Company to host conference call and webcast today at 8:00 a.m. EST
CARMIEL, Israel, Nov. 13, 2025 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx$(R)$ plant cell-based protein expression system, today reported financial results for the quarter ended September 30, 2025, and provided a financial and business update.
"We are pleased to report total revenues of $43.6 million for the first nine months of 2025, an increase of 24%, compared to the same period in 2024. Our total revenues for the third quarter were $17.9 million which reflects a decrease of 1%, compared to revenues for the same period of 2024," said Dror Bashan, Protalix's President and Chief Executive Officer. "We recognize revenues from sales of our products to Chiesi, Pfizer, and Fiocruz in Brazil, and their purchases vary from quarter to quarter as they control their own inventories. Overall, these revenues reflect the continued commercial success of our enzyme replacement therapies and provide a strong foundation to support our research and development efforts."
"We are particularly excited about PRX-115, our recombinant PEGylated uricase candidate under development for the treatment of uncontrolled gout, which we believe has the potential to be a differentiating treatment for uncontrolled gout," continued Mr. Bashan. "Based on encouraging first-in-human data from our phase 1 clinical trial of PRX-115, we believe it has the potential to be a best-in-class therapy with a long-acting profile that could improve patient compliance and outcomes. We are planning to initiate a phase 2 clinical trial of PRX-115 later this year."
Corporate Highlights
-- In October 2025, we submitted an Investigational New Drug (IND) to the US
Food and Drug Administration in connection with our planned phase 2
clinical trial of PRX-115 for the potential treatment of uncontrolled
gout. The IND has become effective following the FDA's standard 30-day
review period.
-- In November 2025, Chiesi Global Rare Diseases, a business unit of the
Chiesi Group, with our collaboration requested a re-examination of the
recent negative opinion issued in October 2025 by the Committee for
Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency
$(EMA)$ on Chiesi's request for a Variation Submission covering the 2 mg/kg
body weight infused every 4 weeks (E4W) dosing regimen for Elfabrio
(pegunigalsidase alfa), in addition to the currently approved 1 mg/kg
body weight infused every 2 weeks (E2W) dosing regimen.
-- The 1 mg/kg E2W regimen is unaffected and remains approved as a dosing
regimen of Elfabrio in the EU.
Third Quarter 2025 Financial Highlights
-- We recorded revenues from selling goods of $17.7 million during the three
months ended September 30, 2025, a decrease of $0.1 million, or 1%,
compared to revenues of $17.8 million for the three months ended
September 30, 2024. These revenues consist of $8.8 million in sales of
Elfabrio to Chiesi, $2.8 million in sales of Elelyso to Pfizer and $6.1
million in sales of alfataliglicerase (Elelyso) to Fiocruz (Brazil).
-- We recorded revenues from license and R&D services of $0.2 million for
the three months ended September 30, 2025, an increase of $0.1 million,
or 100%, compared to $0.1 million for the same period in 2024. Revenues
from license and R&D services are comprised primarily of revenues we
recognized in connection with our license and supply agreements with
Chiesi. Other than potential regulatory milestone payments that may
become payable, we expect to generate minimal revenues from license and
R&D services now that we have completed the clinical development of
Elfabrio.
-- Cost of goods sold was $8.3 million for the three months ended September
30, 2025, a decrease of $0.1 million, or 1%, from $8.4 million for the
same period in 2024. The decrease was primarily the result of the
decrease in sales to Chiesi and Pfizer, partially offset by the increase
in sales to Fiocruz (Brazil).
-- For the three months ended September 30, 2025, our total research and
development expenses were approximately $4.5 million comprised of
approximately $2.6 million of salary and related expenses, approximately
$0.5 million of subcontractor-related expenses, approximately $0.5
million of materials-related expenses and approximately $0.9 million of
other expenses. For the same period in 2024, our total research and
development expenses were approximately $3.0 million comprised of
approximately $1.6 million of salary and related expenses, approximately
$0.6 million of subcontractor---related expenses, approximately $0.2
million of materials-related expenses and approximately $0.6 million of
other expenses. The increase of $1.5 million, or 50%, compared to the
same period of 2024 resulted primarily from preparations for the planned
phase 2 clinical trial of PRX-115.
-- We expect to continue to incur significant research and development
expenses as we enter into a more advanced stage of preclinical and
clinical trials, including the initiation of the phase 2 clinical trial
of PRX-115 and as we develop additional research stage programs.
-- Selling, general and administrative expenses were $2.9 million for the
three months ended September 30, 2025, an increase of $0.3 million, or
12%, compared to $2.6 million for the same period in 2024. The increase
resulted primarily from an increase of $0.1 million in salary and related
expenses and an increase of $0.2 million in selling expenses.
-- Financial income, net was $0.1 million for the three months ended
September 30, 2025, compared to financial expenses, net of $0.1 million
for the same period in 2024. The difference resulted primarily from lower
notes interest expenses due to the September 2024 repayment in full of
all the outstanding principal and interest payable under our then
outstanding convertible promissory notes, or the 2024 Notes.
-- We recorded a tax benefit of approximately $0.1 million for the three
months ended September 30, 2025, compared to tax expenses of
approximately $0.6 million for the same period in 2024. The tax benefit
resulted primarily from taxes on income mainly derived from GILTI income
in respect of Section 174 of the U.S. Tax Cuts and Jobs Act of 2017, or
the TCJA. On July 4, 2025, tax reform legislation was enacted in the
United States through the passage of H.R.1, One Big Beautiful Bill Act,
or HR1, which includes significant corporate tax changes, including a
restoration of the current deductibility for domestic research
expenditures beginning in 2025, with transition options for previously
capitalized amounts.
-- Net income for the three months ended September 30, 2025 was
approximately $2.4 million, or $0.03 per share, basic and diluted,
compared to net income of $3.2 million, or $0.04 per share, basic and
$0.03 per share, diluted, for the same period in 2024.
Year-to-Date 2025 Financial Highlights
-- We recorded revenues from selling goods of $43.1 million for the nine
months ended September 30, 2025, an increase of $8.3 million, or 24%,
compared to revenues of $34.8 million for the same period in 2024. These
revenues consist of $18.6 million in sales of Elfabrio to Chiesi, $15.4
million in sales of Elelyso to Pfizer and $9.1 million in sales of
alfataliglicerase (Elelyso) to Fiocruz (Brazil).
-- We recorded revenues from license and R&D services of $0.5 million for
the nine months ended September 30, 2025, an increase of $0.1 million,
compared to $0.4 million for the same period in 2024. Revenues from
license and R&D services are comprised primarily of revenues we
recognized in connection with our license and supply agreements with
Chiesi. Other than potential regulatory milestone payments that may
become payable, we expect to generate minimal revenues from license and
R&D services now that we have completed the clinical development of
Elfabrio.
-- Cost of goods sold was $22.4 million for the nine months ended September
30, 2025, an increase of $2.0 million, or 10%, from $20.4 million for the
same period in 2024. The increase was primarily the result of increased
sales to Chiesi and Pfizer, partially offset by a decrease in sales to
Fiocruz (Brazil).
-- For the nine months ended September 30, 2025, our total research and
development expenses were approximately $13.9 million, comprised of
approximately $6.5 million of salary and related expenses, $4.3 million
of subcontractor-related expenses, $0.9 million of materials-related
expenses, and $2.2 million of other expenses. For the same period in
2024, R&D expenses were approximately $8.8 million comprised of
approximately $4.8 million of salary and related expenses, approximately
$1.6 million of subcontractor-related expenses, approximately
$0.5 million of materials-related expenses and approximately $1.9 million
of other expenses. The $5.1 million, or 58%, increase compared to the
same period of 2024 resulted primarily from preparations for the planned
phase 2 clinical trial of PRX-115.
-- Selling, general and administrative expenses were $8.2 million for the
nine months ended September 30, 2025, a decrease of $1.0 million, or 11%,
compared to $9.2 million for the same period in 2024. The decrease
(MORE TO FOLLOW) Dow Jones Newswires
November 13, 2025 06:50 ET (11:50 GMT)
Comments