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. Nicox is eligible to receive from Bausch + Lomb up to $165 million in potential payments (at four increasing annual sales levels), if certain regulatory and sales milestones are met, which would result in net milestone payments for Nicox of up to $150 million after considering payments due to Pfizer as part of the 2009 agreement. The next milestone payment of this amount Nicox is eligible to receive is a $20 million payment (of which $15 million is paid to Pfizer as the last Pfizer milestone) on Bausch + Lomb achieving $100 million in net sales. Nicox would also receive potential royalties on sales ranging from 10% to 16% (6% to 12% net of payments due to Pfizer) over three tiers up to December 31, 2018, then over four tiers thereafter.
VYZULTA was launched in the U.S. in December 2017.
Joe Papa, CEO of Valeant commented on the progress of VYZULTATM prescriptions in reply to an analyst question during their Q1 2018 conference call on 8 May 2018. The recording of the conference call is available at: http://ir.valeant.com/events-and-presentations/2018 A transcript of the relevant section, for information purposes only, is provided below. Joseph C. Papa – Valeant Pharmaceuticals International, Inc. “[…] VYZULTA, we’re excited. We continue to see the numbers of prescriptions that are being – waiting for VYZULTA to continue to climb. So we’re excited about that. As we said at the beginning of the launch, 2018 is an important year to get up and running. But we do know we need to get the Part D coverage. And that’s something we’re working on right now. So that’s why the end of the – this 2018 timeframe entering into 2019, we’ll have an appropriate coverage across the entire spectrum of our opportunities. So excited about what it means, we’re getting great feedback about this dual mechanism of action with VYZULTA, and what it means for patient in terms of patients benefits. So we’ll continue to make progress there with the belief that we’ll need to do some additional contracting. Much of that is well underway already for even better 2019.” DISCLAIMER: http://ir.valeant.com/events-and-presentations/2018 is a website operated by Valeant. Nicox doesn’t endorse the content of the website and decline all liabilities with the content of such website.
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.