Protalix BioTherapeutics Reports Second Quarter 2026 Financial and Business Results
Rhea-AI Summary
Protalix BioTherapeutics (NYSE American: PLX) reported strong second quarter and year-to-date 2026 results, with revenues from selling goods rising to $19.8 million in Q2 2026 from $15.4 million a year earlier. Year-to-date total revenue reached $53.6 million versus $25.8 million, including a previously received $25.0 million milestone payment from Chiesi.
Net income was $3.8 million for Q2 2026 and $22.1 million for the first half, compared with a year-to-date net loss of $3.5 million in 2025. Cash, cash equivalents, and short-term deposits totaled $40.7 million at June 30, 2026, and the company reported no outstanding debt or warrants. Protalix reaffirmed 2026 total revenue guidance of $78.0–$83.0 million, including the Chiesi milestone, and product revenue guidance for Elfabrio and Elelyso. Operationally, the company secured a five-year U.S. patent term extension for Elfabrio, new U.S. patent protection for PRX‑115, continued enrollment in the PRX‑115 Phase 2 RELEASE trial, and advanced its PRX‑119 rare renal program.
Positive
- Total revenue H1 2026 $53.6 million vs. $25.8 million H1 2025
- Net income H1 2026 $22.1 million vs. $3.5 million net loss in 2025
- Q2 2026 product sales $19.8 million vs. $15.4 million Q2 2025
- Cash and short-term deposits $40.7 million at June 30, 2026, with no debt or warrants
- 2026 revenue guidance reaffirmed $78–$83 million total, Elfabrio $33–$35 million, Elelyso $20–$23 million
- Elfabrio U.S. patent extension to November 17, 2035, plus South Korea orphan drug designation and marketing authorization
Negative
- Cost of revenues Q2 2026 $7.8 million, up 32% from $5.9 million in Q2 2025
- SG&A expenses H1 2026 $6.2 million vs. $5.2 million H1 2025, driven by higher salary and selling costs
- Taxes on income H1 2026 $3.9 million vs. $0.4 million H1 2025, mainly related to GILTI and the $25 million milestone
- Expected future license and R&D services revenue minimal going forward, other than potential regulatory milestone payments
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 13 | first-quarter earnings | Positive | +1.1% | Reaffirmed revenue guidance, reported profitability, and continued PRX-115 trial enrollment |
| Mar 18 | fiscal-year earnings | Positive | -20.8% | Reported milestone-supported outlook and European Elfabrio dosing approval |
| Nov 13 | third-quarter earnings | Negative | -9.8% | Reported net loss and disclosed negative regulatory opinion on Elfabrio dosing |
| Aug 14 | second-quarter earnings | Positive | -5.6% | Reported higher goods revenue and quarterly profitability from Elfabrio sales |
| May 09 | first-quarter earnings | Negative | -40.5% | Reported revenue growth but remained unprofitable while advancing PRX-115 |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings-tagged events averaged a -15.12% 24-hour reaction, with both aligned and divergent outcomes despite generally positive financial updates.
Key Terms
orphan drug designation regulatory
marketing authorization regulatory
recombinant PEGylated uricase medical
global intangible low-taxed income financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company to host conference call and webcast today at 8:00 a.m. EDT
- Revenues from selling goods increased to
$19.8 million $4.4 million - Total revenue climbed to
$53.6 million $25.8 million $25.0 million - 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 $83.0 million - 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
CARMIEL,
During the second quarter, Protalix grew revenues from selling goods, driven primarily by continued penetration of Elfabrio® 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® 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
Second Quarter 2026 Operational Update
Elfabrio® for Fabry Disease
- On May 4, 2026, the
U.S . Patent and Trademark Office (USPTO) issued a Patent Term Extension certificate forU.S . Patent No. 9,194,011, covering Elfabrio® (pegunigalsidase alfa–iwxj). The extension adds five years to the patent term, moving theU.S . expiration date to November 17, 2035. - Elfabrio® 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:
- Support our commercial partners through the manufacture and supply of our products
- Advance PRX–115 as a potential best–in–class therapy for patients with uncontrolled gout
- 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 $83.0 million $25.0 million - Full–year 2026 revenues from sales of Elfabrio® without milestones to range from approximately
$33.0 million $35.0 million - Full–year 2026 revenues from sales of Elelyso® to range from approximately
$20 $23
- Full–year 2026 revenues from sales of Elfabrio® without milestones to range from approximately
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 $27.2 million $15.4 $25.4 million $4.4 $1.8 million 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 $26.4 million $0.2 $0.3 million $25.0 million - Cost of revenues were
$7.8 $11.9 million $1.9 million 32% ) and a decrease of$2.2 million 15% ) compared to$5.9 $14.1 million 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 $9.8 million $1.6 million $0.3 million $6.0 $9.5 million $2.1 million - Selling, general, and administrative (SG&A) expenses were
$3.1 $6.2 million $0.5 $1.0 million $2.6 $5.2 million $0.3 $0.7 million $0.2 million - Financial income, net was
$0.2 million $0.5 $0.1 million U.S . dollar and the New Israeli Shekel. - Taxes on income were
$1.1 $3.9 million $0.5 $0.4 million $0.6 $3.5 million $25 million - Cash, cash equivalents, and short–term bank deposits were
$40.7 million - Net income for the three months ended June 30, 2026 was
$3.8 million $0.05 $164,000 $0.00 $22.1 million $0.28 $0.27 $3.5 million $0.04
Conference Call and Webcast Information
The Company will host a conference call today, August 12, at 8:00 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: August 12, 2026
Time: 8:00 a.m. Eastern Daylight Time (EDT)
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13761985
Call me™: https://bit.ly/4w2Over
The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
The conference will be webcast live from the Protalix website and will be available via the following links:
Company Link: https://ir.protalix.com/news-events/events
Webcast Link: http://bit.ly/4h4mqOY
Conference ID: 13761985
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is the first company to gain
Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. The terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings of the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in
Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
PROTALIX BIOTHERAPEUTICS, INC. | ||||||
( | ||||||
(Unaudited) | ||||||
June 30, 2026 | December 31, 2025 | |||||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 27,420 | $ | 14,680 | ||
Short-term bank deposits | 13,236 | 15,593 | ||||
Restricted deposit | 720 | 702 | ||||
Accounts receivable | 16,503 | 8,840 | ||||
Other assets | 2,049 | 1,129 | ||||
Inventories | 32,292 | 25,729 | ||||
Total current assets | $ | 92,220 | $ | 66,673 | ||
NON-CURRENT ASSETS: | ||||||
Funds in respect of employee rights upon retirement | $ | - | $ | 578 | ||
Property and equipment, net | 5,467 | 4,879 | ||||
R&D grant receivable | 2,100 | - | ||||
Deferred income tax asset | 2,374 | 2,516 | ||||
Operating lease right of use assets | 8,175 | 7,700 | ||||
Total assets | $ | 110,336 | $ | 82,346 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accruals: | ||||||
Trade | $ | 6,506 | $ | 5,259 | ||
Other | 23,219 | 19,875 | ||||
Operating lease liabilities | 1,666 | 1,384 | ||||
Total current liabilities | $ | 31,391 | $ | 26,518 | ||
LONG TERM LIABILITIES: | ||||||
Liability for employee rights upon retirement | $ | - | $ | 661 | ||
Operating lease liabilities | 7,541 | 6,937 | ||||
Total long-term liabilities | $ | 7,541 | $ | 7,598 | ||
Total liabilities | $ | 38,932 | $ | 34,116 | ||
COMMITMENTS | ||||||
STOCKHOLDERS' EQUITY | 71,404 | 48,230 | ||||
Total liabilities and stockholders' equity | $ | 110,336 | $ | 82,346 | ||
PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ( (Unaudited)
| ||||||||||||
Six Months Ended | Three Months Ended | |||||||||||
June 30, 2026 | June 30, 2025 | June 30, 2026 | June 30, 2025 | |||||||||
REVENUES FROM SELLING GOODS | $ | 27,247 | $ | 25,435 | $ | 19,828 | $ | 15,440 | ||||
REVENUES FROM LICENSE AND R&D SERVICES | 26,399 | 336 | 68 | 218 | ||||||||
TOTAL REVENUE | 53,646 | 25,771 | 19,896 | 15,658 | ||||||||
COST OF REVENUES | (11,889) | (14,050) | (7,762) | (5,870) | ||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET | (9,777) | (9,467) | (4,351) | (5,992) | ||||||||
SELLING, GENERAL, AND ADMINISTRATIVE EXPENSES | (6,162) | (5,227) | (3,111) | (2,624) | ||||||||
OPERATING INCOME (LOSS) | 25,818 | (2,973) | 4,672 | 1,172 | ||||||||
FINANCIAL EXPENSES | (665) | (628) | (494) | (783) | ||||||||
FINANCIAL INCOME | 848 | 530 | 682 | 272 | ||||||||
FINANCIAL INCOME (EXPENSES), NET | 183 | (98) | 188 | (511) | ||||||||
INCOME (LOSS) BEFORE TAXES ON INCOME | 26,001 | (3,071) | 4,860 | 661 | ||||||||
TAXES ON INCOME | 3,907 | 384 | 1,083 | 497 | ||||||||
NET INCOME (LOSS) | $ | 22,094 | $ | (3,455) | $ | 3,777 | $ | 164 | ||||
EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | ||||||||||||
BASIC | $ | 0.28 | $ | (0.04) | $ | 0.05 | $ | 0.00 | ||||
DILUTED | $ | 0.27 | $ | (0.04) | $ | 0.05 | $ | 0.00 | ||||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | ||||||||||||
USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | ||||||||||||
BASIC | 79,884,562 | 77,651,330 | 79,986,325 | 78,663,884 | ||||||||
DILUTED | 82,810,511 | 77,651,330 | 82,560,235 | 81,271,610 | ||||||||
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SOURCE Protalix BioTherapeutics, Inc.