent with the same period last year (€10 million for the first six months of 2018 compared with €10.2 million for the first six months of 2017). Nicox Group recorded a net loss of €7.6 million for the first half, which compares with a net loss of €12.2 million for the same period in 2017.

“Nicox is entering a new and exciting phase with the initiation of the Phase 2 study for our lead product candidate, NCX 470, for IOP reduction in patients with open-angle glaucoma or ocular hypertension, and by strengthening our U.S. presence in our new site in Research Triangle Park in North Carolina,” chairman and chief executive Michele Garufi said in the announcement. “We have assembled the right team to achieve our important near term clinical and corporate milestones and continue delivering on all objectives in line with our growth strategy.”

Separately, Nicox said Thursday that it had previously confidentially submitted a draft registration statement on Form F-1 to the Securities and Exchange Commission relating to a proposed offering of American Depository Shares (ADS) representing Nicox ordinary shares in the U.S. The timing, number of ADS representing ordinary shares and price of the proposed offering have not yet been determined, the company noted.

Among several “key upcoming milestones” and product updates noted by the company are:

  • Q1 2019: Planned Investigational New Drug (IND) submission to the FDA for NCX 4251 to enable a Phase 2 clinical study in patients with acute exacerbations of blepharitis.

  • Q1 2019: Expected delivery of Zerviate (cetirizine ophthalmic solution), 0.24% commercial product to Eyevance Pharmaceuticals LLC, followed by a launch for the spring 2019 allergy season in the U.S. Zerviate is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

  • Vyzulta is now a revenue-generating asset for Nicox, following the U.S. launch in December 2017 by partner Bausch + Lomb. In March 2018, Nicox announced an amendment to the global licensing agreement under which royalties paid to Nicox on worldwide net sales of Vyzulta will increase by 1 percent over the original royalty on net sales above $300 million per year. In addition, the potential milestone payments payable to Nicox by Bausch + Lomb have been increased by $20 million.

  • Nicox expects to ship commercial product and trade samples for Zerviate to partner Eyevance by Q1 2019, which will allow Eyevance to launch the product in the U.S. in time for the 2019 spring allergy season. The shipment of product triggers a $1 million milestone payment to Nicox by Eyevance, with up to $3 million of potential future milestones payments related to certain regulatory acceptance provisions and certain near term manufacturing objectives.