Protalix (PLX) Q3 2026 Earnings Call Transcript

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DATE

Tuesday, Nov. 10, 2026

CALL PARTICIPANTS

• Investor Relations - Mike Moyer
• President and Chief Executive Officer - Dror Bashan
• Senior Vice President and Chief Financial Officer - Gilad Mamlok

TAKEAWAYS

• Total Revenue -- $21.9 million for the third quarter, an increase from $17.9 million in the prior year period driven primarily by higher sales of Elfabrio to Chiesi.
• Revenue from Selling Goods -- $21.8 million for the quarter, compared to $17.7 million in the third quarter of 2025, reflecting increased demand from commercial partners.
• Nine-Month Revenue -- $75.6 million, an increase from $43.6 million in the first nine months of 2025 due to a $25 million milestone payment and growing product sales.
• Net Income -- $4.0 million, or $0.05 per diluted share, for the third quarter compared to $2.4 million, or $0.03 per share, in the prior year period.
• Cash and Bank Deposits -- $48.5 million as of Sept. 30, 2026, compared to $40.7 million as of June 30, 2026, providing liquidity to advance the clinical pipeline.
• Research and Development Expenses -- $6.9 million for the quarter, an increase from $4.5 million last year due to higher subcontractor costs related to the Phase 2 RELEASE study.
• Research and Development Grant -- $1.0 million recorded as a reduction of R&D expenses for the quarter under the R&D law.
• Selling, General, and Administrative Expenses -- $3.1 million for the quarter, up from $2.9 million last year primarily because of increased professional fees and salary expenses.
• Full-Year 2026 Revenue Guidance -- $78.0 million to $83.0 million, including the $25 million milestone received earlier in the year.
• Elfabrio Sales Guidance -- $33.0 million to $35.0 million for the full year, excluding milestone payments.
• Elelyso Sales Guidance -- $20.0 million to $23.0 million for the full year.
• Cost of Revenues -- $7.9 million for the quarter, a decrease from $8.3 million last year despite higher sales because of lower deliveries to Fiocruz.
• Phase 2 RELEASE Study Enrollment -- Actively enrolling patients with top-line results expected in the second half of 2027.
• Income Tax Expense -- $0.7 million in the third quarter compared to a benefit of $0.1 million last year, resulting primarily from taxes on global intangible low-taxed income.
• Net Financial Income -- $0.6 million for the quarter, compared to $0.1 million last year, driven by higher interest income and currency exchange fluctuations.
• Fabry Market Opportunity -- Projected to reach approximately $3.2 billion by 2031, which management indicated supports the global expansion of Elfabrio.
• PRX-115 Phase 1 Data -- Analysis of 18 mg, 24 mg, and 36 mg cohorts showed plasma levels remained measurable for up to 85 days following a single infusion.
• Uncontrolled Gout Patient Population -- Estimated at 180,000 patients in the United States, representing what management described as a blockbuster market opportunity for PRX-115.

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RISKS

• Mamlok stated, "Revenues to Pfizer decreased because there were manufacturing issues last year," explaining the decline in that specific revenue stream for the nine-month period.
• Bashan warned that the PRX-119 program is "being delayed," with a formal decision regarding its entry into clinical trials expected later this quarter.

SUMMARY

Protalix BioTherapeutics, Inc. (NYSEMKT:PLX) reported three-month revenue of $21.9 million and reaffirmed its full-year 2026 revenue guidance of $78.0 million to $83.0 million. Management stated that growth was driven primarily by Elfabrio sales to Chiesi, and the company is seeing increased market penetration in Europe following the March 2026 approval of the four-week dosing regimen. The company is prioritizing the clinical development of PRX-115 for uncontrolled gout, with top-line Phase 2 data anticipated in the second half of 2027. Protalix reported a net income of $26.1 million for the first nine months of the year and maintains a debt-free balance sheet with $48.5 million in cash and deposits.

• CEO Bashan stated, "PRX-115 is a PEGylated uricase designed for high specific activity, prolonged circulation half-life, and reduced immunogenicity."
• Elfabrio received marketing authorization in Brazil for both every-two-weeks and every-four-weeks dosing regimens.
• CFO Mamlok noted, "The Elfabrio margin is higher," indicating a positive impact on overall profitability as that product captures more of the revenue mix.
• Management reported that the Phase 2 RELEASE study for PRX-115 tests five treatment arms, including dosing intervals of four, six, and eight weeks with and without methotrexate.
• Bashan indicated that a successful clinical outcome for PRX-115 would provide an "alternative that patients, together with the treating physician, will consider" for uncontrolled gout management.

INDUSTRY GLOSSARY

• ProCellEx: A proprietary plant cell-based protein expression system used to produce recombinant therapeutic proteins.
• Elfabrio: An enzyme replacement therapy approved for the treatment of adult patients with Fabry disease.
• Elelyso: A recombinant protein treatment used for patients with Gaucher disease.
• PEGylated Uricase: A modified enzyme designed to break down uric acid in the blood for patients with gout.
• Uncontrolled Gout: A severe form of gout where serum uric acid levels remain above target despite standard therapy.
• GILTI: Global intangible low-taxed income, a U.S. tax category for certain income earned by foreign corporations.
• NETs: Neutrophil extracellular traps, which are networks of extracellular fibers that can be associated with inflammatory diseases.

Full Conference Call Transcript

Operator: Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Third 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 LifeSci Advisors, Investor Relations for Protalix. Thank you. Please go ahead.

Mike Moyer: Thank you, operator, and welcome to the Protalix BioTherapeutics Third Quarter 2026 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO, and Gilad Mamlok, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates was issued this morning and is available now on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings 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 Protalix filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror?

Dror Bashan: Thank you, Mike, and thank you, everyone, for joining us for this call. We concluded the first 9 months of 2026 with revenues of $75.6 million, reflecting our continued progress and growing financial position, which supports our ability to execute our strategy and advance our key priorities. We ended the quarter with cash and deposits of $48.5 million, a position of strength that enables us to continue advancing PRX-115 for uncontrolled gout as well as our pipeline in rare renal diseases. Gilad will walk through the details of the quarter. Looking ahead, we see Elfabrio as the foundation of our business with PRX-115 as an important growth opportunity.

Elfabrio continues to expand its global reach with approval in multiple markets outside the U.S. With the global Fabry market projected to reach approximately $3.2 billion by 2031, we believe Elfabrio is positioned to capture a significant portion, supported by our partnership with Chiesi. Our commercial foundation enabled us to advance PRX-115 in uncontrolled gout. Uncontrolled gout is a disease with low quality of life and high unmet need. This represents a blockbuster uricase market opportunity. PRX-115 is a PEGylated uricase designed for high specific activity, prolonged circulation half-life, and reduced immunogenicity. And we believe PRX-115 has the potential to be best-in-class therapy.

Today, at the American College of Rheumatology, or ACR Convergence 2026, we are presenting individual patient data from our Phase I study 115. Individual patient data reinforce our previous findings and show PRX-115 plasma levels measurable up to 85 days. Our positive urate-lowering data supports the potential for less frequent dosing, which is what our Phase II RELEASE study is designed to test. RELEASE is a double-blind, placebo-controlled Phase II study in uncontrolled gout patients. It tests PRX-115 at a fixed dose across different dosing intervals with and without methotrexate. The RELEASE study is actively enrolling, and we expect top line results in the second half of next year. Beyond PRX-115, we are building a pipeline in rare renal diseases.

We believe our partnered commercial business, our balance sheet and no debt or warrants and our focused pipeline limits downside risk while preserving significant upside potential as we advance our pipeline. With that, I will turn the call over to Gilad for a detailed review of the financial results and outlook. Gilad, please?

Gilad Mamlok: Thank you, Dror. For the third quarter of 2026, total revenues were $21.9 million (sic) [ $21.8 million ] compared to $17.9 million (sic) [ $17.7 million ] in the third quarter of 2025. For the first 9 months of 2026, total revenues were $75.6 million compared to $43.6 million for the first 9 months of 2025, which includes the previously reported $25 million milestone payment received from Chiesi. For the third quarter of 2026, revenues from selling goods were $21.8 million compared to $17.7 million in the third quarter of 2025, an increase of $4.1 million.

For the first 9 months of 2026, revenues from selling goods were $49.1 million compared to $43.1 million for the first 9 months of 2025, an increase of $6 million. The increase was driven mainly by higher sales of Elfabrio to Chiesi. For the remainder of the results, I will report only on the third quarter, and you can refer to this morning's press release for additional year-to-date data. Cost of revenues were $7.9 million compared to $8.3 million in the same period in 2025, a decrease of $0.4 million. The decrease was mainly attributable to lower sales to Fiocruz, partially offset by higher sales to Chiesi and Pfizer.

R&D expenses were $6.9 million compared to $4.5 million in the prior year period, an increase of $2.4 million. The increase was mainly driven by higher subcontractor expenses related to the RELEASE study, partially offset by a $1 million grant recorded under the R&D law as a reduction of R&D expenses, which we are eligible for, and we intend to file for grants under the R&D law. We expect to continue to incur expenses as the RELEASE study progresses and additional preclinical and clinical programs advance. SG&A expenses were $3.1 million, up $0.2 million from prior year period, largely attributable to $0.1 million higher professional fees and $0.1 million higher salary and related expenses.

Financial income, net was $0.6 million, compared to $0.1 million in the third quarter of 2025. The change was mainly due to exchange rate fluctuations and higher interest income. Taxes on income were $0.7 million compared to a tax benefit of $0.1 million in the third quarter of 2025. The tax expense resulted mainly from taxes on income derived from global intangible low-taxed income, or GILTI. Net income for the quarter was $4 million, or $0.05 per share, basic and diluted, compared to net income of $2.4 million, or $0.03 per share, basic and diluted in the third quarter of 2025.

For the first 9 months, net income was $26.1 million, or $0.33 per share basic and $0.31 per share diluted. Turning to the balance sheet. Cash, cash equivalents and short-term bank deposits totaled $48.5 million as of September 30, 2026, compared to $40.7 million as of June 30, 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement. With that, I will turn the call back over to Dror.

Dror Bashan: Thank you, Gilad. In closing, I would like to emphasize that we concluded the first 9 months of 2026 with revenues of $75.6 million, reflecting the continued progress and growing financial position, which supports our ability to execute our strategy and advance our key priorities. Now I will ask the operator to open the call for questions.

Operator: [Operator Instructions] Our first question is from Ram Selvaraju from H.C. Wainwright.

Raghuram Selvaraju: Congratulations on all of this recent progress. Two points. Firstly, I was wondering if you could give us some more granularity on the degree of predictability we might be able to expect with regard to revenue recognition coming from Chiesi and sales of Elfabrio. And if the most recent quarterly result indicates a potential new plateau or new level that we should anticipate being able to use as a sort of a baseline reference. I also wanted to ask about the most recent data that you have showcased with 115 and what the implications of this are on 2 fronts.

Firstly, the convenience profile of this asset in the treatment-refractory gout context and how this might position it as a potential best-in-class or best-in-disease drug within the uricase class, as well as the potential implications of less frequent dosing and more stable levels and overall therapeutic activity sustained after more infrequent dosing from an efficacy standpoint compared to existing currently available uricase drugs.

Gilad Mamlok: So regarding the first question, Ram, we do see a very nice year from Chiesi. Also given the approval of every 4 weeks that was received in March this year, including also the milestone payment we received. I can say that we expect this increase to continue. We're not going to provide guidance now. But as we provided guidance for this year at the beginning of this year, we are going to do the same for 2027 once we publish our annual results. We do see a positive momentum that continues.

Dror Bashan: And Ram, just with respect to the -- that, Chiesi performs well. I mean they have a good team around, I would say, the broad commercial front. There's a long-term plan, they execute and they do well. So we see, at least right now, we expect this trend to continue. Regarding 115, can you repeat the question, please?

Raghuram Selvaraju: Just with respect to the data that you have most recently showcased demonstrating the possibility of significantly less frequent dosing and the sustainability of the clinical impact of the drug, what implications does this have for the competitive positioning of this asset versus existing uricase drugs?

Dror Bashan: So thank you. So the outcome of the Phase I are encouraging. We are now actually way into the enrollment, and we hope to finalize it next quarter.

We think that, of course, if we meet any of the arms, the active arms that we are testing and especially the once in 6, or once in 8, or once in 4 weeks without methotrexate, together with outcome of immunogenicity or safety, IRR, which we hope from what we have designed the PEGylation and other changes that we did to the enzyme, we are -- we hope to get a good outcome, which clearly will be beneficial for these patients in uncontrolled gout, meaning, let's say, less frequent dosing for the sake of our discussion, as an example, once in 6 weeks with good immunogenicity and safety profile. Don't ask me to give you a number.

Let's call it a good outcome. It's certainly an alternative that patients, together with the treating physician, will consider. This is how we look into it. This is what we call or define best-in-class.

Operator: [Operator Instructions] Our next question is from John Vandermosten with Zacks SCR.

John Vandermosten: I want to start out with a question on the 4-week dosing for Elfabrio and see if you had any indication from Chiesi what the conversion rate had been for patients shifting to that? And then also perhaps the financial impact of that in terms of -- on the revenue side and proportion of forward-looking revenues.

Operator: John, it looks like there was a disconnection. Please don't hang up the line. We're just experiencing technical difficulty. I'm going to go ahead and add them back in. [Technical Difficulty]

John Vandermosten: Sure.

Operator: We have the speakers back. John, are you still with us?

John Vandermosten: I'm still here.

Operator: Okay. Great. Please proceed with your question. Thank you for holding.

John Vandermosten: Great. No problem. My question was on just the anticipated and current penetration of the 4-week dosing for Elfabrio that you've seen so far? And what you think the opportunity is there on the revenue side in terms of proportion of future revenues?

Dror Bashan: We think from what we see so far, the execution is good and is progressing. Certainly, it enhances the penetration, and I would say, geographic expansion of Elfabrio. We don't divide it between the once in 2 weeks and once in 4 weeks from a guidance point of view. We think it will be enhanced and stronger and stronger outcomes.

Gilad Mamlok: I will add to that, John, that we see an accelerated penetration in terms of number of patients treated in Europe. So we definitely see an effect of that every 4 weeks.

John Vandermosten: Okay. I mean, maybe I'll just phrase it just a little bit differently. Do you think you can get up to maybe about half the patients on the 4-week dosing at some point, given the convenience of it? Or is there some reason why it might top out at some different level?

Dror Bashan: I think it will be a significant portion. It's difficult for me to tell you after 6 months or 7 months from approval exactly the percentage. And it's certainly a significant portion of the patients.

John Vandermosten: Okay. And gross margin was fairly strong this quarter. And similar to the other analyst question on sustainability going forward, do you think that's a new baseline that we can use in terms of product gross margin over the coming quarters? Or is there something particular to the third quarter that supported that being a little bit higher?

Gilad Mamlok: I suggest to look at the year always, the first 9 months. And yes, you can refer it as a baseline because like we explained, revenues to Chiesi are increasing and that improves the gross margin. Revenues to Pfizer decreased because there were manufacturing issues last year. So it was a bit higher than the current steady-state level. So yes, you can refer to as a baseline in a way.

John Vandermosten: And is there a material difference between the Elfabrio and Elelyso gross margins that might support a continued increase as Elfabrio grows more rapidly?

Dror Bashan: Yes. The Elfabrio margin is higher.

John Vandermosten: Okay. Great. And last question for me is just on PRX-119 and what you expect in terms of activities for that program going forward? And when do you think you'll decide whether or not to enter into clinical trials with that asset?

Dror Bashan: Thank you for that. I know it's being delayed, but we assume we'll take decision this quarter what we do with this program, and then we will update. Okay, then it will be clear when we are planning to enter into Phase I.

Operator: We have reached the end of the question-and-answer session. I would like to turn the floor back over to President and CEO, Dror Bashan, for closing comments.

Dror Bashan: So thank you, everybody, again for joining us for this call. As I mentioned earlier, we had a good 9 months of 2026, and we expect a good 2020 -- overall 2026. It reflects our continued progress and growing financial position, and this supports our ability to execute the strategy and advance our key priorities. So thank you. We will talk next quarter, actually in mid-March over the overall 2026 and future 2027. Thank you very much.

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

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