OREANDA-NEWS. Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today reported its first quarter 2016 revenues and cash position and provided an update on its activities.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated, "We have successfully started 2016 with our strongest quarter revenue to date, €3.5 million, reflecting more than 60% growth. We also achieved the important development milestone of the submission last month of the AC-170 NDA for allergic conjunctivitis, for which we expect to hear shortly from the FDA concerning the Priority Review status. In addition, the recent ARVO ophthalmology congress in Seattle featured presentations by both our partner, Bausch + Lomb, on latanoprostene bunod, and the Nicox teams on our NO-donating pipeline, raising significant interest in the scientific community around the results of our new research projects. We look forward to communicating the FDA's feedback on the latanoprostene bunod and AC-170 NDAs in due course."

First-quarter financial highlights

The Group's revenues in the first three months of 2016 totaled €3.5 million and consisted exclusively of European and International product sales. These compare to €2.1 million in the first quarter of 2015, a growth of over 60%. Nicox is currently evaluating a number of strategic options for its European commercial business for which discussions remain ongoing.

The Group had cash, cash equivalents and financial instruments of €20.8 million as of March 31, 2016. The cash burn in the first quarter 2016 included €3.1 million of non-recurrent spending related to submission of  the AC170 New Drug Application (NDA) and additional work so support the AC-170 NDA review.

First-quarter and post-reporting period operational highlights

  • In January 2016, Nicox Ophthalmics, Inc. granted Ora Inc., the world's leading ophthalmic clinical research and product development firm, exclusive worldwide rights for the development and commercialization of the OTC asset AC-120, an innovative drug-candidate for morning eyelid swelling ("puffy eyes").
  • Submission of AC-170 NDA to the U.S. Food and Drug Administration (FDA) on 18 April 2016, with a request for Priority Review, for the treatment of ocular itching associated with allergic conjunctivitis. This NDA has not yet been accepted for review by the FDA. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing, and to confirm if the Priority Review has been granted. AC-170 is a novel formulation of cetirizine, the active ingredient in Zyrtec®1, which has been developed for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis.
  • In May 2016, posters were presented by our partner Bausch + Lomb of clinical results for latanoprostene bunod and by Nicox on pipeline candidates NCX 667, NCX 1653, and NCX 4240 at the Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting (see Press Release dated May 9, 2016).

Key Upcoming Milestones

  • Q2 2016: Decision by the FDA on the Priority Review status for AC-170
  • July 21, 2016: PDUFA date for latanoprostene bunod
  • September 22, 2016: First-half results