28 August 2015
• Product pipeline on track for near-term major progress
o VESNEO™ NDA submitted by Valeant
o Three further regulatory submissions planned by Nicox within the next 12 months
• Accelerating development of additional NO-donating ophthalmology programs
• Revenues from existing products €4.6 million in H1 2015, up 114% from H1 2014
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced its financial results for the six months ended June 30, 2015, and provided an update on its activities.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: “The submission of the NDA for VESNEO™ to the FDA by our partner Valeant is a pivotal milestone for Nicox and provides validation for our high-value NO-donating pipeline. VESNEO™ is the first ophthalmic product to emerge from our proprietary platform, and its progress is a great achievement for both companies. Together with our product pipeline, the growing European commercial platform and the new nitric oxide-donating development programs, Nicox is building a leading presence in the global ophthalmology drug market, which is expected to grow considerably in the next few years.”
Business update for the six months to June 30 2015 and post-reporting period
VESNEO™ NDA submission confirmed by Valeant
Nicox’s licensee Bausch + Lomb (a wholly-owned subsidiary of Valeant group) submitted a New Drug Application (NDA) recently to the US Food and Drug Administration (FDA) 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.
VESNEO™ is a nitric oxide (NO)-donating prostaglandin F2-alpha analog discovered using Nicox’s proprietary R&D platform, which is designed to engineer NO-donating compounds for therapeutic use. Valeant has previously estimated that peak sales of VESNEO™ may exceed $500 million in the US and $1 billion worldwide should the product be approved. The partnership with Valeant could therefore generate significant revenues for Nicox through a mix of milestones (up to $132.5 million net1 mainly on commercial sales targets) and royalties (potential net2 tiered royalties on sales from 6% to 11%) if launched. Following the divestment of Nicox’s US commercial operations, Nicox has informed Valeant that it wishes not to co promote VESNEO™ in the United States.
Results from studies investigating the mechanism of action of VESNEO™ were published in June 2015 by Cavet et al. in Investigative Ophthalmology & Visual Science. In addition, clinical data were presented at major glaucoma conferences: the 25th American Glaucoma Society Annual Meeting (Feb 26 – Mar 1, Coronado), the Glaucoma 360 conference (Feb 5-7, San Francisco) and the World Glaucoma Congress 2015 (June 6-9, Hong Kong).
Ophthalmology pipeline continuing to progress beyond VESNEO™
• AC-170 – Two positive pre-NDA meetings were held with the FDA regarding AC-170, a novel formulation of cetirizine developed for the treatment of ocular itching associated with allergic conjunctivitis. The purpose of the first meeting was to discuss the clinical package for AC-170, and based on the available efficacy and safety data, the FDA recommended submission of an NDA. The second pre-NDA meeting was focused on the Chemistry, Manufacturing and Controls (CMC) data package. The NDA submission remains on track, with the objective to obtain FDA approval by the end of 2016.
• NCX 4251 – Nicox’s nanocrystalline fluticasone propionate (formerly known as AC-155) for the treatment of blepharitis, is expected to go directly into phase 2 clinical trials following toxicity studies and IND filing, pending IND approval by the FDA.
• NCX 470 and the NO-donor pipeline – Nicox has decided to advance several additional programs from its proprietary nitric oxide (NO)-donating platform. These include two programs targeting glaucoma: NCX 470 which will be moved toward clinical-stage trials and next-generation stand-alone NO-donors which are currently in the lead optimization phase. Promising preclinical results were presented at the ARVO 2015 Annual Meeting.
• AzaSite® and BromSite™ – Nicox plans to file European Marketing Authorization Applications (MAAs) for both AzaSite® (azithromycin ophthalmic solution for bacterial conjunctivitis) and BromSite™ (bromfenac ophthalmic solution for pain and inflammation after cataract surgery) by the end of H1 2016. Nicox signed an exclusive license agreement with InSite Vision in February 2015 for AzaSite® and BromSite™ in Europe, Middle East and Africa.
• The development of OHT (RPS-OH), a diagnostic test for ocular herpes in-licensed from Rapid Pathogen Screening, Inc. (RPS®), has been discontinued. AAT (RPS-AP), a diagnostic test for the combined detection of adenoviral and allergic conjunctivitis also in-licensed from RPS®, remains in clinical development.
• Outside the Nicox’s ophthalmology core business field, a decision has been taken by Nicox’s undisclosed financial partner not to advance naproxcinod and other undisclosed compounds in Duchenne muscular dystrophy (DMD).
First-half financial summary
The Group’s revenues in the first half of 2015 totaled €4.6 million compared to €2.1 million a year before3 and consisted exclusively of European and International product sales. The growth in sales was helped by the acquisition of Doliage and the launch of new products in the Xailin™ range.
The Group recorded a net loss of €15.8 million as of June 2015, compared to a net loss of €16.0 million at the same date in 2014. The Group’s net loss remains stable following the divestment of Nicox Inc. at the end of 2014.
The Group had cash, cash equivalents and financial instruments of €39.5 million as of June 30, 2015, compared to €31.9 million on December 31, 2014. Nicox completed a financing in March 2015 with the participation of major institutional investors specialized in life sciences, mainly from the US, which brought gross proceeds of €27 million.
The positive sales momentum seen in the first half is expected to continue in the second half of the year. This is expected to be offset by growing R&D costs, reflecting continued investment in the near-term product pipeline, including the planned submission of regulatory applications for several products over the next 12 months.
Michele Garufi added: “Our Research and Development costs, which we expect will increase in the second half of the year, are fueling significant progress in our late-stage development and regulatory activities. We expect three regulatory filings in the next 12 months in addition to VESNEO™, with the potential for two FDA approvals in 2016. Along with the significant commercial potential of VESNEO™, these investments would create additional substantial value for the Company.”
The half-yearly financial report will be available in French by the end of September 2015 on Nicox’s website www.nicox.com, in the section Investor Information > Regulated information > Financial Information.
The procedures relating to the limited review of the interim financial statements have been carried out. The limited review report will be issued after the finalisation of the procedures required for the publication of the-first half financial report.
1. Potential net milestones from Valeant to Nicox following payments due to Pfizer as part of 2009 agreement
2. Potential net royalties from Valeant to Nicox following payments due to Pfizer as part of 2009 agreement
3. Revenues as of June 30, 2014 have been restated following the divestment of Nicox Inc.