Protalix (PLX) Q2 2026 Earnings Call Transcript

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DATE

Wednesday, Aug. 12, 2026 at 8:00 a.m. ET

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 -- $19.9 million in the second quarter, representing an increase from $15.7 million in the prior year period driven by Elfabrio sales.
• Full Year 2026 Revenue Guidance -- $78.0 million to $83.0 million, including a previously received $25 million milestone payment.
• Elfabrio Sales Guidance -- $33.0 million to $35.0 million for the full year 2026, excluding milestone payments.
• Elelyso Sales Guidance -- $20.0 million to $23.0 million for the full year 2026, reflecting steady demand from Pfizer and Fiocruz.
• Revenue from Selling Goods -- $19.8 million for the quarter, an increase of $4.4 million year over year primarily due to global penetration of Elfabrio through the Chiesi partnership.
• H1 Total Revenue -- $53.6 million for the first six months of 2026, compared to $25.8 million in the first half of 2025.
• License and R&D Services Revenue -- $26.4 million for the first half of 2026, largely comprising the $25 million milestone from Chiesi for dosing approval in Europe.
• Cash Position -- $40.7 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2026.
• Net Income -- $3.8 million for the second quarter, or $0.05 per basic and diluted share, compared to $164,000 in the prior year period.
• H1 Net Income -- $22.1 million for the first half of 2026, compared to a net loss of $3.5 million in the same period last year.
• Cost of Revenues -- $7.8 million for the quarter, an increase of $1.9 million year over year due to higher sales volumes to Chiesi and Fiocruz.
• R&D Expenses -- $4.4 million for the quarter, a decrease of $1.6 million year over year due to a $2.1 million grant recorded under a new R&D law.
• G&A Expenses -- $3.1 million for the quarter, representing a $0.5 million increase driven by higher salary and related expenses.
• Fabry Market Share Target -- 15% to 20% of a projected $3.2 billion global Fabry market by 2031, supported by Chiesi's commercial infrastructure.
• PRX-115 Clinical Timeline -- Top-line results from the Phase 2 RELEASE study are expected in the second half of 2027.
• RELEASE Study Enrollment -- Management expects to finalize patient enrollment for the PRX-115 clinical trial within the next 5 months.
• Patent Term Extension -- Elfabrio patent term extended to Nov. 17, 2035, providing an additional five years of protection in the United States.
• Intellectual Property -- USPTO issued U.S. Patent No. 12,674,146 for modified uricase and uses thereof to Protalix Ltd. on July 7, 2026.
• Tax Expense -- $1.1 million for the quarter, an increase of $0.6 million due to GILTI tax resulting from limitations under IRC Section 174.
• South Korea Approval -- Elfabrio received orphan drug designation and marketing authorization in South Korea in May 2026.
• Finance Income -- $0.2 million for the quarter, compared to a $0.5 million expense in 2025, reflecting exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel.
• Gout Market Trend -- Management noted the uncontrolled gout treatment market is trending toward $1.6 billion annually.
• Elelyso Commercial Rights -- Protalix retains full rights to Elelyso in Brazil, while licensing worldwide development to Pfizer.
• Debt Status -- The company reported zero outstanding debt or warrants as of June 30, 2026.
• PRX-119 Pipeline -- Continued advancement of the long-acting DNase I program focused on rare renal indications.

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RISKS

• Mamlok stated, "our revenues can vary from quarter-to-quarter based on the timing of shipments and orders from our partners," noting that full-year performance is a more reliable metric.
• Mamlok indicated that taxes on income increased mainly from global intangible low-taxed income resulting from limitations under IRC Section 174.

SUMMARY

Management reported a profitable first half of 2026, driven by the global commercial expansion of Elfabrio and a significant milestone payment from partner Chiesi Farmaceutici S.p.A. The company reiterated its full-year revenue guidance and maintained a debt-free balance sheet with a cash position of $40.7 million. Strategic focus remains on advancing the PRX-115 Phase 2 RELEASE study for uncontrolled gout, with top-line results anticipated in the second half of 2027. Operational highlights include a multiyear patent extension for Elfabrio in the United States and new regulatory approval in South Korea, reinforcing the long-term commercial outlook for the company's Fabry disease franchise.

• CFO Mamlok attributed quarterly revenue fluctuations to partner logistics, stating, "We did have a nice quarter from Chiesi, which reflects also their growth of the business, but mainly reflects their inventory management."
• CEO Bashan confirmed the PRX-115 clinical timeline remains on schedule, stating, "We expect to finalize enrollment within the next 5 months, I mean by year-end as we planned."
• The company secured a $2.1 million grant under a new R&D law, which Mamlok noted is available "on an ongoing basis" as a reduction of R&D expenses.
• Elfabrio gained regulatory approval in South Korea in May 2026, with Kwangdong Pharmaceutical Co., Ltd. acting as the local marketing authorization holder.
• Management highlighted the market potential for PRX-115, noting that market leader Krystexxa saw a 23% price increase, signaling a growing opportunity in the $1.6 billion uncontrolled gout space.
• The PRX-115 Phase 2 study design evaluates four treatment arms testing different dosing frequencies, including once every 4 weeks and once every 8 weeks regimens.
• The Elfabrio patent extension adds five years of exclusivity, moving the U.S. expiration date to Nov. 17, 2035.

INDUSTRY GLOSSARY

• Elfabrio (pegunigalsidase alfa-iwxj): An enzyme replacement therapy for adult patients with a confirmed diagnosis of Fabry disease.
• Elelyso (taliglucerase alfa): An enzyme replacement therapy used to treat Gaucher disease.
• PRX-115: A plant cell-expressed recombinant PEGylated uricase currently in Phase 2 clinical trials for uncontrolled gout.
• PRX-119: A long-acting DNase I product candidate targeting neutrophil extracellular traps (NETs) related diseases.
• ProCellEx: A proprietary plant cell-based protein expression system used to produce recombinant therapeutic proteins.
• RELEASE study: The Phase 2 clinical trial (NCT07280156) evaluating the safety and efficacy of PRX-115 in patients with uncontrolled gout.
• GILTI: Global Intangible Low-Taxed Income, a category of income for U.S. taxpayers that is earned by a controlled foreign corporation.
• Uricase: An enzyme that breaks down uric acid; PRX-115 is a modified version designed for longer activity in the body.
• NETs (Neutrophil Extracellular Traps): Networks of extracellular fibers, primarily composed of DNA from neutrophils, which bind pathogens but can cause disease if not regulated.

Full Conference Call Transcript

Operator: Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Second Quarter 2026 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to your host, Mr. Mike Moyer of LifeSci Advisors, Investor Relations for Protalix. Please go ahead.

Mike Moyer: Thank you, operator, and welcome to the Protalix BioTherapeutics Q2 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. 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 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 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 this morning. Our results today reflect the strength of our profitable commercial partnerships, and we remain confident in our outlook for this year. We entered the second half of 2026 with Elfabrio sales through Chiesi continuing to drive growth of our business. Gilad will walk through the financial details, but the key driver in the first half was continued growth in Elfabrio's revenues, together with the previously reported $25 million Chiesi milestone payment recognized in the first quarter of this year. Elfabrio sales through Chiesi continue to drive revenues from selling, and this performance reflects further global penetration of Elfabrio and continued growth.

This continued growth keeps us on track with our full year 2026 revenue guidance with the global Fabry market projected to reach approximately $3.2 billion by 2031, Elfabrio is positioned to capture 15% to 20% of this market, supported by our partnership with Chiesi, which is strengthened by the recent approval of the once every 4 weeks dosing regimen in Europe. We believe our revenue mix, particularly the continued expansion of Elfabrio position us well for sustained long-term value creation and [ profitability ]. On the clinical side, PRX-115 continues to advance as planned.

PRX-115 is designed as a long-acting differentiated uricase, and we believe it has the potential to meaningfully improve quality of life for patients with uncontrolled gout, which could be a significant inflection point and revenue driver for Protalix. There is a significant unmet need in this population, and we expect top line results from our RELEASE study in the second half of 2027. Beyond PRX-115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage, and we remain focused on execution across our partnerships and pipeline, and we believe our business model limits downside risks while preserving meaningful upside as we advance our clinical programs.

With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Gilad, please.

Gilad Mamlok: Thank you, Dror. For the second quarter of 2026, total revenues were $19.9 million compared to $15.7 million in the second quarter of 2025. For the first half of 2026, total revenues were $53.6 million compared to $25.8 million for the first half of 2025. For the second quarter of 2026, revenues from selling goods were $19.8 million compared to $15.4 million in the second quarter of 2025, an increase of $4.4 million. For the first half of 2026, revenues from selling goods were $27.2 million compared to $25.4 million for the first half of 2025, an increase of $1.8 million. The increase was driven mainly by higher sales to Chiesi.

For the remainder of the results, I will report only on the second quarter, and you can refer to this morning's press release for additional year-to-date. Cost of revenues were $7.8 million compared to $5.9 million in the same period in 2025, an increase of $1.9 million. The increase was mainly attributable to higher sales volumes to Chiesi [indiscernible] and partially offset by lower sales to Pfizer. R&D expenses were $4.4 million, down from $6 million in the prior year period, a decrease of $1.6 million. The decrease was mainly driven by a $2.1 million recorded under the new R&D law as a reduction of R&D expenses.

As of 2026, this grant is available for us under the R&D law on an ongoing basis. We expect to continue to incur expenses as the RELEASE study progresses and additional preclinical and clinical programs. G&A expenses were $3.1 million, up $0.5 million from the prior year period, largely attributable to higher salary and related expenses. Finance income net was $0.2 million compared to financial expenses net of $0.5 million in the second quarter of 2025. The change was mainly due to exchange rate fluctuations. Taxes on income were $1.1 million compared to $0.5 million in the second quarter of 2025, an increase of $0.6 million.

This increase resulted mainly from taxes on income derived from global intangible low tax income or GILTI resulting from limitations under IRC Section 174. Net income for the quarter was $3.8 million or $0.05 per share basic and diluted compared to net income of $164,000 or $0 per share basic and diluted in the second quarter of 2025. Turning to the balance sheet, cash, cash equivalents and short-term bank deposits totaled $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 advancements.

As we have noted in prior quarters, our revenues can vary from quarter-to-quarter based on the timing of shipments and orders from our partners. We believe it is more useful to evaluate our business on a full year basis, and we remain confident in our full year 2026 guidance. With that, I will turn the call back over to Dror.

Dror Bashan: Thank you, Gilad. In closing, positive revenue trends keeps us firmly on track to meet our full year 2026 guidance. We have a strong cash position to maintain our operations and advance our clinical and preclinical assets. We are confident in the momentum behind our business and about the opportunities ahead. Now I will ask the operator to open the line for questions.

Operator: [Operator Instructions] And our first question -- our first question will come from Raghuram Selvaraju with H.C. Wainwright.

Unknown Analyst: This is [ Yuan Zhi ] sitting in for Ram Selvaraju. I have 2. The first is, so your presentation highlights E4W without methotrexate and the E8W with MTX as the 2 differentiated profiles within RELEASE. What totality of evidence framework will determine which regimen advances to Phase 3? And could a modest month 6 responder rate difference be outweighed by eliminating MTX or extending dosing to E8W?

Dror Bashan: I repeat the question? Actually, both. I mean if you manage to 1 of the 5 [indiscernible] without methotrexate [indiscernible], which can be a huge competitive edge, but also a lower frequency of using the drug is also a big advantage, and we potentially can have both.

Unknown Analyst: Right. Okay. So yes, I'll repeat the question. It's -- my question is what totality of evidence will determine which regimen advances to Phase 3? And could a modest month 6 responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every 8 weeks?

Dror Bashan: We are running now the multiple dose study on the Phase 2. We have to see the outcome. And by the outcome, we can decide with which regimens we continue. It's difficult to tell you today. I mean, under what we have from the mechanism of action and the data from the Phase 1 and whatever we understand about the molecule and the PEGylation of the molecule and the outcomes we have so far, we think that these 4 arms, I'm not speaking about the placebo could be met, which one will be met better. We have to consider there is an immunogenicity aspect, there is an IRR aspect. So it's not just the frequency.

But let's say, under the assumption immunogenicity is good or low or whatever the definition is and with a pretty low IRR. And then it's only about the frequency and/or with or without methotrexate. We have to see.

Unknown Analyst: Got it. Understood. The other question I have is relating to the 10-K, which reports approximately about 50% of Phase 1 subjects who have developed ADAs and that comes with lower incidence at higher doses. My question is, how does the combined PK, PD and immunogenicity data support selecting that fixed 36-milligram dose? And what ADA profile and RELEASE would support every 4 weeks dosing without methotrexate?

Dror Bashan: So we will -- in Phase 2, we will have the, I would say, the ADA against the enzyme. So we have, I think, a clearer picture of the different ADAs and how -- and what are the outcomes, of course, the different arms. So then we'll see where we are. Don't forget the Phase 2 is the multiple dose.

Phase 1 was a single ascending dose chose 36-milligram according to one, I would say, the PK, PD, if I may say, of course, and also under the assumption that this specific, I would say, regimen could be the highest or the more, I would say, convenient and by the way, for the patients, if I may say, both once in 4 weeks without methotrexate and the once in 8 weeks with methotrexate, which call them like the highest outcomes if possible.

Operator: Our next question will come from John Vandermosten with Zacks SCR.

John Vandermosten: Great. Nice to hear from you guys. And congratulations on Elfabrio's patent term extension and the approval in South Korea. Things are going pretty good for that product. I want to start out with a question on just the trend in purchases of Elfabrio. I'm wondering, is there any benefit to having lumpy purchases because we had a nice increase this quarter. And I'm wondering, is that due perhaps to the new approvals in certain geographies? Or is there some other reason in terms of like product runs or some other reason why it makes sense to have lumpy rather than steady purchases of Elfabrio?

Gilad Mamlok: John, thank you. As we always say, one quarter, we prefer to look at the picture always year-to-date. We did have a nice quarter from Chiesi, which reflects also their growth of the business, but mainly reflects their inventory management.

John Vandermosten: Okay. So there's no -- I mean, there's no rationale behind why they wouldn't make it smooth rather than lumpy.

Dror Bashan: This is not a fair definition, I would say. They operate with a lot of sense and logic, of course, and they are responsible for what they are doing. They have their own -- they see the demand. They know how much they sit on certain amount of inventories globally or continent. And of course, their manufacturing plant vis-a-vis other programs that are marketing with a big company. So all in all, this is how it was decided and applied. And of course, to make sure we sit on enough stocks, both [ DS and DP ].

John Vandermosten: Okay. And jumping to 115, I believe you've opened up some new sites or at least on ClinicalTrials.gov, it seems like there are a number of sites listed there compared to previous -- early in the year. How is that going in terms of site activation? And kind of where are you right now? How much can you tell me? And then how many more do you think might be opening in the future so far in 2026?

Dror Bashan: We have actually maybe one site is missing. That's it. And we -- at present, we expect to finalize enrollment within the next 5 months, I mean by year-end as we planned. We'll have to see if things indeed will go this way. So far, so good, knock on wood. That's it. I think overall, except one site that maybe is missing, we are actually signed on whatever we plan to course.

John Vandermosten: And last question is on kind of a bigger picture question on Amgen. They raised price pretty significantly this year, first quarter and second quarter saw 20-plus percent price increases on Krystexxa. And I'm wondering what does that tell you about the market? Does it make it look more attractive? I'm not sure of the details. Perhaps it was a payer mix or something like that. I didn't get into that. But I'm just wondering if you have any thoughts on what that dramatic price increase means for the space.

Dror Bashan: I don't have any insights on that. And I don't know, you get it from what they say or you get it from calculating sales to estimate the number of patients or...

John Vandermosten: It was in the press release or second quarter press release, they said 23% increase in and pricing, even the volumes were down. And they didn't go into it, but I mean, my thought was there's -- the market will accept a higher price, which may make it look more attractive for you guys for 115. So I just wanted to see if that had any impact on your thoughts for this product and the pathway forward.

Gilad Mamlok: The revenues keep growing. It was $1.3 billion in 2025. We see now the trend going to $1.6 billion. So it's very encouraging for 115 as well, as we said.

Operator: And this now concludes our question-and-answer session. I would like to turn the floor back over to Dror Bashan for closing comments.

Dror Bashan: Thank you. So I just like to thank everybody that joined our call, and we look forward to report on our Q3 results as well. I think overall, we have a good strong cash position to maintain our operations and advance our clinical and preclinical assets. And again, we are confident in the momentum behind our business and about the opportunities ahead. So thank you very much.

Operator: Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.

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