Nicox financial results and activity in the first half of 2021

Press release
Nicox financial results and activity update for the first half of 2021
  • S1 2021 net revenue1 from €1.3 millions of euros and cash of €36.5 million
  • NCX 470 NDA submission stay on track

September 27, 2021 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the financial results of Nicox SA and its subsidiaries (the “Nicox Group”) for the six-month period ended June 30, 2021 and also reported on update on recent events. as progress on key programs.

First half 2021 Financial Highlights

Net revenue1 in the first half of 2021 amounted to € 1.3 million (including € 1.2 million in royalty income) compared to € 2.4 million (including € 1.4 million in royalty income) in the first half of 2020. Expenses operating income for the first half of 2021 amounted to € 13.3 million compared to € 10.2 million in the first half of 2020.

  • The Nicox group recorded a net loss of 11.7 million euros for the six-month period ended June 30, 2021, compared to a net loss of 14.6 million euros for the same period in 2020.
  • As of June 30, 2021, the Nicox group had cash and cash equivalents of € 36.5 million, compared to € 42.0 million as of March 31, 2021 and € 47.2 million as of December 31, 2020. The Company is funded for at least 12 months. , based on the development of the NCX 470 alone.
  • As of June 30, 2021, the Nicox group had a financial debt of 18.0 million euros consisting of 16.0 million euros in the form of a bond financing contract with Kreos Capital signed in January 2019 and a contract of credit of 2 million euros guaranteed by the French State and granted in August 2020 in the context of the COVID-19 pandemic. Details of the bond financing contract are available in the press release dated January 29, 2021.

Recent events

  • The Mississippi Phase 2b clinical trial of NCX 4251 0.1% ophthalmic suspension, evaluated against placebo, although it does not meet the predefined primary endpoint of blepharitis, has demonstrated statistically significant results on the signs and symptoms of blepharitis when they are measured as a change from the baseline. NCX 4251 has been shown to be safe and well tolerated for 14 days of treatment, with no serious adverse events (see press release dated September 23, 2021).
  • VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, recently received regulatory approval in Brazil, Jordan and Singapore. Further approvals and launches of VYZULTA will now be reported by our global partner Bausch + Lomb on a quarterly basis.
  • Dr José Boyer has retired as Interim Director of R&D, although he will continue to advise the Company as a consultant. We would like to thank him for his commitment and contribution to Nicox.
    • Fera’s new application for Orphan Drug Designation (ODD) for naproxcinod in sickle cell disease has been denied by the US Food and Drug Administration (FDA), and Fera is currently seeking to discuss next steps with the FDA. Will continue to review other undisclosed therapeutic indications for naproxcinod.

Key Programs Updates

  • NCX470: The timeline for submitting the new drug application to the US FDA remains in line with our expectations, determined by the 2023 end date for the results of the ongoing Denali Phase 3 clinical trial. In the first phase 3 clinical trial, Mont Blanc, 494 out of 670 (74%) patients had been randomized by September 20, and 398 of these patients had completed the 3-month efficacy evaluation. As recruitment continues to be affected by COVID-19, we are cautiously shifting expectations for the Mont Blanc trial results to Q1 2023 (previously Q2 2022). The Phase 3 program, evaluating the NCX 470 for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, is expected to support NDA submissions in the United States and China, and will also provide data for countries accepting the same package for approval.
  • NCX 4251: Following the results of the Phase 2b trial in Mississippi, the Company plans to meet with the US FDA in early 2022 to discuss the next steps in the development of this innovative product candidate for blepharitis.
  • ZERVIATEMT in China: A Phase 3 clinical trial to support a regulatory approval request in China, led and funded by our partner Ocumension, is underway.

Only the figures as of December 31, 2020 are audited, all other figures in this press release are unaudited.

Remarks

  1. Net revenue consists of revenue from collaborations less royalty payments which we refer to as net profit from collaborations in the condensed consolidated income statements for the six-month period ended June 30, 2021.
About Nicox
Nicox SA is an international ophthalmology company that develops innovative solutions to help maintain vision and improve eye health. Nicox’s primary clinical development program is NCX 470, a novel nitric oxide donor prostaglandin analog for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates income from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb and ZERVIATE® in allergic conjunctivitis, licensed in several geographies, including Eyevance Pharmaceuticals, LLC, in the United States and Ocumension Therapeutics in China and 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 indices.

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

Analyst coverage

Bryan, Garnier & Co Victor Floc’h Paris, France
Cantor Fitzgerald Louise Chen New York, United States
Edison Investment Research Pooya Hemami London, United Kingdom
HC Wainwright & Co Yi Chen New York, United States
Kepler Cheuvreux Damien Choplain Paris, France

The opinions expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. In addition, the information in their reports may not be correct or up to date. Nicox disclaims any obligation to correct or update information contained in analyst reports.
Contacts
Nicox
Gavin Spencer
Executive Vice-President, Chief Business Officer
& Head of business development
T +33 (0) 4 97 24 53 00
[email protected]
Investors and media
United States and Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38
[email protected]
Media
France
LifeSci Advisors, LLC
Sophie Baumont
T +33 (0) 6 27 74 74 49
[email protected]
Forward-looking statements
The information contained in this document is subject to change without notice. This information includes forward-looking statements. These forward-looking statements are not guarantees of future performance. These statements are based on the current expectations or beliefs of Nicox SA management and are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in forward-looking statements. Nicox SA and its affiliates, directors, officers, employees, advisers or agents, do not undertake and have no obligation to provide updates or revise forward-looking statements.

The risk factors likely to have a significant effect on Nicox’s activity are presented in the 3rd chapter of the ‘Universal registration document, annual financial report and management report 2020‘deposited with the French Financial Markets Authority (AMF) as of March 1, 2021 available on the Nicox website (www.nicox.com).

Nicox SA
Drakkar 2
Building 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

nicox her
Intermediate Consolidated Statement of Comprehensive Incomee

6 month period ending June 30
2021 2020
(in thousands of € excluding data per share)
Revenue from collaborations 2,043 3 271
Royalty payments (721) (891)
Net profit from collaborations 1,322 2,380
Research and development expenses (10,000) (6,533)
Administrative expenses (3 263) (3 496)
Other income 466 840
Other expenses (90) (174)
Operating loss before amortization of intangible assets (11,565) (6,983)
Amortization of intangible assets (587) (645)
Operating loss (12,152) (7,628)
Financial income 1,451 1,213
Financial expenditure (1,036) (8,166)(1)
Net financial income / (expense) 415 (6,953)
Loss before tax (11,737) (14,581)
Income tax (charge) / benefit 24 (26)
Net loss for the period (11,713) (14,607)

(1) Includes 6.1 million euros in charges with no impact on cash flow related to the depreciation of VISUfarma assets sold in July 2020.

nicox her
Interim Consolidated Statement of Financial Position

As of June 30, 2021 As of December 31, 2020
(in thousands of €)
ASSETS
Non-current assets
Good will 24,433 23 663
Intangible assets 66,356 64,848
Tangible fixed assets 1,029 1,166
Non-current financial assets 69 68
Total non-current assets 91,887 89,745
Current assets
Clients 1,283 1,723
Government grants receivable 1 130 736
Other current assets 317 237
Advance payments 2,209 2,630
Cash and cash equivalents 36,528 47 195
Total current assets 41,467 52,521
TOTAL ASSETS 133,354 142,266
LIABILITIES AND EQUITY
Equity
Issued capital 37 112 37,030
Sharing bonus 528 513 528,595
Cumulative translation adjustment 4,597 2 959
Own shares (873) (605)
Accumulated deficit (478,033) (467,169)
Total equity 91,316 100,810
Non-current liabilities
Non-current financial liabilities 16,031 13,429
Deferred tax liabilities 12,255 11,868
Non-current provisions 819 754
Total non-current liabilities 29,105 26,051
Current liabilities
Current financial liabilities 2 917 5 646
Trade debts 3 433 2 422
Deferred income 5,113 5 174
Other current liabilities 1,470 2 163
Total current liabilities 12,933 15,405
TOTAL LIABILITIES AND EQUITY 133,354 142,266
  • FR_H1_2021Résultats PR_20210927_F


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