06 March 2018
VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024%, marketed by partner Bausch + Lomb in the U.S. since December 2017
ZERVIATETM (cetirizine ophthalmic solution), 0.24%, U.S. launch planned by partner Eyevance Pharmaceuticals for the 2018 fall allergy season
Pipeline candidates moving towards clinical development, with IND submissions to the U.S. FDA planned for NCX 470 in Q3 2018 and NCX 4251 in Q1 2019
Estimated cash position of €41.4 million as of December 31, 2017
March 6, 2018 – release at 7:30 am CET Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, today provided an overview of its milestones and activities, and announced its estimated financial and operating results for the year ended December 31, 2017. The Company’s Board of Directors will adopt the 2017 consolidated financial statements on March 16, 2018.
“2017 was a year of outstanding achievements for Nicox, with the U.S. Food and Drug Administration approval of our two lead products, VYZULTATM, the first drug based on our proprietary nitric oxide (NO)-donating research platform, and ZERVIATETM. We are off to a strong start in 2018, with VYZULTATM already being marketed in the U.S. by our partner Bausch + Lomb, and ZERVIATETM set to be launched in the U.S. by Eyevance later this year. The future revenue streams from these two products, together with our strong cash balance, leave us well positioned to advance our wholly-owned programs, NCX 470 and NCX 4251, into clinical development,” stated Michele Garufi, Chairman and Chief Executive Officer of Nicox. “We are strengthening the R&D team that will further develop our internal drug candidates with the recent hiring of Tomas Navratil as our Head of Development, and the planned opening of a development office in Research Triangle Park, North Carolina. In 2018 we also expect to make significant advances in our NO-donating research pipeline, targeting IOP reduction, both with our next-generation of stand-alone NO-donors, and with novel therapeutic classes targeting primary outflow. We expect 2018 to be another year of important accomplishments.”
Commercial Stage Products Updates
In 2017, both of Nicox’s lead assets were approved by the U.S. Food and Drug Administration (FDA).
VYZULTATM marketed in the U.S. by Bausch + Lomb: Indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, VYZULTATM, the first prostaglandin analog with one of its metabolites being nitric oxide (NO), is the first approved product to utilize Nicox’s proprietary NO-donating research platform. Bausch + Lomb (a whollyowned subsidiary of Valeant Pharmaceuticals International, Inc.) launched VYZULTATM in the U.S. in December 2017.
Bausch + Lomb holds exclusively licensed worldwide rights to VYZULTATM, which was approved by the U.S. FDA in November 2017. Nicox received $17.5 million from Bausch + Lomb upon the approval, of which $15 million was paid to Pfizer under a previous agreement signed in 2009. The current lead branded products in this market, Travatan Z (travoprost ophthalmic solution), 0.004% and Lumigan (bimatoprost ophthalmic solution), 0.01% and 0.03%, had sales of $570 million and $687 million, respectively, in 20161. Nicox estimates that the U.S. patents covering VYZULTATM could be extended from 2025 to 2030.
ZERVIATETM expected to be launched in the U.S. by Eyevance Pharmaceuticals for the 2018 fall allergy season: Indicated for the treatment of ocular itching associated with allergic conjunctivitis, ZERVIATETM is the first and only topical ocular formulation of cetirizine. ZERVIATETM was approved by the U.S. FDA in May 2017.
In September 2017, Nicox licensed exclusive U.S. commercial rights for ZERVIATETM to Eyevance Pharmaceuticals, LLC, an ophthalmic specialty pharmaceutical company backed by a specialized invesTMent group and led by a team experienced in the U.S. ophthalmic market. Nicox received a non-refundable upfront payment of $6 million upon signature of this agreement. The annual U.S. market for topical ocular allergy products is approximately $700 million2. Eyevance plans to launch ZERVIATETM in the U.S. for the 2018 fall allergy season.
Nicox is currently exploring partnerships for ZERVIATETM outside of the U.S. The product is protected by U.S. patents to 2030 and 2032, and by Japanese patents to 2030.
Nicox continues to progress its two pipeline products towards clinical development and is also advancing several innovative, discovery-stage assets.
NCX 470 Investigational New Drug (IND) submission for Phase 2 planned in Q3 2018: NCX 470 is a novel NO-donating bimatoprost prostaglandin analog in development for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. We believe that NCX 470 has the potential for an IOP-lowering activity greater than VYZULTATM. Nicox is conducting IND-enabling non-clinical studies and, subject to their successful completion, currently plans to submit an IND application to the U.S. FDA in the third quarter of 2018 to support a Phase 2 clinical study.
- NCX 4251 IND submission for Phase 2 planned in Q1 2019: NCX 4251 is a novel, patented ophthalmic formulation of fluticasone propionate being developed for the first time as a targeted topical treatment of the eyelid for acute exacerbation of blepharitis. Blepharitis is a common ocular condition in which the edges of the eyelids become red and swollen, and may contain dandruff-like matter. The annual U.S. revenues of steroids, antibiotics and their combinations prescribed for blepharitis total more than $500 million3. Nicox is conducting formulation and IND-enabling nonclinical studies and, subject to their successful completion, currently plans to submit an IND application to the U.S. FDA in the first quarter of 2019 to support a Phase 2 clinical study.
Next-Generation of Stand-alone NO-donors and Novel NO-Donating Compounds: Nicox has active research programs targeting NO-donation in the eye and has discovered multiple novel compounds that release NO from pharmacologically active and non-active scaffolds. These novel chemical entities are thought to lower IOP by stimulating the primary fluid outflow mechanism from the anterior segment of the eye. The Company’s next-generation of stand-alone NO-donors is designed to optimize NO dosing when administered alone or with current standard-of-care treatments as adjunctive therapy or as fixed-dose combination products to lower IOP in patients with open-angle glaucoma or ocular hypertension. New data on repeated dosing of NCX 667, the lead stand-alone NO-donor, was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2017 Annual Meeting. Multiple candidates currently in the lead optimization stage of development have demonstrated IOP-lowering in various animal models of ocular hypertension. Some of these candidates are currently being investigated for targeted extended release intraocular drug delivery as part of two exploratory strategic collaborations with pSivida Corp. and Re-Vana Therapeutics. The collaborations will evaluate whether their biodegradable extended release technologies are suitable for use with Nicox’s new NO-donating compounds.
Other 2017 and Early 2018 Highlights
- In August 2017, Nicox completed a financing through a reserved capital increase of ordinary shares of the Company with a specific category of investors. Gross proceeds from the financing were €26.3 million, and net proceeds were €24.5 million.
- In September 2017, Nicox and VISUfarma amended certain elements of their agreement relating to the August 2016 transfer of Nicox’s European and International commercial operations to VISUfarma. Subsequently, Nicox and VISUfarma agreed that Nicox would no longer be responsible for completing development and regulatory approval for AzaSite (azithromycin ophthalmic solution) 1% in Europe. These changes result in a net income of €4.7 million.
- In October 2017, Nicox entered into two collaborations to explore the potential for extended release formulations of Nicox’s next-generation of stand-alone NO-donors for the reduction of IOP, with Re-Vana Therapeutics concerning their EyeLief™ long-acting photo-crosslinked biodegradable drug delivery platform, and with pSivida Corp. concerning their biodegradable extended release drug delivery system.
- In January 2018, Nicox appointed Tomas Navratil, Ph.D. as Vice President, Head of Development, effective January 1, 2018. In this newly-created position, reporting to Michael Bergamini, Ph.D., Executive Vice President, Chief Scientific Officer of Nicox, Dr. Navratil is responsible for leading all of the Company’s non-clinical and clinical development activities. Nicox has subsequently decided to open a development office in Research Triangle Park, North Carolina (U.S) and is in the process of recruiting additional development team members to support the IND submissions and the starts of the NCX 470 and NCX 4251 clinical studies.
2017 Financial Summary
This press release presents estimated results for the full-year 2017 (unaudited). The audit procedures by the Statutory auditors are underway. The Company’s Board of Directors will adopt the 2017 consolidated financial statements on March 16, 2018. At the end of December 2017, the estimated Net Loss of the Group amounts to €3.6 million compared to €19.0 million at end of December 2016. This estimated Net Loss includes the European commercial business which is treated as Discontinued Operations since their transfer in August 2016. The Group had estimated cash, cash equivalents and financial instruments of €41.4 million as of December 31, 2017, compared to €28.9 million on December 31, 2016.
- Net revenue for the 12 months to December 2017 was €2.3 million, which is comprised exclusively of the U.S. FDA approval milestone payment from Bausch + Lomb, and royalty revenue following the launch of VYZULTATM in the second half of December 2017, after deduction of Nicox’s milestone and royalty payments to Pfizer under a previous agreement signed in 2009. The nonrefundable upfront payment received from Eyevance was not immediately recognizable as revenue accordingly to IFRS accounting principles. The operating expenses for the period were €20.8 million compared to €21.3 million for the 12 months to December 31, 2016.
- The Group recorded a Net Loss from Continued Operations of €8.3 million as of December 2017, compared to a Net Loss of €6.7 million at the same date in 2016. The net loss for 2017 have been significantly reduced due to the non-cash impact of the reduction of deferred tax liability related to Nicox Ophthalmics, Inc. following the new US tax law voted in December 2017 decreasing significantly the federal corporate tax rate. The 2016 loss was significantly decreased by the noncash impact of the reduction in the value of a potential earn-out payable in shares to Nicox Ophthalmics, Inc. former shareholders.
1. MS Health Analytics 2016 reported sales and TRx (Total Prescriptions)
2. IMS Health Analytics and TRx (Total Prescriptions), not including OTC products for ocular allergy
3. Internal estimate based on IMS Health Analytics data.