Protalix BioTherapeutics Reports First Quarter 2026 Financial and Business Results
Rhea-AI Summary
Protalix BioTherapeutics (NYSE American: PLX) reported Q1 2026 results and reaffirmed 2026 revenue guidance of $78–$83 million, including a $25 million Elfabrio milestone from Chiesi.
Q1 2026 revenue included $7.4 million from product sales and $26.3 million from license/R&D, driving net income of $18.3 million. Cash and deposits were $51.1 million with no debt. Elfabrio’s EU E4W dosing is approved, and the PRX‑115 Phase 2 RELEASE trial continues, with top‑line data expected in H2 2027.
AI-generated analysis. Not financial advice.
Positive
- Q1 2026 net income of $18.3 million versus $3.6 million loss in Q1 2025
- $25.0 million milestone payment from Chiesi recognized in Q1 2026 license revenues
- Q1 2026 license and R&D revenue increased to $26.3 million from $0.1 million
- Cost of revenues decreased 50% to $4.1 million year over year
- Cash, cash equivalents, and short-term deposits of $51.1 million with no outstanding debt
- 2026 total revenue guidance reaffirmed at $78.0–$83.0 million
Negative
- Revenues from selling goods declined to $7.4 million from $10.0 million year over year
- R&D expenses rose 56% to $5.4 million due to PRX-115 Phase 2 activities
- SG&A expenses increased 17% to $3.1 million, mainly from higher salary costs
- Net financial income fell to approximately $0.0 million from $0.4 million
- Income tax expense of $2.8 million in Q1 2026 versus a $0.1 million tax benefit in Q1 2025
- Company expects minimal future license and R&D revenues outside potential milestones
News Market Reaction – PLX
On the day this news was published, PLX gained 1.05%, reflecting a mild positive market reaction. Argus tracked a peak move of +8.5% during that session. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $174.84M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PLX traded down 1.55% while key biotech peers were mixed: AVTX down, but INO, OBIO, MCRB and SGMO up. Moves do not indicate a unified sector trend.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 18 | Annual results 2025 | Positive | -20.8% | Fiscal 2025 results, Elfabrio EU dosing approval and 2026 revenue outlook. |
| Nov 13 | Q3 2025 earnings | Positive | -9.8% | Q3 2025 results with higher YTD revenue and PRX-115 Phase 2 prep. |
| Aug 14 | Q2 2025 earnings | Positive | -5.6% | Q2 2025 revenue growth, return to quarterly profitability and pipeline plans. |
| May 09 | Q1 2025 earnings | Positive | -40.5% | Q1 2025 revenue surge from Pfizer and continued PRX-115 advancement. |
| Mar 17 | Annual results 2024 | Positive | +9.4% | Record 2024 goods revenue, lower R&D and SG&A, and debt repayment. |
Earnings-related releases have often been followed by negative next-day moves despite generally constructive fundamentals and pipeline updates.
Across the last five earnings-tagged events from Mar 17, 2025 through Mar 18, 2026, Protalix repeatedly paired financial updates with progress on Elfabrio and PRX‑115. Results included record 2024 goods revenue of $53.0 million, positive quarters with net income, and later 2025–2026 guidance of $78.0–$83.0 million. Despite these milestones and cash balances in the $29–35 million range, four of the five events saw negative 24‑hour price reactions.
Historical Comparison
In the past five earnings releases, PLX’s average next-day move was -13.46%, often selling off despite operational and pipeline progress similar in tone to this update.
Recent earnings have tracked a shift from record 2024 goods revenue and debt repayment toward 2025–2026 guidance, Elfabrio EU dosing expansion, and PRX‑115’s transition from Phase 1 into the Phase 2 RELEASE study.
Regulatory & Risk Context
The company has a Form S-3/A shelf dated 2025-08-14, filed as a pre-effective amendment to update the auditor consent. The filing is noted as not yet effective, and there has been 1 related 424B5 usage recorded in 2025.
Market Pulse Summary
This announcement highlights a profitable Q1 2026 driven by a $25.0 million Elfabrio milestone, reaffirmed $78.0–$83.0 million 2026 revenue guidance, and a $51.1 million cash balance supporting the PRX‑115 Phase 2 RELEASE trial. Historically, earnings updates averaged a -13.46% move, underscoring how expectations have mattered. Investors may focus on the sustainability of commercial goods revenue, progression of PRX‑115 and PRX‑119, and future regulatory or milestone catalysts.
Key Terms
phase 2 medical
uricase medical
dnase i medical
fabry disease medical
giltI regulatory
internal revenue code section 174 regulatory
AI-generated analysis. Not financial advice.
Company to host conference call and webcast today at 8:00 a.m. EDT
- Elfabrio commercial execution continues following European Commission approval of the 2 mg/kg every–4–weeks (E4W) dosing regimen;
$25 million - PRX–115 Phase 2 study continues to advance as planned with top–line results anticipated in the second half of 2027
- The Company reaffirms its previously stated 2026 revenue guidance of
$78.0 $83.0 million $25.0 million - Cash, cash equivalents, and short–term bank deposits were
$51 million
CARMIEL,
During the first quarter, the Company continued to execute against its commercial partnerships, advance its clinical and preclinical development programs, and reaffirm its strategic priorities and financial outlook for 2026.
"Protalix entered 2026 with positive momentum," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "With the recent regulatory progress for Elfabrio in
First Quarter 2026 Operational Update
Elfabrio® for Fabry Disease
- Protalix and its partner, Chiesi Farmaceutici, continue to support the launch and expansion of Elfabrio across approved markets.
- Following the previously announced European Commission approval of the 2 mg/kg every–4–weeks (E4W) dosing regimen, Protalix believes Elfabrio is well-positioned to reduce treatment burden for patients with Fabry disease in the European Union without compromising efficacy.
- The E4W option enhances Elfabrio's competitive positioning in the European Union and supports broader adoption by providing increased dosing flexibility.
- The FDA-approved dosing regimen for Elfabrio in
the United States remains 1 mg/kg every 2 weeks. - With the global Fabry market projected to reach approximately
$3 billion 15% to20% global market share, supported by strong execution through Protalix's partnership with Chiesi.
PRX-115 for Uncontrolled Gout – RELEASE Phase 2 continues enrollment
- The RELEASE Phase 2 clinical trial (NCT07280156) of PRX–115, a recombinant PEGylated uricase, for the treatment of uncontrolled gout continues to enroll patients.
- The Company continues to anticipate top–line results in the second half of 2027.
- PRX–115 is designed as a potential best–in–class, long–acting uricase therapy, which is supported by favorable Phase 1 data, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout.
- By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX–115 is well-positioned to capture a meaningful share of the uncontrolled gout segment, where even modest penetration represents significant commercial opportunity.
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.
- The Company also continues to collaborate with Secarna to identify RNA–based therapeutic candidates that may complement its proprietary ProCellEx® platform.
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 partnerships
- 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
$20.0 million $23.0 million
- 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.
First Quarter 2026 Financial Highlights
- Revenues from selling goods were
$7.4 million $10.0 million $3.5 million - Revenues from license and R&D services were
$26.3 million $0.1 million $25.0 million - Cost of revenues were
$4.1 million $4.1 million 50% ) compared to$8.2 million - Research & development (R&D) expenses totaled
$5.4 million $3.5 million $1.9 million 56% ). The increase was driven primarily by preparations for and initiation of the Phase 2 RELEASE clinical trial of PRX–115. 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 million $0.5 million 17% ) compared to$2.6 million - Financial income (expenses), net was approximately
$(0.0) million $0.4 million $0.3 million $0.1 million - Taxes on income were approximately
$2.8 million $(0.1) million - Cash, cash equivalents, and short–term bank deposits were
$51.1 million - Net income for the three months ended March 31, 2026 was
$18.3 million $0.23 $0.22 $3.6 million $(0.05)
Conference Call and Webcast Information
The Company will host a conference call today, May 13, 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: May 13, 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: 13760475
Call me™: https://tinyurl.com/yjww2vxn
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: https://tinyurl.com/ykmy9jmr
Conference ID: 13760475
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. | ||||||
March 31, 2026 | December 31, 2025 | |||||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 41,001 | $ | 14,680 | ||
Short-term bank deposits | 10,082 | 15,593 | ||||
Restricted deposit | 711 | 702 | ||||
Accounts receivable | 2,939 | 8,840 | ||||
Other assets | 1,149 | 1,129 | ||||
Inventories | 30,474 | 25,729 | ||||
Total current assets | $ | 86,356 | $ | 66,673 | ||
NON-CURRENT ASSETS: | ||||||
Funds in respect of employee rights upon retirement | $ | 589 | $ | 578 | ||
Property and equipment, net | 5,153 | 4,879 | ||||
Deferred income tax asset | 2,445 | 2,516 | ||||
Operating lease right of use assets | 7,793 | 7,700 | ||||
Total assets | $ | 102,336 | $ | 82,346 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accruals: | ||||||
Trade | $ | 4,285 | $ | 5,259 | ||
Other | 21,670 | 19,875 | ||||
Operating lease liabilities | 1,433 | 1,384 | ||||
Total current liabilities | $ | 27,388 | $ | 26,518 | ||
LONG TERM LIABILITIES: | ||||||
Liability for employee rights upon retirement | $ | 671 | $ | 661 | ||
Operating lease liabilities | 7,048 | 6,937 | ||||
Total long term liabilities | $ | 7,719 | $ | 7,598 | ||
Total liabilities | $ | 35,107 | $ | 34,116 | ||
COMMITMENTS | ||||||
STOCKHOLDERS' EQUITY | 67,229 | 48,230 | ||||
Total liabilities and stockholders' equity | $ | 102,336 | $ | 82,346 | ||
PROTALIX BIOTHERAPEUTICS, INC. | ||||||
Three Months Ended | ||||||
March 31, 2026 | March 31, 2025 | |||||
REVENUES FROM SELLING GOODS | $ | 7,419 | $ | 9,995 | ||
REVENUES FROM LICENSE AND R&D SERVICES | 26,331 | 118 | ||||
TOTAL REVENUE | 33,750 | 10,113 | ||||
COST OF REVENUES | (4,127) | (8,180) | ||||
RESEARCH AND DEVELOPMENT EXPENSES | (5,426) | (3,475) | ||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (3,051) | (2,603) | ||||
OPERATING INCOME (LOSS) | 21,146 | (4,145) | ||||
FINANCIAL EXPENSES | (193) | (6) | ||||
FINANCIAL INCOME | 188 | 419 | ||||
FINANCIAL INCOME (EXPENSES), NET | (5) | 413 | ||||
INCOME (LOSS) BEFORE TAXES ON INCOME | 21,141 | (3,732) | ||||
TAXES ON INCOME (TAX BENEFIT) | 2,824 | (113) | ||||
NET INCOME (LOSS) | $ | 18,317 | $ | (3,619) | ||
EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | ||||||
BASIC | $ | 0.23 | $ | (0.05) | ||
DILUTED | $ | 0.22 | $ | (0.05) | ||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | ||||||
USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | ||||||
BASIC | 79,848,892 | 76,611,980 | ||||
DILUTED | 83,048,596 | 76,611,980 | ||||
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SOURCE Protalix BioTherapeutics, Inc.