Following the Complete Response Letter of August 7th 2017 concerning VYZULTA™ (ophthalmic solution of latanoprostene bunod), 0.024 % received by our licensee Bausch + Lomb, we had no visibility at all on the potential approval timeline for VYZULTA. Several investors were interested in financing us to ensure that we could continue our expansion and development projects even if FDA approval of VYZULTA was delayed.
The investors in the August 2017 PIPE were specialized investment funds in both Europe and the US. It was structured as a private placement, but this refers to the type of financing, not the type of investor.
Yes, the Management Team and the Board members only entered into a 3-month lock-up agreement in connection with the August 2017 PIPE. These lock-up arrangements expired on November 15, 2017.
Eyevance Pharmaceuticals was created and financed by an investment group who has prior established experience with the marketing and commercialization of pharmaceutical products. Jerry St. Peter, who was a key member of the Nicox team that led the acquisition of Aciex Therapeutics and its ZERVIATE asset, was selected by Eyevance’s financial main shareholder to serve as CEO because of his vast and consolidated experience in the US ophthalmology market. With regards to the large pharmaceutical companies in the ophthalmology industry, most of them are developing and marketing competing products to ZERVIATE in the US market, and as a result, none of them would have been a good partner for the commercialization of our product.
When Nicox negotiated back the rights for VYZULTA from Pfizer in 2009, this included access to data developed by Pfizer which was used for the VYZULTA approval. In exchange for this key asset, we negotiated some milestone payments and royalties to Pfizer. Nicox received $17.5 million from Bausch + Lomb on the VYZULTA approval, and made a payment to Pfizer of $15 million as per the terms of the agreement signed in 2009. The next milestone is a payment of $20 million to Nicox by Bausch + Lomb when VYZULTA annual net sales reach $100 million. $15 million of this is paid by Nicox to Pfizer as the last milestone payment due to Pfizer as per the terms of the agreement signed in 2009. There will then be $125 million of remaining potential milestone payments, if certain regulatory and sales milestones are met, with no further milestone payments due to Pfizer. Concerning the royalties, Nicox would receive 10% to 15% on the net sales of VYZULTA. After payment of the royalty due to Pfizer as per the terms of the agreement signed in 2009, the net royalty for Nicox is 6% to 11%. The level of the royalty increases with the level of net sales and has a further step between 6 and 11%.
VYZULTA is launched in the US. Bausch + Lomb informed Nicox that as of December 18, 2017 VYZULTA is being shipped to U.S. wholesalers.
The company is not giving any guidance on future revenue. The current market and lead products in glaucoma and allergic conjunctivitis are shown in the presentation available on Nicox’s website: section Presentations and Events. Nicox will receive royalty payments on sales of VYZULTA and ZERVIATE and additional milestone payments linked to the achievement of sales levels and development milestones for both products.
The company is not giving guidance on potential timing to breakeven. This will depend on the level of revenues obtained and on the investments that the company will decide to make in its development programs.