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Protalix BioTherapeutics (PLX) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 12, 2026

Source: earnings call transcript

Executive summary

Protalix BioTherapeutics Q2 FY26 — Strong Elfabrio Growth and Pipeline Advancement

Protalix BioTherapeutics delivered strong Q2 FY26 results, primarily driven by the continued global expansion of Elfabrio through its partnership with Chiesi and a $25 million milestone payment recognized in Q1. The company reaffirmed its full-year revenue guidance, supported by a robust cash position, while advancing its PRX115 clinical program for uncontrolled gout with top-line Phase 2 results expected in H2 2027.

Highlights

5

  • Total revenues increased to $19.9 million in Q2 FY26 from $15.7 million in Q2 FY25, a 26.8% YoY increase.

  • Net income for Q2 FY26 was $3.8 million, or $0.05 per share, compared to $0.164 million in Q2 FY25.

  • Revenues from selling goods increased by $4.4 million in Q2 FY26 compared to Q2 FY25, driven by higher sales to Chiesi.

  • The company maintains a strong cash position of $40.7 million as of June 30, 2026, with no outstanding debt or warrants.

  • Elfabrio received approval for a once every four weeks dosing regimen in Europe and approval in South Korea, strengthening its global penetration.

Concerns

3

  • Quarterly revenues can vary based on the timing of shipments and orders from partners, making full-year evaluation more useful.

  • Taxes on income increased by $0.6 million in Q2 FY26 due to global intangible low-tax income (GILTI) limitations under IFC Section 174.

  • R&D expenses are expected to continue as the PRX115 study progresses and additional programs advance.

Guidance & targets

CategoryTargetConfidence
Full-year 2026 revenue
On track to meet guidance
high materiality
High

Segment performance

SegmentRevenueYoYQoQMargin
Total Revenues
Total revenues for Q2 FY26 compared to $15.7 million in Q2 FY25. For the first half of 2026, total revenues were $53.6 million compared to $25.8 million for the first half of 2025. The increase in the first half was driven by continued growth in Elfabrio's revenues and a $25 million Chiesi milestone payment recognized in Q1 FY26.
$19.9 million26.8%——
Revenues from Selling Goods
Revenues from selling goods for Q2 FY26 compared to $15.4 million in Q2 FY25. 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. The increase was mainly driven by higher sales to Chiesi, partially offset by lower sales to Pfizer. Cost of revenues increased by $1.9 million to $7.8 million, mainly attributable to higher sales volumes to Chiesi and Fiocruz, partially offset by lower sales to Pfizer.
$19.8 million$4.4 million increase——

Deals & partnerships

Chiesi Commercial partnership for Elfabrio

Partnership for global penetration and continued growth of Elfabrio, strengthened by recent European approval of a once every four weeks dosing regimen.

Fiocruz Sales of goods

Sales volumes to Fiocruz contributed to the increase in cost of revenues.

Pfizer Sales of goods

Lower sales to Pfizer partially offset the increase in revenues from selling goods and the increase in cost of revenues.

Risks & headwinds

Quarterly revenue variability Ongoing

Revenues can vary from quarter to quarter

Mitigation:Management advises evaluating business on a full-year basis.

Taxes on income from GILTI Ongoing

$0.6 million increase in Q2 FY26

Mitigation:Resulted from limitations under IFC Section 174.

Immunogenicity of PRX115 Clinical development

Approximately 50% of Phase 1 subjects developed ADAs, with lower incidence at higher doses.

Mitigation:Phase 2 study will provide clearer data on ADA against PEG and the enzyme across different arms to inform regimen selection.

What to watch in Q3 FY26

PRX115 Phase 2 enrollment completion

By year-end 2026
Current Ongoing
Target Enrollment completed

Why it matters

Completion of enrollment is a key milestone for the PRX115 clinical program, enabling progression towards top-line data readout.

And at present we expect to find another enrollment within the next five months, by year end as we plan.

Find out whether PLX delivers this. Inve re-checks your case every morning.

Q&A highlights

What evidence framework will determine which PRX115 regimen (E4W without MTX vs. E8W with MTX) advances to Phase 3, and could a modest responder rate difference be outweighed by eliminating MTX or extending dosing?

Management stated that the outcomes of the ongoing Phase 2 multiple-dose study will determine the regimen. They emphasized that both eliminating methotrexate and extending dosing frequency are significant competitive advantages. The decision will also consider immunogenicity and infusion-related reaction (IRR) aspects, not just frequency.

“You know, we are running now the multiple dose studies on the phase two. We have to see the outcomes. And by the outcome, we can decide with which regimens we continue. It's difficult to tell you today.”

asked by Unknown Speaker · answered by Dror Bashan

2 min read 5 chapters

Detailed narrative

Elfabrio Commercial Performance and Market Outlook

Elfabrio sales through Chiesi continue to drive revenue growth, reflecting further global penetration. The recent approval of a once every four weeks dosing regimen in Europe and approval in South Korea are expected to strengthen its market position. The global Fabry market is projected to reach approximately $3.2 billion by 2031, with Elfabrio positioned to capture 15% to 20% of this market, supported by the Chiesi partnership.

PRX115 Clinical Development Update

PRX115, a long-acting differentiated uric acid, is advancing in its Phase 2 clinical study for uncontrolled gout. The company expects top-line results from this study in the second half of 2027. Management highlighted the significant unmet need in this patient population and believes PRX115 has the potential to be a significant inflection point and revenue driver. The Phase 2 study is exploring multiple dosing regimens, including once every four weeks without methotrexate and once every eight weeks with methotrexate.

Financial Highlights for Q2 FY26

Total revenues for Q2 FY26 were $19.9 million, up from $15.7 million in Q2 FY25. Revenues from selling goods increased by $4.4 million to $19.8 million, primarily due to higher sales to Chiesi. Net income for the quarter was $3.8 million, or $0.05 per share, a significant increase from $0.164 million in the prior year. The company's strong financial position is underscored by $40.7 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2026, with no outstanding debt.

R&D and SG&A Expenses

R&D expenses decreased to $4.4 million in Q2 FY26 from $6.0 million in Q2 FY25, mainly due to a $2.1 million grant recorded under a new R&D law. This grant is available on an ongoing basis. SG&A expenses increased slightly to $3.1 million, up $0.5 million from the prior year, largely due to higher salary and related expenses. The company expects R&D expenses to continue as clinical programs advance.

Strategic Focus and Business Model

Protalix's strategy remains centered on rare renal diseases, leveraging its capabilities and platform for a clear advantage. The business model, characterized by profitable commercial partnerships, is designed to limit downside risks while preserving meaningful upside as clinical programs advance. The company expressed confidence in its business momentum and future opportunities.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.