Nicox announces third quarter 2014 financial update

Nicox announces third quarter 2014 financial update

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• Total revenues of €4.5 million in the 9 months to September 30 2014 (vs. €0.3 million in same period of 2013)
• Completion of Aciex Therapeutics, Inc. acquisition significantly strengthens Nicox's therapeutic development pipeline
• Positive phase 3 results for VESNEO (latanoprostene bunod) support strong commercial potential
• Acquisition of Doliage in France strengthens established revenue streams and marketing infrastructure

October 30, 2014.

Sophia Antipolis, France.

Nicox S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, today provides an update on its revenues and cash position for the first nine months of 2014.

Michele Garufi, Chief Executive Officer of Nicox, commented: "In the third quarter of this year, we have achieved important progress in building our therapeutic ophthalmic pipeline, thanks to the positive pivotal phase 3 results for VESNEO and the recently completed acquisition of Aciex Therapeutics, Inc. Nicox now has two product candidates which have completed phase 3 trials and this increases our confidence in our future prospects as a competitive International Ophthalmic Group."

Financial summary for the first nine months of 2014

Revenues

The company posted total revenues of €4.5 million for the first nine months of 2014, compared with €0.3 million for the same period in 2013.

The nine months sales revenues represent the first significant recurring revenues from Nicox's growing portfolio of ophthalmic products, currently in the launch phase, including: established sales from Nicox's Italian subsidiary; initial sales from AdenoPlus^® and the Xailin(TM) range in Europe and the rest of the world (ROW), outside North America; and initial sales of Sjö(TM) and RetnaGene(TM) in the United States (US). Nicox markets AdenoPlus^®, a diagnostic test that aids in the differential diagnosis of conjunctivitis, and Xailin(TM), a range of ocular lubricants for dry eye, directly in the 5 major European markets and in other ROW countries through distributors. In addition, the Group's US subsidiary Nicox Inc. launched the RetnaGene(TM) portfolio of tests for evaluation of the risk of advanced Age-related Macular Degeneration (AMD) at the end of June 2014 and continues to roll-out Sjö(TM), for the early detection of Sjögren's syndrome, throughout the US.

Other revenues include an upfront payment of €0.5 million linked to the exclusive distribution agreement granted to Nitto Medic in August 2014 for the commercialization of AdenoPlus^® in the Japanese market.

The table below shows the revenues for the first nine months of 2014 and 2013:

Cash, cash equivalents and current financial instruments

The Company's cash, cash equivalents and current financial instruments amounted to €32.9 million as of September 30, 2014. As of September 30, 2014, Nicox's bank indebtedness was limited to €0.3 million following the consolidation of new entities.

Third-quarter and post-third quarter operational summary

Acquisition of Aciex Therapeutics, Inc.

In July 2014, Nicox signed an agreement to acquire all of the outstanding equity of Aciex Therapeutics, Inc., a private, US-based, ophthalmic development pharmaceutical company with a strong near-term pipeline of therapeutics addressing major segments of the ophthalmic market. The acquisition was completed on October 24, 2014 following the approval of Nicox's shareholders at an Extraordinary General Meeting held on October 22, 2014. Nicox exchanged 20,627,024 newly issued Nicox shares for 100% of Aciex's shares. The transaction also includes contingent value rights giving right to shares for a potential additional value of up to $55 million, based on the potential US FDA approval(s) of AC-170 and of two additional undisclosed products within a pre-determined period.

 VESNEO: Positive top-line phase 3 results to support FDA filing

VESNEO^® (latanoprostene bunod) is a nitric oxide (NO)-donating prostaglandin F2-alpha analog currently in phase 3 clinical development with Bausch + Lomb, a division of Valeant Pharmaceuticals International, Inc., for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension. Positive top-line results from the pivotal phase 3 studies APOLLO and LUNAR conducted with VESNEO were announced in September 2014. Both studies met their primary efficacy endpoint and showed positive results on a number of secondary endpoints. Bausch + Lomb expects to submit a New Drug Application (NDA) to the FDA for the approval of VESNEO in mid-2015, with a potential launch in the US in the first half of 2016, pending FDA approval.

Under the terms of the worldwide licensing agreement signed between Nicox and Bausch + Lomb in March 2010, Nicox stands to receive potential additional regulatory and sales milestones from Bausch + Lomb of up to $162.5 million, which would result in net milestones for Nicox of up to $132.5 million following payments due to Pfizer as part of 2009 agreement. Nicox would also receive potential net tiered royalties on sales, pending FDA approval, ranging from 6% to 11% following payments due to Pfizer. In addition, Nicox exercised its option to co-promote latanoprostene bunod in the US in August 2014.

A review article on the potential of NO in glaucoma, written by scientists from both Bausch + Lomb and Nicox, was published in August 2014 in Investigative Ophthalmology and Visual Science (IOVS).¹  

Acquisition of French ophthalmic company Doliage

In September 2014, Nicox acquired 100% of the shares of Doliage, a privately-held French ophthalmic company, for €5 million in newly-issued Nicox shares. The acquisition provides Nicox with an established and profitable ophthalmic business in France, with Doliage's sales totaling €2.6 million in 2013.

Acquisition of Carragelose^® eye drop program

In September 2014, Nicox acquired the Carragelose^® anti-viral eye drop program from Marinomed Biotechnologie GmbH for a total of €2.65 million in newly issued Nicox shares and up to €2.65 million in potential additional cash payments. The acquisition provides Nicox with an innovative anti-viral ophthalmic product to be developed under the name 'Xailin Viral', which could be launched in Europe as a medical device within two years, pending CE marking.

Xailin Gel launch

In October 2014, Nicox launched Xailin Gel, an innovative multidose carbomer gel lubricant (medical device) that becomes preservative-free in the eye, in Europe. Once Xailin Gel is in contact with the eye surface, the substance released by the preservative is converted to water and oxygen by ocular enzymes, making Xailin Gel 'preservative-free in the eye'. Xailin Gel follows Xailin Night and Xailin Fresh as the third medical device to be introduced in the Xailin(TM) range of dry eye lubricants. Other ocular lubricants are planned to be launched as part of the Xailin range by the end of 2014.

Update on US operations

In July 2014, Nicox acquired the extension of the rights to market Sjö(TM), an advanced diagnostic panel for the early detection of Sjögren's syndrome, to all healthcare practitioners in North America. In July 2014, Nicox and Rapid Pathogen Screening (RPS^®) agreed to restructure the terms of their partnership in North America. RPS^® has assumed responsibility for marketing AdenoPlus^® to eye care professionals in North America, as well as two other diagnostic products currently in development, and will pay Nicox royalties on sales. Nicox retains rights to commercialize AdenoPlus^® and the previously licensed development products in all markets outside North America.

Update on ROW distributions agreements

In August 2014, Nicox entered into an exclusive agreement with Nitto Medic, a leading Japanese ophthalmic company, for the distribution of AdenoPlus^® in Japan. In October 2014, Nicox entered into an exclusive agreement with OptiMed, a leading Australian company distributing ophthalmic diagnostic and therapeutic products, for the distribution of its product portfolio, including AdenoPlus^® and the Xailin(TM) range, in Australia and New Zealand.

Board of Directors

In August 2014, Nicox's Board agreed to co-opt Adrienne Graves, former CEO of Santen Inc., the US subsidiary of Santen, and Luzi von Bidder, former Chairman of Acino Holding AG and former Chairman and CEO of Novartis Ophthalmics AG, as members of the Board, to replace Vaughn Kailian and Vicente Anido. The co-options of Dr. Graves and of Mr von Bidder were approved by Nicox's shareholders at the General Meeting held on October 22, 2014. Shareholders also approved the appointment of Les Kaplan to the Company's Board of Directors. Mr. Kaplan is the former Executive Chairman of Aciex Therapeutics, Inc. and former Executive Vice President and President, Research and Development of Allergan, Inc.

Management team

In August 2014, Nicox appointed Michael Bergamini, Ph.D., as Chief Scientific Officer (CSO) and Executive Vice President. Dr. Bergamini brings over 30 years of experience in the eye care industry and has played key roles in the discovery, translation, development, registration, and US and international launch of a number of pharmaceuticals, as well as several medical device products.

Following a review of the needs of the business, Nicox and Evelyne Nguyen have jointly agreed to change her collaboration framework to part-time Corporate Finance Advisor to support the Group's Corporate Finance activities. She will continue to be a member of Nicox's Executive Committee.
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References:

1. Cavet ME, Vittitow JL, Impagnatiello F, Ongini E, Bastia E. Nitric Oxide (NO): An Emerging Target for the Treatment of Glaucoma. Invest Ophthalmol Vis Sci. 2014, 55(8): 5005-15

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About Nicox

Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an emerging international company focused on the ophthalmic market. With a heritage of innovative R&D, business development and commercial expertise, the Nicox team is building a diversified portfolio of therapies and diagnostic tools that can help people to enhance their sight. The Company's commercial portfolio and near-term pipeline already include several innovative diagnostic tests intended for eye care professionals, as well as a range of eye care products. Nicox's key proprietary asset in ophthalmology is latanoprostene bunod, a novel compound based on Nicox's proprietary nitric oxide (NO)-donating R&D platform, currently in Phase 3 clinical development in collaboration with Bausch + Lomb for the potential treatment of glaucoma and ocular hypertension. Further NO-donors are under development, notably through partners.

Nicox is headquartered in France, with research capabilities in Italy, a growing commercial infrastructure in North America and in the major European markets and an expanding international presence through partners. Nicox S.A. is listed on Euronext Paris (Compartment B: Mid Caps). For more information on Nicox or its products please visit www.nicox.com.

 
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This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.

Risks factors which are likely to have a material effect on Nicox's business are presented in: the 4^th chapter of the "Document de référence, rapport financier annuel et rapport de gestion 2013" filed with the French Autorité des Marchés Financiers (AMF) on April 2^nd, 2014; the "Rapport semestriel financier et d'activité au 30 juin 2014"; the 5^th chapter of the "Actualisation du Document de Référence 2013" filed with the AMF on September 30, 2014 (D. 14-0271-A01); and the section B of the 'Document E' registered with the AMF on September 30, 2014 (E.14-060). All these documents are available on Nicox's website (www.nicox.com).

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