(Boursier.com) — Nicox SA, an international company specializing in ophthalmology, today presents a financial summary and the main activities of Nicox SA and its subsidiaries for the fourth quarter of 2023.
Net sales for the fourth quarter of 2023 amounted to 1.3 million compared to 1 million for the fourth quarter of 2022. Net sales for the full year 2023 were 4.2 million, an increase of 29% compared to net sales for 2022 of 3.3 million. The revenue figures for the years 2022 and 2023 are entirely composed of net royalty payments.
As of December 31, 2023, the Nicox Group had cash and cash equivalents of 11.9 million, compared to 14.6 million as of September 30, 2023 and 27.7 million as of December 31, 2022. The company estimates that it is financed until ‘in June 2024, exclusively based on the development of the NCX 470. The company is continuing licensing discussions and for other revenue-generating agreements. The company is studying several strategic options and is in discussions with its creditors to restructure its debt.
As of December 31, 2023, the financial debt of the Nicox Group amounted to 21.0 million including (i) 18.9 million in bond financing granted by Kreos Capital in January 2019, (ii) 1.3 million in loans guaranteed by the State granted in August 2020 in the context of the COVID-19 pandemic and (iii) 0.8 million current value attributed to the put option2 granted as part of the fundraising carried out in November 2022. The payment of this latter debt would only arise in the event of exercise of the put option, subject to the conditions set out in note 2 below.
The number of prescriptions for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% in the United States was not available for the last month of 2023 for technical reasons independent of the Company. VYZULTA, licensed exclusively globally to Bausch + Lomb, is marketed in more than 15 countries, including the United States, and is also approved in a number of other countries. VYZULTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Events after December 31, 2023
Randomization of 75% of patients to be included in the Denali phase 3 clinical study on NCX 470 conducted in the United States and China. All patients required for the 12-month long-term safety study included in the Denali study have been enrolled.
Key next steps
Approval and commercial launch of ZERVIATE in China by Nicox partner Ocumension Therapeutics, expected in early 2024.
Phase 3b Whistler clinical study aimed at evaluating the dual mechanism of action (nitric oxide and prostaglandin analogue) of NCX 470 in the reduction of IOP: The results of the Whistler study initiated in December 2023 are currently expected in the first quarter 2025.
Phase 3 Denali clinical study evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Denali study on track to achieve topline results in 2025 based on current rate patient recruitment.
The execution and completion of NCX 470-related activities is dependent on the expansion of the Company’s cash horizon.
“The Denali study continues to progress with the randomization of 75% of patients required in this study. The completion of recruitment of all patients for the 12-month long-term safety study included in the Denali study also constitutes an important step. At the same time, all activities relating to the preparation of the marketing authorization application for NCX 470 are continuing as planned. We remain very attentive to the financial situation of the company and are focused on research solutions to extend its cash flow horizon” declared Andreas Segerros, Managing Director of Nicox. “Revenue from licensing agreements, which currently comes mainly from sales of VYZULTA, continues to grow with the payment of annual net royalties to Nicox in an amount reaching for the first time more than 4 million euros “The approval and marketing of ZERVIATE in China, expected in 2024, should also contribute to an increase in revenue from collaborations.”