Protalix BioTherapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for the nine months ended September 30, 2026, reached $75.6 million, an increase of $32.0 million (73%) from $43.6 million in the same period of 2025.
• Revenues from selling goods were $49.1 million for the nine months ended September 30, 2026, compared to $43.1 million in 2025, driven primarily by higher sales to Chiesi.
• Revenues from license and R&D services were $26.5 million for the nine months ended September 30, 2026, compared to $0.5 million in 2025, driven by a $25.0 million milestone payment from Chiesi received in Q1 2026.
• Net income for the third quarter was $4.0 million ($0.05 per share basic and diluted), up from $2.4 million ($0.03 per share) in Q3 2025.
• Net income for the nine months ended September 30, 2026, was $26.1 million ($0.33 basic, $0.31 diluted per share), compared to a net loss of $1.1 million ($0.01 per share) in the same period of 2025.
• Cost of revenues decreased to $19.8 million for the nine months ended September 30, 2026, from $22.4 million in 2025.
• Research and development (R&D) expenses increased to $16.7 million for the nine months ended September 30, 2026, from $13.9 million in 2025, driven by higher subcontractor expenses related to the RELEASE study and salary costs, partially offset by R&D grants totaling $3.1 million.
• Selling, general, and administrative (SG&A) expenses increased to $9.2 million for the nine months ended September 30, 2026, from $8.2 million in 2025.
• Financial income, net, was $0.8 million for the nine months ended September 30, 2026, compared to less than $0.1 million in 2025.
• Taxes on income were $4.6 million for the nine months ended September 30, 2026, compared to a tax expense of $0.3 million in 2025.
• Cash, cash equivalents, and short-term bank deposits were $48.5 million as of September 30, 2026.
• The company has no outstanding debt or warrants.

Guidance and Future Outlook:

• Management expects to meet or exceed 2026 total revenue guidance of approximately $78.0 million to $83.0 million, which includes the $25.0 million milestone payment received from Chiesi in Q1 2026.
• Full-year 2026 revenues from Elfabrio sales (excluding milestones) are expected to be approximately $33.0 million to $35.0 million.
• Full-year 2026 revenues from Elelyso sales are expected to be approximately $20.0 million to $23.0 million.

Business Segments and Product Lines:

• Elfabrio (Fabry Disease): Received marketing authorization in Brazil for both every-two-weeks and every-four-weeks dosing regimens; Chiesi Global Rare Diseases is the partner for global development and commercialization.
• PRX-115 (Uncontrolled Gout): The Phase 2 RELEASE study is ongoing with patient enrollment continuing; top-line results are anticipated in the second half of 2027.
• PRX-115 Clinical Data: New individual patient data presented at ACR Convergence 2026 shows plasma levels remained measurable for up to 85 days in cohorts receiving 18 mg, 24 mg, and 36 mg doses.
• PRX-119 (Rare Renal Indications): The company continues to advance this long-acting DNase I program as part of a strategic focus on rare renal indications.
• Elelyso: Sales performance is included in the "selling goods" revenue category, with lower purchases by Pfizer Inc. noted as a factor in year-over-year comparisons due to manufacturing issues in the previous year.

Market and Competitive Landscape:

• Uncontrolled gout is identified as a substantial unmet need with an estimated 180,000 patients in the U.S., characterized by low quality of life and high morbidity.
• Current uricase therapies face challenges including infusion burden, immunogenicity with loss of efficacy, and safety concerns.
• PRX-115 is designed to address these challenges with reduced immunogenicity, less frequent dosing, and a prolonged circulating half-life.
• Protalix is the first company to gain FDA approval of a protein produced through a plant cell-based suspension expression system.

Risks and Challenges:

• Risks include potential disruption of operations due to regional conflict in Iran and military actions involving Israel, Hamas, Hezbollah, and the Houthis, which could affect suppliers, partners, and regulatory authorities.
• Risks related to the commercialization of Elfabrio, including market acceptance, competition, reimbursement, and regulatory actions.
• Risks associated with the failure or delay of clinical trials, including patient recruitment, safety issues, and dosing determinations.
• Risks related to the compliance of Fiocruz (Brazil) with purchase obligations under its supply and technology transfer agreement.
• Risks involving global conditions such as trade restrictions, supply chain challenges, inflation, and banking industry instability.

Management Commentary and Tone:

• Dror Bashan, President and CEO, stated the company concluded the first nine months of 2026 with growing financial strength that supports executing its strategy.
• Management highlighted the $48.5 million cash position as a strength enabling the advancement of PRX-115 for uncontrolled gout.
• Priorities remain consistent: supporting commercial partners, advancing PRX-115 as a potential best-in-class therapy, and advancing rare renal programs.

Other Key Points:

• A $25.0 million milestone payment was received from Chiesi in Q1 2026 in connection with the E4W dosage approval in the EU.
• The company is presenting a poster at the American College of Rheumatology (ACR) Convergence 2026 covering PRX-115 Phase 1 data.
• The Phase 2 RELEASE study (NCT07280156) is a double-blind, placebo-controlled study testing a fixed 36 mg dose of PRX-115 in five treatment arms of 30 patients each.
• The primary endpoint of the RELEASE study is the proportion of patients demonstrating a reduction in serum uric acid levels to below 6.0 mg/dL for at least 80% of the time during Month 6.