Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Fiscal Year 2024 Financial and Business Results Conference Call. As a reminder, this conference call is being recorded. I will now turn the conference over to your host, Mr. Mike Moyer of LifeSci Advisors, Investor Relations for Protalix. You may begin your conference.

Thank you, operator. And welcome to the Protalix BioTherapeutics fiscal year 2024 financial results and business update conference call. With me today are Dror Bashan, President and CEO of Protalix, and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates was issued this morning and is available now on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Protalix's filings with the U.S. Securities and Exchange Commission. I’ll now turn the call over to Mr. Bashan. Dror?

Thank you, Mike. And thank you everyone for joining the fiscal year of 2024 financial results and business update. I will begin by reviewing our accomplishments over the past year and recent progress. Following my remarks, Eyal will provide a detailed review of our financial results. We will then open the line for questions, of course. 2024 was a very good year for Protalix. As we brought a record revenues from our partners, fully repaid our outstanding debt, and continued to focus R&D efforts on PRX-115, PRX-119, and other early stage candidates. I would like to start with PRX-115, which is our recombinant PEGylated uricase candidate in development for the treatment of uncontrolled gout. We produce PRX-115 through our ProCellEx platform. As we have announced last quarter, we completed all cohorts in the first in-human Phase 1 clinical trial of PRX-115. This study was a double-blind placebo controlled, single ascending dose study designed to evaluate safety, tolerability, pharmacogenetics and pharmacodynamics following a single dose of PRX-115 in subjects with elevated uric acid levels. The results from this study were presented in the late breaking poster at ACR Convergence Conference in November of 2024. A copy of the poster is available in the publication section of the Protalix website. We are pleased with the results from this first in-human study and believe they support moving forward into patients. To that end, we have been preparing for a Phase 2 clinical trial of PRX-115 and have been in dialogue with regulatory authorities in the U.S. regarding such a proposed trial. Our goal is to initiate the Phase 2 study during the second half of this year. Turning now to Elfabrio. Throughout 2024, our commercial partner, Chiesi Global Rare Diseases, continued to increase its focus on Elfabrio and invest heavily in its medical…

Thank you, Dror. And thank you everyone for joining today's call. Let me review our fiscal year 2024 financials. We recorded revenues from selling goods of $53 million for the year ended December 31, 2024, an increase of $12.6 million or 31%, compared to revenues of $40.4 million for the year ended December 31, 2023. The increase resulted primarily from an increase of $11.8 million in sales to Chiesi, an increase of $0.6 million in sales to Brazil, and an increase of $0.1 million in sales to Pfizer. We recorded revenues from license and R&D services of $0.4 million for the year ended December 31, 2024, a decrease of $24.7 million, or 98%, compared to revenues of $25.1 million for the year end of December 31, 2023. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with our license and supply agreements with Chiesi. Revenues from license and R&D services for the year ended December 31, 2023, included the $200 million regulatory milestone payment from Chiesi in connection with the approval by the U.S. Food and Drug Administration, the FDA, of Elfabrio granted during the [debt] (ph) period. The remaining decrease resulted from the completion of our revenue generating research and development obligation with respect to Elfabrio, and as Elfabrio was approved in the United States and the European Union in May 2023, from the completion of their regulatory process related to the review of the biologic license application, the BLA, and the marketing authorization application, the MAA, for Elfabrio by the FDA and the EMA respectively. As a result of the completion of the Fabry clinical program in 2023, we expect to generate minimal revenues from life and R&D services other than potential regulatory and commercial milestone payments. Cost of goods sold was…

Thank you, Eyal. To conclude, 2024 was an exciting year for Protalix as we are building our foundation for the future. We are gearing up for our anticipated Phase 2 study of our GALT candidate PRX-115, and we continue to make progress on our early stage R&D efforts. I am confident that our strategy balance sheet and three streams of revenues will enable the next phase of pipeline development for Protalix. We look forward to updating you on our progress as we continue to drive innovation and create long-term value for both patients and stockholders. Now I would like to ask the operator to open the call for questions please.

Thank you. [Operator Instructions] Our first question comes from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your question.

Hi, thank you very much for taking my questions and congratulations on what has been an excellent and landmark year for Protalix. I wanted to first of all ask about in the long run what you expect to be able to provide in terms of revenue guidance based in particular on the royalty stream from Elfabrio? And what you anticipate Chiesi would permit you to say about how the revenues from Elfabrio are progressing?

And the line was bad. Can you repeat the question, please?

Yes, it was specifically about revenue guidance. When you expect you might be able to be in a position to provide such guidance, particularly as it pertains to the royalty based revenue coming from Elfabrio? And what you expect Chiesi to permit you to say about how revenues from Elfabrio are progressing.

So first, thank you. You know, Chiesi is a private company. We've discussed it in the past, so we are not revealing data on the number of patients and/or I would say estimated revenues from Chiesi. What we can say that they do well, actually every week that passes they add patients onto Elfabrio globally. We have reported now, if I may say, we think a nice outcome of revenues from different free streams including Chiesi. Chiesi along the years will grow. Clearly you can, I mean royalty, most of the revenues will be based on royalty from Chiesi to Protalix, which is a higher margin. We say it also on our website, it is written over there that we estimate north to $100 million in revenues from Chiesi at 2030, estimation of course, under what we see in front of our eyes. You know, if the ones in four weeks we fly, it's a nice upside, it will be higher of course. And we can, as I mentioned, it's a higher margin revenue. So as time goes by, and it cannot be, I think, judged by the quarter, we have to be -- to understand that we sell to Chiesi’s inventory. So we do not sell to their, I’d say, direct sales. So in time, in a 1.5, 2 years, it will be more ongoing, if I may say, and then we can see a growing, I assume, we expect at least, steady stream of revenues of higher margins that what we sell to Brazil or to Pfizer from Elelyso.

Okay, great. And then with…

So we’ll not and we cannot give guidance for 2025. As I mentioned, we sell to inventory. And -- but again, just to emphasize, Chiesi does well. We are pleased with the picture, and we consider this collaboration as positively strategic to Protalix.

Great, and then with respect to PRX-119, I was wondering if you could briefly delineate the differences between PRX-119 and your historical program that I believe was designated PRX-110? And also if you could provide us with some framework, some frame of reference regarding the size of the market opportunity in NETs that you previously mentioned for PRX-119 going forward. Thank you.

Sure. So, what I can say that PRX-119 is actually a long-acting DNS. PRX-110 was an acute one. We are finalizing as we speak, if I may say, the indication selection. We would like to finalize a couple of activities in addition to another, I would say pre-clinical model. And then we will update the market, I hope, within the coming one or two quarters on the size, you know, once we’ll have the indication we can update about the potential size at least, you know.

Okay, and then lastly With respect to PRX-115, I was just wondering if you could provide us with any details regarding the total aggregate cost of the Phase 2 study that you are running, as well as the timeline to release of potential top-line data, as well as strategically what you anticipate doing, assuming positive results from this study? Would you expect to take forward clinical development of this asset yourself, or at that juncture, look to identify a potential development and commercialization partner? Thank you.

So currently we plan to finance the Phase 2 without current means. And we have the means as we mentioned. We have sufficient, if I may say, resources to finance our operations including the early R&D and the Phase 2 of the 115. You know, about the cost, you know, we see something I would say north to $20 million on the third parties expenses or expected payments. This is not including labor or internally. Don't forget we produce it with our own ProCellEx. So there is a portion which we do a significant portion by ourselves. As for a top line result, we estimate something like two years from today, depends on the pace of enrollment of course. Please understand, first patient in will be the second plan to be in the second-half of this year. I assume that if indeed the outcomes will be positive, it makes sense that we look for a commercial partner.

Thank you very much.

Of course.

Thank you. [Operator Instructions] Our next question comes from the line of John Vandermosten with Zach's SCR. Please proceed with your question.

Thank you. And, Eyal, do you have the 4Q Elfabrio revenue number handy?

Yes, I can pull them up.

Go on, John.

Yes. I'll ask another one while you're pulling that up.

Okay.

So on 115, I saw you guys had a poster out and I was wondering if you could elaborate on the mechanism of action for 115 and its impact on the urate crystals? Does it actually go after them or I just want some clarity on how that mechanism is?

John, I don't fully understand what you mean. Maybe you can define it differently.

Sure. So PRX-115, I was reading through the poster and it provided a small amount of detail on how it works? And I assume it eliminates the urate crystals or does it have some other mechanism of action of how it affects GALT? And I wanted to see if you had some clarity on that?

What we use is uricase from, you know, a certain source which is different than Krystexxa for the sake of our discussion. We have our, I would say, specific peg to cover the enzyme, which is covered, I would say, almost completely. You know, what we see so far, and I want to be careful, in humans, with hyperuricemia, which participate in the Phase 1 study, that we reduce the uric acid in, I would say quickly of course, and we see pretty long periods of time that actually the -- I would say the level of the uric acid is very low. You know, once we get into patients with, I would say, refractory gout or severe gout and have results, we can update about the effect of how it does with the [Indiscernible] and the overall disease.

Okay, great. And I just, are you all able to find that? I know you're going to file the 10-K later. I just was going to put it in my model.

10-K was filed already, by the way.

Oh, it was? Okay, I didn't see it. All right, well, I'll just find it there. That's all I had this morning. Thank you.

Okay.

Thank you. Ladies and gentlemen, there are no other questions at this time. I'll turn the floor back to Mr. Bashan for any final comments.

So thank you, and thank you everybody that joined the call. We hope to continue to provide good results in the following quarters, of course. We see with high probability, I would say, a bright future for Protalix. So thank you very much.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.