30 March 2015
- A year of strategic progress:
- Positive phase 3 results for Vesneo™ (Bausch + Lomb); NDA submission on track for Q2 2015
- Significant strengthening of ophthalmic therapeutics pipeline
- Acquisition of Aciex Therapeutics, Doliage and Carragelose® eye drop (Xailin Viral)
- In-licensing of AzaSite® and BromSite™ in Europe (Q1 2015)
- 2014 revenues €6.0 million vs. €0.4 million in 2013 reflecting growing EU & RoW sales
- Completion of €27 million financing supports growth strategy to become a leading global specialty ophthalmic company
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced its financial and operating results for the year ended December 31, 2014, as approved by the Board of Directors on March 27, 2015, and provided an overview of its activities.
“We have made considerable progress in delivering our strategy to build a leading global specialty ophthalmic company, by expanding and advancing our pipeline of promising late-stage therapeutics, investing in our own commercial operations and signing distribution agreements in multiple new markets,” said Michele Garufi, Chairman and CEO of Nicox. “Vesneo continues to make rapid progress, with a US NDA submission for glaucoma by our partner Bausch + Lomb / Valeant anticipated before the end of the first half of 2015. Should the forecasted peak sales by Bausch + Lomb be achieved, Nicox could receive total net milestones and royalties from Vesneo™ of up to $1 billion over the estimated life of the agreement. We believe Vesneo will play a significant role in supporting Nicox’s future development as we prepare to submit three additional products for approval, AC-170 in the US and AzaSite and BromSite in Europe, over the next 15 months. We view the successful financing completed in March 2015, supported by leading US and European institutional investors, as a major endorsement of our strategy and growth potential and we look to the future with confidence.”
2014 operational highlights
Positive phase 3 results for Vesneo™ confirmed potential of Nicox’s lead compound
- Nicox’s licensee Bausch + Lomb (Valeant) plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Vesneo™ in Q2 2015.
Three acquisitions successfully completed
- Aciex Therapeutics, Inc., a US R&D company which significantly strengthened Nicox’s therapeutic pipeline, including the advanced allergic conjunctivitis candidate AC-170.
- Doliage, a French company with a portfolio of marketed products dedicated to major eye diseases such dry eye syndrome, glaucoma and eye infections (2014 sales €2.4 million).
- Xailin Viral, an innovative Carragelose® eye drop in development for the management of viral conjunctivitis.
Direct commercial operations expanded in Europe complemented by exclusive international distribution agreements
- Commercial operations launched by Nicox in the five major European markets: Germany, France, UK, Italy and Spain.
- Seven new products launched, including the Xailin™ range and AdenoPlus®.
- Exclusive distribution agreements now covering approximately 40 countries, including Switzerland, Benelux, Turkey, South Africa, Australia and Japan, to market Nicox’s portfolio and increase its international commercial footprint.
US diagnostics business divested to Valeant, enabling enhanced focus on growing pipeline of ophthalmic therapeutics
- Acquisition by Valeant Pharmaceuticals International, Inc. of Nicox Inc. for up to $20 million ($10 million upfront, potential milestone payments $10 million)
Strengthening of Management and Board
- Three new appointments to the Board of Directors: Adrienne Graves, former CEO of Santen Inc. to replace Vicente Anido; Luzi von Bidder, former Chairman of Acino Holding AG and former Chairman and CEO of Novartis Ophthalmics AG, to replace Vaughn Kailian; and Les Kaplan, former Executive Chairman of Aciex Therapeutics, Inc.
- Appointment of Michael Bergamini, Ph.D. as Chief Scientific Officer and Executive Vice President of Nicox, with more than 30 years in ophthalmology including in the discovery, translation, development, registration and launch of more than a dozen ophthalmic drug and device products.
- Appointment of Sandrine Gestin as Finance Director of Nicox, joining the Company’s Executive Committee. Sandrine has over 25 years of experience in accounting and finance and joined Nicox in 1999.
Post Reporting Period Events
- Financing successfully completed in March 2015 with the participation of institutional investors specialized in life sciences, mainly from the US. The gross proceeds of the financing are approximately €27 million. Net proceeds are intended to provide additional resources to the Company to finance its strategy, in particular: working capital and general corporate purposes; clinical development and regulatory filings related to pipeline candidates; and strengthening the Company’s commercial organization in Europe and the United States.
- Two positive pre-NDA meetings held with the US FDA regarding AC-170, cetirizine ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis.
- Exclusive license agreement signed with InSite Vision for AzaSite® and BromSite™ in Europe, Middle East and Africa.
- Orphan Drug Designation (ODD) granted by the FDA to naproxcinod for the treatment of Duchenne Muscular Dystrophy (DMD). Naproxcinod is currently under evaluation by an undisclosed financial partner for potential clinical development in DMD.
2014 Financial Summary
- In accordance with IFRS5, 2014 and 2013 revenues and expenses set out below do not include Nicox Inc., which was divested to Valeant in November 2014.
- Nicox’s revenues totaled €6.0 million in 2014, compared to €0.4 million in 2013. This significant increase reflects the launch of new products, acquisitions and investment in the Group’s commercial operations. This does not include the 2014 revenues recorded by Nicox Inc., which totaled €1.0 million at the time of its acquisition by Valeant in November 2014 (2013: €0.3 million).
- Selling, Administrative and Research and Development costs amounted to €28.7 million in 2014, compared to €15.0 million in 2013, mostly due to continued investment in building international commercial infrastructure in Europe’s five largest markets. The Group generated an operating loss of €21.8 million in 2014, compared to €11.0 million in 2013.
- On December 31, 2014, the Group’s cash, cash equivalents and financial instruments were €32.0 million, compared to €58.4 million on December 31, 2013. In March 2015, Nicox completed a €27 million financing, strengthening its cash position which stood at approximately €48 million as of March 10, 2015.
Nicox’s development strategy and key upcoming milestones
- Q2 2015: Planned Vesneo™ NDA submission by Bausch + Lomb (Valeant). Bausch + Lomb estimates potential peak sales in the US alone of more than $500 million should the product be approved by the FDA.
- Mid-2015: Update on naproxcinod evaluation in Duchenne Muscular Dystrophy.
- Q1 2016: Planned AzaSite® and BromSite™ MAA filings in Europe.
- The AC-170 NDA submission timing is currently being evaluated, with the objective of obtaining FDA approval by the end of 2016.
- 2015-onwards: Additional product launches in Europe and RoW
Nicox’s objective is to become a leading global specialty ophthalmic company, with an international commercial presence, a diversified product portfolio and an advanced development pipeline. The Group’s strategy is based around three synergistic and complementary axes: a partnership with Bausch + Lomb (Valeant) on Vesneo™ in glaucoma, which could generate significant revenue through milestones and royalties for Nicox; an advanced proprietary therapeutic pipeline which notably includes AC 170, a novel cetirizine eye drop for allergic conjunctivitis; and growing international commercial operations, directly in the five largest European markets and through distribution agreements in the rest of the world. Nicox intends to continue strengthening its product portfolio and development pipeline through further acquisition and in-licensing opportunities in the US and in Europe. Following a year marked by numerous achievements and a successful €27 million financing completed in the first quarter of 2015, Nicox is well positioned to continue achieving its growth objectives.