Nicox Provides First Half 2023 and Third Quarter 2023 Financial Results and Updates Key Milestones
Third quarter 2023 U.S. prescriptions for VYZULTA® increased by 22% over third quarter 2022
NCX 470 Phase 3 Denali clinical trial over 65% randomized
Net revenue €1.7 million for first half 2023 and €1.1 million for third quarter 2023
Cash of €14.6 million on September 30, 2023
October 20, 2023 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided financial results for Nicox SA and its subsidiaries (the “Nicox Group”) for the first half of 2023 and for the third quarter of 2023 and provided an update on key future milestones.
“The NCX 470 Denali trial is on track to report data in 2025, with over 65% of the target number of patients randomized in the trial. NCX 470, a novel nitric oxide donating bimatoprost eyedrop, is our lead clinical asset and earlier this year we announced that potential annual global peak net sales of NCX 470, based on the profile from the first Phase 3 trial Mont Blanc, could exceed $300 million.” said Andreas Segerros, Chief Executive Officer of Nicox. “In parallel with the progress of the Denali trial, and the upcoming commercial launch of ZERVIATE in China, we are particularly focused on our financial situation and are evaluating all avenues to find a sustainable solution for the Company.”
Key Future Milestones
Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: The trial is on track to generate topline results in 2025, based on current recruitment rates.
Initiation of Whistler Phase 3b clinical trial investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure (IOP) lowering: The Whistler trial is expected to be initiated in Q4 2023 and to take approximately one year to complete.
Approval and launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: Expected in 2024.
First Half 2023 Financial Results
As of June 30, 2023, the Nicox Group had cash and cash equivalents of €19.0 million as compared with €21.4 million as of March 31, 2023, and €27.7 million as of December 31, 2022. The Company is currently funded until the end of June 2024, exclusively on the basis of the development of NCX 470. The Company is pursuing licensing discussions which could extend the cash runway. In parallel, the Company has initiated strategic discussions, including regarding potential merger and acquisition transactions and is also initiating discussions with its creditors to restructure its debt.
Net revenue1 for the first half of 2023 was €1.7 million (consisting entirely of net royalty payments) versus €1.4 million (including €1.3 million in royalty revenue) for the first half of 2022.
Operating expenses for the first half of 2023 were €10.4 million compared to €12.7 million for the first half of 2022. The decrease in the operating expenses in the first half of 2023 compared to the first half of 2022 is explained by the completion of the first Phase 3 trial Mont Blanc in the third quarter of 2022.
The Nicox Group recorded a net loss of €6.6 million for the six months ended June 30, 2023, compared to a net loss of €17.0 million for the same period in 2022. The net loss in the first half of 2022 includes €11.1 million of non-cash items due to the decision to seek a partner to pursue the development of NCX 4251 in the U.S.
As of June 30, 2023, the Nicox Group had financial debt of €21.6 million, consisting of (i) €18.8 million in the form of a bond financing agreement with Kreos Capital signed in January 2019, (ii) a €1.6 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic and (iii) €1.2 million of present value attributed to the put option2 granted in the November 2022 equity financing. The payment of this latter debt would only occur if the put option was exercised, subject to the conditions set out in footnote 2 below.
Third Quarter 2023 Financial Highlights
As of September 30, 2023, the Nicox Group had cash and cash equivalents of €14.6 million as compared with €19.0 million as of June 30, 2023, and €27.7 million as of December 31, 2022. Net revenue for the third quarter of 2023 was €1.1 million (entirely composed of net royalty payments). Net revenue for the third quarter of 2022 was €0.8 million (entirely composed of net royalty payments).
As of September 30, 2023, the Nicox Group had financial debt of €21.1 million, consisting of (i) €18.8 million in the form of a bond financing agreement with Kreos Capital signed in January 2019, (ii) a €1.5 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic and (iii) €0.8 million of present value attributed to the put option2 granted in the November 2022 equity financing. The payment of this latter debt would only occur if the put option was exercised, subject to the conditions set out in footnote 2 below.
VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% U.S. prescriptions3 increased by 22% in the third quarter of 2023 compared to the same period in 2022. VYZULTA, exclusively licensed worldwide to Bausch + Lomb, is commercialized in more than 15 countries, including the U.S., and is also approved in a number of other countries. VYZULTA is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.
