Nicox SA, an international ophthalmology company, provided financial and business highlights for the third quarter 2022 for Nicox SA and its subsidiaries and confirmed timing for the upcoming NCX 470 Mont Blanc Phase 3 clinical trial milestone.
Nicox Provides Third Quarter 2022 Financial and Business Highlights
- Topline results of the NCX 470Mont Blanc Phase 3glaucoma trial due in early November 2022
- Third quarter 2022 U.S. prescriptions for VYZULTA® increased by 37% over third quarter 2021
- Net revenue €0.8 million for third quarter 2022; cash of €25.6 million on September 30, 2022
October 19, 2022 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided financial and business highlights for the third quarter 2022 for Nicox SA and its subsidiaries (the “Nicox Group”) and confirmed timing for the upcoming NCX 470 Mont Blanc Phase 3 clinical trial milestone.
Key UpcomingMilestone
- Mont Blanc Phase 3 clinical trial evaluating NCX 470 in patients with open angle glaucoma or ocular hypertension: Topline results due in early November 2022
Third Quarter 2022 Financial Highlights
As of September 30, 2022, the Nicox Group had cash and cash equivalents of €25.6 million as compared with €42.0 million as of December 31, 2021 and €31.6 million as of June 30, 2022. The Company estimates that it is financed until October 31, 2023, and until November 30, 2023 assuming the extension of the interest only period of the existing Kreos debt1, in both cases based on the development of NCX 470 alone. Net revenue2 for the third quarter of 2022 was €0.8 million (consisting entirely of net royalty payments). This compares to net revenue for the third quarter of 2021 of €2.4 million (including €0.7 million of net royalty payments and €1.7 million of licensing payments).
As of September 30, 2022, the Nicox Group had financial debt of €20.6 million consisting of €18.6 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement guaranteed by the French State in August 2020 in the context of the COVID-19 pandemic.
Third Quarter 2022 Business Highlights
- The last patient has completed their final (3-month) visit in the Mont Blanc Phase 3 clinical trial of NCX 470 0.1% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. A total of 691 patients were enrolled in the trial. NCX 470, Nicox’s lead clinical product candidate, is a novel, potentially best-in-class, nitric oxide (NO)-donating prostaglandin analog eye drop. Mont Blanc is a randomized, international, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution, 0.005%. Latanoprost is the most widely prescribed first-line therapy for open-angle glaucoma or ocular hypertension. The primary efficacy evaluation in Mont Blanc is based on reduction from baseline in mean time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3.
- VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% U.S. prescriptions3 increased by 37% in the third quarter of 2022 compared to the same period in 2021. VYZULTA, exclusively licensed worldwide to Bausch + Lomb, is approved in 18 markets and commercialized in 8 of them, with a launch in Brazil expected in the fourth quarter of this year. VYZULTA is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.
Only the figure related to the cash position of the Nicox Group as of December 31, 2021 is audited; all other figures in this press release are non-audited. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also conducting research on NCX 1728, a nitric oxide-donating phosphodiesterase 5 inhibitor, in intraocular pressure lowering and retinal conditions. NCX 4251, a novel, patented, ophthalmic suspension of fluticasone propionate nanocrystals for topical ocular application for dry eye disease, is being developed by Ocumension Therapeutics in China under an exclusive license agreement and is available for partnering elsewhere. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC (a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd.), in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com. Analyst coverage Bryan, Garnier & Co Dylan Van Haaften Paris, France
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Arsene Guekam Paris, France The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.
Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
communications@nicox.com
Investors & Media
United States & Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38
svonderweid@lifesciadvisors.com Forward-Looking Statements The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.
Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2021’ filed with the French Autorité des Marchés Financiers (AMF) on April 29, 2022 which is available on Nicox’s website (www.nicox.com) Nicox S.A.
Drakkar 2
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99
1 Nicox has the option to extend the interest-only period of the existing Kreos debt by 6 months if the Mont Blanc trial on NCX 470 meets its primary endpoint of non-inferiority to latanoprost.
2 Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss.
3 Bloomberg data comparing the period of the weeks ending July 1st, 2022 to September 30, 2022 with the period of the weeks ending July 9, 2021 to October 1st, 2021
Attachment
