Protalix BioTherapeutics, Inc. (AMEX:PLX) Q1 2024 Earnings Call Transcript

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John Vandermosten: Okay. Great. And then you had mentioned that one of the patients experienced anaphylactic reaction. What did you do to alleviate it? It seems like it was easily resolved, but I was just wondering if there was any specific characteristics of that patient or if it was [solve] (ph) that.

Dror Bashan: I think it was the first patient or second patient, cohort number two. It was six minutes into the infusion, meaning very fast, and it was resolved. It was taken care by the physicians and the team of the center. And this is the only one that had this such a reaction. And that’s it. As we mentioned, the majority of the side effect, if I may say, were mild to moderate. And as we went up the cohorts in six and seven, no AEs were recorded.

John Vandermosten: Okay. And then looking ahead to a Phase II, I think you just have sites in Australia right now. I guess as you look towards a more advanced trial, would those sites be more scattered around the globe? And are there any particular geographies that look attractive for that?

Dror Bashan: So we will we did not choose yet, but we have the last very few candidates to choose from as a CRO. I think it will be — we will move probably to the US and other continents as well. Okay.

John Vandermosten: Okay. Sounds good. And then there was also a mention of looking forward, R&D spend. And I guess the three areas are 115, 119 and other early-stage assets. And how do you think about the breakdown of R&D towards those three different areas? I mean, it sounds like probably 115 is going to be the main consumer of R&D. But what about the other two?

Dror Bashan: Yes. So look, the main consumer of R&D, I would say of product under R&D, as you mentioned will be 115. We want to be careful with the spend. As we mentioned, we sit on – I’d say, $48 million end of the quarter, which would be enough — I emphasize it and I will close the loop in a minute, which will be enough to pay the debt by the beginning of September of this year. So meaning we will be by the end of the year from the beginning of September, a company with no debt and enough cash to maintain our operations. Now this is why the PRX-115 is our main R&D spend. And in addition, we will invest, I would say, in early research candidates to potentially address with unmet need in gout disease. But the intent is not to grow, I’d say, above our capabilities at this moment, of course because we want to keep the company solid and stable.

We enjoy three streams of revenues, we assume the one to Chiesi will gradually, and we are pretty much confident of course, we trust Chiesi and we think they do a very good job. So gradually, this will grow, and will enable us to be, I would say, financially stronger.

John Vandermosten: Got it. And then looking at the cash flow statement, there was an increase in contracts liability that added to your cash — positive cash flow from operations. And Eyal, I was wondering if you could give us — give me a clue and maybe it was obvious, I just missed it, but what that was related to on that contracts liability.

Eyal Rubin: Yes. So as I mentioned a couple of times in the past, our sales to Chiesi are based on either projections. And as Joe mentioned, we feel believe and we see evidently they are doing a good job in terms of penetration. But the orders that they’re putting obviously depending on their levels of inventory and the timing of release of the batches. As you all know, Chiesi is also the fill and finish [sub-contractor] (ph). So the increase in contractual obligation is batches that they basically Chiesi are releasing now, but they already paid for, and it’s going to go obviously into revenues in the next quarter or twp. So we didn’t record the revenues there, but the cash is there. Obviously, cash doesn’t grow on the trees, the effect that the cash grew, as you mentioned, on contractual obligations means that they keep on selling, we keep on then selling to them.

And as Joe mentioned, gradually, we believe that they’re going to take a significant market share and position themselves in a very strong and meaningful way.

John Vandermosten: Great. Very good. And last question regarding the RISE study in Japan. I know you’re not conducting that, but I was wondering if Chiesi had given you any indication on when a BLA might be submitted to the Japanese authorities.

Dror Bashan: I don’t have the details. Eyal, maybe you have? As far as I know, the study is ongoing.

Eyal Rubin: Yes. The starting on going. Obviously, we have the data. We know how many patients were obviously enrolled. But since it is Chiesi proprietary data, obviously, when I allowed to share it they are working, as Dror mentioned and I mentioned a couple of times, we see the progress, and we see the seriousness in terms of the trials that we are conducting, the robustness of the programs and obviously, the commercial operations on the ground both in the US and out of the US. So as soon as they complete the study, that will probably announce or allow us to announce the BLA solution in Japan.

John Vandermosten: Okay. Great. And is Chiesi already selling some rare disease products in Japanese market?

Dror Bashan: I don’t control that. I’m sorry.

John Vandermosten: I know they’ve got a bunch of different products that I just Yes, I hadn’t sought to look that up.– all right. Well, thank you. Appreciate the responses to my questions.

Dror Bashan: Thank you.

Operator: Thank you. At this time, there are no additional questions. I will hand the floor back to management for any further remarks.

Dror Bashan: So all I have to say, thank you again for the time. And actually we will look forward to updating you on the next development of the company. And of course, we will meet at the next earnings later this year in August. So thank you very much. And that’s it.

Operator: Thank you. This will conclude today’s conference. You may disconnect your lines at this time. Thank you for your participation.

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