Protalix BioTherapeutics, Inc. (PLX) Earnings Call Transcript & Summary

Greetings, and welcome to the Protalix BioTherapeutics Third Quarter Financial and Business Results Conference Call. [Operator Instructions] 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, operator, and welcome to the Protalix BioTherapeutics Third Quarter 2025 Financial Results and Business Update Conference Call. With me today are Dror Bashan, CEO of Protalix; and Gilad Mamlok, 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 website. Please take a moment to read the disclaimer and 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 filings and with the U.S. 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. And 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 9 months of 2025, total revenues were $43.6 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 recognized revenues from sales of our products to Chiesi, Pfizer and Fiocruz in Brazil and 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 corporation has formally requested the reexamination of the negative opinion issued in October by the Committee for Medicinal Products for Human Use, CHMP, regarding the proposed every 4 weeks dose regimen for Elfabrio in Europe. There should be no misunderstanding. This process has nothing to do with the currently approved every 2 weeks regimen and the May 2023 approval of the every 2 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 in context to support the reexamination of the once in 4 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. Preparations for the Phase II clinical trial are well underway. We filed our IND for the Phase II clinical trial of PRX-115 in October of this year, and the IND has become effective following the FDA's standard 30-day review period. We continue our plans to initiate the trial later this year. Based on the encouraging first-in-human data from our Phase I clinical trial of PRX-115, we believe it has the potential to be best-in-class therapy within -- 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 3 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 3 priorities. Before we turn to the financial results, I want to introduce Gilad Mamlok to this call. Gilad began serving as Protalix's Chief Financial Officer in August of this year, and this is his first earnings call for the company. I'm sure that I speak for everyone on this call, and I wish him 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 9 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 3 months ended September 30, 2025, were $17.7 million, a decrease of $0.1 million or 1% compared to $17.8 million for the same period in 2024. These revenues consist of $8.8 million in sales to Chiesi of Elfabrio, $2.8 million in sales of Elelyso to Pfizer and $6.1 million from sales of Elelyso to Fiocruz in Brazil. As Dror mentioned, we recognize 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 control its own inventories. As a result, the orders we received from our partners may not be timed in relation to the pace of patient acquisition and retention. And accordingly, our product sales to our partner may not reflect patient demand for the product. We recorded revenues from license and R&D services of $0.5 million for the 9 months ended September 30, 2025, an increase of $0.1 million compared to $0.4 million for the same period in 2024. For the 3 months ended September 30, 2025, we recorded revenues from license and R&D services of $0.2 million, an increase of $0.1 million compared to $0.1 million for the same period in 2024. Revenues from license and R&D services are comprised mainly of revenues we recognized 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 license and R&D services now that we have completed the clinical development of Elfabrio. Cost of goods sold for the 9 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 9 months period, partially offset by decrease in sales to Fiocruz. For the 3 months ended September 30, 2025, cost of goods sold was $8.3 million, a decrease of $0.1 million 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 9 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 3 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 3 and 9 months period was mainly due to preparations for our planned Phase II 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 9 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 3 months ended September 30, 2025, selling, general and administrative expenses were $2.9 million, an increase of $0.3 million or 12% compared to $2.6 million for the same period in 2024. The increase resulted mainly from an increase of $0.1 million in salary and related expenses and an increase of $0.2 million in selling expenses. Financial income net was $0.01 million for the 9 months ended September 30, 2025, compared to financial income net of $0.1 million 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 promissory note or the 2024 notes. For the 3 months ended September 30, 2025, financial income net was $0.1 million compared to financial expenses net of $0.1 million 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 $0.3 million for the 9 months ended September 30, 2025, compared to tax expenses of approximately $0.4 million for the same period in 2024. For the 3 months ended September 30, 2025, we recorded a tax benefit of approximately $0.1 million compared to tax expenses of approximately $0.6 million for the same period in 2024. Our tax expenses and benefits result mainly from taxes on GILTI income under the U.S. Tax Cuts and Jobs Act of 2017, the U.S. One Big Beautiful Bill Act, which was signed into law on July 4, 2025, and include a restoration of the current deductibility for domestic research expenditure beginning in 2025 with transition options for previously capitalized amounts. We recorded a net loss of $1.1 million for the 9 months period ended September 30, 2025, or $0.01 per share basic and diluted compared to a net loss of $3.6 million or $0.05 per share for the same period in 2024. For the 3 months ended September 30, 2025, net income was approximately $2.4 million or $0.03 per share basic and diluted compared to net income of $3.2 million or $0.04 per share basic and $0.03 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 12 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. Dora, 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 a Phase II initiation and continue to strengthen our commercial foundation with Elfabrio. We believe these achievements position Protalix for the 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.

[Operator Instructions] Our first question comes from Ram Selvaraju with H.C. Wainwright.

Congratulations on all the recent progress. I first of all, wanted to ask if you could provide us with any granularity regarding the time line for the anticipated reexamination of the CHMP opinion on the every 4-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, Ram. So I will answer you one by one, if it's okay. On the once in 4 weeks reexamination request, we expect to have an answer on Q1 of 2026. And of course, we'll update accordingly. This is one. With regard to the gout, indeed, there are multiple developments, mainly [year-to-one] mechanism of action based, if I may say. When we look at the gout market, we see -- we foresee a significant increase in the overall gout market in the next 5, 6 years. And we think that within the uricases or the uncontrolled gout patients that required uricases, it will grow as well. And if indeed, our Phase II will be successful, so potentially, we have a product that can take very nice market share from this, I would say, increased pool. On the third one, we continue -- Gilad will add if there are any -- will tap, of course. We continue to recognize what we sell to Chiesi's inventory. I'm not aware of any major change. Chiesi does well on the market. We are optimistic when we look into the future. 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.

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 royalty stream.

And this includes, of course, the expenses associated with the Phase II trial on PRX-115, right?

Of course, PRX-115, yes, definitely.

Our next question comes from John Vandermosten with Zacks.

Welcome to the call, Gilad. Regarding the CHMP decision on the every 4-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, 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 Q1 of 2026. If it's positive, great. If it's not positive, Chiesi will discuss internally, and we'll take a decision.

Okay. And it sounds like you're still on track for a start of the trial for PRX-115 before the end of the year. What does the time line 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 Q3 of 2027, we expect top line results.

Okay. And you've identified there's -- you want to have several different assets in your development pipeline. And I know you have 3 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. PRX-119, I hope that we will be -- if indeed, we'll pass all the models and the test that we are going through or the final test, we will update about the mechanism of action and the specific indication.

Okay. And then last one for me. I know you've been getting a few additional approvals in different geographies for 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 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 that in the Q.

Yes, Yes, we will disclose it accordingly and properly.

Our next question comes from [indiscernible].

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 have been basically paid off from the Q3, the end of Q3 receivables. And basically, from what I've seen, it looks like the Brazil and the Pfizer amounts that have been sold this year are basically probably 5% -- 4%, 5% above the all 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 this year. Now based on these assumptions, I mean, is there any kind of indication of like what kind of numbers you could be doing with Chiesi next year? I mean what is your capacity based on royalties being paid every time that you basically sell a product to with 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 II of the 115 because you guys are looking at a pretty sizable Phase II which is actually pretty nice because you can prove your 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 going to stop at that so that you guys can have some time to actually think it over and answer.

Sure. So regarding the first question of field, we are not providing guidance as noted. And also in terms of our revenue, something we mentioned is that we are buying to the inventory. So if you look at the revenues, there is no direct link. Of course, 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 the last quarter of 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 growing and that's without providing any guidance and the numbers, which we cannot give, I can say that they are growing nicely the way we see that. In terms of the R&D growth, yes, definitely, we take this expense into account, the PRX-115. And as we said, we have enough cash for more than 12 months to fund this trial.

Our next question comes from John Vandermosten with Zacks.

The last question, maybe I wonder what your guide or 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 already, John, we are not -- we cannot provide guidance at that stage.

Okay. Even for your costs?

Correct. But what we did say is that -- as I also replied to the previous question, we said that we have enough cash for more than 12 months. And we -- of course, we have in mind that we are funding the PRX-115 Phase II trial.

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'll connect next quarter, please. Thank you.

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