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Nicox Group's revenue was €4.4 million (net income)1 3.9 million euros) Q1 2024
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Nicox Group's cash of 9.1 million euros as of March 31, 2024 will fund the company until at least November 2024.
April 22, 2024 – Released at 7:30 AM CET
Sophia Antipolis, France
Nikox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the first quarter 2024 earnings and cash position of Nicox SA and its subsidiaries (the “Nicox Group”), announced the financial results of the Group. The Company) was approved by its Board of Directors on April 19, 2024, and provided an update on key future milestones. As previously announced, the Company does not report consolidated financial results under IFRS standards and the figures published regarding Nikox Group are for informational purposes only. The Company also announced that CEO Gavin Spencer has joined its Board of Directors.
“Nicox made good progress in 2023 toward topline results from the Denali Phase 3 trial expected in the second half of 2025. The company implemented previously announced cost reductions to focus on Denali testing. Additionally, the Company entered into a new license agreement with Kowa for the NCX 470 for Japan, and completed the signing of a debt restructuring amendment with BlackRock.” Said Gavin Spencer, Nikox Chief Executive Officer; “The company remains fully focused on the development of NCX 470 and the Denali trial, which confirms NCX 470's profile in glaucoma and should pave the way for further strategic options and commercialization beyond existing partnerships. . Our cash runway has been extended to November 2024 and we are in the process of raising further funds, including a number of business development discussions that could provide non-dilutive capital, alongside our plans to raise capital from the equity capital markets. We continue to consider all options. ”
“We are very pleased to welcome our new CEO, Gavin Spencer, to the Nicox Board of Directors. Gavin brings extensive experience across all aspects of the biopharmaceutical industry and deep knowledge of the Nicox business to the Board. As a member of the Association, he will provide valuable expertise.” Said Jean-François Labbet, Chairman of Nikox.
Nicox Group's revenue and cash position for the first quarter of 2024
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Nicox Group's revenue was €4.4 million (net income)1 1.3 million euros (net revenue) in 1Q 2024 compared to 3.9 million euros (including license payments of 3 million euros) in 1Q 2024.1 The first quarter of 2023 consists of EUR 800,000, net royalties only.
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Cash of 9.1 million euros as of March 31, 2024, compared to 11.9 million euros of cash as of December 31, 2023.
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As of March 31, 2024, the Nikox Group had financial liabilities of €20.6 million (wholly owned by Nikox SA), consisting of a debt financing agreement with Creos Capital (an affiliate of BlackRock). 19.4 million euros and a credit agreement of 1.2 million euros guaranteed by the French state and granted against the backdrop of the COVID-19 pandemic.
As part of the Company's debt restructuring announced on February 28, 2024, the Company is required to raise at least EUR 3 million in equity financing by September 30, 2024 in order to extend the interest-only period. , which increases the amount of funding available. First quarter of 2025. A second special general meeting of shareholders will be held on May 6 to approve this funding resolution.
The Company is in advanced business development discussions, including the sale or licensing of certain assets, and is considering several other strategic options that may increase its ability to raise further capital. We evaluate all options for financing and will use the most appropriate one at the time.
Events from Q1 2024 onwards
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The Nicox Board of Directors has hired Dr. Gavin Spencer, CEO of Nicox, as a member of the Board of Directors, effective April 8, 2024. This adoption will be voted on by the General Assembly for fiscal approval in 2023. .
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The World Health Organization (“WHO”) recommends International Nonproprietary Names (“INNs”). bimatoprost glenod For NCX470.
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US Patent 8,058,467 for VYZULTA® (Latanoprostene Bunode Ophthalmic Solution) 0.024% was extended through 2029 under the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the “Hatch-Waxman Act”). VYZULTA is exclusively licensed worldwide to Bausch & Lomb and is commercialized in more than 15 countries, including the United States, and approved in many other countries. VYZULTA is indicated for lowering IOP in patients with open-angle glaucoma or ocular hypertension.
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The debt restructuring amendment bill, which was agreed upon in principle between Nikox and BlackRock and announced on February 28, 2024, was signed.
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The poster originally scheduled to be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting will not be presented for organizational reasons.
Future major milestones
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Approval and launch of ZERVIATE in China by Nicox partner Ocumension Therapeutics: It is expected in 2024.
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The Whistler Phase 3B clinical trial began in December 2023 and is investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of bimatoprost glenod (NCX 470) in lowering IOP. Results are currently expected to be announced in the first quarter of 2025.
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Denali's Phase 3 Clinical Trial Evaluating Bimatoprost Glenod (NCX 470) in Patients with Open-Angle Glaucoma or Ocular Hypertension: The Denali trial is more than 80% randomized and is expected to have topline results in the second half of 2025 based on current adoption rates.
Achievement of milestones related to NCX 470 is dependent on our ability to expand our financing options to cover the completion of these activities.
Nicox Group's revenue and cash position in 2023
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Nicox Group revenue of 6.7 million euros (net income)1 4.2 million euros at December 31, 2023), 5.2 million euros (net income)1 3.3 million euros in the same period in 2022), both consisting entirely of pure royalties.
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Cash of 27.7 million euros as of December 31, 2022 compared to 11.9 million euros of cash as of December 31, 2023.
Nicox SA full year 2023 financial results
Full-year 2023 revenues were €6.9 million, consisting of royalty payments and internal rebills, compared to full-year 2022 revenues of €5.5 million (same source).
Operating expenses for the full year 2023 were €24.2 million and operating expenses for the full year 2022 were €24.8 million.
Nicox SA recorded a net loss of €20.9 million for the twelve months to 31 December 2023. In comparison, his net loss for the same period in 2022 was 31.3 million euros. This difference is due to changes in the equity depreciation reserve. In 2022, it will become an American subsidiary.
Nicox SA's cash and cash equivalents at December 31, 2023 were €11.3 million, compared to €27.1 million at December 31, 2022. The company is currently fundraising until at least the end of November 2024. Development of NCX470.
As of December 31, 2023, Nikox SA had financial liabilities of €20.9 million, of which €19.6 million was entered into in the form of a debt financing agreement with Creos Capital (an affiliate of BlackRock). , including unpaid interest of €100,000 and a credit agreement of €1.3 million guaranteed by the French state and granted against the backdrop of the COVID-19 pandemic.
The audit procedure for Nicox SA's 2023 statutory financial statements has been completed and the certification report is being issued. All other numbers in this press release are unaudited.
Nicox SA is an international ophthalmology company that develops innovative solutions to help preserve vision and improve eye health. Nicox's flagship program in clinical development is bimatoprost glenode (NCX 470), a novel nitric oxide-donating bimatoprost eye drop to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox makes money from his VYZULTA® Glaucoma Treatment, Exclusively Licensed Worldwide to Bausch & Lomb and ZERVIATE® It is a treatment for allergic conjunctivitis and is licensed in multiple territories, including Harrow, Inc. in the United States and Ocumension Therapeutics in China and most markets in Southeast Asia.
Headquartered in Sophia-Antipolis, France, Nicox is listed on Euronext Growth Paris (ticker symbol: ALCOX) and is part of the CAC Healthcare Index.
For more information, please visit www.nicox.com.
The 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 management 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. may be affected by. 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 materially affect Nicox's business are described in Section 2.7 of this document.Rapport Annual Report 2022” and “ Section 4.Relationship between finance and activities in 2023” is available on the Nicox website (www.nicox.com).
Finally, this press release may be written in French and English. In case of different interpretations of both versions, the French version shall prevail.
