14 March 2018
Increase in Royalties by 1% on Annual VYZULTATM Global Sales Revenue Over $300 Million
Additional $20 Million in Potential Milestones
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, today announced an amendment to its global licensing agreement with Bausch + Lomb Incorporated, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International Inc., concerning VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024%.
Under the original agreement signed in 2010, Bausch + Lomb would have paid Nicox royalties of 10% to 15% on worldwide Net Sales of VYZULTATM, comprising three tiers of royalties triggered by increasing, pre-defined annual sales levels. In consideration of final resolution and release relating to certain alleged issues between the parties, the amendment provides that, from January 1, 2019 the royalties due to Nicox according to the original agreement will increase by 1% over the original royalty on Net Sales above $300 million per year. Royalties will now be 10% to 16% over four tiers, reaching the maximum tier if and when global Net Sales exceed $500 million annually. Taking into account Nicox’s royalty payments to Pfizer1, the net royalties to Nicox will be 6% to 12%, compared to 6% to 11% originally.
In addition, the potential milestones payable to Nicox by Bausch + Lomb have been increased by $20 million, added to and split between 3 existing milestones at increasing annual Net Sales levels. The first additional amount payable will be added to the milestone on achievement of $300 million annual Net Sales and the last additional amount payable will be added to the milestone on achievement of $700 million annual Net Sales. The total potential milestones due to Nicox have therefore been increased from $145 million to $165 million2,3. The next sales milestone due from Bausch + Lomb remains as originally agreed at $20 million upon VYZULTATM Net Sales reaching $100 million, with $15 million of this milestone paid to Pfizer4,5.
VYZULTATM was launched in the U. S. by Bausch + Lomb in December 2017.
About VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024%
VYZULTATM, approved by the U.S. Food and Drug Administration (FDA) on November 2, 2017, is a prostaglandin analog indicated for the reduction of IOP in patients with open angle glaucoma or ocular hypertension. It is the first prostaglandin analog with one of its metabolites being nitric oxide (NO). Following topical administration, VYZULTATM, a once daily monotherapy with a dual mechanism of action, works by metabolizing into two moieties, latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humor outflow, and butanediol mononitrate, which releases NO to increase outflow through the trabecular meshwork and Schlemm’s canal. The most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%).
1. Net of royalty due to Pfizer per the agreement in note 4 below
2. $15 million related to the development of a combination product involving latanoprostene bunod
3. Milestones relating to regulatory approvals, achievement of sales targets and future development steps
4. Per the terms of the contract signed with Pfizer in August 2009 by which Nicox recovered the rights to latanoprostene bunod
5. No further milestones payable to Pfizer