Nicox Provides First Half 2023 and Third Quarter 2023 Financial Results and Updates Key Milestones
|Nicox Provides First Half 2023 and Third Quarter 2023 Financial Results and Updates Key Milestones|
October 20, 2023 – release at 7:30 am CET
Nicox SA (Euronext Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided financial results for Nicox SA and its subsidiaries (the “Nicox Group”) for the first half of 2023 and for the third quarter of 2023 and provided an update on key future milestones.
“The NCX 470 Denali trial is on track to report data in 2025, with over 65% of the target number of patients randomized in the trial. NCX 470, a novel nitric oxide donating bimatoprost eyedrop, is our lead clinical asset and earlier this year we announced that potential annual global peak net sales of NCX 470, based on the profile from the first Phase 3 trial Mont Blanc, could exceed $300 million.” said Andreas Segerros, Chief Executive Officer of Nicox. “In parallel with the progress of the Denali trial, and the upcoming commercial launch of ZERVIATE in China, we are particularly focused on our financial situation and are evaluating all avenues to find a sustainable solution for the Company.”
Key Future Milestones
First Half 2023 Financial Results
As of June 30, 2023, the Nicox Group had cash and cash equivalents of €19.0 million as compared with €21.4 million as of March 31, 2023, and €27.7 million as of December 31, 2022. The Company is currently funded until the end of June 2024, exclusively on the basis of the development of NCX 470. The Company is pursuing licensing discussions which could extend the cash runway. In parallel, the Company has initiated strategic discussions, including regarding potential merger and acquisition transactions and is also initiating discussions with its creditors to restructure its debt.
Net revenue1 for the first half of 2023 was €1.7 million (consisting entirely of net royalty payments) versus €1.4 million (including €1.3 million in royalty revenue) for the first half of 2022.
Operating expenses for the first half of 2023 were €10.4 million compared to €12.7 million for the first half of 2022. The decrease in the operating expenses in the first half of 2023 compared to the first half of 2022 is explained by the completion of the first Phase 3 trial Mont Blanc in the third quarter of 2022.
The Nicox Group recorded a net loss of €6.6 million for the six months ended June 30, 2023, compared to a net loss of €17.0 million for the same period in 2022. The net loss in the first half of 2022 includes €11.1 million of non-cash items due to the decision to seek a partner to pursue the development of NCX 4251 in the U.S.
As of June 30, 2023, the Nicox Group had financial debt of €21.6 million, consisting of (i) €18.8 million in the form of a bond financing agreement with Kreos Capital signed in January 2019, (ii) a €1.6 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic and (iii) €1.2 million of present value attributed to the put option2 granted in the November 2022 equity financing. The payment of this latter debt would only occur if the put option was exercised, subject to the conditions set out in footnote 2 below.
Third Quarter 2023 Financial Highlights
As of September 30, 2023, the Nicox Group had cash and cash equivalents of €14.6 million as compared with €19.0 million as of June 30, 2023, and €27.7 million as of December 31, 2022. Net revenue for the third quarter of 2023 was €1.1 million (entirely composed of net royalty payments). Net revenue for the third quarter of 2022 was €0.8 million (entirely composed of net royalty payments).
As of September 30, 2023, the Nicox Group had financial debt of €21.1 million, consisting of (i) €18.8 million in the form of a bond financing agreement with Kreos Capital signed in January 2019, (ii) a €1.5 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic and (iii) €0.8 million of present value attributed to the put option2 granted in the November 2022 equity financing. The payment of this latter debt would only occur if the put option was exercised, subject to the conditions set out in footnote 2 below.
VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% U.S. prescriptions3 increased by 22% in the third quarter of 2023 compared to the same period in 2022. VYZULTA, exclusively licensed worldwide to Bausch + Lomb, is commercialized in more than 15 countries, including the U.S., and is also approved in a number of other countries. 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, 2022, is audited; all other figures in this press release are non-audited.
|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 bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.
Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Bryan, Garnier & Co Eric Yoo 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.|
|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 section 2.7 of the “Rapport Annuel 2022” and in section 4 of the “Rapport semestriel financier et d’activité 2023” which are available on Nicox’s website (www.nicox.com).
Bât D, 2405 route des Dolines
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99
Interim Consolidated statement of Comprehensive Income
|6 Months period ending June 30,|
|(in thousands of € except for per share data)|
|Revenues from collaborations||2,772||2,322|
|Net Profit from collaborations||1,733||1,430|
|Research and development expenditures||(6,690)||(7,778)|
|Operating loss before amortization of intangible assets||(8,243)||(10,891)|
|Amortization of intangible assets||–||–|
|Impairment of intangible assets(1)||–||(10,472)|
|Net financial income/(expense)||1,657||2,678|
|Loss before tax||(6,586)||(18,685)|
|Income tax (expense) / benefit||(20)||1,679|
|Net loss for the period||(6,606)||(17,006)|
(1) Non-cash adjustment on NCX 4251 estimated fair value due to the Group decision to seek a partner to pursue the development in the U.S.
Interim consolidated statement of financial position
|As of June 30, 2023||As of Dec. 31, 2022|
|(in thousands of €)|
|Property, plant and equipment||414||240|
|Non-current financial assets||224||325|
|Total non-current assets||58,496||59,480|
|Government grants receivables||756||504|
|Other current assets||1,118||1,279|
|Cash and cash equivalents||19,011||27,650|
|Total current assets||23,787||33,684|
|EQUITY AND LIABILITIES|
|Cumulative translation adjustment||7,405||7,665|
|Non-current financial liabilities||19,614||24,606|
|Deferred tax liabilities||7,206||7,341|
|Total non-current liabilities||27,506||32,525|
|Current financial liabilities||2,773||828|
|Other current liabilities||1,152||2,093|
|Total current liabilities||9,247||8,206|
|TOTAL LIABILITIES AND EQUITY||82,283||93,164|
1 Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss.
2 In the case of a merger by acquisition (fusion par absorption), merger (fusion par création d’une nouvelle société), division (scission), or a change of control within the meaning assigned in article L.233-3 I of the French commercial code (Code de commerce) where the consideration for such transaction is Nicox shares at a value of less than €1.70, the exercise price of the warrants, Armistice can request that Nicox purchases the warrants granted to Armistice at their Black Scholes value (using pre-defined terms). The present value of this option is revised at each closure and the non-cash adjustment of the present value is recognized in the consolidated statement of profit or loss as a finance income or finance expense.
3 Bloomberg data comparing the period of the weeks ending July 7 to September 29, 2023 with the period of the weeks ending July 8 to September 30, 2022.
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. AfternoonHeadlines.com takes no editorial responsibility for the same.