Latanoprostene Bunod

Gland Pharma Ltd., a generic injectable and ophthalmic-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Latanoprostene Bunod Ophthalmic Solution, 0.024 percent. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024 percent, of Bausch and Lomb, Inc. This Product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Gland Pharma is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of approximately USD 171 million for the twelve months ending February 2025.

Press Release Nicox Provides Full Year 2024 Financial Results Nicox SA revenue of €7.9 million for full year 2024 Exceptional income of €13.7 million following the transfer of VYZULTA’s future revenue stream to Soleus CapitalNicox SA cash of €10.5 million on 31 December 2024 and the Company estimates it is currently financed into the fourth quarter of 2025 Topline results from NCX 470 second Phase 3 clinical trial, Denali, expected in the third quarter of 2025Ongoing discussions and business development outreach underway for NCX 470 U.S. partnership April 30, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided its financial results for the full year of 2024, as approved by the Board of Directors on 28 April 2025, and provided an update on key future milestones. Following the sale of the VYZULTA royalty in October 2024, the Company will no longer be providing quarterly revenue reports.“The achievements of 2024 by the Nicox team and our partners have allowed us to keep our product development on track and prepared to deliver two clinical readouts on NCX 470 in 2025. Our focus is now on ensuring that the Company is in the optimal position to exploit those results through ongoing partnership, business and corporate development discussions.” said Gavin Spencer, Chief Executive Officer of Nicox.Key Future Milestones Whistler Phase 3b clinical trial investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: Results are expected in May 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025.   Full Year 2024 Financial Results for Nicox SARevenue for the full year of 2024 was €7.9 million versus €6.9 million for the full year of 2023, including €3.0 million of VYZULTA royalties, recognized up to 30 June 2024 prior to the sale of the royalties to Soleus Capital, versus €6.6 million, consisting principally of royalty payments, for the full year of 2023. The revenue for 2024 also includes the upfront payment of €3.0 million from Kowa for the Japanese rights to NCX 470 and a non-cash amount of €1.5 million previously recognized as prepaid income. The revenue for 2024 also includes €0.2 million of internal rebilling compared to €0.3 million for 2023.Operating expenses for the full year of 2024 were €18.7 million compared to €24.2 million for the full year of 2023.Exceptional income in 2024 was €13.7 million compared to €0.1 million in 2023. In 2024 this revenue corresponds to the sale of the future milestones and royalty of VYZULTA to Soleus Capital.Nicox SA recorded a net loss of €22.4 million for year ended 31 December 2024, compared to a net loss of €20.9 million for the same period in 2023. The 2024 loss includes a non-cash amount of €27.1 million due to the impairment of an intercompany receivable held by Nicox SA on its U.S. affiliate Nicox Ophthalmics, Inc. The recoverability of this receivable depends on the future royalties the subsidiary is expected to receive from the commercialization of ZERVIATE. In accordance with French GAAP, the Company has adopted a prudent approach based on the most conservative sales forecast amongst other, more favorable scenarios. This led to a downward revaluation of the value of ZERVIATE following a new analysis for the Chinese market. This analysis highlighted developments that reduce the probability of achieving the initially anticipated annual peak sales target of US$100M. Since ZERVIATE is the sole revenue-generating asset in Nicox Ophthalmics, Inc., the intercompany receivable has consequently been impaired. The details concerning this impairment are given in Note 2.4.1 of the statutory accounts of the Company which are available on the Company’s website on the page “Financial and Regulatory Information”.As of 31 December 2024, Nicox SA had cash and cash equivalents of €10.5 million compared to €11.3 million as of 31 December 2023. The Company is currently funded until at least into the fourth quarter of 2025, based on focusing exclusively on the development of NCX 470. As of 31 December 2024, Nicox SA had financial debt of €15.1 million, consisting of €14.2 million in the form of a bond financing agreement with Kreos Capital (an affiliate of BlackRock), and a €0.9 million credit agreement guaranteed by the French State, and granted in the context of the COVID-19 pandemic. The Company is pursuing business development discussions, including the sale or license of certain assets, and exploring multiple other strategic options which could further extend the cash runway. The Company is evaluating all options for financing and will use the most appropriate at the time. About NicoxNicox 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 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from 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 www.nicox.com Analyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. 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. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe 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 3 of the “Rapport Annuel 2024” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Income Statement (in thousands of euros)December 31, 2024December 31, 2023 Sales of services - misc. Chargeback3,315257Patent royalties4,5446,646 REVENUE7,8596,903 Reversals of depreciation, amortization, provisions, expense transfers45313Other income from ordinary activities574225 TOTAL OPERATING INCOME8,8867,141 Other purchases and external expenses(14,552)(18,406)Taxes, duties and similar payments (other than on income)(72)(99)Salaries and wages(2,092)(1,764)Social charges(660)(739)Depreciation and amortisation of tangible and intangible assets(17)(21)Provision of expenses for risks and charges(12)(122)Other expenses(1,335)(3,046) TOTAL OPERATING EXPENSES(18,740)(24,197) OPERATING PROFIT (LOSS)(9,854)(17,056) Other interest and similar income8451,099Income from participating interests3,050-Reversal of provisions and transfer of expenses1339Foreign exchange gains371117 TOTAL FINANCIAL INCOME4,2791,255 Amortization, depreciation and financial provisions(27,776)(3,743)Interest and similar expenses(1,557)(1,633)Foreign exchange loss(45)(244) TOTAL FINANCIAL EXPENSES(29,378)(5,621) FINANCIAL PROFIT (LOSS)(25,099)(4,366) PRE-TAX LOSS(34,952)(21,422) Exceptional income on management operations13,74363Exceptional income on capital operations3- EXCEPTIONAL INCOME13,74663 Exceptional charges on management operations(2)-Exceptional charges on capital operations(922)- EXCEPTIONAL EXPENSES(924)- EXCEPTIONAL INCOME (LOSS)12,82263 Research Tax Credit(259)478 NET PROFIT & LOSS(22,390)(20,881) Balance sheet (in thousands of euros)December 31, 2024December 31, 2023 ASSETS Intangible assets1324Property, plant and equipment1126Financial assets7251,805 TOTAL FIXED ASSETS7491,855 Trade receivables and related accounts1,6433,424Other receivables9,34934,323Cash and cash equivalents10,54211,259Prepaid expenses1,515886 TOTAL CURRENT ASSETS23,04949,893 Unrealized foreign exchange losses and valuation differences - Assets1313Bond redemption premiums6101,218 TOTAL REGULARISATION ACCOUNTS6231,231 TOTAL ASSETS24,42152,980 LIABILITIES Issued Capital69250,170Share premium533,549529,478Retained earnings(508,438)(537,354)Net loss for the period(22,390)(20,881) TOTAL SHAREHOLDERS' EQUITY3,41321,413 Provisions for liabilities1313Provisions for charges268700 TOTAL PROVISIONS FOR LIABILITIES AND CHARGES281713 Loans and debts from lending institutions15,06420,895Loans and other financial debts824,258Accounts payable and related accounts1,6512,499Tax and social security liabilities603648Deferred income7351,919 TOTAL LIABILITIES18,13530,218 Unrealized foreign exchange gains and valuation differences - Liabilities2,592635 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY24,42152,980 Attachment EN_FY2024_PR_FINAL