Nicox presents third quarter 2022 financials and business


press release
Nicox presents financial and business highlights for the third quarter of 2022

  • Top line results of the NCX470 Mont-Blanc Step 3 Glaucoma Experiment Payable In Earlier November 2022
  • Third quarter 2022 American prescPenalties for VYZULTA® increased by 37Over the third quarter of 2021
  • Net income €0.8 million b Third quarter 2022; €25.6 cash million in September 30, 2022

October 19, 2022 – will be released at 7:30 am CET
Sophia-Antipolis, France

Nikox S.A (Euronext Paris: FR0013018124, COX), an international ophthalmic company, today provided financial and business highlights for the third quarter of 2022 for Nicox SA and subsidiaries (“Nicox Group”) and confirmed the upcoming NCX 470 Mont Blanc Phase 3. Critical phase of clinical trial.

Key coming Milestone

  • Montblanc Phase 3 clinical trial of NCX 470 in patients with open-angle glaucoma or ocular hypertension: The maximum result will end in early November 2022

third Quarter 2022 Financial highlights

In the year As of September 30, 2022, Nikox Group’s cash and cash equivalents were €25.6 million, compared to €42.0 million as of December 31, 2021 and June 30, 2022, to €31.6 million. The company expects to be funded through June 30, 2022. In the year October 31, 2023 and until November 30, 2023, if the interest-only extension period of Creos Debt.1, in both cases based solely on the development of NCX 470. net income2 For the third quarter of 2022 it was EUR 0.8 million (comprising entirely net of royalty payments). This compares to net revenue of €2.4 million (including €0.7 million net of royalty payments and €1.7 million in license fees) in the third quarter of 2021.

In the year As of September 30, 2022, Nikox Group had a financial debt of 20.6 million euros, which included the bond financing agreement signed with Kreos Capital in January 2019 and 18.6 million euros from the loan agreement of 2 million euros guaranteed by the French State. August 2020 in the context of the Covid-19 pandemic.

third Quarter 2022 Business Highlights

  • The last patient completed their final (3-month) visit in the Mont Blanc phase 3 clinical trial. NCX470 0.1% to lower 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% versus latanoprost ophthalmic solution, 0.005%. Latanoprost is a widely prescribed first-line treatment for open-angle glaucoma or ocular hypertension. The primary efficacy assessment in Mont Blanc was based on baseline time-averaged IOP readings at 8 AM and 4 PM at weeks 2, 6, and 3.
  • Vizulta® (latanoprostene bunod ophthalmic solution), 0.024% US prescriptions3 In the year In the third quarter of 2022, it increased by 37% compared to the same period in 2021. Worldwide, VYZULTA, licensed exclusively to Bausch + Lomb, has been approved in 18 markets and is commercialized in 8 of them, expected to launch in Brazil in the fourth quarter. This year. VYZULTA is indicated for IOP reduction in patients with open-angle glaucoma or intraocular pressure.

As of December 31, 20, only the figure related to the financial position of Nikox Group21 will be audited; All other figures in This press release has not been audited.

About Nicox
Nikox SA is an international ophthalmic company that develops innovative solutions to protect vision and improve eye health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide donor prostaglandin analog, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In addition, the company is conducting research on NCX 1728, a nitric oxide donor phosphodiesterase 5 inhibitor, in the treatment of intraocular pressure and retinal conditions. NCX 4251, a novel, patented, ophthalmic suspension of fluticasone propionate nanocrystals for the topical ophthalmic treatment of dry eye disease, is being developed by Ocumension Therapeutics in China under an exclusive license agreement and is available elsewhere in partnership. Nicox generates revenue from VYZULTA® In glaucoma, it is licensed worldwide exclusively to Bausch + Lomb, and ZERVIATE.® In allergic conjunctivitis, licensed in several geographies, for Eyevance Pharmaceuticals, LLC (a wholly owned subsidiary of Sunten Pharmaceuticals), Ocumens Therapeutics in the US and China and most Southeast Asian markets.

Headquartered in Sophia Antipolis, France, Nicox is listed on Euronext Paris (Section B: Mid Caps, Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indices.

For more information about Nicox, its products or the faucet, please visit: www.nicox.com.

Analyst coverage
Bryan, Garnier & Co. Dylan Van Haften, Paris, France

Edison Investment Research Pooya Hemami London, UK
HC Wainwright and Ko Yi Chen New York, US
Kepler Cheuvreux Arsene Guekam Paris, France

Opinions expressed by commentators on Nickox coverage are those of the author and do not necessarily reflect the views of Nickox. Additionally, the information in their reports may not be accurate or current. Nikox disclaims any obligation to correct or update 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 and media
United States and Europe
LifeSci Consultants, LLC
Sandhya from Wid
T +41 78 680 05 38
svonderweid@lifesciadvisors.com

Forward-looking statements
The information in this document is subject to change without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on the current expectations or beliefs of the management of Nicox SA and due to a number of factors and uncertainties results may differ materially from those expressed in the forward-looking statements. NICOX SA AND ITS AFFILIATES, DIRECTORS, OFFICERS, EMPLOYEES, ADVISORS OR AGENTS, DO NOT UNDERTAKE ANY OBLIGATION TO PROVIDE UPDATES OR TO UPDATE ANY FORWARD-LOOKING STATEMENTS.

Risk factors that may have a material impact on Nikox’s business are presented in Chapter 3.Universal registration document, annual financial report and management report 2021On April 29, 2022, Nicox’s website (www.nicox.com) was filed with the French Autorité des Marchés Financiers (AMF).

Nikox S.A
Long time 2
Building D, 2405 line 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 an option to extend the current interest-only period of Kreos debt by 6 months if the Montblanc trial of NCX 470 meets the primary endpoint of non-inferiority to latanoprost.
2 Net income Consists of partnership income consisting of royalty payments, which corresponds to net profit in the consolidated statements of profit or loss.
3 Bloomberg data comparing the weeks ending July 1St2022 through the weeks of September 30, 2022 July 9, 2021 through October 1St2021



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