Q2 2026 Protalix BioTherapeutics Inc Earnings Call
Operator: Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Q2 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 and investor relations for Protalix. Please go ahead.
Operator: Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Q2 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 and investor relations for Protalix. Please go ahead.
Speaker #1: I will now turn the conference over to your host, Mr. Mike Moyer of Lifesci Advisors, Investor Relations for Protallix. Please go ahead.
Speaker #2: Thank you, operator, and welcome to the Protallix BioTherapeutics Q2 2026 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.
Mike Moyer: Thank you, operator, and welcome to the Protalix BioTherapeutics Q2 2026 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 Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. 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 Protalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror.
Mike Moyer: Thank you, operator, and welcome to the Protalix BioTherapeutics Q2 2026 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 Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and this teleconference include forward-looking statements.
Speaker #2: Press release announcing the financial results and corporate updates was issued this morning and is available now on the Protallix website. Please take a moment to read the disclaimer, about forward-looking statements in the press conference teleconference include forward-looking statements.
Speaker #2: 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 Protallix's filings with the U.S.
Mike Moyer: 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 Protalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror.
Speaker #2: Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror?
Speaker #3: Thank you, Mike. And thank you, everyone, for joining this morning. Our results today reflect the strength of our profitable commercial partnerships, and we remain confident in our outlook for this year.
Dror Bashan: Thank you, Mike, and thank you everyone for joining me this morning. Our results today reflect the strength of our profitable commercial partnerships, and we remain confident in our outlook for this year. We enter the H2 2026 with Elfabrio sales through Chiesi continuing to drive growth of our business. Gilad will walk through the financial details, but the key driver in the H1 was continued growth in Elfabrio's revenues, together with the previously reported $25 million Chiesi milestone payment recognized in the Q1 of this year. Elfabrio sales through Chiesi continue to drive revenues from selling goods, and this performance reflects further global penetration of Elfabrio and continued growth. This continued growth keeps us on track with our full year 2026 revenue guidance.
Dror Bashan: Thank you, Mike, and thank you everyone for joining me this morning. Our results today reflect the strength of our profitable commercial partnerships, and we remain confident in our outlook for this year. We enter the H2 2026 with Elfabrio sales through Chiesi continuing to drive growth of our business. Gilad will walk through the financial details, but the key driver in the H1 was continued growth in Elfabrio's revenues, together with the previously reported $25 million Chiesi milestone payment recognized in the Q1 of this year. Elfabrio sales through Chiesi continue to drive revenues from selling goods, and this performance reflects further global penetration of Elfabrio and continued growth. This continued growth keeps us on track with our full year 2026 revenue guidance.
Speaker #3: We enter the second half of 2026 with a fabulous sales through Kiezi, continuing to drive growth of our business. Gilad will walk through the financial details, but the key driver in the first half was continued growth in a fabulous revenue together with the previously reported $25 million Kiezi milestone payment recognized in the first quarter of this year.
Speaker #3: A fabulous sales through Kiezi continues to drive revenues from selling goods, and this performance reflects further global penetration of a fabulous and continued growth.
Speaker #3: This continued growth keeps us on track with our full-year 2026 revenue guidance. With a global fabric market projected to reach approximately $3.2 billion by 2031, we're in a fabulous position to capture 15 to 20 percent of this market.
Dror Bashan: With the global Fabry market projected to reach approximately $3.2 billion by 2031, Elfabrio is positioned to capture 16% to 20% of these markets. Supported by our partnership with Chiesi, which is strengthened by the recent approval of the once every four weeks dosing regimen in Europe. We believe our revenue mix, particularly the continuing expansion of Elfabrio, position us well for sustained long-term value creation and profitability. On the clinical side, PRX-115 continues to advance as claimed. PRX-115 is designed as a long-acting differentiated uricase, and we believe it has the potential to meaningfully improve quality of life for patients with uncontrolled gout, which could be a significant inflection point and value driver for Protalix. There is a significant unmet need in this population, and we expect top line results from our RELEASE study in the H2 2027.
Dror Bashan: With the global Fabry market projected to reach approximately $3.2 billion by 2031, Elfabrio is positioned to capture 16% to 20% of these markets. Supported by our partnership with Chiesi, which is strengthened by the recent approval of the once every four weeks dosing regimen in Europe. We believe our revenue mix, particularly the continuing expansion of Elfabrio, position us well for sustained long-term value creation and profitability. On the clinical side, PRX-115 continues to advance as claimed. PRX-115 is designed as a long-acting differentiated uricase, and we believe it has the potential to meaningfully improve quality of life for patients with uncontrolled gout, which could be a significant inflection point and value driver for Protalix. There is a significant unmet need in this population, and we expect top line results from our RELEASE study in the H2 2027.
Speaker #3: Supported by our partnership with Kiezi, which is strengthened by the recent approval of the once-every-four-weeks dosing regimen in Europe. We believe our revenue mix, particularly the continued expansion of a fabulous position us well for sustained long-term value creation and profitability.
Speaker #3: On the clinical side, PRS 115 continues to advance as planned. PRS 115 is designed as a long-acting differentiated uric acid, and we believe it has the potential to meaningfully improve quality of life of patients with uncontrolled gout, which could be a significant inflection point and venue driver for Protallix.
Speaker #3: There is a significant unmet need in this population, and we expect top-line results from our RELEASE study in the second half of 2027. Beyond PRS-115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage. We remain focused on execution across our partnerships and pipeline, and we believe our business model limits downside risks while preserving meaningful upside as we advance our clinical programs.
Dror Bashan: Beyond PRX-115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage. We remain focused on execution across our partnerships and pipeline, and we believe our business model limits downside risks while preserving meaningful upside as we advance our clinical programs. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Gilad, please.
Dror Bashan: Beyond PRX-115, our strategy remains centered on rare renal diseases, where we believe our capabilities and platform offer a clear advantage. We remain focused on execution across our partnerships and pipeline, and we believe our business model limits downside risks while preserving meaningful upside as we advance our clinical programs. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Gilad, please.
Speaker #3: With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Gilad, please.
Speaker #2: Thank you, Dror. For the second quarter of 2026, total revenues were $19.9 million, compared to $15.7 million in the second quarter of 2025. For the first half of 2026, total revenues were $53.6 million, compared to $25.8 million for the first half of 2025.
Gilad Mamlok: Thank you, Dror. For Q2 2026, total revenues were $19.9 million compared to $15.7 million in Q2 2025. For H1 2026, total revenues were $53.6 million compared to $25.8 million for H1 2025. For Q2 2026, revenues from selling goods were $19.8 million compared to $15.4 million in Q2 2025, an increase of $4.4 million. For H1 2026, revenues from sending goods were $27.2 million compared to $25.4 million for H1 2025, an increase of $1.8 million. The increase was driven mainly by higher sales for Elfabrio to Chiesi.
Gilad Mamlok: Thank you, Dror. For Q2 2026, total revenues were $19.9 million compared to $15.7 million in Q2 2025. For H1 2026, total revenues were $53.6 million compared to $25.8 million for H1 2025. For Q2 2026, revenues from selling goods were $19.8 million compared to $15.4 million in Q2 2025, an increase of $4.4 million. For H1 2026, revenues from sending goods were $27.2 million compared to $25.4 million for H1 2025, an increase of $1.8 million. The increase was driven mainly by higher sales for Elfabrio to Chiesi.
Speaker #2: 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, an increase of 4.4 million.
Speaker #2: For the first half of 2026, revenues from selling goods were $27.2 million, compared to $25.4 million for the first half of 2025, an increase of 1.8 million.
Speaker #2: The increase was driven mainly by higher sales of a fabulous to Kiezi. For the remainder of the results, I will report only on the second quarter, and you can refer to this morning's press release for additional year-to-date data.
Gilad Mamlok: For the remainder of the results, I will report only on Q2, and you can refer to this morning's press release for additional year-to-date data. Cost of revenues was $7.8 million compared to $5.9 million in the same period in 2025, an increase of $1.9 million. The increase was mainly attributable to higher sales volumes to Chiesi, partially offset by lower sales to Pfizer. R&D expenses were $4.4 million, down from $6 million in the prior year period, a decrease of $1.6 million. The decrease was mainly driven by a $2.1 million grant recorded under the new R&D law as a reduction of R&D expenses. As of 2026, this grant 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.
Gilad Mamlok: For the remainder of the results, I will report only on Q2, and you can refer to this morning's press release for additional year-to-date data. Cost of revenues was $7.8 million compared to $5.9 million in the same period in 2025, an increase of $1.9 million. The increase was mainly attributable to higher sales volumes to Chiesi, partially offset by lower sales to Pfizer. R&D expenses were $4.4 million, down from $6 million in the prior year period, a decrease of $1.6 million.
Speaker #2: Cost of revenues was $7.8 million, compared to $5.9 million in the same period in 2025, an increase of 1.9 million. The increase was mainly attributable to higher sales volumes to Kiezi and FiorCruz, partially offset by lower sales to Pfizer.
Speaker #2: Average expenses were $4.4 million, down from $6 million in the prior year period, a decrease of 1.6 million. The decrease was mainly driven by a $2.1 million grant recorded under the new R&D law as a reduction of R&D expenses.
Gilad Mamlok: The decrease was mainly driven by a $2.1 million grant recorded under the new R&D law as a reduction of R&D expenses. As of 2026, this grant 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.
Speaker #2: As of 2026, this grant 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.
Speaker #2: SG&A 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.
Gilad Mamlok: SG&A 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 Q2 2025. The change was mainly due to exchange rate fluctuations. Taxes on income were $1.1 million compared to $0.5 million in Q2 2025, an increase 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 Q2 2025. Turning to the balance sheet, cash equivalents, and short-term bank deposits totaled $40.7 million as of 30 June 2026.
Gilad Mamlok: SG&A 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 Q2 2025. The change was mainly due to exchange rate fluctuations. Taxes on income were $1.1 million compared to $0.5 million in Q2 2025, an increase 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 Q2 2025. Turning to the balance sheet, cash equivalents, and short-term bank deposits totaled $40.7 million as of 30 June 2026.
Speaker #2: 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, an increase of 0.6 million.
Speaker #2: 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.
Speaker #2: Turning to the balance sheet, cash, cash equivalents, and short-term bank deposits totaled $40.7 million as of June 30, 2026. We have no extra outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement.
Gilad Mamlok: We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancements. 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 to Dror.
Gilad Mamlok: We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancements. 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 to Dror.
Speaker #2: 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.
Speaker #2: 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 to Dror.
Speaker #2: Thank you, Gilad.
Dror Bashan: Thank you, Gilad. In closing, positive revenue trends keeps us firmly on track to meet our full-year 2026 guidance. We have a strong cash position to maintain our operations and advance our clinical and preclinical 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.
Dror Bashan: Thank you, Gilad. In closing, positive revenue trends keeps us firmly on track to meet our full-year 2026 guidance. We have a strong cash position to maintain our operations and advance our clinical and preclinical 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.
Speaker #3: In closing, positive revenue trends keep us firmly on track to meet our full-year 2026 guidance. We have a strong cash position to maintain our operations and advance our clinical and preclinical assets.
Speaker #3: 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.
Speaker #1: 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.
Dror Bashan: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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. Our first question will come from Ram Selvaraju with H.C. Wainwright.
Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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. Our first question will come from Ram Selvaraju with H.C. Wainwright.
Speaker #1: 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.
Speaker #1: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. For our first question—actually, our first question will come from Raj Haram-Seller Aahu with HC Wainwright.
Speaker #4: Hi, this is Yanzi sitting in for Ram Selvaraju. Thanks for taking my question. I have two. The first is: your presentation highlights E4W without methotrexate, and the E8W with MTX as the two differentiated profiles within release.
Yan Zi: Hi, this is Yan Zi sitting in for Ram Selvaraju. Thanks for taking my question. I have two. The first is, your presentation highlights E4W without 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 III, and could a modest month six responder rate difference be outweighed by eliminating MTX or extending dosing to E8W?
Yan Zi: Hi, this is Yan Zi sitting in for Ram Selvaraju. Thanks for taking my question. I have two. The first is, your presentation highlights E4W without 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 III, and could a modest month six responder rate difference be outweighed by eliminating MTX or extending dosing to E8W?
Speaker #4: 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 dosing to E8W?
Dror Bashan: Can you repeat the question?
Dror Bashan: Can you repeat the question?
Speaker #2: I, by.
Speaker #3: Can you repeat the question?
Speaker #2: Actually, both. I mean, if you manage to, I just see one of the five houses without methotrexate, which can be a huge competitive edge.
Dror Bashan: Actually, both. If we manage to, I just see one of the five pounds is without methotrexate, 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.
Dror Bashan: Actually, both. If we manage to, I just see one of the five pounds is without methotrexate, 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.
Speaker #2: But also, a lower frequency of using the drug is also a big advantage. And we potentially can have both.
Speaker #4: Right. So, okay. So, yeah, I'll repeat the question. It's, I'm Mike. My question is, what totality of evidence will determine which regimen advances to phase 3?
Yan Zi: Right. Okay. I will repeat the question. My question is, what totality of evidence will determine which regimen advances to phase III? Could a modest month 6 responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every 8 weeks?
Yan Zi: Right. Okay. I will repeat the question. My question is, what totality of evidence will determine which regimen advances to phase III? Could a modest month six responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every eight weeks?
Speaker #4: And could a modest, month 6 responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every 8 weeks?
Speaker #3: So, you know, we, we are running now the multi the multiple dose study, the, the phase 2. We would have to see the outcomes and, and by the outcome, we can decide which with which regiment we continue.
Dror Bashan: We are running now the multiple dose studies in the phase II. We will have to see the outcome, and by the outcome, we can decide with which regimens we continue. It is difficult to tell you today. Under what we have from the mechanism of action and the data from the phase I 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 am not speaking about the placebo, could be met. Which one will be met better? We have to consider there is an immunogenicity aspect. There is the IRR aspect. It is not just the frequencies. But let us say under the assumption immunogenicity is good or low or whatever the definition is, and with a pretty low IRR, then it is only about the frequency and/or with or without methotrexate.
Dror Bashan: We are running now the multiple dose studies in the phase II. We will have to see the outcome, and by the outcome, we can decide with which regimens we continue. It is difficult to tell you today. Under what we have from the mechanism of action and the data from the phase I 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 am not speaking about the placebo, could be met.
Speaker #3: It's difficult to tell you today. I mean, under what we have from the mechanism of action and the data from the phase 1 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 of I'm not speaking about the placebo could be met.
Speaker #3: Which one will be met better? You know, we have to consider there is an immunogenicity aspect, and there is the IRR aspect. So it's not just the frequencies.
Dror Bashan: Which one will be met better? We have to consider there is an immunogenicity aspect. There is the IRR aspect. It is not just the frequencies. But let us say under the assumption immunogenicity is good or low or whatever the definition is, and with a pretty low IRR, then it is only about the frequency and/or with or without methotrexate.
Speaker #3: But let's say under the assumption immunogenicity is, is good or low or whatever the definition is, and with a, a pretty low IRR, and then it's only about the frequency and/or with or without methotrexate.
Speaker #3: We will have to see.
Dror Bashan: We have to see.
Dror Bashan: We have to see.
Speaker #4: Got it. Understood. The other question I have is regarding the 10-K, which reports that approximately, you know, about 50% of Phase 1 subjects have developed ADAs.
Yan Zi: Got it. Understood. The other question I have is relating to the 10-K, which reports approximately about 50% of phase I subjects who have developed ADAs, and that comes with lower instance at higher doses. My question is, how did the combined PK/PD and immunogenicity data support selecting that fixed 36 milligram dose? What ADA profile and RELEASE would support every four-week dosing without methotrexate?
Yan Zi: Got it. Understood. The other question I have is relating to the 10-K, which reports approximately about 50% of phase I subjects who have developed ADAs, and that comes with lower instance at higher doses. My question is, how did the combined PK/PD and immunogenicity data support selecting that fixed 36 milligram dose? What ADA profile and RELEASE would support every four-week dosing without methotrexate?
Speaker #4: 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 milligram dose?
Speaker #4: And, what ADA profile and release would support every 4-week dosing without methotrexate?
Speaker #3: So, you know, we will, but in Phase 2, we will have the, I would say, the ADA against the PEG, against the enzyme. So we'll have, I think, a clearer picture of the different ADAs and how, and what are the outcomes, of course.
Dror Bashan: In phase II, we will have, I would say, the ADA against the PEG, against the enzyme. We will have, I think, a clearer picture of the different ADAs and what are the outcomes, of course, per the different arms. Then we will see where we are. Do not forget that phase II is the multiple dose. Phase I was a singular ascending dose. We chose the 36 milligram, according to, one, the PK/PD, if I may say, of course. Also under the assumption that this specific, I would say, regimen could beat the highest or the more, I would say, convenient. By the way, for the patients, if I may say, both the once in four weeks without methotrexate and the once in eight weeks with methotrexate, which let us call them like the highest outcomes if possible.
Dror Bashan: In phase II, we will have, I would say, the ADA against the PEG, against the enzyme. We will have, I think, a clearer picture of the different ADAs and what are the outcomes, of course, per the different arms. Then we will see where we are. Do not forget that phase II is the multiple dose. Phase I was a singular ascending dose. We chose the 36 milligram, according to, one, the PK/PD, if I may say, of course. Also under the assumption that this specific, I would say, regimen could beat the highest or the more, I would say, convenient. By the way, for the patients, if I may say, both the once in four weeks without methotrexate and the once in eight weeks with methotrexate, which let us call them like the highest outcomes if possible.
Speaker #3: Here are the different arms. so, you ou know, then, then we will see where we are. Don't forget the phase 2 is the multiple dose.
Speaker #3: Phase, phase 1 was a single ascending dose. we chose the 36 milligram, according to, one, the, I would say, the, the PK, PD, if I may say, of course.
Speaker #3: and also, under the assumption that this specific, I would say, regiment, could, could beat the highest or the more, I would say, convenient, and by the way, from for the patients, if I may say, both the ones in 4 weeks without methotrexate and the ones in 8 weeks with methotrexate, which let's call them like the, the highest outcomes if possible.
Yan Zi: Got it. Thank you so much for taking my questions.
Yan Zi: Got it. Thank you so much for taking my questions.
Speaker #4: Got it. Thank you so much for taking my questions.
Dror Bashan: Of course. Thank you.
Dror Bashan: Of course. Thank you.
Speaker #3: Of course. Thank you.
Speaker #1: And our next question will come from John Vandermosten with a ZAXSCR.
Dror Bashan: Our next question will come from John Vandermosten with the Zacks SCR.
Operator: Our next question will come from John Vandermosten with the Zacks SCR.
Speaker #5: Great. nice to hear from you guys, Dror, Gilad. And congratulations on, El Fabrio's patent term extension and the approval in South Korea. Things are going pretty good for that product.
John Vandermosten: Great. Nice to hear from you guys, Dror, Gilad, and congratulations on Elfabrio'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 Elfabrio. I am wondering, is there any benefit to having lumpy purchases? Because we had a nice increase this quarter, and I am wondering, is that due perhaps to the new approvals in certain geographies, or is there some other reason in terms of product runs or some other reason why it makes sense to have lumpy rather than steady purchases of Elfabrio?
John Vandermosten: Great. Nice to hear from you guys, Dror, Gilad, and congratulations on Elfabrio'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 Elfabrio. I am wondering, is there any benefit to having lumpy purchases? Because we had a nice increase this quarter, and I am wondering, is that due perhaps to the new approvals in certain geographies, or is there some other reason in terms of product runs or some other reason why it makes sense to have lumpy rather than steady purchases of Elfabrio?
Speaker #5: I want to start out with a, a question on, on just, the, the trend in, in purchases of, El Fabrio. I, I, I'm wondering, is there any benefit to having lumpy purchases?
Speaker #5: you know, because we had a nice, nice increase this quarter. And I'm wondering, you know, per is that due perhaps to the new approvals and certain geographies?
Speaker #5: 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?
Dror Bashan: 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.
Dror Bashan: 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.
Speaker #3: John, good morning, and thank you. as we always say, you know, one quarter we, we prefer to look at the picture always year-to-date. we did have a nice quarter from, Kiezi, which reflects also their, their growth of the business, but mainly reflects their, inventory management.
Speaker #5: Okay. So there's no—I mean, there's no rationale behind why they wouldn't make it smooth rather than lumpy? Okay. Gotcha. Gotcha.
John Vandermosten: Okay. So there's no rationale behind why they wouldn't make it smooth rather than lumpy?
John Vandermosten: Okay. So there's no rationale behind why they wouldn't make it smooth rather than lumpy?
Dror Bashan: John, this is-
Dror Bashan: John, this is-
John Vandermosten: Okay. All right. Got you.
John Vandermosten: Okay. All right. Got you.
Speaker #3: okay. Oh, this is not a fair definition, I would say. They operate with a lot of, sense and logic, of course, and they are responsible for what they are doing.
Dror Bashan: This is not a fair definition, I would say. They operate with a lot of sense and logic, of course, and they are responsible for what they are doing. They see the demand. They know how much they sit on certain amount of inventories globally or per continent. Of course, there are manufacturing plants vis-à-vis other programs that are marketing. It's a big company. 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.
Dror Bashan: This is not a fair definition, I would say. They operate with a lot of sense and logic, of course, and they are responsible for what they are doing. They see the demand. They know how much they sit on certain amount of inventories globally or per continent. Of course, there are manufacturing plants vis-à-vis other programs that are marketing. It's a big company. 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.
Speaker #3: They have their own, they see the demand. They know how much they sit on, a certain amount of inventories globally or per continent. And of course, they have many manufacturing plants vis-à-vis other programs that are marketing.
Speaker #3: It's a big company, so only, only known, this is how it was decided and applied. And, of course, to make sure we sit on enough stocks, both DS and DP.
Speaker #5: Okay. 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.
John Vandermosten: Okay. Jumping to PRX-115, I believe you have 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 where are you right now? How much can you tell me? How many more do you think might be opening in the future so far in 2026?
John Vandermosten: Okay. Jumping to PRX-115, I believe you have 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 where are you right now? How much can you tell me? How many more do you think might be opening in the future so far in 2026?
Speaker #5: compared to previous or earlier in the year, how has that going in terms of site activation and, you know, how kind of where are you right now?
Speaker #5: How much can you tell me? And then, you know, how many more do you think might be opening? in, in the future? so far in 2026.
Speaker #3: We—actually, maybe one site is missing. That's it. And at present, we expect to finalize enrollment within the next five months.
Dror Bashan: We have actually, maybe one site is missing. That is it. We, as present, we expect to finalize enrollment within the next 5 months, I mean, by year end, as we planned. We have to see if things indeed will go this way. So far, so good. Knock on wood. That is it.
Dror Bashan: We have actually, maybe one site is missing. That is it. We, as present, we expect to finalize enrollment within the next five months, I mean, by year end, as we planned. We have to see if things indeed will go this way. So far, so good. Knock on wood. That is it.
Speaker #3: I mean, by year-end, as we planned. we'll have to see if things in this indeed will go this way. So far, so good. Knock on wood.
Speaker #3: that's it. Nothing, but fine. It's, it's I think overall, except one site that maybe is missing, we are actually signed on, on whatever we plan to, of course.
John Vandermosten: Okay.
John Vandermosten: Okay.
Dror Bashan: Nothing to define. I think overall, except one site that maybe is missing, we are actually signed on whatever we planned to, of course.
Dror Bashan: Nothing to define. I think overall, except one site that maybe is missing, we are actually signed on whatever we planned to, of course.
Speaker #5: And, last question is on, kind of a, a bigger picture, question on Amgenda. They raised price pretty significantly this year. First quarter and second quarter saw 20-plus percent price increases on Krystexa.
John Vandermosten: Last question is on kind of a bigger picture question on Amgen Inc. They raised price pretty significantly this year. Q1 and Q2 saw 20%+ price increases on KRYSTEXXA. I am wondering, what does that tell you about the market? Does it make it look more attractive? I am not sure of the details. Perhaps it was payer mix or something like that. I did not get into that, but I am just wondering if you had any thoughts on what that dramatic price increase means for the space.
John Vandermosten: Last question is on kind of a bigger picture question on Amgen Inc. They raised price pretty significantly this year. Q1 and Q2 saw 20%+ price increases on KRYSTEXXA. I am wondering, what does that tell you about the market? Does it make it look more attractive? I am not sure of the details. Perhaps it was payer mix or something like that. I did not get into that, but I am just wondering if you had any thoughts on what that dramatic price increase means for the space.
Speaker #5: And I'm wondering, you know, what does that tell you about the market? Does it make it look more attractive? You know, I'm not sure of the details.
Speaker #5: Perhaps it was a, you know, payer mix or something like that. I didn't get into that, but I just wondering, if you if you had any thoughts on what that dramatic price increase means for the space.
Speaker #3: Well, I—I don't have any insights on that. And I don't know how you get it from what they say, or if you get it from calculating sales to estimate the number of patients, or—
Dror Bashan: I don't have any insights on that, and I don't know. You get it from what they say, or you get it from calculating sales to estimate the number of patients or
Dror Bashan: I don't have any insights on that, and I don't know. You get it from what they say, or you get it from calculating sales to estimate the number of patients or
John Vandermosten: It was in their press release, their Q2 press release. They said 23% increase in pricing, even the volumes were down. They didn't go into it, but my thought was the market will accept a higher price, which may make it look more attractive for you guys for PRX-115. Just wanted to see if that had any impact on your thoughts for this product and the pathway forward.
John Vandermosten: It was in their press release, their Q2 press release. They said 23% increase in pricing, even the volumes were down. They didn't go into it, but my thought was the market will accept a higher price, which may make it look more attractive for you guys for PRX-115. Just wanted to see if that had any impact on your thoughts for this product and the pathway forward.
Speaker #5: Oh, it was in it was in their press release their second quarter press release. They said 23% increase in, in pricing, even the volumes were down.
Speaker #5: And I, I, I they didn't go into it, but I mean, my, my thought was, you know, there's, there's the, the market will accept a higher price, which may make it look more attractive, for you guys for 115.
Speaker #5: So, you know, just wanted to see, see if that had any impact on your thoughts. For, you know, this product in the, in the pathway forward.
Dror Bashan: The revenues keep growing. It was $1.3 billion in 2025. We see now the trend going to $1.6 billion, so it's very encouraging for PRX-115 as well, as you said.
Dror Bashan: The revenues keep growing. It was $1.3 billion in 2025. We see now the trend going to $1.6 billion, so it's very encouraging for PRX-115 as well, as you said.
Speaker #3: The re you know, 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.
Speaker #5: Exactly. Okay, well, great. I appreciate your time, and thanks for taking my questions.
John Vandermosten: Exactly. Well, great. I appreciate you guys' time, and thanks for taking my questions.
John Vandermosten: Exactly. Well, great. I appreciate you guys' time, and thanks for taking my questions.
Speaker #3: Thank you. Thank you.
Dror Bashan: Thank you.
Dror Bashan: Thank you.
Speaker #1: And this now concludes our question and answer session. I would like to turn the floor back over to Dror Bashan for closing comments.
Dror Bashan: And this now concludes our question and answer session. I would like to turn the floor back over to Dror Bashan for closing comments.
Operator: And this now concludes our question and answer session. I would like to turn the floor back over to Dror Bashan for closing comments.
Speaker #3: Thank you. So, I just wanted to thank everybody that joined our call, and we look forward to reporting on our Q3 results as well.
Dror Bashan: Thank you. I just want to thank everybody that joined our call, and we look forward to reporting on our Q3 results as well. I think overall, we have a good, strong cash position to maintain our operations and advance our clinical and preclinical assets. Again, we are confident in the momentum behind our business and about the opportunities ahead. Thank you very much.
Dror Bashan: Thank you. I just want to thank everybody that joined our call, and we look forward to reporting on our Q3 results as well. I think overall, we have a good, strong cash position to maintain our operations and advance our clinical and preclinical assets. Again, we are confident in the momentum behind our business and about the opportunities ahead. Thank you very much.
Speaker #3: I think overall, we have a good, strong cash position to maintain our operations and advance our clinical and pregnant assets. And again, we are confident in the momentum behind our business and about the opportunities ahead.
Speaker #3: So thank you very much.
Speaker #1: Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.
Dror Bashan: Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.
Operator: Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.
