Nicox Announces 2020 Financial Results and 2021 Key Milestones

Press Release
Nicox Announces 2020 Financial Results and 2021 Key Milestones
Net revenue1 of €12.9 million in 2020 almost doubled versus 2019 Cash position increased to €47.2 million as of December 31, 2020 March 1st, 2021 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the financial and operating results for Nicox and its subsidiaries (the “Nicox Group”) for the year ended December 31, 2020, as approved by the Board of Directors on February 26, 2021, and provided upcoming 2021 key milestones. 2020 Financial Summary Net revenue1 for the full year 2020 was €12.9 million (€2.4 million in net royalties, €10.5 million in license payments), compared to €6.9 million (€2.1 million in net royalties, €4.8 million in upfront and milestone payments) for the full year 2019. Net revenue has been revised upwards from that reported in the Q4 2020 business update due to an accounting adjustment reflecting a non-cash item of deferred income received from Ocumension in March 2020. Operating expenses for the year 2020 decreased to €19.5 million from €25.5 million for the 12 months to December 31, 2019. Research and development expenses decreased by €5.0 million while administrative and other expenses decreased by €1.0 million. Nicox’s research and development efforts remained strong in 2020, mainly concentrated in the second part of the year with 3 clinical trials initiated since June. Net loss of the Nicox Group for the full year 2020 was €18.1 million against €18.9 million for the full year 2019. As of December 31, 2020, the Nicox Group had cash and cash equivalents of €47.2 million as compared with €28.1 million at December 31, 2019. As of December 31, 2020, the Nicox Group had financial debt of €17.9 million consisting of €15.9 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2.0 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic. The position includes the prepayment to Kreos of the January 2021 period. Events after the Reporting Period VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, was launched by Nicox’s global partner Bausch + Lomb in Mexico. It is already commercialized in U.S. (2017), Canada (2019), Argentina (2020) and Hong Kong (2020), and approved in 4 other territories, Colombia, South Korea, Taiwan and Ukraine. Bausch + Lomb is planning to launch VYZULTA in Taiwan in 2021 and in South Korea in 2022. Nicox amended its bond financing agreement with Kreos Capital, introducing an additional one-year period of interest-only payments on the outstanding principal starting on February 1, 2021, and an extension of the overall period of the loan by 6 months to July 2024. The new one-year interest-only period is expected to provide approximately €5.5 million of additional flexibility for investment in development activities in 2021. The interest rate of the bonds remains unchanged as a result of this amendment. Pre-clinical intraocular pressure (IOP)-lowering results on a new class of non-prostaglandin analog, nitric oxide (NO)-donating compounds, was published in the Journal of Ocular Pharmacology and Therapeutics, a leading scientific journal. Increased IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 inhibition within the same molecule. Key Expected Upcoming Milestones NCX 470 first Phase 3 clinical trial, Mont Blanc: Nicox’s lead clinical product candidate, NCX 470 is a novel NO-donating prostaglandin analog. Mont Blanc is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Top-line results are currently expected in H1 2022. NCX 4251 Phase 2b clinical trial, Mississippi: NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. Mississippi is evaluating once-daily dosing NCX 4251 0.1% versus placebo for the treatment of acute exacerbations of blepharitis. Top-line results are currently expected in Q4 2021. We expect to enter into additional agreements for ZERVIATE® (cetirizine ophthalmic solution), 0.24%, further enlarging the licensed territories and increasing potential future revenue. We continue to closely watch the spread and impact of the COVID-19 pandemic and we will provide an update of any delays.
About Nicox
Nicox S.A. 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 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 revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East 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 indexes. For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Analyst coverage
Bryan, Garnier & Co Victor Floc’h Paris, France Cantor Fitzgerald Louise Chen New York, U.S. Edison Investment Research Pooya Hemami London, UK H.C. Wainwright & Co Yi Chen New York, U.S. Kepler Cheuvreux Damien Choplain 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.
Contacts
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 & Media United States & Europe LifeSci Advisors, LLC Mary-Ann Chang T +44 7483 284 853 mchang@lifesciadvisors.com	Media France LifeSci Advisors, LLC Sophie Baumont M +33 (0)6 27 74 74 49 sophie@lifesciadvisors.com
Forward-Looking Statements
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 the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com) and as restated in the 4th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website.
Nicox S.A. Drakkar 2 Bât 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

Consolidated statements of profit or loss

	As of December 31:
	2020	2019
Revenue from collaborations	14,423	8,260
Royalty payments	(1,516)	(1,405)
Net profit	12,907	6,855
Research and development expenditures	(12,728)	(17,747)
Administrative expenses	(6,677)	(7,666)
Other income	1,083	970
Other expenses	(93)	(85)
Operating loss before amortization of intangible assets	(5,508)	(17,673)
Amortization of intangible assets	(1,252)	(659)
Operating loss	(6 760)	(18,332)
Finance income	1,168	2,565
Finance expense (1)	(12,478)	(7,013)
Net financial income, (expense)	(11,310)	(4,446)
Loss before tax	(18,070)	(22,778)
Income tax (expense) / benefit (2)	(28)	3,856
Loss after tax	(18,098)	(18,922)
Loss for the period	(18,098)	(18,922)

⁽¹⁾ Finance expense in 2020 included a net loss of € (6.9) million following the divestment of the VISUfarma shareholding, € (2.2) million of loan interests paid to Kreos and € (3.4) million of foreign exchange loss. In 2019 Finance expenses included an impairment of € (6.1) million related to VISUfarma shareholding and (0.8) million of loan interests paid to Kreos.

⁽²⁾ Income tax (expense) / benefit in 2019 included a non-cash item of €3.7 million for the first recognition of deferred tax assets related to ZERVIATE

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

	As of December 31:
	2020	2019
ASSETS
Non-current assets
Goodwill	23,663	25,847
Intangible assets	64,848	72,120
Property, plant and equipment	1,166	1,670
Non-Current financial assets (1)	68	11,023
Total non-current assets	89,745	110,660
Current assets
Trade receivables	1,723	1,069
Government grants receivables	736	864
Other current assets	237	1,297
Prepayments	2,630	814
Cash and cash equivalents	47,195	28,102
Total current assets	52,521	32,146
TOTAL ASSETS	142,266	142,806
EQUITY AND LIABILITIES
Shareholders’ equity
Issued capital	37,030	33,231
Share premium	528,595	518,441
Cumulative translation adjustement	2,959	7,811
Treasury Shares	(605)	-
Accumulated deficit	(467,169)	(450,186)
Total equity	100,810	109,297
Non-current liabilities
Non-current financial liabilities	13,429	10,168
Deferred taxes liabilities	11,868	12,964
Provisions	754	549
Total non-current liabilities	26,051	23,681
Current liabilities
Current financial liabilities	5,646	2,481
Trade payables	2,422	4,996
Deferred income	5,174	-
Other current liabilities	2,163	2,351
Total current liabilities	15,405	9,828
TOTAL LIABILITIES AND EQUITY	142,266	142,806

(1) Divestment of VISUfarma shareholding and loan notes in 2020

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¹ Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss

Attachment

• EN_FY2020Results_PR_20210301_F