On September 17, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial results for Nicox and its subsidiaries (the "Nicox Group") for the six months ending June 30, 2019 and provided an update on its activities as well as key upcoming milestones (Press release, NicOx, SEP 17, 2019, View Source [SID1234539574]).
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Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: "This is a compelling and potentially transformative time for Nicox, as we make strong progress in our growth strategy. Our two Phase 2 clinical trials have progressed in accordance with our expected timeline, with data expected early in the fourth quarter for our lead product candidate NCX 470 for glaucoma and later in the year for NCX 4251 in blepharitis. We are optimizing the value of our assets through licensing agreements outside of the U.S. and Europe, including the recent deal for NCX 4251 in the Chinese market, and continuing discussions with potential partners in several markets. With solid foundations in place, we are very much looking forward to continuing the exciting development of our company."
Key Upcoming Clinical Milestones
NCX 470 Phase 2 results: Top-line data from the Phase 2 "DOLOMITES" safety and efficacy clinical trial, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension expected on time early in the fourth quarter of this year.
NCX 4251 Phase 2 results: Safety and tolerability clinical trial in patients with acute exacerbations of blepharitis progressing as planned, with top-line data expected in the fourth quarter of this year.
Product and Product Candidates Updates
Enrollment of patients completed in the DOLOMITES trial, our multicenter, U.S. Phase 2 safety and efficacy clinical trial evaluating NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog, in patients with glaucoma or ocular hypertension. This trial is a head-to-head comparison of once-daily administration of three different doses of NCX 470 versus latanoprost, 0,005%, which is the most widely prescribed first-line therapy for glaucoma and ocular hypertension. The primary endpoint of this trial is the mean reduction in diurnal IOP after 28 days of treatment, while the overall objective is to identify the appropriate dose of NCX 470 to be advanced into Phase 3 trials. 433 patients were randomized at clinical sites across the U.S. and top-line data is expected early in the fourth quarter of this year. In December 2018, Nicox entered into an exclusive license agreement with Ocumension Therapeutics, Inc. for the development and commercialization of NCX 470 in the Chinese market.
The Phase 2 safety and tolerability clinical trial of NCX 4251, a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals, in patients with acute exacerbations of blepharitis, is on track with top-line data expected in the fourth quarter of this year. The next stage of development will be a larger Phase 2b clinical trial. In July 2019, Nicox entered into an exclusive license agreement with Ocumension for the development and commercialization of NCX 4251 in the Chinese market and received a €2.0 million upfront payment from Ocumension.
Completed regulatory and manufacturing responsibilities concerning ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S., and received a $3.0 million milestone payment from U.S. partner Eyevance Pharmaceuticals. From now on, all manufacturing and regulatory responsibilities, together with decisions on launch timing, lie with Eyevance. Eyevance has informed Nicox that the launch of ZERVIATE in the U.S. is currently projected in the first half of 2020. ZERVIATE is also partnered with Ocumension in the Chinese market pursuant to an exclusive license agreement that it entered into with Ocumension in March 2019.
VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is now marketed in Canada, in addition to the U.S., by global partner Bausch + Lomb. Nicox has received royalties since December 2017 from this collaboration. The total number of prescriptions for VYZULTA in the U.S. in the first half of 2019 increased by 54% compared to the second half of 20183 and by 228% compared to the first half of 20183.
Research activities continue to advance with first data presented at ARVO 2019 on NO-donating phosphodiesterase-5 (PDE5) inhibitors, a new drug class designed to lower IOP, in which NCX 1741, the first lead molecule from the PDE5 inhibitor program, showed a substantial lowering of IOP in a non-human primate model of ocular hypertension. Nicox expects to announce an IND-track candidate from our NO-donating PDE5 research program in 2020. Research activities are focused on combining NO-donation with other complementary mechanisms of action which are not currently utilized in any approved ophthalmic product, including PDE5 inhibition and soluble guanylate cyclase stimulation. Molecules from these classes could be developed either as adjunctive therapies or in fixed-dose combinations with latanoprost or other prostaglandin analogs for IOP lowering.
First Half 2019 Financial Highlights
Net revenue1 for the first half of 2019 was €5.6 million versus €0.3 million for the first half of 2018.
Operating expenses for the first half of 2019 were €11.4 million compared to €10.0 million for the first half of 2018. The increase in operating expenses was mainly due to costs associated with the two ongoing Phase 2 clinical trials for NCX 470 and NCX 4251.
The Nicox Group recorded a net loss of €0.8 million for the six months ended June 30, 2019, compared to a net loss of €7.6 million for the same period in 2018. The net loss in the first half of 2019 has been reduced due to the contribution of the €2.0 million upfront payment and the $3.0 million milestone payment respectively invoiced to our partners Ocumension and Eyevance, the royalties received from Bausch + Lomb for VYZULTA and the recognition of non-cash income of €3.8 million for deferred tax assets recognized by our U.S. subsidiary.
As of June 30, 2019, the Nicox Group had cash and cash equivalents of €17.3 million, adjusted to €22.0 million including license payments recorded as revenue in June 2019 but paid in July 2019, as compared with €23.5 million at March 31, 2019 and €22.1 million at year end December 31, 2018.
As of June 30, 2019, the Nicox Group had financial debt of €7.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019. Nicox drew down a first tranche of €8.0 million in January 2019 under the agreement and has the option but not the obligation to draw down either €7.0 million or €12.0 million on November 1, 2019, subject to notice to Kreos by October 10, 2019. Full details of the bond financing agreement can be found in the Press Release of January 25, 2019 – View Source
References
1. Net revenue consists of revenue from collaborations less royalty payments which we refer to as net profit from collaborations in the condensed consolidated statements of profit or loss for the six-month period ended June 30, 2019.
2. Net loss reduced due to exceptional licensing income and non-cash deferred tax income.
3. Bloomberg data, comparing the period of the weeks ending 4 January 2019 to 28 June 2019 with the periods of the weeks ending 6 July 2018 to 28 December 2018 and 5 January 2018 to 29 June 2018.
The diligences related to the half-year review were performed by the auditors. The review report will be issued once procedures will be finalized over the half-year financial report.