midastouch017
3週前
Protalix BioTherapeutics Reports First Quarter 2026 Financial and Business Results
Wed, May 13, 2026 at 1:50 PM GMT+3 16 min read
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 milestone received from Chiesi
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 including the $25.0 million milestone received from Chiesi
Cash, cash equivalents, and short–term bank deposits were $51 million as of March 31, 2026, providing sufficient capital to fund ongoing operations including the Phase 2 RELEASE clinical trial of PRX-115
CARMIEL, Israel, May 13, 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 first quarter ended March 31, 2026, and provided a business and clinical update.
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 Europe which triggered the $25 million milestone payment, the continued enrollment of our PRX–115 Phase 2 RELEASE study, and a growing focus on rare renal diseases, we believe the company is entering a pivotal period of growth and clinical advancement. We are confident in our strategy and reaffirm our guidance for 2026. We believe our business model positions us well to generate long–term value while advancing therapies that meaningfully address unmet needs."
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 by 2031, Elfabrio® is positioned as a leading therapy with the potential to achieve a meaningful 15% to 20% 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 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 without milestones to range from approximately $33.0 million to $35.0 million.
Full–year 2026 revenues from sales of Elelyso 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.
First Quarter 2026 Financial Highlights
Revenues from selling goods were $7.4 million for the three months ended March 31, 2026, compared to $10.0 million for the same period in 2025. The change was primarily due to a timing shift in Pfizer's purchases this past quarter, following elevated Elelyso orders in the same period during 2025 to address unexpected manufacturing issues on their end. This timing related impact was partially offset by $3.5 million in sales to Chiesi, which did not occur in the prior–year period.
Revenues from license and R&D services were $26.3 million for the first quarter of 2026, compared to $0.1 million for the first quarter of 2025. The increase resulted primarily from a $25.0 million milestone payment received from Chiesi in connection with the approval of the E4W dosage in the European Union. The Company expects to generate minimal revenues from license and R&D services, having completed the clinical development of Elfabrio, other than potential regulatory milestone payments.
Cost of revenues were $4.1 million for the first quarter of 2026, a decrease of $4.1 million (50%) compared to $8.2 million for the same period in 2025. The decrease was primarily attributable to lower sales volumes to Pfizer and Fiocruz, partially offset by increased sales to Chiesi.
Research & development (R&D) expenses totaled $5.4 million for the first quarter of 2026, compared to $3.5 million for the first quarter of 2025, representing an increase of $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 for the first quarter of 2026, an increase of $0.5 million (17%) compared to $2.6 million for the prior-year period. The increase was driven primarily by higher salary and related expenses.
Financial income (expenses), net was approximately $(0.0) million for the first quarter of 2026, compared to income of $0.4 million for the first quarter of 2025. The change resulted primarily from a $0.3 million exchange rate influence and $0.1 million lower interest income.
Taxes on income were approximately $2.8 million for the first quarter of 2026 and tax benefit was approximately $(0.1) million for the first quarter of 2025. Income tax expense primarily reflects taxes on income derived from global intangible low-taxed income (GILTI), including the impact of capitalization requirements under Internal Revenue Code Section 174.
Cash, cash equivalents, and short–term bank deposits were $51.1 million on March 31, 2026.
Net income for the three months ended March 31, 2026 was $18.3 million, or $0.23 per share - basic and $0.22 per share – diluted, compared to a net loss of $3.6 million, or $(0.05) per share - basic and diluted, for the same period in 2025. The net income was driven primarily by the milestone revenue recognized from Chiesi.
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.
midastouch017
4月前
A March Decision That Could Change Protalix BioTherapeutics Outlook
Feb 01, 2026 09:27 PM | Protalix BioTherapeutics, Inc.(PLX) |
By: Petri Dish Reports
Summary
Protalix Bio Therapeutics (PLX) received a positive CHMP opinion for Elfabrio’s every-four-weeks dosing in stable adult Fabry patients, pending EC approval by March.
PLX’s Elfabrio could halve infusion frequency, improving patient quality of life and potentially strengthening its competitive position in the Fabry market.
Elfabrio drove over half of PLX’s FY24 product revenue, with sales rising and a potential $25 million milestone tied to EU approval.
PLX trades at a modest 2.7x EV/sales, but investor sentiment remains highly sensitive to Elfabrio uptake and regulatory milestones.
Thesis
As you know, Protalix Bio Therapeutics (PLX) has just announced some news that should serve as a very positive regulatory and clinical milestone for their Fabry disease treatment in Europe. You see, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has just issued a positive opinion recommending approval of a dosing regimen of Elfabrio, which can take place every-four-weeks (E4W) for stable adult patients. I think this could potentially transform how enzyme replacement therapy is delivered if the European Commission goes on to confirm this decision by March. It would mean that any eligible patients who now need infusions every two weeks could potentially halve their treatment visits, which would be a massive improvement for patients. It would, of course, reduce physical, emotional, and logistical burden whilst still maintaining the same safety and efficacy. Shares traded up about 14% on the news.
Now, this opinion is supported by some long-term clinical data from the BRIGHT study and its ongoing label expansion. There is also robust pharmacokinetic and exposure–response modeling to support the decision. Overall, the data suggest that the less frequent regimen can sustain therapeutic drug levels over time. So, beyond just an improved patient quality of life, I think this shift should have much broader implications for healthcare systems by simply decreasing the demand at infusion centres and resource utilisation. On the strategic side of things, this kind of decision should go a long way in strengthening Elfabrio’s competitive position in the Fabry market. It also goes to show how validated Protalix’s plant-cell-based ProCellEx platform is now in terms of manufacturing approaches. Elsewhere, the decision could come with a potential $25 million milestone payment for Protalix upon EC approval. However, keep in mind that so far we’ve only received a positive opinion from the CHMP, which is essentially a recommendation and not the actual approval. The file now has to go to the European Commission to make a decision for the EU, but after taking a good look at the supporting data, I’m relatively bullish on a positive outcome for Protalix.
Elfabrio
As a quick recap, Elfabrio or pegunigalsidase alfa is a PEGylated enzyme replacement therapy. It was specifically developed to treat Fabry disease, which is a rare inherited lysosomal storage disorder caused by a deficiency of the enzyme alpha-galactosidase A. Now, this deficiency eventually leads to a harmful buildup of globotriaosylceramide (Gb3) in organs such as the kidneys and heart. So the drug’s goal is to provide a recombinant form of the missing human enzyme, which Protalix are able to produce via plant cell-based recombinant DNA technology. This helps patients’ cells break down accumulated Gb3 and mitigate overall disease progression.
Mechanistically speaking, the PEGylation, so just the attachment of polyethene glycol chains, stabilises the enzyme and helps prolong its circulation time in patients. So the longer this circulation time, the more sustained the reduction of substrate accumulation. But keep in mind the efficacy of this treatment method also comes down to other things, such as the half-life in plasma and how well the cells uptake the drug into lysosomes.
We saw Elfabrio get approved back in May 2023 for marketing in the U.S. and the EU for adult patients. It was approved for a 1 mg/kg intravenous infusion every two weeks as the standard regimen, and has also received further approvals in Great Britain, Switzerland, Peru, Russia, Singapore, and some other jurisdictions. The treatment option is also recommended by NICE in England and available for patients via the NHS. As of now, every two weeks dosing remains the standard, so the big stock catalyst will be if regulators in the EU approve an every-four-weeks option.
Revenue so far
As for financials, the therapy has quickly become a pretty meaningful contributor for Protalix. For FY24, Protalix reported total revenues of about $53.0 million. Now, this was mainly from product sales, of which approximately $29.3 million came from Elfabrio sales alone to its partner Chiesi. So the treatment represents well more than half of the company’s product revenue. Elfabrio sales have also been on an upward trend yearly, with FY23 seeing Elfabrio bring in about $17.5 million in product sales. Protalix also received a $20 million regulatory milestone payment tied to the drug’s FDA approval that year. So far in 2025, for the first nine months, Protalix has posted $43.1 million in product revenues, with roughly $18.6 million so far attributable to Elfabrio. Their other two main revenue sources would be sales of Elelyso for Gaucher disease.
The competition
So the investor confidence from the stock run-up is more about the implications Elfabrio could have in the context of the competition. The main idea is that the new potential dosing schedule is far more attractive, and thus we could see more people adopt the treatment. However, before we take a look at the competition, I think it's worth getting a deeper understanding of what the treatment itself involves. You see, for people living with Fabry disease, lifelong enzyme replacement therapy (ERT) has been a decent backbone of disease management. Despite this, it comes with a significant treatment burden. Traditional ERTs such as Fabrazyme/agalsidase beta and Replagal/agalsidase alfa are given as intravenous infusions every two weeks, just like ELfabio is now. When a patient goes in for treatment, each session can last several hours in a clinic/hospital setting. It means patients have to repeatedly schedule time, possibly off work or school hours, to travel to infusion sites. They then usually have to wait for IV access and monitoring before and after the infusion, and in some cases, many also receive pre-treatments like antihistamines to help reduce infusion-related reactions. Overall its a very lengthy visit. So the infusions have a hefty impact on daily life and social plans, and keep in mind the strain gets stretched over years of chronic therapy.
Now, Elfabrio, like the other ERTs, is administered intravenously and with a potential approval at 1 mg/kg every four weeks, the treatment hours of clinic time and observation could essentially get slashed in half. Protalix’s therapy was engineered using PEGylation so it can persist longer in the bloodstream. This is the key to supporting stable enzyme levels between doses. On the market right now, there are a couple of other ERT options I mentioned, like Fabrazyme, which is the longest-standing standard, dosed 1 mg/kg IV every two weeks. Elsewhere, Replagal is used in many regions outside the U.S. and is typically a 0.2 mg/kg IV every two weeks. It has shorter infusion times in some cases, but it still requires those regular clinic visits twice a month. It’s worth noting that there is also a non-infusion option for a small subset of patients. Migalastat/Galafold is an oral pharmacological chaperone taken every other day, but it is only effective in patients with very specific amenable GLA gene variants and doesn’t actually serve all Fabry patients. So I don’t see this affecting a decent uptick in Elfabrio adoption should there be a positive decision made in March.
As for a new dosing schedule, compared with these approved regimens, Elfabrio could halve it from about 26 per year to just 13. Fewer disruptions to everyday life, reduced travel and scheduling challenges, less cumulative time spent in healthcare settings, and, the biggest implication often overlooked, we could see lower indirect costs for patients. The less frequent infusions may also have a healthy effect on the cumulative risk of infusion-related reactions and the logistical complexity of long-term ERT. For patients balancing school, employment, or family responsibilities.
Risk
Despite the positive CHMP opinion, we have to realise it is still only an opinion. The regulatory outcome is not yet final. The CHMP’s recommendation is only advisory in nature, and the application still has to go through a formal review and approval by the European Commission. However, the majority of CHMP positive opinions are usually upheld, so the risk is quite minimal and more of a residual risk that the Commission could delay or request additional clarification. If approval is delayed than Elfabrio would remain limited to its current biweekly dosing schedule. The sooner patients can get access to the new scheduel the sooner we may see those adoption numbers increase. A good portion of the recent share price strength reflects anticipation of a future approval, so the stock is now somewhat vulnerable to downside should the final decision not align with the CHMP current recommendation.
Valuation
As for a fair valuation, we have to keep in mind that Protalix is currently heading towards more of a revenue-generating rare-disease company than a development-stage biotech, so some metrics need to be taken in context. However, the stock still carries the volatility typical of small-cap pharma. They hold a market cap of about $188 million and an enterprise value of roughly $167 million. If you glance at the valuation page, the stock is most meaningfully assessed via sales-based multiples rather than earnings, in my opinion, since profitability still remains inconsistent. So on that basis, Protalix trades at a trailing twelve-month EV to sales of about 2.7x and a forward EV to sales of 2.8x, both below the healthcare sector median. So it would suggest that the market is discounting either the execution risk going forward or possibly a slower uptake of products despite the rising revenues from Elfabrio.
On the flip side, earnings multiples are far less informative with the company’s forward GAAP price to earnings of 94x for 2025. This is mainly due to depressed near-term earnings, while consensus projections are showing us a sharp inflexion by 2026 to 2027, with revenue scaling expected to improve margins. Overall, Protalix’s valuation would best be viewed as revenue-driven and growth-optional. The mid-$2 stock is also priced quite modestly relative to sales, but with earnings still rather fragile, investor confidence seems to be highly sensitive to Elfabrio uptake and the regulatory milestones. The stock also trades with a relatively modest average three-month volume of about 720,000 shares. So it's clear this is still in small-cap status and carries the typical liquidity of a niche biotech stock.
In terms of balance sheet flexibility, as of September 30th last year, Protalix held about $29.4 million in cash and cash equivalents. Operating expenses for the first nine months were in the $14 million range, and if we use this as a proxy for cash burn, it gives us a burn of about $1.55 million. So based on this burn rate, the company has an estimated runway of around 12 months, extending into late 2026, but of course, this could improve with growing revenues from Elfabrio and Elelyso.
SEC Filing
Protalix BioTherapeutics, Inc.
Looking ahead
Next, the big focus should be on the European Commission’s decision. We can expect it sometime by March, and if positive, I think the stock will see another strong upward movement. Now, investors will still want to see early revenue signals, such as increases in Chiesi orders for Elfabrio. This would tell us that the new dosing schedule is starting to indicate patient/physician adoption. So if approved, I think an uptick in sales could start appearing in 2Q26 to 3Q26 by the earliest, since infusion centres would still need to adjust schedules. Protalix’s next earnings report should come sometime in mid-March and coincide with the European Commission's decision. Managments outlook on the call should also tell us a lot.
This article was written by
Petri Dish Reports
866 Followers
I hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the rigor and challenges behind drug development, which I now bring into my work as an investor and analyst. For the past five years, I have been active in the investing space, with the last four years dedicated to working as a biotech equity analyst alongside my lab work. My focus is on identifying promising biotechnology companies that are innovating in unique and differentiated ways, whether through novel mechanisms of action, first-in-class therapies, or platform technologies with the potential to reshape treatment paradigms. By combining my lab-based scientific expertise with financial and market analysis, I aim to deliver research that is both technically sound and investment-driven. On Seeking Alpha, I plan to write primarily about the biotech sector, covering companies at different stages of development, from early clinical pipelines to commercial-stage biotechs. My approach emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and the potential market opportunity, all while balancing financial fundamentals and valuation. My goal in publishing here is to share some insights that help investors better understand both the opportunities and of course the many risks in biotech. This is a sector where breakthrough science can translate into outsized returns, but also where careful scrutiny is essential. I look forward to contributing thoughtful analysis and engaging with readers who share an interest in this dynamic and rapidly evolving space.
Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
midastouch017
10月前
Protalix BioTherapeutics Reports Second Quarter 2025 Financial and Business Results
https://finance.yahoo.com/news/protalix-biotherapeutics-reports-second-quarter-105000636.html
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, Aug. 14, 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® plant cell-based protein expression system, today reported financial results for the quarter ended June 30, 2025, and provided a business and clinical update.
We experienced a 50% increase in revenues from selling goods in the first half of 2025 compared to the same period in 2024," said Dror Bashan, Protalix's President and Chief Executive Officer. "The increase in revenues was driven primarily by sales of Elfabrio® to Chiesi. Chiesi is an ideally suited partner for commercialization of Elfabrio for Fabry disease, which represents a global market of approximately $2.3 billion currently and which is forecasted to grow to $3.2 billion by 2030. As we are still in the early launch phase for Elfabrio, we expect global ordering patterns to fluctuate quarterly while underlying demand characteristics stabilize, the launch matures, and Elfabrio market share expands. We are confident in the growth of our Elfabrio franchise over the long term."
"We continue to advance in our development efforts for PRX-115, our recombinant PEGylated uricase product candidate in development as a potential treatment for uncontrolled gout. We anticipate initiation of a randomized Phase 2 trial in the second half of 2025 and enrollment of the first patient in the fourth quarter of 2025. We look forward to continuing to execute on our strategic plan," added Mr. Bashan.
"As we recently announced, Eyal Rubin is stepping down as our Chief Financial Officer after six years of dedicated service to Protalix. Eyal and I have worked closely and collaboratively on Protalix's transformation. He contributed greatly to strengthening the Company's capital and preparing us for growth. On behalf of our Board of Directors and the Protalix family, we thank Eyal for all of his contributions, and wish him continued and well-earned success in the future," continued Mr. Bashan. "Eyal is to be succeeded by Gilad Mamlok. Gilad is a seasoned financial executive with deep experience in healthcare and technology companies, and has an extensive background in capital markets transactions, mergers and acquisitions and business development. We are happy to welcome Gilad to the team and have every confidence that he will play an important role in Protalix's management as we continue to work toward future growth."
Second Quarter 2025 and Recent Business Highlights
Corporate Highlights
Appointment of Gilad Mamlok to serve as the Company's new Senior Vice President and Chief Financial Officer, effective August 24, 2025, succeeding Eyal Rubin. To ensure a seamless transition, Mr. Mamlok has joined the company and is working alongside Mr. Rubin. After his tenure as Chief Financial Officer ends, Mr. Rubin will continue to be available to the Company as necessary until October 2025.
Company has been added to the Russell 3000® and Russell 2000® Indexes, effective as of the U.S. market close on June 27, 2025, as part of the 2025 Russell indexes annual reconstitution.
The European Medicine Agency continues its evaluation of Chiesi's variation submission for the Elfabrio label to include a dose of 2 mg/kg administered every four weeks in adult patients with Fabry disease. The variation submission was accepted for review in December 2024.
Second Quarter 2025 Financial Highlights
We recorded revenues from selling goods of $15.4 million during the three months ended June 30, 2025, an increase of $2.1 million, or 16%, compared to revenues of $13.3 million for the three months ended June 30, 2024. The increase resulted primarily from an increase of $8.0 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Fiocruz (Brazil) and of $1.2 million in sales to Pfizer.
We recorded revenues from license and R&D services of $0.2 million for the three months ended June 30, 2025, and June 30, 2024. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements. We expect to generate minimal revenues from license and R&D services other than potential regulatory milestone payments.
Cost of goods sold was $5.9 million for the three months ended June 30, 2025, a decrease of $3.6 million, or 38%, from cost of goods sold of $9.5 million for the three months ended June 30, 2024. The decrease in cost of goods sold was primarily the result of the decrease in sales to Pfizer and Fiocruz (Brazil) partially offset by the increase in sales to Chiesi.
For the three months ended June 30, 2025, our total research and development expenses were approximately $6.0 million comprised of approximately $3.0 million in subcontractor-related expenses, approximately $2.0 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.8 million of other expenses. For the three months ended June 30, 2024, our total research and development expenses were approximately $3.0 million comprised of approximately $1.6 million of salary and related expenses, approximately $0.5 million in subcontractor-related expenses, approximately $0.2 million of materials-related expenses and approximately $0.7 million of other expenses. Total increase in research and developments expenses for the three months ended June 30, 2025 was $3.0 million, or 100%, compared to research and developments expenses of $3.0 million for the three months ended June 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned phase II clinical trial of PRX-115. We expect to continue to incur significant, increasing research and development expenses as we enter into a more advanced stage of preclinical and clinical trials for certain of our product candidates.
Selling, general and administrative expenses were $2.6 million for the three months ended June 30, 2025, a decrease of $0.9 million, or 26%, compared to $3.5 million for the three months ended June 30, 2024. The decrease resulted primarily from a decrease of $0.6 million in salary and related expenses and a decrease of $0.3 million in selling expenses.
Financial expenses, net was $0.5 million for the three months ended June 30, 2025, compared to financial income, net of $0.2 million for the three months ended June 30, 2024. The increase in financial expenses, net resulted primarily from exchange rate costs and lower interest income on bank deposits partially offset by lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the convertible promissory notes then outstanding.
We recorded a tax expense of approximately $0.5 million for the three months ended June 30, 2025, compared to a tax benefit of approximately $(0.1) million for the three months ended June 30, 2024. The tax expenses or benefits resulted primarily from taxes on income mainly derived from GILTI income mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act of 2017, or the TCJA. Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States, rather than deducting such costs in the current year. On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, the One Big Beautiful Bill Act, 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. We continue to evaluate the impact that the new legislation will have on the consolidated financial statements.
At June 30, 2025, we had $33.4 million in cash and cash equivalents and short-term bank deposits.
Net income for the three months ended June 30, 2025 was approximately $164,000, or $0.00 per share, basic and diluted, compared to net loss of $2.2 million, or $(0.03) per share, basic and diluted, for the same period in 2024.
Conference Call and Webcast Information
We will host a conference call today, August 14, 2025, at 8:30 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: Thursday, August 14, 2025
Time: 8:30 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: 13755073
Call me™: https://tinyurl.com/6uc7hkxf
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/yc272tbr
Conference ID: 13755073
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 development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023.
Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long acting DNase I for the treatment of NETs-related diseases; and others.
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. 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 for 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; the possible disruption of our operations due to the war declared by Israel's security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict; 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; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, new trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity or debt markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials 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; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer and Chiesi; risks related to the amount and sufficiency of our cash and cash equivalents and short-term bank deposits; risks relating to changes to interim, top-line or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, an arm of the Brazilian Ministry of Health, with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
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PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
June 30, 2025
December 31, 2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
17,895
$
19,760
Short-term bank deposits
15,503
15,070
Accounts receivable – Trade
9,443
2,909
Other assets
1,513
1,096
Inventories
21,131
21,243
Total current assets
$
65,485
$
60,078
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement
$
520
$
462
Property and equipment, net
4,746
4,591
Deferred income tax asset
2,738
2,856
Operating lease right of use assets
4,997
5,430
Total assets
$
78,486
$
73,417
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade
$
6,689
$
4,533
Other
15,930
19,588
Operating lease liabilities
1,472
1,500
Total current liabilities
$
24,091
$
25,621
LONG TERM LIABILITIES:
Liability for employee rights upon retirement
$
615
$
559
Operating lease liabilities
3,877
4,026
Total long term liabilities
$
4,492
$
4,585
Total liabilities
$
28,583
$
30,206
COMMITMENTS
STOCKHOLDERS' EQUITY
49,903
43,211
Total liabilities and stockholders' equity
$
78,486
$
73,417
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Six Months Ended
Three Months Ended
June 30, 2025
June 30, 2024
June 30, 2025
June 30, 2024
REVENUES FROM SELLING GOODS
$
25,435
$
16,981
$
15,440
$
13,304
REVENUES FROM LICENSE AND R&D SERVICES
336
241
218
170
TOTAL REVENUE
25,771
17,222
15,658
13,474
COST OF GOODS SOLD
(14,050)
(12,058)
(5,870)
(9,456)
RESEARCH AND DEVELOPMENT EXPENSES
(9,467)
(5,848)
(5,992)
(2,961)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
(5,227)
(6,599)
(2,624)
(3,484)
OPERATING INCOME (LOSS)
(2,973)
(7,283)
1,172
(2,427)
FINANCIAL EXPENSES
(628)
(757)
(783)
(367)
FINANCIAL INCOME
530
1,035
272
522
FINANCIAL INCOME (EXPENSES), NET
(98)
278
(511)
155
INCOME (LOSS) BEFORE TAXES ON INCOME
(3,071)
(7,005)
661
(2,272)
TAXES ON INCOME (TAX BENEFIT)
384
(207)
497
(69)
NET INCOME (LOSS)
$
(3,455)
$
(6,798)
$
164
$
(2,203)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK:
BASIC
$
(0.04)
$
(0.09)
$
0.00
$
(0.03)
DILUTED
$
(0.04)
$
(0.09)
$
0.00
$
(0.03)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK
USED IN COMPUTING EARNINGS (LOSS) PER SHARE:
BASIC
77,651,330
73,172,980
78,663,884
73,308,281
DILUTED
77,651,330
73,172,980
81,271,610
73,308,281
Cision
View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-second-quarter-2025-financial-and-business-results-302530021.html
SOURCE Protalix BioTherapeutics, Inc.
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