Protalix BioTherapeutics, Inc. (AMEX:PLX) Q2 2023 Earnings Call Transcript

With regard to a commercial platform or a commercial partner, right now, we don’t have the means, and we are still small and we have to be to stay modest. So we will clearly develop the products until a certain stage, and then we will consider to join forces with a partner. 5 to 10 years down the road, it’s a different ball game. Hopefully, we will do well, and then we can consider maybe to have a phase — this is part of, if I may say, a vision, but not the two, three years plan right now.

Boobalan Pachaiyappan: Okay, alright, thanks so much for your time.

Dror Bashan: Thank you.

Operator: Our next question is from John Vandermosten with Zacks. Please proceed.

John Vandermosten: Thank you and hello Dror, Eyal, how are you guys doing?

Dror Bashan: Good, how are you John.

John Vandermosten: I am doing pretty good. So let me start with a question on any potential future studies for Elfabrio. I think it had been mentioned that there might be a pediatric study and potentially some others. Would Chiesi be completely responsible for those or would Protalix get involved as well? And also, do you know if there are any of these trials — future trials, especially for pediatrics being considered?

Dror Bashan: So again, under the agreement with Chiesi, our responsibility is to actually to supply the drug product to Chiesi. The rest is Chiesi’s responsibility, including the medical plan and of course, the whole commercialization efforts. As part of it, they do plan a pretty deep long-term medical plan with additional studies. As you mentioned, pediatric study, I think by the FDA requirement, it is written and it’s public as well, pregnant women study, etcetera. So I suggest we wait and we will — once it will be initiated, it will be fully available, I mean, from a data point of view. And also you can approach Chiesi and ask them for more information but overall I believe that within the next 6 to 12 months, we will be in the — not we, Chiesi will be executing a very deep long-term medical plan.

Since Protalix developed the product, there are some key senior employees that are consulted with Chiesi or Chiesi is consulting with them, but this is their responsibility.

John Vandermosten: Great, yeah, thank you for that. Also, I want to understand, I guess, how revenues will flow through from the product and there’s two components there, [indiscernible]. I mean, the milestone, there’s the product revenues and then there’s the royalty revenues. And you recognized, I think, $11 million so far in product revenues. Should we expect a continued trend like that on the product revenue side as we progress through the year? And then will they build up inventory and then work it down, I mean, what is your sense of how those revenues will flow for the rest of this year and into 2024?

Eyal Rubin: So John, Eyal. Let me try to elaborate. So first, in Elfabrio we have the product, royalties and milestones. We have only two type of revenue stream from Elfabrio. The first one is obviously the royalties in both the U.S. and outside the U.S., which ranges 15% to 35% outside the U.S. and 15% to 40% of the lease royalties for sales conducted in the U.S. On top of it, we have milestones, regulatory and commercial milestones, obviously. In terms of what we’ve recorded this quarter and what we anticipate to record in the following quarters, obviously, as Chiesi are getting prepared for launch in the various countries, both in the U.S., which the product was launched and out of the U.S., obviously, they are building up their inventory, and those are the sales that we recorded.