First-quarter financial summary
Revenues in the first three months of 2014 totalled €1.1 million, compared with €0.1 million in the first quarter of 2013. The Group had cash, cash equivalents and current financial instruments of €49.6 million as of March 31, 2014, with no bank indebtedness. The Company will issue comprehensive six-month financial results on July 31, 2014.
The first-quarter revenues represent the first significant recurring revenues from Nicox’s growing portfolio of ophthalmic products, currently in the launch phase, including initial sales from AdenoPlus® and the Xailin™ dry eye product range in Europe and of Sjö™ in the United States. AdenoPlus® is now commercialized in Europe and in the US for differential diagnosis of conjunctivitis. Nicox’s new range of tear lubricants for relief of dry eye symptoms, starting with Xailin Night and Xailin Fresh, were launched in Europe in March 2014. The Company expects to launch the RetnaGene™ AMD test, for evaluation of the risk of Age-related Macular Degeneration progression, in the US by the end of June 2014 and to continue to roll out Sjö™ in the major US markets for the early detection of Sjögren’s syndrome.
First-quarter operational summary
Agreement with Sequenom in age-related macular degeneration (AMD)
In January 2014, Nicox was granted the North American promotional rights to the Sequenom Laboratories RetnaGene™ AMD laboratory-developed test, for the evaluation of a patient’s risk of AMD disease progression within 2, 5 and 10 years. Nicox expects to begin promoting in the United States by end June 2014 the RetnaGene™ AMD test as well as an additional AMD laboratory-developed test also covered by the agreement with Sequenom Laboratories.
European launch of Xailin™ range and AdenoPlus®
In March 2014, Nicox launched Xailin™, a new range of tear lubricants for relief of dry eye symptoms, in Europe (classed as medical devices). Other tear lubricants are planned to be launched throughout 2014, offering ophthalmologists a full range of options. In parallel, Nicox also launched AdenoPlus® in Europe, an in vitro diagnostic medical device that aids in the identification of adenovirus to assist in the differential diagnosis of acute conjunctivitis. Nicox has already established specialist sales teams in Italy, the UK, Spain and France. A team is currently being built Germany, with product launches expected to begin in the second quarter of 2014.
Expansion of the Group’s U.S. commercial team
In the first quarter of 2014, Nicox continued strengthening its American subsidiary, Nicox Inc., to support the upcoming roll-out of Sjö™ and launch of RetnaGene™ AMD. Nicox Inc. appointed Mark Jasek, PhD, as Senior Director and Head, Medical & Scientific Affairs. Dr. Jasek will serve as a key scientific affairs expert as well as act as liaison between Nicox and the North American ophthalmic scientific community. Dennis Pardo OD, MPH, FAAO, was appointed to the position of Director of Professional Affairs. In this role, Dr. Pardo will partner with key opinion leaders in the Retina and Rheumatology areas and will serve as the primary liaison between Nicox and the Sjögren’s Syndrome Foundation.
Presence at major international congresses
Nicox attended several key international congresses in the ophthalmic area, including the Hawaiian Eye meeting in Hawaii, United States, the Società Italiana Trapianto di Cornea (SITRAC) National Congress in Padova, Italy, the International Ocular Inflammation Society Congress (IOIS) in Valencia, Spain, the South Eastern Congress of Optometry International (SECO) in Atlanta, United States and the Journées Réflexions Ophtalmologiques (JRO) in Paris, France.
Naproxcinod repositioned in Duchenne muscular dystrophy (DMD)
In February 2014, Nicox granted an undisclosed financial partner the right to enter into a period of exclusive evaluation to assess the potential development of naproxcinod, a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate, and of next generation nitric oxide-donors outside the ophthalmology area. The evaluation will be entirely funded by the partner and will be focused initially on DMD. Promising preclinical results obtained with naproxcinod in models of muscular dystrophy were published in Human Molecular Genetics in early 20141. Naproxcinod was granted orphan drug designation in Europe in October 2013 for the treatment of DMD.
In February 2014, Evelyne Nguyen was appointed Chief Financial Officer (CFO) of Nicox, succeeding Eric Castaldi.
Post-first quarter events
Clinical and preclinical results obtained with latanoprostene bunod were presented by Bausch + Lomb at the Association for Research in Vision and Ophthalmology (ARVO) Annual meeting in Orlando, Florida (May 4‑8), including results from two clinical studies (CONSTELLATION and KRONUS) as well as some preclinical results on the effect of latanoprostene bunod on primary human trabecular meshwork cell contractility and underlying signaling pathways2. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog currently in Phase 3 clinical development with Bausch + Lomb for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension. Top-line Phase 3 data are expected during the fourth quarter of 2014.
Nicox attended the 2014 ASCRS (American Society of Cataract and Refractive Surgery) • ASOA (American Society of Ophthalmic Administrators) Symposium & Congress in Boston, Massachusetts (April 25-29), as well as the Société Française d’Ophtalmologie (SFO) Congress in Paris, France (May 10-13).
Hum Mol Genet. 2014, Early online publication Jan 23, 2014.