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Protalix Q3 Revenue Hits $21.9M, Reaffirms $78M-$83M 2026 Guidance

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Source: SEC EDGAR

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Key Takeaways

  • 1Protalix's profit is milestone-driven, so the $33M-$35M Elfabrio sales guide is the number that matters for 2026.

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Protalix BioTherapeutics (NYSE American: PLX) reported third-quarter 2026 total revenues of $21.9 million on 10 November 2026, up from $17.9 million a year earlier, with net income of $4.0 million, or $0.05 per diluted share, versus $2.4 million in the prior-year quarter. Nine-month revenues reached $75.6 million against $43.6 million in 2025, and net income was $26.1 million, or $0.31 per diluted share, compared with a $1.1 million net loss a year earlier. The company said it expects to meet or exceed its 2026 revenue guidance.

Context — why Protalix's revenue jump matters now

The swing from a nine-month net loss of $1.1 million in 2025 to net income of $26.1 million in 2026 rests on a single non-recurring item. Protalix said it received a $25.0 million milestone payment from Chiesi in the first quarter of 2026 tied to European approval of the every-four-weeks Elfabrio dosing regimen. That payment flowed through license and R&D services revenue, which jumped to $26.5 million for the nine months from $514,000 a year earlier.

Strip the milestone out and the underlying business still grew, but far more modestly. Revenues from selling goods rose to $49.1 million from $43.1 million across the nine months, a $6.0 million increase the company attributed primarily to higher sales to Chiesi, partly offset by lower purchases from Pfizer and weaker sales to Fiocruz in Brazil.

The Pfizer decline is the detail worth flagging. Protalix said the drop was mainly due to Pfizer's manufacturing issues in the previous year, which means the comparison base was depressed rather than the current quarter being unusually strong. Fiocruz softness, by contrast, the company tied to delivery timing rather than any change in underlying Brazilian demand.

Management framed the quarter around balance-sheet strength rather than the headline profit. Chief executive Dror Bashan said the company ended the period with cash and deposits of $48.5 million, calling it a position of strength that supports advancing PRX-115.

Data — what the numbers show

The quarter's revenue mix shifted materially. Goods sales of $21.8 million in Q3 dwarfed the $91,000 booked in license and R&D services, reversing the nine-month pattern where the milestone payment dominated. Cost of revenues fell to $7.9 million from $8.3 million, so the gross margin on goods expanded even as total revenue rose.

Operating expenses moved the other way. R&D rose to $6.9 million in the quarter from $4.5 million, driven by subcontractor costs tied to the RELEASE study, partly offset by a $1.0 million grant recorded under a new R&D law. SG&A edged up to $3.1 million from $2.9 million.

MetricQ3 2026Q3 2025
Total revenue$21.9M$17.9M
Goods revenue$21.8M$17.7M
Net income$4.0M$2.4M
Diluted EPS$0.05$0.03

Taxes on income were $0.7 million in the quarter versus a $0.1 million benefit a year earlier, which the company linked to global intangible low-taxed income rules and IRC Section 174 limitations. For the nine months, tax expense reached $4.6 million. Balance-sheet cash, equivalents, and short-term deposits stood at $48.5 million on 30 September 2026, against $14.7 million in cash and $15.6 million in deposits at the end of 2025. Total assets rose to $118.2 million from $82.3 million.

Analysis — what it means for PLX and rare-disease peers

The revenue beat is real but its composition matters for anyone modelling the stock. Roughly a third of the nine-month top line came from a one-time milestone, so the sustainable run-rate sits closer to the goods-sales figure. Management's own guidance split reflects this: full-year Elfabrio sales excluding milestones of $33.0 million to $35.0 million, and Elelyso sales of $20.0 million to $23.0 million.

That guidance implies fourth-quarter goods revenue of roughly $4 million to $9 million, well below the $21.8 million booked in Q3. The company did not explain the sequential step-down, but the Q3 figure included delivery timing to Chiesi and Pfizer that may not repeat.

The bull case rests on PRX-115. Protalix is presenting Phase 1 data at ACR Convergence 2026 covering the 18 mg, 24 mg, and 36 mg cohorts, with six participants per cohort followed for 85 days. The company said individual patient data show PRX-115 plasma levels remained measurable for up to 85 days, supporting less frequent dosing than existing uricase therapies.

The counter-argument is timing. Top-line RELEASE results are not expected until the second half of 2027, leaving more than a year of development spend before any readout. R&D costs are already climbing, and the company carries no debt or warrants, which limits financial risk but also means no use to amplify a positive trial outcome.

For positioning, PLX sits in the speculative biotech bucket where flow tracks clinical catalysts rather than quarterly earnings. The cash position of $48.5 million gives roughly two years of runway at the current burn, which covers the RELEASE readout window.

Outlook — what to watch next

Three catalysts matter. First, the ACR Convergence 2026 poster on PRX-115 Phase 1 data, which the company said will be posted on its publications page. Second, enrollment progress in the Phase 2 RELEASE study, which continues with top-line results guided to the second half of 2027. Third, any further Elfabrio geographic approvals following the Brazilian marketing authorization for both dosing regimens.

On the financial side, the Q4 goods-revenue figure will show whether the Chiesi and Pfizer delivery timing that lifted Q3 was a one-off. Investors should also watch whether the $25.0 million milestone is followed by additional Chiesi payments tied to further approvals, though the company gave no schedule.

The stock's reaction will hinge on whether the market treats the $26.1 million nine-month profit as repeatable. Guidance reaffirmation suggests management is comfortable with the current trajectory, but the milestone-driven nature of the profit means the clean comparison is the goods-sales line.

Frequently Asked Questions

What does Protalix's Q3 2026 earnings mean for retail investors?

The quarter showed $4.0 million of net income and $21.9 million in total revenue, but the bigger story is the $25.0 million Chiesi milestone booked earlier in the year. Retail investors should focus on the goods-sales line of $49.1 million for nine months, which reflects actual product demand rather than one-time payments.

What happens next for Protalix's PRX-115 gout program?

Patient enrollment continues in the Phase 2 RELEASE study, a double-blind, placebo-controlled trial testing a fixed 36 mg dose across five arms of 30 patients each. Top-line results are anticipated in the second half of 2027. The company is also presenting Phase 1 data at ACR Convergence 2026.

Why did Protalix's tax expense rise so sharply in 2026?

Taxes on income reached $4.6 million for the nine months versus $0.3 million a year earlier. The company attributed the increase primarily to global intangible low-taxed income taxes stemming from IRC Section 174 limitations, plus taxes tied to receiving the $25 million milestone payment in the first quarter.

Bottom Line

Protalix's profit is milestone-driven, so the $33M-$35M Elfabrio sales guide is the number that matters for 2026.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. CFD trading carries high risk of capital loss.

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