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    PLX
    Earnings call· Jun 2026(Q2 FY26)

    Protalix BioTherapeutics Q2 FY26 earnings call PLX

    Aug 12, 2026 Source

    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

    1
    CategoryTargetConfidence
    Full-year 2026 revenue
    On track to meet guidance
    high materiality
    High

    Segment performance

    2
    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——

    Operational metrics

    8
    Cost of revenues
    $7.8 millionincreased by $1.9 million YoY
    Q2 FY26

    Compared to $5.9 million in Q2 FY25. Increase mainly attributable to higher sales volumes to Chiesi and Fiocruz, partially offset by lower sales to Pfizer.

    R&D expenses
    $4.4 milliondown from $6.0 million YoY
    Q2 FY26

    The grant is available on an ongoing basis. Expect to continue to incur expenses as the PRX115 study progresses and additional preclinical and clinical programs advance.

    SG&A expenses
    $3.1 millionup $0.5 million YoY
    Q2 FY26

    Compared to prior year period, largely attributable to higher salary and related expenses.

    Finance income net
    $0.2 millioncompared to financial expenses net of $0.5 million in Q2 FY25
    Q2 FY26

    Change mainly due to exchange rate fluctuations.

    Taxes on income
    $1.1 millioncompared to $0.5 million in Q2 FY25
    Q2 FY26

    Increase resulted mainly from taxes on income derived from global intangible low-tax income (GILTI), resulting from limitations under IFC Section 174.

    Net income
    $3.8 millioncompared to $0.164 million in Q2 FY25
    Q2 FY26

    Net income for the quarter.

    EPS basic and diluted
    $0.05compared to $0.00 in Q2 FY25
    Q2 FY26

    Per share basic and diluted.

    Cash, cash equivalents, and short-term bank deposits
    $40.7 million
    as of June 30, 2026

    No outstanding debt or warrants, providing substantial financial flexibility.

    Industry KPIs

    6
    MetricValueDetails
    Pipeline read out calendarSecond half of 2027
    Regulatory approvals filingsApproved
    Peak long term sales guidance$3.2 billionUSD
    Therapeutic drug market share15% to 20%%
    Clinical trial efficacy safety dataApproximately 50%%
    Collaboration milestone royalty revenue$25 millionUSD

    Deals & partnerships

    3
    ChiesiCommercial 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.

    FiocruzSales of goods

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

    PfizerSales of goods

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

    Risks & headwinds

    3
    Quarterly revenue variabilityOngoing

    Revenues can vary from quarter to quarter

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

    Taxes on income from GILTIOngoing

    $0.6 million increase in Q2 FY26

    Mitigation: Resulted from limitations under IFC Section 174.

    Immunogenicity of PRX115Clinical 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

    3

    PRX115 Phase 2 enrollment completion

    By year-end 2026
    CurrentOngoing
    TargetEnrollment 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.

    Q&A highlights

    5

    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 read5 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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.

    04

    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.

    05

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.