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Nicox Provides Third Quarter 2022 Financials and Business

press release
Nicox Provides Third Quarter 2022 Financial and Business Highlights

  • top line results of NCX470 Mont Blanc Phase 3 Glaucoma trial Deadline Men quick November 2022
  • Q3 2022 US prescriptionReption of VYZULTA® gain 37Percentage Q3 2021
  • Net revenue €0.8 a million third quarter 2022; 25.6 euro cash million in september 30th, 2022

October 19, 2022 – Released at 7:30am CET
Sophia Antipolis, France

Nikox SA (Euronext Paris: FR0013018124, COX) today provides financial and business highlights for the third quarter of 2022 for Nicox SA and its subsidiaries (“Nicox Group”), confirming the timing of the upcoming NCX 470 Montblanc Phase 3 Did. Clinical trial milestone.

key from now on M.Ilstone

  • Montblanc Phase 3 Clinical Trial Evaluating NCX 470 in Patients With Open-Angle Glaucoma or Ocular Hypertension: Topline results expected in early November 2022

Third 202 quarter2 financial highlights

At 30 September 2022, the Nicox Group had €25.6 million in cash and cash equivalents, compared to €42 million at 31 December 2021 and €31.6 million at 30 June 2022. was. October 31, 2023 to November 30, 2023 subject to the extension of the interest-free period of his existing Kreos debt1, in both cases based on the development of the NCX 470 only.net income2 Revenue for the third quarter of 2022 was €800,000 (consisting only of net royalty payments). This compares to a net revenue of €2.4m in Q3 2021 (including €70m royalty payments and he €1.7m license fee).

As of September 30, 2022, Nicox Group consists 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 government. It had financial liabilities of €20.6 million. August 2020 in connection with the COVID-19 pandemic.

Third Quarter 2022 work highlight

  • The last patient completed the final (3-month) visit of the Montblanc Phase 3 clinical trial. NCX470 0.1% for lowering 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 and potentially best-in-class nitric oxide (NO) donating prostaglandin analog eye drop. Montblanc is a randomized, international, double-mask, 3-month, parallel-group study 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 drug for open-angle glaucoma or ocular hypertension. The primary efficacy assessment at Montblanc is based on the reduction from baseline in mean hourly IOP at 8am and 4pm at Weeks 2, 6 and 3.
  • Vizulta® (latanoprosten ophthalmic solution), 0.024% US prescription3 In the third quarter of 2022, it increased by 37% compared to the same period in 2021. VYZULTA is exclusively licensed to Bausch + Lomb worldwide and has been approved in 18 markets, 8 of which are commercialized, with a planned launch in Brazil in the fourth quarter. This year’s. VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Figures only for the cash position of the Nikox Group as of December 31, 2020twenty one Audited.all other numbers of This press release is unaudited.

About Nikox
Nicox SA is an international ophthalmology company that develops innovative solutions to help preserve vision and improve eye health. Nikox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analogue for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also studying NCX 1728, a nitric oxide donating phosphodiesterase 5 inhibitor, in reducing intraocular pressure and retinal conditions. NCX 4251 is a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals for topical ocular application of dry eye disease, developed under an exclusive license agreement by Ocumension Therapeutics of China, Partnerships elsewhere are possible. Nicox generates revenue from his VYZULTA® Exclusively licensed worldwide to Bausch & Lomb and Zelviate.® It is licensed in multiple territories, including Eyevance Pharmaceuticals, LLC (a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd.) in the United States and Ocumension Therapeutics in China and most of the Southeast Asian market for the treatment of allergic conjunctivitis.

Headquartered in Sophia Antipolis, France, Nikox is listed on Euronext Paris (Compartment B: Midcap, ticker symbol: COX) and is part of CAC Healthcare, CAC Pharma & Bio and the Next 150 Index .

For more information about Nicox, its products or pipeline, please visit www.nicox.com.

analyst coverage
Bryan, Garnier & Co Dylan Van Harten Paris, France

Edison Investment Research Pooya Hemami London, UK
HC Wainwright & Co Yi Chen New York, USA
Kepler Cheuvreux Arsene Guekam Paris, France

Analyst views regarding Nicox are those of the authors and do not reflect the views of Nicox. Additionally, the information contained in the report may be incorrect or out of date. Nicox disclaims any obligation to correct or update information contained in analyst reports.

Nikox
Gavin Spencer
Vice President, Chief Business Officer
& Corporate Development Head
T +33 (0)4 97 24 53 00
communication@nicox.com

investors and media
US and Europe
Life Science Advisors, LLC
Sandia von der Weidt
Phone +41 78 680 05 38
svonderweid@lifesciaadvisors.com

Forward-Looking Statements
Information contained in this document is subject to change without notice. This information contains forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on the current expectations or beliefs of Nicox SA’s management and are subject to a number of factors that could cause actual results to differ materially from those set forth in the forward-looking statements. Subject to uncertainty. Nicox SA and its affiliates, directors, officers, employees, advisors or agents undertake no obligation to update or revise any forward-looking statements.

Risk factors that may have a material impact on Nikox’s business are:Document d’enregistrement Universel, rapport financier annuel et rapport de gestion 2021Filed with the French Financial Markets Authority (AMF) on April 29, 2022 and available on the Nicox website (www.nicox.com).

Nikox SA
Drucker 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 Nikox has an option to extend the interest-only term of existing Kreos debt for another six months if the Montblanc study in NCX 470 meets the primary endpoint of non-inferiority to latanoprost.
2 Net revenues are alliance revenues less royalty payments and correspond to net income in the consolidated statements of income.
3 Bloomberg data comparing the weeks ending July 1stthe week from 2022 to 30 September 2022 and from 9 July to 1 October 2021st2021

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