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Nicox S.A. — Earnings Release 2017
Apr 27, 2017
1556_iss_2017-04-27_c3247c7e-a93d-4c9f-b919-fa9b18ae3992.pdf
Earnings Release
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Press Release
Nicox first quarter 2017 business update and cash position
- Vyzulta™1 PDUFA date set for August 24, 2017 $\blacksquare$
- ZERVIATE2 PDUFA date set for September 8, 2017
- NCX 4251 and NCX 470 on track to enter Phase 2
- Cash position of $\bigoplus$ 5 million3 as of March 31, 2017
April 27, 2017 Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided an update on its activities and cash position as of March 31, 2017.
"With the PDUFA dates now set for both Vyzulta™ and ZERVIATE, we are focussing our resources on the partnering activities for ZERVIATE in the United States and on preparing for the initiation of the Phase 2 studies evaluating our promising pipeline candidates NCX 4251 in the fourth quarter of 2017 and NCX 470 in the first quarter of 2018," said Michele Garufi, Chairman and Chief Executive Officer of Nicox. "Subject to approval by the FDA, we expect to have two revenue-generating assets and have two candidates in the clinic within the next 12 months, which would put us in a strong position as a major R&D player with an extensive clinical and preclinical pipeline in the ophthalmic space."
First-quarter 2017 financial highlights
The Group had cash, cash equivalents and financial instruments of $E$ 25.0 million3 as of March 31, 2017. compared to €28.9 million as of December 31, 2016. The Group recorded no revenues for the first quarter 2017.
First-quarter 2017 and recent operational highlights
- Resubmission to the U.S. Food and Drug Administration (FDA) on February 24, 2017 by Nicox's licensee, Bausch + Lomb (a wholly-owned subsidiary of Valent Pharmaceuticals Inc.), of the New Drug Application (NDA) for Vyzulta™ (latanoprostene bunod ophthalmic solution) 0.024%. Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT). The FDA has set a PDUFA date of August 24, 2017 (see press release dated March 20, 2017).
- Resubmission to the U.S. FDA, by Nicox, on March 8, 2017 of the NDA for ZERVIATE (cetirizine ophthalmic solution) 0.24%. Nicox's novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The FDA has set a PDUFA date of September 8. 2017 (see press release dated April 11, 2017).
Key upcoming milestones
- August 24, 2017: Potential U.S. FDA approval of Vyzulta™ NDA
- September 8, 2017; Potential U.S. FDA approval of ZERVIATE NDA
-
H2 2017: Expected launch of Vyzulta™ in the United States by Bausch + Lomb, subject to FDA $\bullet$ approval
-
Q4 2017: Expected start of Phase 2 clinical study for NCX 4251
- Q1 2018: Expected start of Phase 2 clinical study for NCX 470 $\bullet$
Notes:
- Vyzulta™ is the provisionally approved tradename for latanoprostene bunod ophthalmic solution, 0.024% $\mathbf{1}$
- ZERVIATE is the tradename provisionally approved for cetirizine ophthalmic solution, 0.24% $\overline{2}$
- $\overline{3}$ Figures non audited
About Nicox
Nicox is an international ophthalmic R&D company utilizing innovative science to maintain vision and improve ocular health. By leveraging its proprietary expertise in nitric oxide donation and other technologies, the Company is developing an extensive portfolio of novel therapies that target multiple ophthalmic conditions, including glaucoma. Nicox currently has two products at the pre-approval stage with the U.S. Food and Drug Administration (FDA) and a promising pipeline including next-generation stand-alone nitric-oxide donors, with the U.S. Food and Drug Administration (FDA) and a promising pipeline including next-gener (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 | Michael Chane-Du | Paris, France |
|---|---|---|
| Invest Securities | Martial Descoutures | Paris, France |
| Gilbert Dupont | Damien Choplain | Paris, France |
| Stifel | Christian Glennie | London, UK |
Upcoming financial and business conferences
Deutsche Bank 42nd Annual Health Care Conference May 3-4 May 22-23 BioEquity Europe Gilbert Dupont 15th Annual Healthcare Conference $M$ ay 30 June 19-22 2017 BIO International Convention September 25-27 Cantor Fitzgerald's 3rd Annual Healthcare Conference Boston, US Paris, France Paris. France
San Diego, US
New York; US
Contacts
Nicox
Gavin Spencer, Executive Vice President Corporate Development T +33 (0)4 97 24 53 00 [email protected]
Investor Relations
Europe NewCap Julien Perez, Valentine Brouchot T +33 (0) 1 44 71 94 94 [email protected]
United States
Argot Partners Melissa Forst T+1 (212) 600-1902 [email protected]
Media Relations
United Kingdom Jonathan Birt T +44 7860 361 746 [email protected]
France
NewCap Nicolas Merigeau T +33 (0) 1 44 71 94 98 [email protected]
United States
Argot Partners Eliza Schleifstein T+1 (917) 763-8106 [email protected]
Disclaimer
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 affil agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.