Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics First Quarter 2026 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Mike Moyer of Lakeside Advisors Investor Relations for Protallix. Thank you. Please go ahead.

Thank you, Operator, and welcome to the Protallix Biotherapeutics Q1 2026 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Portalix, and Gilad Mamlach, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate 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 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 Bratalex's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan.

Thank you, Mike, and thank you, everyone, for joining our Q1 2026 financial results and business update call. I want to begin by highlighting two points that underscore the strength of our business today. First, during the quarter we received the $25 million milestone from Chiesi, following the European Commission approval of El Fabrio's every four weeks dosing regime. As a result, we ended the first quarter of this year with $51 million in cash, providing us with a strong balance sheet and substantial financial flexibility. sufficient funds to support our ongoing operations, as well as our Phase II release study with PRX115. Second, we are reaffirming our 2026 guidance. We continue to expect total revenue for the year to range from approximately $78 to $83 million, inclusive of the $25 million milestones received from QIES. Within that outlook, we anticipated Fabio revenues excluding milestones of approximately 33 to 35 million and ELISO revenues of approximately 20 to 23 million. Taken together, this guidance reflects the strength of our commercial partnerships and our confidence in execution across our business for the year ahead. We entered 2026 with a good momentum, with the regulatory progress for El Fabio in Europe, which triggered the $25 million milestone payment, the continued enrollment of our PRX115 Phase 2 release study, and a growing focus on our rare renal disease preclinical pipeline. We remain confident in our strategy for the years ahead. Our partner, Chiesi, continues to execute its way with El Fabio across approved markets. Following the European Commission recent approval of every four weeks regimen, we believe El Fabio is well positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy. This added dosing flexibility strengthens El Fabio's competitive position and supports broader adaption over time. In the United States, the FDA approved dosing regimen remains unchanged. Looking longer term with the global Fabry market projected to approach approximately 3.2 billion by 2031, we believe El Fabrio has the potential to achieve a meaningful 15 to 20% market share globally, supported by its differentiated profile. We believe our revenue mix, particularly the continued expansion of El Fabrio, positions us well for substantial long-term value creation. On our clinical side, PRX115 continues to move forward as planned. The Phase 2 release study is actively evolving, and we remain encouraged by the program profile based on the Phase 1 data. We believe it has the potential to improve outcomes for patients with uncontrolled doubts. We continue to expect top-line results in the second half of 2027. Beyond PRX115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage. In our view, our business model limits downside risk while preserving meaningful upside as we advance our clinical programs and continue our commercial partnership. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Thank you, Rolf.

For the first quarter of 2026, total revenue was $33.8 million, driven mainly by the $25 million milestone payment received from PSE following approval of the every-four-week storage investment for El Fabio in Europe. This milestone underscores the value embedded in our commercial partnerships. Revenues from selling goods were $7.4 million compared to $10 million in the first quarter of 2025. This change reflects low fertilizer purchases by Pfizer and Fucus, mainly due to timing and inventory dynamics, and was partially offset by sales to KC. As we have noted previously, quarterly product revenues can fluctuate based on part of purchasing patterns, and we encourage investors to focus on full-year performance rather than quarter-to-quarter viability. Cost of revenues was $4.1 million compared to $8.2 million for the same period in 2025. The decrease was mainly attributable to lower sales volumes to Pfizer and Fiocruz, partially offset by increased sales to KC. R&D expenses increased to $5.4 million up from 3.5 million in the prior year period, driven mainly by preparations for and initiation of the PRS-115 Phase II release study. This increase reflects a deliberate allocation of capital towards advancing PRS-115, which remains our top clinical priority. SG&A expenses were 3.1 million, up 0.5 million, reflecting modest growth year-over-year, largely attributable to personnel-related costs. As a result of the mizoned revenues and ongoing cost discipline, net income for the quarter was $18.3 million, or $0.23 per share, and $0.22 on a fully diluted basis, compared to a net loss of $3.6 million, or $0.05 per share, in the prior year period. Importantly, the company continues to operate a profitable commercial business and might soon provide additional upside without changing our underlying expense base. Turning to the balance sheet, cash, cash equivalent, and short-term bank deposits, total $51 million as of March 1, 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline and transform. 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 Rob.

Rob? Thank you, Gilad. To conclude, as we look ahead, we do so from a position of strength. With a $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as of March 31st of this year. giving us the financial flexibility to continue investing in programs and partnerships that will drive our next stage of growth. We are reaffirming our 2026 guidance and our expectation that El Fabio can achieve 15% to 20% market share of the Fabri market by 2031. This reflects our confidence in the product, our partnership with Chiesi, and the continued expansion of El Fabio globally. Now, I would like to ask the operator to open the call for questions.

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 Surveju with HC Wainwright. Please proceed.

Thank you so much for taking our questions and congratulations on a good quarter. I wanted to ask if you could comment on the core determinants of the cadence with which you expect to receive revenue from Chiesi regarding El Fabrio sales and what you think the likelihood is, if any, of increases to the full year 2026 guidance for El Fabrio-related royalty-based revenue. Thank you.

So, thank you. So, I think as we mentioned last time, we just received the approval for one in four weeks on 5th of March. And Kiery is now in the process of going country by country and getting the local reimbursement approval. So, I think we are going to see the effect mostly in the second half of the year. And we expect the second half of the year to be much stronger with regards to Kiery's sales.

At that point of time, we still stick to the same guidelines we provided.

And secondly, can you provide any commentary on how enrollment is going in the release trial and if you can potentially provide us with timing for completion of enrollment?

As we said before, we are not updating regarding the continuing progress of the enrollment. It does progress. As we mentioned, we have many sites open. Our target is to finish enrollment by the end of 2026 and have the top-line results in the second half of 2027.

And then lastly, with respect to the positioning of 115 in the overall gout market, do you expect this to change meaningfully with the advent of next-generation URAP1 inhibitors Or do you anticipate that the treatment refractory gout, the refractory gout market segment is more or less likely to remain the same?

So, Ram, this is Golo. Thank you. We believe it would be, I would say, this segment of uncontrolled gout patients which stay and there would be, I would say, enough room and growing even for patients qualified for uric acid.

Thank you.

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

Good morning, Dror and Galan, or good afternoon. I know you mentioned that it's only the very first initial stages of the launch of El Fabrio for every four weeks, but do you have any initial data or initial insight into the uptake in the market on that approach?

It's too early for that, John. Good morning and thank you. But we do see, I mean, when we talk with CASE, I mean, they're optimistic about the progress and they expect to see the progress. But again, in terms of seeing the actual results, I don't think we're going to see them before the second half of the year.

Understood. And there was a mention in the press release about CASE continuing launches and regulatory efforts. around the globe. And can you give us an update on how things are going in that respect, any new geographies, and any geographies that we should expect in the next few months or next quarters in terms of expanding exposure of patients to L-fabio?

So there are a few targets from KERI in the next 12 months, I would say. Some are more significant, some are less, but we are going to report them immediately once there's approval. But it's a continuous route of getting more approvals, and we see what they have in the pipeline, and we will update as soon as they receive the approval.

And then there's also mention of PRX119, and I was wondering, what's the next milestone for PRX119? And I'm thinking also, you know, in terms of, like, getting into the clinic or IND submission or something like that. How does that look, that program?

You know, we are developing and, you know, putting together different activities, as I may say, to make sure that we have, you know, we are on the right path, if I may say. We will update soon, I believe, I hope, by the end of this quarter. I mean, to which specific indication this mechanism of action works, and then we will, of course, detail when we expect to start phase one.

Okay. All right. Thank you for taking my questions. Thank you.

There are no further questions at this time. I would like to turn the floor back over to Dror Bishan for closing remarks.

So thank you, everybody, for joining us today, and we are looking forward to talk to you next quarter. Thank you.

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