On April 18, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported Q1 2019 operational highlights, revenue and cash position for Nicox and its subsidiaries (the "Nicox Group"), as well as key upcoming milestones (Press release, NicOx, APR 18, 2019, View Source [SID1234535194]).
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Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, "With two exciting programs in advanced clinical development and two products approved in the U.S. we are continuing apace to fully leverage our scientific, clinical, and commercial assets. Enrollment has now reached over 85% in the NCX 470 glaucoma clinical trial, and both this and the NCX 4251 blepharitis trial should generate topline results in Q4 of this year. We expect our recurrent revenues to ramp up as Bausch + Lomb progresses the international rollout of VYZULTA, and with the launch by Eyevance of ZERVIATE in the U.S. In addition, our ongoing discussions for ZERVIATE outside of the U.S. could result in agreements in the near future with further upfront, milestone and royalty payments."
Key Upcoming Milestones
NCX 470 Phase 2 results: Top-line data from the NCX 470 Phase 2 clinical trial for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension expected in Q4 of this year.
NCX 4251 Phase 2 results: Phase 2 clinical trial in patients with acute exacerbations of blepharitis ongoing with top-line data expected in Q4 of this year.
ZERVIATE U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. planned by our partner Eyevance Pharmaceuticals for summer of this year. Nicox eligible for up to $3 million of a potential future milestone payment from Eyevance related to certain regulatory and near-term manufacturing objectives, which are expected to be received prior to the U.S. launch.
ZERVIATE ex-US partnering: Multiple discussions ongoing for potential new licensing agreements in significant markets.
Nicox’s ophthalmology programs to be presented at key scientific conferences including the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
First Quarter 2019 and Recent Operational Highlights
The total number of prescriptions for VYZULTA in the U.S. in the first quarter of 2019 increased by 18% compared to Q4 20181 and by 360% compared to the first quarter 20181.
On March 19, 2019, we announced the initiation of a Phase 2 clinical trial evaluating NCX 4251, our novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. We expect to report top-line results from this Phase 2 trial in the fourth quarter of 2019.
On March 15, 2019, we announced that we had we entered into an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of Nicox’s product ZERVIATE (cetirizine ophthalmic solution), 0.24% for the treatment of allergic conjunctivitis for the Chinese market.
On January 25, 2019, we announced that we had entered into a bond financing for up to €20 million from Kreos Capital. The financing is structured as three tranches of which only the first tranche of €8 million has been drawn down. The exercise of the two other tranches is at Nicox’s sole discretion.
On January 8, 2019 we announced that we had reached the 50% patient enrollment threshold of our multicenter, U.S. Phase 2 clinical trial evaluating our lead product candidate, NCX 470, ahead of schedule. NCX 470 is a novel, second-generation nitric oxide (NO)-donating prostaglandin analog for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension that has demonstrated 2 to 3 mmHg superior IOP lowering vs. the U.S. market leader LUMIGAN in head-to-head preclinical evaluations.
Also in January, our global partner, Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies, Inc., received approval in Canada of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%. VYZULTA is indicated for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.
First Quarter 2019 Financial Highlights
As of March 31, 2019, the Nicox Group had cash and cash equivalents of €23.5 million as compared with €22.0 million at December 30, 2018. Net revenue2 for the first quarter of 2019 was €0.430 million versus €0.075 million in the first quarter of 2018.