Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to Protallix Biotherapeutics Full Year 2025 Financial Results and Business Update Conference Call. As a reminder, this call is being recorded. I will now turn the conference over to Mike Moyer, Managing Director of LifeSite Advisors and Investor Relations Representative for Protallix. Thank you. You may begin.

Thank you, Operator, and welcome to the Portalix Biotherapeutics Full Year 2025 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO, and also with Portalix, Gilad Mamlok, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and business updates were issued this morning and are available now on the Portalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings released in the teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause the actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Fatalex's filings with the 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. Today's discussion will include our forward-looking financial outlook, which emphasizes the strength and durability of our business as we enter 2026. However, I want to first discuss our important recent news. As previously announced, the European Commission has approved the 2 mg per kg every four weeks dosing regimen for El Fabrio for adults living with Fabry disease who are stable with an enzyme replacement therapy. This approval strengthens the treatment landscape for adult patients with Fabry disease across the European Union by introducing an additional dosing regimen that has the potential to enhance long-term management and represent a meaningful advancement, not only for the adults with living Fabry disease, but also for their families. The FDA-approved dosing regimen in the U.S. remains 1 mg per kg every two weeks. Protalyx is proud of this achievement. We also want to thank our partner Chiesi. This achievement is a testament to Chiesi's dedicated efforts and professional execution for which we are most appreciative. The every four weeks approval in the EU entitles us to $25 million regulatory milestone payment from Chiesi. Having earned this milestone, we project a cash balance of approximately $50 million by early April 2026. This enables us to execute comfortably our strategy, including our clinical trials. For 2026, we expect total revenues to range from approximately $78 million to $83 million, including the $25 million milestone payment. This projection includes expected total revenues of approximately $33 to $35 million from Chiesi, excluding milestones, and approximately $20 to $23 million from El Eliza. Gilad will walk through the full financial details later in this call. Operationally, 2025 was a year of consistent execution with our partners. Chiesi continued to perform well across the United States and key ex-US markets, with consistent increasing patient numbers in all markets. The recent approval of the every-four-weeks regimen in Europe significantly enhances El Fabrio's competitive positioning. We remain encouraged by the long-term trajectory of the Fabri market which is projected to reach approximately 3.4 billion by 2030. El Fabrio's differentiated profile and strong commercial execution strengthen its position in the market. Turning to our pipeline, we continue to advance PRX115 with strong momentum. Our phase two trial, our release study, is now enrolling, and the first patients have been randomized. We anticipate top line results in the second half of 2027. Uncontrolled gout remains a high need indication. And we believe that PRX115 has the potential to become a best-in-class therapy and ultimately our third commercial product. We are also expanding our renal pipeline with PRX119, our long-acting DNA candidate, and through our RNA-based collaboration with CECARNA, as well as other programs. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Thank you.

Thank you to all. For the full year 2025, revenues from selling goods totaled $51.8 million, a modest decrease compared to 2024. This was driven by change of quantities we saw to care the inventory, as well as a change in average net selling price of the drug product due to increased commercial patients in Europe. Increasing revenues recorded from sales to Pfizer resulted mainly from increased purchase of fertilizer by Pfizer, to address unexpected manufacturing issues on their end. Chiesi increasingly represents the majority of our long-term revenue opportunity, and revenues from Chiesi remain at a high margin. We expect the revenue mix to shift toward Chiesi over time, further solidifying our margin profit. Revenues from licensed and R&D services increased to $0.9 million, mainly related to our agreements with Chiesi. Apart from potential regulatory milestones, we continue to expect this category to remain minimal. Cost of goods sold increased to $27 million, reflecting higher sales volume to Pfizer with fewer crews, partially offset by lower sales to KZ. R&D expenses increased to $19.6 million, rising 51% year-over-year. This increase was driven mainly by spending on our PRX105 release study, and we expect R&D investment to continue increasing as PRX105 and our renal programs advance. SG&A expenses declined slightly to $11.7 million, mainly due to the lower share-based compensation expenses. Financial expenses resulted in a net expansion of $0.1 million due largely to foreign exchange effects, partially offset by lower interest expenses, following the full repayment of our secured convertible notes in 2024. Income tax expense was $1 million, mainly related to U.S. tax regulations governing global intangible lower tax income, the GILTI. For 2025, we recorded a net loss of $6.6 million compared to a net income of $2.9 million in 2024. The loss reflects increased investment in our clinical pipeline. As of December 31, 2025, we held $30.3 million in cash, cash equivalent, and short-term bank deposits. Importantly, the $25 million milestone payment triggered by the European Commission's approval of the every-four-weeks regimen supports a projected cash balance of approximately $50 million by early April 2026, significantly strengthening our financial flexibility. Now turning to forward-looking guidance. For full year 2026, total revenue is expected to range from approximately $78 million to $83 million, including the anticipating $25 million milestone from Chiesi. Within that, total revenues from Chiesi are projected to be approximately $33 million to $35 million, representing growth of more than 50%. Revenues from ELIZO are expected to be approximately $20 million to $23 million. We believe that our expected 2026 revenue mix, driven predominantly by KZ high margin contributions, positions us well for further growth and improved profitability over time. As always, revenues from all partners may fluctuate quarter by quarter based on their inventory management and purchasing patterns. and we encourage investors to focus on annual trends rather than quarterly viability. In summary, we remain in a strong financial position and well-capitalized to advance our key programs to the next set of clinical and commercial milestones. With that, I will turn the call back over to Dwar. Dwar?

Thank you, Gilad. In summary, we enter 2026 with strong business flexibility, driven by a projected $50 million cash position by early April. a growing commercial foundation for our partners, and a pipeline advancing towards significant clinical and commercial milestones. Furthermore, our projected revenues growth in 2026 of greater than 50% is a testament to the growing number of patients on El Fabrio. As we look ahead, we do so from a position of strength, and we are looking forward to a productive 2026. Now I will turn to the operator and open the call for questions, please.

Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Ram Suvarju with HC Wainwright. Please proceed.

Thanks so much for taking my questions and congratulations on all the recent progress. Firstly, with respect to El Fabrio, can you maybe give us some insight into additional marketing and promotional initiatives that Chiesi has planned to accelerate the market uptake of this product, specifically in the United States over the course of the remainder of 2026? And also, if you can comment on how you expect the recent approval of the less frequent dosing regimen in Europe to potentially affect the sales trajectory there. And if you can offer us any additional perspectives on how you see the timing for potential approval of this dosing regimen in the United States, that would be very helpful.

So, Gilad, you would like to take it?

Yes. So, I think in terms of – well, first, thank you. In terms of marketing and promotion activities, I mean, the 12 alternate awards symposium, and I think most of the focus was on El Fabio. There are many promotions they are doing. We know from them that they manage to increase very nicely the naive patients and also the switch patients by doing promotions with patients that serve as ASADOS in the U.S., which you cannot do in Europe. In terms of the one-to-four effect, that is a major thing for us, for KESI. It will probably take a bit of time until all the countries in Europe get the approval, the reimbursement approval, because there is always some logistics and some regulatory parts that you have to follow. But in Europe, it's a major thing. It reduces the burden for the patients. As you know, it's a huge competitive edge because the competitors don't have the one to four weeks regimen. And in terms of timing of approval to the U.S., I think it's a bit early to reply on that. What we can share is that the fact that it was approved in Europe, we think it's going to accelerate potentially the approval in the U.S., but it's too early to say.

Okay, and then with respect to PRX115 in gout, can you maybe provide us with some additional insight into how this agent might be positioned in the gout market if it were to be approved and what you expect the principal competitive advantages to look like and how that might translate commercially given the fact that gout is so much larger of an indication than anything that the company has previously gotten product approvals for. You know, clearly gout is very different from Gaucher or Fabry. And in particular, it would be helpful to understand whether you expect to have not only advantages in dosing frequency, meaning improved convenience, but also potential safety. Thank you.

So Ram, I would like to answer you if it's okay. First, just to add on, to tap on what Gilad mentioned. Chiesi does, and I say it again and again, and I think the picture is very much pink. They do very nicely. And I think and positive that the once in four weeks approval will enhance significantly their positioning wherever it is approved on the label, of course. With regard to the U.S., Chiesi will take their decisions, and we will update when we can. Again, we are very pleased, and you can see our trajectory or guidance for 2026. And as I said in the past, we expect good years ahead of us. Second, with regard to 115, as you know, we enter, as we speak, we are screening and enrolling patients to this study. The design of the study is out there. We have five arms. One is placebo. One arm is one month without methotrexate. And then there are three arms, once in four, once in six, and once in eight weeks with metotrexate. Clearly, hitting one month without metotrexate or once in six or eight weeks with metotrexate is a significant differentiation, if I may say. In addition to that, and we cannot say right now, of course, because the phase two is the multiple dose study, we will know by the end of the study and what we think that the... The current molecule, I mean the enzyme with the peg, and we did a couple of changes to that, and we have a small peg. This is not the time to go to all the differences, but it's public, of course. Potentially, we have a better, or we expect, I'm sorry, a favorable immunogenicity or immunogenic profile. This we'll see by the end of phase two. With all that, I think if indeed we hit, we have a very nice potential asset. I hope I – in addition, I just want to add, I think that by the time we will get to the market, which will be 2031, 2032, depends on the phase three, enrollment time, et cetera, this specific, I would say, uncontrolled gout segment will be bigger. I would dare to guess north to $2 billion market, maybe more. And I think if, indeed, we come out with differentiated assets, it will grab – we'll be able to achieve a nice market share.

Okay, that's very helpful. One last question from me. PRX119, I was wondering if you could elaborate on specifically which rare renal conditions you expect to target with this asset and what kinds of markets these represent, and if any of them are pediatric in nature and might potentially allow you to be eligible if there is one day an approval for a priority review voucher. Just wanted to better understand which renal markets you are looking at and what kinds of commercial opportunities these might provide.

So we will update, as we said, I hope by the end of Q2. By then we'll have all the, we expect to have all the data from additional experiments that we are conducting, the specific indication, the specific mechanism of action, which is very much important. We target the high unmet need reliant indication, and we think that if this potential mechanism of action will work, It will be very, very interesting for the patients. So please bear with us a few more months and we'll update accordingly.

If it's okay. Thank you.

Our next question is from John Vandermoysen with SACS. Please proceed.

Great. Thank you for taking my questions. So with the Fabrio and the four-week dosing, what is the estimated timeline for rollout? And when will it be available to patients?

You speak about Elfabrio once in four weeks in the EU?

Correct.

Okay, so in some of the markets, it will be available very soon. And maybe Gilad has the exact details. I don't have it in front of my eyes. In other markets, it will take a few months. I'm speaking about the EU. Outside the EU, it's a... process, which I don't have right now, we think relatively in a short time. So we will see, I thought, for the second half of 2026, already a trend, I hope, or, you know, I cannot tell you it will happen today, because it was just approved on the 5th of March, okay? But in some of the markets, it is actually approved the day after. In some of the markets, there is a procedure. Of course, there should be a reimbursement scheme around, although the price, as far as we know, is unchanged. So it's not supposed to be a hurdle. Maybe Gilad can tap on that.

Yes, we just said to that, John, that the approval was just received, so the QEDs themselves didn't analyze country by country because it is a country by country in Europe. I would assume that based on what we know now and we are waiting for further information from them, we expect the effect to start taking place as of the second half of 2026 and obviously much more in 2027 and further.

Okay. And is there a physician education effort that will accompany that kind of rollout, I guess? I mean, I know it's different in Europe than the United States, but will that be required?

I think there's a... is on it, of course, in a professional way. So they are in touch with all treating physicians and all the relevant stakeholders across Europe and further market that this new or additional regimen will be approved. So I'm positive it is.

Okay, great. Thanks for taking my questions. Thank you.

We have reached the end of our session. question and answer session, I would like to turn the conference back over to Draw for closing remarks.

So thank you, and thank you everybody for joining us. We are looking, I would say, into 2026 with a smile, and I'm happy to update you within about, I would say, two months on the outcomes of the first quarter of this year. Thank you very much.

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.

Thank you.