Company to host conference call and webcast today at 8:00 a.m. EDT
-- Revenues from selling goods increased to $19.8 million in the second
quarter of 2026, up $4.4 million from the second quarter of 2025, driven
primarily by sales of Elfabrio$(R)$
-- Total revenue climbed to $53.6 million, year to date, from $25.8 million
for the same period in 2025, which includes the previously reported $25.0
million Chiesi milestone payment
-- Year-to-date, the Company achieved profitability with a net income of
$22.1 million
-- The Company reiterates full-year 2026 guidance of $78.0 million to $83.0
million in total revenue
-- PRX-115 Phase 2 study continues to advance as planned, with top-line
results anticipated in the second half of 2027
-- Cash, cash equivalents, and short-term bank deposits were $40.7 million
as of June 30, 2026, providing sufficient capital to fund ongoing
operations including the Phase 2 RELEASE clinical trial of PRX-115
CARMIEL, Israel, Aug. 12, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the second quarter ended June 30, 2026, and provided a business and clinical update.
During the second quarter, Protalix grew revenues from selling goods, driven primarily by continued penetration of Elfabrio(R) globally, advanced enrollment in the PRX-115 Phase 2 RELEASE clinical trial, and reaffirmed its strategic priorities and financial outlook for 2026.
"We enter the second half of 2026 in a position of strength, driven by the continued penetration and growth of Elfabrio(R) through our partnership with Chiesi, a trend toward achieving our financial goals for 2026," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "Total revenue climbed to $53.6 million from $25.8 million for the same period in 2025. With $40.7 million in cash and short-term deposits, we are well-positioned to fund execution across our operations. We remain focused on continued enrollment in our PRX-115 Phase 2 RELEASE study and our pipeline addressing rare renal indications."
Second Quarter 2026 Operational Update
Elfabrio(R) for Fabry Disease
-- On May 4, 2026, the U.S. Patent and Trademark Office (USPTO) issued a
Patent Term Extension certificate for U.S. Patent No. 9,194,011, covering
Elfabrio(R) (pegunigalsidase alfa--iwxj). The extension adds five years
to the patent term, moving the U.S. expiration date to November 17, 2035.
-- Elfabrio(R) received orphan drug designation and Marketing Authorization
in South Korea in May 2026, with Kwangdong Pharmaceutical Co., Ltd. as
the local marketing authorization holder.
PRX-115 for Uncontrolled Gout -- RELEASE Phase 2 continues enrollment
-- On July 7, 2026, the USPTO issued U.S. Patent No. 12,674,146, "Modified
Uricase and Uses Thereof," to Protalix Ltd., strengthening the Company's
intellectual property position around PRX-115.
-- Patient enrollment continues in the Company's RELEASE Phase 2 clinical
trial (NCT07280156) of PRX--115, a recombinant PEGylated uricase, for the
treatment of uncontrolled gout.
-- The Company continues to anticipate top--line results in the second half
of 2027.
Focus on Rare Renal Indications (Preclinical Programs)
-- The Company continues to advance PRX--119, its long--acting DNase I
program, as part of a broader strategic focus on rare renal indications,
as well as other research collaborations.
Financial Outlook: Building Durable Growth and Long--Term Value
The Company operates a profitable growing commercial business through its partnerships, and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical and preclinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale.
Priorities remain consistent:
1. Support our commercial partners through the manufacture and supply of our
products
2. Advance PRX--115 as a potential best--in--class therapy for patients with
uncontrolled gout
3. Advance rare renal programs leveraging the Company's R&D strengths
The Company reaffirms its previously stated 2026 revenue expectations:
-- Total revenue in 2026 to range from approximately $78.0 million to $83.0
million including the $25.0 million milestone which the Company has
received from Chiesi.
-- Full--year 2026 revenues from sales of Elfabrio(R) without
milestones to range from approximately $33.0 million to $35.0
million.
-- Full--year 2026 revenues from sales of Elelyso(R) to range from
approximately $20.0 million to $23.0 million.
This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See "Forward-Looking Statements" for additional information.
Second Quarter and Year-to-Date 2026 Financials highlights
-- Revenues from selling goods were $19.8 and $27.2 million for the three
and six months ended June 30, 2026, respectively compared to $15.4 and
$25.4 million for the same periods in 2025, respectively, an increase of
$4.4 and $1.8 million, respectively. The increase was driven primarily by
higher sales to Chiesi and Fiocruz (Brazil), partially offset by lower
Pfizer purchases mainly due to Pfizer's manufacturing issues in the
previous year.
-- Revenues from license and R&D services were $0.1 and $26.4 million for
the three and six months ended June 30, 2026, respectively, compared to
$0.2 and $0.3 million for the same periods in 2025, the decrease in the
second quarter was due to a lower amount of services provided to Chiesi
in the second quarter of 2026. The increase in the first half of 2026
resulted from the $25.0 million milestone payment received from Chiesi in
connection with the E4W dosage approval in the EU in the first quarter of
2026. Other than potential regulatory milestone payments, the Company
expects to generate minimal revenues from license and R&D services going
forward, having completed the clinical development of Elfabrio(R).
-- Cost of revenues were $7.8 and $11.9 million for the three and six months
ended June 30, 2026, respectively, an increase of $1.9 million (32%) and
a decrease of $2.2 million (15%) compared to $5.9 and $14.1 million for
the same periods in 2025. The increase in the second quarter was driven
primarily by higher sales to Chiesi and Fiocruz (Brazil), partially
offset by lower sales to Pfizer. The decrease in the first half of 2026
resulted primarily from a decrease in sales to Pfizer which was partially
offset by an increase in sales to Chiesi and to Fiocruz (Brazil).
-- Research and development (R&D) expenses were $4.4 and $9.8 million for
the three and six months ended June 30, 2026, respectively, a decrease of
$1.6 million and an increase of $0.3 million compared to $6.0 and $9.5
million for the same periods in 2025. Both periods reflect a $2.1 million
grant receivable recorded under the new R&D law as a reduction of R&D
expenses. The Company expects to continue to incur R&D expenses as the
RELEASE study progresses and additional preclinical and clinical programs
advance.
-- Selling, general, and administrative (SG&A) expenses were $3.1 and $6.2
million for the three and six months ended June 30, 2026, respectively,
an increase of $0.5 and $1.0 million, respectively, compared to $2.6 and
$5.2 million for the prior-year periods, driven primarily by $0.3 and
$0.7 million in higher salary and related expenses, respectively, and of
$0.2 million higher selling expenses for the three and six months ended
June 30, 2026.
-- Financial income, net was $0.2 million for the three and six months ended
June 30,2026, compared to financial expenses, net of $0.5 and $0.1
million for the same periods in 2025. The change resulted primarily from
exchange rate fluctuations between the U.S. dollar and the New Israeli
Shekel.
-- Taxes on income were $1.1 and $3.9 million for the three and six months
ended June 30, 2026, respectively, compared to $0.5 and $0.4 million for
the same periods in 2025 an increase of $0.6 and $3.5 million,
respectively. The increase resulted primarily from taxes on income
derived from global intangible low-taxed income (GILTI) resulting from
limitations under IRC Section 174 and from taxes related to the Company's
receipt of the $25 million milestone payment in the first quarter of
2026.
-- Cash, cash equivalents, and short--term bank deposits were $40.7 million
at June 30, 2026.
-- Net income for the three months ended June 30, 2026 was $3.8 million or
$0.05 per share, basic and diluted, compared to net income of $164,000 or
$0.00 per share, basic and diluted, for the same period in 2025. Net
income for the six months ended June 30, 2026 was $22.1 million, or $0.28
per share, basic, and $0.27 per share, diluted, compared to a net loss of
$3.5 million, or $0.04 per share, basic and diluted, for the same period
in 2025.
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