On March 1, 2021 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial and operating results for Nicox and its subsidiaries (the "Nicox Group") for the year ended December 31, 2020, as approved by the Board of Directors on February 26, 2021, and provided upcoming 2021 key milestones (Press release, NicOx, MAR 1, 2021, View Source [SID1234575805]).
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2020 Financial Summary
Net revenue[1] for the full year 2020 was €12.9 million (€2.4 million in net royalties, €10.5 million in license payments), compared to €6.9 million (€2.1 million in net royalties, €4.8 million in upfront and milestone payments) for the full year 2019. Net revenue has been revised upwards from that reported in the Q4 2020 business update due to an accounting adjustment reflecting a non-cash item of deferred income received from Ocumension in March 2020.
Operating expenses for the year 2020 decreased to €19.5 million from €25.5 million for the 12 months to December 31, 2019. Research and development expenses decreased by €5.0 million while administrative and other expenses decreased by €1.0 million. Nicox’s research and development efforts remained strong in 2020, mainly concentrated in the second part of the year with 3 clinical trials initiated since June.
Net loss of the Nicox Group for the full year 2020 was €18.1 million against €18.9 million for the full year 2019.
As of December 31, 2020, the Nicox Group had cash and cash equivalents of €47.2 million as compared with €28.1 million at December 31, 2019.
As of December 31, 2020, the Nicox Group had financial debt of €17.9 million consisting of €15.9 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2.0 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic. The position includes the prepayment to Kreos of the January 2021 period.
Events after the Reporting Period
VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, was launched by Nicox’s global partner Bausch + Lomb in Mexico. It is already commercialized in U.S. (2017), Canada (2019), Argentina (2020) and Hong Kong (2020), and approved in 4 other territories, Colombia, South Korea, Taiwan and Ukraine. Bausch + Lomb is planning to launch VYZULTA in Taiwan in 2021 and in South Korea in 2022.
Nicox amended its bond financing agreement with Kreos Capital, introducing an additional one-year period of interest-only payments on the outstanding principal starting on February 1, 2021, and an extension of the overall period of the loan by 6 months to July 2024. The new one-year interest-only period is expected to provide approximately €5.5 million of additional flexibility for investment in development activities in 2021. The interest rate of the bonds remains unchanged as a result of this amendment.
Pre-clinical intraocular pressure (IOP)-lowering results on a new class of non-prostaglandin analog, nitric oxide (NO)-donating compounds, was published in the Journal of Ocular Pharmacology and Therapeutics, a leading scientific journal. Increased IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 inhibition within the same molecule.
Key Expected Upcoming Milestones
NCX 470 first Phase 3 clinical trial, Mont Blanc: Nicox’s lead clinical product candidate, NCX 470 is a novel NO-donating prostaglandin analog. Mont Blanc is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Top-line results are currently expected in H1 2022.
NCX 4251 Phase 2b clinical trial, Mississippi: NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. Mississippi is evaluating once-daily dosing NCX 4251 0.1% versus placebo for the treatment of acute exacerbations of blepharitis. Top-line results are currently expected in Q4 2021.
We expect to enter into additional agreements for ZERVIATE (cetirizine ophthalmic solution), 0.24%, further enlarging the licensed territories and increasing potential future revenue.
We continue to closely watch the spread and impact of the COVID-19 pandemic and we will provide an update of any delays.
[1] Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss