Protalix BioTherapeutics (AMEX:PLX) released first-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below.
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<h2>Summary</h2>
Protalix BioTherapeutics reported a $25 million milestone payment from Chiesi due to European Commission approval of a new dosing regimen for El Fabrio, ending the quarter with $51 million in cash.

The company reaffirmed its 2026 revenue guidance of $78 to $83 million, with key revenue drivers being El Fabrio and PRX115's Phase 2 study and ongoing partnerships.

The company plans to capture 15-20% of the global Fabry market by 2031, with strategic focus on expanding El Fabrio's presence in Europe and advancing PRX115 for uncontrolled gout.

First-quarter revenue was $33.8 million, with an increase in R&amp;D expenses to $5.4 million due to the PRX115 Phase 2 study, while maintaining a strong financial position with no debt.

Management expressed confidence in achieving long-term growth through strategic partnerships and pipeline advancement, with expectations for significant revenue growth in the second half of 2026.

<h2>Full Transcript</h2>
OPERATOR
. Good morning ladies and gentlemen and welcome to Protalix 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 LASCI Advisors, Investor Relations for Protalix. Thank you. Please go ahead.

Mike Moyer (Investor Relations)
Thank you Operator and welcome to Protalix BioTherapeutics Q1 2026 financial results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Protalix, 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 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. They 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 will now turn the call over to Mr. Dror Bashan.

Dror Bashan
Thank you Mike and thank you everyone for joining our Q1 2026 financial results and Business Update for 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 a Elfabrio every four weeks dosing regimen. 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 and sufficient funds to support our ongoing operations as well as our phase two 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 dollars inclusive of the 25 million dollar milestones received from Chiesi. Within that outlook, we anticipated Elfabrio revenues excluding milestones of approximately 33 to 35 million and PRX-102 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 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 well with Elfabrio across approved markets. Following the European Commission recent approval of every four weeks regiment, we believe Elfabrio is well positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy. This added dosing flexibility strengthens the Elfabrio competitive position and supports broader adoption 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 Elfabrio 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 Fablo, 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 one data, we believe it has the potential to improve outcomes for patients with uncontrolled gout. We continue to expect top line results in the second half of 2027. Beyond 115, 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.

Gilad Mamlach (Senior Vice President and Chief Financial Officer)
Thank you Dror. For the first quarter of 2026, total revenue was 33.8 million, driven mainly by the 25 million milestone payment received from Chiesi following approval of the every four weeks dosing regimen for Elfabrio in Europe. This milestone underscores the value embedded in our commercial partnerships. Revenues from selling goods was 7.4 million compared to 10 million in the first quarter of 2025. This change reflects lower Fabry purchases by Pfizer and Fuel crews mainly due to timing and inventory dynamics, and was partially offset by sales to Kiese. As we have noted previously, quarterly product revenues can fluctuate based on party 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 Pfizer, partially offset by increased sales to Chiesi R&amp;D expenses increased to 5.4 million, up from 2.5 million in the prior year period, driven mainly by preparations for an Initiation of the PRX115 phase 2 release study. This increase reflects a deliberate allocation of capital toward advancing PRX115, which remains our top clinical priority. SGA 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 milestone 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. profitable commercial business and milestone 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 31, 2026. We have no outstanding debt or warrants providing us with substantial financial flexibility to support our continued pipeline advancement. 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 Dror Bashan

Dror Bashan
thank you Gilant. To conclude, as we look ahead, we do so from a position of strength. With the $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as 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 Elfabrio 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 Elfabrio globally. Now I will turn. I would like to ask the operator to open the call for questions.

OPERATOR
Thank you. If you would like to ask a question, please press Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two 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 key. Our first question is from Ram Sirvaju with HC Wainwright. Please proceed.

Ram Sirvaju (Analyst)
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.

Dror Bashan
So. Thank you. So I think as we mentioned last time, we just Chiesi, we received the approval for every four weeks on 5th of March. And Chiesi 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 Kez sales at that point of time. We still stick to the same guidelines we provided.

Ram Sirvaju (Analyst)
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?

Dror Bashan
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 end results in the second half of 2027.

Ram Sirvaju (Analyst)
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 URAT1 inhibitors or do you anticipate that the treatment, refractory gout, the refractory gout market segment is more or less likely to remain the same.

Goro
So Ram, this is Goro. Thank you. We believe, I would say this segment of uncontrolled gout patients will stay and there will be, I would say, enough room and growing even for patients qualified for Uricas. Thank you.

Ram Sirvaju (Analyst)
Thank you.

OPERATOR
Our next question is from John Vandermeuyen with Saks. Please proceed.

John Vandermeuyen (Analyst)
Good morning, Dror Bashan and Gilad Mamlach, 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, you know, the uptake in the market on that, on that approach?

Dror Bashan
It's too early for dad. Joan, good morning and thank you. But we do see, I mean, when we talk with Chiesi, I mean they're optimistic about the progress and they expect to make 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.

John Vandermeuyen (Analyst)
Understood. And there was a mention in the press release about TAZ 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 El Fabria.

Dror Bashan
So there are a few targets from CHIES 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.

John Vandermeuyen (Analyst)
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. How do we. How does that look, that program?

Dror Bashan
You know, we are developing and, you know, putting together different activities, if 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 to which specific indication this mechanism of action works. And then we will, of course, detail when we expect to start Phase one.

John Vandermeuyen (Analyst)
Okay. All right. Thank you for taking my questions.

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

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

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.

LABU

IBBQ

Protalix BioTherapeutics (AMEX:PLX) reported its Q1 2026 financial results, highlighting a $25 million milestone payment from Chiesi due to European approval of a new dosing regimen for El Fabrio. The company ended the quarter with $51 million in cash and reaffirmed its revenue guidance of $78 to $83 million for 2026. Key revenue drivers include El Fabrio and PRX115's Phase 2 study. Protalix aims to capture 15-20% of the global Fabry market by 2031, with a focus on expanding El Fabrio in Europe and advancing PRX115 for uncontrolled gout.

Transcript: Protalix BioTherapeutics Q1 2026 Earnings Conference Call