Greetings, and welcome to the Protalix BioTherapeutics, Inc. Third Quarter Financial and Business Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, Investor Relations. Thank you, sir. You may begin.

Thank you. One moment, please. Thank you, operator, and welcome to the Protalix BioTherapeutics, Inc. Third Quarter 2025 Financial Results and Business Update Conference Call. With me today are Dror Bashan, CEO of Protalix BioTherapeutics, Inc., and Gilad Mamluk, Senior Vice President and Chief Financial Officer. A press release announcing the financial results for the quarter and corporate updates was issued this morning and is available now on the Protalix BioTherapeutics, Inc. website. Please take a moment to read the disclaimer regarding forward-looking statements in the press release. The earnings release and 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 in the Protalix BioTherapeutics, Inc. filings with the US Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror?

Thank you, Mike. And thank you, everyone, for joining this call. I will begin by reviewing our recent accomplishments. Following my remarks, Gilad will provide a detailed review of our quarterly and year-to-date financial results, and then we will open the line for your questions. We are pleased to report another strong quarter and a solid year-to-date performance. For the first nine months of 2025, total revenues were $46.436 million, representing a 24% increase compared to the same period last year. Our total revenues for the third quarter were $17.9 million, which reflects a decrease of 1% compared to the same period of 2024. We recognize revenues from sales of our products to Chiesi, Pfizer, and Fiocruz in Brazil. Their purchases vary from quarter to quarter as they control their own inventories. Overall, these revenues reflect the continued commercial success of our enzyme replacement therapies and provide a strong foundation to support our research and development efforts. On the regulatory front, as we have announced previously, Chiesi, with our cooperation, has formally requested the reexamination of the negative opinion issued in October by the Committee of Medicinal Products for Human Use (CHMP) regarding the proposed every four weeks dose regimen for Elfabrio in Europe. There should be no misunderstanding. This process has nothing to do with the currently approved every two weeks regimen, and the May 2023 approval of the every two weeks regimen in the EU is unaffected, and Elfabrio remains available to patients in the EU. We remain confident in Elfabrio's long-term potential, and we are working closely with Chiesi to provide additional data and context to support the reexamination of the once-in-four-weeks regimen, which we believe could offer meaningful benefits to patients and caregivers. Turning to our pipeline, we are particularly excited about PRX-115, our recombinant pegylated uricase candidate under development for the potential treatment of uncontrolled gout. Preparation for the Phase Two clinical trial is well underway. We filed our IND for the Phase Two clinical trial of PRX-115 in October, and the IND has become effective following the FDA's standard thirty-day review period. We continue our plans to initiate the trial later this year. Based on the encouraging first-in-human data from a Phase One clinical trial of PRX-115, we believe it has the potential to be a best-in-class therapy with a long-acting profile that could improve patient compliance and outcomes. If successful, this program represents a significant opportunity in the market with a high unmet need. We look forward to updating you about the trial as data becomes available. Finally, I would emphasize that our operating strategy remains focused on three pillars: driving commercial success with Elfabrio, advancing PRX-115 and other early-stage pipeline programs, and maintaining financial discipline. With a strong cash position and positive quarterly net income, we are well positioned to execute on these three priorities. Before we turn to the financial results, I want to introduce Gilad Mamluk to this call. Gilad began serving as Protalix BioTherapeutics, Inc. Chief Financial Officer in August, and this is his first earnings call with the company. I'm sure that I speak for everyone on this call when I wish you much success in the new position. Welcome, Gilad. And I'll now turn the call over to you to present a detailed review of our financial results. Gilad, please.

Thank you, Dror, and good morning, everyone. Total revenues from selling goods for the nine months ended September 30, 2025, were $43.1 million, an increase of $8.3 million or 24% compared to the $34.8 million for the same period in 2024. These revenues consist of $18.6 million in sales of Elfabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer, and $9.1 million in sales of Elelyso to Fiocruz in Brazil. Total revenues from selling goods for the three months ended September 30, 2025, were $17.7 million, a decrease of $100,000 or 1% compared to $17.8 million for the same period in 2024. These revenues consist of $8.8 million in sales of Elfabrio to Chiesi, $2.8 million in sales for Elelyso to Pfizer, and $6.9 million from sales to Fiocruz in Brazil. As Dror mentioned, we recognized revenues from sales of our products to our partners, Chiesi, Pfizer, and Fiocruz in Brazil, and the individual purchases change from quarter to quarter, as each of our partners controls their own inventories. As a result, the orders we receive from our partners may not be timed to the pace of patient acquisition and retention, and accordingly, our product sales to our partners may not reflect patient demand for the product. We recorded revenues from license and R&D services of $550,000 for the nine months ended September 30, 2025, an increase of $100,000 compared to $400,000 for the same period in 2024. For the three months ended September 30, 2025, we recorded revenues from license and R&D services of $200,000, an increase of $100,000 compared to $100,000 for the same period in 2024. Revenues from license and R&D services are comprised mainly of revenues we recognize in connection with our license and supply agreement with Chiesi. Other than potential regulatory milestone payments that may become payable, we expect to generate minimal revenues from licensed R&D services now that we have completed the clinical development of Elfabrio. Cost of goods sold for the nine months ended September 30, 2025, was $22.4 million, up $2 million or 10% from $20.4 million for the same period last year, reflecting increased sales to Chiesi and Pfizer for the nine-month period, partially offset by a decrease in sales to Fiocruz. For the three months ended September 30, 2025, the cost of goods sold was $8.3 million, a decrease of $100,000 or 1% from $8.4 million for the same period in 2024. The decrease was mainly the result of the decrease in sales to Chiesi and Pfizer for the quarter, partially offset by the increase in sales to Fiocruz. Research and development expenses for the nine months ended September 30, 2025, totaled $13.9 million, an increase of $5.1 million or 58% compared to $8.8 million for the prior year period. For the three months ended September 30, 2025, total research and development expenses were approximately $4.5 million, an increase of $1.5 million or 50% compared to $3 million for the same period of 2024. The increase for both the three and nine-month periods was mainly due to preparations for our planned phase two clinical trial of PRX-115, which we view as a strategic investment in our pipeline and long-term growth. Selling, general, and administrative expenses for the nine months ended September 30, 2025, were $8.2 million, down $1 million or 11% from $9.2 million for the same period last year. The decrease resulted mainly from lower salary and selling expenses. For the three months ended September 30, 2025, selling, general, and administrative expenses were $2.9 million, an increase of $300,000 or 12% compared to $2.6 million for the same period in 2024. The increase resulted mainly from an increase of $100,000 in salary and related expenses and an increase of $200,000 in selling expenses. Financial income net was $10,000 for the nine months ended September 30, 2025, compared to financial income net of $100,000 for the same period in 2024. The decrease resulted mainly from exchange rate costs and lower interest income on bank deposits, which was partially offset by lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under our then-outstanding convertible notes, or the 2024 notes. For the three months ended September 30, 2025, financial income net was $100,000 compared to financial expenses net of $100,000 for the same period in 2024. The difference resulted mainly from lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the 2024 notes. We recorded tax expenses of approximately $300,000 for the nine months ended September 30, 2025, compared to tax expenses of approximately $400,000 for the same period in 2024. For the three months ended September 30, 2025, we recorded a tax benefit of approximately $100,000 compared to tax expenses of approximately $600,000 for the same period in 2024. Our tax expenses and benefits result mainly from taxes on GILTI income under the US Tax Cuts and Jobs Act of 2017, the US 'One Big Beautiful Bill' Act, which was signed into law on July 4, 2025, and includes a restoration of the current deductibility for domestic regional expenditure beginning in 2025, retransmission options for previously capitalized amounts. We recorded a net loss of $1.1 million for the nine-month period ended September 30, 2025, or 1¢ per share basic and diluted, compared to a net loss of $3.6 million or 5¢ per share for the same period in 2024. For the three months ended September 30, 2025, net income was approximately $2.4 million or 3¢ per share, basic and diluted, compared to net income of $3.2 million or 4¢ per share basic and 3¢ per share diluted for the same period in 2024. At September 30, 2025, we had $29.4 million in cash and cash equivalents and short-term bank deposits, which we believe are sufficient to satisfy our capital needs for at least twelve months from the date we issue our quarterly report for the quarter ended September 30, 2025. Overall, these results reflect strong execution and financial discipline as we continue to invest in our pipeline while maintaining a solid balance sheet. Dror, back to you.

Thanks, Gilad. To conclude, we are proud of our progress over the course of 2025 so far. We delivered strong year-to-date financial performance. We advanced PRX-115 towards phase two initiation and continue to strengthen our commercial foundation with Elfabrio. We believe these achievements position Protalix BioTherapeutics, Inc. for long-term growth and value creation. We appreciate your continued support and look forward to updating you on our progress in the coming months. Operator, please open the line for questions.

Thank you. We will now be conducting a question and answer session. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question comes from Ram Selvaraju with H. C. Wainwright. Please proceed with your question.

Thanks so much for taking my questions, and congratulations on all the recent progress. I first of all wanted to ask if you could provide us with any granularity regarding the timeline for the reexamination of the CHMP opinion on the every four-week dosing regimen of Elfabrio. Secondly, I wanted to see if you had any additional comments on the evolving competitive landscape in treatment-refractory gout and what implications this may have for the ultimate size of the commercial opportunity for PRX-115. And then lastly, with respect to ongoing financial reporting, I was just wondering if you anticipate further predictability of the royalty-based revenue recognition related to Elfabrio sales going forward, or if you anticipate any additional sources of volatility that may impact how you recognize revenue stemming from sales of Elfabrio? Thank you.

So thank you, Ram. I will answer you one by one if it's okay. On the once every four weeks reexamination request, we expect to have an answer in 2026, and, of course, we will update accordingly. This is one. With regard to the gout, indeed, there are multiple developments mainly uricase-based mechanisms of action. When we look at the gout market, we foresee a significant increase in the overall gout market in the next five to six years. And we think that within the uricases or the uncontrolled gout patient population that requires uricases will grow as well. And if indeed our phase two will be successful, potentially we have a product that can take a very nice market share from this increased pool. On the third one, you know, we continue to recognize what we sell to Chiesi's inventory. And I'm not aware of any major change. Chiesi does well in the market. We are optimistic when we look into the future. And this is it.

I would just add to that, Ram, that we have good predictability in terms of our revenues, and we do hope to give some more visibility also in our annual report. But as you know, we are limited in what we can say, given our agreement with Chiesi, and Chiesi is a privately held company.

Thank you very much for all of those responses. I just had one other quick one maybe for Gilad. Regarding the cash runway guidance, I just wanted to clarify whether this is based solely on the expenditures, the operating expenditures that you expect, or if this is factoring in the continued receipt of royalty-based revenue on Elfabrio.

It's based on both. And as I said, we have good predictability regarding the revenue stream.

And this includes, of course, the expenses associated with the phase two trial on PRX-115. Right?

Yeah. That's fine. Yeah. Okay.

Definitely.

Okay. Thank you.

Our next question comes from John Vandermosten with Zacks. Please proceed with your question.

Thank you. And, hi, Dror, and welcome to the call, Gilad. Regarding the CHMP decision on the every four-week dosing, does it make sense to run a new trial to get the information that the EMA might be looking for to get that different dosing regimen, assuming that they don't find a favorable decision?

Okay. Right now, you know, Chiesi submitted a request for reexamination. They will put their arguments together in the coming months. And then there will be discussions within the CHMP, and the verdict will be given, of course, as I mentioned, in 2026. If it's positive, great. If it's not positive, Chiesi will decide internally and take a decision.

Okay. And it sounds like you're still on track for the start of the trial for PRX-115 before the end of the year. What does the timeline look like for that if you get started in the next few weeks in terms of top-line readout and enrollment and everything?

Yes. Indeed. We plan to start screening patients in a few weeks. In 2027, we expect top-line results.

Okay. And you've identified that you want to have several different assets in your development pipeline. And I know you have three right now listed. And I was just wondering what's emerging as a follow-on to PRX-115 as another candidate?

So we hope to update the market soon. You know, PRX-119, I hope that we will be able to, if indeed we'll pass all the models and the tests that we are going through for the final test, we will update about the mechanism of action and the specific indication.

Okay. And then a last one for me. I know you've been getting a few additional approvals in different geographies for, or Chiesi has, new approvals. Has anything emerged recently since the last update in terms of that?

I'm not aware of anything significant or something I'm aware of.

There is a long list of markets Chiesi is under submission or planning to submit for in the next few years to come. So we are not concerned on this front. This is part of the further expansion of Elfabrio globally.

Sounds good. And I guess you'll disclose that as it happens. I know in the past you've disclosed them in the queue.

Yes. Yes. We will disclose it accordingly and properly.

You're welcome.

Our next question comes from Ophil Menkes. Please proceed with your question.

Hi. I'm just an individual investor, but I have a couple of questions for you. Number one is there seems to be a pattern of basically receivables going up at the end of the year and then being cleaned up at Q1. Now so far, $9.9 million has been basically paid off from the end of Q3 receivables. And basically, from what I've seen, it looks like the Brazil and the Pfizer amount that we sold this year are basically probably 4% to 5% above the whole of last year. And assuming that they have about 10% growth, that means that they haven't got much, well, a lot of orders to get easier. Now based on these assumptions, I mean, is there any kind of indication of, like, what kind of numbers you could be doing next year? I mean, what is your capacity based on royalties being paid every time that you basically sell a product to Chiesi? Is there any kind of ballpark number or something like that? That would be question number one. Question number two is, do you guys have any kind of anticipated R&D growth during the phase two for PRX-115 because you guys are looking at a pretty sizable phase two, which is actually pretty nice because you can prove your product candidate pretty nicely with that, but that's costing a lot of money. So, I mean, I have a lot of other questions, but I'm gonna stop at that so that you guys can have some questions, some time to think it over and then so. Thank you.

So regarding the first question, Ophil, we are not providing guidance as noted. Also in terms of our revenue, you know, something we mentioned is that we are buying to the inventory. So if you look at the revenues, there is no direct link, there is a link, but there is no direct link between the revenues and the revenues of Chiesi, for example, because if Chiesi is buying to the inventory in 2024, just for the example, then they may buy less in the first quarter and vice versa. So it may be a bit misleading to try to relate that directly. I can tell you that they keep going. That's without providing any guidance in their numbers, which we cannot give, I can say that they are going nicely the way we see that. In terms of the R&D growth, yes, definitely, we take this expense into account for PRX-115. And as we said, we have enough cash for more than twelve months to fund this trial.

Our next question comes from John Vandermosten with Zacks. Please proceed with your question.

Great. Thanks for letting me ask another one. The last question made me wonder what your thoughts are in terms of cash burn for 2026 and how that might split between R&D and SG&A?

So as I said over this one, we are not, we cannot provide guidance at that stage.

Okay. Even for your cost?

Correct. But what we did say is that, and I also replied to the previous question, we said that we have enough cash for more than twelve months. And we of course have in mind that we are funding the PRX-115 phase two trial.

Okay. Alright. Thank you.

We have now reached the end of our question and answer session. I would now like to turn the floor back over to Dror for closing comments.

So thank you, everybody, for the time. And we will keep updating you. And we will connect next quarter, please.

Thank you.

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