PLX Protalix BioTherapeutics Inc
$2.57
Protalix BioTherapeutics Inc Q3 F2026 Earnings Call Transcript
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Conference Operator
Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics Third Quarter 2026 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Mike Moyer of LifeSci Advisors Investor Relations for Protallix. Thank you. Please go ahead.
Mike Moyer
LifeSci Advisors Investor Relations
Thank you, Operator, and welcome to the Protallix Biotherapeutics Third Quarter2026 Financial Results and Business Update Conference Call With me today are Dror Bashan, President and CEO, and Gilad Mamlok, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates was issued this morning and is available now on the Portalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings in this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Pertalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror? Thank you, Mike.
Dror Bashan
President and Chief Executive Officer
And thank you everyone for joining us for this call. We concluded the first nine months of 2026 with revenues of $75.6 million, reflecting our continued progress and growing financial position, which supports our ability to execute our strategy and advance our key priorities. We end the quarter with cash and deposit of $48.5 million, a position of strength that enabled us to continue advancing PRX115 for uncontrolled gout, as well as our pipeline in gray renal disease. Gilad will walk through the details of the quarter. Looking ahead, we see Alfablo as the foundation of our business with PRX 115 as an important growth opportunity. Alfablo continues to expand its global reach with approval in multiple markets outside the U.S. With a global fabri market projected to reach approximately $3.2 billion by 2031, we believe that Fabrio is positioned to capture a significant portion supported by our partnership with EA. Our commercial foundation enabled us to advance PRS 115 in uncontrolled gout. Uncontrolled gout is a disease with low quality of life and high unmet need. This represents a blockbuster Eureka's market opportunity. PRX115 is a PEGI-nated uric acid designed for life-specific activity, prolonged circulation, half-life, and reduced immunogenicity. And we believe PRX115 has the potential to be best-in-class therapy. Today, at the American College of Rheumatology, or ACR, Convergence 2026, we are presenting individual patient data from our Phase 1 study. The individual patient data reinforce our previous findings and show PRS-115 plasma levels measurable up to 85 days. Our positive uric lowering data supports the potential for less frequent dosing, which is what our Phase II release study is designed to test. This is a double-blind placebo-controlled Phase II study in uncontrolled gout patients. PRX115 with a fixed dose across different dosing intervals with and without methotrexate. The ready study is actively enrolling and we expect top-line results in the second half of next year. Beyond PRX115, we are building a pipeline in rare renal diseases. We believe our partner of commercial business, our balance sheet and no debt to warrants and our focused pipeline limits downside risk while preserving significant upside potential as we advance our pipeline. With that, I will turn the call over to Gilad for a detailed review of the financial results and outlook. Gilad, please.
Gilad Mamlok
Senior Vice President and Chief Financial Officer
Thank you, Dror. For the third quarter of 2026, total revenues were $21.9 million compared to $17.9 million in the third quarter of 2025. For the first nine months of 2026, total revenues were $75.6 million compared to $43.6 million for the first nine months of 2025, which includes the previously reported 25 milestone payment received from KIERDI. For the third quarter of 2026, revenues from selling goods were $21.8 million compared to $17.7 million in the third quarter of 2025, an increase of $4.1 million. For the first nine months of 2026, revenues from selling goods were felled to $49.1 million, compared to $43.1 million for the first nine months of 2025, an increase of $6 million. The increase was driven mainly by higher sales for Fabio Tocchiesi. For the remainder of the results, I will report only on the third quarter, and you can refer to this morning's press release for additional year-to-date data. Cost of revenues was $7.9 million, compared to $8.3 million in the same period in 2025, A decrease of $0.4 million. The decrease was mainly attributable to lower sales to fire crews, partially offset by higher sales to Chiesi and Pfizer. R&D expenses were $6.9 million compared to $4.5 million in the prior year period, an increase of $2.4 million. The increase was mainly driven by higher subcontractor expenses related to the relief study. Partially offset by a $1 million grant recorded under the R&D law as a reduction of R&D expenses, which we are eligible for, and we intend to file for grants under the R&D law. We expect to continue to incur expenses as the release study progresses and additional preclinical and clinical programs advance. SG&A expenses were $3.1 million up to $0.2 million from prior year period, largely attributable to $0.1 higher professional fees and $0.1 million higher salary and related expenses. Financial income net was $0.6 million compared to $0.1 million in the third quarter of 2025. The change was mainly due to exchange rate fluctuations and higher interest income. Taxes on income were $0.7 million compared to a tax benefit of $0.1 million in the third quarter of 2025. The tax expense resulted mainly from taxes on income derived from global intangible low tax income or GILTI. Net income for the quarter was $4 million or $0.05 per share basic and diluted compared to net income of $2.4 million or $0.03 per share basic and diluted in the third quarter of 2025. For the first nine months, net income was $26.1 million, or $0.33 per share basic and $0.31 per share diluted. Adding to the balance sheet, cash, cash equivalent and short-term bank deposits total $48.5 million as of September 30, 2026, compared to $40.7 million as of June 30, 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement. With that, I will turn the call back over to Dror.
Dror Bashan
President and Chief Executive Officer
Thank you, Gilad. In closing, I would like to emphasize that we concluded the first nine months of 2026 with revenues of $75.6 million, reflecting the continued progress in growing financial position, which supports our ability to execute our strategy and advance our key priorities.
Dror Bashan
President and Chief Executive Officer
Now, I will ask the operator to open the call for questions.
Anne
Conference Operator
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from Rom. and Selva Raju from HC Wainwright. Please proceed with your question.
Ram Selvaraju
Analyst, H.C. Wainwright
Thanks so much for taking our questions and congratulations on all of this recent progress. Two points. Firstly, I was wondering if you could give us some more granularity on the degree of predictability we might be able to expect with regard to revenue recognition coming from Chiesi and sales of El Fabrio and if the most recent quarterly result indicates a potential new plateau or a new level that we should anticipate being able to use as a sort of a baseline reference. I also wanted to ask about the most recent data that you have showcased with 115 and what the implications of this are on two fronts. Firstly, the convenience profile of this asset in the treatment refractory gout context and how this might position it as a potential best-in-class or best-in-disease drug within the uricase class, as well as the potential implications of less frequent dosing and more stable levels and overall therapeutic activity sustained after more infrequent dosing from an efficacy standpoint compared to existing currently available uricase drugs. Thank you.
Dror Bashan
President and Chief Executive Officer
Regarding the first question, Ram, we do see a very nice year from Kerry.
Gilad Mamlok
Senior Vice President and Chief Financial Officer
Also, given the approval of every four weeks that was received in March this year, including also the mice containment we received, I can say that we expect this increase to continue. We're not going to provide guidance now, but as we provided guidance first year at the beginning of this year, we are going to do the same for 2027 once we publish our annual results.
Dror Bashan
President and Chief Executive Officer
But we do see a positive momentum that continues. Yaron, just to add, I mean, KFV performs well.
Dror Bashan
President and Chief Executive Officer
I mean, they have a good team around the world commercial front. There's a long-term plan they execute, and they do well. We see, at least right now, we expect this trend to continue.
Dror Bashan
President and Chief Executive Officer
Regarding 115, can you repeat the question, please?
Ram Selvaraju
Analyst, H.C. Wainwright
Just with respect to the data that you have most recently showcased demonstrating the possibility of significantly less frequent dosing and the sustainability of the clinical impact of the drug, what implications does this have for the competitive positioning of this asset versus existing UR case drugs? Thank you.
Dror Bashan
President and Chief Executive Officer
So, thank you.
Dror Bashan
President and Chief Executive Officer
So, you know, the outcome of the phase one were encouraging. We are now actually way into the enrollment, and we hope to finalize it next quarter. We think that, of course, if we meet any of the arms, the active arms that we are testing, and especially the The one with a 1 in 6 or 1 in 8 or 1 in 4 without methotrexate together with an outcome of immunogenicity of safety IRR which we hope from what we have designed the PEG and other changes that we did to the enzyme we hope to get a good outcome which clearly will be beneficial for these patients in uncontrolled gout. Meaning, let's say, less frequent dosing, for the sake of our discussion as an example, once in six weeks, with good immunogenicity and safety profile. Don't ask me to give you a number. Let's call it a good outcome. It's certainly an alternative that patients, together with the treating physician, will consider. This is how we look into it.
Dror Bashan
President and Chief Executive Officer
This is what we call or define best-in-class. Thank you.
Anne
Conference Operator
Once again, if you would like to ask a question, please press star one on your telephone keypad. Our next question is from John Vandermosen with Zach's SCR. Please proceed with your question.
John Vandermosten
Analyst, Zacks Small-Cap Research
Thank you, Anne. Hello, Dror and Gilad. I wanted to start out with a question on the four-week dosing for Alfabrio and see if you'd had any indication from KeyAZ of what the conversion rate had been for patients shifting to that. and then also perhaps the financial impact of that in terms of, you know, on the revenue side and proportion of forward-looking revenues.
Anne
Conference Operator
John, it looks like there was a disconnection.
Anne
Conference Operator
Please don't hang up the line. We're just experiencing technical difficulty. I'm going to go ahead and add them back in.
Dror Bashan
President and Chief Executive Officer
Please hold. Okay, should I? Sure. www.youtube.com Yaron Naos, Gilad Mamlok, Yael Fellous Yaron Naos, Gilad Mamlok, Yael Fellous Yaron Naos, Gilad Mamlok, Yael Fellous Yaron Naos, Gilad Mamlok, Yael Fellous
Anne
Conference Operator
We have the speakers back. John, are you still with us?
John Vandermosten
Analyst, Zacks Small-Cap Research
I'm still here.
Anne
Conference Operator
Okay, great. Please proceed with your questions. Thank you for holding.
John Vandermosten
Analyst, Zacks Small-Cap Research
Great, no problem. Hey, Dror Gilad, how are you doing? My question was on just the anticipated and current penetration of the four-week dosing for El Fabrio that you've seen so far and what you think the opportunity is there on the revenue side in terms of proportion to future revenues.
Dror Bashan
President and Chief Executive Officer
From what we see so far,
Dror Bashan
President and Chief Executive Officer
The execution is good and the case is progressing. Certainly, it enhances the penetration and I would say geographic expansion of El Fabio. You know, we don't divide it between the once in two weeks and once in four weeks from a guidance point of view. We think it will be enhanced and stronger and stronger outcomes.
Gilad Mamlok
Senior Vice President and Chief Financial Officer
I will add to that, John. Good morning. We see an accelerated penetration in terms of number of patients joining in Europe. So we definitely see an effect of the four weeks.
John Vandermosten
Analyst, Zacks Small-Cap Research
Okay. Maybe I'll just phrase it just a little bit differently. Do you think you can get up to maybe about half the patients on the four-week dosing at some point, given the convenience of it? Or is there some reason why it might top out at some different level?
Dror Bashan
President and Chief Executive Officer
I think it will be a significant portion. It's difficult for me to tell you after six months or seven months from approval exactly the percentage. It's certainly a significant portion of the patients. Okay.
John Vandermosten
Analyst, Zacks Small-Cap Research
And gross margin was fairly strong this quarter. Similar to the other analyst's question on sustainability going forward, do you think that's a new baseline that we can use in terms of product gross margin over the coming quarters, or is there something particular to the third quarter that supported that being a little bit higher?
Gilad Mamlok
Senior Vice President and Chief Financial Officer
I suggest to look at the year always, at the first nine months, and, yes, you can refer to the baseline because, like we explained, Revenues to Chiesi are increasing, and that improves the gross margin. Revenues to Fiverr decreased because there were manufacturing issues last year, so it was a bit higher than the current steady-state level. So, yes, you can refer to the other baseline, in a way.
John Vandermosten
Analyst, Zacks Small-Cap Research
And is there a material difference between the El Fabio and El Lyso gross margins that might support a continued increase as El Fabio grows? Thank you for that. I know it's being delayed, but
Dror Bashan
President and Chief Executive Officer
We have reached the end of the question and answer session. I would like to turn the floor back over to President and CEO Dror Bashan for closing comments. So thank you, everybody, again, for joining us for this call. As I mentioned earlier, we had a good nine months of 2026, and we expect a good 2020, overall 2026. It reflects our continued progress and growing financial position. And this supports our ability to execute the strategy and advance our key priorities. So thank you. We will talk next.
Anne
Conference Operator
This concludes today's teleconference you may disconnect your lines at this time. Thank you for your participation