Total sales increased by almost 120% over 2014

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Sophia Antipolis, France

Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today reported its revenues for the nine month to September 30, 2015 as well as its cash position, and provided an update on its activities.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: “The first nine months of 2015 were marked by the continuous sales growth of our European commercial operations, which increased by 119% over the same period of 2014, and as well as by the NDA acceptance for filing of VESNEO, our leading nitric oxide-donating candidate partnered with Valeant in glaucoma. The FDA set a target PDUFA date for July 21, 2016 to finalize its evaluation and we look forward to the potential subsequent launch of VESNEO in the United States. Together with our proprietary cetirizine eye drop, AC-170, we could have two FDA approvals by the end of 2016, which we believe places Nicox in a unique position among the European specialty pharmaceutical companies.”

Third-quarter financial highlights

The Group’s revenues in the first nine months of 2015 totaled €7.0 million and consisted exclusively of European and International product sales. These compare to €3.2 million in the first nine months of 20141. The Company expects a continuous progression of the revenues throughout the last quarter of 2015.

The Group had cash, cash equivalents and financial instruments of €34.5 million as of September 30, 2015.

Third-quarter and recent highlights

  • Beyond VESNEO™, Nicox expects to submit an NDA to the U.S. FDA for AC-170, a novel cetirizine eye drop formulation developed for the treatment of ocular itching associated with allergic conjunctivitis, during the first half of 2016. The Company is planning to seek Priority Review for this drug-candidate, and, if obtained, approval could occur by the end of 2016 based on PDUFA performance goals.
  • In July 2015, Nicox’s licensee Bausch + Lomb (a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc.) submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for VESNEO™ (latanoprostene bunod ophthalmic solution 0.024%), an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension. If approved, VESNEO™ will be the first nitric oxide donating prostaglandin receptor agonist available for the above indication. The FDA accepted this NDA for review in September 2015 and set an action date of July 21, 2016 to complete its review, as per the Prescription Drug User Fee Act (PDUFA)
  • Nicox’s European pipeline features two pre-Marketing Authorization Application (MAA) candidates: AzaSite® for bacterial conjunctivitis and BromSite™ for pain and inflammation after cataract surgery. Nicox expects to file both MAAs for AzaSite® and BromSite™ by the end of 2016
  • As approved by Nicox’s shareholders at the October 13, 2015 Extraordinary General Meeting, the Board of Directors is implementing a 5-for-1 reverse stock split, which will become effective as of December 3, 2015. Nicox believes this reverse stock split is a critical step in a larger strategic initiative to increase awareness and visibility for Nicox ahead of the potential FDA approval of VESNEO™ in 2016.
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Note

1. In accordance with IFRS5, the revenues of €3.2 million for the first nine months of 2014 do not include Nicox Inc., which was divested to Valeant in November 2014.