Protalix BioTherapeutics, Inc. (AMEX:PLX) Q4 2022 Earnings Call Transcript

Dror Bashan: I apologize. We expect to run it until the end of this year, so I hope we will be able to finalize the CSR by the beginning of next year.

Boobalan Pachaiyappan: Okay, thanks so much for taking my questions.

Dror Bashan: Of course.

Operator: Once again ladies and gentlemen, to ask a question, please press star, one on your telephone keypad. Our next question comes from John Vandermosten with Zacks. Please proceed.

John Vandermosten: Thank you, and good afternoon Dror and Eyal. Let me start out with a question on just milestones that we expect after May. May is supposed to be a big month with both EMA and FDA expected, but after that, what should we look for on the horizon in terms of milestones for the company?

Dror Bashan: Eyal, please?

Eyal Rubin: Yes, I think John, you’re referring to clinical milestones, right, not financial ones?

John Vandermosten: Well, just any major events. I mean, you have the other two programs which Dror talked about just a little bit on 115, in terms of that Phase I; but just anything else we should keep an eye out for on the horizon?

Eyal Rubin: Not at this point. As Dror mentioned, we plan to move forward with our first-in-human the next couple of weeks on the PRX-115 and finish it by the end of this year with potentially we’re going to be with early next year, the first main major milestones that we can foresee the current pipeline.

John Vandermosten: Okay, thank you Eyal. In terms of the financial cash flows and everything that’s related to PRX-102, when do we expect–you know, assuming that sales are made in the second quarter or even the third quarter, when might those cash flows be received and when might they be recognized on the financial statements?

Eyal Rubin: with the regulatory approvals should be received within 60 days from the event, and obviously they’re going to be recorded as we get them from Chiesi and we’ll report them to the street, along with the financials.

John Vandermosten: Okay, very good. I saw that you mentioned in the K–and we’ve talked about this before, but you mentioned in the K this time that Vpriv no longer has exclusivity in the EU and Elelyso is marketed globally. What does this mean for future revenues?

Eyal Rubin: Since we don’t commercialize Elelyso and it’s been marketed and commercialized by Pfizer, whether to start the marketing in Europe serving them Pfizer, based on the POs we receive from them. They’ll have to re-think internally as whether to penetrate market by market. We are calling it the EU, but at the end of the day, it’s a market by market struggle, so they’ll have to make up their minds and then we’ll be working accordingly.

John Vandermosten: Okay, great, and I assume that you have regular conversations with them on how things are going with the product sales. You guys obviously have to plan production and everything like that, so I assume that you have conversations with them, right?

Eyal Rubin: Yes, that’s correct. Again, it’s a question for them, they’re holding the commercial rights.

John Vandermosten: Got it. Last one for me is also saw that your agreement with Chiesi for fill finish activities, and just was wondering what the geographic location was of that since you’re going to be producing the drug product in Israel, and then I guess where is it going to be shipped for their disposition?