Protalix BioTherapeutics, Inc. (PLX) Q2 2026 Earnings Call Transcript

Good morning, ladies and gentlemen, and welcome to the ProTelix Biotherapeutics Second Quarter 2026 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to your host, Mr. Mike Moyer of LifeSci Advisors, Investor Relations for ProTelix. Please go ahead.

Thank you, Operator, and welcome to the ProTelix Biotherapeutics Q2-2026 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO, and Gilad Mamlak, Senior Vice President and Chief Financial Officer. Press release announcing the financial results and corporate updates was issued this morning and is available now on the Pertallix website. Please take a moment to read the disclaimer about forward-looking statements in the press The earnings release and 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 Pertalex's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bichon.

Thank you, Mike, and thank you, everyone, for joining this morning. Our results today reflect the strengths of our Profitable Commercial Partnerships, and and we remain confident in our outlook for this year. We enter the second half of 2026 with El Fabio sales through Chiesi, continuing to drive growth of our business. We walk through the financial details, but the key driver in the first half was continued growth in El Fabio's revenues, together with the previously reported $25 million Chiesi milestone payment recognized in the first quarter of this year. El Fabio saves from selling goods, and this performance reflects on continued growth. This continued growth keeps us on track with our full year 2026 revenue guidance. With the global Fabri market projected to reach approximately $3.2 billion by 2031, El Fabio is positioned to percent of these markets. Supported by our partnership with Chiesi, which is strengthened by the recent approval of the once-every-four weeks, particularly the continued expansion of Alfabrio position as well. On the clinical side, PRS-115 is designed as a long-acting differentiated uricase, and we believe it has the potential to minimize this uncontrolled significant inflection point and value driver for products. There is a significant unmet of partnerships and priorities.

Thank you, Droz. For the second quarter of 2026, $15.9 million compared to $15.7 million in the second quarter of 2025. $53.6 million compared to $25.8 million. For the second quarter of 2026, revenues from selling goods were $19.8 million compared to $15.4 million in the second quarter of 2025. The first half of 2026, revenues from selling goods were $27.2 million in 2025 and in year-to-date data. $7.8 million, compared to $5.9 million in the scarcity and fewer $6 million in the prior year period, a decrease of $1.6 million. Recorded under the new R&D law as a reduction of R&D expenses, is available for us under the R&D law on an ongoing basis. We expect to continue to incur expenses as the release study progresses and additional preclinical and clinical programs advance. FGNA expenses were $3.1 million, up $0.5 million from the prior year period, largely attributable to higher salary and related expenses. Finance income net was $0.2 million compared to financial expenses net of $0.5 million in the second quarter of 2025. The change was mainly due to exchange rate fluctuations. Taxes on income were $1.1 million compared to $0.5 million in the second quarter of 2025 and increased of $0.6 million. This increase resulted mainly from taxes on income derived from global intangible low-tax income or GILTI resulting from limitations under IRC Section 174. Net income for the quarter was $3.8 million, or $0.05 per share, basic and diluted, compared to net income of $164,000, or $0 per share, basic and diluted, in the second quarter of 2025. Turning to the balance sheet, cash, cash equivalents, and short-term bank deposit, they totaled $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 advances. As we have noted in prior quarters, our revenues can vary from quarter to quarter based on the timing of shipments and orders from our partners. We believe it is more useful to evaluate our business on a full-year basis, and we remain confident in our full-year 2026 guidance. With that, I will turn the call back over the board.

Thank you, Gilad. In closing, positive revenue trends keeps us firmly on track to meet our full year 2026 We have a strong cash position to maintain our operations and advance our clinical and pre-clinical assets. We are confident in the momentum behind our business and about the opportunities ahead. Now, I will ask the operator to open the line for questions.

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. And our first question will come from Raj Haram Selvaraju with HC Wainwright.

Hi, this is Yanzi sitting in for Ram Selvaraju. Thanks for taking my question. I have two. The first is, so your presentation highlights E4W without a methotrexate and the E8W with MTX as the two differentiated profiles within release. What totality of evidence framework will determine which regimen advances to phase 3 and could a modest month 6 responder rate difference be outweighed by eliminating MTX or extending can go synch to E8W.

Can you repeat the question? Actually, both. I mean, if you manage to, I just see, one of the five pharmacies without methotrexat, which can be a huge competitive edge, but also a lower frequency of using the drug is also a big advantage, and we potentially can have both.

Okay. So, yeah, I'll repeat the question. My question is, what totality of evidence will determine which regimen advances to Phase And could a modest month-six responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every eight weeks?

We are running now the multiple-dose studies of the phase two. We have to see the outcomes, and by the outcome, we can decide with which regimens we continue. It's difficult to tell you today. I mean, under what we have, and the data from the phase one, and whatever we understand about the molecule and the regulation of the molecule, and the outcomes we have so far, we think that these four arms, I'm not speaking about the placebo, could be met. Which one will be met better? You know, we have to consider there is an immunogenicity aspect, there is the IRR aspect, so it's not just the frequencies. But let's say under the assumption immunogenicity is good or low or whatever the definition is and with a pretty low IRR, and then it's only about the frequency and or we have to see.

The other question I have is relating to the 10K, which reports approximately, you know, about 50% of phase one subjects who've developed ADAs, and that comes with lower incidence at higher doses. My question is, how did the combined PK, PD, and immunogenicity data support selecting that fixed 36 mg dose, and what ADA profile and release would support every 4 weeks dosing without methotrexate?

You know, we will, against the peg, a clearer picture of the different ADAs and how a single ascending dose. We chose the 36 mg D5SA, of course, and the assumption of weeks without methotrexate, and the ones in eight weeks with me.

Thank you so much for taking my questions.

And our next question will come from John Vander Mosten with Zax SCR.

Great. Nice to hear from you guys, Dora Galad. And congratulations on El Fabrio's patent term extension and the approval in South Korea. Things are going pretty good for that product. I want to start out with a question on just the trend in purchases of El Fabrio. So I'm wondering, is there any benefit to having lumpy purchases? Because we had a nice increase this quarter. And I'm wondering, is that due perhaps to the new approvals in certain geographies? Or is there some other reason in terms of like product runs or some other reason why it makes sense to have lumpy rather than steady purchases of El Fabrio?

John, good morning and thank you.

As we always say, one quarter, we prefer to look at the picture always year to date. We did have a nice quarter from Chiesi, which reflects also their growth of the business, but mainly reflects their inventory management.

Okay, so there's no rationale behind why they wouldn't make it smooth rather than lumpy?

Okay, all right, gotcha, gotcha. Fair definition, I would say. They operate with a lot of sense and logic, of course, and they're responsible for what they are doing. They have their own – they see the demand. They know how much they sit on certain amount of inventories globally or per continent. And, of course, there are manufacturing plants vis-à-vis other programs that are marketing. It's a big company. So all in all, this is how it was decided and applied. And, of course, to make sure we sit on enough stocks, both DS and DP.

And jumping to 115, You know, I believe you've opened up some new sites, or at least on clinicaltrials.gov, it seems like there are a number of sites listed there compared to previous or earlier in the year. How is that going in terms of site activation, and, you know, kind of where are you right How much can you tell me? And then, you know, how many more do you think might be opening in the future so far in 2026?

We have actually maybe one site is missing. And at present, we expect to finalize enrollment within the next five months and by year-end as we plan. We have to see if things in this, indeed, will go this way. So far, so good, knock on wood.

This question is kind of a bigger picture question on Amgen. They raised price pretty significantly this year, first quarter and second quarter, saw 20-plus percent price increases on Christexa. And I'm wondering, what does that tell you about the market? Does it make it look more attractive? So, you know, I'm not sure of the details. Perhaps it was a, you know, payer mix or something like that. I didn't get into that. But I'm just wondering if you had any thoughts on what that dramatic price increase means for the space.

I don't have any insights on that. And I don't know if you get it from what they say or you get it from calculating sales to estimated number of patients?

Oh, it was in their press release, their second quarter press release. They said 23% increase in pricing, even the volumes were down. And they didn't go into it, but I mean, my thought was, you know, the market will accept a higher price, which may make it look more attractive for you guys for 115. So, you know, just wanted to see if that had any impact on your thoughts for, you know, this product and the pathway forward.

The revenues keep growing. It was 1.3 billion in 2025. We see now the trend going to 1.6. So it's very encouraging for 115 as well, as you said.

Exactly.

I appreciate you guys' time, and thanks for taking my questions.

Thank you.

And this now concludes our question and answer session. I would like to turn the floor back over to Dror Bashan for closing comments.

I'll see you then in the momentum behind our business and about the opportunity.

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.