Nicox Announces 2019 Financial Results and 2020 Key Milestones

March 6, 2020

  • Increase of net royalties by 105 %

  • Cash position of €28.1 million as of December 31, 2019

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the financial and operating results for Nicox and its subsidiaries (the “Nicox Group”) for the year ended December 31, 2019, as approved by the Board of Directors on March 5, 2020, and provided upcoming 2020 key milestones.

2019 Financial Summary

Net revenue1 for the full year 2019 was €6.9 million (€2.1 million in net royalties, €4.8 million in upfront and milestone payments), compared to €4.0 million (€1 million in net royalties and €3 million in an upfront payment) for the full year 2018.

Operating expenses for the period 2019 decreased to €25.5 million from €26.5 million for the 12 months to December 31, 2018. Research and development expenses increased by €1.4 million reflecting the investments in the successful clinical trials for NCX 470 and NCX 4251 while administrative and other expenses decreased by €2.4 million.

Net loss of the Nicox Group for the full year 2019 was €18.9 million against €18.4 million in the full year 2018.

As of December 31, 2019, the Nicox Group had cash and cash equivalents of €28.1 million as compared with €22.1 million at December 31, 2018. The December 31, 2019 cash position does not include the last tranche of loan under the bond financing agreement with Kreos Capital which was drawn down in December 2019 but received on January 2, 2020, adding approximately €7.7 million to the year-end cash position of the Group.

As of December 31, 2019, the Nicox Group had a financial debt of €11.1 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 adjusted to approximately €18.8 million by including the last tranche of loan drawn down in December 2019.

Events after the Reporting Period

  • Nicox successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) (see Press Release of March 5, 2020). The Mont Blanc trial, the first Phase 3 clinical trial of NCX 470, is expected to start by the end of Q2 2020, with top-line results expected in Q3 2021. The Mont Blanc trial will be initiated with 0.065% and 0.1% doses of NCX 470, with one dose being selected during the trial through an adaptive design.
  • Nicox received approval from the U.S. Patent and Trademark Office of a formulation patent for NCX 470, extending the U.S. patent coverage to 2039 (see Press Release of February 3, 2020). Nicox has also received approval of this patent in Japan.
  • Nicox presented NCX 470 Dolomites Phase 2 results at the Glaucoma 360 New Horizons Forum (February 7, 2020) and at the American Glaucoma Society (AGS) Annual Meeting (February 27 – March 1, 2020). NCX 4251 Danube Phase 2 results were also presented at AGS.
  • Nicox’s research activities are being concentrated on nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors program for glaucoma for which we expect to be able to announce an Investigational New Drug (IND)-track candidate in 2020 and therefore we are terminating our research collaboration with Cyclerion Therapeutics, Inc.
  • We strengthened our Clinical Development function by appointing Kristie Veasey to the position of Director Clinical Operations, effective March 2, 2020. Reporting to Dr. José Boyer, Vice President of Clinical Development, Ms. Veasey will be responsible for leading clinical operations for some of our upcoming clinical trials. She brings over 19 years of experience in clinical research and development in both the Pharmaceutical Industry and Clinical Research Organizations, with the majority of her professional experience in the therapeutic area of ophthalmology including at Lexitas Pharma Services, Clearside Biomedical and Inspire Pharmaceuticals, Inc.

Key Expected Upcoming Milestones

  • NCX 470 Phase 3 clinical trial preparation: Phase 3 clinical trial (‘Mont Blanc’) is expected to be initiated by the end of Q2 2020.
  • NCX 4251: Meeting with the U.S. FDA is scheduled in Q1 2020 to discuss the next steps of the clinical development plan.
  • ZERVIATETM U.S. launch: Commercial launch of ZERVIATETM (cetirizine ophthalmic solution), 0.24% in the U.S. is planned by Nicox’s partner Eyevance Pharmaceuticals in H1 2020.
  • Presentations on Nicox’s ophthalmology research and development programs at key U.S. scientific conferences including the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss

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