Nicox Provides Third Quarter 2018 Business Update and Financial Highlights

Nicox SA provided upcoming milestones and operational highlights, as well as revenue and cash position for Nicox and its subsidiaries, as of September 30, 2018.

Key Upcoming Milestones

• Q1 2019: Planned investigational new drug submission to the US 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 partner Eyevance Pharmaceuticals, followed by a commercial launch in the US planned for the spring 2019 allergy season.
• H2 2019: Expected top-line data from the NCX 470 phase 2 clinical study for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.

Third Quarter 2018 and Recent Operational Highlights

• In September 2018, Nicox and Fera Pharmaceuticals amended their 2015 agreement, granting Fera exclusive rights to develop and commercialize naproxcinod for the US market. The development of naproxcinod will focus on an undisclosed rare disease for which Fera expects to apply for an orphan drug designation from the FDA. Nicox will be eligible to potentially receive a single $40 million sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the US. Royalties remain at 7% of net sales of naproxcinod in the US. Fera remains responsible for all clinical development, manufacturing, regulatory, and commercialization activities.
• In Q3 2018, Nicox’s lead product candidate NCX 470, a novel second-generation nitric oxide-donating prostaglandin analog, entered phase 2 clinical study to evaluate its efficacy and safety compared to latanoprost 0.005% for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension and to select the optimal phase 3 dose. The study is expected to randomize 420 patients in clinical sites across the US. Top-line data are expected in the second half of 2019.

Third Quarter 2018 Financial Highlights

As of September 30, 2018, the Nicox Group had cash and cash equivalents of €25.7 million as compared with €32.7 million at June 30, 2018 and €41.4 million at December 31, 2017.  Net revenue for the third quarter of 2018 was $0.438 million, comprised exclusively of royalties on third-quarter 2018 sales of Vyzulta by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. This represents an increase of 66% in net revenue received by Nicox compared to the second quarter of 2018. The Nicox Group recorded no revenues for the third quarter of 2017.